Is It Time to Talk (Again) About Reforming Australia’s ‘Best Method’ Requirement?

The recent Full Federal Court decision in Zoetis Services LLC v Boehringer Ingelheim Animal Health USA Inc [2024] FCAFC 145 has highlighted fundamental flaws in the Australian patent law’s ‘best method’ requirement.  While the court's application of existing principles appears sound, the resulting analysis reveals that the requirement is not only arbitrary in its operation, but potentially counterproductive to innovation.

The Australian Patents Act 1990 sets out requirements for patent specifications in section 40.  These include that the specification must: disclose the invention in a manner clear enough and complete enough for the invention to be performed by a person skilled in the relevant art (the enablement requirement);  disclose the best method known to the applicant of performing the invention (the best method requirement);  and that the claims must be supported by matter disclosed in the specification (the support requirement).  While failure to satisfy enablement or support might affect only certain claims, failure to disclose the best method is fatal to the entire patent.  It is, in effect, a ‘nuclear’ ground of invalidity that cannot be remedied by amendment or partial revocation.

The Zoetis case concerned three patent applications for pig vaccines that were found invalid for failing to disclose the best method of performing the inventions.  While the applications disclosed ranges of antigen concentrations that would work, they did not reveal the specific concentrations used in Zoetis's successful experimental vaccines.  The court’s analysis of why this was fatal to the applications exposes deep problems with the requirement itself.

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Tags: Australia, Best method/mode, Public policy

Patentee Punished for Failing to Heed Attorney’s Recommendation

A judge of the Federal Court of Australia has denied a request by patentee Les Laboratoires Servier (‘Servier’) to amend a patent in order to avoid cancellation for failure to disclose the best method of performing the claimed invention solely because it opted not to follow a recommendation made by its Australian patent attorneys during examination of the original application back in 2004: Apotex Pty Ltd v Les Laboratoires Servier (No 4) [2015] FCA 104.

Just be absolutely clear here, the court found that the requested amendment was allowable in principle (i.e. was not precluded by any provision of the Patents Act 1990), and that in all other respects Servier had acted promptly and appropriately, such that the court would otherwise have exercised its discretion to allow the amendment.  The one and only reason given for refusing the amendment request was that the patent attorneys had suggested that a similar amendment might be made prior to grant of the patent, but that the responsible person within Servier was of the opinion that the disclosure within the patent specification was adequate, and that the amendment was therefore not necessary.  The court bluntly describes this as ‘an error on her part’ (at [180]).

I find this decision frankly extraordinary, and I fully expect that it will be appealed.  The patent in question covers the compound perindopril arginine, which is the active ingredient in the brand name drug COVERSYL, which is used to treat hypertension (i.e. high blood pressure).  This patent, and foreign counterparts, have been extensively litigated in Australia and overseas.  It is clear that there is a great deal at stake in this case, and Servier is unlikely to abandon its efforts to save a patent that has been found, in all other respects, to be valid.

I should say, at this point, that the patent attorney firm in question here was Watermark, where I work.  However, Watermark no longer acts for Servier in relation to this matter, and nothing that I shall say in this article is based on anything other than publicly available information.  Opinions, as always, are my own, and should not be taken as representing the views of Watermark, its Principals, management, other employees or clients (past or present).

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Tags: Amendments, Australia, Best method/mode, Pharmaceuticals, Validity

What Materials Can I File With My Patent Application?

It is widely understood that the kinds of materials that may make up a patent application are quite strictly limited.  However, comments by the judge in a recent decision of the Federal Court of Australia suggest that IP Australia may be obliged to make reasonable efforts to access, review and take into account any materials filed by an applicant is support of a patent application or, at the very least, expressly advise the applicant if unable to do so.

When applying for a patent in Australia, it is necessary to file a specification comprising a description, claims and (where necessary or helpful to explain the invention) accompanying drawings.  Regulation 3.1(1) also requires that an abstract be filed.  Schedule 3 of the Patents Regulations 1991 sets out the general requirements for the format of these documents.

Beyond the basic application documents, the Patents Act 1990, the Regulations, and IP Australia’s Electronic Business Rules, appear to leave little scope for filing of additional materials to support a patent application.  It is possible to include such things as engineering designs, example program code for software-based systems, and other implementation details of prototypes or fully-functional implementations of an invention.  However, these are generally provided simply as annexures to the patent specification, in the form of text and/or drawings which are subject to the usual format rules as set out in Schedule 3 of the Regulations.

Gene sequence listings, which may be required to provide full disclosure of certain inventions in the field of biotechnology, are a special case, because of their sheer size.  They may therefore be filed electronically, as separate files structured in accordance with the standards specified in Annex C of the Administrative Instructions of the PCT.

Finally, microbiological materials that are not otherwise available, and which are necessary to put the invention disclosed in the specification into effect, must be deposited with an approved depository institution (see section 6 and section 41 of the Patents Act).

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Tags: Australia, Best method/mode, Examination, Patent filing, Patent Office, Patent specifications

Patent Fails to Disclose ‘Best Method’, But Will It Be Revoked?

Apotex Pty Ltd v Servier Laboratories (Aust) Pty Ltd [2013] FCA 1426 (24 December 2013)

An Australian Federal Court judge has found that the specification of Australian patent no. 2003200700 does not disclose the ‘best method’ of performing the claimed invention (in this case, the compound perindopril arginine, which is sold under the name COVERSYL as a drug to treat hypertension).  The patent is owned by French pharmaceutical company Les Laboratoires Servier, and was challenged by generic drug manufacturer Apotex, which wishes to bring its own version of the drug to market.

Not surprisingly, Apotex applied to the court for revocation of the Servier patent on a number of additional grounds: lack of novelty; lack of inventive step; lack of fair basis for the claims in the description; and that the patent was obtained by false suggestion or misrepresentation.  Apotex failed on all of these grounds, succeeding only in persuading the court that the patent did not describe the best method known to Servier of performing the invention.

Lack of novelty, inventive step or fair basis is assessed on a claim-by-claim basis, i.e. for any of these grounds the patent might have been only partially invalid.  Failure to disclose the best method, on the other hand, would usually be expected to result in the patent being declared wholly invalid (I shall explain why below), making Apotex entirely successful in its application for revocation of the Servier patent.

Interestingly, however, in this case the court has stopped short of immediately ordering revocation of the patent.  The judge (Justice Rares) has instead indicated that he will hear further submissions from the parties on the question of appropriate relief, as well as on the matter of an award of costs.

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Tags: Australia, Best method/mode, Pharmaceuticals, Validity

No Summary Judgment on Question of ‘Best Method’

Expo-Net Danmark A/S v Buono-Net Australia Pty Ltd (No 2) [2011] FCA 710 (23 June 2011)

Validity – best method – criteria for assessing whether patent specification describes ‘the best method known to the applicant of performing the invention’

Procedure – summary judgment – whether patentee has ‘no reasonable prospects of success’ in defending an allegation of failure to describe best method

In this decision of the Federal Court, Justice Bennett was required to consider the criteria for assessing whether a patent specification describes the best method known to the applicant for performing the claimed invention, and whether it would be appropriate to grant summary judgment revoking a patent on the ground that the best method is not described.

Her Honour found that, in this case at least, determining whether the best method was described is a complex question that requires careful consideration of a range of relevant facts and conflicting evidence of the parties.  As such, it could not be said that the patentee had no reasonable prospect of success in defending the allegation that the best method known was not described, and summary judgment was not appropriate.

We find this decision interesting firstly for its discussion of the criteria for assessing whether the best method has been disclosed in a patent specification, and also for its demonstration of the difficulties inherent in obtaining summary judgment in patent cases, which almost invariably involve complex questions of fact and law.

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Tags: Australia, Best method/mode, Federal Court practice, Summary judgment, Validity