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Case Briefing

BY ALM Staff
September 01, 2003

District Court's Outrage At Profit Motivation Can't Justify Attorney-Fee Award

Because the U.S. District Court for the Eastern District of Pennsylvania correctly determined that the asserted patent claims for antidiarrheal medicine Imodium(R) Advanced were invalid, but clearly erred in finding this to be an exceptional case within the meaning of 35 U.S.C. ' 285 and awarding attorney fees to defendant, the U.S. Court of Appeals for the Federal Circuit affirmed in part and reversed in part. McNeil-PPC Inc. v. L. Perrigo Co., NO. 02-1516, 2003 U.S. App. LEXIS 15442 (Fed. Cir., 8/1/03).

In the late 1980s, facing the then-imminent expiration of its patent covering the best-selling antidiarrheal product Imodium R A-D, McNeil-PPC sought patentable improvements that would allow it to extend its position as market leader. McNeil scientists evaluated a combination of Imodium(R) A-D's active ingredient (2 mg loperamide) and 125 mg simethicone (an anti-gas drug), and allegedly found that the combination produced a synergistic effect. McNeil was granted two patents on the combination, as well as two patents for a method for increasing the drug's shelf life McNeil has sold the resulting tablets as Imodium(R) Advanced since 1997, pursuant to an approved New Drug Application (NDA).

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