By Chris Holman
Sanofi-Aventis Deutschland GMBH v. Mylan Pharms Inc., 2023 WL 3311549, — F.4th — (Fed. Cir. May 9, 2023).
The “analogous arts” test is used in patent law to determine whether a particular reference is relevant for the purposes of an obviousness analysis. Under this two prong test, a reference is relevant if it is from the same field of endeavor as the invention at issue, or if it is reasonably pertinent to the problem the invention is trying to solve. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004)
In its 2007 KSR v. Teleflex decision, the Supreme Court ruled that the obviousness analysis should be more flexible and not confined to rigid rules or tests. Rather, KSR emphasized an “expansive and flexible approach” to obviousness. While KSR did not directly address the analogous arts test, it could be interpreted as calling for a more flexible approach allowing courts and the PTO more leeway to consider prior art from a broader range of sources as being “analogous” or “reasonably pertinent,” which in principle should make it easier for challengers to invalidate patents.
In inter partes review (IPR) proceedings, the Patent Trial and Appeal Board (PTAB) has invalidated patents claims for obviousness based on cited prior art that the PTAB found to be analogous, and until now the Federal Circuit has consistently affirmed those decisions on appeal. Unwired Planet, LLC v. Google Inc., 841 F.3d 995 (Fed. Cir. 2016); Smartdoor Holdings, Inc. v. Edmit Indus., Inc., 707 F. App’x 705 (Fed. Cir. 2017); Toyota Motor Corp. v. Reactive Surfaces Ltd., LLP, 816 F. App’x 480 (Fed. Cir. 2020); CyWee Grp. Ltd. v. Google LLC, 847 F. App’x 910 (Fed. Cir. 2021); and Kamstrup A/S v. Axioma Metering UAB, 43 F.4th 1374 (Fed. Cir. 2022)).
On occasion, the PTAB has found cited prior art to be non-analogous, and thus irrelevant for purposes of the obviousness inquiry. The Federal has twice affirmed those decisions on appeal. Polygroup Ltd. MCO v. Willis Elec. Co., Ltd, 759 F. App’x 934 (Fed. Cir. 2019) and Broadcom Corp. v. Int’l Trade Comm’n, 28 F.4th 240 (Fed. Cir. 2022)). In one reported decision, Donner Tech., LLC v. Pro Stage Gear, LLC, 979 F.3d 1353 (Fed. Cir. 2020), the Federal Circuit vacated and remanded after concluding that the Board had applied the wrong standard when it determined that a cited prior art reference was not analogous art.
On May 9, in Sanofi-Aventis Deutschland GmbH v. Mylan Pharms. Inc., the Federal Circuit held for the first time (to the best of my knowledge) that the PTAB erred in finding cited prior art to be analogous in an IPR. Significantly, the Federal Circuit’s decision did not address the merits of the analogous art question, but instead was based entirely on the fact that the patent challenger (Mylan) had failed to allege that the cited prior art was analogous to the challenged patent (U.S. Patent No. RE47,614, which relates to pen injectors used for the delivery of drugs such as insulin).
The court observed that:
A petitioner is not required to anticipate and raise analogous art arguments in its petition; instead a petitioner can use its reply to “respond to arguments raised in the corresponding opposition, patent owner preliminary response, patent owner response, or decision on institution.” See 37 C.F.R. § 42.23. However, Mylan did not use its reply to explain how de Gennes is analogous to the ‘614 patent.
The court reversed the PTAB’s finding of nonobviousness because it had relied upon a finding that the de Gennes reference was analogous prior art, but Mylan had never made the required analogous art argument. Mylan argued on appeal that it had, in its IPR petition, effectively argued that the de Gennes reference was analogous to another other cited prior art reference, i.e., Burren, and that Burren and the challenged Sanofi patent address the “same problem.” However, the court found Mylan’s arguments as to Burren insufficient to carry its burden because they did not directly address the challenged patent.
The court explained that:
In evaluating whether a reference is analogous, we have consistently held that a patent challenger must compare the reference to the challenged patent. This conclusion is reinforced by the purpose of the analogous art test, which is to examine whether a reference can be considered as prior art to the challenged patent in the first place. [The] purpose of the “prior art” must be evaluated with reference to the inventor’s purported invention disclosed within the challenged patent.