The U.S. Court of Appeals for the Federal Circuit on April 16, 2026 reinstated a $177 million jury verdict in favor of Teva Pharmaceuticals International GmbH against Eli Lilly and Company (Case No. 2024-1094), reversing the district court’s grant of judgment as a matter of law (JMOL) that had overturned the jury’s findings of willful infringement and damages. Judge Prost, writing for a unanimous panel, held that the Section 112 written description and enablement requirements under 35 U.S.C. § 112 apply differently to method-of-use claims directed to a known genus of compounds than to claims that cover the compounds themselves.
The dispute centers on competing drugs in the preventive migraine treatment market. Both Teva’s Ajovy and Lilly’s Emgality are monoclonal antibodies targeting CGRP (calcitonin gene-related peptide), a protein implicated in migraine pathophysiology. Teva holds U.S. Patent No. 8,586,045, No. 9,884,907, and No. 9,884,908, all directed to methods of treating headache using humanized anti-CGRP antagonist antibodies. After a Massachusetts district court judge vacated a $177 million jury verdict through JMOL, Teva appealed to the Federal Circuit.
Lilly argued that the asserted patents failed the written description and enablement requirements of Section 112, relying on the Supreme Court’s 2023 decision in Amgen Inc. v. Sanofi. That decision held that for composition-of-matter claims defined by function, a patent must enable a person of ordinary skill in the art to make and use the full scope of the claimed compounds without undue experimentation. Lilly argued that Teva’s patents, which cover a broad genus of anti-CGRP antibodies, should be evaluated under the same demanding standard.
The Federal Circuit disagreed. Writing for the panel, Judge Prost drew a clear line between composition claims and method-of-use claims. Teva’s patents do not claim the anti-CGRP antibodies themselves; they claim a method of using a known genus of such antibodies to treat headache. For this type of claim, the court held, the inquiry under Section 112 is evaluated differently. A patent claiming a method of using compounds from a known genus is not required to provide enabling disclosure for every compound in that genus. Applying this framework, the panel found all three patents valid and enforceable, reversed the JMOL, and reinstated the $177 million damages award.
The decision carries significant implications for the pharmaceutical and biopharmaceutical industries. Following Amgen, there had been growing concern that antibody patents defined by functional properties were vulnerable to invalidity challenges under Section 112. This ruling establishes that method-of-use patents directed to known compound genera occupy a meaningfully different legal position — a distinction that patent drafters should factor explicitly into claim strategy. For companies developing antibody therapeutics targeting peptide or protein pathways, method-of-use claims may offer a more resilient path to patent protection than broad composition claims.
The panel also upheld the jury’s finding of willful infringement, declining to disturb the jury’s determination that Lilly proceeded with Emgality despite awareness of Teva’s patent rights. This is significant because willful infringement can support an award of up to treble damages under 35 U.S.C. § 284, meaning the ultimate damages figure could increase substantially if Teva pursues enhanced damages on remand. Lilly stated it “disagrees with the decision and is evaluating all available options,” while noting the ruling does not affect its ability to supply Emgality to patients. Whether Lilly seeks certiorari from the Supreme Court — and how the high court would treat the Amgen-method distinction — will be closely watched across the industry.
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