Analogous References: The Same Field Or Problem Domain As The Invention

• Published date: 27 June 2023
• Subject Matter: Intellectual Property, Patent
• Law Firm: NovoTech Patent Firm
• Author: Mr Babak Akhlaghi

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...