Monday, August 16, 2021

Lilly loses challenges to Teva patents; interpreting preambles

Lilly loses on U.S. Patents 8,586,045 (“’045 patent”), 9,884,907 (“’907 patent”), and 9,884,908 (“’908 patent”) are not unpatentable as obvious.

Eli Lilly and Company (“Lilly”) 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 8,586,045 (“’045 patent”), 9,884,907 (“’907 patent”), and 9,884,908 (“’908 patent”) are not unpatentable as obvious. Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, Nos. IPR2018-01710, IPR2018-01711, IPR2018-01712, 2020 WL 1540364 (P.T.A.B. Mar. 31, 2020) (“Board Decision”). For the reasons provided below, we affirm

The issues

While Lilly makes a number of interrelated arguments in its briefing, Lilly’s appeal can be broadly broken down into two primary challenges. In its first challenge, Lilly contends that the Board erred by reading a result into the constructions of the preambles and the term “effective amount,” which led the Board to erroneously require Lilly to prove that a skilled artisan would have expected to achieve results that are unclaimed. In its second challenge, Lilly contends that even if the preambles are limiting and the claims thus require administration of an antibody with an expectation of results, the Board erred by applying too high a standard when weighing the evidence to determine whether a skilled artisan would have had a reasonable expectation of success. We address each challenge in turn

Preamble issue

Teva responds that Lilly’s argument is based on a false dichotomy between limiting preambles as contrasted with preambles that are merely statements of intended purpose. Teva further argues that the preambles here are limiting because they are central to the invention, they provide antecedent basis for later claim limitations, and they give meaning to the substantive claim requirement of administering an “effective amount,” which, Teva argues, the Board construed correctly. First, we agree with Teva that our case law does not support Lilly’s proposed binary distinction between statements of mere intended purpose on the one hand and limiting preambles on the other. On the contrary, we have stressed that there is no “litmus test” for determining whether a preamble is limiting. See Bicon, Inc. v. Straumann Co., 441 F.3d 945, 952 (Fed. Cir. 2006) (citing Catalina Mktg. Int’l, Inc. v., Inc., 289 F.3d 801, 808 (Fed. Cir. 2002)). Rather, “[w]hether to treat a preamble as a claim limitation is determined on the facts of each case in light of the claim as a whole and the invention described in the patent.” Storage Tech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 831 (Fed. Cir. 2003).
Even with respect to apparatus or composition claims, however, we have, when warranted by the facts, found statements of intended purpose to be limiting. For example, in Bicon, we considered a claim in which the preamble recited an apparatus and its intended use: “[a]n emergence cuff member for use in preserving the interdental papilla during the procedure of placing an abutment on a root member implanted in the alveolar bone of a patient.” 441 F.3d at 948. We held that the preamble’s statement of intended use was limiting because it “recites essential elements of the invention pertaining to the structure of the abutment that is used with the claimed emergence cuff.” Id. at 952. We further noted that the body of the claim “refers back to the features of the abutment described in the preamble”—i.e., the preamble provided antecedent basis for the structural terms in the body of the claim.


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