The Federal Circuit held in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., 23-2254 that a reissued patent receives patent term extension (PTE) based on the issue date of the original patent, not the reissue patent, agreeing with the district court.
Here, the Court found that Merck was entitled to a five-year PTE on its reissued patent, holding that “[a] reissued patent is entitled to PTE based on the original patent’s issue date where, as here, the original patent included the same claims directed to a drug product subject to FDA review.” Slip Op. at 14-15. The Court interpreted 35 U.S.C. § 156(c) as allowing patent term to be extended by a period equal to the regulatory review period occurring “after the date the patent is issued” but considered subsection 156(c) ambiguous as to whether “the patent” referred to an original or reissued patent. Id. at 16.
The Court concluded that Section 156(c) should be construed as using the original patent’s issue date for PTE calculations. According to the Court, this interpretation complies with the Hatch-Waxman Act’s intent to compensate pharmaceutical companies for patent term that might be lost during the regulatory approval process for new drug applications. Id. at 12-13.
In the end, the Court believed that using the reissued patent’s date would deny a patent owner, such as Merck, its entitled full amount of time lost to lengthy regulatory review of new drug applications.
