InSite Vision Inc. (INSV,INSV.OB), Monday said it will join Merck (MRK) and Pfizer Inc. (PFE) in filing a patent infringement lawsuit against Mylan Pharmaceuticals, Inc. Mylan recently filed an Abbreviated New Drug Application or ANDA with the US Food and Drug Administration or FDA to market a generic version of AzaSite before expiration of the patents covering AzaSite and its use.
InSite owns four U.S. patents covering AzaSite and its use, and an exclusive license to a Pfizer-owned azithromycin patent.
AzaSite is marketed by Merck in the U.S. Post the filing of the ANDA, InSite received notice on May 2 that it has 45 days to file a patent infringement lawsuit. This lawsuit 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.
InSite and Merck filed a similar patent infringement lawsuit against Sandoz Inc. last year, and the trial date for the same has been set for July 11. Each company will be responsible for their own legal costs, and have agreed that Merck will take the lead in prosecuting both lawsuits, and InSite will assume a monitoring role.
Under the license agreement between InSite and Merck, Merck has the exclusive use of these patents in the U.S. in return for a 25 percent royalty payable to InSite based on AzaSite net sales. InSite believes that its four patents and the Pfizer patent were properly prosecuted with the U.S. Patent and Trademark Office and are valid, and will provide AzaSite exclusivity until March 2019.
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