Any applicant for patent protection in Australia must disclose the best method for performing the invention known to it at the time of filing a complete application. Failing to disclose the best method will impact not just one or two claims, but can invalidate an entire patent.

Under “Old Act” patent legislation this dire situation could potentially be saved by simply amending the specification to add in a previously omitted best method - supposedly at any time up to grant. However, The Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (RTB) introduced more stringent amendment provisions that prohibit the addition of new subject matter to a patent specification. Under current post-RTB “New Act” provisions, the simple option of adding a best method no longer exists. Essentially, there is no cure for invalidity caused by omitting a best method disclosure under current Australian patent law.

The requirement to disclose a best method with essentially no cure for its omission is a combination that is peculiar to Australia and represents an unusual position on the international stage. Overseas applicants therefore have to pay particular attention to ensure drafting is conducted with Australian practice in mind. For Australia, a best method disclosure should be placed in the specification when drafting a provisional application and, if necessary, it should be updated when filing the complete application.

The best method requirement

The best method requirement evolves from the social contract of a patent: the patentee discloses the most effective means of performing an invention for the benefit of the public in exchange for a term of monopoly. What is required is an additional utmost good faith disclosure, at a higher level over and above that required for sufficiency/enablement of the claims.

The question of whether the applicant has provided the best method of performing the invention known to it at filing is necessarily one of fact which inherently lies with the applicant. Evidence on this issue is unlikely to be available at examination, hence best method is typically not considered during examination. The earliest the issue of best method is likely to arise is during opposition proceedings. In fact, the issue of best method has been the dominion of the Federal Court during infringement/revocation proceedings (and even then it has received little judicial consideration).

Notable exceptions aside, it has been rare for a patent or claims of a patent to be found invalid due to a failure to disclose a best method, at least under the “Old Act”. First, it must be proved that the applicant knew of a better method than that disclosed at the time of filing of the complete specification: this comes down to the difficult task of proving the applicant’s subjective state of mind. Secondly, even if this first hurdle is cleared it is a hollow reward: the specification can be amended, at least under “Old Act” provisions, to include the best method - if leave to amend is allowed.

The lesson of Les Laboratoires Serviers and Apotex

In Les Laboratoires Servier v Apotex Pty Ltd [2016] FCAFC 27 (Servier and Apotex), leave to amend was not allowed and the patent in suit was invalidated on failure to disclose the best method alone.

Although Servier and Apotex was decided under “Old Act” provisions, it provides a chilling lesson as to what might happen under current Australian patent law. That is, a failure to disclose the best method may lie dormant as a patent application proceeds to acceptance/grant. At this point, the patentee may discover that the deficiency cannot be corrected because leave to amend is not allowed.

The case may be summarised as an overseas applicant (Servier) underestimating the high threshold for the best method requirement in Australia. Although only product claims were included in the patent, evidence established that the properties of the product were method dependent. In this case, the Court found that the best method of making the product had to be disclosed - the existing generic method mentioned in the application was deemed to be “wholly inadequate”.

Despite advice from their Australian patent attorney to amend the patent application during prosecution to satisfy written description requirements, Servier chose to await comments from the Examiner. “We will see later” was the response to the attorney’s advice. But, best method is typically not examined in Australia. There were no further comments from the Examiner and the application proceeded to grant. “We will see later” came back to haunt Servier, twelve years later, in revocation proceedings instigated by Apotex.

As Servier did not heed their patent attorney’s advice, the Court exercised its discretion to not allow amendment of the specification to introduce a best method. It was held that the damage to the public interest involved in Servier’s failure to disclose the best method was not reasonable and it outweighed the proprietorial interest in being able to save the patent. Servier’s patent was revoked in its entirety.

New amendment law prohibits addition of new subject matter

Under the “New Act”, amendments that extend the disclosure of a patent specification are prohibited. This prohibition on added subject matter, however, is yet to be tested judicially in Australia. Nonetheless, it was the intent of RTB to bring Australian patent law into line with that of overseas jurisdictions which can help inform Australian interpretation of new provisions. Following relevant UK and European case law, amendments to add new subject matter are allowable only if the new matter can be directly derived, either explicitly or implicitly, from a reading of the specification as filed (together with certain prescribed documents (if any)). The correct approach (espoused in Section 2.23.8.1A of the Australian Patent Office Manual of Practice and Procedure), to consider whether an amendment adds new subject matter is “to ask whether the skilled addressee 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”.

No cure for omitting best method

Essentially, there is no cure for invalidity caused by omitting the best method under current Australian patent law. Simply amending a patent specification to add in the new subject matter of an omitted best method is not allowed. Instead, the applicant is left with the task of arguing that the best method is somehow implicitly disclosed in the specification as filed (together with the certain prescribed documents) or proposing an amendment that would have to rely on that implicit disclosure. Applying the principle adopted by the Australian Patent Office, the applicant has to argue that the skilled addressee has not learnt anything further from the proposed best method amendment. In most cases, this task will be onerous.

Importantly, it is not a case of “we will see later” for Examiner’s comments during prosecution: best method is not typically considered at examination. Even if best method is raised at examination, it is too late - it is unlikely that an objection can be addressed. A divisional application with an updated best method disclosure could be filed to preserve rights. However, this action is not guaranteed as it comes with the risk that claims will lose priority by adding in new subject matter that represents a different invention from that disclosed in the provisional application.

New law has misaligned Australia practice with overseas jurisdictions

The requirement to disclose a best method with, essentially no cure for its omission is a combination that is peculiar to Australia. Contrary to RTB legislative intent, current Australian patent law on best method is out of step with that of other jurisdictions. There is no need to disclose a best method in the United Kingdom and Europe. Failure to disclose a best method is not a ground for invalidity in China or Japan. There is a requirement to disclose a best method in the United States, but it is no longer a ground of invalidity. Given the peculiarity of the best method requirement in Australia, overseas applicants have to pay particular attention to ensure drafting is conducted with Australian practice in mind.

The best method practice

We advise drafting a provisional application around the best method, i.e., the most effective means of performing the invention and, if necessary, updating this to ensure the best method is present when filing the complete application.

The Court’s consideration in Servier and Apotex provides a check list to keep in mind when drafting:

  • Each essential feature for performaning the invention must be described.

    • Even if performing the invention is self-evident, the best method must be disclosed.

  • The best method is the best method of performing the invention as described in the specification.

    • Importantly, the requirement to disclose a best method is not determined with sole reference to the claims. If there is a product claim, the disclosure may still need to include the best method for product manufacture.

  • The best method requirement is assessed on the basis of the applicant’s knowledge at the time of filing the complete application.

  • Applicant means all staff – all R&D, all legal, all business development and corporate.

    • The best method of performing the invention known across all staff must be communicated and placed in the specification and updated where necessary.

    • Expect trouble if a full-scale commercial process is developed, while only an experimental process is included in the specification before the filing date.

  • No need to amend the specification if a better method is found subsequently.

  • No need to identify the best method as such just as long as it is there.

It is imperative to remember that failure to disclose the best method at filing can be fatal under current Australian patent law because amendments are now more tightly restricted by “New Act” provisions. Our recommendation is to take a proactive, preventative approach and disclose the best method.

Where to now for best method?

The unusual combination of best method and amendment law brought in by RTB also breathes new life into best method as a ground in opposition proceedings where once before it was rarely pressed. With a prohibition on added subject matter now in place, opponents will no longer be warned off from running best method because the applicant ultimately has the potential to simply amend the specification. Opponents may now be more vigilant in comparing the disclosure of a specification with any product launch, studies or marketing propaganda released subsequent to filing. For example, evidence to suggest a commercial scale process was in place before filing the complete application, which contains relatively little detail (as argued in Servier and Apotex), can tip the scales of justice in favour of the opponent.

Best method reform?

Contrary to the harmonising intent of RTB, Australia is now strangely out of step with overseas jurisdictions in respect to best method and amendment law. This inconsistency hampers the patent system and burdens applicants with increased costs as they have to take account of idiosyncrasies when preparing patent applications. Industry bodies believe that there has been a failure to investigate how the current best method requirement and prohibition on added subject matter in Australia may interact with each other and on the international stage which has sparked a call for further legislative reform. A submission by the Law Council of Australia identifies inconsistencies with current best method legislation and suggests that the best method requirement be repealed.