Forest Laboratories, Inc. (NYSE: FRX) and Forest Laboratories Holdings, Ltd. (collectively, “Forest”) announced that Forest 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 (“the ‘040 patent”), 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 these 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 aforementioned lawsuits were commenced before the expiration of forty-five days from the date of receipt of each notification letter.
About Forest Laboratories
Forest Laboratories’ (NYSE: FRX) longstanding global partnerships and track record developing and marketing pharmaceutical products in the United States have yielded its well-established central nervous system and cardiovascular franchises and innovations in anti-infective and respiratory medicine. The Company’s pipeline, the most robust in its history, includes product candidates in all stages of development across a wide range of therapeutic areas. The Company is headquartered in New York, NY. To learn more, visit www.FRX.com.
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories’ Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.
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