H Lundbeck A/S v Alphapharm Pty Ltd - [2009] FCAFC 70 - FCAFC 2009 case summary — Zoe

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H Lundbeck A/S v Alphapharm Pty Ltd

[2009] FCAFC 70

Federal Court of Australia (Full Court)|2009-07-01|Before: Middleton JJ

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Court

Federal Court of Australia (Full Court)

Decision date

2009-07-01

Before

Middleton JJ

Source

Original judgment source is linked above.

Judgment (64 paragraphs)

[1]

INTRODUCTION 1 These appeals and cross appeals, which were heard together, relate to Australian Patent Number 623144 (the Patent). They are concerned with the validity of certain Claims of the Patent, with alleged infringement of another of the Claims of the Patent and with the validity of an extension of the term of the Patent. 2 The Patent was granted to H. Lundbeck A/S (Lundbeck), a Danish pharmaceutical company, pursuant to an application dated 13 June 1989. The application was a Convention application based on an application for a patent made in the United Kingdom on 14 June 1988. The title of the Patent is: (+)-Enantiomer of Citalopram and process for the preparation thereof. Citalopram, which is the subject of Australian Patent Number 509445 (the Citalopram Patent), is used for the treatment of depression. Lundbeck is the holder of the Citalopram Patent. Citalopram is a chiral molecule, being a molecule that can exist in two isomeric forms, each of which is the mirror image of the other but is not superimposable on the other. The non-superimposable mirror images are called enantiomers. Citalopram is a racemic mixture, or racemate, comprising the two enantiomers in equal parts. 3 Enantiomers are designated either (+) or (-) according to their effect on the rotation of plane-polarised light. Enantiomers are also designated R or S according to their three dimensional structure. There is no correlation between the (+) or (-) designation, on the one hand, and the R or S designation, on the other. Which of the (+)-enantiomer or the (-)-enantiomer is the R-enantiomer or S-enantiomer can only be determined through empirical observation and experimentation, after the (+)-enantiomer and the (-)-enantiomer have been obtained by resolution of the racemate. 4 Observation and experimentation after the priority date of the Patent has established that the (+)-enantiomer of the Patent is in fact the S-enantiomer. That enantiomer is commonly referred to as S‑citalopram or Escitalopram, which is the subject of the Patent. The Patent discloses that Escitalopram is therapeutically more active than Citalopram. It also discloses that Escitalopram, the (+)-enantiomer, is one hundred times more active than the (-)-enantiomer. 5 The term of the Patent was due to expire on 13 June 2009. However, the term was extended pursuant to Part 3 of Chapter 6 of the Patents Act 1990 (Cth) (the 1990 Act), which deals with the extension of the term of patents relating to pharmaceutical substances. Escitalopram is a pharmaceutical substance within the meaning of Part 3 of Chapter 6.

[2]

THE PROCEEDINGS 6 The appeals and cross-appeals arise out of three separate proceedings commenced in the Court. Those three proceedings, together with a fourth proceeding, were heard together by a judge of the Court, who made orders in the proceedings on 19 June 2008. There are appeals and cross appeals in relation to the orders made in three of the proceedings. There is no appeal from the orders made in the fourth proceeding and it is not necessary to refer further to that proceeding. 7 In the first relevant proceeding, NSD 1120 of 2005 (the Alphapharm Proceeding), Alphapharm Pty Ltd (Alphapharm) sought revocation of the Patent. In addition, Alphapharm claimed an order pursuant to s 192 of the 1990 Act that the Register of Patents be rectified to remove the record of the extension of the term of the Patent. Lundbeck and the exclusive licensee of the Patent in Australia, Lundbeck Australia Pty Ltd (Lundbeck Australia), filed a cross-claim against Alphapharm asserting infringement of the Patent by Alphapharm and seeking orders restraining further infringement. 8 In the Alphapharm Proceeding, the primary judge made substantive orders to the following effect: (1) Alphapharm has infringed Claims 1, 3 and 6 of the Patent. (2) Alphapharm be permanently restrained from exploiting the Patent. (3) The District Registrar of the Court issue a certificate, certifying that the validity of each of Claims 1, 2, 3, 4 and 6 of the Patent was questioned. (4) Claim 5 of the Patent is invalid. (5) Claim 5 of the Patent be revoked. (6) The Register of Patents be rectified by removing the extension of the term of the Patent. 9 By an amended notice of appeal, Lundbeck and Lundbeck Australia (together the Lundbeck Companies) appeal from orders (4), (5) and (6). By its notice of cross-appeal, Alphapharm appeals from orders (1), (2) and (3). Other ancillary orders were made and are the subject of the appeal but it is not necessary to deal with them at this stage. 10 In the second relevant proceeding, NSD 954 of 2006 (the Arrow Proceeding), Arrow Pharmaceuticals Pty Ltd (Arrow) also sought revocation of the Patent and an order that the Register of Patents be rectified to remove the record of the extension of the term of the Patent. The primary judge made orders in the Arrow Proceeding to the same effect as Orders (3), (4), (5) and (6) in the Alphapharm Proceeding. By an amended notice of appeal, Lundbeck appeals from the orders that Claim 5 of the Patent is invalid and be revoked and that the Register of Patents be rectified to remove the extension of the term of the Patent. By its notice of cross-appeal, Arrow appeals from the order concerning the validity of Claims 1, 2, 3, 4 and 5 of the Patent. 11 An extension of the term of the Patent was granted on 27 May 2004, no one having opposed the grant. However, Alphapharm subsequently wrote to the Commissioner of Patents (the Commissioner) asserting that the Commissioner had been misled and, on 13 July 2005, the Commissioner stated that she considered that she was obliged to amend the entry in the Register as to the date of the expiry of the term of the Patent from 13 June 2014 to 9 December 2012. On 19 May 2006, the Commissioner, by her delegate, Dr S.D. Barker, made a decision directing that the entry in the Register of Patents in respect of the Patent be amended by alteration of the expiry of the extension to 9 December 2012. 12 In the third relevant proceeding, NSD 1078 of 2006 (the Extension Proceeding), Lundbeck appealed from part of the delegate's decision. Lundbeck's notice of appeal in the Extension Proceeding joined the Commissioner as a respondent. Alphapharm was subsequently joined as a respondent in the Extension Proceeding. The primary judge made orders in the Extension Proceeding that the Commissioner correct the Register of Patents by removing from it the extension of the term of the Patent. By an amended notice of appeal, the Lundbeck Companies appeal from that order. 13 The primary judge also made costs orders in all of the proceedings. Lundbeck appeals from the costs orders made in the Alphapharm Proceeding and in the Arrow Proceeding, whether or not it succeeds in the substantive appeals and cross-appeals to which reference has already been made. Clearly, if the substantive orders are varied on appeal, the costs orders may also require variation. The parties have asked the Court to make no orders concerning the costs of the proceedings at first instance or of the appeals and cross-appeals until the Court has published its conclusions on the substantive questions in the appeals. 14 The effect of the orders made by the primary judge concerning the extension of the term of the Patent is that the Patent will now expire on 13 June 2009, the date that is 20 years after the date of the application for the Patent. Accordingly, the parties have urged the Court to publish its conclusions prior to that date.

[10]

Atoms and molecules 21 Organic chemistry is a specialised branch of chemistry dedicated to the study of molecules that contain carbon atoms. Atoms are the building blocks of all matter. They are composed of three types of particles: protons, which carry a positive (+1) charge; neutrons, which carry no charge; and electrons, which carry a negative (-1) charge. Protons and neutrons are held together by very strong forces and constitute the "nucleus" of an atom. Electrons orbit the nucleus at different levels. 22 The chemical elements, such as carbon, hydrogen and oxygen, are particular types of atoms. Each element has a unique number of protons, which, if the element is uncharged, is equal to its number of electrons. Some elements have a more stable number of electrons than other elements. Stability is achieved by filling orbitals known as electron shells. The first electron shell requires two electrons. The second and third each require eight electrons. The greatest stability is reached when the outermost electron shell for the particular element is full. Elements interact with each other in order to achieve a stable number of electrons either by gaining, losing or sharing electrons. 23 Molecules are combinations of atoms. They are described by molecular formulae, which utilise chemical symbols for each element followed by numeric subscripts for the number of atoms of that element in the molecule. For example, a molecule of water is shown as H2O to signify that the molecule comprises two atoms of hydrogen (H) and one of oxygen (O). Citalopram consists of the elements hydrogen, oxygen, carbon (C), fluorine (F) and nitrogen (N). In complicated molecules, groups of atoms with a specific function are called functional groups. An example in this case is the hydroxyl group (OH). 24 Atoms are held together in molecules by electron sharing, in a process called covalent bonding. A covalent bond refers to the sharing of two electrons between two atoms, so that both electrons fall within the outer shell of each atom. Most elements need to share a certain number of electrons to be stable. For example, in order to achieve stability, hydrogen, which has one electron and needs to fill the first electron shell (which has a capacity of two electrons), forms one covalent bond. Carbon, which has six electrons and needs to fill both the first electron shell and the second electron shell (which has a capacity of eight electrons), forms four covalent bonds. Chlorine (Cl), which has seventeen electrons and needs to fill the first, second and third electron shells, forms one covalent bond. When an atom of hydrogen reacts with an atom of chlorine, they share one electron with each other to make a covalent bond. Once that happens, both atoms have a stable number of electrons and a molecule of hydrogen chloride is the result. Pictorially, a hydrogen chloride molecule (HCl) is represented by a line joining the two atoms to indicate a covalent bond (H-Cl). 25 Stereochemistry is the study of the three-dimensional structure of molecules. A molecular formula generally conveys little about how the constituent atoms are physically arranged with respect to each other. Structural formulae have been developed to convey two-dimensional (2D) and, where appropriate, three-dimensional (3D) arrangements of atoms within a given molecule. 26 Diagram I below shows several ways of representing the molecule methane. Within that diagram, Drawing 1 is the molecular formula. Drawing 2 is a 2D structural formula that shows the connectivity of the atoms, but not their orientation in space. Drawing 3 is a projection drawing showing the 3D spatial arrangement of the atoms. The solid wedge indicates that the hydrogen atom at the lower right is coming directly out of the plane of the paper, whereas the broken or hashed wedge shows that the hydrogen atom to the right lies behind the plane of the paper. Straight lines show bonds in the plane of the paper. Diagram I - Various formulaic representations of methane

[11]

Isomers and enantiomers 27 Molecules with the same molecular formulae but different connections or different spatial arrangements between atoms are called isomers. Structural isomers differ in the way in which the atoms are connected together. In the case of stereoisomers, the atoms are connected in the same way, but the atoms are arranged differently in space. Stereoisomers behave similarly in many chemical reactions. However, in some chemical reactions, they behave quite differently. This is particularly the case when stereoisomers interact with molecules within living organisms, such as enzymes within the human central nervous system. 28 There are two types of stereoisomers: enantiomers and diastereoisomers. Enantiomers are non-superimposable mirror images of each other, much like a person's left hand and right hand. Diastereoisomers are not mirror images of each other and have different physical and chemical properties. Objects that have a non-superimposable mirror image, such as human hands, are chiral. A chiral molecule can exist in two isomeric forms, each of which is the mirror image of the other; that it to say, neither is superimposable on the other. An achiral molecule lacks that feature: its isomeric forms are superimposable on one another. In organic chemistry, a molecule that contains a carbon atom bonded to four different atoms or functional groups is chiral. For example, the molecule bromochlorofluoromethane is chiral because it has bromine (Br), chlorine, fluorine and hydrogen atoms attached to the central carbon atom. In Diagram II below, Drawing 4 shows the 2D structure of bromochlorofluoromethane and Drawings 5 and 6 show the 3D structures of the two enantiomers. Diagram II - 2D structure (4) and two enantiomers (5 and 6) of bromochlorofluoromethane 29 It is common ground that, in 1988, an ordinary skilled but non-inventive chemist, being given a 2D structural formula with a single chiral centre (such as Drawing 4) would recognise the presence of two enantiomers (Drawings 5 and 6). The 2D structural formula would represent either a single enantiomer or, if the molecule was part of a mixture, the two enantiomers in either equal or unequal parts. It is also common ground that, if that chemist was also given some background to the origin of the molecule or mixture, the chemist would be able to determine which of those situations applied. That is because of what was known about how enantiomers are produced. 30 Generally speaking, chiral molecules exist in nature only as one enantiomer. However, when chiral molecules are synthesised in a laboratory, there is a 50% probability that either enantiomer will be produced, such that the two enantiomers are produced in equal parts. The resultant mixture is known as a racemate or racemic mixture. It may be a solid, liquid or gas. To obtain an unequal mixture of the enantiomers, or a single enantiomer, some specific step must be taken in the synthesis (enantio-selective synthesis).

[12]

Labelling enantiomers as (+) or (-) and as R or S 31 There are two conventions for describing enantiomers. The first depends on the physical property of optical activity. Enantiomers rotate plane-polarised light in opposite directions. Enantiomers are designated (+) (dextrorotatory) or (-) (levorotatory) on the basis of whether, in solution, they rotate plane-polarised light clockwise (to the right) or anti-clockwise (to the left), respectively. Because enantiomers rotate plane-polarised light in opposite directions to equal extents, a racemate has no net rotation of plane-polarised light. It is optically inactive. 32 The second way of describing enantiomers is an abstract theoretical description (as distinct from requiring physical testing) and provides an absolute configuration. Enantiomers are designated R or S on the basis of the direction of rotation when the molecule is abstractly positioned according to certain standard rules, known as the Cahn Ingold Prelog rules (CIP Rules). The CIP Rules are based on the atomic number of each atom or functional group connected to the chiral centre. The atomic number of an atom is determined by the number of protons in the atom. 33 First, each atom or functional group is labelled 1 to 4, with 1 indicating the highest atomic number and 4 indicating the lowest atomic number. Second, the molecule is visualised, so that the atom or group labelled 1 (and so having the highest atomic number) is directed into the page. Third, a curved arrow is drawn from the 1 position to the 2 position and then to the 3 position, and from the 3 position to the 4 position. If the arrow points clockwise, the configuration is designated R (Latin: rectus, right); if it points anticlockwise, the configuration is designated S (Latin: sinister, left). Diagram III below shows the two enantiomers of bromochlorofluoromethane, reoriented so that the atom with the lowest atomic number, H, is facing away from the page. The enantiomers are designated R and S based on the descending priority of the other three elements. Diagram III - 3D structure and R and S designations of two enantiomers (7 and 8) of bromochlorofluoromethane 34 It is common ground that, in 1988, an ordinary skilled but non-inventive chemist, being given a 2D structural formula with a single chiral centre, could, by applying the CIP Rules, have drawn the absolute configuration of each of the two enantiomers, R and S.

[16]

The Specification also states that the present invention relates to the use of those enantiomers as antidepressant compounds as well as the possible use in geriatrics or in the cure of obesity or alcoholism. The use of the plural may be significant. 40 The Specification then goes on to state that the invention also includes pharmaceutically acceptable salts of the enantiomers of the compound in Formula 1 (Compound I) formed with non-toxic, organic or inorganic salts. Such salts are easily prepared by methods known to the art. Again, the use of the plural may be significant. 41 Next, the Specification states that the invention is also concerned with a method to resolve the racemate of Compound I into the individual isomers. It states that Citalopram has proven to be an efficient antidepressant compound in man and that all work in the development of that compound has been made with the racemate. It states that Citalopram has been shown pharmacologically to be a very selective inhibitor of 5-HT reuptake and that previous attempts to crystallise diastereoisomeric salts of Citalopram enantiomers had failed. 42 The Specification then says that, surprisingly, it has now proven possible to resolve a specified compound (Compound II) into its enantiomers and finally, in a stereoselective way, to convert those enantiomers to the corresponding Citalopram enantiomers. The Specification states that, likewise, monoesters of Compound II, formed by optically active carboxylic acids, could be separated into the corresponding diastereoisomers and subsequently converted directly into Citalopram enantiomers in a stereoselective ringclosure reaction. It states that the intermediate diol, Compound II, has been disclosed in a US patent as a racemic mixture. The Specification then sets out the following formula (Formula II) for Compound II: The Specification states that the enantiomers of Compound II, as well as monoesters, fall within the scope of the claimed invention. Once again, the use of the plural may be significant. The Specification then states that it was shown, to the surprise of the inventors, that almost the entire 5-HT uptake inhibition resided in the (+)-Citalopram enantiomer. 43 Next, the Specification states that the claimed invention also includes a new method of synthesising Compound I from Compound II by esterification of the primary alcohol group into a labile ester, which, in the presence of a base, undergoes spontaneous ringclosure to Citalopram or, if enantiomerically pure Compound II is esterified, the corresponding Citalopram enantiomer is produced with full conservation of stereo configuration. 44 After setting out details of various reactions and examples of resolution and the testing of enantiomers so produced, the Specification sets out the Claims as follows: 1. (+)-1-(3-dimethylaminopropyl)-1-(4'-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile and non-toxic acid addition salts thereof. 2. The pamoic acid salt of (+)-1-(3-dimethylaminopropyl)-1-(4'-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile. 3. A pharmaceutical composition in unit dosage form comprising as an active ingredient, a compound as defined in claim 1, together with a pharmaceutically accepta[ble] carrier or excipient. 4. A pharmaceutical composition in unit dosage form comprising, as an active ingredient, the compound of claim 2, together with a pharmaceutically acceptable carrier or excipient. 5. A pharmaceutical composition in unit dosage form, according to claim 3 or 4, wherein the active ingredient is present in an amount from 0.1 to 100 milligram per unit dose, together with a pharmaceutically acceptable carrier or excipient. 6. A method for the preparation of the compound of claim 1, which comprises: (a) reacting a compound of the formula with an enantiomerically pure acid derivative as an acid chloride, anhydride or labile ester, subsequently separating the resolved intermediate enantiomer for (+)-citalopram having the formula wherein R is a labile ester group; by HPLC or fractional crystallization, and then treating said intermediate enantiomer with strong base: or (b) reacting a compound of formula II with the enantiomer of an optically active acid affording the pure enantiomer salt of the compound of formula II for (+)-citalopram, and subsequently performing ringclosure via a labile ester by reacting the pure enantiomer of formula II as a base with an activated acid with simultaneous addition of a base and, if desired, transferring the (+)-citalopram obtained to a pharmaceutically acceptable salt thereof. 45 It is apparent that Claims 1 to 5 are product or substance claims. Claim 6 is a method or process claim.

[17]

CONSTRUCTION OF THE PATENT 46 The symbol (+), which appears in Claim 1, indicates the particular enantiomer that is distinguished by the property of rotating plane-polarised light to the right. The property of rotating plane-polarised light to the right or to the left distinguishes one enantiomer from the other and distinguishes each enantiomer from the racemate. That property is able to be detected only when the relevant enantiomer is present other than as a part of the racemate because, when in a racemic mixture, the polarisation of light by each enantiomer is cancelled out by the polarisation by the other enantiomer. No net polarisation of light is therefore exhibited. 47 The primary judge concluded that the skilled addressee as at the priority date of Claim 1 would have understood Claim 1 to refer specifically to the (+)-enantiomer and not to either the (-)-enantiomer or to the racemic mixture of the two enantiomers. His Honour considered that such a skilled addressee, in the absence of any context suggesting the contrary, would not have understood Claim 1 to refer to the (+)-enantiomer merely as part of the racemic mixture consisting of equal parts of the (-)-enantiomer as well as the (+)-enantiomer. His Honour found that such a skilled addressee would have understood Claim 1 to refer to the (+)-enantiomer as something that had an existence independent of the racemic mixture. 48 The primary judge accepted that it was part of common general knowledge as at the priority date of Claim 1 that: · Racemates contained in equal parts the (+)-enantiomer and the (-)-enantiomer. · The enantiomers of a racemate are potentially separable and it was possible that an enantiomer might have a stable existence as a compound separate from being part of the racemate. · Some racemates had in fact been resolved into their separate enantiomers. · Racemates were commonly represented by the symbol (+/-) to indicate the presence of both enantiomers. 49 The primary judge accepted that the (+)-enantiomer of the Citalopram compound exists when it is part of the racemate. However, his Honour considered that the relevant skilled addressee would have understood that the (+)-enantiomer exists whether or not it is a part of the racemate, and that the purpose of the (+) symbol is only to distinguish it from the (-)-enantiomer and from its being merely part of the racemate (+/-) or of some other mixture. His Honour concluded that the (+) symbol or the (-) symbol, devoid of any context suggesting the contrary, implies distinctness from the racemate. His Honour concluded, accordingly, that the reference to the (+)-enantiomer in Claim 1 refers to something different from the (+)-enantiomer as an indistinguishable part of the unresolved racemate. 50 His Honour considered that, when the (+)-enantiomer of Citalopram is present only as 50% of a racemic mixture, it does not meet the description in Claim 1. However, his Honour accepted that, in the absence of anything further, the question of how much impurity would prevent a compound from meeting the description in Claim 1 is not specified in Claim 1 or the Specification. Nevertheless, his Honour concluded that a convention as to the way in which chemists understand references to compounds would answer that question. His Honour concluded that, according to that convention, the reference in Claim 1 denotes material of at least 95% enantiomeric purity. 51 As indicated above, Alphapharm and Arrow dispute the construction of Claim 1 propounded by Lundbeck and accepted by the primary judge. The question of construction is whether Claim 1 refers only to the (+)-enantiomer in an isolated form and not to the (+)-enantiomer in a mixture, such as would be found in the racemate. 52 The primary judge summarised the approach that he took to the construction question as follows: · The construction of a specification is a question of law and is a matter for the Court, although the Court must construe a specification as it would be understood by the notional skilled addressee as at the relevant date. Evidence from a skilled addressee in the field of the invention as to how he or she would have understood the specification at the relevant date is admissible evidence. · The claims of a specification must be construed in the context of the complete specification as a whole: the rest of the specification may explain the background to the claims, assist in ascertaining the meaning of technical terms or aid in the resolving of ambiguities in the construction of the claims. · A specification must be given a purposive rather than a purely literal construction and must be construed in a practical commonsense manner, avoiding a too technical or narrow construction in favour of a construction under which the invention will work, as against one according to which it may not work. · The hypothetical addressee of a patent is the non-inventive person, with the common general knowledge of a person, skilled in the relevant art at the priority date. · The words used in the specification and the claims of a patent are to be given the meanings that that skilled addressee would give them, both in the light of his or her own general knowledge and what is disclosed in the body of the specification. 53 While the last proposition is correct, and evidence as to how the hypothetical addressee would have understood a specification at the relevant date may strictly be admissible, the underlying principle is that contained in the first proposition stated above, namely, that the construction of a specification, including the claims, is a question of law for the Court. However, the Court may be informed, for example, as to the way in which particular terms were, as a general rule, used by relevant addressee at the relevant time or what the use of a particular term or expression disclosed or conveyed to a relevant addressee at the relevant time, so long as it is shown that an understanding different from the ordinary usage of English was generally accepted by relevant addressees. 54 In that regard, there should be no difference in the approach to the construction of a patent from the approach to the construction of any other commercial instrument. That is to say, neither a patent nor any other commercial instrument should be construed in a vacuum but must be construed in the context in which the patent or instrument is being considered. Thus, the claims and specification of a patent must be construed in the way in which they would be understood by the relevant addressee. In the same way, a commercial instrument would be construed in the light of facts that might reasonably be expected to be known to the parties to the commercial instrument. 55 The primary judge held that the (+) in Claim 1 indicated the particular enantiomer that is distinguished by the feature of rotating plane-polarised light to the right, namely clockwise, which distinguishes that enantiomer from the other enantiomer, which has the property of rotating plain polarised light to the left, namely anti-clockwise. That property is able to be detected only when the relevant enantiomer is isolated from the other enantiomer. When it is present only as part of the racemate, or a racemic mixture, the polarisation of light by each enantiomer is cancelled out by the other enantiomer. Thus, his Honour held that the skilled addressee of the Patent in 1988, the priority date, would have understood Claim 1 to refer specifically to the (+)-enantiomer, isolated from the (-)-enantiomer. 56 Alphapharm and Arrow complain that the primary judge erred in that construction of Claim 1 by impermissibly adding one or more integers that are not to be found in Claim 1. Alphapharm and Arrow contend that the correct construction of Claim I is for a unique molecule possessing a unique, three dimensional configuration. Claim 1 does not specify purity: it does not do so because what is claimed is the molecule itself. Claim 1 does not refer to the solution or other environment in which the molecule is found. It does not refer, by exclusion or otherwise, to the racemate or any other mixture. They say that, while Lundbeck might have intended to cover the (+)-enantiomer, it did not limit itself to the pure enantiomer, in the wording of Claim I. Thus, they say, Claim 1 will be infringed by the independently existing (+)-enantiomer, but it will also be infringed by the racemate, which, by definition, includes the (+)-enantiomer. 57 Alphapharm and Arrow contend that the primary judge erred in reading into Claim 1, three additional integers as follows: · First, his Honour read in the additional limitation of "independently existing" or "existing independently of the racemate". · Secondly, his Honour read in a degree of purity, namely, 95%. · Thirdly, his Honour read in a type of purity. 58 It is not legitimate to narrow or expand the boundaries of monopoly as fixed by the words of a claim by adding to those words glosses drawn from other parts of the specification. Because a patent operates as a public instrument, the monopoly must be expressed in such a way that it is not capable of being misunderstood. The plain and unambiguous meaning of a claim cannot be varied or qualified by reference to the body of the specification (see Welch Perrin & Co Pty Ltd v Worrel (1961) 106 CLR 588 at 610 and Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) 207 CLR 1 at [15]). 59 Alphapharm contends that the primary judge erred in that, while Claim 1 refers simply to (+)-Citalopram, his Honour read in the words "otherwise than as part of the racemate" that could include the proportions 60:40, 80:20; 90:10 and so on. His Honour then read in a further integer to limit that lack of clarity, by reading in a degree of purity of 95%. It may be that his Honour was intending to refer to enantiomeric purity, which is referred to in Claim 6. However, the only type of purity described in the body of the Specification is optical purity. 60 There is no warranty for adopting a method of construction that gives a patentee what it might have wished or intended to claim, rather than what the words of the relevant claim actually say. While such an approach may be appropriate where there is a genuine ambiguity, it is not permissible to read an entire limiting integer into the claim as written, when the claim clearly does not contain it. 61 Claim 1 is for the (+)-enantiomer of the compound shown in the diagram on page 1 of the Specification. There is no reason why Claim 1 should be construed as referring to anything other than the enantiomer as a substance. There is nothing in Claim 1 to indicate that the reference is intended to be to the (+)-enantiomer isolated from the (-)-enantiomer. Putting aside how the relevant skilled addressee might understand the reference in Claim 1, Claim 1 by itself simply identifies the substance, in whatever surroundings it may exist. 62 There is indeed force, as the primary judge accepted, that the use of words such as "individual", "pure", "separated" and "isolated", in the body of the Specification indicates that when reference was made to the (+)-enantiomer in Claim 1, without the use of such qualifying words, Claim 1 was intended to mean what it says, namely, the substance in the abstract, irrespective of its physical contiguity with other substances, such as the (-)-enantiomer. 63 The primary judge referred to a number of textual matters in the body of the Specification that were relied upon by Lundbeck as supporting its construction. His Honour considered that, if Claim 1 is ambiguous, the Specification as a whole teaches that Claim 1 refers to the independently existing (+)-enantiomer, and not to merely the (+)-enantiomer, when a part of unresolved (+/-)-Citalopram. However, his Honour did not consider that Claim 1 is ambiguous and, accordingly, did not in his reasoning have regard to those textual matters. 64 Once those textual matters are put aside, however, there is no real reason for applying anything other than a literal construction of Claim 1. Claim 1 is for the product or substance, namely, the (+)-enantiomer. It is not permissible to construe a claim or the specification with a view to avoiding the effect of prior documents. His Honour observed that, in the absence of a context permitting otherwise, the relevant skilled addressee would not have understood the claim to the invention of (+)-Citalopram to refer to that compound merely as part of the unresolved racemate. Rather, his Honour said, the skilled addressee would have understood the claim to the invention of (+)-Citalopram to refer to that compound as something that had an existence independent of that of the racemate. 65 It is correct, as his Honour says, that the reference in Claim 1 is a specific reference to the enantiomer of Citalopram that rotates plane-polarised light to the right. However, his Honour then says that the reference is not apt to refer to the (+)-enantiomer merely as present in the racemate. The reasoning given for that conclusion is that there is no context suggesting a different possibility. However, the task is to construe the words of Claim 1. Those words describe a product or substance. They do not suggest in any way that the product or substance must be isolated from other products or substances. There is nothing in Claim 1 to suggest that the (+)-enantiomer is disclosed with a degree of purity. The racemate is no more than a mixture of the two enantiomers. Each of those two compounds is present in the racemate and can be separated. Further, at the relevant time, the relevant hypothetical skilled addressee was aware that the racemate contained both compounds and that the two compounds could be separated. 66 It may be that some inference can be drawn that Lundbeck, in applying for a patent in respect of the (+)-enantiomer, was intending to claim something that had not been disclosed by the Citalopram Patent. If so, it would have been a simple matter to specify in Claim 1 an integer requiring that the substance disclosed be separate from the (-)-enantiomer. Thus, it would have been possible to amend Claim 1 to specify "substantially pure (+)-Citalopram". Alternatively, Claim 1 could have been qualified by claiming the (+)-enantiomer "substantially free of" or "substantially separated from" the (-)-enantiomer. No such qualifying words are to be found in Claim 1. To read into Claim 1 such qualifying words is impermissible as a matter of construing the clear and unambiguous words used by Lundbeck. 67 It follows that the primary judge erred in his Honour's construction of Claim 1.

[19]

The Citalopram Patent 71 Claim 1 of the Citalopram Patent was for the racemate or racemic mixture formed by the (+)-enantiomer of the Patent and the (-)-enantiomer of the same compound. The relevant skilled addressee, as at the priority date for Claim 1 of the Patent, would know that the racemic compound claimed in Claim 1 of the Citalopram Patent consisted of a mixture of the (+)-enantiomer and the (-)-enantiomer of that compound. In so far as the Patent claims the (+)-enantiomer, as a substance, irrespective of its purity, Claim 1 of the Citalopram Patent discloses sufficient information to enable the relevant skilled addressee to know the (+)-enantiomer. Claim 1 of the Patent is not for a process for the resolution of the (+)-enantiomer, but simply for the substance or compound itself. 72 Alphapharm contended that a person who follows the teaching of the Citalopram Patent will make the racemic mixture, which contains the (+)-enantiomer; the (+)-enantiomer is the subject of the Patent. The primary judge considered that the Citalopram Patent did not expressly, or by implication, disclose the individual enantiomers of the compound. It disclosed the racemate and enabled the obtaining of it. In the light of his Honour's construction of Claim 1, his Honour concluded that the relevant skilled addressee who read the Citalopram Patent would have understood that the racemate consisted of the (+)-enantiomer of Citalopram and the (-)-enantiomer of Citalopram, each as to 50%, and would have been able to identify the formula for each of the S enantiomer and the R enantiomer. However, that addressee would not have known, in the absence of experimentation, which was the (+)-enantiomer and which was the (-)-enantiomer. Accordingly, his Honour concluded that that knowledge would not point specifically to the independent existence of the enantiomers, which, according to his Honour's construction, is of the essence of Claim 1. 73 For the reasons indicated above, the primary judge erred concerning the proper construction of Claim 1 of the Patent. That is to say, Claim 1 does not require that the (+)-enantiomer, the substance disclosed by Claim 1, be separate from the (-)-enantiomer. The Citalopram Patent claimed the racemate consisting of a mixture of the (+)-enantiomer and the (-)-enantiomer, being a mixture of the R-enantiomer and the S-enantiomer, in equal parts. Thus, the Citalopram Patent disclosed each of those enantiomers. One of those is the substance or compound that is the subject of Claim 1 of the Patent. When Claim 1 of the Patent is construed as indicated above, as being limited to the substance, it is clearly anticipated by the Citalopram Patent. It follows that the so called invention of Claim 1 of the Patent and the so called inventions of Claims 2, 3, 4 and 5 of the invention were not novel as at the priority date, in the light of the Citalopram Patent.

[20]

The Smith Article 74 The Smith Article is concerned with the effect of stereoisomers on 5-HT uptake in brain tissue and/or blood platelets. It concerns studies in which stereoisomers have been used to investigate the uptake of 5-HT in brain tissue and/or blood platelets. The review had two aims. One was to give a concise account of available information on the effects of stereoisomers on 5-HT uptake. The other was to use the information to derive a topographical map of the hypothetical 5-HT uptake area. 75 The Smith Article concluded that the model propounded in the article can rationalise most, if not all, known differences between inhibitory effects of stereoisomers on 5-HT uptake in brain tissue and blood platelets. The Smith Article asserted that the model permitted predictions to be made about spatial features of stereoisomers that influence 5-HT uptake. The Smith Article also said that it was of interest to mention Citalopram, which it described as a racemic drug with potent inhibitory effect on 5-HT uptake. The Smith Article said that, although effects of the individual enantiomers of Citalopram have never been studied, the model predicted that the R enantiomer of Citalopram was far more potent than the S enantiomer as a 5-HT uptake inhibitor. The Smith Article concluded that the model propounded could be tested by determining whether those predictions are correct. 76 Thus, the Smith Article suggests that the R enantiomer, rather than the S enantiomer, could be expected to be the more potent of the two. That prediction has now been shown to be wrong. That is to say, it is common ground that, in the case of Citalopram, the R enantiomer is the (-)-enantiomer and the S enantiomer is the (+)-enantiomer. The Patent relates to the (+)-enantiomer. His Honour concluded, therefore, that the Smith Article points away from the claimed invention of the Patent. His Honour observed that the relevant skilled addressee would have to conduct further experiments, conduct research and gain further information to determine that it was the (+)-enantiomer that was more potent than the (-)-enantiomer and that the Smith Article was therefore a distraction. His Honour concluded that the Smith Article was, therefore, not an anticipation of the claimed invention of the Patent, as construed by his Honour. 77 In the light of the conclusion reached above concerning want of novelty in the light of the Citalopram Patent, it is unnecessary to express a view concerning the Smith Article.

[21]

SECTIONS 40(2)(B) AND 40(3) OF THE 1990 ACT 78 Section 40(2)(b) relevantly provides that a complete specification must describe the invention fully and end with a claim or claims defining the invention. Alphapharm contended that, if Claim 1 is not for the (+)-enantiomer of Citalopram on a molecular level, Claim 1 does not define the alleged invention because it could include any mixture of enantiomers in the absolute configuration of the S enantiomer and the R enantiomer in any proportion ranging from 51% to 100%. The primary judge considered that there was no substance in that contention, having held that Claim 1 relates specifically to the (+)-enantiomer, as an independent molecule, and not to that enantiomer merely as part of an unresolved racemate. 79 Section 40(3) of the 1990 Act requires that each claim must be clear and succinct. Alphapharm contend that Claim 1 lacks clarity in two respects: · It does not identify the conditions in which the (+)-enantiomer of Claim 1 will rotate a plane of polarised light to the right: although there is a convention about wave length, there is no convention about the solvent to be used and the examples given in the Specification make it clear that the solvent needs to be specified. · The claims fail to identify the level of purity required. 80 In relation to the first contention, the primary judge concluded that there is a standard set of solvents and those are standard conditions and standard concentrations and that, accordingly, there was no lack of clarity in the description of the product of Claim 1. In relation to the second contention, the convention of 95% purity accepted by his Honour as being applicable to the construction of Claim 1 would demonstrate to the relevant skilled addressee that Claim 1 referred to a (+)-enantiomer of at least 95% purity. In the light of the conclusion reached above concerning want of novelty, it is unnecessary to express a view concerning the contentions raised in relation to s 40 of the 1990 Act.

[22]

LACK OF UTILITY 81 Under s 18(1)(c) of the 1990 Act, a patentable invention, so far as claimed in any claim, must be useful. In its further amended particulars of invalidity, Alphapharm contended that, in so far as the alleged invention claimed in Claim 5 includes a unit dose containing other than a therapeutically effective compound of (+)-citalopram, the alleged invention is not useful. A claim is bad if it covers means that will not produce the desired result, even if a skilled person would know which means to avoid. That is to say, everything that is within the scope of a claim must be useful, otherwise the claim will fail for inutility (see William WM Wrigley Junior Company v Cadbury Schweppes Pty Ltd (2005) 66 IPR 298 at [138]). Professor Montgomery, who was called on behalf of the Lundbeck Companies, said in cross-examination that the highest therapeutically useful unit dose of Escitalopram was 20 mg although, in treating obsessive compulsive disorder, clinicians normally use above that level and unit dosages of 30 mg and 40 mg are often used in the treatment of resistant obsessive compulsive disorder. However, there was no suggestion that up to 100 mg of escitalopram was harmful. Accordingly, any dosage up to 100 mg would be useful. 82 When Professor Montgomery was asked what would be the minimum useful dose, he said that 5 mg was found to be effective in the treatment of social anxiety disorder in a very large study but that that amount was found to be ineffective in the treatment of generalised anxiety disorder. He also said that there was a general notion that one should use lower doses in the case of elderly and that the 5 mg dosage is used for the treatment of the elderly. 83 Alphapharm contends that Claim 5 lacks utility in so far as it claims quantities below 5 mg. His Honour accepted that contention in concluding that Claim 5 was invalid for inutility. In the light of the conclusion concerning lack of novelty, it is unnecessary to express a view as to whether his Honour erred in concluding that Claim 5 was invalid for lack of utility.

[23]

INFRINGEMENT 84 The Lundbeck Companies allege that Alphapharm has infringed and threatens to infringe Claims 1, 3 and 5, which are product claims, and Claim 6(b), which is a method claim. They allege that Alphapharm has committed infringing acts in relation to (+)-Citalopram, or a salt thereof, as claimed in Claim 1 of the Patent, or a pharmaceutical composition as claimed in Claims 3 or 5 of the Patent, or has done any of those acts in respect of a product resulting from the use of the method claimed in Claim 6(b) of the Patent. The Lundbeck Companies rely on Alphapharm's threat to manufacture and sell goods containing Escitalopram in Australia if Alphapharm obtains the necessary regulatory approvals and listings under the Therapeutic Goods Act 1989 (Cth) (the TG Act). 85 The issue on the appeal concerned alleged infringement of Claim 6(b). Alphapharm accepts that, if Claims 1, 3 and 5 are valid, there will have been infringement of the claims. However, it disputes that it has infringed Claim 6(b), assuming the validity of Claim 6(b). 86 Claim 6(b) is relevantly for a method for the preparation of the compound of Claim 1, being Escitalopram, which comprises: · Reacting a compound of the Formula II set out in Claim 6(a) with the enantiomer of an optically active acid. · Affording the pure enantiomer salt of the compound of Formula II for (+)-citalopram. · Subsequently performing ringclosure via a labile ester by reacting the pure enantiomer of Formula II as a base with an activated acid with simultaneous addition to a base. Thus, there are three steps involved in the method disclosed by claim 6(b). 87 The compound of Formula II is a diol, as appears from the two OH molecules in Formula II. The NC molecule signifies that the formula is the cyano-diol. The method employed by Alphapharm departs from the method disclosed by Claim 6(b) in that it involves the use of a bromo-diol rather than the cyano-diol. 88 The primary judge approached the question of infringement of Claim 6(b) on the basis that it is necessary to consider how the relevant skilled addressee as at the priority date of Claim 6(b), would have understood the words of Claim 6(b). His Honour concluded that the relevant skilled addressee at the relevant time would have chosen to use the bromo-diol for the purpose, rather than the cyano-diol, if instructed that the cyano-diol was not available. While there are differences between the use of the two diols, those differences are not of relevance in the present context. His Honour found that the process adopted by Alphapharm involved no more than creating an additional step, the product of which it later removed. His Honour concluded that that substitution, which his Honour characterised as "evanescent", did not constitute a material change in the process and that the process adopted by Alphapharm, albeit with that change, was the same as that spelt out in Claim 6(b). 89 The primary judge accepted evidence that it would have been apparent to any chemist in 1988 that the cyano-diol of the process disclosed in Claim 6(b) could be replaced by the bromo-diol, or indeed a diol with any halogen or pseudo-halogen in place of the cyano group, without making any material difference to the way in which the process worked. That was because those different substituents have very similar properties, none of the chemistry involved in the process disclosed in Claim 6(b) involves interaction with those substituents and the substituents can be replaced with the desired cyano group by a straight forward and well known cyanation process at any stage in the synthetic route. On that basis, his Honour concluded that the process adopted by Alphapharm, notwithstanding the substitution, infringed the method disclosed by Claim 6(b). 90 Alphapharm contends that, on its proper construction, Claim 6(b) excludes the possibility of substituting the NC molecule with any substituent because of a contrast between Formula II in Claim 6(a) and the second Formula II' disclosed in claim 6(a) as follows: 91 In the second Formula II', the symbol "OR" has been substituted for one of the "OH" symbols shown in Formula II. The symbol "R" is used when substitution is permissible. Thus, an element other than H can be substituted for the H in one of the "OH" symbols. The fact that another element can be substituted for the H element indicates that the H element in the second Formula II' is not an essential integer of Formula II'. 92 In contrast, the "NC" symbol is shown in both of the formulas, thereby indicating that NC was regarded as an essential integer of each formula. Alphapharm refers to other references in the Specification to Formula II, indicating that the reference to the cyano-diol was not intended to be substitutable. 93 As indicated above, the method employed by Alphapharm involves the substitution of a bromo-diol, rather than the cyano-diol, NC. If the method disclosed by Claim 6(b) was not to be construed as being limited to the use of the cyano-diol, represented by the symbol "NC", the symbol "R" could have been substituted in the symbol NC. The author of Claim 6(b) clearly had in mind the existence of a convention whereby a substitutable element could be represented by the symbol "R". The failure to use that symbol instead of the symbol "NC" signified that the cyano-diol was an essential integer of the method disclosed by Claim 6(b). It follows that a method that involves substitution of the bromo-diol for the cyano-diol does not infringe the method disclosed by Claim 6(b). 94 The primary judge erred in concluding that Alphapharm's method for producing Escitalopram infringed Claim 6(b) of the Patent.

[24]

EXTENSION 95 Part 3 of Chapter 6 of the 1990 Act deals with the extension of the term of standard patents relating to pharmaceutical substances. Under the Dictionary in Schedule 1 to the 1990 Act, a pharmaceutical substance is, relevantly, a substance, including a mixture or compound of substances, for therapeutic use, whose application involves a chemical interaction or physico-chemical interaction with a human physiological system. 96 As I have said, it is common ground that Escitalopram is a pharmaceutical substance within the meaning of Part 3 of Chapter 6 of the 1990 Act. Under the Dictionary, therapeutic use is use for the purpose of: · preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; · influencing, inhibiting or modifying a physiological process in persons, or · testing the susceptibility of persons to a disease or ailment. 97 Part 3 of Chapter 6 of the 1990 Act consists of ss 70 to 79A inclusive. Section 70(1), provides that the patentee of a standard patent may apply for an extension of the term of the patent, if the requirements set out in ss 70(2), 70(3) and 70(4) are satisfied. In the present case, s 70(4) has no relevance. The question is whether the requirements set out in ss 70(2) and 70(3) are satisfied. 98 At least one of the conditions set out in s 70(2) must be satisfied. The first condition is that one or more pharmaceutical substances per se must, in substance, be disclosed in the complete specification of the relevant patent and must, in substance, fall within the scope of the claims of that specification. The second condition is not directly relevant, but may have some bearing on the meaning of the other parts of s 70. The second condition is that one or more pharmaceutical substances, when produced by a process that involves the use of recombinant DNA technology, must, in substance, be disclosed in the complete specification of the relevant patent and must, in substance, fall within the scope of the claims of that specification. 99 Thus, there is a symmetry in the two conditions described in s 70(2), in that each requires that one or more pharmaceutical substances must be disclosed in the complete specification of the relevant patent and must fall within the scope of the claims of that specification. There are two different aspects of the pharmaceutical substance that must be disclosed. In one case, a pharmaceutical substance per se must be disclosed. In the other case, a pharmaceutical substance when produced by a particular process must be disclosed. 100 Section 70(3) then imposes two further conditions, each of which must be satisfied in relation to at least one of the pharmaceutical substances disclosed in accordance with s 70(2). The first condition in s 70(3) is that goods containing, or consisting of, the substance must be included in the Australian Register of Therapeutic Goods, being the register maintained under s 9A of the TG Act (the Therapeutic Register). The second condition in s 70(3) is that the period beginning on the date of the relevant patent and ending on the first regulatory approval date for the substance must be at least five years. Section 70(5) relevantly defines the first regulatory approval date as being the date of commencement of the first inclusion in the Therapeutic Register of goods that contain, or consist of, the substance. 101 Section 71(2) relevantly provides that an application for an extension of the term of a standard patent must be made during the term of the patent and within six months after the later of: · the date the patent was granted; and · the date of commencement of the first inclusion in the Therapeutic Register of goods that contain, or consist of, any of the pharmaceutical substances referred to in s 70(3). Section 72 requires that, if a patentee makes an application for an extension, the Commissioner must publish a notice to that effect in the Official Journal. Under s 74(1), the Commissioner must accept an application for an extension if the Commissioner is satisfied that the requirements of ss 70 and 71 are satisfied in relation to the application. 102 Section 75 permits any person to oppose the grant of the extension of the term of a standard patent on the ground that one or more of the requirements of ss 70 and 71 are not satisfied in relation to the application for the extension. An extension may not be opposed on any other ground. Under s 75, if the grant of an extension is opposed, the Commissioner must decide the case in accordance with the Regulations, after giving the applicant and the opponent a reasonable opportunity to be heard. There is a right of appeal to the Federal Court against a decision of the Commissioner under s 75. Section 76(1) provides that the Commissioner must grant an extension if there is no opposition. If the Commissioner grants an extension, the Commissioner must publish a notice of the grant in the Official Journal. 103 Section 77(1) provides that, if the Commissioner grants an extension, the term of the extension is equal to the period specified in s 77(1)(a), reduced by five years but not below zero. However, under s 77(2), the term of the extension cannot be longer than five years. The period referred to in s 77(1)(a) is the period beginning on the date of the relevant patent and ending on the earliest first regulatory approval date, as referred to in s 70(5), in relation to any of the pharmaceutical substances referred to in s 70(2). 104 Under s 78, the exclusive rights of a patentee during the term of an extension are limited. Thus, the exclusive rights of the patentee during the term of the extension are not infringed by a person exploiting a pharmaceutical substance such as is described in s 70(2) for a purpose other than therapeutic use or by a person exploiting any form of the invention other than such a pharmaceutical substance. 105 Under s 67 of the 1990 Act, the term of a standard patent is 20 years from the date of the patent. Under s 65, the date of a patent is the date of filing of the complete specification. In the present case, that was 13 June 1989. The Patent would therefore have expired on 13 June 2009, but for any extension. Lundbeck applied for extension of the Patent on 22 December 2003. The Commissioner granted an extension. The term of the extension ultimately granted was for the period from and including 14 June 2009 to 9 December 2012. 106 Since 3 January 1998, Lundbeck Australia has marketed an anti-depressant medicine in Australia under the trade mark "Cipramil". Cipramil was included in the Therapeutic Register on 29 December 1997, as citalopram hydrobromide, an acid addition salt of Citalopram. Since 1 October 2003, Lundbeck Australia has also marketed an anti-depressant medicine in Australia under the trade mark "Lexapro". Lexapro was included in the Therapeutic Register on 16 September 2003, as escitalopram oxalate. 107 If the relevant first inclusion in the Therapeutic Register was the inclusion of Cipramil on 29 December 1997, it was necessary for Lundbeck to apply for an extension no later than 29 June 1998, being six months after that first inclusion of Cipramil. It did not do so. The question is whether, for the purposes of Part 3 of Chapter 6, Cipramil contains Escitalopram, the (+)-enantiomer of Citalopram. Cipramil contains a substance that is a mixture of the (+)-enantiomer of Citalopram and the (-)-enantiomer of Citalopram, namely, the racemate. Lundbeck denies that Cipramil contains the (+)-enantiomer of Citalopram. 108 The primary judge considered that the racemate, Citalopram, is the pharmaceutical substance per se disclosed in the complete specification of the Citalopram Patent and that the (+)-enantiomer of that racemate is the pharmaceutical substance per se disclosed in the complete specification of the Patent. His Honour concluded that the inclusion in the Therapeutic Register of Cipramil on 9 December 1997 signified the inclusion in the Therapeutic Register of goods that consisted of, or contained, the pharmaceutical substance, Citalopram. His Honour also concluded that the inclusion of Lexapro in the Therapeutic Register on 16 September 2003 signified the inclusion in that register of goods that consisted of, or contained, the pharmaceutical substance (+)-Citalopram, namely Escitalopram. 109 The primary judge observed that ss 70(3), 70(5), 71(2) and 77(1) refer to one or more of the pharmaceutical substances referred to in the first condition in s 70(2), but that the expression "per se" did not carry over into those provisions. On the other hand, the expression "per se" appears in s 78. His Honour considered, therefore, that the omission of the expression "per se" means that it would suffice that the goods that are included in the Therapeutic Register contain only non-essentially, or incidentally, the pharmaceutical substance that is required to be disclosed per se in the complete specification. 110 The primary judge characterised the question as being simply whether Cipramil contains the (+)-enantiomer of Citalopram, which was disclosed in the Patent. Citalopram consists of a mixture of the two enantiomers of Citalopram, namely, (+)-Citalopram and (-)-Citalopram, in equal amounts. His Honour concluded that Citalopram contains the molecule that is identified as (+)-citalopram, namely, Escitalopram, the substance of Claim 1. His Honour concluded, therefore, that Lundbeck's appeal from the decision of the Commissioner's delegate should be dismissed and that the Register of Patents should be rectified by the omission from it of any reference to an extension of the term of the Patent. 111 Having regard to the conclusion I have reached above concerning the validity of Claims 1 to 5, the question of extension does not arise. If it did, I would be disposed to accept his Honour's conclusions as correct. That is to say, the Patent would, in any event, expire on 13 June 2009.

[28]

BENNETT J: CONSTRUCTION OF CLAIM 1.................................................................................... [117] The principles................................................................................................................ [118] The primary judge's construction of claim 1.................................................................... [121] Alphapharm and Arrow's submissions on the construction of claim 1.............................. [122] Lundbeck's response..................................................................................................... [131] The decisions in the United Kingdom and the United States............................................ [139] Consideration................................................................................................................ [149] NOVELTY....................................................................................................................... [161] General propositions...................................................................................................... [173] Hill v Evans............................................................................................................. [174] Conclusion on anticipation and "enabling disclosure"....................................................... [178] The alleged anticipations................................................................................................ [193] The prior citalopram patent for the racemate......................................................... [193] The Smith Article..................................................................................................... [196] CLARITY......................................................................................................................... [212] UTILITY.......................................................................................................................... [216] INFRINGEMENT............................................................................................................ [222] THE EXTENSION OF THE TERM OF THE PATENT................................................... [223] ORDERS.......................................................................................................................... [248]

[31]

The principles 118 There is little if any dispute between the parties as to the correct principles to apply to the construction of a claim. Whether reference is made to the discussion of the High Court in Welch Perrin and Company Proprietary Limited v Worrel (1961) 106 CLR 588and Kimberly-Clark Australia Pty Limited v Arico Trading International Pty Limited (2001) 207 CLR 1, Sheppard J in Décor Corporation Pty Ltd v Dart Industries Inc (1988) 13 IPR 385,Hely J in Flexible Steel Lacing Company v Beltreco Ltd (2000) 49 IPR 331, Bennett J in Sachtler GmbH and Co KG (formerly Sachtler AG) v RE Miller Pty Ltd (2005) 221 ALR 373, or the elegant exposition of claim construction by Lord Hoffman in Kirin-Amgen Inc v Hoechst Marion Roussel Ltd (2004) 64 IPR 444, the end point is that the words in a claim should be read through the eyes of the skilled addressee in the context in which they appear. Words used in a specification are to be given the meaning which the person skilled in the art would attach to them, having regard to his or her own general knowledge and to what is disclosed in the body of the specification (Jupiters Ltd v Neurizon Pty Ltd (2005) 222 ALR 155 at [67]). This applies to words used in the claims. As Emmett J observed at [53], the construction of a specification, including the claims, is ultimately a question of law for the Court. 119 The claims are part of the specification (Kimberly-Clark at [14]). While the claims define the monopoly claimed in the words of the patentee's choosing, the specification should be read as a whole (Welch Perrin at 610). Those who attempt to elevate the "purposive construction" utilised by Lord Diplock in Catnic Components Limited v Hill & Smith Limited [1982] RPC 183 should understand the application of that approach to construction as explained by Lord Hoffman in Kirin-Amgen at [33]-[34] (see also Sachtler at [42]). 120 It is not permissible to read into a claim an additional integer or limitation to vary or qualify the claim by reference to the body of the specification (Kimberly-Clark at [15]; Welch Perrin at 610). This is particularly relevant when the question concerns infringement of a claim or the sufficiency of a claim to define the invention. However, terms in the claim which are unclear may be defined or clarified by reference to the body of the specification (Welch Perrin at 610; Kimberly-Clark at [15]). The language of the claims may have no positive meaning when read apart from the specification but the meaning may become clear and the invention sufficiently defined when read using the body of the specification as a dictionary of the jargon and ascertaining the nature of the invention (Welch Perrin at 616).

[32]

The primary judge's construction of claim 1 121 There are a number of aspects about the content of claim 1 which were the subject of consideration or observation by the primary judge: · The property of rotating plane-polarised light to the right (clockwise) or the left (anticlockwise) which distinguishes one enantiomer from the other, and each from the racemate, is able to be detected only when that enantiomer is present other than as part of the racemate. When in the racemic mixture (50:50, represented by (±)), the polarisation of light by each enantiomer is cancelled out by the other enantiomer and there is no net polarisation of light. · The skilled addressee in 1988 would have understood claim 1 to refer specifically to (+)-citalopram. · (+)-citalopram does exist when it is part of the racemate. · The purpose of the (+) or (-) symbol is to distinguish the enantiomers from each other. · The purpose of the (+) or (-) symbol is also to distinguish the (+) and (-) enantiomers from being merely part of the racemate or some other mixture. · The unqualified reference to the (+)-enantiomer of citalopram in claim 1 refers to something different from that enantiomer as an indistinguishable part of the unresolved racemate. · The construction of claim 1 to indicate the particular enantiomer and not the enantiomer as part of an unresolved racemate leaves unanswered the question how much impurity would prevent a compound from meeting the formula in claim 1. · The evidence was that when the absolute purity of a pure compound is not specified, there is a convention that it is understood to mean at least 95% pure. His Honour understood the evidence that drew this conclusion 'where no purity is given' to extend to a situation where no explicit reference to purity is made. He rejected the suggestion that it only refers to a situation where the compound is described as "pure". His Honour held that the convention applied to a patent claim and therefore to claim 1. · There exist references in the specification that support the view that claim 1 is to the isolated (+)-enantiomer, although his Honour accepted that there was force in the point that the patentee had chosen not to limit the claim by reference to the words relied upon in the specification, such as "individual", "pure", "separated" and "isolated".

[33]

Alphapharm and Arrow's submissions on the construction of claim 1 122 Alphapharm/Arrow submit that the essential error in his Honour's reasoning was impermissibly to add one or more integers to claim 1. They submit that the correct construction of claim 1 is to 'a unique molecule possessing a unique 3 dimensional configuration'. While that is now known as the S-configuration, Alphapharm/Arrow say that nothing turns on the use of (+) rather than S. They submit that the claim does not specify purity because it is a claim to the molecule itself, without reference to the racemate or any other mixture. It will be infringed by the independently existing (+)-enantiomer, by mixtures containing that enantiomer and by the racemate. Arrow submits further that the phrase "(+)-citalopram" refers to the physical thing, the molecule, and does not import any connotation in relation to the state in which it exists, whether as to purity or otherwise. 123 Alphapharm/Arrow acknowledge the repeated references to "individual" or "pure" (+)-citalopramin the specification as set out by the primary judge at [141]. They note that Lundbeck does not maintain that the claim is ambiguous and that his Honour did not find that it was. Alphapharm/Arrow submit that there is no need to resort to the body of the specification and no basis for importing an additional integer into the claim which, they say, gives rise to an impermissible broadening or narrowing of the claim by glosses drawn from the body of the specification (Welch Perrin at 610). 124 Alphapharm/Arrow accept that the specification describes how to obtain the (+)-enantiomer and its advantages but say that the words "substantially pure" or "independently existing" are necessary to achieve a claim to a "pure" enantiomer. They note references in the specification to "pure" and, indeed, to levels of optical purity of 99.6% or 99.9% when that qualification or meaning is intended to be conveyed. These have not been included in the claim. 125 Alphapharm/Arrow submit that there are reasons why Lundbeck would choose to claim a compound to include its presence in mixtures and to choose a broader claim. Alphapharm/Arrow point to support in the specification where both enantiomers are referred to. Arrow also points out that, where Lundbeck chooses to refer to purity in the specification, it does so. Arrow emphasises that claim 6 refers to an "enantiomerically pure acid derivative". 126 Alphapharm/Arrow also submit that, if the primary judge did not err in importing an additional integer of "pure" into claim 1, his Honour erred by importing an additional integer of the level of purity, 95%. To the extent that the primary judge relied upon expert evidence to support the criterion of 95%, Alphapharm/Arrow say that it is not supported by the evidence. They say that the evidence was that such a criterion is "read in" by the skilled addressee when there is already reference to the compound being "pure" or to an "individual enantiomer", or when it is clear from what is said in the relevant literature that there is an assertion of purity. Alphapharm/Arrow contend that, properly understood, that is the limited application of the convention to which his Honour referred. 127 Additionally, the reference to 95% purity leaves open the type of purity referred to. Alphapharm/Arrow state that there are four different types of purity: (1) chemical purity - purity vis-a-vis impurities such as a solvent or water; (2) enantiomeric purity - purity vis-a-vis the other enantiomer;

[35]

(4) isomeric purity - purity vis-a-vis another structural isomer, which is not an enantiomer. 128 It follows, say Alphapharm/Arrow, that the only level of purity that could be read in would be that found in the specification relating to optical purity. There is no basis in the convention, Arrow submits, to limit the application to enantiomeric purity as opposed to chemical purity. The convention is generally expressed and Arrow submits that his Honour erred in implicitly treating it as meaning enantiomeric purity in the context of the claim. 129 Arrow seizes upon Lundbeck's submission that a mixture of (+)-citalopram and (-)-citalopram in the ratio of 95:5 is within the claim, albeit at the boundary of the claim. In such a mixture, Arrow says, the (+)-enantiomer exists no more independently than in the racemate. Indeed, it says that one way of looking at such a mixture is 90% of the (+)-enantiomer and 10% of the racemate. Arrow says that, without the extra qualification of at least 95% purity, the scope of the claim, as his Honour recognised, is undefined. Accordingly, the further limitation is necessary to maintain the validity of the claim and this can only be imported by reference to the 95% purity convention, which is a second-tier limitation reliant on the first-tier importation of a reference to a "pure" enantiomer, or an assertion of purity. 130 Arrow submits, further, that a convention that applies to chemical literature or, indeed to catalogues of purified chemicals for sale, does not apply to a patent claim, the function of which is to mark out the boundaries of a monopoly, let alone apply to a claim to a molecule. In any event, Arrow says, the purpose of expert evidence is to assist the Court in understanding technical words and phrases used in a claim but not to look at a claim and provide an opinion as to its scope. Arrow challenges his Honour's use of evidence from the skilled addressee as to how that person would have understood the claim at the relevant date. In particular, it challenges the acceptance that such evidence was admissible for the purposes of s 55(1) of the Evidence Act 1995 (Cth) (cf. Jupiters; Clorox Australia Pty Ltd v International Consolidated Business Pty Ltd (2006) 68 IPR 254; Root Quality Pty Ltd v Root Control Technologies Pty Ltd (2000) 177 ALR 231).

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Lundbeck's response 131 Lundbeck emphasises that the question is not whether molecules of (+)-citalopram are present in a racemic mixture. Further, it contends, there is no need to read an additional integer into the claim. Rather, Lundbeck submits, Alphapharm/Arrow are reading out, or ignoring, the (+) symbol, which indicates that the enantiomer rotates plane-polarised light, a property not manifested in the racemate. Lundbeck supports the conclusion of the primary judge that the plain and unambiguous reading of claim 1 is a specific reference to the (+)-enantiomer, distinct from the (-)-enantiomer and not as present in a racemic mixture. That is, Lundbeck says, claim 1 is to the isolated, purified or separated (+)-enantiomer. 132 This construction was, as found by his Honour, supported by the specification and the way in which the skilled reader would understand the claim. 133 Lundbeck points to the following evidence of Professor Banwell and Professor Davies as to the terminology: · A racemate refers to any substance containing equal amounts of enantiomerically related molecules regardless of its physical state. · R/S is used to denote the enantiomer by reference to its absolute configuration and refers to a molecule. · Reference to the optical properties (±) means the compound in solution. It refers to a macroscopic property of a sample of material rather than to the specific orientation of separate molecules (R/S). · (+) cannot cover the racemate or the constituent enantiomers when present in the racemate because the racemate will not exhibit any rotation of polarised light. The racemate is not made up of equal amounts of (+) and (-) molecules, because the (+) and (-) do not refer to the properties of individual molecules but to the macroscopic property of a particular material. · (+) can only refer to a material which contains significantly more of the enantiomer that rotates polarised light in a clockwise direction, in this case, the S-enantiomer. 134 There was no dispute that the claim to the (+)-enantiomer denotes a specific enantiomeric form of the compound and not the racemate. There was a dispute as to whether or not claim 1 covers the (+)-enantiomer when it is present as part of a mixture, including as part of the racemate. 135 This left the question of the degree of purity which, Lundbeck points out, is an issue that applies to many if not all claims to chemical compounds. It was not relevant to infringement, as Alphapharm did not claim that its product was sufficiently impure to be outside the scope of the claim to a product containing a 95% pure (+)-enantiomer. 136 Professor Davies concluded that claim 1, in the context of the Patent, refers to the individual enantiomerically pure (+)-enantiomer of citalopram, that is, S-citalopram. He then explained why he read that as at least 95% pure. Professor Banwell agreed that the claim refers to the single (+)-enantiomer but said that purity is not relevant: '[y]ou either have the (+) enantiomer, or you do not have the (+) enantiomer'. He did not accept that the convention that applied in the "open literature" would be applied by chemists to a patent. 137 Professor Day also gave evidence that the (+) symbol in claim 1 indicated a compound which rotated plane-polarised light to the right when in solution and that the (+)- enantiomer refers to the single enantiomer that rotates light to the right. This distinguished the compound from the racemate. 138 Lundbeck submits that the evidence properly accepted by the primary judge was as to the way in which the skilled addressee would read the term in claim 1. He or she would read the claim as being to the isolated (+)-enantiomer, that is the pure (+)-enantiomer, and then, in the absence of a specification of purity, apply the convention to understand that the level of purity would be at least 95%. This is not, Lundbeck says, to add a limitation to the claim but to construe the term in the claim as it would be read by the skilled addressee.

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The decisions in the United Kingdom and the United States 139 Alphapharm/Arrow submit that it is impermissible to adopt an approach, apparently accepted in the United Kingdom, of a beneficial construction to express what the patentee would have intended to claim in the absence of any genuine ambiguity, let alone by permitting the addition of a limiting integer not included in the claim. Similarly, Alphapharm/Arrow contend that in the United Kingdom, the courts have, in construing the equivalent patent, arrived at a limitation similar to that of the primary judge but by a method of construction that is impermissible in Australian law, namely, reading into the claim a limitation derived from the body of the specification. 140 However, this submission is based on a number of assumptions, including an absence of ambiguity and the characterisation of the primary judge's reasoning as importing a limitation derived from the body of the specification as a matter of construction. Further, is it correct to say that Lord Hoffman in H Lundbeck A/S v Generics (UK) Ltd [2008] RPC 437 determined what the patentee intended to claim rather than construe the words in the claim as would the skilled addressee, reading the specification as a whole? This will be discussed later in these reasons, although the primary judge was careful to form his own view and did not simply apply United Kingdom law or reasoning. 141 Alphapharm/Arrow also submit that the primary judge erred in construing the claim in the Patent by reference to the alleged infringement and the alleged anticipation and that this led to his Honour's conclusion that the skilled addressee would have understood the claim to be to a compound that had an existence independent of the racemate. 142 Alphapharm/Arrow agree with a construction that (+)-citalopram is a specific reference to the enantiomer of citalopram that rotates plane-polarised light to the right. Alphapharm/Arrow adopt the view of Kitchin J in the United Kingdom proceedings (Generics (UK) Ltd v H Lundbeck A/S [2007] RPC 729) that there was no force in the point made by Lundbeck that the racemate will not rotate plane-polarised light, contrary to the primary judge's apparent reliance on that point at [116] and [123]. Alphapharm/Arrow point out that the (+)-enantiomer does exist and does rotate plane-polarised light when in the racemate, it is just that the (-)-enantiomer rotates plane-polarised light in the opposite direction so that, in the racemate, there is a cancellation of the effect of the rotation of light by the (+)-enantiomer. However, if the relevant criterion is the rotation of plane-polarised light, then any mixture of enantiomers in which the (+)-enantiomer exists in a percentage greater than 50% would be encompassed by the claim. 143 In the United Kingdom, Kitchin J considered whether claim 1 of the equivalent patent, a claim to the (+)-enantiomer, covers the (+)-enantiomer in the racemate. His Honour noted that the claim contained no express limitation as to purity, whether as measured in relation to the other enantiomer or in relation to other organic or inorganic material. Turning to what a person skilled in the art would have understood the patentee to mean, his Honour commented that 'the meaning of words is highly sensitive to context'. He acknowledged that, absent the description, the person skilled in the art might well regard the language of the claims as ambiguous but, in the context of the specification, that ambiguity is resolved in favour of a claim to the individual enantiomer. Justice Kitchin recognised that a product claim, conventionally, would be to the product wherever it was found but said that where, as here, the claim is to the isolated product, the monopoly will not extend to that product whatever form it takes and does not extend to the enantiomer in the racemate. The same applied to a pharmaceutical composition comprising the isolated product as an active ingredient. 144 It is of interest that Kitchin J rejected Professor Davies' evidence that, because the (+) symbol designated a macroscopic property of a material, it could not cover the enantiomers in the racemate because the racemate will not rotate polarised light. Justice Kitchin noted that this opinion was inconsistent with the text book exhibited to Professor Davies' report (Organic Chemistry by Morrison and Boyd, 1987), where the (+) designation was used to identify an enantiomer in a racemate and in a mixture containing more of one enantiomer than the other. Rather, his Honour repeated his view that the meaning given is driven by context. Justice Kitchin also rejected the application of the convention concerning the degree of purity but it was not necessary for his decision. 145 On appeal, Lord Hoffman, in construing the equivalent claim in the United Kingdom patent, considered how the skilled person would have understood the patent. His Lordship concluded that it would not be construed as including an unresolved part of the racemate. His Lordship construed the claim in the context of the specification, having regard to the evidence of the skilled addressee. Similarly, as a pure question of construction, Jacob LJ said that the claim did not cover the (+)-enantiomer when in the racemate as the patentee was plainly not intending to cover the racemate. I take it from this that Jacob LJ construed the claim in the context of the whole of the specification. It is apparent that when Lord Hoffman and Jacob LJ referred to understanding what the patentee meant the claim to mean, they were not considering that matter subjectively but in the sense of what a reasonable person, the notional addressee to whom the utterance was addressed, would have understood the author to be using the words to mean, as in the construction of any document (Kirin-Amgen at [32] per Lord Hoffman). When this approach was applied in the United States by Keeley DCJ to a claim to an S (-) -pyridobenzoxazine compound represented by a certain formula, her Honour came to the same conclusion (Ortho-McNeil Pharmaceutical Inc v Mylan Laboratories Inc (2004) 348 F Supp 2d 713). 146 However, I am mindful of differences in the patent jurisprudence of the United Kingdom and the United States and in the statutory provisions. As did the primary judge, I approach the question of construction on the basis of the principles laid down by the High Court and applied by the courts of Australia. 147 Alphapharm/Arrow urge caution in applying the reasoning of other courts. They point out that, in the United States, Lundbeck amended the equivalent patent to include the limitation "substantially pure" and that decisions in the United States referred to by Lundbeck and by the primary judge were in the context of claims to "pure" or "substantially pure" enantiomers. They say that his Honour's reference to Keeley DCJ in Ortho-McNeil was misplaced as her Honour mistakenly relied upon In re May (1978) 574 F 2d 1082 and Re Williams (1948) 171 F 2d 319 as authority for the proposition that a racemate does not anticipate an enantiomer when that case was based upon a claim to an isomer being "substantially free" from the other isomer. It does seem, however, from the cases cited by Alphapharm/Arrow, that other United States courts, for example in Pfizer Inc v Ranbaxy Laboratories Limited (2005) 405 F Supp 2d 495, have similarly drawn on In re May, Re Williams and Ortho-McNeil as authority for the proposition that a racemate does not anticipate the individual isomers of the racemate. 148 Again, the primary judge came to his own view as to the construction of claim 1 in the Australian patent. While the reasoning in other jurisdictions is of interest as to the approach to the scientific aspects, it is important to approach the construction of the claims afresh. I agree, with respect, with the observations of Emmett J at [53]-[54].

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Consideration 149 The Patent is entitled "(+)-Enantiomer of Citalopram and process for the preparation thereof". Citalopram is the racemate. The Patent discloses a method for the preparation of the compound of claim 1, being a method of obtaining the (+)-enantiomer from the racemate. The invention is said to relate to the two novel enantiomers of the racemate, citalopram. The invention is also said to be concerned with a method to resolve the racemate into the individual isomers. While the specification refers to the enantiomers, in the plural, it is in the context of their separate identity. The specification recites the fact that almost the entire serotonin uptake inhibition (the biological activity) resided in the (+)-citalopram enantiomer. 150 The primary judge was entitled to accept the evidence that the skilled addressee would read claim 1 as referring to the isolated (+)-enantiomer. In the context of the whole of the specification, this was in contrast to the (+)-enantiomer as present in the racemate or in a mixture with the (-)-enantiomer. 151 That is, claim 1 is to the separated or isolated or pure (+)-enantiomer. 152 The decision of Dr Barker in Emory University v Biochem Pharma Inc [1999] APO 50 analysed, in the Patent Office in this country, the question whether a claim to a (-)-enantiomer included within its scope the (-)-enantiomer in admixture with the (+)-enantiomer. He concluded that it did not. Dr Barker said that, to a technical person, a claim to 'the (-)-enantiomer of' would indicate the (-)-enantiomer in its purified state. Dr Barker then considered whether, in a patent claim defining a monopoly so that it is not reasonably capable of being misunderstood (Welch Perrin at 610), such a claim represents a disclaimer of 'in admixture with the (+)-enantiomer'. He drew a distinction between a reading of the claim in the context of the specification to understand what the claim is talking about (as did Burchett J in International Business Machines Corporation v Commissioner of Patents (1991) 33 FCR 218), where the whole thrust of the specification makes a limitation clear, and impermissibly importing a limitation from "mere comments" in the description. Dr Barker concluded that, as the specification was concerned with separated enantiomers or, at least, enantiomerically enriched material, the claims to the (-)-enantiomer should be understood as referring to the (-)-enantiomer substantially free of the (+)-enantiomer. 153 The next question is whether the skilled addressee would import into claim 1 of the Patent a measure of purity. The claim is silent on the degree of purity. There is no discussion in the specification of the presence of impurities in the isolated (+)-enantiomer, other than a reference in example 1 to optical purity of greater than 99%. 154 Lundbeck seeks to overcome this by the application of a convention, said to apply generally, to import a requirement of at least 95% purity. The evidence of the skilled addressee was that such a convention is applied in the "open literature" and in respect of catalogues for the sale of chemical products. There was a dispute as to whether it applies to a patent claim. 155 I have some difficulty with the application of the convention. First, while patents may be ascertained in searches of the "open literature", as has often been stated they are in a particular category of document governed by statute and giving rise to rights in rem. Professor Banwell recognised that distinction, although Professor Davies did not. Professor Davies based his opinion on the application of the convention in the "open literature". The primary judge accepted that a skilled addressee would apply the convention to claim 1 of the Patent, which his Honour found to encompass the independently existing (+)-enantiomer. 156 The construction of the claim is for the Court. I do not accept that a convention that applies to publications of research results or to chemical catalogues necessarily applies to the construction of a claim by a court. 157 In my opinion, whether there is a limitation of purity depends on the words of the claim, in the context of the specification. If the conclusion is that the claim should be construed to mean the isolated, separated enantiomer, not in a mixture or in a racemate, it seems to me to be inconsistent then to "water down" this meaning to allow for some mixture and some presence in a racemate. I see some tension between Lundbeck's case that the claim is to the isolated enantiomer and not the enantiomer in a mixture or racemate and, on the other hand, that it should be read to include a mixture of 95% (+)-enantiomer and 5% (-)-enantiomer or, put another way, 90% (+)-enantiomer and 10% racemate. 158 The specification does not support the limitation on the level of purity contended for by Lundbeck (ie. at least 95%). Further, it does not support a limitation to enantiomeric purity. Example 1 refers to optical purity but at 99.6% and 99.9%. 159 The construction contended for by Lundbeck also raises questions of clarity and uncertainty of infringement. 160 It follows that, in my view, claim 1 is to the pure or isolated or separated (+)-enantiomer but should not be construed to limit the purity of the (+)-enantiomer to at least 95% purity, let alone to 95% enantiomeric purity. In the absence of a qualification of purity expressed in the claim or made clear in the specification, none should be imported. To that extent, in my opinion, the primary judge was in error.

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NOVELTY 161 It is important to remember the test for novelty in s 7 of the Patents Act 1990 (Cth) ('the 1990 Act'). That section relevantly provides: (1) For the purposes of this Act, an invention is to be taken to be novel when compared with the prior art base unless it is not novel in the light of any one of the following kinds of information, each of which must be considered separately: (a) prior art information (other than that mentioned in paragraph (c)) made publicly available in a single document or through doing a single act; 162 The 1990 Act makes no reference to "disclosure" or "enablement" in the context of novelty, nor does the Patents Act 1952 (Cth) ('the 1952 Act'). 163 The question is whether an invention is novel when compared to prior art information made publicly available. The test is not whether the invention has been made publicly available. 164 Section 2 of the Patents Act 1977 (UK) ('the 1977 Act (UK)') provides a test for novelty relevantly as follows: (1) An invention shall be taken to be new if it does not form part of the state of the art. (2) The state of the art in the case of an invention shall be taken to comprise all matter (whether a product, a process, information about either, or anything else) which has at any time before the priority date of that invention been made available to the public (whether in the United Kingdom or elsewhere) by written or oral description, by use or in any other way. 165 Care must be taken in applying United Kingdom jurisprudence on the 1977 Act (UK) to Australian patents. 166 The primary judge noted at [157] that it was common ground that the basic test for lack of novelty in Australia is the reverse infringement test enunciated by Aickin J in Meyers Taylor Pty Limited v Vicarr Industries Limited (1977) 137 CLR 228. Lundbeck submitted to the primary judge, as it does here, that an alleged anticipation must not only disclose all the essential features of a particular claim, it must also enable the addressee to carry out the invention. Alphapharm submitted before the primary judge that, even if the doctrine of "enabling disclosure" were to apply in Australia, Lundbeck's submissions misapplied it. 167 The primary judge accepted that an earlier disclosure must be "enabling" and said at [161] that "enabling disclosure" in the context of a claimed product means that the earlier disclosure must point unmistakably to the (+)-enantiomer of citalopram, as distinct from the racemate, as a drug desirable to obtain. Where the claim is to a product, the requirement for a disclosure that renders a subsequent claim to that product not novel is that the prior publication either contains a clear description of the product or clear and unmistakable directions to make the product. 168 I agree that the earlier disclosure must point unmistakably to the (+)-enantiomer of citalopram. However, claim 1 is not limited to the enantiomer as a drug, desirable or otherwise. 169 In Apotex Pty Ltd (formerly Genrx Pty Ltd) v Sanofi-Aventis (2008) 78 IPR 485, Gyles J analysed the cases in which the principles of novelty have been applied, commencing with Hill v Evans (1862) 1A IPR 1. In summary, his Honour relevantly observed as follows: · The expression "enabling disclosure" was brought to prominence in Biogen Inc v Medeva plc (1996) 36 IPR 438, a decision that did not concern anticipation but whether a later patent was "supported" by an earlier specification. · Enabling disclosure may relate to the disclosure required for there to be anticipation of a process or method claim but is not relevant to anticipation of a product claim or a claim for a chemical compound by formula. · For a product claim, the novelty must lie in the product not the means of producing it. · The starting point is Hill v Evans and the test that: the antecedent statement must be such that a person of ordinary knowledge of the subject would at once perceive, understand, and be able practically to apply the discovery without the necessity of making further experiments and gaining further information before the invention can be made useful. …[T]he information as to the alleged invention given by the prior publication must, for the purposes of practical utility, be equal to that given by the subsequent patent. The invention must be shewn to have been before made known. Whatever, therefore, is essential to the invention must be read out of the prior publication.

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· The principle that emerged from Hill v Evans was that all integers of an invention must be in the prior specification if novelty is to be defeated. In the case of a process or method, that means each integer of the process or method. · In C Van der Lely NV v Bamfords Ltd (1962) 1A IPR 86, it was stated to be sufficient if there were a definite statement of fact and material from which the ordinary skilled addressee would clearly infer its existence. · In General Tire & Rubber Company v Firestone Tyre and Rubber Company Ltd (1971) 1A IPR 121, it was said to be sufficient if the prior publication contained a clear description of, or clear instructions to make, something that would infringe the subsequent claim. Where a product has been differently described, there will be a lack of novelty where it is clear from the directions given that the same device is produced. The directions have to be clear and unmistakeable. If the directions may be carried out in a way that would result in an infringement and in a way in which infringement would not occur, there will be no anticipation. There must be clear and unmistakeable directions to do what the patentee claims to have invented. · General Tire made it clear that, where there is a clear description of a product that would infringe the patentee's claim, the subsequent product would lack novelty. Where the prior publication only contained instructions to make a product that would infringe the patentee's claim, those instructions to make the product had to be clear and unmistakeable for the patentee's claim to lack novelty. · This was extended in the United Kingdom in Re Genentech Inc's (Human Growth Hormone) Patent [1989] RPC 613 where Falconer J's decision, upheld by the House of Lords, was that disclosure of a chemical compound by formula was not disclosure for the purposes of anticipation unless the cited document contained sufficient directions to enable the compound to be made. · The current United Kingdom position is as set out by Lord Hoffman in SmithKline Beecham plc's (Paroxetine Methanesulfonate) Patent [2006] RPC 323. Under the 1977 Act (UK), "disclosure" and "enablement" are separate concepts and are cumulative requirements for anticipation, although with some possible exceptions. There his Lordship was considering the circumstance of the disclosure of a class of chemicals defined by reference to a formula, thereby disclosing "a myriad of compounds". In his Lordship's view, there was no doubt that the existence of a particular compound within that formula was disclosed. The "flag" of General Tire was planted, even though the author or maker of the prior art was not aware of doing so. · The suggestion in Bristol-Myers Squibb Company v FH Faulding & Co Limited (2000) 97 FCR 524 that it was necessary to "teach" the subsequent invention can be distinguished, as relevant to a method of administration of a dosage regime.

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· An invention is a piece of information (Merrell Dow Pharmaceuticals Inc v HN Norton & Co Ltd (1995) 33 IPR 1 at 8). It follows that a disclosure is the communication of information. · Commonly the only question may be whether the prior publication describes the claimed invention with sufficient clarity (Bristol-Myers at [67]). · The disclosure is assessed by reference to the skilled addressee, a person of ordinary skill in the art. · The question is whether the prior publication is sufficient to make the claimed invention apparent to the skilled addressee (Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 at 529). · A prior publication does not invalidate a patent unless it supplies sufficient information to enable a person of ordinary skill to produce the product subsequently claimed (Acme Bedstead Company Limited v Newlands Brothers Limited (1937) 58 CLR 689 at 707). A specification is not to be read as in a vacuum but by the reader having at least the common knowledge of the art (Acme Bedstead at 701; Nicaro at 530). · The requirement is that a person of ordinary knowledge of the relevant subject would be able practically to apply the prior published discovery without the necessity of making further experiments (Hill v Evans at 6-7). · The further experiments do not include those that formed part of standard procedure or common general knowledge. They are experiments with a view to discovering something not disclosed (Van der Lely at 90). · The further experiments do not mean ordinary methods of trial and error (Van der Lely at 90). · If the alleged anticipation is to a process that produces the claimed product, it is not an anticipation if the process would not necessarily achieve the result claimed for it (Olin Corporation v Super Cartridge Co Pty Ltd (1977) 180 CLR 236 at 260-261). · Something less than a full description of the invention allegedly anticipated may be sufficient to invalidate it for want of novelty (Nicaro at 529). · Something less than a full description of an effective means by which the combination claimed in a patent may be produced may be sufficient to a reader having common general knowledge in the art (Nicaro at 531). · A direction, recommendation or suggestion may be implicit in what is described (Bristol-Myers at [67]). · A disclosure that describes an effective means by which a claimed invention may be produced falls short of anticipation if it requires the exercise of inventive ingenuity or the taking of any inventive step (Nicaro at 531). · Where the prior disclosure is to a broad chemical claim encompassing many compounds, there may not be anticipation in the absence of the skilled addressee understanding or perceiving a specific compound in the disclosure (Imperial Chemicals Industries Pty Ltd v Commissioner of Patents (2005) 213 ALR 399 at [64]-[65]). That is, there is no actual description of the particular compound to the skilled addressee; there is no relevant disclosure. There may be a distinction, albeit fine, between a "fleeting" or "paper' disclosure or the "intellectual content" of a disclosure on the one hand and a "disclosure for novelty purposes" or "enabling disclosure" on the other (Imperial Chemicals at [68]; University of Georgia Research Foundation v Biochem Pharma Inc (2000) 51 IPR 222, a decision of Dr Barker of the Patent Office described by Crennan J in Imperial Chemicals as a'sound account of the relevant distinctions between a "paper disclosure" and an "enabling disclosure" in the field of chemistry' (at 412)). It depends on what the skilled reader would understand.

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Hill v Evans 174 A reading of Hill v Evans, the acknowledged foundation of the law of novelty, is worthwhile. Lord Westbury made a number of points in the context of his opinion as to whether there was matter in a prior specification which rendered the subsequent invention a matter of public knowledge and therefore a matter of public property anterior to the granting of the patent. The expression is often quoted that the antecedent statement 'must be such that a person of ordinary knowledge of the subject would at once perceive, understand, and be able practically to apply the discovery without the necessity of making further experiments and gaining further information before the invention can be made useful' (Hill v Evans at 6). However, his Lordship continued to explain what that means in a context where a prior publication does or does not actually disclose the subsequent invention. He said that the information as to the alleged invention given by the prior publication must, for the purposes of practical utility, be equal to that given by the subsequent patent. It is apparent that in Hill v Evans, the disclosures in the prior publications were not of the integers of the subsequently claimed invention. His Lordship did not say that the invention had to have been previously made but that it had to have been previously made known. 175 Interestingly, in the context of a discussion as to whether further information is required over a prior application for it to be novelty defeating, the example that Lord Westbury gave was the difference between the ore and the refined and pure metal which is extracted from it. His Lordship also observed that in such cases it is not true to say that knowledge and the means of obtaining knowledge are the same. It was in that context that he said (at 7) '[t]o carry me to the place at which I wish to arrive is very different from merely putting me on the road that leads to it', which undoubtedly formed the basis for the frequently cited comment in General Tire as to the planting of a flag. 176 'Upon principle', Lord Westbury concluded that the prior knowledge of an invention to avoid a patent must be knowledge equal to that required to be given by the patent. 177 Lord Westbury endorsed the conclusions in Househill Co v Neilson 1 Webst Pat Ca 718. In that case, Lord Lyndhurst held that where a prior publication included a distinct and clear description of a machine, there was anticipation if the description corresponded with that in the patent, even though the machine as described in the prior publication had never been worked. In Hill v Evans, there was information missing in the prior publications and there was no anticipation.

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Conclusion on anticipation and "enabling disclosure" 178 Care must be taken to distinguish between the tests for novelty and want of inventive step, in particular when looking to see what the prior art "teaches". The concept of novelty in Australia involves a comparison between the invention as claimed in the claims of the patent and prior art information. Often, this must be determined by looking to prior publications which are to be read by the skilled addressee to determine what they disclose. Generally speaking, the consideration of what a prior publication "teaches", especially when one talks of "teaching away" from the claimed invention, tends to be relevant to questions of obviousness and inventive step. 179 As Lord Hoffman said in Merrell Dow at 8,an invention is a piece of information and making matter available to the public therefore requires the communication of information. Whether or not such information has been communicated depends on the subject matter of the claim and the extent of the prior disclosure to the skilled addressee. 180 Where the prior publication discloses exactly what is claimed, there is anticipation. This can be objectively determined and, apart from an understanding of terms of art, the evidence of the skilled addressee is not likely to be of much further assistance. However, this does not always occur and many of the authorities contain discussions of the extent to which a disclosure less than the entirety of the claim constitutes an anticipation of a product or a process to deprive the claimed invention of novelty. 181 If the prior art discloses some but not all integers of a claimed patent to a product, such as a combination, there is anticipation if the skilled addressee would add the missing information as a matter of course and without the application of inventive ingenuity or undue experimentation (Nicaro at 530-531). 182 It may be that the prior disclosure is of a method that produces the claimed product. If that method leads inexorably to the product, there is anticipation (General Tire at 138). If it may or may not result in the claimed product, there is no anticipation. 183 It is these last two examples that, in Australia, could be said to be within a shorthand description of "enabling disclosure". That is, the disclosure is not complete but it is sufficient to enable the skilled addressee, in the ordinary course and without invention, to add what is missing in the prior publication to obtain the claimed invention. The term "enabling disclosure" may also be apposite to disclosure to the skilled addressee of an asserted prior use: whether what the skilled addressee observes on inspection is sufficient to enable him or her to comprehend the complete invention (eg. Insta Image Pty Ltd v KD Kanopy Australasia Pty Ltd (2008) 78 IPR 20; Jupiters), that is, whether it is sufficient to amount to a disclosure of the invention. 184 It is necessary to be careful in applying more recent United Kingdom decisions. In Nicaro, Gummow J noted at 529 that there had been some 'drift in the authorities as to the degree of rigour with which the alleged anticipation is to be tested'. Further, there are differences between the test for novelty in the 1977 Act (UK) and the 1990 Act and the 1952 Act. While care must be taken in a reading of post-1977 United Kingdom decisions, a discussion of the earlier authorities is enlightening. An understanding that the earlier authorities drew a distinction between a prior disclosure of the invention itself and a prior disclosure of a means of obtaining the invention, or of some but not all of the integers of the claimed invention, was restated by Lord Hoffman in SmithKline Beecham, commencing at [22]. Under the heading "Disclosure", after reciting the tests in Hill v Evans and General Tire, Lord Hoffman said (at [22]): If I may summarise the effect of these two well-known statements, the matter relied upon as prior art must disclose subject matter which, if performed, would necessarily result in an infringement of the patent. That may be because the prior art discloses the same invention. In that case there will be no question that performance of the earlier invention would infringe and usually it will be apparent to someone who is aware of both the prior art and the patent that it will do so. … [W]henever subject matter described in the prior disclosure is capable of being performed and is such that, if performed, it must result in the patent being infringed, the disclosure condition is satisfied. The flag has been planted, even though the author or maker of the prior art was not aware that he was doing so. (Emphasis added) 185 As to a description of a means of obtaining the claimed product, his Lordship said at [23] that it was not sufficient if infringement were a possible or even a likely consequence of performing the invention disclosed by the prior disclosure. It must be necessarily entailed. It is not sufficient even if it may be obvious to perform the prior disclosure in a way that would lead to the subsequently claimed invention. Again, his Lordship, emphasised that the prior disclosure must be construed as it would have been understood by the skilled person. 186 "Enablement" was dealt with by Lord Hoffman under a separate heading and as a separate requirement, under United Kingdom law, for anticipation. In the United Kingdom, there is a requirement for novelty under s 2 of the 1977 Act (UK) that an invention does not form part of the state of the art but also that the invention has been made "available to the public". The test of enablement of a prior disclosure for the purposes of anticipation as discussed by Lord Hoffman was the same as the test of enablement of the patent for the purposes of sufficiency. Lord Hoffman emphasised at [28] that the concepts of disclosure and enablement are distinct concepts each of which has to be satisfied under United Kingdom law and each of which has its own rules. 187 Lord Hoffman accepted that, even under the UK test, the same disclosure may satisfy the requirements of disclosure and enablement. His Lordship said (at [29]): Indeed, when the prior art is a product, the product itself, though dumb, may be enabling if it is "available to the public" and a person skilled in the art can discover its composition or internal structure and reproduce it without undue burden. 188 This is consistent with Nicaro. 189 For the purposes of disclosure, the prior art must disclose an invention which, if performed, would necessarily infringe the patent. Once the very subject matter of the invention has been disclosed, the person skilled in the art is assumed to be willing to make trial and error experiments to get it to work. For the purposes of disclosure, the disclosure is either of an invention which, if performed, would infringe the patent, or it is not. When Lord Hoffman went on to say that, for the purposes of enablement, the question is no longer what the skilled person would think the disclosure meant but whether he was able to work the invention which the court has held it to disclose, his Lordship was talking of what, in Australia, is covered by sufficiency of disclosure or description. 190 It follows that, where the prior publication is of the subsequently claimed invention, that is sufficient. Where the prior disclosure falls short of a complete disclosure, the question of the sufficiency of that disclosure arises. It is there that consideration must be given to the quality of a disclosure to the skilled addressee armed with common general knowledge. It is in that context that, in a limited fashion, questions of "enablement" can be said to arise. The use of that expression tends to cause confusion between anticipation and sufficiency. Rather, the Court, armed with the evidence of the skilled addressee as to terms of art and the nature and extent of the disclosure in the prior art document, must determine whether the prior disclosure is sufficient to enable the skilled addressee to perceive, understand and, where appropriate, apply the prior disclosure necessarily to obtain the invention. 191 Where the prior disclosure is of large numbers of compounds by reference to a chemical formula, evidence will establish whether or not such a form of disclosure in the context of the examples and the discussion in the specification is disclosure of any particular subsequently claimed compound. I agree with Dr Barker in University of Georgia that a disclosure of a racemate does not necessarily amount to a disclosure of the individual enantiomers. It depends upon the disclosure in the context of the prior art document. 192 The primary judge said that enabling disclosure in the context of a product claim means simply that the earlier disclosure must point unmistakably to the (+)-enantiomer of citalopram as distinct from the racemate. That is consistent with authority. When his Honour added 'as a drug desirable to obtain', I take that to mean that one takes into account the context of a specification to ascertain whether the earlier disclosure is a disclosure of the (+)-enantiomer where it is not specifically referred to.

[47]

The Smith article 196 Alphapharm/Arrow also rely upon an article entitled "The Stereoselectivity of Serotonin Uptake in Brain Tissue and Blood Platelets: The Topography of the Serotonin Uptake Area" by Donald F Smith ('the Smith article'). It refers to the use of stereoisomers as molecular probes and proposes a model to make predictions about spatial features of stereoisomers that influence 5-HT (serotonin) uptake. The model predicts that the S-enantiomer of fluoxetine is more potent than its 'antipode' as a serotonin uptake inhibitor and then mentions that citalopram is a racemic drug with potent inhibitory effect on serotonin uptake. The article acknowledges that no effects of the individual enantiomers of citalopram have been studied but predicts that the R-enantiomer will be far more potent than the S-enantiomer as a serotonin uptake inhibitor. 197 Lundbeck submits that the Smith article did not put the public in possession of the (+)-enantiomer for the following reasons: · Until the enantiomers are separated and their absolute configuration determined, it is not possible to predict which will be the R and which will be the S. · The Smith article did not fulfil "the disclosure requirement" or "the enablement requirement" (whether the latter is a separate requirement or part of the former requirement). · The Smith article did not disclose the (+)-enantiomer as a drug that was desirable to obtain nor that it had advantages over the racemate and the (-)-enantiomer. · The Smith article "taught away" from the production of the (+)-enantiomer. There were no clear and unmistakeable directions or instructions in the Smith article to produce (+)-citalopram. · Claims 3 and 5 have additional integers not disclosed in the Smith article. 198 Alphapharm/Arrow and the analysis of the authorities provide a response to each reason: · The Smith article provides the structure of citalopram in a form of solid and dashed wedges that, by convention, depict the R-enantiomer. The skilled addressee must immediately deduce its mirror image. · The Smith article discloses that citalopram exists as two isomers. The formula by which the structure of both the R and S enantiomers may be inferred is disclosed. It therefore disclosed the S, or (+)-enantiomer. That disclosure was either express or clearly inferred within the meaning of Van der Lely. · The S-enantiomer would infringe claim 1 of the Patent. · If the (+)-enantiomer is disclosed to the skilled reader, there is no further requirement for "enablement". · It is irrelevant that the article did not disclose the (+)-enantiomer as the desirable drug nor that it had advantages over the racemate and the (-)-enantiomer. Claim 1 is not limited to its use as a drug or as to its efficacy. · There is only a need for clear and unmistakable directions to produce (+)-citalopram where the (+)-enantiomer is not itself disclosed. The "teaching away" is in respect of the use of the (+)-enantiomer as a drug. It is not a case of directions to produce an undisclosed product.

[48]

199 Alphapharm/Arrow also submit that a person who followed the direction in the article to make the R and S enantiomers would inevitably produce the (+) (S) and (-) (R) enantiomers. However, if the (+)-enantiomer was not disclosed to the skilled reader, a direction to make it would not be sufficient as the making of the enantiomer was found to involve an inventive step. In any event, it does not seem to be in issue that there would be different methodologies that could be adopted, not all of which would necessarily be successful. 200 The relevant passage in the Smith article refers to the inhibitory effects of stereoisomers on serotonin uptake in brain tissue and blood platelets. It predicts that the S-enantiomer of fluoxetine is more potent. It notes that the effects of the individual enantiomers of citalopram have not been studied. It provides a structural drawing of the R-enantiomer of citalopram. There was no dispute before the primary judge that the structural drawing disclosed each of the two enantiomers, the S-enantiomer being the mirror image of the R-enantiomer. That was sufficient to anticipate each of the R and S enantiomers. 201 It is, perhaps, worth mentioning, that Gyles J observed in Apotex at [55] that the first case to which he was referred that suggested that disclosure of a chemical compound by formula was not disclosure for the purposes of anticipation was the decision of Falconer J in Re Genentech. There, at 629-635, it was held that, for a disclosure of a chemical compound in a prior document to anticipate a later claim to that compound, the cited document must contain sufficient directions to enable the compound to be made. That is the case to which Gummow J referred in his authoritative analysis of the law of anticipation in Australia in Nicaro at 529 in the context of the drift in the authorities as to the degree of rigour with which an alleged anticipation is to be tested. 202 The S-enantiomer of citalopram is the (+)-enantiomer. They are the same product. It is not disputed by Lundbeck that the Smith article referred to the existence of the R and S enantiomers of citalopram. It predicted that the R-enantiomer, which turned out to be the (-)-enantiomer, was likely to be the desirable enantiomer. It is the S-enantiomer that has the characteristic that causes plane-polarised light to rotate to the right. 203 As Emmett J records at [32]-[33] of his Honour's reasons, the R and S designation is an abstract theoretical description that does not require physical testing. It does, however, tell the skilled reader that there are two enantiomers and he or she would know immediately that one of them is (+) and the other (-). That information is conveyed by the disclosure. Testing of the ability to rotate plane-polarised light enables the allocation of the (+) and (-) designation to those enantiomers. 204 The prior art information made publicly available in the Smith article was each of the R and S enantiomers of citalopram. As Emmett J notes at [29] of his reasons, it is common ground that an ordinary skilled but non-inventive chemist given a 2D structural formula with a single chiral centre would recognise the presence of two enantiomers. 205 However, the (+)-enantiomer has a particular, measurable, characteristic: the ability to rotate plane-polarised light to the right. That cannot be ascertained until the enantiomer is obtained. If one viewed that characteristic as an essential integer, the disclosure in the Smith article would only be sufficient for anticipation if that characteristic could be measured without undue experimentation or the exercise of inventive ingenuity. In this case, it is conceded that the preparation of the (+)-enantiomers involved an inventive step. It would follow that there was no anticipation. 206 Further, I have construed claim 1 to mean the purified or isolated enantiomer. That requires the preparation of the (+)-enantiomer. Again, if the person of ordinary skill in the art could have obtained the (+)-enantiomer without the exercise of inventive ingenuity, the disclosure would be sufficient to deprive the claim of novelty (Nicaro at 531). However, there is no dispute in the appeal that the preparation of the isolated (+)-enantiomer did involve an inventive step. 207 Accordingly, the Smith article does not deprive claim 1 (or, it follows, claims 2, 3, 4 and 5) of novelty. 208 The Smith article stated that the author's model predicted that, in the case of citalopram, the R-enantiomer was more potent than the S-enantiomer and said that, thus, the model can be tested by determining whether this prediction is correct. As it turns out, as noted by the primary judge at [166], Dr Smith's prediction was wrong but that is not relevant to the issue of novelty. It is not a question of what the article "teaches". That may be relevant to questions of inventive step but not to questions of novelty. It is a question of the extent of the disclosure to the skilled reader. In any event, the disclosure amounts to a disclosure of the S-enantiomer as an enantiomer to be made and tested, if only to compare its activity to the R-enantiomer. There is implicit in the article a direction to make both enantiomers but there is no method disclosed that leads directly to the claimed enantiomer. 209 The Smith article does not describe the (+)-enantiomer. It does not disclose whether the R- or the S-enantiomer is the (+)-enantiomer. It does not give directions to obtain the (+)-enantiomer. The skilled addressee wishing to obtain an enantiomer of citalopram would, as the primary judge observed at [168], have to conduct further experiments, conduct research and gain further information to hit upon the present invention. Such experimentation and the steps that it would entail were not inevitable. 210 The Smith article does not contain information equivalent to the disclosure of the (+)-enantiomer of claim 1. It does not anticipate claim 1 of the Patent. 211 The primary judge was not in error in concluding that the attack on the Patent on the ground that the invention lacked novelty fails.

[50]

UTILITY 216 Justice Emmett sets out at [81]-[83] of his reasons the contention of the parties and the conclusions of the primary judge in respect of Alphapharm/Arrow's contention that claim 5 lacks utility. Justice Emmett did not need to come to a conclusion on that ground of invalidity. 217 There is no dispute between the parties that the test set out by the primary judge at [468], that all that is within the scope of a claim must be useful, is the correct test. The test for utility was set out and discussed in Ranbaxy Australia Pty Ltd v Warner-Lambert Co LLC (2008) 77 IPR 449 at [141]-[143] and also in Austal Ships Pty Ltd v Stena Rederi Aktiebolag (2005) 66 IPR 420 at [216] and [227]-[242]. 218 Claim 5 relevantly claims a dosage form where the active ingredient is present in an amount from 0.1 to 100 mg per unit dose. The primary judge accepted the evidence that demonstrated that the claimed range of 0.1 to 100 mg per unit dose includes quantities below the useful minimum of 5 mg and above the useful maximum of 40 mg (at [471]-[472]). His Honour concluded that no minimum or maximum can be implied into the claim as to do so would be inconsistent with the claim and would amount to an amendment of it. Accordingly, his Honour held that claim 5 failed for inutility and should be revoked on the ground that the invention, so far as claimed in claim 5, is not a patentable invention because it is not useful within the meaning of s 18(1) of the 1990 Act (at [474]). 219 Lundbeck's attack on the primary judge's conclusions is that the evidence did not establish that doses above 40 mg were not useful or less effective or harmful or that those below 5 mg did not work. Accordingly, Lundbeck says, the evidence did not positively establish a lack of utility (Austal Ships at [252]-[253] and [258] per Bennett J). 220 The onus was on Alphapharm/Arrow to establish a lack of utility. There is no suggestion that the primary judge applied the wrong test. His Honour came to his conclusion on the basis of the evidence before him and concluded that Alphapharm/Arrow had satisfied that onus. That conclusion was open on the evidence and Lundbeck has not established error on the part of the primary judge. 221 It follows that the ground of appeal based on the finding that claim 5 should be revoked for inutility fails.

[52]

THE EXTENSION OF THE TERM OF THE PATENT 223 Part 3 of Ch 6 of the 1990 Act provides for the extension of term of standard patents relating to pharmaceutical substances. Lundbeck caused the product containing the racemate, Cipramil, to be registered on the Australian Register of Therapeutic Goods ('ARTG') on 9 December 1997. The product containing the (+)-enantiomer, Lexapro, was registered on the ARTG on 16 September 2003. These registration dates are relevant to the application of s 70(3) of the 1990 Act. The issue in this aspect of the appeal is whether Lundbeck was entitled to an extension of term of the Patent and, if so, the expiry date of such extension. 224 The primary judge upheld the decision of the delegate of the Commissioner of Patents to the effect that Lundbeck was not entitled to an extension of the term of the Patent as from the date of the registration of Lexapro on the ARTG but only to an extension by reference to the registration of Cipramil. As the time for an application for an extension by reference to the registration of Cipramil had expired, the primary judge held at [544] that Lundbeck's appeal from the decision of the delegate should be dismissed and that the Register of Patents should be rectified by the omission from it of any reference to an extension of the term of the Patent. 225 Section 70 of the 1990 Act relevantly provides: (1) The patentee of a standard patent may apply to the Commissioner for an extension of the term of the patent if the requirements set out in subsections (2), (3) and (4) are satisfied. (2) Either or both of the following conditions must be satisfied: (a) one or more pharmaceutical substances per se must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification; … (3) Both of the following conditions must be satisfied in relation to at least one of those pharmaceutical substances: (a) goods containing, or consisting of, the substance must be included in the Australian Register of Therapeutic Goods; (b) the period beginning on the date of the patent and ending on the first regulatory approval date for the substance must be at least 5 years. (4) The term of the patent must not have been previously extended under this Part. (5) For the purposes of this section, the first regulatory approval date, in relation to a pharmaceutical substance, is: (a) if no pre-TGA marketing approval was given in relation to the substance - the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, the substance; or (b) if pre-TGA marketing approval was given in relation to the substance - the date of the first approval. … 226 The primary judge distilled the issue as follows (at [482]): Much of the argument … is semantic. The (+)-enantiomer of citalopram is a pharmaceutical substance of which Lexapro consists or which it contains. That enantiomer provides the therapeutic use of Lexapro (see the definitions of "pharmaceutical substance" and "therapeutic use" set out [in Schedule 1 to the 1990 Act]). Lundbeck submits, however, that it is incorrect to say that the racemate citalopram, and therefore Cipramil, contains (+)-citalopram.

[53]

227 One aspect of the semantic argument was whether the expression "per se" referred to in s 70(2)(a) does or does not carry over into the other provisions of s 70. If it does, Lundbeck submitted, the registration of Cipramil did not amount to the inclusion on the ARTG of goods that contained or consisted of the pharmaceutical substance per se, (+)-citalopram, because Cipramil contains a different pharmaceutical substance per se, the racemate. Lundbeck points out that the racemate is not disclosed in the complete specification of the Patent and is not in substance within the scope of the claims. 228 His Honour rejected this submission and held at [510] that the expression "per se" does not carry over to references to the "substance" or "pharmaceutical substance" in ss 70(3)(a), 70(5), 71(2)(b) or 77(1)(a) of the 1990 Act. His Honour concluded that the per se qualification has done its work once the pharmaceutical substance disclosed in the specification has been identified. His Honour explained: The "substance" or "pharmaceutical substances" referred to in ss 70(3)(a), (5), 71(2)(b) and 77(1)(a) refer to the "one or more pharmaceutical substances" referred to in s 70(2)(a), but I do not think that the expression "per se" carries over into those provisions, otherwise the Parliament would have used it again in them. Parliament did in fact use it again in s 78(2)(a) - again in respect of the disclosure in the complete specification of a patent. The disclosure in the complete specification of which s 70(2)(a) speaks is different from the notions of "inclusion", "containing" and "consisting of" that are referable to the ARTG which are addressed in the later provisions. The omission of "per se" from those later provisions suggests that it is to suffice that the goods that are included in the ARTG "contain" only non-essentially or incidentally the pharmaceutical substance that is required to be disclosed per se in the complete specification. In my view, the per se qualification has done its work once the pharmaceutical substance disclosed in the complete specification has been identified. Thereafter, the question is the simple one whether the goods included in the ARTG contain or consist of that pharmaceutical substance, unencumbered by any per se notion.

[55]

231 There is no dispute that the pharmaceutical substance for the purposes of s 70(2)(a) is (+)-citalopram. However, the remaining approach suggested by Lundbeck finds no support in the language of s 70, particularly once s 70(3) is considered in context. 232 I accept Alphapharm/Arrow's submission that s 70(2) operates to identify a candidate patent for extension, where the pharmaceutical substance per se is in substance disclosed and in substance within the scope of a claim. Once that patent and the substance are identified, the inquiry turns to s 70(3) and whether that pharmaceutical substance is contained in goods on the ARTG. 233 The next level of inquiry is under s 70(3) where one asks: are there goods on the ARTG that contain (+)-citalopram, the (+)-enantiomer? 234 This raised the other aspect of the semantic argument referred to by the primary judge, the meaning of "contain" in s 70(3)(a). The question was whether Cipramil, the racemate, was a good that contained the pharmaceutical substance (+)-citalopram (at [509]). The primary judge recognised that the racemate is not one and the same thing as the enantiomer (at [529]), and that the racemate and enantiomer are involved in different physico-chemical interactions manifested in different pharmacodynamics and pharmacokinetics (at [530]). However, his Honour held that the word "contain" is a word of plain meaning, used in the 1990 Act in conjunction with the alternative "consist of", and held that Citalopram contains the molecule that is identified as (+)-citalopram. 235 In my view, the primary judge's reasoning at [484] and following is compelling. However, to the extent that his Honour relied on the decision Wilcox J in Merck & Co Inc v Arrow Pharmaceuticals Ltd (2003) 59 IPR 226, I reserve my position on Wilcox J's conclusion that it was sufficient for the purposes of s 70(3) if there was de minimis inclusion of the pharmaceutical substance in the ARTG listing. In any event, that is not the case here. The racemate is made up of equal parts of the (+) and (-) enantiomers and (+)-citalopram is the major, if not the only, active ingredient in Cipramil. I do not propose to repeat all of his Honour's reasons and instead refer the reader to them. 236 As to the "contain" issue, his Honour concluded (at [512]): I do not accept this submission either. Both (+)-citalopram and racemic citalopram are for a therapeutic use which is of the same kind in each case. Indeed, the therapeutic benefit of citalopram comes from the presence in it of (+)-citalopram. It would not be right to say that Cipramil does not contain (+)-citalopram merely because the therapeutic effect of the racemate is less effective because of the additional presence in it of (-)-citalopram.

[57]

238 The definition of pharmaceutical substance focuses on the ingredient for therapeutic use that involves the relevant type of interaction. It is the (+)-enantiomer molecule that has the relevant therapeutic effect. Indeed, as his Honour observed at [512], the therapeutic benefit of citalopram comes from the presence in it of (+)-citalopram. 239 The level of the inquiry required by s 70(3) does not look to the therapeutic effect of the pharmaceutical substance. Rather, it is a simple comparison of the pharmaceutical substance with the "ingredients" of the goods on the ARTG. The question is whether Cipramil contains or consists of the (+)-enantiomer molecule. Given that the racemic mixture includes both the (-)-enantiomer and the (+)-enantiomer in equal parts, Cipramil must "contain" the (+)-enantiomer. The third step posed by Lundbeck is, therefore, redundant. 240 There is no requirement in s 70(3) to compare or contrast the effectiveness of the pharmaceutical substance with the goods with ARTG approval, nor to consider the purity of the pharmaceutical substances. There is no suggestion from the words of s 70(3) that the relevant "goods" could or must include no more than one pharmaceutical substance. What is required is an analysis of whether there are goods containing or consisting of (+)-citalopram and, if so, which of those goods had the first regulatory approval date. 241 I see no error in his Honour's conclusions. The word "contain" does not import into the administrative process of determining whether an extension of term of a patent is warranted a comparison of therapeutic effect or efficacy of the pharmaceutical substance. As the primary judge noted at [535] when referring to s 70(5) (which has the same combination of words as s 70(3)): In s 70(5)(a) it is "goods" that are to contain or are to consist of the pharmaceutical substance in question. In this context, "contain" signifies a physical relationship that is something less than "consist of". If goods A consist of B and C, they may be seen to contain B and to contain C, but not to consist of either alone. B and C will also be goods, although they need not be recognised as continuing to have a separate existence. For example, there is no difficulty in saying that a cake "contains" milk and eggs although they are no longer recognised as having a separate existence in the cake.

[58]

242 In my view, s 70 recognises that the pharmaceutical substance per se may not equate with the subject matter of the claim of the patent in terms. For example, a chemical compound claimed in a patent may not have the necessary therapeutic use or enable the required physico-chemical interaction unless formulated. It is sufficient if the pharmaceutical substance is in substance disclosed in the specification and in substance falls within the scope of the claim or claims. At that point in the scheme of s 70, the satisfaction of s 70(2), the necessary definition of the pharmaceutical substance by reference to the patent ceases. 243 A patent may be obtained if it discloses and claims, for example, a new method of preparation, or purification that results in greater efficacy, or improvement in the delivery of a known pharmaceutical substance already listed on the ARTG. The scheme of the 1990 Act does not provide for the extension of term of each such patent which relates to the same substance. 244 I have concluded, as a matter of construction, that the subject matter of claim 1 of the Patent is the separated or purified or isolated (+)-enantiomer, (+)-citalopram. I have also concluded that the claim is not anticipated by the racemate. Lundbeck submits that such a conclusion is inconsistent with a finding that the racemate "contains" the (+)-enantiomer. However, the pharmaceutical substance per se is the molecule, the (+)-enantiomer. The racemic mixture is a solution that contains both (+) and (-) enantiomers in equal proportions. That (+)-enantiomer molecule per se fulfils the requirements of s 70(2). It is the molecule that "works" as a pharmaceutical substance alone, or together with other substances, in goods listed on the ARTG. These other substances may be components of a formulation or may otherwise be described as impurities, such as the (-)-enantiomer. 245 The primary judge considered at [542] whether the conclusion that the racemate contains the (+)-enantiomer is inconsistent with his construction of claim 1 and did not accept that it was. In considering this aspect of the appeal, his Honour's construction is not relevantly different from the one I have preferred. I agree with his Honour that there is no inconsistency. 246 Having determined that, for the purposes of s 70 and in particular s 70(3), it is unnecessary to evaluate the therapeutic performance of the comparative substances, there is no need to rule on the issue of admissibility of evidence before the primary judge as to the relative pharmacological effect of the racemate and the (+)-enantiomer. 247 It follows that the term of any extension of the Patent is limited by the date of registration of Cipramil, that is, to 9 December 2012. However, as noted by the primary judge at [29], the time for such an application has expired. For that reason, as his Honour concluded at [544], the Register should be rectified by the omission from it of any reference to an extension of term of the Patent.

Parties

Applicant/Plaintiff:

H Lundbeck A/S

Respondent/Defendant:

Alphapharm Pty Ltd

Legislation Cited (5)

Patents Act 1952(Cth)

Patents Act 1990(Cth)ss 7, 18, 40, 65, 67, 70, 71, 72, 74, 75, 76, 77, 78

Therapeutic Goods Act 1989(Cth)s 9A

Evidence Act 1995(Cth)

Australian Register of Therapeutic Goods Evidence Act 1995(Cth)s 55

Cases Cited (27)

H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70 PATENTS - construction of claims - whether reference to (+)-enantiomer in claim is a reference to (+)-enantiomer isolated from the (-)-enantiomer - relevance of degree of purity - whether primary judge added integers to claim - relevance of text of specification to construction of claims PATENTS - novelty - whether a racemate anticipates an enantiomer - clarity - whether claims are clear - whether claims define the invention - utility - range of dosage in claim - whether entire range of dosage claimed has to be useful - whether entire range of dosage is useful PATENTS - infringement - method for preparation of a compound - whether method claim in patent-in-suit excluded possibility of substituting another halogen or pseudo-halogen for the cyano group disclosed in the claim - whether the cyano-diol was an essential integer PATENTS - extension - whether pharmaceutical substance per se - whether (+)-enantiomer disclosed in patent is contained in racemate included in Australian Register of Therapeutic Goods

Acme Bedstead Company Limited v Newlands Brothers Limited (1937) 58 CLR 689 Apotex Pty Ltd (formerly Genrx Pty Ltd) v Sanofi-Aventis (2008) 78 IPR 485 Austal Ships Pty Ltd v Stena Rederi Aktiebolag (2005) 66 IPR 420 Biogen Inc v Medeva plc (1996) 36 IPR 438 Bristol-Myers Squibb Company v FH Faulding & Co Limited (2000) 97 FCR 524 C Van der Lely NV v Bamfords Ltd (1962) 1A IPR 86 Catnic Components Limited v Hill & Smith Limited [1982] RPC 183 Clorox Australia Pty Ltd v International Consolidated Business Pty Ltd (2006) 68 IPR 254 Décor Corporation Pty Ltd v Dart Industries Inc (1988) 13 IPR 385 Emory University v Biochem Pharma Inc [1999] APO 50 Flexible Steel Lacing Company v Beltreco Ltd (2000) 49 IPR 331 General Tire & Rubber Company v Firestone Tyre and Rubber Company Ltd (1971) 1A IPR 121 Generics (UK) Ltd v H Lundbeck A/S [2007] RPC 729 H Lundbeck A/S v Generics (UK) Ltd [2008] RPC 437 Hill v Evans (1862) 1A IPR 1 Househill Co v Neilson 1 Webst Pat Ca 718 In re May (1978) 574 F 2d 1082 Insta Image Pty Ltd v KD Kanopy Australasia Pty Ltd (2008) 78 IPR 20 International Business Machines Corporation v Commissioner of Patents (1991) 33 FCR 218 Imperial Chemicals Industries Pty Ltd v Commissioner of Patents (2005) 213 ALR 399 Jupiters Ltd v Neurizon Pty Ltd (2005) 222 ALR 155 Kimberly-Clark Australia Pty Limited v Arico Trading International Pty Limited (2001) 207 CLR 1 Kirin-Amgen Inc v Hoechst Marion Roussel Ltd (2004) 64 IPR 444 Merck & Co Inc v Arrow Pharmaceuticals Ltd (2003) 59 IPR 226 Merrell Dow Pharmaceuticals Inc v HN Norton & Co Ltd (1995) 33 IPR 1 Meyers Taylor Pty Limited v Vicarr Industries Limited (1977) 137 CLR 228 Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 Olin Corporation v Super Cartridge Co Pty Ltd (1977) 180 CLR 236 Ortho-McNeil Pharmaceutical Inc v Mylan Laboratories Inc (2004) 348 F Supp 2d 713 Pfizer Inc v Ranbaxy Laboratories Limited (2005) 405 F Supp 2d 495 Ranbaxy Australia Pty Ltd v Warner-Lambert Co LLC (2008) 77 IPR 449 Re Genentech Inc's (Human Growth Hormone) Patent [1989] RPC 613 Re Williams (1948) 171 F 2d 319 Root Quality Pty Ltd v Root Control Technologies Pty Ltd (2000) 177 ALR 231 Sachtler GmbH and Co KG (formerly Sachtler AG) v RE Miller Pty Ltd (2005) 221 ALR 373 SmithKline Beecham plc's (Paroxetine Methanesulfonate) Patent [2006] RPC 323 University of Georgia Research Foundation v Biochem Pharma Inc (2000) 51 IPR 222 Welch Perrin and Company Proprietary Limited v Worrel (1961) 106 CLR 588 William WM Wrigley Junior Company v Cadbury Schweppes Pty Ltd (2005) 66 IPR 298 H. LUNDBECK A/S and ANOR v ALPHAPHARM PTY LTD (ACN 002 359 739)

(1937) 58 CLR 689

(2008) 78 IPR 485

(2005) 66 IPR 420

(1996) 36 IPR 438

(2000) 97 FCR 524

(2006) 68 IPR 254

(1988) 13 IPR 385

(2000) 49 IPR 331

(2008) 78 IPR 20

(1991) 33 FCR 218

(2005) 213 ALR 399

(2005) 222 ALR 155

(2001) 207 CLR 1

(2004) 64 IPR 444

(2003) 59 IPR 226

(1995) 33 IPR 1

(1977) 137 CLR 228

(1990) 91 ALR 513

(1977) 180 CLR 236

(2008) 77 IPR 449

(2000) 177 ALR 231

(2005) 221 ALR 373

(2000) 51 IPR 222

(1961) 106 CLR 588

(2005) 66 IPR 298