vaccinations

Malcolm Lyons looks at the recent Federal Court decision in Ono Pharmaceutical Co, Ltd v Commissioner of Patents [2021] FCA 643 which has provided long needed clarity on requests for patent term extension.

In a readily digested, well written decision dated 11 June 2021, Beach J of the Federal Court of Australia has provided long needed clarity on requests for patent term extension (PTE). In particular, Beach J has provided a logically consistent interpretation of the statutory term “earliest first regulatory approval date”, which had caused difficulty for many patentees.

As made clear in the decision, PTE aims to provide an effective patent life for a patent covering a new and inventive pharmaceutical substance by compensating for the delay between grant of the patent and regulatory approval when the patent may be exploited. In Australia, regulatory approval is listing of the pharmaceutical substance on the Australian Register of Therapeutic Goods (ARTG).

The decision was a Judicial Review of an earlier decision of a Delegate of the Commissioner of Patents refusing PTE of a patent based on nivolumab marketed as OPDIVO. Based on an earlier decision of the Federal Court of Australia, Pfizer Corporation v Commissioner of Patents (No 2) (2006) 69 IPR 525 (Pfizer), the Delegate had interpreted “earliest first regulatory approval date” as applying to a pharmaceutical substance listed on the ARTG by any party, irrespective of whether the pharmaceutical substance was that of the patentee or a competitor. In this instance, the Delegate found that the earliest first regulatory approval date was that of pembrolizumab marketed as KEYTRUDA by another party.

In contrast, Beach J held that the PTE legislative provisions required beneficial and remedial construction. In doing so, Beach J was able to distinguish Pfizer. Reasons that were persuasive included:

  • determining whether a competitor product falls within the claims of a patent (to determine its first regulatory approval date is the “earliest”) may require information which can only be provided by the competitor if the Court were to order discovery of relevant documents, which is a non-trivial task to say the least
  • products may be removed from the ARTG in certain circumstances, including upon request by the sponsor, and therefore the ARTG is not necessarily a complete database of all the possible “first regulatory approval dates” in existence.

Beach J concluded that the construction advanced by the Delegate and maintained upon judicial review resulted in manifest absurdity or unreasonableness. Consequently, the appeal was allowed, and the PTE was granted based on nivolumab / OPDIVO.

It will be interesting to see if the Commissioner of Patents appeals this decision to the Full Court of the Federal Court of Australia. If so, leave to appeal must be sought by 25 June 2021. However, given Beach J’s grounds for distinguishing Pfizer, this seems unlikely. In which case it will be interesting to see also if patentees seek reconsideration of PTEs refused by the Commissioner of Patents on the basis of Pfizer.

Although this decision has simplified PTE requests for patentees and provided a degree of certainty by allowing a patentee to ignore third party pharmaceutical substances listed on the ARTG, there remain issues regarding a patent covering two or more pharmaceutical substances listed on the ARTG by the patentee. At [174] to [178], Beach J explained that a patentee will not be permitted to wait and elect to apply for PTE based on a good that may be second, third, or last on the ARTG, nor to pick and choose which of its products to nominate as the pharmaceutical substance for the purposes of requesting PTE. In these circumstances, the latest ARTG listing would provide the greatest PTE. Consequently, it remains best practice to pursue multiple pharmaceutical substances likely to be listed on the ARTG in separate divisional applications.

For more information, please contact Malcolm Lyons

Our Expert Project Lead