In re Sugammadex Bridion® (Sugammadex Sodium)

Robins Kaplan LLP

Robins Kaplan LLP

Case Name: In re Sugammadex, No. 20-CV-2576 (CCC/LDW), 2023 WL 3966146 (D.N.J. June 13, 2023) (Cecchi, J.)

Drug Product and Patent(s)-in-Suit: Bridion® (sugammadex sodium); U.S. Patent No. RE44,733 (“the ’733 patent”)

Nature of the Case and Issue(s) Presented: In Merck’s consolidated action against various ANDA filers, the court took up one issue: whether a patent term extension (PTE) was invalid. The ANDA filers challenged the reissue patent’s five-year PTE (a consequence of FDA’s nearly 12-year regulatory review of Bridion). Specifically, Defendants contended that calculation of a PTE for a reissue patent must be based on the date that the reissue patent issued, pursuant to § 156(c) of the Patent Act. Defendants argued that reading § 156(c) in this way entitles Merck to only 686 days PTE, rather than the five years that the PTO granted. Defendants’ validity challenge, if meritorious, would render the portion of the patent after December 14, 2022, invalid under 35 U.S.C. § 282(c). In response, Merck argued that “the date the patent is issued,” read in the proper context, refers to the date that the original patent issued.

Thus, “the crux of the legal dispute concerns whether the Patent Act requires a patent term extension of a reissued patent to be calculated based on the issue date of the original patent—the term of which is inherited by the reissue patent—or, conversely, based on the issue date of the reissued patent.” After a one-day bench trial, the court found that the PTE was not invalid under § 282(c).

Why Merck Prevailed: The facts of the case were almost entirely undisputed. Merck’s original patent covering sugammadex issued on December 20, 2003. But Merck could not market its product until December 15, 2015, nearly 12 years later. Because the Hatch-Waxman Act allows for restoration of patent term lost to lengthy FDA regulatory review, Merck sought a PTE (maximum five years). And the PTO granted it.

The issue here arises from the reissue patent. When Merck applied for a PTE in 2016, the original patent had been surrendered and the reissue patent put in its place. 35 U.S.C. § 156(c) requires calculation of PTE based on the “regulatory review period for the approved product” that “occurs after the date the patent is issued.” Understanding “the date the patent is issued” in § 156(c) to refer to the term of the original patent, Merck calculated that it was entitled to the maximum allowable five-year PTE. The PTO agreed. But the ANDA filers contended that the PTO should have used the date that the reissue patent issued—which reduces the PTE to less than two years.

The court ultimately determined that, when read in the proper context alongside statutes addressing reissue, the issue date of the original patent is used for calculating PTE. Defendants’ proposal creates an untenable reading of the statutory scheme on the whole and conflicts with other provisions of the Patent Act. Moreover, Defendants’ interpretation would undermine the purpose of the Hatch-Waxman Act, in contrast to Merck's interpretation, which aligns with it. Using the original issue date also comports with the PTO’s policy and longstanding practice of treating reissued patents as if they were originally granted in amended form for purposes relevant to the PTO’s administration of the Patent Act.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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