Full Federal Court clarifies rules for patent term extensions – Part 2

Commissioner of Patents v Ono Pharmaceutical Co. Ltd & Anr [2022] FCAFC 39

18 March 2022

Full Federal Court of Australia

Allsop CJ, Yates and Burley JJ

Background

Australian Patent No. 2011203119 (Patent) covers antibodies that bind the immune checkpoint inhibitor PD-1 and includes claims directed to game-changing, blockbuster cancer drugs OPDIVO (patentees’ product) and KEYTRUDA (competitor’s product). Regulatory approval for OPDIVO® and KEYTRUDA® in Australia was obtained on 11 January 2016 and 16 April 2015, respectively.

Ono Pharmaceutical Co. Ltd (Ono) sought a patent term extension (PTE) based on OPDIVO.  The Patent Office found that the pharmaceutical product with the earliest regulatory approval date covered by the claims of the patent was KEYTRUDA® and, as such, the patentees’ PTE request was refused.

On appeal in the Federal Court, Beach J held that the PTE provisions of the Patents Act 1990 (Cth) (Act) which required a PTE to be based on the earliest regulatory approval, were not intended to encompass competitor products and so reversed the Patent Office decision.  The Commissioner appealed to the Full Federal Court.

Key Issues

Australian law, patents that cover certain pharmaceutical inventions are eligible for a PTE of up to five years.   The claims must relate to a pharmaceutical substance per se, or a pharmaceutical substance produced using recombinant DNA technology.

Further, sub-section 70(3) of the Act requires that the following conditions be satisfied in relation to at least one pharmaceutical substance:

a) goods containing, or consisting of, the substance must be included in the Australian Register of Therapeutic Goods (ARTG); and
b) the period beginning on the date of the patent and ending on the first regulatory approval date for the substance must be at least 5 years.

Crucial to the determination in this case were the timing requirements for submitting a PTE application, set out in sub-section 71(2)(b) which states that an application for an extension of the term must be made during the term of the patent and within 6 months after the latest of the following dates:

a) the date the patent was granted;
b) the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, any of the pharmaceutical substances referred to in subsection 70(3).

The patentee argued that the phrase “at least one” in s70(3) recognises that the conditions in ss70(3)(a) and (b) may be satisfied by more than one of the pharmaceutical substances disclosed and claimed, and that the relevant “first regulatory approval date” is that of the good containing the pharmaceutical substance specified in the application for the PTE, which in the present case was OPDIVO®, the patentee’s product.

The Commissioner of Patents argued that none of the relevant PTE provisions impose a requirement that there be any relationship between the patentee seeking the extension and the entity that holds the regulatory approval of the product.  Further, the Commissioner argued that s71(2)(b) does not operate by reference to whichever substance an applicant for a PTE chooses to nominate in an application form, much less by reference to the patentee’s “good” or “goods”.  Rather, s71(2)(b) operates by reference to the “first inclusion” in the ARTG that contains any of the pharmaceutical substances referred to in subsection 70(3).

Outcome

The decision in the Ono case was handed down on the same day as the decision of the Full Federal Court in Merck Sharp & Dohme & Anor v Sandoz Pty Ltd [2022] FCAFC 40, reported at page 42.  In that case, the Full Court affirmed the primary judge’s analysis of ss70-71 of the Act, concluding on a straight forward reading of the provisions that the earliest regulatory approval date of any product falling within the scope of the claims which must form the basis for a PTE.

The result in Ono predictably followed suit, even though the earlier product was not sponsored by the patentee.  The Full Court confirmed that Ono could not rely on the approval of its later product, OPTIVO® in light of the earlier listing of KEYTRUDA®.  The conclusion of the primary judge that the PTE provisions should be construed liberally on policy grounds was not accepted, bearing in mind that the legislative policy rested on a balancing of various interests, now  explicitly recited in the objects clause.  On the plain wording of the relevant provisions there is no discrimination between products of the patentee or others.

Implications

The Full Federal Court’s decision confirms the Patent Office practice of requiring PTEs to be based on the first approved product, even where it is that of a competitor.  This means that patentees must be aware of competitor products registered on the ARTG which may fall within the scope of their patents and seek PTEs within the necessary time frame.

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