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The Federal Circuit (in an unpublished opinion) recently reaffirmed the difficulty generic challengers face when trying to establish chemical structural obviousness to invalidate a drug compound patent claim.
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This recent ruling involved Takeda’s U.S. Patent No. 7,807,689 (“the ‘689 Patent”), which claims alogliptin, a uracil-containing dipeptidyl peptidase IV (“DPP-IV”) inhibitor used to treat Type II diabetes. The ‘689 Patent is listed in the Orange Book for Takeda’s anti-diabetes drug products, Nesina
®, Kazano
®, and Oseni
®, each of which contains alogliptin benzoate as an active ingredient. Two ANDA applicants, Torrent and Indoco, challenged the validity of claims 4 and 12 of the ‘689 Patent as obvious under 35 U.S.C. § 103 and for non-statutory obviousness-type double patenting (“OTDP”).