3 November, 2017
Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129 (18 August 2017)
What you need to know
The Full Federal Court has held that “Swiss-type” patent claims are not eligible for term extension under s 70(2)(b) of the Patents Act 1990 (Cth) (Patents Act), reversing a decision of the Administrative Appeals Tribunal.
This decision significantly clarifies the availability of term extensions for Australian patents relating to pharmaceutical substances that are manufactured by processes involving the use of recombinant DNA technology.
What you need to do
Patent owners should carefully review their patent portfolio and consult with their legal advisors on the application of Australia’s patent term extension regime.
To increase the prospects of obtaining a valid term extension, Australian patents relating to pharmaceutical substances made using recombinant DNA technology should include product or product-by-process claims wherever possible.
Background
AbbVie Biotechnology Ltd markets the biological medicine adalimumab under the brand name Humira® for the treatment of certain inflammatory and autoimmune diseases. Adalimumab is a fully human monoclonal antibody produced using recombinant DNA technology.
AbbVie applied to the Australian Patent Office for patent term extension (PTE) of three patents. All of the claims in each of the three patents were “Swiss-type” medical use claims. Swiss-type claims are purpose-limited process claims, generally having the form “use of drug [x] in the manufacture of a medicament for use in treatment of disease [y]”. The claims at issue in this case were directed to the use of adalimumab in the manufacture of a medicament for use in the treatment of specified inflammatory and autoimmune disorders.
In selected circumstances, the term of an Australian pharmaceutical patent may be extended to compensate the patent owner for delay between grant of the patent and regulatory approval to market the pharmaceutical in Australia. Relevantly for this case, term extension may be available where a pharmaceutical substance produced by recombinant DNA technology falls within the scope of the patent’s claims, and the period between grant of the patent and first regulatory approval for the pharmaceutical substance exceeds five years.
At first instance, each of AbbVie’s PTE applications was refused by the Patent Office, on multiple grounds.
The Deputy Commissioner of Patents considered that a pharmaceutical substance when produced by recombinant DNA technology does not, in substance, fall within the scope of a Swiss-type claim. In those circumstances, the Deputy Commissioner found that the three patents were not eligible for PTE at least for the reason that the requirements of section 70(2)(b) of the Patents Act had not been satisfied.
AAT Decision
AbbVie applied to the Administrative Appeals Tribunal (AAT) for a review of the Deputy Commissioner’s decision. AbbVie was successful on some, although not all, grounds of appeal.
Notably, the AAT disagreed with the Deputy Commissioner’s finding that Swiss-type claims are ineligible for PTE because they are not directed to a “pharmaceutical substance … produced by a process that involves the use of recombinant DNA technology”, as required by s 70(2)(b) of the Patents Act.
The AAT noted that, by contrast to s 70(2)(a) of the Patents Act, s 70(2)(b) refers to a “pharmaceutical substance” rather than a “pharmaceutical substance per se”. The AAT considered that the absence of the term “per se” from s 70(2)(b) was significant and the provision should be interpreted as extending to process claims which involve the use of recombinant DNA technology.
The Commissioner of Patents appealed from the decision of the AAT to the Full Federal Court on a question of law regarding the correct interpretation of s 70(2)(b).
Full Federal Court Decision
The Full Federal Court set aside the finding by the AAT that a PTE may be based on Swiss-type claims.
In reaching this decision, the Full Court considered the meaning of “pharmaceutical substance” in s 70(2), referring to existing case law and to the Explanatory Memorandum for the Bill which inserted the current PTE provisions into the Patents Act. The Court concluded that, to be eligible for PTE, a patent must include at least one claim that is directed to a product, rather than a method or process. Further, to meet the requirements of s 70(2)(b), that product must have been produced by a process involving the use of recombinant DNA technology. The Full Court found that those requirements are not satisfied by Swiss-type claims, which are directed to a method or process in which a pharmaceutical substance is used to produce a medicament, further limited by the therapeutic purpose for which that medicament is to be used. Swiss-type claims were therefore considered
by the Court to be fundamentally different from the type of claims to which s 70(2) is directed.
The Full Court held that the AAT had erred in finding that production of a pharmaceutical substance by a process involving recombinant DNA technology was, of itself, sufficient to satisfy the requirements of s 70(2)(b). According to the Full Court, the AAT had “overlooked the requirement in s 70(2)(b) that, even though produced by a process involving recombinant DNA technology, the pharmaceutical substance must also, in substance, fall within the scope of the claim or claims of the [patent] specification in suit”. According to the Full Court, “[p]roperly construed, this means that it is the pharmaceutical substance that must be the subject matter of the claim or claims, not methods or processes (beyond recombinant DNA technology) concerning or involving the pharmaceutical substance”.
Having regard to the reasoning of the Full Court in this case, it appears that s 70(2)(b) should be understood as directed to “product-by-process” claims, where the process involves the use of recombinant DNA technology. However, further judicial interpretation will be required to fully assess the scope of operation of s 70(2)(b) of the Patents Act.
Conclusion
The Full Court’s decision suggests that, under the Patents Act, term extension will only be available where a patent includes at least one product claim directed to a pharmaceutical substance itself, or at least one product-by-process claim directed to a pharmaceutical substance when produced using recombinant DNA technology. Claims directed to a second (or subsequent) medical use of a pharmaceutical substance, including Swiss-type claims, will not be eligible for patent term extension in Australia. This applies regardless of whether the pharmaceutical substance in question was produced by a process involving recombinant DNA technology.
It is worthwhile bearing in mind that AbbVie did not contest this matter before the Full Federal Court. For this reason, the Court did not have the benefit of a contradictor to present arguments in support of the proposition that Swiss-type claims should be eligible for term extension under the Patents Act. Notwithstanding this limitation, the Full Court’s decision does represent strong authority against term extension eligibility for Swiss-type claims in Australia.
For further information please contact:
Andrew Rankine, Partner, Ashurst
andrew.rankine@ashurst.com
