The U.S. Court of Appeals for the Federal Circuit Dec. 3 rejected King Pharmaceuticals Inc.'s bid for a rehearing and rehearing en banc in a case that invalidated the composition of matter patent for the blood pressure medication Altace (ramipril) due to obviousness (Aventis Pharma Deutschland GmbH v. Lupin Ltd., Fed. Cir., No. 06-1530, rehearing denied 12/3/07).
King filed a petition for rehearing or rehearing en banc arguing that the court misapplied the U.S. Supreme Court's 2007 holding in KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727 (2007), which cautions against a rigid application of the "teaching, suggestion, or motivation" (TSM) test for obviousness, to invalidate the Altace patent on the basis of obviousness.
King argued that "this application of the law [in KSR] is not consistent with other recent rulings of the Federal Circuit Court." King also argued that the Federal Circuit's decision in the Altace case (5 PLIR 929, 9/14/07 ) relied on factual inaccuracies.
King said in a statement it was "evaluating its remaining legal options with respect to the patent" after the petition's denial.
If the ruling stands, it means that India-based Lupin Ltd., which is seeking to market generic ramipril capsules before the patent on Altace expires, will be able to enter the market with a generic version of Altace before the patent expiration date of Oct. 19, 2008.
The patent at issue, U.S. Patent No. 5,061,722, (the '722 patent), is held by Aventis Pharma Deutschland GmbH, but Bristol, Tenn.-based King is the exclusive licensee. The '722 patent, which covers ramipril isomers, their hypotensive compositions, and their method of use for reducing blood pressure.
King has called Altace, which in 2006, accounted for $653 million worth of sales for King, its "flagship cardiovascular product."
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