Year in review: pharmaceutical intellectual property and competition in Australia

The law affecting pharmaceutical patents continues to evolve in a number of important respects.

The Full Court of the Federal Court of Australia delivered its much anticipated judgment in Commonwealth of Australia v Sanofi [2023] FCAFC 97, dismissing the Commonwealth’s claim for compensation against Sanofi and BMS under the usual undertaking as to damages given by the parties in return for the grant of interlocutory injunctions restraining the launch by Apotex of generic Plavix. The legal position, however, remains far from settled, with the High Court of Australia in December 2023 granting the Commonwealth special leave to appeal the Full Court decision, with the appeal hearing likely to be scheduled in the second half of 2024, and with a separate claim by the Commonwealth against Otsuka and BMS (in relation to the undertaking given in return for the grant of an injunction restraining the launch of generic Abilify by Generic Health) currently before the Federal Court of Australia.

The limited body of case law on support and sufficiency requirements under the Patents Act as amended by the Raising the Bar legislation has now received appellate attention in the Full Court’s decision in Jusand Nominees Pty Ltd v. Rattlejack Innovations Pty Ltd [2023] FCAFC 178. The Full Court gave detailed consideration to the leading UK case on sufficiency (Regeneron Pharmaceuticals Ltd v. Kymab Ltd [2020] UKSC 27) and held inter alia that in the context of deciding whether a claimed range of options is sufficiently enabled by the specification, consideration ought to be given to the 'essence or core' of the invention. The Court’s decision confirms that the threshold for sufficiency and support is significantly raised post Raising the Bar.

The post Raising the Bar requirements for claiming ‘priority’ also received much needed judicial guidance in ToolGen Incorporated v. Fisher (No 2) [2023] FCA 794, with the Court holding that the document to which priority is claimed must disclose the claimed invention and in a manner that is clear enough and complete enough for the invention to be performed by the person skilled in the art, a significant departure from the pre-Raising the Bar requirement for priority.

The Federal Court’s decision in Neurim Pharmaceuticals (1991) Ltd v. Generic Partners Pty Ltd (No 5)  provided guidance including as to the conduct that will constitute direct infringement of Swiss-style claims, highlighting the importance of the language of the TGA approved indication and product information compared to that of the claims.1

The law on patentability of computer implemented invention also continues to develop with several Federal Court decisions2 now grappling with the implications of the High Court’s 3-3 split in Aristocrat v. Commissioner of Patents [2022] HCA 29. Although not the subject matter of these decisions, they clearly have potential significance in the medical technology sector.

On the regulatory front, it appears the TGA has at least temporarily abandoned a previously proposed regime to require generic and biosimilar manufacturers to provide patentees with early notification of their applications for marketing approval.3  

There have also not been any further developments on the ACCC’s proposed ‘patents settlement register’ though its implementation remains a possibility given the registers maintained by some international antitrust regulators including in the United States.