Sanofi-Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2023)

McDonnell Boehnen Hulbert & Berghoff LLP

In those (in retrospect) halcyon days more than a decade ago (before Mayo, Myriad, Alice, and the subject matter eligibility quagmire arose), perhaps the most significant Supreme Court decision was KSR Int'l Co. v. Teleflex Inc. (2007), where the Court addressed the proper standard for determining obviousness for the first time since the Federal Circuit was created by Congress in 1982. While the consequences of that decision may have been somewhat less dire than first feared (see "Implications of the Supreme Court's KSR v. Teleflex Decision for Biotechnology"; "Bayer Schering Pharma AG v. Barr Laboratories, Inc. (Fed. Cir. 2009)"), the impact of the decision continues to be felt (as does the Court's decision in Dickerson v. Zurko regarding judicial deference to the USPTO on questions of fact) as illustrated by the Federal Circuit decision earlier this year in Sanofi-Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc.

The case arose in an inter partes review initiated by Mylan Pharmaceuticals over Reissue Patent No. RE47,617. The reissue patent was directed to drug delivery devices having settings permitting selection of different dose sizes; Claim 1 was considered to be representative:

1. A drug delivery device comprising:
a housing with a proximal end and a distal end,
a cartridge adapted to accommodate a drug,
a cartridge retaining member adapted to retain the cartridge, the cartridge retaining member releasably secured to the housing, and
a spring washer arranged within the housing so as to exert a force on the cartridge and to secure the cartridge against movement with respect to the cartridge retaining member,
wherein the spring washer has at least two fixing elements configured to axially and rotationally fix the spring washer relative to the housing.

(wherein the italicized limitations were relevant to the issues on appeal). As explained in the opinion, the spring washer is secured to the device housing to "prevent relative axial movement between [the] spring washer and housing" wherein the spring washer "exert[s] a force on the cartridge and secure[s] the cartridge against movement."

Challenger Mylan asserted a combination of three prior art references: (1) U.S. Patent Application No. 2007/0021718 ("Burren"); (2) U.S. Patent No. 2,882,901 ("Venezia"); and (3) U.S. Patent No. 4,144,957 (a patent directed to clutch bearings in an automobile). Mylan argued that the '718 application disclosed the use of springs in a drug delivery device and that the combination of this reference with the '901 patent taught using spring washers in drug delivery devices. Mylan's petition and position before the Board was that the '957 patent "addresse[d] a problem analogous to that addressed in [the '901 patent] ([axial] fixation and support of two components relative to one another)"; this argument was supported by expert testimony. As it did on appeal, Sanofi argued that the '957 patent was non-analogous art (cars versus drug delivery devices) wherein "a person of ordinary skill in the art 'would not have considered a clutch bearing to be within the same field of endeavor'." Mylan in response argued that the problem to be solved was the same and that the skilled worker would have considered the solution disclosed in the '957 patent to be relevant to the claimed drug delivery device. The PTAB rendered a Final Written Decision finding all eighteen challenged claims of the '617 reissue patent to be invalid for obviousness, stating that the combination of the '718 application and the '901 patent was not sufficient to support an obviousness determination, but the addition of the '957 patent's teachings rendered the challenged claims obvious. In doing so, the Board held that the '957 patent was analogous art to the '718 application (wherein the common problem to be solved was "axially fixing two components relative towards each other" as argued by Mylan). This appeal followed.

The Federal Circuit reversed, in an opinion by Judge Cunningham joined by Judges Reyna and Mayer. Sanofi's argument on appeal was based on the Mylan's purported failure to argue that the '957 patent was analogous art to the claimed invention in the '617 reissue patent, instead arguing that the '957 patent was analogous art to another prior art reference, the '901 patent. Mylan argued that there was "no functional difference" between the problem addressed in the '718 patent and the solution/invention claimed in the '617 reissue patent.

In reversing the Board, the Federal Circuit held that Mylan had not shown that the '957 patent was analogous art to the '614 reissue claims. According to the opinion, the test for analogous art is either that the art is from the same field of endeavor, "regardless of the problem addressed," or that when it is not within the same field of endeavor, "whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved," citing In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004); In re Clay, 966 F.2d 656, 658–59 (Fed. Cir. 1992); and In re Wood, 599 F.2d 1032, 1036 (CCPA 1979). The Federal Circuit stated that it had "consistently held that a patent challenger must compare the reference to the challenged patent" (which was clearly not what the Board had done here), citing Donner Tech., LLC v. Pro Stage Gear, LLC, 979 F.3d 1353, 1358 (Fed. Cir. 2020), and Unwired Planet, LLC v. Google Inc., 841 F.3d 995, 1001 (Fed. Cir. 2016). The rationale for these principles is that the factfinder must "examine whether a reference can be considered as prior art to the challenged patent in the first place," citing Chemours Co. FC, LLC v. Daikin Indus., Ltd., 4 F.4th 1370, 1376 (Fed. Cir. 2021). The defects in Mylan's assertions that the '957 patent was analogous art was that the Federal Circuit's jurisprudence consistently required a determination of whether art is analogous to be in comparison to the claimed invention, the Court stated. The opinion also distinguished the factual predicates in cases cited by Mylan in support of its argument, which included Mandel Bros., Inc. v. Wallace, 335 U.S. 291, 295–96 (1948), and In re Mariani, 177 F.2d 293, 294–96 (CCPA 1949). The deficiencies in Mylan's interpretation of precedent were that they would "allow a challenger to focus on the problems of alleged prior art references while ignoring the problems of the challenged patent," the panel stated. Although analogous art can (or must, according to Mylan) be construed broadly because "familiar items may have obvious uses beyond their primary purposes," citing KSR and Wyers v. Master Lock Co., 616 F.3d 1231, 1238 (Fed. Cir. 2010) (italics in opinion), "that conclusion does not allow a fact finder to focus on the problems contained in other prior art references to the exclusion of the problem of the challenged patent" according to the Federal Circuit's opinion here.

Turning to the facts before the Board, the panel held that Mylan had not borne its burden to assert substantial evidence supporting its obviousness argument, because Mylan did not show that the '957 patent was analogous art to the challenged '614 reissue patent claims. After asserting its precedent that the challenger has the burden of showing obviousness and that the Court will reverse PTAB obviousness determinations where a challenger fails to satisfy its burden (e.g., on motivation to combine, citing In re Magnum Oil Tools International, Ltd., 829 F.3d 1364 (Fed. Cir. 2016)), the panel held Mylan's failure to argue that the '957 patent was analogous art to the challenged '617 reissue patent claims was fatal to its IPR challenge (noting, no doubt to Mylan's chagrin, that it had passed up the opportunity to remedy this deficiency in its Reply to the patent owner's "opposition, patent owner preliminary response, patent owner response, or [the Board's] decision on institution).

Sanofi-Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2023)
Panel: Circuit Judges Reyna, Mayer, and Cunningham
Opinion by Circuit Judge Cunningham

[View source.]

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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