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Novartis Ag v. Noven Pharmaceuticals Inc.

United States Court of Appeals, Federal Circuit

April 4, 2017

NOVARTIS AG, LTS LOHMANN THERAPIE-SYSTEME AG, Appellants
v.
NOVEN PHARMACEUTICALS INC., Appellee

         Appeals from the United States Patent and Trademark Office, Patent Trial and Appeal Board in Nos. IPR2014-00549, IPR2014-00550, IPR2015-00265, IPR2015-00268.

          Charlotte Jacobsen, Fitzpatrick, Cella, Harper & Scinto, New York, NY, argued for appellants. Also represented by Nicholas N. Kallas, Christopher Earl Loh, Jared Levi Stringham.

          Steven J. Lee, Andrews Kurth Kenyon LLP, New York, NY, for appellee. Also represented by Christopher Justin Coulson, Kulsoom Zehra Hasan, Michael K. Levy.

          Frances Lynch, Office of the Solicitor, United States Patent and Trademark Office, Alexandria, VA, argued for intervenor Michelle K. Lee. Also represented by Nathan K. Kelley, Kakoli Caprihan, Scott Weidenfeller.

          Before Prost, Chief Judge, Wallach and Stoll, Circuit Judges.

          Wallach, Circuit Judge.

         The instant appeals concern inter partes reviews of U.S. Patent Nos. 6, 316, 023 ("the '023 patent") and 6, 335, 031 ("the '031 patent") (together, "the Patents-in-Suit"). In two separate final written decisions, the U.S. Patent and Trademark Office's ("USPTO") Patent Trial and Appeal Board ("PTAB") found that various claims of the Patents-in-Suit ("the Asserted Claims")[1] would have been obvious over the prior art. See Noven Pharm., Inc. v. Novartis AG (Noven I), No. IPR2014-00549, 2015 WL 5782080, at *23 (P.T.A.B. Sept. 28, 2015) (finding the disputed claims of the '023 patent unpatentable as obvious); Noven Pharm., Inc. v. Novartis AG (Noven II), No. IPR2014-00550, 2015 WL 5782081, at *23 (P.T.A.B. Sept. 28, 2015) (finding the disputed claims of the '031 patent unpatentable as obvious). The PTAB maintained its findings when asked to reconsider them. See Noven Pharm., Inc. v. Novartis AG (Noven III), No. IPR2014-00549, 2015 WL 9599194, at *8 (P.T.A.B. Nov. 30, 2015) (denying request to reconsider Noven I); Noven Pharm., Inc. v. Novartis AG (Noven IV), No. IPR2014-00550, 2015 WL 9599195, at *8 (P.T.A.B. Nov. 30, 2015) (denying request to reconsider Noven II). Appellants Novartis AG and LTS Lohmann Therapie-Systeme AG (together, "Novartis") contest numerous aspects of the Final Written Decisions, including the PTAB's conclusion that prior judicial opinions did not control its inquiry and the PTAB's factual findings in support of its obviousness conclusion. We affirm.

         Discussion I.

         Subject Matter Jurisdiction and Standard of Review

         We possess subject matter jurisdiction pursuant to 28 U.S.C. § 1295(a)(4)(A) (2012). "We review the PTAB's factual findings for substantial evidence and its legal conclusions de novo." Redline Detection, LLC v. Star Envirotech, Inc., 811 F.3d 435, 449 (Fed. Cir. 2015) (citation omitted). "Substantial evidence is something less than the weight of the evidence but more than a mere scintilla of evidence, " meaning that "[i]t is such relevant evidence as a reasonable mind might accept as adequate to support a conclusion." In re NuVasive, Inc., 842 F.3d 1376, 1379-80 (Fed. Cir. 2016) (internal quotation marks and citations omitted).

         II. The PTAB Properly Concluded that the Asserted Claims of the Patents-in-Suit Would Have Been Obvious

         A patent claim is unpatentable when "the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art [('PHOSITA')] to which said subject matter pertains." 35 U.S.C. § 103(a) (2006).[2] Obviousness "is a question of law based on underlying findings of fact." In re Gartside, 203 F.3d 1305, 1316 (Fed. Cir. 2000) (citation omitted). The underlying factual findings include (1) "the scope and content of the prior art, " (2) "differences between the prior art and the claims at issue, " (3) "the level of ordinary skill in the pertinent art, " and (4) the presence of secondary considerations of nonobviousness such "as commercial success, long felt but unsolved needs, failure of others, " and unexpected results. Graham v. John Deere Co. of Kan. City, 383 U.S. 1, 17 (1966); see United States v. Adams, 383 U.S. 39, 50-52 (1966).

         The PTAB found that the Asserted Claims of the Pa-tents-in-Suit would have been obvious over several different combinations of prior art references. See Noven I, 2015 WL 5782080, at *23; Noven II, 2015 WL 5782081, at *23. The PTAB found that claims 1-2, 4-5, and 7 of the '023 patent would have been obvious over a combination of two prior art references-United Kingdom Patent Application GB 2, 203, 040 ("Enz") (J.A. 588-610) and Japanese Patent Application 59-184121 ("Sasaki") (J.A. 634-37)-and that claim 8 would have been obvious over a combination of Enz, Sasaki, and two other references.[3]See Noven I, 2015 WL 5782080, at *23. The PTAB also found that claims 1-3, 7, 15-16, and 18 of the '031 patent would have been obvious over Enz and Sasaki. See Noven II, 2015 WL 5782081, at *23.

         Instead of raising arguments on the basis of a specific claim, patent, or Final Written Decision, Novartis raises broad legal and factual arguments with application to both of the Final Written Decisions. See Appellants' Br. 6 n.1 (stating that the appealed decisions "are substantively nearly the same" and that it will refer only to Noven II throughout its brief), 35-65 (presenting arguments); see also Appellee's Br. 1 n.1 (agreeing to follow Novartis's convention and cite ...


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