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ARTICLE · 13 JUNE 2012

The "Lead Compound" Approach To Obviousness And Obviousness-Type Double Patenting

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In Otsuka Pharmaceutical Co. v. Sandoz, Inc., the Federal Circuit upheld the district court’s determination that the claims at issue were neither obvious nor invalid under the doctrine of obviousness-type double patenting based on a "lead compound" approach to the obviousness determinations.

United StatesIntellectual Property
Courtenay Brinckerhoff
Courtenay Brinckerhoff
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In Otsuka Pharmaceutical Co. v. Sandoz, Inc., the Federal Circuit upheld the district court's determination that the claims at issue were neither obvious nor invalid under the doctrine of obviousness-type double patenting based on a "lead compound" approach to the obviousness determinations. This case reaffirms the applicability of the "lead compound" analytical framework, and highlights subtle differences in its application to questions of obviousness and obviousness-type double patenting.

The Patent at Issue

The patent at issue was Otsuka's U.S. Patent 5,006,528. Claims 12, 17, and 23 are specifically directed to aripiprazole, the active ingredient it Otsuka's Abilify® product:

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