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The patent dispute in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc. is about the calculation of patent term extension (PTE) for a reissued patent. Aurobindo, one of the defendants in the ANDA (abbreviated new drug application) litigation, argued that PTE should be calculated based on the grant date of the reissued patent, not the original patent. Merck, the plaintiff, contended that PTE should be calculated from the grant date of the original patent. The Federal Circuit agreed with Merck, finding that the reissue patent inherited the unexpired term of the original patent.
The case involves a reissued patent for sugammadex, a medication used to assist patients in recovering from muscle function after surgery. The original patent, U.S. Patent No. 6,670,340, issued in 2003, and the reissue patent, U.S. Reissue Patent No. RE44,733, was granted in 2014. Aurobindo argued that PTE should be calculated based on the grant date of the reissued patent, not the original patent. Merck argued that PTE should be calculated from the grant date of the original patent, citing 35 U.S.C. § 156 and the Intellectual Property Green Book (MPEP section 2766).
The District Court and the Federal Circuit both rejected Aurobindo’s argument, finding that the original patent grant date should be used to calculate PTE. The Court held that using the original patent grant date aligns with the congressional intent to compensate pharmaceutical companies for the delay in obtaining FDA approval, which is the purpose of the Hatch-Waxman Act. The Court also found that Aurobindo’s interpretation would undermine the purpose of the Hatch-Waxman Act and create unintended results.
The Federal Circuit opinion was written by Circuit Judge Dyk and joined by Judges Mayer and Reyna. The panel concluded that the original patent grant date should be used to calculate PTE, citing 35 U.S.C. § 156(c) and the Intellectual Property Green Book (MPEP section 2766). The panel also noted that Aurobindo’s argument would deny Merck compensation for the majority of the delay, which is not in line with congressional intent. The opinion acknowledges that the panel’s interpretation is consistent with the PTO’s construction of the statute and the overwhelming number of cases in which the issue has arisen.