Forest Laboratories, Inc. (FRX) and Forest Laboratories Holdings, Ltd. said Wednesday that they and Janssen Pharmaceutica NV have jointly filed a lawsuit in the U.S. District Court for the District of Delaware against several companies for infringement of U.S. Patent No. 6,545,040, relating to Forest's BYSTOLIC product.
Forest licenses the '040 patent from Janssen. The '040 patent expires in December 2021, including patent term extension.
The defendants named in the lawsuit include Amerigen Pharmaceuticals, Inc., Glenmark Generics, Inc., Hetero USA Inc., Torrent Pharmaceuticals Ltd., Watson Laboratories, Inc., and related companies and subsidiaries thereof.
Janssen and Forest also filed a lawsuit in the U.S. District Court for the Northern District of Illinois against Alkem Laboratories Limited and Indchemie Health Specialties Pvt. Ltd for infringement of the '040 patent.
Janssen and Forest received notification from those companies that they had filed Abbreviated New Drug Applications with Paragraph IV certifications seeking approval to market generic versions of BYSTOLIC before the expiration of the '040 patent. The lawsuits were commenced before the expiration of forty-five days from the date of receipt of each notification letter.
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