US coalition targets BMS patent

The US Stop Patient Abuse Now (Span) coalition of 21 consumer, senoirs and AIDS groups has petitioned the FDA to delist a patent for a metabolite formed in patients who ingest the antianxiety drug buspirone. The Bristol-Myers Squibb patent was listed inthe FDA's Orange Book on 22 November last year, and prevents generic sales of the drug.

It cites a recent objection to another drug, and claims the FDA is being inconsistent. In March, the FDA objected to the listing of a patent from Biovail for the hypertension drug Tiazac. Its competitors complained to the FDA that this patent was improperly listed in order to prevent the sale of generic versions.

BMS submitted its new patent to the FDA on the same day its original buspirone patent expired. The FDA required the company to certify that its new patent covered 'approved' uses of buspirone. Span says BMS provided a written statement that said the patent 'contains a claim for the approved uses' of the drug, and told the ES Patent and Trademark office that the patent covers a use that 'differs from the known standard method' and is 'directly counter to the past method'.

'The FDA moved against a smaller company that tried this,' said Tim Fuller, executive director of the Gray Panthers in the US. ' It should not be afraid to move against Bristol-Myers Squibb. BMS appears to be engaged in a strategy of deceiving federal agencies. The result has been to prevent competition for critical medicine while producing billion-dollar windfalls for the company.'