June 22, 2006

On Friday, Merck & Co., Inc., may face its first wave of generic competition for its drug Zocor® as the patent is set to expire. U.S. Patent No. 4,444,784, entitled “Antihypercholesterolemic compounds,” issued on April 24, 1984, includes a total of 18 method and composition claims. The patent relates to “6(R)-[2-(8'-acyloxy-2'-methyl-6'-methyl(or hydrogen)-polyhydronaphthyl-1')-ethyl]-4(R)-hydroxy-3,4,5,6-tetrahydro-2H- pyran-2-ones,” including the hydroxy acid form of said pyranones and associated salts, as well as methods for treating hypercholesterolemia. Zocor® (simvastatin) has been sold by Merck to treat high cholesterol for several years, and according to Merck’s most recent Annual Report, sales of Zocor® over the last three years has been $14.6B, while Merck’s R&D expenditures was $11.1B over the same time period. According to the USPTO, Merck (and its international affiliates) were awarded 6,932 U.S. patents, with over 300 currently pending published U.S. patent applications being prosecuted.

U.S. Patent No. 4,444,784: LINK
IndyStar.com News Article: LINK
Zocor Consumer Website: LINK

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Mark Reichel
Reichel IP LLC

I am a patent attorney with Reichel IP LLC, where I concentrate my practice on patent drafting and prosecution, trademarks, and general intellectual property matters. I currently focus on the preparation and prosecution of medical device and other life sciences patent applications, and being actively involved in a number of local not-for-profit organizations.

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