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

29th Jun 2010 23:05

(Adds details about patent expiration in second paragaph; stock price in fourth paragraph; analyst reaction in fifth graph; additional details.) By Peter Loftus Of DOW JONES NEWSWIRES PHILADELPHIA (Dow Jones)--A U.S. judge has ruled that the patent for AstraZeneca PLC's (AZN, AZN.LN) blockbuster cholesterol drug, Crestor, is valid and enforceable, a victory in AstraZeneca'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 in 2016. Protecting Crestor from generic competition is critical for AstraZeneca because the drug had U.S. sales of $2.1 billion for 2009; global sales were $4.5 billion. Sales have gotten a boost recently from clinical studies suggesting it could help prevent heart attacks in additional patient populations. AstraZeneca's American depositary shares jumped on the victory, closing up $4.02, or 9%, at $48.74. "Most in the investment community felt AstraZeneca would very likely win, but given how devastating a loss would...have been, actually securing a favorable ruling removes an overhang," Bernstein analyst Tim Anderson wrote in a research note. 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 licensed the Crestor patent from Shionogi Seiyaku Kabushiki Kaisha of Japan. U.K.-based 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 before 2016. 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 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." The judge also granted the generics companies' request to dismiss an AstraZeneca unit, AstraZeneca Pharmaceuticals LP, from the case because it lacked standing. In addition, Farnan ruled that one of the generics manufacturers that applied to market generic Crestor, Apotex Corp., may be held liable for infringement of the Crestor patent. Spokesmen for Apotex, Mylan and Sun Pharma couldn't immediately be reached. -Peter Loftus, Dow Jones Newswires; +1-215-656-8289; [email protected] (END) Dow Jones Newswires June 29, 2010 18:05 ET (22:05 GMT)