Patent Case Summaries August 25, 2021

Patent Case Summaries | Week Ending August 20, 2021

A weekly summary of the precedential patent-related opinions issued by the Court of Appeals for the Federal Circuit and the opinions designated precedential or informative by the Patent Trial and Appeal Board.

Eli Lilly & Co. v. Teva Pharmaceuticals International GmbH, Nos. 2020-1876, -1877, -1878 (Fed. Cir. (PTAB) Aug. 16, 2021). Opinion by Lourie, joined by Bryson and O’Malley.

Teva owns three patents directed to “methods of treatment using humanized antibodies that antagonize CGRP [calcitonin gene-related peptide] and thus inhibit its activity in the body.” Lilly filed petitions for IPR challenging various claims as obvious over a combination of prior art references.

In construing the claims, the Patent Trial and Appeal Board found the preambles to be “limiting to the extent that they require that the recited method must be performed with the intentional purpose of ‘reducing incidence of or treating’ at least one vasomotor symptom … or headache.” Based on that construction, the Board determined that there was no reasonable expectation of successfully achieving the claimed inventions based on the prior art’s teachings, and thus Lilly had not met its burden of demonstrating that the claims were obvious.

On appeal, the Federal Circuit affirmed. First, the court agreed with the Board that the claim preambles are limiting. The court noted that method claims “typically rely entirely on what the method ‘does,’” and “what a method does is usually recited in its preamble.” In Teva’s patents, each preamble recites a method for treating a vasomotor symptom such as a headache. The Federal Circuit explained that these preambles “are not merely statements of effect but rather statements of the intentional purpose for which the methods must be performed.”

The Federal Circuit explained that further support for the limiting nature of the preambles is found in the body of the claims. Each claim requires a step of administering an “effective amount” of an anti-CGRP antibody. The Federal Circuit ruled that the preambles “provide the only metric by which one practicing the claim could determine whether the amount administered is an ‘effective amount.’”

Addressing a second issue, the Federal Circuit agreed with the Board that Lilly had not demonstrated that skilled artisans would have had a reasonable expectation of success. In particular, the Federal Circuit upheld the Board’s conclusion that “what is required is not proof that the recited method would actually bring about the recited result, but rather proof that a person of ordinary skill in the art would have had a reasonable expectation that performing the recited method would bring about the recited result.”

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Teva Pharmaceuticals International GmbH v. Eli Lilly & Co., Nos. 2020-1747, -1748, -1750 (Fed. Cir. (PTAB) Aug. 16, 2021). Opinion by Lourie, joined by Bryson and O’Malley.

In addition to the method-of-treatment patents discussed in the preceding summary, Teva also owns three patents directed to “humanized antibodies that antagonize CGRP [calcitonin gene-related peptide] and thus inhibit its activity in the body.” Lilly filed petitions for IPR challenging various claims in these patents as obvious over a combination of prior art references. The Patent Trial and Appeal Board agreed with Lilly and held the challenged claims unpatentable as obvious.

On appeal, Teva raised three primary arguments but the Federal Circuit rejected each one. First, the Federal Circuit determined that, in finding a motivation to combine, the Board did not deviate from the motivation asserted by Lilly. “Lilly argued in its petition that a skilled artisan would have been motivated to make the claimed humanized antibody for therapeutic use in humans,” and “that was precisely the motivation that the Board found.” The Federal Circuit emphasized that the question concerned motivation to make the claimed humanized antibodies, not to use those antibodies to treat human disease.

Second, the Federal Circuit concluded that substantial evidence supports the Board’s finding of a motivation to make the claimed antibody. Lilly identified evidence supporting “the Board’s reasonable readings of each reference.” Teva disagreed, but the Federal Circuit explained that under the applicable “deferential standard of review, we cannot replace the Board’s reasonable interpretation of references with Teva’s interpretation.”

Lastly, the Federal Circuit addressed the Board’s treatment of Teva’s evidence on secondary considerations of nonobviousness. Teva’s evidence was based on two commercial products—its own AJOVY® product and Lilly’s Emgality® product—that are antibodies within the scope of the claims and that, according to Teva, have received industry-wide acclaim, satisfied a long-felt need, achieved unexpected results, faced industry skepticism, and achieved commercial success. Teva also presented evidence of a license that covered the challenged patents among a group of 188 total patents. The Board found that the commercial products and the license lacked sufficient nexus to the challenged claims.

Addressing the commercial products, the Federal Circuit concluded that the Board incorrectly articulated the legal standard, but the error was harmless because the Board correctly found that no presumption of nexus applies. Because the presumption was Teva’s sole basis for its assertion of nexus, the Federal Circuit ruled that there is no nexus.

Addressing the license, the Federal Circuit held that the Board’s conclusion (that the license lacked nexus to the challenged claims) was supported by substantial evidence. “Here, given that 188 patents were licensed, the nexus between the license and the validity of any particular claim is rather tenuous to say the least.” And Teva provided no other evidence beyond the existence of the license.

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Valve Corp. v. Ironburg Inventions Ltd., Nos. 2020-1315, -1316, -1379 (Fed. Cir. (PTAB) Aug. 17, 2021). Opinion by Dyk, joined by Newman and Lourie.

In two IPRs, Valve challenged the patentability of various claims in two patents owned by Ironburg related to video game controllers. In the first IPR, the Patent Trial and Appeal Board determined that some challenged claims were anticipated by “Uy,” while other challenged claims were not shown to be unpatentable because a cited reference—the “Burns article”—did not qualify as prior art. In the second IPR, the Board determined that none of the claims were anticipated by Uy, and that, once again, Burns did not qualify as prior art.

A core aspect of the appeal centered on whether the copy of the Burns article relied on by Valve qualified as prior art. The Burns article was cited and enclosed in the prosecution histories for the two patents, and Valve argued that its version—referred to as “the Exhibit”—qualified as prior art. The Board found, however, that Valve failed to show that the Exhibit was the same as the asserted prior art documents in the prosecution histories.

The Federal Circuit reversed the Board’s determination that the Exhibit is not prior art and vacated the associated patentability determinations.

First, the Federal Circuit explained that “the Exhibit and the prosecution documents are virtually identical.” The Board had declined to compare them, and the Federal Circuit disagreed with that approach: “The Board had an obligation to make the comparison, as Rule 901(b)(3) [of the Federal Rules of Evidence] contemplates and as the cases require.”

The Federal Circuit also concluded that “there is overwhelming evidence that [the Burns article] is prior art, and thus, the Exhibit, which is substantively the same, is also prior art.” Valve provided “strong evidence that the [Burns article] was publicly accessible.” Also, during prosecution, the applicants did not dispute the article’s publication date and did not dispute the examiner’s characterization of it as “prior art.” Similarly, in district court litigation, the patent owner confirmed the article’s publication date.

The Federal Circuit also addressed the Board’s rulings on anticipation by Uy as well as the Board’s obviousness rulings, affirming each of the substantive rulings.

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Campbell Soup Co., et al. v. Gamon Plus, Inc., Nos. 2020-2344, 2021-1019 (Fed. Cir. (PTAB) Aug. 19, 2021). Opinion by Moore, joined by Prost and Stoll.

Campbell filed IPR petitions directed to two design patents that claim an “ornamental design for a gravity feed dispenser display, as shown and described.” The Patent Trial and Appeal Board instituted trial but held that Campbell did not establish unpatentability because neither the “Linz” reference nor the “Samways” reference was similar enough to the claimed designs to constitute a proper primary reference. Campbell appealed, and the Federal Circuit vacated and remanded.

On remand, the Board again held that Campbell failed to prove unpatentability. The Board reasoned that although Linz creates “the same overall visual appearance as the claimed designs,” it is outweighed by objective indicia of nonobviousness. Campbell again appealed.

The Federal Circuit reversed. Addressing the evidence of objective indicia of nonobviousness, which included evidence of commercial success and praise, the Federal Circuit reiterated that the evidence “must have a nexus to the claims.” The Board had found both a presumption of nexus and a nexus-in-fact between the claimed designs and the evidence of commercial success and praise. The Federal Circuit disagreed, ruling that “substantial evidence does not support either finding.”

A nexus will be presumed “if the objective indicia evidence is tied to a specific product that is ‘coextensive’ with the claimed invention.” The Board, however, limited its analysis to ornamental significance, employing circular reasoning that “reflects a misunderstanding of the law.” The Federal Circuit explained the pertinent standard: “In determining coextensiveness, the question is not whether unclaimed features are insignificant to a product’s ornamental design. The question is instead whether unclaimed features are ‘insignificant,’ period.” Applying the correct legal standard, the Federal Circuit ruled that “substantial evidence does not support the Board’s finding of coextensiveness.”

A patentee may still establish a nexus absent the presumption “by showing that the objective indicia are the ‘direct result of the unique characteristics of the claimed invention” rather than “a feature that was known in the prior art.” Here, the patentee did not present evidence that the commercial success and praise derived from the “unique characteristics” of its commercial embodiment. Instead, the patentee “presented evidence that merely ties commercial success and praise to aspects of the label area that were already present in the prior art.”

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