Sunovion Pharms. v. Teva Pharms.

When a generic manufacturer’s Abbreviated New Drug Application falls within the scope of a valid patent claim, the generic manufacturer infringes that claim. A certification by the generic manufacturer that it will not, despite the terms of its ANDA, manufacture an infringing product is insufficient to avoid a holding that the ANDA infringes the patent as a matter of law.

Opinion (Lourie): Sunovion Pharmeceuticals, Inc. ("Sunovion") owns Patent No. 6,444,673, which covers the active ingredient in the drug Lunesta. Claim 1 of the ‘673 patent requires the compound be “essentially free” of the levorotatory isomer (R)-zopiclone. As a condition of approving Lunesta, the Food and Drug Administration required that the drug contain not more than 0.3% (R)-zopiclone. Following the listing of Lunesta in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations publication, Dr. Reddy’s Laboratory ("Reddy") filed an Abbreviated New Drug Application (ANDA) seeking permission to manufacture, use, and sell generic versions of Lunesta prior to the expiration of the ‘673 patent. Reddy’s amended ANDA specified a drug containing not more than 0.6% (R)-zopiclone. Sunovion sued Reddy, alleging that its ANDA constituted infringement of 3 claims in the ‘673 patent. Following claim construction, where the District Court held “essentially free” to mean less than 0.25% (R)-zopiclone, Reddy certified that despite its ANDA, it would not sell versions of its drug containing less than 0.3% (R)-zopiclone and then moved for summary judgment of noninfringement. The District Court granted the motion, from which Sunovion appealed. After upholding the District Court’s construction of “essentially free,” the Federal Circuit considered whether Reddy’s ANDA infringed the ‘673 patent. If a generic manufacturer’s ANDA falls within the scope of a valid claim, the manufacturer infringes that claim. Although Reddy certified that it would not produce a drug with less than 0.3% (R)-zopiclone, it was bound by the terms of its ANDA and the court could not accept its unenforceable promise to manufacture a noninfringing drug when Reddy had asked the FDA to approve a drug that fell within the ‘673 patent’s claims. Accordingly, the Federal Circuit held that Reddy INFRINGED the ‘673 patent as a matter of law.