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, patent term extension (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 patent term extension—the maximum allowed under Section 156(c)—based on the ʼ340 patent’s original issue date.

Aurobindo, which submitted an Abbreviated New Drug Application for sugammadex, argued that the PTO should have calculated Merck’s PTE based on the issue date of Merck’s reissue patent and not the original patent (in which case Merck would only have been entitled to 686 days of PTE and not the full five years), because the original patent is “dead” upon reissue. The Federal Circuit flatly rejected this argument, relying heavily on the purpose and legislative intent underlying the Hatch Waxman Act, which was “to compensate pharmaceutical companies for the effective truncation of their patent terms while waiting for regulatory approval of new drug applications.”

Adopting Aurobindo’s argument, the court said, would eviscerate this purpose and compensate patent owners for only a small period of delay caused by FDA review. The Federal Circuit emphasized that Merck was entitled to the full PTE based on the original patent’s issue date because the reissue patent included all of the original claims of the ʼ340 patent that was subject to FDA review.

Takeaways

Because the Federal Circuit’s decision only applies to reissue patents with the same claims as the original patent, patent owners with drug products under regulatory review should think twice before canceling claims in a reissue application, as doing so will result in forfeiture of PTE if the canceled claims cover the drug product that is under review. However, the Federal Circuit did not address how PTE should be calculated when a reissue patent significantly modifies the scope of the original claims but does not cancel them, which remains an open question.