Teva Pharmaceutical Industries Ltd. (TEVA) recently received a boost with the US District Court for the Southern District of New York issuing a favorable ruling related to the company’s patent infringement lawsuit against Novartis AG (NVS)/Momenta Pharmaceuticals, Inc. (MNTA) and Mylan Inc. (MYL)/Natco Pharma Ltd.
The lawsuit is regarding the company’s lead drug Copaxone, marketed for the treatment of multiple sclerosis (MS).
The Court adopted all relevant claim construction interpretations of Teva and rejected all the claim construction interpretations put forth by Novartis/Momenta and Mylan/Natco. Moreover, the Court denied Mylan's motion for summary judgment that the disputed patents are invalid for indefiniteness.
We note that Teva’s patent for Copaxone is set to expire in 2014. The company has filed a Citizen Petition (CP) with the US Food and Drug Administration (FDA) asking the agency to refuse the approval of generic versions of Copaxone. Teva has also asked the FDA to get any abbreviated new drug application (ANDA) for Copaxone to be reviewed by an advisory panel.
The trial date for the lawsuit has been set for September 7, 2011. It is very crucial for Teva to win this lawsuit as Copaxone is one of its biggest revenue generators.
The drug posted global in-market sales of $957 million in the second quarter of 2011, reflecting an increase of 24% year-over-year. While US in-market sales increased 29% to $682 million, ex-US in-market sales grew 13% to $275 million.
Neutral on Teva
We currently have a Neutral recommendation on Teva Pharma. The stock carries a Zacks #3 Rank (Hold rating) in the short-run. We remain concerned about the intense competition and pricing pressure that Teva faces in the generics market. However, the company’s upcoming acquisition of Cephalon should help Teva expand and strengthen its branded and specialty pharma business.
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