Apotex Pty Ltd v Les Laboratoires Servier (No 4)

Apotex Pty Ltd v Les Laboratoires Servier (No 4) concerned an application by Servier to amend its patent under section 105 of the Patents Act 1990 (Cth). The dispute centred on Servier's failure to disclose the best method of performing the invention known to it, as required by section 40(2)(a) of the Act. This omission came to light after Apotex raised the issue during litigation, leading Servier to apply for an amendment to its complete specification to include the best method it knew of at the time of filing. The court had to determine whether the complete specification could be amended post-filing and post-grant, whether a belief or state of mind falling short of knowledge required disclosure, and the extent of the patentee's obligation to fully disclose all relevant matters in respect of the application to amend the patent.

The court addressed several legal issues. Firstly, it examined the timing and reasonableness of Servier's application for amendment, considering the delay in applying for the amendment after the non-compliance with section 40(2)(a) was raised. Secondly, the court deliberated on the public interest versus the patentee's interest in maintaining the patent, assessing whether Servier's failure to disclose the best method outweighed its proprietary interest. Thirdly, the court considered the scope of the patentee's obligation to disclose all relevant matters, including whether earlier decisions not to include certain subject matter in the original application affected the discretion to grant the amendment.

The court concluded that Servier's failure to disclose the 1986 and 1991 methods in the complete specification, despite knowing about them, was not reasonable and significantly harmed the public interest. This damage outweighed Servier's interest in saving the patent from revocation. Consequently, the court denied Servier's application to amend the patent, leading to the revocation of the patent on the grounds that the specification did not comply with section 40(2)(a) of the Act. The court ordered that the patent be amended by deleting certain claims, but dismissed the application otherwise. Additionally, the court directed the parties to provide written submissions regarding the costs of the trial and amendment application, reflecting the extensive nature of the proceedings.

The court's decision underscores the importance of timely and accurate disclosure in patent applications, balancing the interests of the patentee with the broader public interest. The outcome also highlights the court's discretion in allowing patent amendments, considering factors such as the timing of the application and the public interest in full disclosure.