In Teva Pharmaceuticals International GmbH v. Eli Lilly and Company, [2020-1747, 2020-1748, 2020-1750] (August 16, 2021), the Federal Circuit affirmed the Board’s determination that the claims of U.S. Patent Nos. 9,340,614, 9,266,951, and 9,890,210 are unpatentable because they would have been obvious over the cited prior art.

The patents are directed to humanized antagonist antibodies that target calcitonin gene-related peptide (“CGRP”), that has been shown to be a potent vasodilator in the periphery.

Teva raised three challenges to the Board’s decision. First, Teva contended that the Board erred as a matter of law in its motivation to combine analysis by deviating from the motivation asserted by Lilly in its petitions for Inter Partes Review.

Second, Teva contended that even under the motivation to combine that the Board did analyze, substantial evidence does not support the Board’s factual findings.

And third, Teva contended that the Board erred in its analysis of secondary considerations of non-obviousness.

Lilly asserted that a skilled artisan would have been motivated to combine the teachings of the references to make a humanized anti-CGRP monoclonal antibody for therapeutic use in humans, but the Board instead considered whether a skilled artisan would have been motivated to make the antibody merely to study or use it. Teva insists that by not requiring Lilly to support its therapeutic motivation, the Board incorrectly discounted important safety and efficacy concerns that would have been demotivating factors — i.e., reasons why a skilled artisan would have been motivated not to make a humanized anti-CGRP monoclonal antibody. The Federal Circuit held that the Board did apply the motivation that Lilly asserted. The Federal Circuit said that “common sense and scientific reality dictate that scientists do not “study or use” humanized anti-bodies with an end goal of treating diseases in test tubes or in rats. At bottom, the prior art supports a motivation to humanize antibodies with the goal of treating human disease.”

Teva also argued that the substantial evidence did not support the Board’s factual findings. The Federal Circuit agreed with Lilly that substantial evidence supports a motivation to make a humanized anti-CGRP antibody to study its therapeutic potential for use in treatment of human disease, noting that Lilly identified evidence that supports the Board’s reasonable readings of each reference. Under the deferential standard of review, the Federal Circuit could not replace the Board’s reasonable interpretation of references with Teva’s interpretation.

Finally, with respect to secondary considerations, the Board found that the commercial products and the license lacked sufficient nexus to the challenged claims. Teva argued that the Board made two legal errors:

1. In finding no presumption of nexus between the claims and the secondary considerations based on the commercial products
2. With regard to the asserted licenses, Teva argued that the Board erred by focusing on the licensee’s products rather than the scope of the license

The Federal Circuit found that the Board erred in its articulation of the standard for presuming nexus, but nonetheless conducting the necessary factual analysis of the unclaimed features of the commercial products, and reached the correct conclusion that no presumption of nexus applied.

The Federal Circuit noted that the claims at issue used functional language, and that a claim to “anything that works” hardly has a nexus to any particular product. Because the claims in this case have a broad scope due to their lack of structural limitations, the unclaimed features in the commercial products cited here are of particular importance to the coextensiveness analysis. The Federal Circuit thus found that the Board’s factual findings regarding unclaimed features are thus supported by substantial evidence, and Teva has not shown otherwise.

Teva also argued that the Board erred by requiring a direct nexus between the challenged claims and the licensee’s products. The Federal Circuit found that the Board’s conclusion that the license lacked nexus to the challenged claims was supported by substantial evidence.

The significance of licensing a patent as a secondary consideration in enhancing the nonobviousness of an invention is that an independent party with an interest in being free of the patent has chosen to respect it and pay a royalty under it rather than litigate and invalidate it. Such action tends to support its validity. The Federal Circuit said that 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. The Federal Circuit noted that Teva failed to show anything more than the existence of the license. Teva did not present direct evidence that the licensee’s motivation for entering into the license was related to the validity or enforceability of the patents at issue.