Nebivolol (Bystolic): USPTO Confirms Validity of Product Patent

Forest Lab announced Here 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(R) 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 US6545040 (which covers a composition consisting of the compound [2R, alpha S,2'S,.alpha.'S]-.alpha.,.alpha.'-[iminobismethylene]bis[6-fluo ro-3,4-dihydro-2H-1-benzopyran-2-methanol] or a pharmaceutically acceptable acid addition salt thereof.) 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.
Earlier in September 2008, USPTO rejected all pending claims of ‘040 patent (as reported earlier by IPPHARMADOC Here)