Since 1948, the Federal Government’s Pharmaceutical Benefits Scheme (PBS) has aimed to provide timely, reliable and affordable access to medicines. This is achieved through price subsidisation amounting to a cost of AUD13.8 billion in 2020-2021. Whilst both originator and generic medicines are listed on the PBS, maintaining exclusivity for a patented medicine is obviously valuable.

The Patents Act 1990 provides that the normal 20 year term for human pharmaceutical patents may be extended for up to five years. Whilst the requirements to qualify for a patent term extension are quite prescriptive, the determination of the extension is relatively generous.

Qualifying for a PTE

The Patents Act 1990 requires for small molecules that:

(a) one or more pharmaceutical substances per se are in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification;

(b) goods containing, or consisting of, the substance been have included in the Australian Register of Therapeutic Goods (ARTG); and

(c) a PTE application must be filed by the later of six months after the issue of the patent or ARTG listing.

“Pharmaceutical per se” means that only claims to compounds or pharmaceutical compositions qualify for a PTE.

Calculation of Extension

The difference between the period beginning on the date of the patent and ending on the earliest first regulatory approval date … in relation to any of the pharmaceutical substances reduced (but not below zero) by five years.

Restriction of patentee rights?

Generally patents qualifying for a PTE will only claim one pharmaceutical substance per se for which there must be a first regulatory approval date. But are extensions available when there are two or more pharmaceutical substances claimed in a single patent where the respective products have been included on the ARTG?

Further, is a PTE obtainable based on a patentee’s product which is included on the ARTG but a third-party product exists having an earlier ARTG listing date falling within the scope of the patent?

Finally, can a claim in EPC 2000 format support a PTE?

These three questions have been considered by the Federal Court and all have been answered in the negative. Although negative, we maintain the first two decisions are entirely consistent with the requirements of the Act. However, if the third is correct, it does represent an erosion of a patentee’s right to a PTE.

Merck Sharp & Dohme Corp. v Sandoz Pty Ltd [2022] FCAFC 40

Merck Sharp & Dohme Corp (MSD) Australian patent 2002320303 dated 5 July 2002 disclosed and claimed two pharmaceutical substances per se. These were listed separately on the ARTG as JANUVIA® (sitagliptin) on 16 November 2006 and JANUMET® (sitagliptin and metformin combination) on 27 November 2008.

MSD took infringement action against Sandoz Pty Ltd which resulted in the Federal Court finding that a PTE was available but the term was zero. This finding was based on the Acts references to “one or more pharmaceutical substances per se” and “the period beginning on the date of the patent and ending on the earliest first regulatory approval date … in relation to any of the pharmaceutical substances”. Consequently the date of inclusion of JANUVIA® was determinative in the term calculation.

This outcome could have been avoided if the patentee had made each product the subject respectively of parent and divisional patents.

Commissioner of Patents v Ono Pharmaceutical Co. Ltd [2022] FCAFC 39

At first instance, the Patent Office determined that Ono was entitled to a zero extension of term because a product, KEYTRUDA, had an earlier ARTG listing date and it fell within the scope of a claim of Ono’s patent. KEYTRUDA is a third party product.

On full Federal Court appeal (considered concurrently with MSD), it was found that ownership of the earlier product was irrelevant. Therefore a PTE calculation required reference to the KEYTRUDA listing date. This accords with the MSD decision.

Biogen International GmbH v Pharmacor Pty Ltd [2021] FCA 1591

Biogen sought an interlocutory injunction to restrain a Pharmacor infringing product. Biogen had been granted a PTE for its patent by the Patent Office based on a claim in EPC2000 format. According to the Federal Court, a claim in EPC 2000 format is not a claim to a pharmaceutical substance per se but rather a purpose limited claim. Based on the potential invalidity of the PTE and other factors, the injunction was refused.

In our view this construction of an EPC 2000 format claim is flawed. “For” merely requires suitability for the intended purpose. Nevertheless, given the economic importance of pharmaceutical patents, it is to be expected that further PTE litigation will ensue.