Sanofi-Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc.

Docket No. 2021-1981 (IPR2019-01657) (https://cafc.uscourts.gov/opinions-orders/21-1981.OPINION.5-9-2023_2123775.pdf)

REYNA, MAYER, CUNNINGHAM

May 9, 2023

Brief Summary:   IPR decision finding Sanofi’s claims obvious reversed as Mylan did not show art relied upon was analogous to Sanofi’s invention. Summary:  Sanofi appealed USPTO PTAB (“Board”) IPR decision finding all of the claims of US RE47,614 directed to “[a] drug delivery device comprising” including multiple components including “a spring washer” having “at least to fixing elements” unpatentable as obvious over the prior art (US 4,144,957 (“de Gennes”)).  Mylan brought the IPR and alleged obviousness in view of three prior art references including the Burren US patent publication, the Venenzia US patent, and deGennes. Mylan argued the ‘614 patents were obvious because “Burren with Venezia…teach the use of spring washers within drug-delivery devices and de Gennes to add ‘snap-fit engagement grips’ to secure the spring washer”.  “De Gennes”, Mylan and its expert argued, “while concerned with a clutch bearing [in automobiles], addresses a problem analogous to that addressed in Burren (axially [sic] fixation and support of two components relative to one another).”  “Sanofi argued that de Gennes is not analogous art to the ’614 patent” as it “relates to cars and not drug delivery devices or medical devices, such that a person of ordinary skill in the art “would not have considered a clutch bearing to be within the same field of endeavor” or “‘reasonably pertinent’ to the ’614 patent’s problem…which it asserted is ‘secur[ing] a cartridge against movement within a housing’”.  Mylan successfully argued to the Board that “Sanofi’s analogousness arguments relied on a ‘faulty understanding of controlling law’”, the Board finding de Gennes to be “analogous to the ’614 patent” because it “is reasonably pertinent to axially fixing two components relative towards each other, a problem addressed by the inventors of the ’614 patent.”  The FC panel explained that “[w]hether a reference is analogous art is an issue of fact” reviewed for substantial evidence.  In its appeal, Sanofi argued “the Board improperly shifted the burden of persuasion from Mylan—to prove the claims of the ’614 patent are unpatentable—to Sanofi—to defend the claims of the ’614 patent as patentable” (citing In re Magnum Oils, FC 2016) and “‘adopted Mylan’s problem statement derived from Burren and then worked backward to relate that problem to the ’614 patent,’ which led the Board to a ‘legally erroneous conclusion that lacks substantial evidence.’”  The FC panel agreed “with Sanofi that Mylan did not carry its burden to argue that de Gennes is analogous to the ’614 patent”, and that the Board relied on Mylan’s arguments regarding the problem of Burren (In re Bigio, FC 2004 (“same field of endeavor, regardless of the problem addressed”, “whether the reference still is reasonably pertinent to the particular problem”); Mandel, US 1948 (chemistry/cosmetics); In re Mariani, CCPA 1949 (“analogous to the claimed invention”)).  The Board decision was therefore reversed.

Patrick Halloran

Pat has a Ph.D. in Microbiology and Immunology from The University of Health Sciences / The Chicago Medical School (now the Rosalind Franklin Institute (North Chicago, IL) (1994)). He also completed post-doctoral studies at The National Cancer Institute (1994-1996) where he developed novel…

Pat has a Ph.D. in Microbiology and Immunology from The University of Health Sciences / The Chicago Medical School (now the Rosalind Franklin Institute (North Chicago, IL) (1994)). He also completed post-doctoral studies at The National Cancer Institute (1994-1996) where he developed novel approaches for gene therapy of melanoma. Pat has been an attorney (IL) since 1999 after graduating from Chicago-Kent College of Law, which was recently ranked as one of the top five law schools for Intellectual Property in the U.S. (U.S. News and World Report link). Pat also has a B.A. in Biology from Augustana College (Rock Island, IL; 1989) where he was on two NCAA Division III National Championship football teams (1985, 1986). He currently resides in Center Valley, PA.