Gilead Sciences Inc. (GILD) said it was notified that Sigmapharm Laboratories LLC has submitted an abbreviated new drug application to the FDA, requesting permission to manufacture and market a generic version of Hepsera.
In a Paragraph IV Certification notice letter, Sigmapharm alleges that two patents associated with Hepsera owned by Gilead Sciences are invalid, unenforceable and/or will not be infringed by Sigmapharm's manufacture, use or sale of the product described in its ANDA submission.
Gilead said it is currently reviewing the notice letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against Sigmapharm.
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