The Australian Federal Court has confirmed in
Background
Australian patent law permits an extension of term, of up to five years, on patents that cover approved pharmaceutical substances. Under the relevant provisions, an extension of term application must be made based on the “first regulatory approval date” of a pharmaceutical substance covered by the patent, and at least five years must have elapsed between the effective filing date of the patent application and the first regulatory approval date. Notwithstanding, in
Patent-in-suit
Australian patent No. 2002320303, in the name of
- sitagliptin, which was approved as Januvia® in
Australia on16 November 2006 ; and -
a composition containing a combination of sitagliptin and metformin, approved as Janumet® in
Australia on27 November 2008 .
Since less than five years had elapsed between the date of the patent and regulatory approval of sitagliptin, a PTE application was submitted and ultimately granted based on the regulatory approval of the combination product of sitagliptin and metformin. However,
Issues considered
Merck submitted that term “earliest first approval date” in the context of the relevant PTE provisions, which it said did not cover sitagliptin alone because at least five years had not elapsed between the date of the patent and its regulatory approval. Merck's position was that the regulatory approval of the combination product of sitagliptin and metformin qualified as the earliest first approval date. In contrast,
Ultimately, the Court agreed with
Practical implications
This decision has crucial practical implications for patentees of pharmaceutical patents, particularly in relation to the breadth of the claims and the timing of PTE applications. It is essential that patentees are aware of all the pharmaceutical substances covered by their claims and the relevant regulatory approval dates of these pharmaceutical substances. It is also critical that the review of issues relating to the PTE be undertaken well before the PTE deadline to allow for appropriate amendment of the claims, if necessary, in order to exclude (generally by a narrow proviso) products that might jeopardise the request, and to pursue additional pharmaceutical substances in one or more divisional applications. This will ensure that PTE requests are based on the relevant pharmaceutical substance and that the PTE request is filed within the required time.
This decision is equally important for other stakeholders such as generics and biosimilars manufacturers, who should ensure that term extensions on relevant competitor patents are based on the first regulatory approval of all approved products covered by the claims
Concluding remarks
It is uncertain at this stage whether Merck will seek to appeal this decision to the
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Mr
Pearce IP
Level 5/
Tel: 29023 9988
URL: www.pearceip.law
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