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The long wait for Sanofi-Aventis and Bristol-Myers Squibb to find out the fate of Plavix® (clopidogrel) is over as a US court has finally upheld its the firms’ patent on the blockbuster blood-thinner, a move which has restarted merger rumours.
A judge in the Southern District of New York has upheld the validity and enforceability of the firms’ US patent covering Plavix, ensuring protection for the product until November 2011. Judge Sidney Stein said the other key player in the case, the Canadian generic drugmaker Apotex, “has failed to prove by clear and convincing evidence that the Plavix patent is invalid or unenforceable” and he issued a permanent injunction prohibiting Apotex from further infringement.
Problems initially arose when a deal between B-MS and Apotex, which was designed to keep generic Plavix off the market, collapsed last year and the latter firm sent out several months’ supply of cheaper copies of clopidogrel before an injunction was issued. The fallout included job losses among senior B-MS management, including that of chief executive Peter Dolan.
Apotex insists it will immediately appeal this latest decision and is confident of winning. Chief executive Barry Sherman said: “We are unwavering in our belief” that the Plavix patent “will ultimately be held invalid”. He promised to “pursue the Plavix case full bore and work relentlessly to invalidate” it. The Canadian firm feels the case is similar to that occurring when it challenged the patent on Pfizer’s blood-pressure drug Norvasc® (amlodipine), in which Apotex lost at court level but won on appeal.
However, Apotex’s confidence is not shared by analysts, who are already looking to see what the consequences of the Plavix decision are and whether they will lead to Sanofi and B-MS tying the knot permanently. Such a deal seemed on the cards a few months ago but the attractiveness of such a link-up is less clear now.
The trans-Atlantic takeover would improve Paris-based Sanofi’s weakened new-drug pipeline and allow significant cost savings. But analysts said serious obstacles remained to any deal, including differences between top executives at the firms.
In March, Sanofi denied there was a rift at the top with chairman Jean-François Dehecq backing a bid for B-MS, while chief executive Gérard le Fur was thought to prefer organic growth, although this latter position may have shifted somewhat after an FDA panel refused to recommend the obesity drug Acomplia® (rimonabant) for approval. Regardless of the management line, investors may baulk at the asking price, thought to be in the region of $60m.
It is also highly debatable whether B-MS would welcome any takeover bid, as it has new drugs performing well, notably the antipsychotic Abilify® (aripiprazole), the leukaemia drug Sprycel® (dasatanib), and the rheumatoid arthritis drug Orencia® (abatacept). The New York-based firm has also signed some interesting late-stage deals recently, with Pfizer for the anticoagulant apixaban and a diabetes link-up with AstraZeneca.
PharmaTimes 20/6/2007
