Last week, the U.S. Court of Appeals for the Federal Circuit issued an opinion in Sanofi-Aventis Deutschland GmBH v. Mylan Pharmaceuticals, Inc., No. 2021‑1981 (May 9, 2023), reversing the Patent Trial and Appeal Board’s determination that the prior art on which Mylan relied to invalidate Sanofi’s patent was analogous art.
The Sanofi patent at issue relates to drug delivery devices. Specifically, Sanofi claimed to have invented improved dosage control by using a spring washer to secure a cartridge and prevent axial movement. Mylan petitioned for inter partes review of Sanofi’s patent, contending that the challenged claims were invalid as obvious over the combination of a patent application (“Burren”) and two patents (“Venezia” and “de Gennes”). The Board instituted the IPR and issued a final written decision in which it found that Burren in combination with Venezia and de Gennes renders the challenged claims unpatentable. In particular, the Board found that the “snap-fit connection” of de Gennes taught the “fixing elements” of the Sanofi patent. Although de Gennes related to cars rather than drug delivery devices, the Board found de Gennes was analogous art because of its pertinence to axially fixing two components relative to each other. Sanofi appealed.
The Federal Circuit reversed. The Court first explained that in seeking to demonstrate that a prior art reference is analogous art a patent challenger must compare the reference to the challenged patent. Reviewing the arguments Mylan made about de Gennes in the IPR, the Court concluded that Mylan only argued that de Gennes was analogous to Burren—another prior art reference—not to the challenged patent. The Court rejected Mylan’s assertion that both Burren and the challenged patent were addressed to the same problem, such that its arguments were properly construed as also applying to the challenged patent. The Court explained that “even if a reference is analogous to one problem considered in another reference, it does not necessarily follow that the reference would be analogous to the problems of the challenged patent.” Because Mylan’s IPR petition only asserted that de Gennes is analogous to another prior art reference, and not to the challenged patent, the Court concluded that Mylan failed to carry its burden and that the Board’s finding that de Gennes is analogous art was unsupported by substantial evidence.