Australian court rejects AbbVie’s Humira extension claim

Pharmaceutical company AbbVie’s attempt to obtain an extension on its Humira (adalimumab) patents has been rejected by an Australian court.

A panel of three judges at the Federal Court of Australia affirmed an earlier decision rejecting extensions to the patents, covering the treatment of ulcerative colitis, Crohn’s disease and rheumatoid spondylitis.

Humira was first marketed to treat rheumatoid arthritis.

The patents in question describe the pharmaceutical substance adalimumab that is the product of a process of recombinant DNA technology.

AbbVie filed the request to extend the patents’ term in 2014, but it was rejected by the deputy commissioner of patents in Australia. The deputy commissioner concluded that the extensions point to new therapeutic uses for old substances.

He argued that a “substance when produced by a process that involves the use of recombinant DNA technology will not fall within the scope claim that is characterised by a therapeutic use in the same way a pharmaceutical substance per se does not fall within the scope of such claims”.

Further, the deputy commissioner stated that the extension dates, if approved, could only reach December 2018, rather than 2021 and 2022 as requested by AbbVie, pointing to the reference date being the date of the original marketing authorisation for the pharmaceutical substance.

AbbVie appealed against the decision to the Administrative Appeals Tribunal (AAT).

Differences arose between the deputy commissioner and the AAT over the disqualification of recombinant DNA technology from second medical use claims. For the AAT, recombinant DNA technology does qualify.

The AAT said it is apparent that “eligibility for extension of a patent would be applied to product claims and to process claims but only where such claims were made in respect of a substance produced by a process of recombinant DNA technology”.

In its final judgment the Federal Court disagreed with the AAT, instead ruling that it is the substance that must be the subject of a patent term extension, not the process itself.

The court said 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 specification in suit”.

“Properly 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,” the court said.