Patent Extension for Humira® Denied by Australian Court

Biosimilar News

The Australian Federal Court recently ruled that to be eligible for an extension, a patent must cover a “product” rather than a “method of use.” AbbVie Biotechnology Ltd (AbbVie) filed requests to extend Australian patents 2012261708, 2013203420 and 2013257402, which cover methods of producing adalimumab using recombinant DNA technology. AbbVie argued that claims to the processes for producing adalimumab are product claims, not “method of use” claims.  The Australian Federal Court rejected AbbVie’s requests, ruling “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.”

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