Bridion® (sugammadex)
Case Name: Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., No. 2023-2254, 2025 WL 795317 (Fed. Cir. Mar. 13, 2025) (Circuit Judges Dyk, Mayer, and Reyna presiding; Opinion by Dyk, C.J.) (Appeal from D.N.J., Cecchi, J.)
Drug Product and Patent(s)-in-Suit: Bridion® (sugammadex); U.S. Patent No. RE44,733 (“the RE’733 patent”)
Nature of the Case and Issue(s) Presented: Merck owned U.S. Patent No. 6,670,340 (“the ‘’340 patent”), which issued on Dec. 30, 2003, and claimed a class of 6-mercaptocyclodextrin derivatives, including sugammadex. On Apr. 13, 2004, Merck filed an NDA with FDA for approval of sugammadex, a drug that is administered intravenously to reverse neuromuscular blockade, a form of paralysis induced by rocuronium bromide and vecuronium bromide in certain types of surgery. While Merck’s NDA was pending, it filed an application with the PTO to reissue the ’340 patent. The reissue application retained the original claims of the ’340 patent and included narrower claims directed specifically to sugammadex. On Jan. 28, 2014, the ’340 patent was reissued as the RE’733 patent. None of the ’340 patent’s nine original claims were cancelled. FDA approved Merck’s NDA for sugammadex on Dec. 15, 2015. Therefore, Merck could not market sugammadex for nearly twelve years of the ’340 patent’s original term, which was set to expire on Jan. 27, 2021. On Feb. 10, 2016, Merck filed a PTE application for the RE’733 patent, seeking the maximum five-year PTE based on the ’340 patent’s original issue date. On Feb. 2020, the PTO granted a five-year PTE to the RE’733 patent based on the ’340 patent’s original issue date. The RE’733 patent’s expiration date was accordingly shifted from Jan. 27, 2021, to Jan. 27, 2026.
In early 2020, Defendants filed ANDAs, which included Paragraph IV certification notices with respect to the RE’733 patent, seeking approval to make and sell generic Bridion. At trial, Defendants argued that the RE’733 patent was not entitled to a five-year PTE and had therefore expired. Specifically, they argued that the PTO erred in calculating the RE’733 patent’s PTE based on the ’340 patent’s original issue date, urging that the plain text of subsection 156(c) required the PTO to calculate PTE based on the issue date of “the patent” for which PTE was sought: the RE’733 patent. Defendants argued that the RE’733 patent was only entitled to a 686-day PTE (corresponding to an expiration date of Dec. 14, 2022), since “only 686 days of the 4,265-day regulatory review period for Bridion occurred after the date the RE’733 patent issued. The district court disagreed, holding that “the patent” in subsection 156(c) must refer to the original patent, not the reissued patent. Aurobindo appealed and the Federal Circuit affirmed.
Why Merck Prevailed: The formula for calculating PTE is set forth in subsection 156(c), which provides that “[t]he term of a patent ... shall be extended by the time equal to the regulatory review period ... occur[ring] after the date the patent is issued.” The sole issue on appeal is whether PTE for a reissued patent should be calculated based on the issue date of the original patent or the reissued patent; in other words, whether the reference to “the patent” in subsection 156(c) is to the original patent or the reissued patent. Using the issue date of the reissued patent would usually result in shorter PTE because review that occurs before the issue date does not affect PTE.
Aurobindo argued that “the patent” referred to the reissued patent since “the ‘patent eligible for extension’ is the [reissued] patent.” The logic behind that interpretation is that the reissued patent is distinct from the original patent, and the latter ceases to exist on the date the former is issued. On the other hand, Merck argued that the statutory text, together with other patent statutes and the history of patent reissue, demonstrated that 156(c) refers to the original issue date. The Federal Circuit agreed with Merck. It conceded that the language of subsection 156(c) standing alone is ambiguous. But the purpose of the section is clear: to compensate pharmaceutical companies for the effective truncation of their patent terms while waiting for regulatory approval of new drug applications. Thus, in the context of reissued patents, the Hatch-Waxman Act contemplates PTE for those patents and only those patents with claims directed to drug products whose period of exclusivity was delayed by FDA review. That purpose applied in this case, since construing “the patent” in subsection 156(c) as the original patent compensated Merck for the period of exclusivity lost due to regulatory delay. Adopting Defendants’ construction would deny Merck compensation for all but a small period of the delay. “There is no reason why the Hatch-Waxman Act’s purpose would be served by disabling extensions of the unexpired term solely based on a patent holder’s decision to seek reissue, and [Defendants] offer[] none.”
