Federal Circuit’s Decision on Nexus between Challenged Claims and the Commercial Products

On August 16, 2021, the US Court of Appeals for the Federal Circuit affirmed a patent trial and appeal board decision which upheld the validity of three Teva Pharmaceutical Industries Ltd patents related to its migraine drug Ajovy- which is also known as the CGRP (calcitonin gene-related peptide). It also affirmed PTAB decisions that invalidated it with six others at Eli Lilly and co’s request. Eli Lilly & Co. v. Teva Pharm. Int’l GmbH, 2020-1876 (Fed. Cir. Aug. 16, 2021)

The challenged patents explain that CGRP has been noted for its possible connection to vasomotor symptoms such as all forms of vascular headache, including migraines. At that time, the pathophysiology of migraine was not well understood, and dilation of blood vessels was associated with and thought to exacerbate the pain symptoms of migraine. Thus, even before the patents were challenged, the possible connection between CGRP as a vasodilator and the pathology of migraine informed the development of treatments for migraine that sought to restrict the activity of CGRP in the body.

 Eli Lilly and Company filed petitions for inter partes review of claims 1–7 and 15–20 of the ’614 patent, claims 1–6 and 14–19 of the ’951 patent, and claims 1–5 of the ’210 patent before Patent Trial and Appeal Board.[1] But as Lilly failed to prove that parts of all of the patents were invalid based on prior art that allegedly disclosed the antibody treatment, the petitions were dismissed. On the other side, Teva sued Eli Lilly in Boston federal court in 2017 and 2018, alleging that the migraine drug infringed the patents. In response, Lilly challenged the patents’ validity at the PTAB, arguing the relevant parts of them were obvious based on a combination of prior art publications including clinical trials, studies, and an earlier patent.

Teva appealed from the Board’s combined final written decision with respect to each of the three challenged patents, and the court consolidated the appeals. Teva challenged the Board’s decision on the merits, including the legal and factual issues underlying the Board’s decision regarding patentability. Additionally, Teva argued that the panel that issued the Board’s final written decision, in this case, consisted of members who were unconstitutionally appointed in violation of the Appointments Clause. 

At first, the Board issued a written decision holding that the challenged claims in all three patents are unpatentable. But after referring to evidence, the Board found “that anti-CGRP antagonist antibodies were well known in the art, and that the art encouraged the development of humanized anti-CGRP antibodies”. The Board also found “no evidence that making a humanized anti-CGRP antagonist antibody would raise any safety concerns sufficient to discourage a person of ordinary skill in the art from making a human or humanized anti-CGRP antagonist antibody.

Later Teva’s proposal was rejected and was instead ordered to elect one of the two options for (i) a request that would be issued for a remand for a limited purpose of allowing Teva the opportunity to request Director rehearing of the final written decision, or (ii) a waiver of its right to seek Director rehearing of the final written decision.

But the PTAB ruled that three of the patents were valid, while six others were obvious. Lourie supported the PTAB’s decisions that were obvious based on the prior art, which concluded that as there is substantial evidence to support PTAB’s finding. i.e-“to combine the teachings of the references, and the potential safety and efficacy concerns would not have dissuaded a skilled artisan from making the claimed antibodies to study their therapeutic potential.”

Thus, there is no presumption of nexus between the challenged claims and the commercial products even though the PTAB articulated an incorrect standard. To do so, it requires the fact finder to consider the unclaimed features of the stated products to determine their level of significance and their impact on the correspondence between the claim and the products, and because the unclaimed features were critical to the functionality of the commercial products.

[1] Eli Lilly & Co. v. Teva Pharms. USA Inc., No. C17-0267JLR (W.D. Wash. Mar. 16, 2017)

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