CORRECT: US Judge Upholds Patent For AstraZeneca's Crestor >AZN

29th Jun 2010 23:05

("US Judge Upholds Patent For AstraZeneca's Crestor" published at 5:08 p.m. EDT incorrectly implied in the third paragraph that global sales for Crestor in 2009 were $2.1 billion. That was the U.S. sales figure. A corrected version follows:) By Peter Loftus Of DOW JONES NEWSWIRES PHILADELPHIA (Dow Jones)--A U.S. judge has ruled that the patent for AstraZeneca PLC's (AZN) blockbuster cholesterol drug, Crestor, is valid and enforceable, a victory in Astra's effort to ward off early generic competition. The ruling stemmed from AstraZeneca's patent-infringement lawsuits against several generics manufacturers, which had applied for U.S. regulatory approval to market copycat versions of Crestor before a key patent expires. Protecting Crestor from generic competition is critical for AstraZeneca because the drug had U.S. sales of $2.1 billion for 2009. Sales have gotten a boost recently from clinical studies suggesting it could help prevent heart attacks in additional patient populations. The generics makers, including Mylan Inc. (MYL) and Sun Pharmaceutical Industries Ltd. (524715.BY), had challenged the validity of the Crestor patent, essentially arguing its invention was obvious to anyone skilled in the art of drug development. They also argued the patent was unenforceable because they alleged the original patent applicants withheld certain information from the U.S. Patent & Trademark Office. AstraZeneca disputed these claims, arguing the patent was valid and enforceable, and asked a federal judge to block the generics manufacturers from selling copycat versions. A trial in the case was held in February in U.S. District Court in Wilmington, Del. U.S. Judge Joseph J. Farnan sided with AstraZeneca on the key points of the case in a ruling released Tuesday. "After evaluating the extensive arguments of the parties and the evidence adduced at trial, the Court concludes that Defendants have not demonstrated by clear and convincing evidence that the ... patent is invalid as obvious," Farnan wrote. He added that AstraZeneca provided compelling evidence that "significant work was needed" to develop Crestor. "AstraZeneca is pleased with the court's decision upholding the validity of the ... patent," AstraZeneca Chief Executive David Brennan said in a written statement. "The court's decision reaffirms the strength of the intellectual property protecting Crestor." AstraZeneca licensed the Crestor patent from Shionogi Seiyaku Kabushiki Kaisha of Japan. -Peter Loftus, Dow Jones Newswires; +1-215-656-8289; [email protected] (END) Dow Jones Newswires June 29, 2010 18:05 ET (22:05 GMT)