Australia’s patent law requires that, in addition to describing the invention “fully”, a patent specification must also disclose the “best method of performing the invention”.

Sub-section 40(2) of the Australian Patents Act 1990 requires that:

This requirement stems from the need to fully describe the invention claimed so as to not keep any details of the invention secret which would otherwise need to be shared with the public to allow the person skilled in the art to recreate the invention to the best level known to the applicant. This is part of the bargain of teaching society the invention in exchange for a limited term of monopoly afforded by a patent.

Failure to disclose the best method known to the applicant can result in the invalidation of any patent subsequently granted on the application.

In a recent Decision¹ by the Australian Patent Office, one of the issues considered was that of best method. In Merial, Inc. v Bayer New Zealand Limited, the Hearing Officer considered the issue of best method in the form of three questions:

1. what is the invention for which a best method must be provided;
2. what method is described in the specification; and
3. was the applicant aware of a better method?

While it is established law that the best method known to the applicant that must be disclosed in the specification is that known by the applicant at the time of filing the application,² there is still some question as to when this requirement needs to be fulfilled, i.e. is it possible to subsequently amend the specification as filed to add the best method should the specification as filed be deemed to be lacking disclosure of the best method?

In the Full Federal Court decision of Pfizer Overseas Pharmaceuticals v Eli Lilly,³ it was held that the specification can be amended to include the best method at least until the time of grant, but left open the possibility of including the best method even after grant of the patent.

This decision therefore made it quite possible to correct an otherwise-deficient specification in regards to best method and did not necessarily result in the automatic invalidation of a patent (although great care should be taken not to fall foul of the provisions⁴ of the Patents Act which give a court discretion in allowing (or refusing) amendments, which in one case resulted in a patentee being refused the opportunity to amend their patent to overcome a finding of lack of best method, resulting in the ultimate revocation of the patent).⁵

Pre-Raising the Bar Amendment Provisions

These latter decisions were made in respect of patents filed prior to the “Raising the Bar” provisions,⁶ which governed all patent applications for which a Request for Examination was filed on or after 15 April 2013. These provisions served, in part, to increase the validity thresholds for the granting of a patent in Australia.

Prior to Raising the Bar, the provisions dictating what amendments were not allowable, were set out in Section 102. In particular, subsection 102(1) provided:

1. An amendment of a complete specification is not allowable if, as a result of the amendment, the specification would claim matter not in substance disclosed in the specification as filed.

Thus, under the “old law”, it was possible to amend a specification which added new matter, provided that it did not result in the claiming of that new matter.

Accordingly, the scope to add new matter to add a best method description after the application was filed, and therefore correct an otherwise deficient specification, was quite generous.

Post-Raising the Bar Amendment Provisions

Under the current Act as amended under the Raising the Bar provisions, the equivalent subsection 102(1) provides:

1. (1) An amendment of a complete specification is not allowable if, as a result of the amendment, the specification would claim or disclose matter that extends beyond that disclosed in the following documents taken together:
2. 1. the complete specification as filed;
   2. other prescribed documents (if any).⁷

It will be noted that the new provision now prohibits the making of an amendment which would result in disclosing matter that extends beyond that disclosed in the specification as filed.

In the context of amending a specification after filing to correct a deficient specification by adding information relating to a best method, this tightened provision appears to close off (or at least severely restrict) any opportunity to correct a best method defect. This effectively requires that the specification include the best method at the time of filing the application.

In the Patent Office Decision referred to above (Merial, Inc. v Bayer),⁸ the Hearing Officer found the opposed patent application not to have disclosed the best method of performing the invention. While the opposed patent was governed by the Raising the Bar provisions, the Hearing Officer nevertheless allowed the Applicant a period of 2 months to propose amendments to overcome the deficiency (of the finding of lack of best method). The Officer however stated that “It is not clear to me how the deficiencies in the opposed application may be overcome since it appears that any proposed amendments would result in adding new matter that was not present in the originally filed specification, and therefore would not be allowable under section 102 of the Act.”

It remains to be seen how the Applicant responds.

The new requirement that the specification as proposed to be amended does not claim or disclose matter that extends beyond that disclosed in the complete specification as filed in combination with the prescribed documents has yet to be considered fully by the courts. However, in another, even more recent Patent Office Decision⁹ in Steven Borovec v K-Fee System GmbH, the Hearing Officer in considering this question, cited guidance provided by the Australian Patent Examiner’s Manual of Practice and Procedure¹⁰:

Thus, the correct approach to considering whether an amendment adds new matter is to ask whether the skilled person would, on looking at the specification as proposed to be amended, learn anything about the invention which they could not learn from the combined disclosure of the complete specification as filed and other prescribed documents. This comparison is a strict one in the sense that subject matter will be added unless it is clearly and unambiguously disclosed, either explicitly or implicitly, in the relevant documents”.

Accordingly, while the new provisions appear to be extremely limiting in allowing amendments to overcome a finding of lack of best method in a specification for an application governed under the Raising the Bar law, there may well be some small “wiggle room” in some cases by being able to combine information from the specification as filed with information in the “prescribed documents”, as well as the possibility of relying on information that is “implicitly” disclosed in the combination of these documents.

With the ground of lack of best method being used more frequently in recent years to attack the validity of an Australian patent, and with more patents being granted under the Raising the Bar provisions, it is only a matter of time until a case comes before the courts to provide more guidance on the issue.

Footnotes

¹Merial, Inc. v Bayer New Zealand Limited [2018] APO 14 (22 February 2018) [Merial]

²Rescare Ltd v Anaesthetic Supplies Pty Ltd (1992), 25 IPR 119

³Pfizer Overseas Pharmaceuticals v Eli Lilly [2005] FCAFC 224

⁴Section 105 Australian Patents Act 1990

⁵Les Laboratoires Servier v Apotex Pty Ltd [2016] FCAFC 27 (8 March 2016)

6IP Laws Amendment (Raising the Bar) Act 2012

⁷Regulation 10.2A of the Patents Regulations 1991 defines “prescribed documents” for the purpose of paragraph 102(1)(b) as an abstract filed with the complete specification; any part missing from the compete specification at filing that was later incorporated into the specification under reg.3.5A or PCT Rule 20.5 or Rule 20.6; and an amendment that has been made to the complete specification after filing, for the purpose of: I. Correcting a clerical error or obvious mistake; or ii. complying with sec 6(c) (micro-organism deposit requirements).

⁸Merial, supra note 1 at 239

⁹Steven Borovec v K-Fee System GmbH [2018] APO 18 (9 March 2018)

¹⁰Australian Patent Examiner’s Manual of Practice and Procedure Section 2.23.8.1A