Understandably, obviousness comes up frequently in disputes between innovator companies and generics manufacturers who look to market generics in light of the innovator patent being obvious, especially patents related to formulations, enantomers and alternative salts. In one of the first cases to rely on the Supreme Court's decision, Merck's formulation patent for Pepcid Complete was held invalid (McNeil-PPC versus Perrigo Co.; Nature Rev. Drug Disc. 6, 510; 2007), and Pfizer's petition for rehearing in its battle to prevent generic Norvasc entering the market was also denied (Nature Rev. Drug Disc. 6, 511; 2007) even in light of the obviousness decision; however, other subsequent cases have had different outcomes. The CAFC decided that Takeda's patent for Actos was valid (Takeda Pharmaceuticals versus Alphapharm et al.; Nature Rev. Drug Disc. 6, 594; 2007), concluding that there still needs to be “some reason” for chemical modifications of a known compound before changes can be deemed obvious.
In February 2007, Genentech had a key patent — commonly known as Cabilly II — rejected on the grounds of “obvious-type double patenting” after re-examination by the US Patent and Trademark Office (PTO) (Nature Rev. Drug Disc. 6, 262; 2007). The patent covers the production of monoclonal antibodies from recombinant DNA technology, and is a lucrative source of revenue for the company; nearly any company wishing to use host cell culture to make therapeutic recombinant antibodies has to obtain rights to the patent. Genentech is set to appeal the decision — which will probably be a long process lasting years — and won't lose out on royalties during this time as the patent remains valid throughout.
This is a preview of subscription content, access via your institution