Analogous References: the Same Field or Problem Domain as the Invention

By Babak Akhlaghi on June 16, 2023

The US Court of Appeals for the Federal Circuit has overturned the Patent Trial & Appeal Board’s determination of obviousness, stating that a prior art reference concerning automotive engine parts is not analogous to the challenged patent, which focused on injection devices designed for drug delivery. Sanofi-Aventis Deutschland GMBH v. Mylan Pharmaceuticals Inc., Case No. 21-1981 (Fed. Cir. May 9, 2023) (Reyna, Mayer, Cunningham, JJ.)

Sanofi-Aventis owns U.S. Patent No. RE47,614 (“the ’614 patent”). The ‘614 patent pertains to a drug delivery device that can be customized to administer varying dosage quantities. Mylan petitioned the Board to institute IPR proceedings on the ground that the ‘614 patent is obvious based on a combination of three prior art references: Burren, Venezia, and de Gennes.  Mylan relied on Burren, which was referenced in the ‘614 patent, to show implementation of springs within a drug-delivery device.  Mylan combined Burren with Venezia to teach the use of spring washers within drug-delivery devices and de Gennes to incorporate “snap-fit engagement grips” to secure the spring washer.

Sanofi argued that de Gennes was not an analogous art to the ‘614 patent since it related to vehicles and not medical or drug-delivery devices. As a result, a person of ordinary skill in the art would not have recognized a clutch bearing as being part of the same area of endeavor as the ‘614 patent. Sanofi also argued that de Gennes was not reasonably pertinent to the problem addressed by the ‘614 patent, which it argued was to secure a cartridge against movement within a housing. Mylan, in response, criticized Sanofi’s analogousness arguments as relying on a flawed understanding of controlling law.  Mylan accused Sanofi of attempting to alter the relevant issue by bringing in specific problems/solutions stated in the ‘614 patent. Mylan insisted that Burren’s teaching provides the relevant problem in this case and that a skilled artisan reading Burren, instead of reading the goals of the ’614 patent with hindsight, would have considered de Gennes to be highly relevant.  The Board agreed with Mylan and Sanofi appealed.

“Two separate tests define the scope of analogous prior art: (1) whether the art is from the same field of endeavor, regardless of the problem addressed and, (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004) (citations omitted); see also In re Clay, 966 F.2d 656, 658–59 (Fed. Cir. 1992); In re Wood, 599 F.2d 1032, 1036 (CCPA 1979).

The Federal Circuit noted that it has consistently held that a patent challenger must compare the reference to the challenged patent to determine whether it is analogous. Mylan’s arguments, on the other hand, would allow a challenger to concentrate on the issues of alleged prior art references while disregarding the problems of the challenged patent. Just because de Gennes is analogous to one problem in Burren, it does not imply that de Gennes would be analogous to the problems of the ‘614 patent. Moving on, the Court looked at whether Mylan provided sufficient support for its claim that de Gennes is analogous art to the ‘614 patent. Since Mylan failed to do so, the Court held that the Board’s decision that de Gennes is analogous to the ‘614 patent lacks substantial evidence and is reversed.

Practice Tips:

This case serves as a reminder for patent practitioners to precisely identify the problem that the inventor is aiming to address in the patent’s specification and offer a precise solution. By defining both the problem and solution, not only can you assist in overcoming Section 101 challenges, particularly in the area of software innovations, but you can also help narrow the scope of prior art that would be deemed analogous to your invention.