What you need to know
- The Australia Patent Office has confirmed that a request for a pharmaceutical patent term extension (PTE) must be based on the earliest first product to gain regulatory approval that falls within the scope of the patent's claims, regardless of whether that product is owned, was developed, or is sponsored, by the patentee or a competitor.
What you need to do
- Patent applicants must be aware of all pharmaceutical substances, and their respective regulatory approval dates, that may be within the scope of their patent claims.
- Relevant products for the purpose of patent term extension requests would include products developed independently by third parties and those developed by licensees or collaboration partners under the patent.
- If you become aware of an issue relating to your PTE request, seek to amend the patent claims promptly.
Background
Ono Pharmaceutical Co., Ltd and E.R. Squibb & Sons, L.L.C (the patentee) sought a patent term extension in relation to Australian Patent No. 2011203119 (the Patent) which covers monoclonal antibodies that inhibit PD-1, supressing tumour growth.
The Patent included claims for two cancer immunotherapy drugs, Merck Sharp & Dohme's KEYTRUDA and the patentee's OPDIVO, both of which received regulatory approval in Australia but on different dates.
Taking no chances, the patentee filed two PTE requests. The first was based on the earlier KEYTRUDA regulatory approval date, and the second was based on the later OPDIVO regulatory approval date which, if accepted, would provide the patentee with an additional 8 months and 26 days.
The Australia Patent Office refused the extension request based on OPDIVO on the basis that KEYTRUDA was included on the Australian Register of Therapeutic Goods (ARTG) first and should, therefore, form the basis of the patentee's PTE request.
The patentee submitted that the "first regulatory approval date" should be the approval date of their own product, OPDIVO. The Delegate disagreed, deciding that a request for a PTE must be based on the product with the earliest first regulatory approval date, regardless of whether the product was owned by a third party.
Earliest first regulatory approval date
The Patents Act 1990 (the Act) provides a patent term extension for up to five years to account for the delays that occur when patentees obtain regulatory approval for a pharmaceutical product.
The extension is available if goods containing, or consisting of, the pharmaceutical substance, the subject of the patent specification, are included on the ARTG. Furthermore, the PTE application must be based on the earliest first included goods on the ARTG.
Maintaining the "purity" of the Register
The central issue at stake in the proceedings was whether the relevant pharmaceutical substance referred to in the Act is only that belonging to or sponsored by the patentee or whether it includes other, equivalent substances developed or supplied by third parties.
The patentee submitted a range of reasons as to why it would be "manifestly absurd or unreasonable" if the Act were to be interpreted so as to require a PTE application to be based on a product other than its own.
It argued that such a position would place an onerous burden on patentees and the Commissioner of Patents to monitor regulatory approvals of third party products. This would significantly heighten the risk that an extension would be granted incorrectly and taint the "purity" of the ARTG.
The Delegate quelled these concerns, affirming that while there was a risk that incorrect information may be recorded on the ARTG, the Act adequately contemplated this by providing the Commissioner with the power to correct errors on the ARTG.
The purpose of the regime
According to the Explanatory Memorandum and Second Reading Speech of the Act, the purpose of the PTE provisions is to restore the time lost to patentees prior to gaining marketing approval, and compensate the patentee for the additional time, expense and difficulty in developing and commercialising a "new drug". The patentee submitted that OPDIVO was such a new drug.
Accordingly, the patentee argued that it was only logical, given that the regime is beneficial and remedial, that the purpose of the PTE provisions is to reward patentees for their work and, by implication, not the work of others. Otherwise, the patentee would not receive the full extension of term for its product.
The Delegate rejected the patentee's broader purposive interpretation of the Act. According to the Delegate, such a construction would encourage patentees to develop a pharmaceutical substance that is not new and seek to place goods on the ARTG as late as possible, secure in the knowledge that a term extension will be granted for the (not new) substance. This type of regime, the Delegate noted, would not incentivise the development of new drugs. Rather, it would just incentivise new extension applications.
As such, the Delegate refused the patentee's request for a PTE based on OPDVIO, finding that the substance with the earliest first regulatory approval date for the purpose of the patentee's PTE request was KEYTRUDA.
Judicial Review
Rather than pursuing a PTE application on the basis of KEYTRUDA, the patentee has elected to challenge the Australian Patent Office decision and pursue a Judicial Review in the Federal Court. We will report further when there are new developments.
Authors: Tal Maman, Lawyer; and Kellech Smith, Partner.
