Thursday, March 29, 2007

Para IV Move: ZETIA™ (Schering-Plough/Glenmark)

Schering-Plough has filed a patent infringement lawsuit in the US District Court for the Distirct of New Jersey against Glenmark in response to Glenmark’s ANDA submission with the US FDA seeking approval to market generic Zetia tablet, generically known as ezetimibe before expiry of the Orange Book listed patents. Zetia which is worth US $ 1.9 billion in 2006 is developed by Schering-Plough and co-marketed by Merck & Co. In its complaint, Schering-Plough alleges that Glenmark “had no adequate good faith basis” for claiming to the FDA that its version of Zetia would not infringe any valid and enforceable patents. Glenmark, which filed ANDA in October, last year, believes to have first-to-file status for Zetia and likely to entitled for 180-day market exclusivity period.

1 comment:

  1. Patents are territorial, and infringement is only possible in a country where a patent is in force. If a patent is filed in the United States, then anyone in the United States is prohibited from making, using, selling or importing the patented item, while people in other countries may be free to make the patented item in their country. For Schering-Plough, patent infringement insurance covers legal costs in case they have to sue an infringer to enforce their patent.