Kimberly-Clark Australia Pty Limited v Multigate Medical Products Pty Limited - [2010] FCA 1318 - FCA 2010 case summary — Zoe

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Kimberly-Clark Australia Pty Limited v Multigate Medical Products Pty Limited

[2010] FCA 1318

Federal Court of Australia|2010-11-30|Before: Stone J

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Court

Federal Court of Australia

Decision date

2010-11-30

Before

Stone J

Source

Original judgment source is linked above.

Judgment (38 paragraphs)

[1]

The application be dismissed.
The cross-claim be dismissed.
The applicants pay the respondent's costs of the application.
The respondent pay the applicants' costs of the cross-claim. Note: Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules. The text of entered orders can be located using Federal Law Search on the Court's website. IN THE FEDERAL COURT OF AUSTRALIA NEW SOUTH WALES DISTRICT REGISTRY GENERAL DIVISION NSD 149 of 2009

[2]

JUDGE: STONE J DATE: 30 NOVEMBER 2010 PLACE: SYDNEY

[3]

REASONS FOR JUDGMENT 1 The second applicant, Kimberly-Clark Worldwide Inc, (KCW) is the registered proprietor of the three Australian patents in suit (the Patents), namely 695238 (the Grandparent), 715940 (the Parent) and 758905 (the Child). The Child is a divisional of the Parent, and the Parent is a divisional of the Grandparent. Each patent is entitled, "Single Step Sterilization Wrap System". The priority date for all claims in each patent is 30 June 1993. This priority date stems from the filing of US Patent 08/084851. 2 The first applicant, Kimberly-Clark Australia Pty Limited, is the exclusive licensee in Australia of the three patents. I shall refer to the applicants, collectively, as Kimberly-Clark unless it is necessary to distinguish between them. 3 The patents are for a single step sterilisation wrap system. Sterilisation wrap systems are designed to facilitate the sterilisation and storage of instruments, generally surgical instruments, and other supplies, by wrapping them before the sterilisation procedure. After sterilisation the sterile wrap remains in place protecting the items and allowing them to be stored without contamination until required for use. Sterile wraps are designed to allow the permeation of the sterilising agent but not contaminating agents. 4 The specifications in each of the three patents state that the Association of Operating Room Nurses (AORN) recommends double wrapping for in-hospital sterilisation of instrument packages. The practice of double wrapping is said to reduce tears, holes and wetness that may compromise sterility. Double wrapping can be effected by sequential single wrapping or by wrapping in two sheets simultaneously. Simultaneous wrapping is said to have the advantage over sequential wrapping of saving time however that advantage may be lost by the awkwardness involved in manipulating the loose sheets and the time taken to align the two sheets of wrapping. 5 The patents in suit address the problems involved in double wrapping with loose sheets and allow double wrapping to be completed in one step while avoiding these difficulties. The inventions which are the subject of the patents provide a combination of inner and outer wrapping sheets that have been joined together. The sheets are joined in a way that it is obvious to the user that double wrapping is being achieved, albeit in one step. The applicant claims that this system "provides an efficient and consistent single step system which was unachievable using the products and methods of the prior art".

[11]

Defence to infringement 15 The respondent primarily denies infringement on the simple basis that the Multigate Product is comprised of a single sheet which is folded over to give two layers. This contention applies to all the pleaded claims and therefore is central to the infringement case. Inherent in this defence is the proposition that the inventions claimed in the Patents are predicated on the two sheets referred to in the Patents initially being separate, physically unconnected, sheets that are subsequently joined. In contrast the Multigate Product achieves the advantages of double wrapping by folding without resorting to two sheets. There are also some other iterations concerning bond sites that the respondent relies on to rebut the claim of infringement. 16 The parties identified four claims in respect of which submissions on infringement would be made. The four claims were selected on the basis that if the Multigate product did not infringe any of the four it would not infringe the balance of the claims said to be infringed by the Multigate product. For instance, it was accepted that if (a) the claims require the joining of sheets that are initially unconnected; and (b) the Multigate product consists of only one sheet that is folded over is correct, then the respondent will have defeated all claims of infringement. 17 Multigate also submits that its product does not infringe claims having a requirement of a plurality of bonds. It contends that the Multigate product has a single bond and no form of it has a plurality of bonds. 18 Multigate also submits that the structure of its product is such that it does not infringe certain of the claims that specify a particular structure for the sheets. In so far as the claim in the applicants' patents specify a structure of the fabric comprising the wrap, it is described as being a laminate which consists of a spunbond layer, a meltblown layer and a second spunbond layer. Multigate contends that the fabric of its product is comprised of a spunbond layer, a further spunbond layer, a meltblown layer, a further meltblown layer and a spunbond layer and that this structure does not fall within those claims. Expert evidence was given by Dr Niall Finn, a research scientist with the Commonwealth Scientific and Industrial Research Organisation (CSIRO) who affirmed two affidavits (dated respectively 5 August and 12 November 2009). In his first affidavit Dr Finn provided a general primer "on the relevant aspects of the technology relating to technical textiles and nonwoven fabrics" and copies of images made with a scanning electron microscope while looking at samples of the fabric used in the Multigate product. Dr Finn also provided information on spunbond and meltblown processes, the manufacture of composite fabrics and ultrasonic bonding as well as comments on the patents in suit. 19 Following comments and suggestions for amendment made by the solicitors for Multigate, Dr Finn prepared an amended primer (attached to his second affidavit) incorporating some of the suggested amendments and rejecting others. The parties agreed that the differences between them were not substantial. There was some disagreement between the parties as to whether Dr Finn's expertise qualified him as a person skilled in the art as it was at the relevant priority dates. As it transpired, both from the submissions of the parties and from my consideration of the issue, the points of difference were not material.

[12]

The Cross-claim 20 In its cross-claim filed on 2 July 2009, Multigate challenges the priority and validity each of the patents. Multigate submits that the integrity of the priority chain from US 08/084851 (see [7] above) on which each patent depends for its claim to the 30 June 1993 priority date, has been broken. It submits: This priority chain depends on the claims of each of the Patents being fairly based on the matter disclosed in the specification as filed, the specification filed for its relevant priority document or respective parent (and in turn, where relevant, grandparent), and through them, back to US 08/084851. Multigate contends that the Patents cannot so claim priority. The links in the priority chain are broken. The priority dates are significant, because if the claims are not entitled to priority as claimed (specifically, to the filing date of the Grandparent application - 27 May 1994), then the Publication of Bourne 1 (in the case of all three Patents) and Bourne 2 and Bourne 3 (in the case of the Parent and Child) will be relevant on novelty. 21 The details of this challenge to priority were provided in Multigate's Amended Particulars of Invalidity and are summarised in the following paragraphs. The Grandparent 22 Priority. None of claims 1 to 22 of the complete specification is entitled to the earliest priority date claimed, namely 30 June 1993. The allegation is that these claims contain matter that was not disclosed in the specification as filed in respect of the Grandparent (that is as filed on 27 May 1994) but was first introduced into the specification and disclosed by amendments contained in a statement of proposed amendments filed on 30 May 1997. It is submitted that by reason of s 114 of the Patents Act 1990 (Cth) and Regulation 3.14(b) none of claims 1-22 inclusive, is entitled to a priority date earlier than 30 May 1997. 23 Novelty. This claim follows from the circumstances described in the preceding paragraph. It is alleged that the invention as claimed in each of claims 1 to 22 inclusive of the complete specification is not a patentable invention within the meaning of the Act because, when compared with the prior art base as it existed before the priority date of each claim, the alleged invention is not novel as required by s 18(1)(b)(i) of the Act. In particular Multigate relies on the disclosure of the specification by the publication of PCT/US94/06047 published by WIPO as WO95/001135 on 12 January 1995. Consequently, it is submitted that the patent is invalid and liable to be revoked. 24 Fair basis - non-compliance with s 40(3) of the Act. All claims of the complete specification other than claims 23 and 24 are invalid because the complete specification does not comply with the requirements of s 40(3) of the Act. Multigate submits that the specification "describes a sterilization wrap which comprises two separate sheets of sterilisation wrap … or individual sheets fused together so as to be suitable for use as a sterilization wrap". Contrary to the construction advanced by Multigate in its defence of the applicants' infringement claim, in its challenge based on s 40(3) it submits that the claims are not limited to the sterilisation wrap being comprised of initially unconnected sheets. It claims that the complete specification discloses an invention that comprises one or more of: (i) a sterilization wrap which comprises two separate sheets of sterilization wrap or individual sheets fused together so as to be suitable for use as a sterilization wrap; (ii) a method of sterilizing an article by wrapping an article with a sterilization wrap wherein the sterilization wrap of the method comprise two separate sheets of sterilization wrap. 25 Multigate also asserts that claims 13-22 inclusive are not fairly based on the specification in that the specification fails to disclose an invention in which the sheets of the sterilization wrap are joined by a plurality of bond sites occupying less than the percentage of the surface area of each sheet specified in the relevant claim.

[15]

The Child 28 Priority. None of the claims of the complete specification of the Child patent is entitled to claim priority from the Grandparent in that the Child patent was filed as a divisional application from the Parent patent and, consequently, no claim of the Child is entitled to any earlier priority than that of the Parent patent, namely 10 June 1998. 29 Fair basis - non-compliance with s 40(3) of the Act. The complete specification does not comply with the requirements of s 40(3) of the Act in that its claims are not fairly based on the matter described in the complete specification. The particulars provided in relation to this submission are the same as those in respect of the Grandparent; see [23] above. 30 Novelty. The alleged invention claimed in each of the impugned Child claims is not a patentable invention within the meaning of the Act because, when compared with the prior art base as it existed before the priority date of each claim, the alleged invention is not novel as required by s 18(1)(b)(i) of the Patents Act. The particulars refer to the "whole of the disclosure of the specifications" of the patents and patent applications set out in the table in [26] above. They refer to disclosures in each of those patents and patent applications as set out in Schedule 3 attached to the particulars of invalidity. 31 Multiple claims contrary to s 40(4) of the Act. Multigate submits that it is a person aggrieved within the meaning of s 192(1) and that it may apply to this Court for rectification of the Register. Initially it made this claim on two bases: (a) that the Child patent involves double claiming contrary to s 64(2) of the Act; and (b) that the Child patent includes claims to five different inventions contrary to s 40(4) of the Act. At the outset of the hearing, however, Multigate advised that it did not intend to press the claim based on s 64(2). Consequently it is only necessary to consider the claim based on s 40(4). 32 Multigate submits that the Child includes claims to five different inventions. Multigate provided a table which identified the characteristics of the five different groups of claims, each group being alleged to embody a different invention. The salient features of each group may be summarised as follows: Group 1 - claims 1-12, 13-16, 32-46, 54-55, 65-71, 81-88: a single step sterilization wrap system comprising two independent sterilisation sheets, being an outer sheet "superposed" on an inner sheet and joined to one another at one or more bond sites. Group 2 - claims 17-31, 47-53, 56-64, 72-80: a method of sterilising an article using a sterilisation wrap system which comprises an inner wrap sheet and an outer wrap sheet each having a peripheral edge with at least a portion of the first peripheral edge being aligned with but not joined to a portion of the second peripheral edge. The sheets are joined at one or more points within an area surrounded by the peripheral edges. The system exposes the wrapped article to sterilising conditions for a sufficient time for sterilisation. Group 3 - claims 89-243, 251-265: a sterilisation wrap system which comprises an inner wrap sheet and an outer wrap sheet joined together at a plurality of bond sites occupying less than a nominated percentage of the surface area or each sheet and so that the sheets are visually distinguishable as separate sheets. Each sheet is composed of a spunbonded/meltblown/spunbonded laminate. At least one pound of tensile force is required to separate the joined sheets together at a plurality of bond sites which occupy less than a nominated percentage of the surface area or each sheet and so that the sheets are visually distinguishable as separate sheets. Group 4 - claims 244-250: a sterilisation wrap system which comprises an inner wrap sheet and an outer wrap sheet, each being a spunbonded/meltblown/spunbonded laminate, joined together at a plurality of bond sites. The joining of the sheets and the arrangement of the bond sites is such that the inner and outer sheets are visually distinct. Group 5 - claims 266-278: a sterilisation wrap system which comprises a first wrap sheet and a second wrap sheet, each being a spunbonded/meltblown/spunbonded laminate and having a basis weight of from about 0.5 to about 3.5 ounces per square yard. The wrap has a periphery at which the sheets are joined by a plurality of "spaced apart and separate bond points".

[22]

Construction 37 Central to the question of infringement is the construction of the claims. As explained above the main issue is whether the sterilisation wrap the subject of the claims is limited to one which has been made by joining two previously unconnected pieces of material. If this is the case then the respondents' sterilisation wrap, comprising one piece of material folded over to form two layers, cannot infringe the claim. 38 It is for the court to construe the language of the patent claims. The principles guiding construction are not significantly different from the principles applicable to the construction of any written instrument; Nobel's Explosives Company Limited v Anderson (1894) 11 RPC 519 at 523 per Lord Esher MR. Ordinary words should be given their ordinary meaning unless a person skilled in the relevant art would, in the context of the claim, give a special meaning or unless the specification ascribes a special meaning to them: Décor Corporation Pty Ltd v Dart Industries Inc (1988) 13 IPR 385 at 391 per Lockhart J and at 400 and 410-411 per Sheppard J. Expert evidence may be given in support of a claim that a word has a technical meaning but, in the absence of a special technical meaning expert evidence is not admissible to assist the court in construing claims; PhotoCure ASA v Queen's University at Kingston (2005) 216 ALR 41 at [170]. In so far as concerns the question whether any of the claims is limited to a sterilisation wrap made from previously unconnected sheets of fabric, neither party has submitted that the relevant language involves any terms of art or that observing the features of the Multigate product requires any particular expertise. 39 As meaning may vary with context it is necessary with any question of construction to read the whole of the relevant instrument whether or not there is any apparent ambiguity in the language to be construed; NV Phillips Gloeilampenfabrieken v Mirabella International Pty Ltd (1993) 44 FCR 239 at 286 per Burchett J; Clorox Australia Pty Ltd v International Consolidated Business Pty Ltd (2006) 68 IPR 254; [2006] FCA 261 at [13]-[22]. Ultimately , however, it is the claims that are to be construed and while the context provided by the whole of the specification may assist, it cannot limit vary or qualify the clear meaning of the claims; Décor Corp Pty Ltd v Dart Industries Inc at 404 per Sheppard J. See also Kirin-Amgen Inc v Hoechst Marion Roussel Ltd (2004) 64 IPR 444 at 454. This point and others were made forcefully by the Full Court in Kinabalu Investments Pty Ltd v Barron & Rawson Pty Ltd [2008] FCAFC 178 at [44]-[45]: When determining the nature and extent of the monopoly claimed, the specification must be read as a whole. But as a whole it is made up of several parts which have different functions. The claims mark out the legal limits of the monopoly granted. The specification describes how to carry out the process claimed and the best method known to the patentee of doing that. Although the claims are construed in the context of the specification as a whole, it is not legitimate to narrow or expand the boundaries of monopoly as fixed by the words of the claim, by adding to those words glosses drawn from other parts of the specification. If the claim is clear and unambiguous, it is not to be varied, qualified or made obscure by statements found in other parts of the document. It is legitimate, however, to refer to the rest of the specification to explain the background of the claims to ascertain the meaning of technical terms and resolve ambiguities in the construction of the claims. See Flexible Steel Lacing Co v Beltreco Ltd [2000] FCA 890; (2000) 49 IP are 331 at [73] [75] … Other more specific principles of construction collected in Flexible Steel at [81] are: • a specification should be given a purposive construction rather than a purely literal one; • the hypothetical addressee of the specification is the non-inventive person skilled in the art before the priority date; • the words used in a specification are to be given the meaning of the hypothetical addressee would attach to them, both in the light of the addressee's own general knowledge and in the light of what is disclosed in the body of the specification; • as a general rule, the terms of the specification should be accorded their ordinary English meaning; • evidence can be given by experts on the meaning of those skilled in the art would give to technical or scientific terms and phrases and on unusual or special meanings given by such persons to words which might otherwise be the ordinary meaning; • however the construction of the specification is for the court, not for the expert. In so far as a view expressed by an expert depends upon a reading of the patent, it cannot carry the day unless the court reads the patent in the same way. 40 The applicants submit that Multigate's construction imports a limitation into the claims to the effect that the inner and outer wrap sheets must be created by taking two previously unconnected pieces of material and joining them together. The applicants contend that, fairly construed, the term "sheet" used in the claims equally applies to a single piece of sterilisation wrap as to previously unconnected pieces of material. 41 The applicants refer to the Macquarie Dictionary, 2nd Revised Edition, 1987, definition of "sheet", namely, "a broad, thin mass, layer, or covering". They submit that this ordinary meaning is an appropriate definition for the purposes of the Patents. As the applicant puts it the Patents are concerned with "wrap" sheets used to wrap the article for sterilisation and the concept of "coverings" is apt to describe this function. An "outer sheet" is a covering which is further away from the article it covers than an inner covering. Thus, the applicant submits there is nothing in any of those definitions which requires or suggests that an "inner wrap sheet" and an "outer wrap sheet" must once have been physically unconnected. The applicants add that "the claims are simply not concerned with the form of the material" from which the inner and outer wrap sheets are made but are only concerned with the "characteristics of the finished sterilisation wrap product". 42 The applicants' submissions also focus on functional aspects of the claims. They submit that: the need for double wrapping "does not imply any requirement that the inner and outer sheet were once unconnected prior to being joined. One simply requires the results, namely two coverings"; the efficiency achieved by simultaneous double wrapping of joined sheets does not require that the combination of joined sheets be achieved by taking two previously unconnected sheets; "the ability to observe that one is wrapping an article with two joined sheets also implies nothing about whether the sheets were unconnected prior to having being joined". 43 The applicants also submit that if the patentee wished to include the limitation contended for by Multigate, namely that the invention requires that the wrap sheets be initially unconnected, it could easily have done so. This submission starts from an implied premise which is misconceived. The question is not what the patentee could have done, but what it did. I agree with the applicant that it is not for the Court to imply a limitation into the claims in the sense of adding something to the meaning which is not already there. This, however, is not the issue. 44 The question is, "What does the language of the claims, fairly construed, actually mean?". If, fairly construed, the language of the claims refers to sheets of fabric that were previously unconnected then the claim cannot extend to a sheet that has been folded over. The point is neatly encapsulated in the oft-quoted comment of Lord Parker in Fellows v Thomas William Lench Ltd (1917) 34 IPC 45 at 55: A claiming clause operates as a disclaimer of what he is not specifically claimed, and for such disclaimer there may be reasons known to the inventor but not to the Court. 45 The meaning adopted by the applicant may well be an appropriate definition for the purposes of the Patents and I do not understand the respondents to contend otherwise. That meaning of "sheet" is, however, one of many similar meanings that various dictionaries give to the word. The New Shorter Oxford English Dictionary 1993, for instance, gives a number of definitions that are similar in that they refer to a sheet as being a "piece" of something, for instance: "a broad piece of linen, cotton or other fabric for covering, wrapping, protecting against damage, cold etc."; "a large rectangular piece of cotton or other fabric …"; "a complete piece of paper of the size in which it was made or sold …". These definitions, and others given by the Macquarie Dictionary, use the concept of a piece in defining a sheet. In doing so the definitions embody the concept of a separate or detached part or bit. The Macquarie Dictionary definition put forward by the applicant does not use "piece" but it does use the indefinite article to the same effect. This suggests to me that the concept of a sheet involves a separate piece. 46 It may be that the "piece" is used for covering or wrapping as the applicant contends but, in so far as the word "sheet" is used to describe the article which is used for wrapping, in my view it describes a separate object. This meaning is supported when the use of the word is considered in the context of each of the claims.

[23]

Patent 695238 - Grandparent 47 Claim 1 of the Grandparent Patent is a method claim that defines the sterilisation wrap as used in the method by the structure of the fabric used in the wrapping material, the structure of the completed wrap used to wrap the articles to be sterilised and the manner in which the sheets are joined together. It refers to "an inner wrap sheet" and "an outer wrap sheet" which together comprise the sterilisation wrap. The construction advocated by the applicants would read the reference to an "inner wrap sheet" as capable of referring to the inner surface of a single piece of fabric that is folded so as to create a double thickness. Similarly the "outer wrap sheet" would refer to the outer surface of the folded fabric. 48 The applicants submit that the specification does not call for the wrap to be comprised of two, initially disconnected, pieces of material, except in the case of more refined embodiments such as where the two sheets have different properties. They draw attention to the title of the patent, "Single Step Sterilization Wrap System" and submit that a single sheet or piece of fabric such as the Multigate product would infringe claim 1. 49 I cannot accept the applicants' construction. It is not how the language would be understood in ordinary parlance. In my view the two terms indicate two pieces or sheets, initially separate, but together comprising the "sterilization wrap". 50 The words of the claim refer to a wrap that is comprised of two sheets, "an inner wrap sheet and an outer wrap sheet". It describes the structure of "each sheet". Again the reference to "each sheet" indicates that the reference is two pieces or sheets. This is made abundantly clear by the statement that the sheets are joined together at "a plurality of bond sites" which occupy no more than the specified area "of either of the sheets". To my mind the inference of two pieces of fabric that are initially not connected is inescapable. 51 This construction is consistent with the language of the specifications both in the patent as granted and in the application as originally filed. The patent as granted uses similar language to the claim. If anything, it more clearly refers to the use of disconnected sheets. 52 In describing the background of the invention reference is made, at page 1a, to "multi-plied materials made from individual sheets". The Summary of the Invention says, at page 4, that the "said sheets are visually distinguishable as separate sheets". Later, the specification refers to being able to see "that the item is being wrapped by two separate sheets of sterile wrap"; page 8. At page 10 there is a reference to "two separate sheets of sterilization wrap". Throughout the specification there are references to "separate sheets", "individual sheets", "each sheet" or "each wrap", "one of the sheets", "the other sheet". The specification recognises the possibility of the sheets being "designed to have particular properties which may be the same or different from the other sheet of the single step sterilization wrap system". 53 The applicant submits that the proper construction is that the patent allows for the sheets or the inner and outer wrap to be initially unconnected but does not require it. If that were the case one would expect the reference to sheets having different properties to advert to that distinction. In my view, the language clearly indicates that the two sheets are not connected prior to bonding in accordance with the specification. The language supports the construction of claim 1 that I have drawn from the language of that claim. I have also reviewed claims 2-22 inclusive of the Grandparent and am satisfied that there is nothing in those claims that would suggest any meaning of "sheet", "inner wrap sheet" or "outer wrap sheet" as used in those claims other than the meaning I have found in relation to claim 1.

[27]

The Grandparent 59 The cross-claim contains a cascading series of challenges to the priority of the patents. The Grandparent claims priority from US patent application 08/084851 which was filed on 30 June 1993. No challenge has been made to the proposition that at the time it was filed (27 May 1994) the Grandparent application (Bourne 1) was able to claim 30 June 1993 as a priority date. The Parent and the Child claim the same priority date, the Parent as a divisional of the Grandparent and the Child as a divisional of the Parent; see s 79B and reg 3.12(1)(c) and reg 3.12(2C). 60 As put by Mr Macaw in opening, the priority issue hinges on whether the real and reasonably clear disclosure in the application for the Grandparent, Bourne 1, is limited to a disclosure wherein the inner wrap sheet and the outer wrap sheet are created by joining two previously unconnected pieces of wrapping material. In their written submissions the applicants state that, the Grandparent application consistently discloses the objectives, advantages and features of the invention without reference to any such limitation. There is, in short, a disclosure of: (a) a sterilisation wrap having an inner and outer wrap sheet, the purpose of which sheets is to provide double wrapping in accordance with the recommended hospital procedure; (b) the inner and outer wrap sheets being joined in order to secure the advantage of simultaneous double wrapping over sequential double wrapping, while avoiding the awkwardness and time costs associated with simultaneous double wrapping using unjoined sheets; and (c) the inner and outer wrap sheets being visually distinguishable, so that the user can observe that he or she is double wrapping according to the recommended procedure. 61 The applicants submit that there is nothing in the above that indicates that the inner and outer wrap sheets be made by joining two previously unconnected pieces of material. For reasons given in respect of the applicants' claim of infringement by the Multigate Product, I do not accept this construction. As previously explained the concept of "inner and outer wrap sheets" presupposes that the pieces of fabric were previously unconnected. I my view the Grandparent application consistently discloses objectives, advantages and features of the invention which necessarily included this meaning, or as the applicants prefer to express it, this limitation. The following extracts illustrate the point. 62 As filed on 27 May 1994 the Grandparent application stated the focus of the invention as follows: The present invention is directed to sterilization wrap materials. More particularly, the present invention is directed to multi-plied materials made from individual sheets which are fused together so as to be suitable for use as a sterilization wrap for wrapping surgical instruments and supplies for sterilization and storage in conjunction with surgical procedures and for other applications such as packaging items for bone marrow units. 63 The description gives an account of double wrapping using two unconnected sheets and the disadvantages of such a procedure. It continues: The present invention provides an improved means for simultaneously wrapping and unwrapping items which must be sterilized prior to use. This is accomplished by bonding or joining two separate sheets of sterilization wrap together at one or more locations to create a single step system wherein the separate sheets are prealigned and joined to one another to facilitate the wrapping process as well as the unwrapping process. As a result, the amount of time needed to wrap and unwrap an item is decreased and the ease of wrapping is improved. In addition, each of the individual sheets of the single step sterilization wrap system can be specifically engineered or designed to impart special or different features to the overall system. The single step sterilization wrap system includes an outer wrap made from a first sterilization sheet which is superposed on an inner wrap made from a second sterilization sheet with each of the sheets being independent of one another and joined to one another at one or more bond sites. 64 These extracts from the specification clearly show that the specification envisages only an invention that is made from two individual unconnected sheets. This can also be seen on page 10 of the specification by the emphasis placed on the fact that the user of the sterilisation wrap can actually see "that the system does in fact include two separate sheets of sterilization wrap". There is nothing in the specification of the Grandparent application as filed that is inconsistent with a requirement that the sterilisation wrap be made from two sheets initially unconnected but joined at bond sites that occupy no more than 50% of the surface area of the sheets. This is not inconsistent with the fact that the application as filed allows that in more refined embodiments the two sheets may have different qualities. 65 The second amendment to the Grandparent application filed on 30 May 1997 made extensive changes to the application. The greater part of the summary of the invention was deleted (including the passages quoted in [62] and [63] above) and all 16 of the claims. The amendment substituted 80 claims which, by the third and fourth amendments (filed on 23 December 1997 and 4 June 1998 respectively) were reduced to the 22 claims and two omnibus claims (23 and 24) of the Grandparent as granted. 66 On the construction of the Grandparent complete specification that I have accepted, the Multigate Product does not infringe the claims of the Grandparent and those claims are fully and fairly disclosed in the specification as it existed both prior to and subsequent to the 1997 amendments. That being so there is no basis for concluding that the priority date of 30 June 1993 does not apply to all three of the patents in suit. 67 The challenge to the priority date arises only if the applicant's construction of the claims of the Grandparent were to be accepted with the consequence that the Multigate product would infringe some or all of those claims in the Grandparent. Given my conclusions as to construction and infringement, it is not strictly necessary to consider the priority issue raised by the cross-claim however, in deference to the full argument put by both parties and in case my conclusions as to construction and infringement are wrong, I shall consider the issue on that basis. It is in this context that Multigate submits: If the claims of the Grandparent [as granted] encompass the Multigate Product as alleged by the applicants, it can only be because the wrap system of the claims does not have the feature that there are two separate sheets, and that visual distinctiveness as two sheets does not require that the system does in fact include two separate sheets of sterilization wrap, as disclosed in the Grandparent as filed. 68 Multigate contends that on that construction, claims 1-22 of the Grandparent extend to matter that "in substance" was first disclosed in the 30 May 1997 amendment of the specification. If that were so the combination of s 114 of the Act and reg 3.14 would result in priority for claims 1-22 of the Grandparent having priority only from the date of the amendments, namely 30 May 1997. The combination of s 114 of the Act and reg 3.14 provides that where a claim of a complete specification includes matter that was disclosed as a result of amending the specification, the priority date of the claim is the date of filing the statement of proposed amendments that brought about the disclosure. 69 This would, however, only be the result if my conclusion were wrong as to the construction of the claims but correct as to the construction of the specification as filed. It is true that the requirement of two initially unconnected sheets is more clearly stated in the specification as filed than in the Grandparent (as granted). It is nevertheless the applicants' position, and indeed the respondent's, that the claims as granted and the specification as filed are consistent albeit that they each contend for a different construction. Except in relation to this issue neither party has submitted that different considerations should apply to the construction of the specification as filed and the claims in the Grandparent. 70 For the Court to assume that the conclusion reached as to construction is correct in relation to the claims but wrong in relation to the application would be to assume a construction for which neither party has contended. The familiar exercise of asking, "What if I am wrong?" has the implied addendum "in rejecting a position advocated by one party". Having asked that question, one proceeds to consider the rejected position. That approach is entirely appropriate; it is procedurally driven, not results driven. It is not appropriate to assume that the position reached is wrong and then look for a different position merely to support an outcome advocated by one or other of the parties. 71 I am prepared to assume that the construction of the Grandparent application (Bourne 1) and the complete specification of the Grandparent for which the applicant contends is the correct construction. On that assumption, the claims in the Grandparent and the specification in Bourne 1 are consistent and therefore the priority date of 30 June 1993 is correct. On that basis Multigate's contention in the cross-claim as to the priority accorded to the Grandparent must be rejected.

[30]

The Grandparent 75 The discussion above in relation to priority concerned whether the specification in Bourne 1 fully and fairly disclosed the claims made in the Grandparent. In other words it concerned external fair basis; that is, whether the claims in the Grandparent were fairly based on that specification. Section 40(3) of the Act is concerned with internal fair basis and requires that the claim or claims in a complete specification must be fairly based on the matter described in the specification. A patent wherein the specification does not comply with s 40(3) may be revoked pursuant to s 138(3)(f). 76 Multigate contends that the Grandparent does not comply with s 40(3) in that the invention claimed is not fully and fairly disclosed in the specification. As Multigate points out, internal fair basis requires a distinction to be drawn between the claims and the body of the specification in order to see if the claims are fairly based on the body of the specification. In Olin Corporation v Super Cartridge Co Pty Ltd (1977) 180 CLR 236 at 240 Barwick CJ addressed the question of fair basis: The question whether the claim is fairly based is not to be resolved, in my opinion, by considering whether a monopoly in the product would be an undue reward for the disclosure. Rather, the question is a narrow one, namely whether the claim to the product being new, useful and inventive, that is to say, the claim, as expressed, travels beyond the matter disclosed in the specification. 77 The Chief Justice's approach is consistent with the approach of the majority in Olin. In Lockwood Security Products Pty Limited v Doric Products Pty Limited (2004) 217 CLR 274 at 300, the High Court expressed its view of the approach required by s 40(3) with reference both to what the section does not call for and what it requires: Erroneous principles. The comparison which s 40(3) calls for is not analogous to that between a claim and an alleged anticipation or infringement. It is wrong to employ "an over meticulous verbal analysis". It is wrong to seek to isolate in the body of the specification "essential integers" or "essential features" of an alleged invention and to ask whether they correspond with the essential integers of the claim in question. "Real and reasonably clear disclosure". Section 40(3) requires, in Fullagar J's words, "a real and reasonably clear disclosure". But those words, when used in connection with s 40(3), do not limit disclosures to preferred embodiments. 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." [Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1998 81 ALR 79 at 95, per Gummow J] Fullagar J's phrase serves the function of compelling attention to the construction of the specification as a whole, putting aside particular parts which, although in isolation they might appear to point against the "real" disclosure, are in truth only loose or stray remarks. 78 In its written submissions, Multigate states that the clear disclosure in the body of the specification of the Grandparent "is of a sterilisation wrap which comprises two separate sheets". For reasons given in relation to the issue of priority I agree with this submission. In relation to claims 1 to 22 however, Multigate submits that : The claims, however, are not limited to a method of sterilizing an article by wrapping the article with the sterilization wrap which comprises an inner wrap sheet and an outer wrap sheet that are two separate sheets of sterilization wrap or individual sheets fused together as disclosed in the specification. 79 This claim is based on a construction of the claims which I have already rejected in relation to the applicants' claims of infringement. Each of those claims include what I might refer to as the individual or unconnected sheet requirement which, as I have already concluded, is fully and fairly disclosed in the specification. 80 Multigate also contends that each of claims 13 to 22 fails to comply with s 40(3) in that each claim is not fairly based on the matter described in the complete specification as the body of the specification does not disclose an invention where the sheets of sterilization wrap are joined together by a plurality of bond sites which occupy less than (variously) 40%, 30%, 20%, 10% or 5% of the surface area of either site. 81 I do not accept the submission as to claims 13 to 22. In my view the specification fully and fairly discloses the requirement that the sheets be joined by a plurality of bond sites which occupy a percentage of the surface area which, in the separate claims does not exceed 50% of the surface area of either sheet and ranges in the separate claims from 5% to 50%. 82 It should be remembered that s 40(3) concerns claims. It stipulates that the claims must be clear and succinct and fairly based on the matter in the specification. It is s 40(2) that states the requirements for a "complete specification". The Dictionary in Schedule 1 of the Act defines "complete specification" as being (other than in s 116) "a specification filed in respect of a complete patent application or, if the specification has been amended, the complete specification as amended". In the summary of the invention included in the specification of the Grandparent there is the following specific reference to the requirement for bonding referred to in claims 13 to 22: … and the sheets are joined together at a plurality of bond sites which occupy no more than 50% of the surface area of either of the sheets … … Preferably, said sheets are joined together at a plurality of bond sites which occupy less than 40% of the surface area of either sheet. More preferably, said sheets are joined together at a plurality of bond sites which occupy less than 30% of the surface area of either sheet. More preferably, said sheets are joined together at a plurality of bond sites which occupy less than 20% of the surface area of either sheet. More preferably, said sheets are joined together at a plurality of bond sites which occupy less than 10% of the surface area of either sheet. More preferably, said sheets are joined together at a plurality of bond sites which occupy less than 5% of the surface area of either sheet. 83 There is no mention of these requirements in the material dealing with the preferred embodiment however that part of the specification, including the accompanying diagrams, does refer, in some detail, to the variety of ways and the varying extent to which the sheets may be bonded. Reading the whole of the specification I am satisfied that the specific requirements of claims 13-22 are fully and fairly disclosed in the specification such that the claims may be said to be fairly based on matter described in the specification in accordance with s 40(3).

[32]

Novelty 86 Novelty is an essential requirement for a patentable invention; s 18. A patent that lacks novelty may be revoked by order of a court; s 138(3)(b). Section 18 states: (1) Subject to subsection (2), an invention is a patentable invention for the purposes of a standard patent if the invention, so far as claimed in any claim: (a) is a manner of manufacture within the meaning of section 6 of the Statute of Monopolies; and (b) when compared with the prior art base as it existed before the priority date of that claim: (i) is novel; and (ii) involves an inventive step; and (c) is useful; and (d) was not secretly used in the patent area before the priority date of that claim by, or on behalf of, or with the authority of, the patentee or nominated person or the patentee's or nominated person's predecessor in title to the invention. 87 The concept of novelty is not defined in the Act however s 7 gives some guidance as to the way in which novelty (or the lack of it) is to be determined. The section 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; (b) prior art information (other than that mentioned in paragraph (c)) made publicly available in 2 or more related documents, or through doing 2 or more related acts, if the relationship between the documents or acts is such that a person skilled in the relevant art would treat them as a single source of that information; (c) prior art information contained in a single specification of the kind mentioned in subparagraph (b)(ii) of the definition of prior art base in Schedule 1. 88 Subparagraph (b)(ii) of the definition of "prior art base" in Schedule 1 is as follows: (ii) information contained in a published specification filed in respect of a complete application where: (A) if the information is, or were to be, the subject of a claim of the specification, the claim has, or would have, a priority date earlier than that of the claim under consideration; and (B) the specification was published after the priority date of the claim under consideration; and (C) the information was contained in the specification on its filing date and when it was published. 89 As outlined in [22] above Multigate submits that the invention as claimed in each of claims 1 to 22 of the Grandparent lack the novelty required under s 18(1)(b)(i). The submission depends upon Multigate establishing that the claims of the Grandparent have a priority date of 30 May 1997 as a result of the amendments filed at that time. If that were to be established then, it is submitted, the Grandparent would be deprived of novelty by the self-publication of Bourne 1 on 12 January 1995. The reasons given for rejecting the challenge to priority also lead me to reject the challenge to novelty (see [65]-[69] above) in relation to the Grandparent. 90 Multigate contends that the following claims of the Parent are not novel when those claims are compared to the prior art: 1, 2, 4-11, 15-19, 23, 25-28, 35-44. The following claims of the Child are challenged on the same basis: 17, 18, 20-22, 24, 27, 47, 56-64, 72-80, 89-100, 102-105, 109-113, 116, 122-124, 126-130, 132-135, 139-143, 146, 151-155, 157-162, 164-167, 171-174, 178, 182-183, 186-208, 210-214, 216-227, 229-236, 240-244, 249, 251, 255-259, 266-269, 273 and 277. 91 The most common test for novelty is that propounded by Aickin J in Meyers Taylor Pty Limited v Vicarr Industries Limited (1997) 137 CLR 228 and generally referred to as the "reverse infringement test". His Honour, at 235, identified the "basic test for anticipation or want of novelty" as the same as the test for infringement and explained, "generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement". In Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 at 517, Lockhart J explained the test in more detail: It is well established that the prior art must disclose all features of the invention embodied in the patent in suit and must do so in clear, unequivocal and unmistakeable terms. The prior art must enable the notional skilled addressee at once to perceive and understand and be able practically to apply the discovery without the necessity of making further experiments. Whatever is essential to the invention must be read out of or gleaned from the prior publication … As Multigate submitted, the disclosure must be sufficient to "enable that skilled addressee to produce something within each claim without new inventions or additions or prolonged study of matters presenting initial difficulty". The prior publication must contain "clear and unmistakeable directions" to make what is claimed under the impugned patent. Alternately the disclosure in the prior publication must be of equal practical validity. The prior art relied upon by the respondent is to be found in the Crabb, Brock and Cox patents (Prior Art Patents) all of which were publicly available prior to 1993.

[36]

Consideration 97 Multigate made brief submissions in support of its submission that Crabb, Brock and Cox anticipated certain claims of the Parent and Child. In addition to this, the respondent relied upon two documents (Novelty Charts) which, in tabular form, purported to identify aspects of Crabb, Brock and Cox said to anticipate particular claims of the Parent and Child. The applicants submitted that the Novelty Charts merely cherry-picked "references from the prior art in [an] artificial, fanciful and piecemeal manner". Such an approach would be inconsistent with the observation of Lockhart J in Nicaro Holdings at 517: The invention must appear in a single disclosure, so it is not permissible to make a pattern or mosaic of or to read together various pieces of prior art in different patents. 98 To the extent that the Novelty Charts attempt to do this they are misconceived however it is not clear to me that the allegation is justified. The Novelty Charts contain a vast amount of detail and it is difficult to see how they might assist in assessing whether a skilled addressee could produce something within each claim said to be anticipated without new inventions or additions or prolonged study of matter presenting initial difficulty. Both the applicants' and the respondent's submissions on the point were minimal, however, given the view that I have formed as to what each of the Prior Art Patents teaches when read in its entirety it is not necessary for me to consider the detail further. 99 I am not persuaded that any of the Prior Art Patents disclose to a person skilled in the art the inventions claimed in the Parent and the Child so that if the directions in the Prior Art Patents were performed the Parent and Child would be infringed. 100 In relation to Crabb, it was submitted that the requirement for two layers of fabric enclosing the item to be sterilised anticipates the inner and outer wrap sheets of the Parent and Child. I do not accept that submission. The Crabb invention is in effect an envelope and the article is placed in the envelope between the two layers of fabric such that there is one layer of fabric between the article and the outside. This cannot be said to anticipate the inner and outer wrap sheets of the Parent and the Child which, as recommended by AORN, provide two layers of fabric between the article to be sterilised and the outside of the wrapped package. As the applicant submitted, the Crabb invention "does not teach an inner and outer wrap sheet [but rather] teaches a wrap that encloses an article in a single protective layer". 101 As outlined above, the Brock invention is a method of producing non-woven thermoplastic fabrics which are said to be useful for wrapping items to be sterilised. Brock discloses a multi-layer laminate which, as the applicant submitted, may be used as the inner or the outer wrap sheet of the single step sterilisation system of the Patents. Multigate submitted, however, that the Brock invention consists of two layers which are visually distinguishable and which are joined at a plurality of bond sites occupying no greater than 50 per cent of the area of the wrap, all of which anticipate certain claims of the Parent. I do not accept this characterisation which confuses layers of the Brock laminate with the inner and outer wrap sheets of the Parent and the Child. 102 The layers of the Brock invention are not visually distinguishable "so that the end user can visually see that the item is being wrapped by two separate sheets of sterile wrap". To the contrary, Brock is explicit that the invention has a unitary structure; claim 1 refers to the component filaments being bonded by the application of heat and pressure to "provide a unitary structure having desirable textile like appearance and drape characteristics ... ". In my view, the Brock invention does not anticipate the claims of the Parent and Child as contended by Multigate. 103 Similarly, I do not accept that the Cox patent anticipates any of claims 1, 7, 11 and 16 of the Parent or claims 17, 27, 226, 232, 236 and 242 of the Child. The respondent submitted that the Cox invention wraps the item to be sterilised in two layers of wrap however, as I understand it Cox teaches an invention which wraps the item to be sterilised in one sheet of wrap that at various points overlap. It does not teach an invention consisting inner and outer wrap sheets which are joined together so that the item is wholly enclosed in two layers of wrap.

[37]

Multiple claims contrary to s 40(4) of the Act 104 Multigate submits that the Child includes claims to five different inventions contrary to s 40(4) of the Act. The details of this claim are given above at [30]-[31]. It seeks orders that the Commissioner of Patents be directed to rectify the Register pursuant to s 192 because of this non-compliance. Specifically, Multigate seeks orders that the Commissioner: (a) [remove] the grant of the Child from the Register insofar as the grant relates to more than one invention; (b) [endorse] on the Register that the Child is contrary to s 40(4) of the Act, and that accordingly the Child with the claims to the multiple invention claimed is void. 105 The Commissioner of Patents has a statutory right to appear and be heard in relation to a claim for rectification of the Register; see s 192(3)(b). The Commissioner did not wish to make oral submissions but, with the leave of the Court provided written submissions. These submissions have been of assistance to the Court in determining whether it is appropriate to grant the relief sought by the respondent under s 192. 106 Section 40 of the Act is in the following terms: (1) A provisional specification must describe the invention. (2) A complete specification must: (a) describe the invention fully, including the best method known to the applicant of performing the invention; and (b) where it relates to an application for a standard patent - end with a claim or claims defining the invention; and (c) where it relates to an application for an innovation patent - end with at least one and no more than 5 claims defining the invention. (3) The claim or claims must be clear and succinct and fairly based on the matter described in the specification. (4) The claim or claims must relate to one invention only. 107 Multigate contends that non-compliance with s 40(4) entitles it to an order directing the Commissioner to rectify the Register pursuant to s 192. Section 192(1) provides that a 'person aggrieved' may apply to a prescribed court for an order that the Register of Patents be rectified where the person has been aggrieved by: (a) the omission of an entry from the Register; or (b) an entry made in the Register without sufficient cause; or (c) an entry wrongly existing in the Register; or (d) an error or defect in an entry in the Register…. Multigate submitted that it has been sued for infringing the Child in circumstances where the Child should not have been registered and therefore it is a person aggrieved within the meaning of the section. 108 For reasons that follow, I have concluded that even if the Child does claim more than one invention and therefore does not comply with s 40(4), Multigate is not entitled to the orders which it seeks with respect to the Register. It is therefore, not necessary for me to resolve the issue of whether the Child does in fact claim more than one invention. 109 Section 40 is to be found in Chapter 3 of the Act, specifically in Part 1, Division 2. Division 2 is concerned with specifications in the context of patent applications. Section 29(4) requires that a standard patent request relating to a 'complete application' must be accompanied by a 'complete specification'. The context indicates that s 40 is directed to regulating the content of specifications in patent applications and as the Commissioner submits "streamlining" the patent application process. The section directs that specifications in patent applications conform to certain requirements. Significantly, it does not address the consequences for a patentee if a specification which does not comply with the requirements of s 40 is accepted by the Patent Office. 110 Implicit in Multigate's argument is the proposition that non-compliance with s 40(4) renders a patent invalid or "void" to the extent that it claims more than one invention. This reads more into the section than the words of the section allow and ignores the context within which the section appears in the Act. While it is clear that the Commissioner can take issue with an application that does not comply with the section, there is nothing in the section to suggest that non-compliance with any of those requirements renders a patent once granted as susceptible to a claim of invalidity, either in whole or in part, on that ground. 111 This conclusion is supported by recognition that, as the Commissioner points out, non-compliance with the prohibition of multiple inventions "has not historically been a ground for revocation after grant". So much was recognised by Fullagar J in Société Des Usines Chimiques Rhône-Poulenc v Commissioner of Patents (1958) 100 CLR 5 at 28. His Honour there was considering the issues before him in the context of the Patents Act 1952 (Cth) but was not relying on a provision of that Act as authority for stating that the fact "that a patent relates to more than one invention is not a ground for revocation after grant". 112 This conclusion is also supported by the fact that non-compliance with s 40(4) is not a ground on which revocation of a patent may be granted. Those grounds are set out in s 138(3) of the Act which expressly provides that such an order may be made on the grounds listed in subsections 3(a)-(f) inclusive "but on no other ground". Significantly, those grounds include non-compliance with ss 40(2) or 40(3) but not s 40(4). It is unlikely that the legislature would have expressly excluded revocation of a patent that was void because of non-compliance with a provision of the Act. 113 Understandably, Multigate does not ask for revocation however the conclusions stated above about the legal consequence of non-compliance is relevant to the consideration of whether the relief Multigate seeks should be granted. The Commissioner points to an important difference between ss 138 and 192, namely that the "former is directed at rights, the latter at the recording of those rights". I am persuaded by the Commissioner's submissions as to what follows from this distinction: The Register is a public record of rights conferred under the Act and the history of those rights. The presence of entries in the Register does not itself confer rights. Entries in the Register are never removed. They are only ever altered transparently to show what changes have occurred. Even when a patent is revoked by court order, the entry in the Register is not removed, but clearly marked and indorsed with the terms of the order. Similarly, there is no removal of the specification. In fact the Register does not contain specifications of patents. The Commissioner keeps records of all specifications filed, and retains such specifications even when the patent has been revoked. The Commissioner submits that s 192(1) cannot be used, in effect, to revoke a patent in circumstances where there would be no grounds for revocation under s 138(3) of the Act. An order made pursuant to s 192(1) cannot be used to affect substantive rights under the Act. Section 192(1) was intended merely to allow for the correction of clerical errors, or other mistakes of that type in the Register - it was not intended to operate as a mechanism to challenge the validity of patents generally. This is quite clear from the text of the subsection. The alternative construction would undermine the proper working of the Act. … An order under s 192(1) in the terms sought by the respondent … would therefore not in itself change the fact that a valid, sealed, patent is in force. All it would do would be to create an incongruity between the Register and reality, whereas the entire point of s 192(1) is to remove such incongruities. 114 As the Commissioner's submissions indicate, the orders sought by Multigate would be counter-productive. Given that position and my conclusion that non-compliance with s 40(4) does not lead to invalidity I am not prepared to make the orders sought by Multigate.

Kimberly-Clark Australia Pty Limited v Multigate Medical Products Pty Limited

At a glance

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Judgment (38 paragraphs)

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Legislation Cited (2)

Cases Cited (14)

Cited By (1)