aai Pharma patents may block generic Prilosec

US firm aai Pharma has been awarded two US patents which could representan additional obstacle to companies seeking to market generic forms of AstraZeneca's proton pump inhibitor Prilosec (omeprazole) in the USA. The patents, which cover crystalline structures of omeprazole which occur within the finished product, are licensed to AstraZeneca on a non-exclusive basis. aai Pharma says it would be prepared to license them to generics firms, but would consider legal action if a manufacturer refused to enter into such a licensing deal.

Analysts quoted by the Wall Street Journal note that the patents are unlikely to be defensible in court, but any legal action could itself delay the launch of Prilosec generics by some months, which would be worth a few hundred million dollars to AstraZeneca. Listing the patents in the US Food and Drug Administration's Orange Book could lead to an even longer delay (up to 30 months), but generics firm Andrx said that such an action "would constitute a transparent abuse of the Waxman-Hatch Act in order to extend patent protection...in violation of federal and state antitrust and unfair competition laws."