Les Laboratoires Servier v Apotex Pty Ltd [2016] FCAFC 27, a recent Australian Full Federal Court decision, recently clarified the best method requirement in Australia.
The decision related to Australian Patent No. 2003200700 (“the Patent”), owned by Les Laboratories Servier (“Servier”). The Patent particularly related to the arginine salt of perindopril (perindopril arginine) and its hydrates. The Patent was drafted in Europe and it seems that it was expected that the Patent would meet the US best method requirement, and consequently that the Patent would also meet the Australian best method requirement (paragraph [205], and paragraphs [32-34] of the primary decision). Ultimately, this expectation was shown to be incorrect.
The sole disclosure of the preparation of the arginine salt in the Patent specification was that perindopril arginine “has been prepared according to a classical method of salification [salt making] of organic chemistry”. No further disclosure of how perindopril arginine was made was provided. The inventor and Servier also knew that perindopril arginine had been prepared in 1986 and 1991 using specific salification methods, but these were not disclosed in the specification. So a question to be answered was: given that the claims relate to a product per se, is it necessary for the Patent specification to disclose the best method for making that product, or is a disclosure of the best product sufficient to meet the best method requirement?
The Court found that if the subject of the claims is a product, it may be necessary to provide the best method of making that product. Patent applicants have an obligation to provide the best method known to them of performing the invention that will best fulfil the promises of the invention. In meeting this obligation it is necessary to first decide what the invention is. In the present case, the point of the invention is the improved storage ability of perindopril arginine. It was found that there are numerous methods possible for forming the perindopril arginine salt (encompassed by a “classical method of salification”), and these can produce different forms of perindopril arginine, and storage ability can vary depending on the nature of the salt that is formed. Consequently, the Court concluded that Servier had to disclose the best method of making the product, even though the claims related to a product per se.
As a consequence, the Patent was found to be invalid only due to a failure to meet the best method requirement.
Servier sought leave to amend the specification after grant to include a best method for making perindopril arginine, but was ultimately unsuccessful. Importantly, this may be possible for patent applications for which examination was requested before 15 April 2013, but not for patent applications for which examination was requested after this date. Due to amendments to the Australian Patents Act, if examination is requested after 15 April 2013, amendment of the specification which would result in disclosure of matter that extends beyond that disclosed in application documents as original filed is not allowed (with limited exceptions).
This case illustrates that when drafting chemical and biochemical patent specifications (in particular), attorneys should endeavour to include the best method of making claimed products, even if the claims are directed to the products themselves. If this requirement has not been met for an Australian patent for which examination was requested prior to 15 April 2013, instructors should discuss this issue with their Australian attorneys as it may be possible to correct the patent to meet this requirement.