Monday, September 6, 2010

Eli Lilly and a generic

The U.S. Federal Circuit recently upheld a district court on a patent law matter concerning Eli Lilly's drug, Evista (chemical name, raloxifene).

The district court enjoined any manufacture or distribution of a generic version of raloxifene, which is used in the treatment of osteoporosis in postmenopausal women.

The defendant, Teva Pharmaceuticals, disputed the validity of Eli Lilly's patents on the ground of obviousness. In the words of the court, Teva contended "that the Bone Loss Patents or the Low Does Patent would have been obvious to one of ordinary skill in the art."

In finding nonobviousness, the Federal Circuit discussed an earlier study of te use of raloxifene, the Buzdar study, under the heading of "prior art." The critical fact here is that the Buzdar study failed, and "in light of Dr. Budzar's published report describing that failure, the district court correctly found that a person of ordinary skill would have been discouraged from using raloxifene" in further tests. Thus, the scientists working for Lilly were using something more than ordinary skill, and the patent is upheld.

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