Two recent decisions issued by the Australian Patent Office address the requirements for extending the term of a patent encompassing a pharmaceutical substance ‘when produced by a process that involves the use of recombinant DNA technology’: ImmunoGen, Inc.  APO 88 and Novartis Vaccines and Diagnostics S.r.l.  APO 2.
What is interesting about both these cases is that, while recombinant DNA techniques are employed in manufacturing the pharmaceutical products, neither patent directly claims a new product resulting from the use recombinant DNA technology. In both cases, the patent claims are principally directed to processes for making the products, and extensions of term have nonetheless been granted.
The decisions relate to the anti-cancer drug KADCYLA, and the meningitis vaccine BEXSERO, both of which will now enjoy an extended term of patent protection in Australia.