InSite Vision joins Merck & Co and Pfizer in patent infringement law suit against

17 June 2013

InSite Vision (OTC BB: INSV) that it will US pharma giants join Merck & CO (NYSE: MRK) and Pfizer (NYSE: PFE) in filing a patent infringement law suit against generic drugmaker Mylan (Nasdaq: MYL).

Mylan recently filed an Abbreviated New Drug Application with the US Food and Drug Administration seeking to market a generic version of AzaSite (azithromycin 1% ophthalmic solution) before expiration of the patents covering AzaSite and its use. AzaSite - which uses the InSite DuraSite platform, is marketed by Merck in the USA. The complaint will be filed in Federal District Court in Trenton, New Jersey.

Mylan filed an ANDA application for AzaSite with the FDA of which InSite received notice on May 2, 2013, and InSite has 45 days to file a patent infringement law suit. With this filing today, that time requirement has been met. This law suit also triggers an automatic stay, or bar, of the FDA’s approval of the ANDA for up to 30 months or until a final court decision of the infringement lawsuit, whichever comes first.

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