E-News No.46

E-News No.46

The Australian best method requirement casts a long shadow – the Servier decision

by Clare Cunliffe (List G Barristers -Australia)

In Australia (unlike most jurisdictions), it is possible to revoke patents on the basis that the patentee has failed to disclose the best method of performing the invention.

Australia recently introduced more stringent disclosure requirements, which are likely to require the patentee to disclose enough information to enable the skilled addressee to perform the invention across the width of the claims. Previously, the patentee was only required to give sufficient disclosure to make something within the scope of each claim. This enablement requirement is additional to the best method requirement.

Further, it is not possible for a patentee to amend a patent specifications for which examination was requested after 15 April 2013 if the amendment would result in the specification disclosing matter which extends beyond that disclosed in the complete specification as filed or prescribed documents. This prohibition was introduced to prevent patentees from amending specifications to deal with a lack of enablement.

The cumulative effect of these provisions is that a patentee must disclose the best method of performing an invention in the specification as filed, or risk having the patent invalidated.

So, what is the best method requirement, and how does it differ from the enablement requirement?

As the result of a very recent decision by the Full Federal Court, Les Laboratoires Servier v Apotex Pty Ltd [2016] FCAFC 27 (Servier), the law is that:

  • The requirement to disclose the best method of manufacture is not necessarily confined to process claims. Even for product claims, it may be necessary to disclose the best method of manufacturing. It will depend on the nature of the invention.
  • The best method requirement may be more onerous than sufficiency. The fact that a skilled addressee can perform the invention without undue experimentation does not necessarily mean that the best method requirement has been met.
  • As a result, provision of an “umbrella” methodology (such as “classical methods of salification”) may not suffice, even where the choice of variables between the particular methods would be a routine matter.
  • There may be a failure to disclose a best method in the absence of evidence that alternative methods produce a worse result, if there is any uncertainty whether a particular parameter may affect the result. That is to say, there may be a failure to comply with best method even where the patentee has not deliberately omitted a “trick” which improves the end result.

The Full Court in Servier did not identify the level of detail required, although it indicated that a description which gives certainty of method is better than one which allows “possible dead ends and false starts”. However, the skilled addressee’s knowledge will not be taken into account in assessing whether the best method requirement has been complied with. For example, one variable which was not specified in Servier was the choice of water as a solvent – which was proven to be a matter of common general knowledge. The trial judge had found that “it was relatively easy to form a salt”.

Servier is difficult to reconcile with earlier authority that an invention need not be described “with that wealth of detail with which the specification of the manufacturer of something is usually put before the workman”.

It is difficult to see what purpose the best method requirement as articulated by Servier serves, in light of the enablement requirement, and since the best method requirement is not limited to instances of bad faith.

The patentee in Servier has filed an application for special leave to appeal to the High Court of Australia, and the Law Council previously made submissions that the best method requirement should be abolished. Hopefully, the best method requirement will be reviewed, either by the High Court or by the legislature.
In the meantime:

  • patent attorneys filing specifications in Australia should be aware of the best method requirement, particularly since matter cannot be added after filing; and
  • parties litigating in Australia should be aware that the ground exists, and is likely to be used more frequently.
  1. See s 40(2)(aa) of the Patents Act 1990 (Cth) and predecessor versions of s 40(2).
  2. S 40(2)(a) of the Patents Act 1990 (Cth).
  3. Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) 207 CLR 1 (Kimberly-Clark).
  4. See s 102 of the Patents Act 1990).
  5. As occurred in Pfizer Overseas Pharmaceuticals v Eli Lilly and Company [2005] FCAFC 224, 225 ALR 416.
  6. Servier at [129].
  7. Servier at [68] – [69].
  8. Servier at [172].
  9. Servier at [172].
  10. Servier at [173].
  11. Servier at [20] to [21].
  12. Apotex Pty Ltd v Les Laboratoires Servier [2013] FCA 1426 at [184].
  13. No-Fume Ltd v Frank Pitchford & Co Ltd (1935) 52 RPC 231 at 243, approved in Kimberly-Clark at [16] – [17].