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Federal Appeals Court Affirms the Role of ‘Balance’ in Scheme for Extending Term of Pharmaceutical Patents
On 18 March 2022, the Full Court of the Federal Court of Australia issued decisions relating to term extensions of patents covering pharmaceutical products: Commissioner of Patents v Ono Pharmaceutical Co. Ltd [2022] FCAFC 39 (‘Ono’); and Merck Sharp & Dohme Corp. v Sandoz Pty Ltd [2022] FCAFC 40 (‘MSD’). The two decisions have (at least) three things in common. First, both were decided unanimously by a panel comprising Chief Justice Alsop and Justices Yates and Burley. Second, both found against the patentee, with the court reversing the primary judge’s decision in Ono granting an extension of term, and confirming the primary judge’s decision in MSD nullifying a previously granted extension of term. And, third, both referred to the principle set out in the objects clause (section 2A) of the Patents Act 1990 that ‘the patent system balances over time the interests of producers, owners and users of technology and the public’ (emphasis added).
The scheme for extending the term of pharmaceutical patents inherently involves a balancing act. Its primary purpose is to ensure that patentees are not excessively disadvantaged by delays in securing regulatory approval to market patented products. For example, if a drug is not approved for use until 10 years or more after a patent application is filed, the patentee may have less than half of the standard 20 year patent term remaining to compensate for its investment in discovery and development before becoming exposed to generic competition. On the other hand, an extended period without competition necessarily exposes the wider public to higher costs of medical treatment. In an effort to balance these competing interests, the relatively complex provisions of the Patents Act aim to ensure that a ‘typical’ pharmaceutical patentee benefits from up to 15 years of exclusivity, by granting extensions of the patent term of up to five years, i.e. to a maximum of 25 years from filing. (A 2013 review of pharmaceuticals patents – which the government initially declined to release – found that 53% of such patents have an effective life of 15 years, while 89% have an effective life of over 10 years.)
The primary provisions of the Patents Act governing extensions of patent term are:
- section 70, which sets out the conditions that must be satisfied before a patentee can apply for an extension of the term of its patent;
- section 71, which sets time limits for filing of applications for extensions of term; and
- section 77, which specifies how the duration of an extension of term is to be calculated.
In each of Ono and MSD, the patentee sought to obtain an advantage, or avoid disadvantage, by arguing for beneficial interpretations of the extension of term provisions. In each case they failed. And in both cases the Full Court upheld the principle that the purpose of the extension of term scheme is to balance the competing interests of the patentee of a pharmaceutical substance against the public interest in the unrestricted use of the pharmaceutical invention after expiry of the patent. In Ono, in particular, the Full Court rejected the proposition that sections 70, 71, and 77 should be construed to achieve a commercial outcome for the patentee. In MSD the Full Court again invoked the principle of ‘balance’ in declining to permit an extension of term based on a later Australian marketing approval, in circumstances where the patentee had already obtained the benefit of an ‘export only’ approval of a substance falling within its patent claims with an effective life of over 15 years.
The relevance of the Full Court’s focus on balancing of interests, and its references to the objects clause, could extend beyond these cases. The three judges here are all among the five who recently heard the appeal in the Thaler ‘AI inventor’ case, in which the competing interests of developers and owners of ‘invention machines’, and of the broader public (who might not see the same benefit in granting patent monopolies on automatically-generated inventions), are potentially at stake. It will be interesting to see whether they adopt a similar approach to weighing up the balance of interests in that case, also.
Read more »GALA Prices inside a Bull Flag, Surges 11% as Buyers Target $0.38
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