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Ortho-McNeil Pharmaceutical, Inc. v. Lupin Pharmaceuticals, Inc. (Fed. Cir. 2010)

By Donald Zuhn, Kevin Noonan, Chris Singer, Sherri Oslick, and Jason Derry

By Kevin E. Noonan -- In Ortho-McNeil Pharmaceutical, Inc. v. Lupin Pharmaceuticals, Inc., the Federal Circuit has rendered a decision on the question of whether separate enantiomers can have "first commercial marketing or use" status for purposes of patent term extension under 35 U.S.C. § 156. The Hatch-Waxman regime for patent term extension (the Drug Price Competition and Patent Term Restoration Act, codified in part at 35 U.S.C. § 156 et seq.) permits an extension of a patent that claims a drug that required regulatory approval prior to being put on the market. One of the limitations on patents entitled...

Full post as published by Patent Docs on May 17, 2010 (boomark / email).