{"id":3376,"date":"2020-12-02T14:57:52","date_gmt":"2020-12-02T01:57:52","guid":{"rendered":"https:\/\/www.jamesandwells.com\/unallowable-the-federal-court-of-australia-requests-amendment-of-history\/"},"modified":"2020-12-02T14:57:52","modified_gmt":"2020-12-02T01:57:52","slug":"unallowable-the-federal-court-of-australia-requests-amendment-of-history","status":"publish","type":"post","link":"https:\/\/www.jamesandwells.com\/intl\/unallowable-the-federal-court-of-australia-requests-amendment-of-history\/","title":{"rendered":"Unallowable \u2013 the Federal Court of Australia requests amendment of history"},"content":{"rendered":"
In our\u00a0first article\u00a0in this series on Australian and New Zealand law, we reported on the current law on amendment allowability following Australia\u2019s \u201cRaising the Bar\u201d reforms and the decision of the Federal Court of Australia in\u00a0CSIRO v BASF Plant Science GmbH<\/em>\u00a0and how that decision has been applied by the Australian Patent Office.<\/h6>\n

In this second article, we highlight a troubling aspect of Beach J\u2019s decision in\u00a0CSIRO v BASF Plant Science GmbH<\/em>, suggest how it might be used to invalidate a large number of patents granted under the pre-Raising the Bar legislation, and give one example of where it has already gained traction.<\/p>\n

For patents\/applications for which examination was requested\u00a0before 15 April 2013<\/u>\u00a0the\u00a0CSIRO v BASF Plant Science GmbH<\/em>1<\/sup>\u00a0decision has reagitated an issue thought to be resolved and has suggested an additional set of criteria for a sub-set of cases. As explained below, it would be prudent for patentees of valuable older patents which were amended during prosecution to review the strengths and weaknesses of the granted claims in light of this decision.<\/p>\n

In spite of the earlier reference to the Explanatory Memorandum,2<\/sup>\u00a0which clearly showed that the legislators thought that there was a difference between the old and new versions of the\u00a0Patents Act 1990<\/em>, there was one paragraph in Beach J\u2019s decision which sent shivers down the spines of these authors.<\/p>\n

While admittedly in\u00a0obiter<\/em>, at [221] Beach J posed:<\/p>\n

Are the requirements of s 102(1) now stricter?<\/em><\/p>\n

If there is a difference in scope, then the distinction may be subtle.<\/em><\/p>\n

Essentially, Beach J was suggesting that the previous requirement for \u201cin substance disclosure\u201d was very similar to the current requirement that, as a result of the amendment, the specification does not \u201cclaim or disclose matter that extends beyond\u201d the disclosure of the original specification.<\/p>\n

Beach J supported the suggestion on three bases:<\/p>\n

    \n
  1. By reference3<\/sup>\u00a0to the decision of\u00a0Pumfrey J\u00a0<\/em>in\u00a0Palmaz\u2019s European Patents\u00a0(UK)4<\/sup>\u00a0(Palmaz)<\/em>, in which Pumfrey J used the expression \u201cin substance disclosed\u201d in a part of the decision discussing \u201cintermediate generalizations\u201d;<\/li>\n
  2. By reference5<\/sup>\u00a0to the 13th edition (published in 1982) of\u00a0Terrell on The Law of Patents (Terrell)<\/em>, in which the authors noted that \u201cthe then new section 76(2) would likely be construed \u201cmore or less the same as the requirement under the old law that there must be a fair basis for the amendment in the unamended specification\u201d\u201d; and<\/li>\n
  3. By reference6<\/sup>\u00a0to the decision of the Full Federal Court in\u00a0Les Laboratoires Servier v Apotex<\/em>7<\/sup>\u00a0in which Emmett J tested whether an amended claim feature \u201clinks back\u201d to the original disclosure of that feature in isolation.<\/li>\n<\/ol>\n

    Respectfully, these authors believe that Beach J\u2019s three bases of support for the suggestion that the current requirements of s 102(1) are not any stricter than the previous requirements are misplaced for the following reasons:<\/p>\n

    Palmaz<\/h6>\n

    The part of\u00a0Palmaz<\/em>\u00a0referred to by Beach J was not considered, let alone upheld on appeal \u2013 in fact Aldous LJ said that it was not necessary to decide that issue at all and he declined to do so (Henry LJ in agreement). Still further, decisions subsequent to\u00a0Palmaz<\/em>\u00a0that were also referred to by Beach J did not advance any closer relationship between the expression \u201cin substance disclosed\u201d and \u201cintermediate generalization\u201d, and in fact applied the law less narrowly than Pumfrey J had, determining that the specification does not need to specify that the newly amended combination of features provides any inventive significance before it could be allowed, which was contrary to the position that Pumfrey J had put forward.<\/p>\n

    Further, in the paragraph immediately preceding that expression in\u00a0Palmaz<\/em>, Pumfrey J explains that an intermediate generalization is one where features are isolated from a particular context in which they are originally described. Pumfrey J then describes that \u201cfeature H\u201d is \u201cin substance disclosed\u201d since it had not been taken out of context. When describing the amendment to incorporate \u201cfeature I\u201d, Pumfrey J stated that this was \u201cin a different category\u201d, had been isolated from the context in which it was originally described, and was therefore an \u201cintermediate generalization\u201d which was unallowable.<\/p>\n

    As such, we prefer an alternate reading of\u00a0Palmaz<\/em>\u00a0\u2013 namely that the expression \u201cin substance disclosed\u201d has\u00a0no<\/u>\u00a0relationship with \u201cintermediate generalization\u201d, that the two were not equated at all, and that Pumfrey J used the expression plainly, rather than to deliberately link the criteria for the\u00a0UK Patents Act 1977<\/em>\u00a0to the\u00a0UK Patents Act 1949<\/em>.<\/p>\n

    Terrell<\/h6>\n

    Terrell<\/em>\u00a0in fact suggested that\u00a0fair basis<\/em>\u00a0was an appropriate test for determining whether an intermediate generalization was allowable, not some stricter assessment. On that basis\u00a0Terrell<\/em>\u00a0stood for the proposition that the Australian High Court\u2019s liberal approach in\u00a0Lockwood v Doric<\/em>8<\/sup>\u00a0was the appropriate test.<\/p>\n

    It is also worthwhile noting that the version of Terrell relied on by Beach J was authored at a time when the UK had no clear authority on the relevance of the principle of \u201cfair basis\u201d to the\u00a0UK Patents Act 1977<\/em>\u00a0which no longer referred to that concept, instead following Europe\u2019s requirement for \u201csupport\u201d.<\/p>\n

    This raises a further point \u2013 that there is nothing new, unusual, or necessarily improper in amending a claim to create an \u201cintermediate generalization\u201d\u00a0per se.<\/em>\u00a0The European authorities have grappled with intermediate generalizations in numerous decisions and they have repeatedly determined that some intermediate generalizations are allowable and some are unallowable \u2013 and that the determinant will be whether the specification discloses additional\u00a0technically relevant<\/em>\u00a0information as a result of the amendment.9<\/sup><\/p>\n

    Les Laboratoires Servier v Apotex<\/h6>\n

    First, the sole authority relied on by Emmett J in\u00a0Les Laboratoires Servier v Apotex<\/em>\u00a0was\u00a0Lockwood v Doric<\/em>\u00a0and neither the High Court in that proceeding nor Emmett J in his decision used the expression \u201cintermediate generalization\u201d. Moreover,\u00a0Lockwood v Doric<\/em>\u00a0is widely regarded as setting a low bar to considering what is fairly based.<\/p>\n

    Second, Emmett J\u2019s discussion did not form part of the ratio of the Full Court in\u00a0Les Laboratoires Servier v Apotex<\/em>, instead the majority (Kenny and Stone JJ) stated that the primary judge was correct to not exercise her discretion to allow any amendment, and they hence did not consider the criteria for allowability of the particular amendment that was proposed. Emmett J\u2019s\u00a0separate<\/em>\u00a0judgment did consider the allowability of the amendment and took a narrow view that the new feature was inextricably linked back to other features of the invention and that seeking to isolate it should not be allowed.10<\/sup>\u00a0In line with the majority, Emmett J additionally decided that the primary judge was correct to not award the discretion to allow the amendment.<\/p>\n

    Third, the primary judge in\u00a0Apotex v Les Laboratoires Servier11<\/sup><\/em>\u00a0followed the well-established principles of the Full Federal Court (in particular) that \u201cin substance disclosed\u201d is similar to \u201cfair basis\u201d or possibly even more liberal. That extensive higher court authority for the law on fair basis, in substance disclosure and amendment allowability has been sufficiently well developed under Australian law that reference to UK and EP jurisprudence by Beach J in\u00a0obiter<\/em>\u00a0should, respectfully, carry no weight.<\/p>\n

    Possible consequences<\/h6>\n

    Despite our analysis, Beach J\u2019s speculation that the \u201cnew\u201d law on amendment allowability may apply as strictly to the \u201cold\u201d law is troublesome since many of the granted patents currently in force in Australia were subject to the pre-Raising the Bar version of the\u00a0Patents Act 1990<\/em>, and those patents may stay on the register for another decade or more.<\/p>\n

    If amendment of any one of the originally filed claims was previously allowed by the Patent Office, but is later deemed unallowable by a Court, the priority date of that claim will be deferred12<\/sup>\u00a0which may lead to invalidation of the patent for lack of inventive step or (curiously) even lack of novelty.<\/p>\n

    That was precisely the outcome in\u00a0AstraZeneca v Apotex<\/em>13<\/sup>\u00a0where the majority held that: an amended claim was \u201cfundamentally inconsistent\u201d14<\/sup>\u00a0with the original disclosure; that the amendment should therefore not have been allowed; that, as a result, the priority date of the amended claim should be deferred; and that the claim lacked novelty. Relevantly, the parties to the decision of the Full Court in\u00a0AstraZeneca<\/em>\u00a0both directed15<\/sup>\u00a0the Court to the liberal test for \u201cfair basis\u201d as determined in\u00a0Lockwood v Doric.<\/em><\/p>\n

    It is not difficult to imagine a similarly fatal outcome for a large number of patents in which the Patent Office has allowed an \u201cintermediate generalization\u201d amendment which could be tested in invalidity proceedings under Beach J\u2019s suggested criteria for amendment allowability.<\/p>\n

    In our view, Beach J\u2019s speculation in\u00a0CSIRO v BASF Plant Science GmbH<\/em>\u00a0should\u00a0not<\/u>\u00a0(but may inevitably) provide fertile ground for any defendant to revisit the amendment history of a granted patent with an eye to applying stricter requirements for amendment allowability, so as to invalidate that patent.<\/p>\n

    This is precisely the logic that was applied in a recent decision of the Australian Patent Office in\u00a0Merck & Cie<\/em>,16<\/sup>\u00a0where a very experienced Deputy Commissioner of Patents conducted a hearing following re-examination of an application which was subject to the pre-Raising the Bar law. The sole focus of the hearing was to determine whether certain amended claims defined a non-obvious invention. However, after determining that the amended claims did not lack an inventive step,17<\/sup>\u00a0the Deputy Commissioner (in\u00a0obiter<\/em>18<\/sup>) also cited the obiter reference in\u00a0CSIRO v BASF Plant Science GmbH<\/em>\u00a0which was to the\u00a0obiter<\/em>\u00a0reference in\u00a0Les Laboratoires Servier v Apotex Pty Ltd<\/em>\u00a0as basis for applying the law on \u201cintermediate generalizations\u201d to the amended claims being re-examined. The Deputy Commissioner expressed \u201cconcerns\u201d that the original specification did not provide a \u201cspecific\u201d enough disclosure of the combination of features in the amended claims for them to be fairly based. This approach seems to favour Emmett J\u2019s\u00a0obiter<\/em>19<\/sup>\u00a0over the full weight of the High Court in\u00a0Lockwood v Doric<\/em>20<\/sup>, and may prove troublesome for the patentee.<\/p>\n

    In our view, the compounding of non-binding obiter is unhelpful to the development of coherent law, and this decision validates the authors\u2019 concerns for future developments in this area.<\/p>\n

    The appropriate standard<\/h6>\n

    We argue that Beach J\u2019s suggestion that the standard for amendment allowability has\u00a0always<\/em>\u00a0been strict is not appropriate.<\/p>\n

    Before the Federal Court of Australia, James & Wells successfully appealed against a decision of the Australian Patent Office to disallow a set of complex amendments in\u00a0United States Gypsum Company v CSR Building Products Ltd<\/em>21<\/sup>. On one interpretation the amended claims could be characterized as intermediate generalizations. Moshinsky J applied established authority in asking \u201cwhether there is \u201ca real and reasonably clear disclosure\u201d in the relevant specification of what is claimed in the amended claim, such that \u201cthe alleged invention as claimed is broadly, that is to say in a general sense, described in the body of the specification\u201d\u201d.22<\/sup>\u00a0The amendments were allowed.<\/p>\n

    Very recently James & Wells appeared again in the Federal Court of Australia before Besanko J in\u00a0Boehringer Ingelheim Animal Health USA Inc v Elanco New Zealand<\/em>,23<\/sup>\u00a0this time defending an appeal against a decision of the Australian Patent Office to allow amendment of a set of claims to introduce a disclaimer of matter not explicitly referred to. At its heart the proceeding was probing whether such a disclaimer \u201cadded matter\u201d and whether the claimed invention was \u201cfundamentally inconsistent\u201d with the invention originally described. The decision in\u00a0AstraZeneca v Apotex<\/em>\u00a0was relied on heavily by both parties \u2013 a decision in which Besanko J was a member of the Full Court\u2019s bench. We look forward to Besanko J\u2019s further clarification of the law of amendment allowability.<\/p>\n

    In the recent Full Federal Court decision in\u00a0Meat and Livestock Australia Limited v Branhaven LLC<\/em>,24<\/sup>\u00a0the Full Court did not cite any of the three authorities discussed above that Beach J referred to in\u00a0CSIRO v BASF<\/em>\u00a0and instead indicated that (emphasis added):<\/p>\n

    All other things being equal, a claim that defines an invention in terms that are narrower than a more general description in the body of the specification would support is not likely to travel beyond what is more generally described. But there may be some situations in which what is more specifically defined results in a claim that travels beyond what is described in the specification\u2026 In these situations a claim may be invalid\u00a0if the invention more specifically defined is an invention that is different from the invention described in the specification as opposed to some narrower embodiment of the latter.<\/u><\/em><\/p>\n

    Conclusion<\/h6>\n

    With the greatest of respect to an accomplished Intellectual Property Justice of the Federal Court of Australia, we submit that there\u00a0is<\/em>\u00a0a difference in scope between the previous version of s 102(1) and its current form, and that the distinction is\u00a0not<\/em>\u00a0subtle. Rather:<\/p>\n

      \n
    • the pre-Raising the Bar version of s 102(1) requires that there simply be a \u201creal and reasonably clear disclosure\u201d of the matter introduced as a result of the amendment and that it should not \u201ctravel beyond\u201d the invention originally described. The provision \u201cshould generally be given a liberal construction\u201d25<\/sup>\u00a0and that the phrase \u201cnot in substance disclosed\u201d should be interpreted in \u201ca broad common sense way\u201d.26<\/sup>\u00a0There should be a focus on whether the amendments result in an\u00a0invention<\/em>\u00a0that is \u201cdifferent from\u201d,27<\/sup>\u00a0or \u201cfundamentally inconsistent\u201d28<\/sup>\u00a0with the originally described invention; as against<\/li>\n
    • the post-Raising the Bar version of s 102(1) which provides a \u201cstrict\u201d requirement for a \u201cclear and unambiguous\u201d disclosure of the matter introduced as a result of the amendment unfettered by any \u201ccontext\u201d which would prohibit its isolation from that context.29<\/sup><\/li>\n<\/ul>\n

      As always, seeking advice from experienced patent attorneys who have substantial prosecution and litigation experience will help you to avoid the unintended consequences of what is otherwise a \u201csimple\u201d amendment. We look forward to talking with you.<\/p>\n

      In our next article we discuss how these developments might impact on New Zealand law.<\/em><\/p>\n

      1. [2020] FCA 328.
      \n<\/em>2. Item 29: Amendments not allowable; Intellectual Property Laws Amendment (Raising The Bar) Bill 2011.
      \n<\/em>3. CSIRO v BASF Plant Science GmbH\u00a0[2020] FCA 328, [221].
      \n<\/em>4. [1999] RPC 47.
      \n<\/em>5. CSIRO v BASF Plant Science GmbH\u00a0[2020] FCA 328, [221].
      \n<\/em>6. CSIRO v BASF Plant Science GmbH\u00a0[2020] FCA 328, [219].
      \n<\/em>7. Les Laboratoires Servier v Apotex Pty Ltd [2010] FCAFC 131.
      \n<\/em>8. Lockwood Security Products Pty Limited v Doric Products Pty Limited (2004) 217 CLR 274.
      \n<\/em>9. T1906\/11.
      \n<\/em>10. Les Laboratoires Servier v Apotex Pty Ltd [2010] FCAFC 131, [25].
      \n<\/em>11. Apotex Pty Ltd v Les Laboratoires Servier (No 2) [2009] FCA 1019.
      \n<\/em>12. Patents Act 1990 s 114(1); Reg 3.14.
      \n<\/em>13. AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99.
      \n<\/em>14. Ibid.[247].
      \n<\/em>15. Ibid. [240].
      \n<\/em>16. [2020] APO 45.
      \n<\/em>17. [2020] APO 45 at [117].
      \n<\/em>18. [2020] APO 45 at [120].
      \n<\/em>19. Les Laboratoires Servier v Apotex Pty Ltd [2010] FCAFC 131, [25].
      \n<\/em>20. (2004) 217 CLR 274 at [69] per Gleeson CJ, McHugh, Gummow, Hayne and Heydon JJ, quoting\u00a0Gummow J in Rehm Pty Ltd v Webster\u2019s Security Systems (International) Pty Ltd (1988) 81 ALR 79 at 95 with\u00a0approval.
      \n<\/em>21. [2017] FCA 595.
      \n<\/em>22. United States Gypsum Company v CSR Building Products Ltd [2017] FCA 595., [45].
      \n<\/em>23. No. VID 581 of 2019 [not yet determined].
      \n<\/em>24. [2020] FCAFC 171 at [104].
      \n<\/em>25. Gambro Pty Ltd & Anor v Fresenius Medical Care South East Asia Pty Ltd (1999) 48 IPR 625 at [25]; Gambro Pty\u00a0Ltd & Anor v Fresenius Medical Care South East Asia Pty Ltd (2000) 49 IPR 321 at [18] per Burchett, Heerey and\u00a0Lehane JJ.
      \n<\/em>26. Re Ethyl Corp\u2019s Patent [1972] RPC 169; applied in Gambro Pty Ltd & Anor v Fresenius Medical Care South East\u00a0Asia Pty Ltd (1999) 48 IPR 625 at [25].
      \n<\/em>27. Meat and Livestock Australia Limited v Branhaven LLC [2020] FCAFC 171.
      \n<\/em>28. AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99.<\/em><\/div>\n","protected":false},"excerpt":{"rendered":"

      In our\u00a0first article\u00a0in this series on Australian and New Zealand law, we reported on the current law on amendment allowability following Australia\u2019s \u201cRaising the Bar\u201d reforms and the decision of the Federal Court of Australia in\u00a0CSIRO v BASF Plant Science GmbH\u00a0and how that decision has been applied by the Australian Patent Office. In this second…<\/p>\n","protected":false},"author":8,"featured_media":3004,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"content-type":"","footnotes":""},"categories":[243,254],"class_list":["post-3376","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-ip-update-intl","category-patents-intl","insight-resource-articles-intl","insight-resource-ip-updates-intl"],"acf":[],"yoast_head":"\nUnallowable \u2013 the Federal Court of Australia requests amendment of history - James & Wells<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.jamesandwells.com\/intl\/unallowable-the-federal-court-of-australia-requests-amendment-of-history\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Unallowable \u2013 the Federal Court of Australia requests amendment of history - James & Wells\" \/>\n<meta property=\"og:description\" content=\"In our\u00a0first article\u00a0in this series on Australian and New Zealand law, we reported on the current law on amendment allowability following Australia\u2019s \u201cRaising the Bar\u201d reforms and the decision of the Federal Court of Australia in\u00a0CSIRO v BASF Plant Science GmbH\u00a0and how that decision has been applied by the Australian Patent Office. 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