Novartis unit sues Bristol, Watson

Novartis’ Lek unit sued Bristol-Myers Squibb Co. and Watson Pharmaceuticals Inc., seeking royalties on the cholesterol medicine Pravachol.

Lek owns two patents for crystalline forms of pravastatin, the key ingredient in Pravachol. Changes in the crystal make the compound more stable and pure, according to the patents issued in May 2004 and July 2006. Lek claims that the Bristol-Myers version of the drug uses pravastatin in the forms covered by the patents.

Pravachol, approved by U.S. regulators in 1991, was the second-biggest product for New York-based Bristol-Myers behind the blood thinner Plavix until the patent on the main compound expired in April. U.S. sales dropped 45% to $503 million in the first nine months of 2006. Watson sells a generic version under an agreement with Bristol-Myers.

“Because of the substantial volume of Pravachol that Bristol-Myers sells, it should have known about any patents affecting it,” Lek said in a complaint filed Dec. 29 in federal court in Marshall, Texas.

Lek seeks cash compensation and a court order to bar Bristol-Myers and Watson from infringing the patents.

Lek received Food and Drug Administration approval to sell a generic form of Pravachol in October.

Other companies also have approval for copycat versions of the drug, including Canada’s Apotex Inc., India’s Dr. Reddy’s Laboratories Ltd. and Croatia’s Pliva, which was bought in October by Barr Pharmaceuticals Inc.

Bristol-Myers spokesman Jeff MacDonald said the company didn’t comment on pending litigation. Corona-based Watson didn’t immediately comment.

Lek, based in Slovenia, was bought by Basel, Switzerland- based Novartis in 2002.