Update: Extension of term on 'Swiss-style' pharmaceutical claims

In August 2015, we reported on a decision of the Australian Patent Office dealing with three applications by Abbvie Biotechnology for extensions of term to its Australia Patents 2012261708, 2013203420 and 2013257402 on the basis of ‘Swiss-Style’ claims.

Abbvie’s applications for an extension of term were rejected on the basis that “Swiss-type claims are purpose limited, they are not directed to substances when produced by a process that involves the use of recombinant DNA technology”. Abbvie appealed the decision to the Administrative Appeals Tribunal of Australia (AATA).

The Appeal

Subject matter of an extendable patent

The AATA handed down its decision on 5 September 2016 (Abbvie Biotechnology v Commissioner of Patents [2016] AATA 682). In contrast to the Patent Office, the AATA has opened the way for ‘Swiss-Style’ claims to form the basis of an application for a pharmaceutical extension of term.

The AATA considered the “manner in which [the subsection of the Patent Act] has been construed by the delegate [of the Patent Office] overlooks the express requirement which qualifies process claims based upon a substance produced by recombinant DNA technology”. In making its decision, the AATA held at that “the legislation does not address such a limitation and does not use terminology to state that “Swiss style” claims are not included in the eligibility for extension”. Accordingly, the AATA stated that “[t]he only requirement, for extension of a patent for a substance produced by recombinant DNA technology, is that it be disclosed in the complete specification of the patent and fall within the scope of the patent. The patents sought to be extended satisfy such criteria.”

Accordingly, the AATA found that Abbvie’s applications for extensions of term are not disqualified because they are drafted in a ‘Swiss-style’.

Approval date for an extension

Despite finding that the patents qualify for a patent term extension, the AATA held that the patents would not be extended. This is based on the finding that when considering the correct approval date for determining a patent term extension, “the therapeutic effect of the pharmaceutical substance is to be ignored when the question arises of the date of first registration of the pharmaceutical substance.” Thus, the correct date is the first date for approval of adalimumab and not the medical use encompassed by the Swiss-style claim.

The parties agreed that the maximum extension available to the applications if the patents are to be extended is 10 December 2018. However, AATA held that Abbvie had identified the wrong ARTG registration date on the applications and therefore, Abbvie is not entitled to an extension on the basis of the applications as filed. Abbvie can apply to correct the error.

Summary

Abbvie’s applications for an extension of term on the basis of ‘Swiss-Style’ claims were held eligible for extension on the basis of the original approval date of the drug. Thus, the current state of play in relation to extensions of term in Australia remains, i.e., the following type of claims may be extended:

• Claims defining the pharmaceutical substance per se; and
• Claims encompassing products of recombinant DNA techniques (including process claims resulting in such products and Swiss-style claims), even if the recombinant DNA technique is not recited in the claims.

The AATA’s decision has paved the way for manufacturers of biotherapeutics to obtain additional patent term extensions for patents directed to a second or subsequent medical use of a known pharmaceutical substance produced using recombinant DNA technology.

While this decision may still be appealed to the Federal Court, it is worthwhile considering your portfolio and whether or not it is worthwhile filing for additional patent term extensions.