Astra sues as more firms threaten Crestor

By Ben Hirschler

LONDON (Reuters) - AstraZeneca (AZN.L) has filed patent infringement actions in the United States against seven generic drugmakers aiming to sell generic versions of its blockbuster cholesterol pill Crestor, it said on Wednesday.

Britain's second-biggest drugs group first announced last month it faced a generic challenge from Cobalt Pharmaceuticals. But since then it has received similar challenges from another eight generic drug manufacturers.

The speed at which rivals have joined the fray highlights the intense pressure on makers of branded pharmaceuticals as generic companies race to find loopholes in their patent protection.

The challenge to Crestor represents a further blow for AstraZeneca, which is already fighting generic threats to its two biggest revenue generators, Nexium for stomach ulcers and the anti-psychotic drug Seroquel.

AstraZeneca shares were 1.3 percent lower at 22.69 pounds by 0835 GMT.

The active ingredient in Crestor, which had worldwide sales of $691 million (338.2 million pounds) in the third quarter, is covered by a key patent that is valid until January 2016.

Generic drugmakers aim to get their copycat versions to market well before then, although it will not happen overnight.

30-MONTH STAY

By filing suit, AstraZeneca has triggered a legal delay on any approval of a generic form of Crestor until 30 months after U.S. data exclusivity expires in August 2008 -- unless the issue gets settled at trial before then.

All nine generic firms claim they have either found a way not to infringe AstraZeneca's Crestor patents or else that the patents are invalid or unenforceable.

AstraZeneca said challenges had come from Teva Pharmaceutical Industries Ltd (TEVA.O), Aurobindo Pharma Ltd (ARBN.BO), Apotex Inc, Par Pharmaceutical Cos Inc (PRX.N), Novartis AG's (NOVN.VX) Sandoz, Mylan Inc MYL.N, Glenmark Pharmaceuticals Ltd (GLEN.BO), and Sun Pharmaceutical Industries Ltd (SUN.BO).

AstraZeneca has filed individual patent infringement actions in the U.S. District Court, District of Delaware, against Aurobindo, Apotex, Cobalt, Par, Sandoz, Mylan and Sun, alleging infringement of the 2016 patent, number 37,314.

Action has not been taken against Teva and Glenmark, since they did notify AstraZeneca that they intended to market a generic before the 2016 patent expires.

Instead, they are challenging two later patents, expiring in 2020 and 2021.

An AstraZeneca spokesman said the Anglo-Swedish company was still evaluating its legal position over these patents.

AstraZeneca originally licensed Crestor from Japan's Shionogi & Co Ltd (4507.T), which receives royalties on sales.

(Reporting by Ben Hirschler)