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the product on which PTE is based can be a third party product (Commissioner of Patents v
- where a patent covers two or more different pharmaceutical substances PTE must be based on the first product within the scope of the claims to be included in the ARTG, regardless of the type of inclusion (listing or registration), or whether it has subsequently been removed (
Merck Sharp & Dohme Corp. vSandoz Pty Ltd [2022] FCAFC 40); and - where PTE is requested before expiry of the initial 20 year patent term but is granted after that expiry, only the patentee can commence infringement proceedings in respect of actions taken during the intervening period ( Lundbeck A/S v
Sandoz Pty Ltd ;CNS Pharma Pty Ltd vSandoz Pty Ltd [2022] HCA 4).
The relevant provisions
PTE eligibility
Under
For such a patent to be eligible for PTE, goods containing (or consisting of) the relevant pharmaceutical substance must be included in the ARTG and more than 5 years must have elapsed between the date of the patent and the "first regulatory approval date" of such goods. Further, a PTE application must be filed within 6 months from the date of grant of the patent or within 6 months from the date of first inclusion of goods containing the relevant pharmaceutical substance in the ARTG, whichever is later.2
Duration of extensions
In accordance with section 77 of the Patents Act 1990 (Cth) (the Act), the term of any extension granted will be equal to the period beginning on the date of the patent (the effective filing date of the application from which the patent is derived) and ending on the "earliest first regulatory approval date" of any relevant pharmaceutical substance, reduced (but not below zero) by 5 years. In
...recognises that the patent may cover more than one pharmaceutical substance and provides that the term of the extension is based on the earliest of the approval dates that apply to the patent.
The term "first regulatory approval date" is defined in the Act as "the date of commencement of the first inclusion in the
Who can bring infringement proceedings?
Generally, patentees and exclusive licensees have a statutory right to bring patent infringement proceedings.3 However, section 79 of the Act relates to a special circumstance where a patentee applies for PTE before expiry of the initial 20 year patent term but the PTE is not granted until after the initial expiry date. In that case, section 79 provides that the patentee has the same right to start proceeding in respects of an act done during the intervening period as if the extension had been granted at the time when the act was done.4 Notably, there is no mention of exclusive licensees in section 79.
The relevant decisions
Commissioner v
We previously discussed the primary judge's decision,5 which concerned whether a PTE application could be based on the third party product. Beach J considered such an outcome to be "manifestly absurd or unreasonable", reading a limitation into the Act that PTE can only be based on the "goods of the patentee", i.e., products listed on the ARTG by or with the consent of the patentee.
In accordance with our analysis of that decision as being inconsistent with the actual wording of the Act and the ambiguities it introduced, the Full Federal Court (Alsop CJ, Yates and Burley JJ) overturned the primary judge's decision. In particular, the Full Court agreed with the Commissioner that the wording of the act was chosen with a view to balancing a range of competing interests (not just those of the patentee), and that reading of the concept of "goods of the patentee" into the Act introduces unnecessary ambiguity and indeterminacy.
MSD v
The same three Full Court judges also dismissed an appeal against a first instance decision that the duration of any PTE granted must be calculated from the date on which regulatory approval was first secured for any product covered by the patent. That decision concerned the extension of an MSD patent based on the product Janumet® (sitagliptin/metformin), where there had been an earlier export only listing of another product within the scope of the claims, Januvia® (sitagliptin), which had since been cancelled.
The Full Court upheld the decision by the primary judge that section 77 of the Act should not be read down to encompass only registered goods (as opposed to any listed goods, including export only listings) and considered there was no reason to depart from the decision in
Lundbeck v
In a long-running dispute between the parties,
While the full extent of the issues before the
Concluding remarks
The Full Court's decision in Commissioner v
As always, pharmaceutical patentees should continue to be aware when formulating their patent strategy that covering more than one ARTG-listed product in the claims of a single patent can be problematic. Therefore, it is recommended that a divisional application is obtained (or rights maintained via one or more divisionals) to pursue different commercial products in separate applications. It should be noted that narrowing post-grant amendments are permitted in
Patentees and exclusive licensees should also be aware that where there is delay between the initial patent term expiring and grant of a PTE, only the patentee can bring an infringement action in respect of actions taken during that delay. In those circumstances, the patentee can only commence infringement proceedings once the PTE has been granted. While the circumstances contemplated by the decision are relatively rare, the impact on the amount of damages available where they do arise could be significant where damage is suffered primarily by an exclusive licensee.
Footnotes
1 Patents Act 1990 (Cth), s 70(2)
2 Patents Act 1990 (Cth), s 70(3)
3 Patents Act 1990 (Cth), s 120
4 Notably, the exclusive rights of a patentee are limited during the extension period to claimed pharmaceutical substances per se or pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology insofar as they are used therapeutically.
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The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
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