The Full Federal Court of Australia provided further certainty over the specifics of the Pharmaceutical Patent Term Extension (PTE) regime in Australia in Commissioner of Patents v Ono Pharmaceutical Co. Ltd  FCAFC 39 (Ono) and Merck Sharp & Dohme Corp. v Sandoz Pty Ltd  FCAFC 40 (MSD case).
Both cases involved multiple registered goods on the Australian Register of Therapeutic Goods (ARTG) that fell within the scope of the claims of the patent. The patent term extensions (PTE) were based on respective application based on different goods in the ARTG. In Ono, the earlier registered substance was from a third party that was unrelated to the patentee and, in MSD, the earlier registered substance had been developed by the patentee.
The Ono Case
There were two substances that fell within the scope of Australian Patent No. 2011203119; KEYTRUDA (a third-party product) and OPDIVO (the patentees product). The KEYTRUDA product was registered on the ARTG prior to OPDIVO, and thus a PTE application based on the OPDIVO product would result in a longer PTE. The Patent Office decided that a PTE must be based on the earliest first regulatory approval of any substance falling within the scope of the claims, and this must be KEYTRUDA.
The patentee appealed this decision to the Federal Court. The Federal Court considered both a literal interpretation of the Act put forward by the Commissioner (the ‘first regulatory approval’ for a PTE meant that the earliest ARTG registered good claimed in the patent) and a purposive interpretation of the Act put forward by the patentee (where the earliest ARTG registered good by the patentee would be the subject of the PTE application). The Federal Court preferred the patentees interpretation for a number of reasons (including the burden placed on the patentee to be aware of each and every approval on the ARTG).
The Commissioner appealed the decision to the Full Federal Court. Ultimately, the Full Federal Court overturned the Federal Court in a unanimous decision. The Full Federal Court accepted the Commissioners argument that there was no notion of choice as put forward in the patentees interpretation. In this decision, the Full Federal Court noted that the PTE regime seeks to balance a range of interests and not just the interests of the patentee.
In summary, the Full Federal Court unanimously overturned the Full Court’s decision, finding that pharmaceutical patentees must apply for a PTE within six months of the first inclusion on the Australian Register of Therapeutics Goods (ARTG) of any product containing a pharmaceutical substance falling within the claims of the patent, regardless of whether it is the patentee’s own product.
The MSD Case
Australian Patent No. 2002320303 contained claims directed to sitagliptin and claims directed to a composition comprising sitagliptin and metafomin. Sitagliptin was approved in Australia on 16 November 2006, and the composition containing a combination of sitagliptin and metformin was approved on 27 November 2008. MSD had successfully obtained a PTE for 17 months based on the ARTG regulatory approval date on the combination of sitagliptin and metformin.
MSD subsequently alleged that Sandoz infringed the patent during the PTE. Following this, Sandoz sought to reduce the PTE to 0 years on the basis that the earliest regulatory approval date should be based on the sitagliptin approval date.
The Federal Court agreed with Sandoz that the PTE is required to be calculated from the ‘first regulatory approval date’ of ‘any pharmaceutical substance’ disclosed in the patent. As such, the PTE afforded to MSD was reduced to zero.
MSD appealed this decision. However, the Full Federal Court dismissed the appeal. Like the Ono decision, the Full Federal Court found that a PTE must be based on the first inclusion on the ARTG of any product containing a pharmaceutical substance falling within the claims of the patent. More particularly, the Full Federal Court accepted that where a patent claims more than one pharmaceutical substance and there are multiple regulatory approvals, the PTE regime must be calculated from the earliest ARTG inclusion of any of those substances.
The Full Federal Court again stressed that the PTE seeks to balance a range of interests and not just the interests of the patentee.
The Ono and MSD cases have provided further clarity in relation to the PTE regime in Australia. Particularly, a PTE will need to be based on the pharmaceutical substance (whether their own or a third-party) falling within the scope of the claims that was first approved on the ARTG.
In view of the decisions, pharmaceutical patentees will need to ensure that they are aware of competitor activities on the ARTG as this can affect their own PTE applications. There are strategies to alleviate the risk of the above, such as filing one or more divisional patent application to separate substances, and amendment of the claims in view of the regulatory approvals.
Our patent attorneys can assist with strategies for pharmaceutical and complex IP protection. Please do not hesitate to contact us at Michael Buck IP for further information.