Monday, August 16, 2021

Teva loses at CAFC on US patents 9,340,614 (“’614 patent”), 9,266,951 (“’951 patent”), and 9,890,210 (“’210 patent”)

Teva loses appeal on US patents 9,340,614 (“’614 patent”), 9,266,951 (“’951 patent”), and 9,890,210 (“’210 patent”) :

Teva Pharmaceuticals International GmbH (“Teva”) appeals from a combined final written decision of the U.S. Patent and Trademark Office (“PTO”) Patent Trial and Appeal Board (“Board”) holding that the claims of U.S. Patents 9,340,614 (“’614 patent”), 9,266,951 (“’951 patent”), and 9,890,210 (“’210 patent”) are unpatentable because they would have been obvious over the cited prior art. Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, Nos. IPR2018- 01422, IPR2018-01423, IPR2018-01425, 2020 WL 806932 (P.T.A.B. Feb. 18, 2020) (“Board Decision”). For the reasons provided below, we affirm.

The patents are directed to directed to humanized antagonist antibodies that target calcitonin gene-related peptide (“CGRP”). CGRP is a 37-amino acid peptide that is “a neurotransmitter in the central nervous system, and has been shown to be a potent vasodilator in the periphery, where CGRP-containing neurons are closely associated with blood vessels.”

On motivation to combine

As an alternative to its argument that the Board deviated from Lilly’s asserted motivation to combine, Teva argues that the Board relied on unsupported interpretations of isolated statements in the prior art to find a motivation to study or use humanized anti-CGRP antibodies. For example, Teva contends that the Board misinterpreted the phrase “CGRP antagonists and humanized monoclonal antibodies” in Wimalawansa as referring to antibodies that target the CGRP ligand, even though, Teva asserts, a skilled artisan would have understood that term as referring to the extremely specific receptor antagonists that are the focus of Wimalawansa’s section on CGRP antagonism. At best, Teva argues, Wimalawansa cautions that further study is needed before CGRP antagonists could be evaluated in humans. Regarding Tan, Teva emphasizes that the full-length antibody was unsuccessful in achieving immunoblockade in rats, and Teva contends that Tan’s expression of optimism that its negative results could be overcome does not support a motivation to further explore the full-length antibody.

Of competing interpretations

Unsurprisingly, Teva disagrees with the Board’s interpretations of Tan and Wimalawansa. But what a piece of prior art teaches presents a question of fact that is reviewed for substantial evidence. See, e.g., In re Warsaw Orthopedic, Inc., 832 F.3d 1327, 1332 (Fed. Cir. 2016) (“An examination of the scope and content of the prior art produces factual findings reviewed for substantial evidence.” (citing Gartside, 203 F.3d at 1316)). When it comes to competing interpretations of the teachings of prior art references, we must uphold the principle that “[i]f two ‘inconsistent conclusions may reasonably be drawn from the evidence in record, the PTAB’s decision to favor one conclusion over the other is the epitome of a decision that must be sustained upon review for substantial evidence.’” Elbit Sys. of Am., LLC v. Thales Visionix, Inc., 881 F.3d 1354, 1356 (Fed. Cir. 2018) (internal brackets omitted) (quoting In re Cree, Inc., 818 F.3d 694, 701 (Fed. Cir. 2016)). Under this deferential standard of review, we cannot replace the Board’s reasonable interpretation of references with Teva’s interpretation. For the foregoing reasons, we are not persuaded that the Board committed reversible error with regard to its analysis of the motivation to combine the teachings of the prior art references.

Of secondary considerations

Teva argues that the Board made two legal errors. First, Teva argues that, in finding no presumption of nexus between the claims and the secondary considerations based on the commercial products, the Board misapplied this court’s holding in Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366 (Fed. Cir. 2019). Second, with regard to the AlderBio license, Teva argues that the Board erred by focusing on AlderBio’s products rather than the scope of the license. We address each of Teva’s arguments below.
It is well-established law that in order to accord substantial weight to secondary considerations of nonobviousness, “the evidence of secondary considerations must have a ‘nexus’ to the claims, i.e., there must be ‘a legally and factually sufficient connection’ between the evidence and the patented invention.” Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1332 (Fed. Cir. 2019) (quoting Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988)). “The patentee bears the burden of showing that a nexus exists . . . .” WMS Gaming Inc. v. Int’l Game Tech., 184 F.3d 1339, 1359 (Fed. Cir. 1999) (citing Cable Elec. Prods., Inc. v. Genmark, Inc., 770 F.2d 1015, 1027 (Fed. Cir. 1985)). “To determine whether the patentee has met that burden, we consider the correspondence between the objective evidence and the claim scope.” Henny Penny, 938 F.3d at 1332. It has long been recognized that “a patentee is entitled to a rebuttable presumption of nexus between the asserted evidence of secondary considerations and a patent claim if the patentee shows that the asserted evidence is tied to a specific product and that the product ‘is the invention disclosed and claimed.’” Fox Factory, 944 F.3d at 1373 (quoting Demaco, 851 F.2d at 1392). The presumption applies “when the patentee shows that the asserted objective evidence is tied to a specific product and that product ‘embodies the claimed features, and is coextensive with them.’” Polaris Indus., Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1072 (Fed. Cir. 2018) (quoting Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120, 1130 (Fed. Cir. 2000)). “Conversely, ‘[w]hen the thing that is commercially successful is not coextensive with the patented invention— for example, if the patented invention is only a component of a commercially successful machine or process,’ the patentee is not entitled to a presumption of nexus.” Fox Factory, 944 F.3d at 1373 (quoting Demaco, 851 F.2d at 1392).


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