Federal Circuit Confirms Calculation of PTE for Reissue Patents Under Regulatory Review
Consistent with the purpose and legislative intent of the Hatch Waxman Act, the Federal Circuit confirmed that patent term extensions for drug products under regulatory review is calculated based on the issue date of the original patent, not the reissue patent.
In Merck Sharp & Dohme B.V. et al. v. Aurobindo Pharma USA, Inc. et al, the U.S. Court of Appeals for the Federal Circuit addressed the narrow question of whether patent term extensions (PTE) for patents covering drug products that are under regulatory review pursuant to 35 U.S.C. § 156(c) is based on the issue date of the original patent or the reissue patent. The Federal Circuit sided with the district court and the patent owner, Merck, finding that the term “patent,” as used in Section § 156(c), refers to the original patent and not the reissued patent. As a result, PTE is calculated based on the issue date of the original patent.
Merck’s ʼ340 patent covering sugammadex, the active ingredient in BRIDION®, was issued on Dec. 30, 2003. Merck applied for a reissue patent while sugammadex was under regulatory review, adding 12 narrower claims. The reissue patent was issued as the REʼ733 patent on Jan. 28, 2014, and sugammadex was approved by the Food and Drug Administration (FDA) on Dec. 15, 2015. The U.S. Patent and Trademark Office (PTO) granted Merck’s request for a five-year PTE — the maximum allowed under Section 156(c) — based on the ʼ340 patent’s original issue date.
Keep Up to Date in a Changing World
