way to do what can be done already but is, in fact, a significant advance in therapeutic capability". Example 5 is as follows:
"ALA was dissolved in isotonic saline and then administered systemically to mice by either subcutaneous or intraperitoneal injection, at a dose of 100 to 500 mg per kg of body weight. Three hours later, the mice were sacrificed and frozen sections were taken of the uterus. [W]hen these sections were examined by fluorescence microscopy, the endometrium showed strong protoporphyrin fluorescence while the underlying myometrium did not. Since the ALA was administered systemically, it certainly must have been present in the myometrium, and the ensuing lack of protoporphyrin fluorescence in the myometrium must indicate that when supplied with an excess of exogenous ALA. The myometrium therefore will not become photosensitized if ALA is applied directly to the surface of the endometrium, and subsequent exposure of both the endometrium and the myometrium of the uterus to photoactivating light should result in preferential ablation of the endometrial tissue."
"Ablation" in that context means the removal of abnormal growths.
111 With respect to menorrhagia Professor Moore indicated that he would have concluded from the patent that the invention should be worked by administering ALA systemically and exposing the endometrium to light in the usual way. Professor Moore gave the following evidence (at T 180-181):
"CATTERNS: … Could I just confine myself to the patent. With the teaching of the patent, even though there are a limited number of examples, you would have sufficient information to conduct standard tests to use the method of the patent with respect to tissues other than those that appear in the examples?
MOORE: Yes.
CATTERNS: That's the case whether it be malignant or non-malignant lesions?
MOORE: That would be so, yes.
CATTERNS: In the case of menorrhagia - you understand that's an abnormality of the endometrium. Is that right?
MOORE: I'm not a gynaecologist or obstetrician, therefore I cannot comment specifically on the precise clinical definition of this but, yes, that's my understanding of it.
CATTERNS: It often leads to greatly excessive bleeding?
MOORE: Yes.
CATTERNS: The mouse experiment there showed localisation of the - by all means have a look at the patent if we need it. The mouse experiment showed localisation of fluorescence in the endometrium. Is that right?
MOORE: That's correct, yes.
CATTERNS: Rather than in underlying tissue?
MOORE: Rather than in the myometrium, yes.
CATTERNS: So does that lead you to understand that if one applied - sorry, the method of application of the method for dealing with menorrhagia would be to apply the ALA systemically. Is that right?
MOORE: I must assume this would be the case, yes.
CATTERNS: Upon its going into the endometrium, then you shine light on it in the usual PDT way using fibre optics or whatever?
MOORE: Using an appropriate light source, yes."
112 Professor Waner (at T 355) gave the following evidence as to what he could glean from example 5 about the use of the invention to treat menorrhagia:
"Well, the treatment of menorrhagia prior to this, I think the conventional treatment - and once again [I'm not a] gynaecologist - that is, a D and C, dilatation and curettage. The process of curettage means evacuating the contents of the uterus. The hypervascular endometrium is scraped off the uterus leaving the lining and the muscle behind. So what he's stating here [in example 5] is that by systemically administering ALA the endometrium accumulates a high concentration of drug whereas the myometrium does not, and that would mean that if one subsequently exposed the uterus or the inside of the uterus to light, the endometrium would be destroyed and the muscle there, the myometrium, would not be destroyed. So what he's doing is, he's setting the ground or he's establishing the fact that it would be possible to treat some abnormality of the endometrium without destroying the myometrium, whether this was an endometrial carcinoma or just menorrhagia, given that the normal treatment for menorrhagia was dilatation and curettage. Having said that, I would say that example 5 does not specifically refer to menorrhagia and so it merely obliquely refers to the - or it merely refers to a differential concentration between the lining of the uterus and the muscle of the uterus. But it does not refer specifically to menorrhagia."
113 Although Professor Waner did not accept that the results permit an extrapolation as to whether the same treatment would work on a human patient, that relates to utility rather than sufficiency. Also, while the example did not expressly relate to the treatment of any condition, I am satisfied that a person skilled in the art would understand that the example is being proffered as a method for treating menorrhagia. That interpretation is supported by the context, by the specification read as a whole, by claim 1 (treatment of the endometrium) and by claim 5 (treatment of menorrhagia) and the expert evidence to which I have referred.
114 Keeping in mind that s 40(2)(a) questions are to be resolved by a reading of the specification as a whole, including the body of the specification and the claims, I am of the view that a reader skilled in the art would conclude that example 5 is an example of a systemic use of the invention described in the patent for the treatment of menorrhagia. In the light of the above matters, including the evidence of Professors Moore and Waner, a person skilled in the art would have been able to work the menorrhagia treatment "without new inventions or additions or prolonged study of matters presenting initial difficulty" (Kimberly-Clark at [25]).
115 In relation to its "best method" arguments, PhotoCure's particulars allege that the patent fails to describe the best methods for (a) treating a patient with menorrhagia; and (b) detecting malignant and non-malignant tissue abnormalities and lesions of the skin, mucosa, endometrium and urothelium in a patient.
116 In order to demonstrate invalidity on this basis it is necessary to show that at the time of filing of the complete specification, the patentee was aware of a specific "best method" of performing the invention that was not included in the specification: Rescare at 220-222. Although PhotoCure cross-examined Professor Kennedy on this issue, it failed to adduce evidence that would satisfy the criterion stated in Rescare.
(d) Lack of definition
117 Section 40(2)(b) of the Act requires that a complete specification must "end with a claim or claims defining the invention". This requirement is related to the requirement in s 40(3) that the claims must be clear and succinct, in that if sufficient ambiguity attends a claim it may be invalid for failing to define the invention. However, invalidity will only arise if the claim is "incapable of resolution by a skilled addressee by the application of common sense and common knowledge": see Innovative Agriculture Products Pty Ltd v Cranshaw (1996)35 IPR 643 ("Innovative Agriculture") at 666. This test from Electric & Musical Industries Ltd v Lissen Ltd [1938] 4 All ER 221 ("Electric & Musical") at 224 acknowledges the function of the claims, namely:
"… to define clearly and with precision the monopoly claimed, so that others may know the exact boundaries of the area within which they will be trespassers. Their primary object is to limit, and not to extend, the monopoly. What is not claimed is disclaimed."
118 In its particulars of invalidity, PhotoCure alleged that claims 1, 11 and 12 were defective in that they did not define the invention. Those grounds were not raised in closing submissions, however as there was no express indication that they were no longer pressed I will briefly consider them.
119 The arguments arise out of what might have been difficulties of interpretation. In the case of claim 1 this was said to be because of ambiguity as to what part of the phrase "malignant and non-malignant tissue abnormalities and lesions of the skin; conjunctiva; respiratory, digestive and vaginal mucosa; endometrium; and urothelium" is referred back to by the phrase "said lesions". Claim 11 was said to be defective in that it relates to a method for the detection of abnormalities and lesions, however it refers to the use of that method "in a patient in need of such treatment" [emphasis added]. Both of these difficulties appear to me to fall within what the High Court in Welch Perrin and Company Pty Ltd v Worrel (1961) 106 CLR 588 ("Welch Perrin") referred to at 610 as "purely verbal or grammatical question[s] that can be resolved according to ordinary rules for the construction of written documents" and which therefore do not create uncertainty in the definition of the invention so as invalidate the claims in question. See also Kauzal v Lee (1936) 58 CLR 670 at 685. In the case of claim 11 it seems clear that the reference to "a patient in need of such treatment" would be read by the skilled addressee as if it referred to "a patient in need of such detection" that is, detection of any of the abnormalities or lesions referred to in claim 11.
120 In respect of claim 1 there are two reasons for treating the phrase "in said lesions" as referring back to all of the previously mentioned lesions and abnormalities. The first is that the specification does not appear to draw a distinction between its use of the terms "lesion" and "abnormality". Although Professor Waner gave evidence tending to suggest that those skilled in the art might usually treat the term "abnormality" as encompassing, but being slightly wider than, the term "lesion", it is possible that they are used in the patent in a different way and it is therefore necessary to read them in the light of the specification as a whole: Kimberly Clark at 12 [15]. In that respect the patent appears, in several places, to use the terms almost interchangeably. One example of this is that although the consistory clause titled "Statement of Invention" refers to the detection and treatment of "lesions", the sections titled "Field of Invention" and "Object of Invention" only refer to the detection and treatment of "tissue abnormalities". Nothing said in the specification indicates any reason why the references to "lesions" would be narrower than the references to "tissue abnormalities", or any reason why the invention might be appropriate for use on the former but not the latter. Also, if the phrase "said lesions" in claim 1 was to be treated as exclusive of the "tissue abnormalities" referred to in the first line of that claim, the reference to "tissue abnormalities" would be made entirely meaningless. For the above reasons I am satisfied that the meaning of claim 1 is sufficiently clear.
121 Claim 12 was said to lack definition on two grounds. The first ground was that it claims "a method of treatment" according to claim 11, whereas claim 11 is for "a method of detecting…". As explained above I do not consider that there is any merit in that ground.
122 The second ground was that claim 12 claims a method according to claim 5 as described in the patent with reference to the examples. PhotoCure claimed that there are no examples of treating menorrhagia in patients. However, as explained above, a person skilled in the art would regard example 5 as being related to the treatment of menorrhagia.
123 Further, there is nothing unusual about a claim that is based on an example. A claim by reference to the description in the body of the specification is not per se impermissible (Raleigh Cycle Co Ltd v H Miller & Co Ltd [1948] 1 All ER 308 ("Raleigh Cycle Co"); General Steel Industries Inc v State of New South Wales (1967) 40 ALJR 464at 467 and Windsurfing International Inc v Petit [1984] 2 NSWLR 196), although it may be where the description referred to is insufficiently specific to define the scope of the monopoly claimed: see for example: Philpott v Hanbury (1885) 2 RPC 33 at 39-40; Rose Street Foundry and Engineering Company Ld v India Rubber Gutta Percha and Telegraph Works Company Ld (1929) 46 RPC 294 at 309; and Cincinnati Grinders (Inc) v B.S.A. Tools Ld (1931) 48 RPC 33 at 76 and 85.
124 In Raleigh Cycle Co at 320-321 Lord Morton explained the rationale behind claims such as claim 12:
"…For many years it has been a common practice to insert, as the last claim in a patent specification, a claim on the same lines as claim 5 in the present case. I think that the reason why such a claim has been inserted, in the present case and in countless other cases, is as follows. The patentee fears that his earlier claims may be held invalid because they cover too wide an area or fail sufficiently and clearly to ascertain the scope of the monopoly claimed. He reasons: 'If I have made a patentable invention and have described the preferred embodiment of my invention clearly and accurately and without any insufficiency in the directions given, I must surely be entitled to protection for that preferred embodiment, and that protection may fairly extend to cover anything which is substantially the same as the preferred embodiment.'"
125 The test of validity in respect of such claims is the same as that generally applicable. The claim must be sufficiently clear to indicate to the notional addressee what are the limits of what is being claimed. The evidence and other matters to which I referred in relation to the question of sufficiency in relation to claim 5 would enable the notional addressee to define the limits of claim 12 by reference to claims 1 and 5, example 5 and the invention described in the patent.
126 Accordingly, PhotoCure's challenge on the ground of lack of definition also fails.
(e) Fair basis
127 Section 40(3) of the Act requires that the claim or claims in a patent "must be clear and succinct and fairly based on the matter described in the specification". A consideration of fair basis involves a comparison between the scope of the claim or claims that are challenged on the one hand, and the description of the invention that is provided in the specification pursuant to s 40(2)(a) on the other: Kimberly-Clark at 12 [15].
128 The body of the specification must provide a "real and reasonably clear disclosure" of the matters that are claimed: in Société des Usines Chimiques Rhône-Poulenc v Commissioner of Patents (1958) 100 CLR 5 per Fullagar J at 11, followed in F. Hoffman-La Roche & Co. Aktien-Gesellschaft v Commissioner of Patents (1971) 123 CLR 529 at 359, Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 81 ALR 79 ("Rehm") at 93, Leonardis at 142, CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260 at 281-282 and Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (2004) 212 ALR 1 ("Lockwood") at 69. Correlatively, the claims must not travel beyond the matter described in the body of the specification: per Barwick CJ in Olin at 240, followed in Kimberly-Clark at 12 [15], and Lockwood at 26 [91]. See also Atlantis Corporation Pty Ltd v Schindler (1997) 39 IPR 29 at 50.
129 PhotoCure's case on lack of fair basis related to the following matters:
(1) the use of precursors in the biosynthetic pathway to heme other than ALA
PhotoCure argued that claims 9 and 11 are not fairly based on the description contained in the specification to the extent that they refer to the use of precursors to PpIX in the biosynthetic pathway for heme other than ALA.
(2) the use of ALA and other precursors of PpIX in the detection of abnormalities and lesions
PhotoCure argued that claim 11 is not fairly based because it relates to the detection of abnormalities and lesions, as opposed to the treatment of abnormalities and lesions.
(3) the methods used for the administration of ALA
PhotoCure argued that claims 1-6 and 8-11 are not fairly based in so far as they include the administration of ALA by means other than topical application.
(4) the types of lesions and abnormalities which may be treated or detected
PhotoCure argued that the claims in the patent are too broad and are therefore not fairly based by reason of including too broad a range of lesions, abnormalities and tissues that may be treated or be the subject of detection. In this respect it pleaded that:
· claim 1 and the other claims dependent on it (claims 2, 3, 4, 6, 7 and 8) are too broad to the extent that they include the treatment of lesions other than hyperproliferative lesions;
· claims 1-10 are too broad to the extent that they relate to lesions other than squamous and basal cell carcinomas; and
· claims 1-6 and 8-11 are too broad to the extent that they relate to the conjunctiva; the respiratory, digestive and vaginal mucosa; the endometrium; and the urothelium.
130 Further, although not included in its particulars of invalidity, PhotoCure submitted in its written closing submissions that the reference to the treatment of menorrhagia in claim 5 is not supported by any disclosure in the specification.
131 PhotoCure also argued that claims 1 and 9 and the claims dependent on them (claims 2, 3, 4, 6, 7, 8, 10 and 12) are too broad to the extent that they "include all lesions" and not only those that can synthesise clinically useful amounts of PpIX when provided with an excess of ALA. However, claims 1 and 9 (and therefore the claims dependent on them) are limited, by the inclusion of the words "so as to induce synthesis of protoporphyrin IX", to use in the treatment of lesions that are able to synthesise PpIX. Further, a reader skilled in the art would interpret those claims in the context of the patent as limited to lesions that are able to synthesise what PhotoCure refers to as "clinically useful amounts" of PpIX. That reading follows from the "limitation by result" included in claim 1.
132 Before considering each of these submissions in detail, it is necessary to set out some points of principle. Firstly, to a large extent, PhotoCure's arguments were premised on the contention that the claims should not travel beyond the disclosure set out in the examples. The patent specification contains five examples. Three of these involve the treatment of squamous cell carcinomas in the skin by topical application of ALA; one involves the treatment of basal cell carcinomas in the skin by topical application of ALA; and one involves the injection of ALA into mice, followed by examination by fluorescence microscopy of their uteri. PhotoCure in effect argued that the claims should not be permitted to travel beyond the disclosure in those examples. For example, it submitted that "[t]here can be no fair basis for a claim to the treatment of the numerous malignant and non malignant tissue abnormalities and lesions of the skin from which a patient might suffer other than those referred to in the examples".
133 But the disclosure in the specification is not limited to that which is contained in the five examples. In Lockwood, Gleeson CJ, McHugh, Gummow, Hayne and Heydon JJ emphasised the need to consider the specification as a whole in order to ascertain what it discloses as the invention. Their Honours observed at [69] and [99] that the "inquiry is into what the body of the specification read as a whole discloses as the invention". At [69] their Honours warned against an approach to fair basis that focuses on particular sections of the specification rather than considering it as a whole, and cited the following passage from Rehm at 95:
"…The circumstance that something is a requirement for the best method of performing an invention does not make it necessarily a requirement for all claims; likewise, the circumstance that material is part of the description of the invention does not mean that it must be included as an integer of each claim. Rather, the question is whether there is a real and reasonably clear disclosure in the body of the specification of what is then claimed, so that the alleged invention as claimed is broadly, that is to say in a general sense, described in the body of the specification."
134 There is therefore no reason to restrict the consideration of the specification's disclosure, for the purpose of fair basing, to the examples. When s 40(3) requires that a patent's claims must be fairly based on "the matter described in the specification", it refers back to the description of the invention required by s 40(2) (see Lockwood at [53]). That is not limited to the examples. Rather, the specification must be read as a whole in order to ascertain what it discloses as the invention.
135 It is clear that the scope of the description set out in the specification extends significantly beyond the content of the examples. For example, the specification:
(1) says that "treatment of basal cell, baso-squamous and squamous cell carcinomas and other lesions of the skin, mucosa (respiratory, digestive, and vaginal), endometrium and urothelium is contemplated" and that "[t]reatment of non-malignant lesions such as genital warts and psoriasis is also contemplated.";
(2) sets out an extensive list of the sites on which the invention could be used:
"Sites could include lesions involving (i) skin and conjunctiva; (ii) the lining of the mouth, pharynx, esophagus, stomach, intestines and intestinal appendages, rectum, and anal canal; (iii) the lining of the nasal passages, nasal sinuses, nasopharynx, trachea, bronchi, and bronchioles; (iv) the lining of the ureters, urinary bladder, and urethra; (v) the lining of the vagina, uterine cervix, and uterus; (vi) the parietal and visceral pleura; (vii) the lining of the peritoneal and pelvic cavities, and the surface of the organs contained within those cavities; (viii) the dura mater and meninges; (ix) any tumors in solid tissues that can be made accessible to photoactivating light either directly, at time of surgery, or via an optical fibre inserted through a needle." (p 9);
(3) refers three times to the administration of precursors to PpIX in the biosynthetic pathway other than ALA (pp 7-8);
(4) states that an object of the invention, and "one aspect of" the invention, is its use in detecting malignant and non-malignant lesions in a patient (pp6 and 7); and
(5) states that the treatment may be achieved by the administration "systemically or topically" of the precursor to PpIX (p 7); and, referring specifically to ALA, that it may be administered "orally, topically or by injection", with the "oral and parenteral routes lead[ing] to the induction of clinically useful concentrations of PpIX in certain benign and malignant tissues throughout the body" (pp 8-9) and that it "is an effective inducer of PpIX when given by mouth, by topical application, or by injection" (p 11).
It is therefore clear that the scope of the specification is far wider than the examples looked at alone.
136 In effect, the submission made by PhotoCure was that the examples provide the only "real and reasonably clear disclosure" in the specification. The difficulty with that qualitative approach is that in Lockwood at [87] the High Court observed that it is possible for a claim to be fairly based on nothing more than a use of the same words in the specification (including in a consistory clause), as long as those words reflect the disclosure provided in the specification when read as a whole. Thus, s 40(3) does not require that the specification describe the invention in a different or more detailed way than the supported claims.
137 However, PhotoCure's additional submission was that, in effect, much of the disclosure in the specification outside the examples amounts to "no more than speculation" as to whether the invention will work and that invalidity should result from speculative claiming. In particular, PhotoCure referred to a portion of the specification stating that certain uses of the invention are "contemplated". The specification states that at the present time, treatment of basal cell, baso-squamous and squamous cell carcinomas and other lesions of the skin, mucosa (respiratory, digestive, and vaginal), endometrium and urothelium "is contemplated" and that treatment of non-malignant lesions such as genital warts and psoriasis is also contemplated." However, I do not consider that the use of that language would have communicated to the skilled addressee that the patentee was merely speculating about possible uses of the treatment. Rather, the phrase communicates that such uses are contemplated "at the present time". Read together with the examples, four of which concern actual uses of the treatment carried out on squamous and basal cell carcinomas of the skin, I do not accept that this section of the specification is "no more than speculation". Further, there is no reason why the inclusion in claims of some embodiments which have not yet been proven to work would fall foul of s 40(3). Even if some such embodiments are subsequently shown not to work, that does not invalidate the claims in respect of those embodiments on the ground of lack of fair basis. In Alphapharm (FCA) at [201] Lehane J explained:
"…The authorities do not, in my view, support a proposition that a claim will be fairly based on a specification only if every way of performing the invention, within the terms of the claim, will produce the result claimed for the invention. There may be questions of degree; but it cannot be right that a claim of the patent in suit would be fairly based only if it claimed particular compounds, particular quantities and particular combinations which the specification disclosed as effective to produce (to some extent, though not necessarily to the extent achieved by the inventor's best method) the purpose of the invention."
That position was confirmed by the Full Court in Bristol-Myers at 552-553 [77]-[79]:
"The invention claimed is, after all, a very simple one. The fact (if it is the fact) that not every method of performing the invention will, for example, have a therapeutic effect on every kind of cancer would not mean that the specifications do not meet the requirement of 'sufficiency' as ordinarily understood. …
…
To an extent, at least, similar comments might be made in relation to fair basing. …Questions of fair basing may, no doubt, involve matters of degree (see, for example Aktiebolaget Hässle v Alphapharm Pty Ltd (1999) 44 IPR 593 at 646 [200] and 646-647 [201]): and there is a point at which matters of the kind relied on here by the respondent go to inutility (a ground of invalidity which the respondent does not raise) rather than lack of fair basing."
138 I now turn to consider the specific allegations of lack of fair basing that I have summarised above.
139 The first submission relates to the claiming of the use of precursors of PpIX in the biosynthetic pathway to heme other than ALA. As explained above, the body of the specification refers not only to ALA but to precursors of PpIX in the biosynthetic pathway generally. This is done in the consistory clause. There appears to be no reason why a description provided in a consistory clause is not sufficient to base a claim, so long as it is not in conflict with the description that is provided by the body of the specification when read as a whole (Lockwood at [99]). In the present case I consider that a reading of the body of the specification as a whole indicates that the use of ALA is merely the "preferred embodiment" of the invention, and that the description of the invention includes other precursors to PpIX in the biosynthetic pathway to heme.
140 PhotoCure also pressed this aspect of its fair basis argument by submitting that not all precursors to PpIX in the biosynthetic pathway to heme would be effective as PDT agents. However, as explained above, that is relevant to a challenge on the ground of inutility rather than fair basis, but PhotoCure made no challenge on that ground.
141 The second submission relates to the claiming of a method for the detection of abnormalities and lesions. Again, I consider that disclosure of this aspect of the invention is adequately made in the consistory clause, which is also supported by the discussion in the opening section of the patent headed "Background of Invention" which discusses the use of porphyrins in detecting tissue abnormalities.
142 The third submission concerns the claiming of means of administering ALA in the biosynthetic pathway to heme other than by topical application. However, that process is also described sufficiently in the body of the specification. PhotoCure's contentions in this respect were based on the fact that examples 1 to 4 involve only topical application of ALA. But, as I have indicated above, the examples cannot be read in isolation from the rest of the body of the specification. The specification makes repeated reference to the systemic administration of ALA, including oral administration and administration by injection.
143 In respect of the fourth submission, the questions that arise are whether there is a fair and reasonable disclosure in the specification of the following matters:
(i) the treatment of lesions other than squamous and basal cell carcinomas;
(ii) the treatment of lesions other than hyperproliferative lesions; and
(iii) the treatment of lesions occurring in the conjunctiva; respiratory, digestive and vaginal mucosa; endometrium and urothelium.
144 The consistory clause headed "Statement of Invention" (p 7) describes an aspect of the invention as "a method for treating malignant and non-malignant hyperproliferative lesions of the skin, mucosa, endometrium and urothelium…" [emphasis added]. In the section headed "Detailed Description of Preferred Embodiment" the specification states that:
"At the present time, treatment of basal cell, baso-squamous and squamous cell carcinomas and other lesions of the skin, mucosa (respiratory, digestive, and vaginal), endometrium and urothelium is contemplated. Treatment of non-malignant lesions such as genital warts and psoriasis is also contemplated. Sites could include lesions involving (i) skin and conjunctiva; (ii) the lining of the mouth, pharynx, esophagus, stomach, intestines and intestinal appendages, rectum, and anal canal [the digestive mucosa]; (iii) the lining of the nasal passages, nasal sinuses, nasopharynx, trachea, bronchi, and bronchioles; (iv) the lining of the ureters, urinary bladder, and urethra; (v) the lining of the vagina, uterine cervix, and uterus; (vi) the parietal and visceral pleura; (vii) the lining of the peritoneal and pelvic cavities, and the surface of the organs contained within those cavities; (viii) the dura mater and meninges; (ix) any tumors in solid tissues that can be made accessible to photoactivating light either directly, at time of surgery, or via an optical fibre inserted through a needle." [Emphasis added]
145 As explained above, I do not consider that the use of the words "is contemplated" detracts from the quality or extent of the disclosure that is made. In my view these sections of the specification, when read in the context of the specification as a whole (and even without reference to evidence as to whether "sites" (ii) to (ix) referred to would necessarily indicate that the treatment was directed to the respiratory, digestive and vaginal mucosa; the endometrium; or the urothelium), are sufficient to encompass the treatment of malignant and non-malignant lesions, including but not limited to squamous, basal and baso-squamous cell carcinomas, psoriasis and genital warts, when they occur in the conjunctiva; the respiratory, digestive or vaginal mucosa; the endometrium, or the urothelium.
146 This leaves the question of whether the disclosure contained in the patent is limited in its scope to the treatment of hyperproliferative lesions. The consistory clause refers to "a method for treating malignant and non-malignant hyperproliferative lesions of the skin, mucosa, endometrium and urothelium in a patient…" [emphasis added]. Professor Moore defined "hyperproliferative" as meaning "the abnormally increased or excessive reproduction or multiplication of similar forms, especially of cells, and refers to cells which have higher rates of hyperplasia, that is, growth in cell numbers." Professor Waner gave substantially the same definition and explained the relationship between the concept of hyperproliferation and malignancy:
"…hyperproliferative means that the cells are dividing at a rate which is greater than the normal rate of cell division. If those cells are both dividing and spreading, then it's malignant; if they're dividing and remaining locally, then it's a benign process, but both are hyperproliferative." (T 344)
It is necessary to consider whether the specification, read as a whole, discloses the treatment of non-hyperproliferative lesions. After the consistory clause, under the heading "Detailed Description of Preferred Embodiment", where the types of lesions and sites in respect of which treatment is contemplated are discussed, no mention is made of a requirement of hyperproliferation. The only lesions referred to are basal cell, baso-squamous and squamous cell carcinomas and other lesions of the skin, mucosa (respiratory, digestive, and vaginal), endometrium and urothelium; genital warts; and psoriasis. However, other than Professor Waner's observation (at T 344) that "most cancers result from proliferation of cells in an uncontrolled manner" it was not clear from PhotoCure's evidence whether these conditions were all hyperproliferative in nature and whether that would lead a reader skilled in the art to conclude that the disclosure in the body of the specification related only to the detection and treatment of hyperproliferative lesions. Neither did PhotoCure lead evidence indicating that there was some biochemical or pharmacological reason why the notional addressee might consider that the method might work in relation to hyperproliferative lesions and not in respect of other abnormalities. In all the circumstances, I am not satisfied that a reader skilled in the art would have regarded the disclosures in the specification as limited only to hyperproliferative lesions.
147 In its closing written submissions PhotoCure additionally argued that claim 5 is invalid for lack of fair basis in that there is insufficient disclosure in the body of the specification relating to menorrhagia. Although this point was not raised in PhotoCure's particulars of invalidity, it appeared from the opening submissions (see for example T 104) that this ground was raised and no objection was taken by DUSA to it being relied upon. In support of its arguments in this respect, PhotoCure relied on certain testimony from Professor Waner, (at T 355-356) to the effect that:
· example 5 does not refer specifically, but rather only "obliquely", to menorrhagia; and
· one should not extrapolate from results obtained on healthy mouse tissue to what might occur in the treatment of menorrhagia in a human.
148 Neither of these statements would be sufficient to cause claim 5 to be invalid for lack of fair basis. In respect of the first point, as I have explained, the evidence does not establish that the body of the specification, including through example 5, did not disclose menorrhagia as an application of the invention to the notional skilled addressee at the priority date. For the reasons explained in relation to sufficiency, the patent specification read as a whole discloses such an application, even if it does not do so expressly. While it would be preferable for a patent specification to set out its parameters expressly, this is not the test under s 40(3). PhotoCure has not established that a skilled addressee would not have understood the body of the specification as disclosing the treatment of menorrhagia.
149 The second point set out above appears to relate again to the notion of "speculative claiming". It appears to be correct that the body of the specification does not expressly disclose that the invention had been tested on, and would work for, cases of menorrhagia. However, the views of Lehane J in Alphapharm (FCA) at [201] and the Full Court in Bristol-Myers at [77]-[79], to which I have referred, indicate that it is not necessary for fair basis that every possible application of the invention has been demonstrated to work.
150 PhotoCure also argued that if it was found that any of the claims include a method that covered the use of methyl-ALA, that claim would not be fairly based on any disclosure in the specification. However, as I later conclude that such a method is not covered by the claims, I do not need to further consider that submission.
151 For the above reasons, PhotoCure's claim for revocation of the patent on the ground of invalidity must be refused.
5. Infringement
152 DUSA's infringement case is based on the marketing, supply and use of Metvix and Metvix PDT, which were developed by PhotoCure and licensed to Galderma.
153 Metvix PDT is a method for treating basal cell carcinoma and actinic keratoses. The process involves the topical application of Metvix to a patient followed by exposing the area to be treated to red light within a continuous spectrum of 570 to 670 nm.