Sanofi-Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc. (USPTO as Intervenor)

Docket No. 2020-2066, -2068-9 (IPRs 2018-01679-80, -82) (https://cafc.uscourts.gov/opinions-orders/20-2066.OPINION.12-29-2021_1886477.pdf) (Non-Precedential)

DYK, CLEVENGER, TARANTO

December 29, 2021

Brief Summary:  Board IPR decision finding Sanofi’s patents obvious because priority application does not provide proper written description for proposed substitute claims affirmed.

Summary:  Sanofi appealed three IPR decisions finding its US 8,992,486 and 9,526,844 relating to pen-type injectors as shown to be invalid for obviousness in part because the Great Britain (GB) priority document (“GB Application”) lacks proper written description for its proposed substitute claims. In the ‘679 IPR, Sanofi’s proposed substitute claims are directed to an injector including “an arc-shaped body (‘ASB’) that tracks each set dose of medicament” and two “different versions of a clicker (‘Clicker A’ and ‘Clicker B’) that produce audible clicks corresponding to a unit dose of medicament”.  Sanofi chiefly argued “that the Board inappropriately relied on common knowledge to supply limitations missing in the prior art and on its Clicker A analysis, which the Board also used for the Clicker B claims”.  “[T]he Board found Mylan’s arguments and evidence to be “more persuasive” in light of evidence demonstrating a POSA’s knowledge” and relied on “numerous exhibits” including Mylan’s expert testimony to provide “substantial evidence for its findings.” 

The ‘844 patent relies upon the GB priority application that was filed one month before the “Giambattista” reference upon which Mylan relied its obviousness arguments.  But the Board held that “the GB Application does not provide written description support for an internally-threaded piston rod” but “only a piston rod with external threads”, concluding that “a POSA reading the GB Application would not understand the inventors to be in possession of an internally-threaded piston rod”.  In proposed amendments in the ‘680 and ‘682 IPRs, Sanofi proposed amendments reciting “a piston rod comprising a fourth thread that is engaged with the third thread” which the Board found not to be described in the GB Application.  Sanofi argued “that the GB Application’s disclosure of an externally-threaded piston rod is sufficient to describe the genus of threaded piston rods because a POSA would understand that externally-threaded and internally-threaded piston rods are the only two species in that genus”.  “The Board found Sanofi’s references to be unconvincing, crediting [Mylan’s expert] testimony regarding what a POSA would understand from the GB Application and Sanofi’s references” and rejecting Sanofi’s expert testimony as “not credible, conclusory, and inconsistent with the GB Application’s disclosure.”

The Board IPR decisions were therefore affirmed.

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.