This is a patent infringement case. Innovasystems, Inc. (“Innova”) appeals from the final judgment of the United States District Court for the District of Massachusetts that it infringed claims 3-10 and 13 of United States Patent No. 6,785,400 (the “’400 patent”) owned by Proveris Scientific Corporation (“Proveris”). Proveris Scientific Corp. v. Innovasystems, Inc., No. 05-12424 (D. Mass. May 11, 2007). On appeal, Innova argues that the district court erred in ruling that the so-called “safe harbor” provision of the Drug Price Competition and Patent Term Restoration Act of 1984, known as the “Hatch-Waxman Act,” Pub. L. No. 98-417, 98 Stat. 1585 (1984), codified at 21 U.S.C. §§ 355, 360cc (2000), and 35 U.S.C. §§ 156, 271, 282 (2000), does not immunize its accused activity from infringement of the ’400 patent. Innova also argues that the district court erred in entering judgment as a matter of law (“JMOL”) (i) that it infringed claims 3-10 and 13 of the ’400 patent and (ii) in favor of Proveris on Innova’s affirmative defenses that claims 1, 2, and 9 are invalid by reason of obviousness and that claims 3-8 and 10 and 13 are invalid as anticipated by a single prior art reference. Because we conclude that Innova is not entitled to the protection of the Hatch-Waxman Act safe harbor provision, and that the district court did not err in granting JMOL in favor of Proveris on infringement and on Innova’s affirmative defenses, we affirm.