The Full Federal Court has confirmed that the relevant regulatory approval date for requesting a pharmaceutical patent term extension (PTE) is the earliest inclusion in the Australian Register of Therapeutic Goods (ARTG) of any goods which include a pharmaceutical substance which is claimed and disclosed in the patent, regardless of whether those goods belong to the patentee or an unrelated third party.
The patentees, Ono Pharmaceutical Co, Ltd and E.R. Squibb & Sons, LLC, had made two applications to extend the term of their patent:
- The first application was based on their own pharmaceutical product marketed under the name OPDIVO which was included in the ARTG on 11 January 2016.
- The second application was based on an earlier pharmaceutical product called KEYTRUDA marketed by a third-party competitor of the patentees, which was included in the ARTG on 16 April 2015.
The patentees’ preferred extension application was the OPDIVO application because, if granted, it would result in a longer extension of term than the KEYTRUDA application.
When the matter was considered by the Patent Office, the Delegate held that the OPDIVO application was not based on the good on the ARTG with the earliest regulatory approval date, which was KEYTRUDA. The patentees appealed to the Federal Court, arguing that the relevant “first regulatory approval date” should be the approval date of their own product, not the approval date of a third party’s goods. They contended that where two substances within the scope of the patent had been included in the ARTG at different times, the PTE could be based on any one of the pharmaceutical substances which fulfilled the PTE requirements and that the relevant “first regulatory approval date” is that of the good containing the pharmaceutical substance specified in the PTE request. The Primary Judge agreed with the patentees’ construction and held that the relevant goods and pharmaceutical substance for the purpose of PTE were those of the patentee, OPDIVO, and not those of an unrelated third party.
The Full Court disagreed, however, and ruled that the PTE requirements are a matter of objective fact. As a result, where two or more pharmaceutical substances within the scope of the patent have been included in the ARTG at different times, the relevant “first regulatory approval date” is the date of approval of the earliest registered goods, regardless of whether those goods belong to the patentee.
The Patent Office had changed their practice in response to the primary decision and have been requesting that patentees indicate whether the inclusion of the goods in the ARTG was made following an application by the patentee, or with their consent. It remains to be seen whether this requirement will be updated in light of the successful appeal.
This case serves as a warning to PTE applicants to monitor the claims of any patents covering potentially registrable pharmaceuticals, and to consider divisional applications focused on their specific pharmaceutical product. While broad patents are generally desirable, they may be harder to extend as it is more likely that they will claim and disclose an earlier registered pharmaceutical. Having one or more divisional applications with claims focused on the patentee’s commercial embodiment can help mitigate this risk.
For any questions regarding pharmaceutical patent protection, please contact firstname.lastname@example.org