Nov 24 2008
Forest Laboratories, Inc. announced today that the U.S. Patent and Trademark Office ("USPTO") has closed prosecution on the merits of the reexamination proceedings for the patent for Bystolic and confirmed the validity of all of the previously granted claims.
As a result, the USPTO has issued a Notice of Intent to Issue Ex Parte Reexamination Certificate for U.S. Patent No. 6,545,040 (the '040 patent) to Janssen Pharmaceutica N.V., the patent holder. The Notice withdraws all of the enumerated rejections and confirms such validity. The '040 patent covers nebivolol, the active ingredient in Bystolic(R), a beta-blocker that is currently approved in the United States for the treatment of hypertension. The '040 patent expires in April 2020. Forest has applied for patent term extension for this patent until December 2021.
Forest licensed U.S. and Canadian rights to nebivolol from Mylan Laboratories Inc. in January 2006. Forest markets nebivolol under the Bystolic trademark in the U.S. Mylan licensed the U.S. and Canadian rights to nebivolol from Janssen Pharmaceutica N.V. in February 2001, and has obtained Janssen's consent to sub-license nebivolol to Forest Laboratories in those territories.