By Kevin E. Noonan --
Early last year, Aurobindo, one of the Defendants* in ANDA litigation against Merck, advanced the proposition that in cases where a patent had been reissued patent term extension ("PTE") under 35 U.S.C. § 156 should be calculated based on the grant date of the reissue patent and not of the "original" patent from which the reissue was obtained. The Federal Circuit weighed in on this argument and found it unavailing (at least under the circumstances of these patents) in its Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc. decision handed down earlier this month.
The case arose in ANDA litigation between Plaintiffs Merck Sharp & Dohme B.V and Merck Sharp & Dohme LLC and a variety of Defendants over sugammadex (6-per-deoxy-6-per-(2-carboxyethyl)thio-γ-cyclodextrin), the active ingredient in Merck's Bridion drug, which is used to "assist[] patients' recovery of muscle function after a form of paralysis induced during surgery":
The patent at issue was U.S. Reissue Patent No. RE44,733** having claims expressly reciting the active ingredient and methods of use thereof without cancelling any of the claims of U.S. Patent No. 6,670,340 from which it originated. Importantly, the '340 patent issued on December 30, 2003 and had an original expiration date of January 27, 2021. The reissue patent was granted on January 28, 2014, 686 days before FDA approval on December 15, 2015, and Merck applied for patent term extension (PTE) on the reissue patent. The USPTO granted to RE '733 the maximum PTE of five years (until January 27, 2026) due to nearly 12 years of FDA delay as calculated from the December 30, 2002 grant date of the '340 patent.
Defendants did not challenge Merck's assertion that their generic sugammadex would infringe but instead argued that the portion of the term extending after December 14, 2022 was improperly granted. According to Defendants, the plain meaning interpretation of the statutory language of § 156(c) regarding proper calculation of PTE was from "the date the patent issued," and because the patent whose term was extended was RE '733, not the '340 patent, the proper length of PTE should be 686 days, not five years (or 1,825 days). Their argument was that the PTO improperly interpreted the statute and they moved that the District Court determine the correct, shorter PTE term based on their statutory interpretation.
Merck argued against Aurobindo's position by relying on § 251 and § 252 (regarding the effects of reissue), and § 156 of the Patent Act, as well as provisions in the MPEP (amended close upon this litigation) at § 2766:
With respect to calculating the amount of extension to which the reissued patent is entitled to receive, so long as the original patent claimed the approved product and the reissued patent claims the approved product, the original patent grant date would be used to calculate the extension to which the reissued patent would be entitled.
(which constitutes current Office policy). While the PTO's position was not dispositive, the District Court stated that "the Court may 'take notice of public reports and filings, such as those prepared by an administrative agency or pursuant to government regulation, to extent they have indicia of authenticity," citing In re Plum Baby Food Litig., No. 21-2417, 2022 WL 16552786, at *3 (D.N.J. Oct. 31, 2022) (citing Sturgeon v. Pharmerica Corp., 438 F. Supp. 3d 246, 259 (E.D. Pa. 2020)).
The District Court held that, "when read in its proper context alongside the provisions of the Patent Act addressing reissues," the use by the USPTO of the grant date of the '340 patent instead of the reissue RE '733 patent was proper "unambiguously," inter alia, because it did not create a conflict with either § 251 or § 252 regarding the effect and characteristics of reissue applications, was consistent with established USPTO practice, and did not contravene the policy choices evinced by Congress in passage of the Hatch-Waxman Act. These policy provisions and considerations included that PTE established in the Act "provides the holders of patents on approved patented products with an extended term of protection under the patent to compensate for the delay in obtaining FDA approval," citing Merck & Co., Inc. v. Kessler, 80 F.3d 1543, 1547 (Fed. Cir. 1996). The District Court opinion characterized Defendants' position as being "an untenable reading of the statutory scheme on the whole, creating conflict with various provisions of the Patent Act as well as unintended results." And on policy grounds, the opinion asserted that Defendants' "plain meaning" of the statute "would undermine the purpose of the Hatch-Waxman Act, in contrast to Merck's interpretation, which aligns with it." Finally, the opinion held that in the face of an ambiguity the District Court did not recognize but Defendants' contend has arisen in the statute, the District Court held that consistent PTO practice of using the grant date of the original patent deserves deference under Skidmore v. Swift & Co., 323 U.S. 134 (1944). This appeal followed.
The Federal Circuit affirmed the District Court's determination that PTE was properly calculated from the grant date of the '340 patent, in an opinion by Judge Dyk joined by Judges Mayer and Reyna (a substantial percentage of which opinion was set forth in extensive footnotes). The panel differed with the parties on the relevant statutory term, stating that it was not the word "issue" but rather the term "the patent" with regard to which patent's issue date should be used under § 156(c):
The term of a patent eligible for extension under subsection (a) shall be extended by the time equal to the regulatory review period for the approved product which period occurs after the date the patent is issued[.] 35 U.S.C. § 156(c) [emphasis added].
The Court agreed with the Patent Office that § 156(c) is ambiguous with regard to whether it is the original or the reissue patent that is "the patent." Relying on the Supreme Court's opinion in Caraco Pharm. Lab'ys, Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 412 (2012), the Court assessed the meaning of the term by the statutory text in the context in which it is used (wherein in Caraco the Court interpreted the meaning of 21 U.S.C. § 355(j)(5)(C)(ii)(I))) regarding the distinctions, if there were any, between "not an" and "not any" for counterclaims a generic drugmaker could raise in ANDA litigation). In Caraco, the Court held that "[w]ithin [the Hatch-Waxman Act's] framework, the counterclaim naturally functions to challenge the brand's assertion of rights over whichever discrete use (or uses) the generic company wishes to pursue." Here, the panel assessed the statutory meaning with regard to the "specific" context in which it was used and the "broader" context of the statute "as a whole," citing Robinson v. Shell Oil Co., 519 U.S. 337, 341 (1997); Dep't of Homeland Sec. v. MacLean, 574 U.S. 383, 393 (2015); and Centripetal Networks, Inc. v. Cisco Sys., Inc., 38 F.4th 1025, 1031 (Fed. Cir. 2022). That "broader" context involved Congressional intent to "compensate pharmaceutical companies for the effective truncation of their patent terms while waiting for regulatory approval of new drug applications" according to the opinion, citing Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1568 (Fed. Cir. 1997); Merck & Co. v. Hi-Tech Pharmacal Co., 482 F.3d 1317, 1323 (Fed. Cir. 2007); PhotoCure ASA v. Kappos, 603 F.3d 1372, 1374 (Fed. Cir. 2010); and Merck & Co. v. Kessler.
Accordingly, the opinion states that Congressional purpose was for PTE to be granted to patents ("and only those patents") that claimed drugs for which regulatory approval delayed the benefit of patent exclusivity. Finding for Merck, the opinion states, satisfies this Congressional intent, whereas agreeing with Aurobindo would "den[y] 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 Aurobindo offers none," according to the panel.
The opinion addresses Aurobindo's argument that it would be improper statutory construction to use the original patent grant date for calculating PTE term because that original '340 patent was "dead" upon reissue, citing case law interpreting the effects of reissue including Seattle Box Co. v. Indus. Crating & Packing, 731 F.2d 818, 827 (Fed. Cir. 1984), and others extending back into the 19th Century. The distinction the Court drew in rejecting this argument was that the status of the original patent was "irrelevant" because "the reissued patent inherits 'the unexpired part of the term of the original patent'" under 35 U.S.C. § 251(a) and mentioning that this date is unambiguous (albeit stating in a footnote that the panel did not find the parties' reliance on this portion of the status to be helpful because "it does not shed any light on the meaning of the term "the patent'" ). "[A] 'reissue patent does not simply replace an original patent nunc pro tunc'" according to the opinion, citing Intel Corp. v. Negotiated Data Sols., Inc., 703 F.3d 1360, 1364 (Fed. Cir. 2012).
The opinion holds further that the panel's conclusion is consistent with § 156(a) regarding the provision that "the term of a patent . . . shall be extended . . . from the original expiration date of the patent" (emphasis added) (stating this is "the most natural reading" of this statutory language to refer to the original patent) as well as § 154(a)(2) regarding calculation of patent term.
The opinion concludes by acknowledging that the panel's interpretation is also consistent with how the PTO has construed the statute (in the overwhelming number of cases in which the issue has arisen) and, in the face of Aurobindo's argument, expressly revised the MPEP in this regard (consistent with the Court's assessment of the Hatch-Waxman statutory scheme).
* The complete roster of ANDA defendants before the District Court in consolidated actions were Aurobindo Pharma USA, Inc.; Aurobindo Pharma, Ltd.; Eugia Pharma Specialties Ltd.; Gland Pharma Ltd.; Mankind Pharma Ltd.; Lifestar Pharma LLC; Mylan API US LLC; Mylan Pharmaceuticals Inc.; Mylan Inc.; Sandoz Inc.; LekcPharmaceuticals d.d.; Sun Pharmaceutical Industries, Inc.; Sun Pharmaceutical Industries Ltd.; Fresenius Kabi USA, LLC; Dr. Reddy's Laboratories, Inc.; Dr. Reddy's Laboratories, Ltd.; and USV Private Ltd.
** In a footnote, the panel noted that Merck filed its reissue application only after the Federal Circuit held that the addition of narrower claims could provide a proper basis for a reissue filing, in In re Tanaka, 640 F.3d 1246, 1251 (Fed. Cir. 2011).
Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc. (Fed. Cir. 2025)
Panel: Circuit Judges Dyk, Mayer, and Reyna
Opinion by Circuit Judge Dyk