Eli Lilly v. Teva: Anti-CGRP Migraine Antibody Appeal Voluntarily Dismissed
Eli Lilly and Teva Pharmaceuticals jointly moved to dismiss Federal Circuit Appeal No. 24-1149, covering nine patents protecting anti-CGRP antagonist antibody methods for migraine treatment. The appeal ran 664 days before the parties stipulated to dismissal, with each side bearing its own costs — leaving the underlying merits unresolved on the appellate record.
Nine CGRP Migraine Patents, One Stipulated Dismissal — Merits Left Open
Eli Lilly & Company, represented by Finnegan Henderson, filed Federal Circuit Appeal No. 24-1149 on 14 November 2023 against Teva Pharmaceutical Industries Ltd. and Teva Pharmaceuticals USA, Inc. The dispute centred on nine U.S. patents — including US9890210B2, US9340614B2, and US8597649B2 — covering methods of treating migraine headache using anti-CGRP antagonist antibodies, a biologics class central to Lilly’s Emgality franchise and Teva’s Ajovy programme.
On 8 September 2025, after 664 days of appellate proceedings, the parties filed a joint stipulation to dismiss the appeal under Federal Rule of Appellate Procedure 42(b). The Federal Circuit ordered the dismissal, with each side bearing its own costs. The order modifies the official case caption, reflecting the inclusion of Teva Pharmaceuticals International GmbH. The basis of termination is recorded as voluntary dismissal; the public record does not specify whether the underlying district court action was dismissed with or without prejudice.
A 664-day appellate lifespan before voluntary dismissal is consistent with the parties having reached a commercial resolution — potentially a licensing arrangement or market-access agreement — though the record is silent on any such terms. The mutual cost-bearing provision suggests a negotiated exit rather than capitulation by either side. What remains unknown is whether the nine asserted patents survive intact for enforcement against other CGRP-pathway competitors, or whether any claim amendments or covenants-not-to-sue form part of an undisclosed settlement.
Filing to Voluntary dismissal in 664 days
664 days — above average for a Federal Circuit appeal voluntarily dismissed before decision
Voluntarily dismissed: what the Federal Circuit order means for both parties
Fed. R. App. P. 42(b) — joint stipulation to dismiss
Rule 42(b) allows parties to a Federal Circuit appeal to jointly stipulate to dismissal without a merits ruling. The court issues an order giving effect to the agreement and allocating costs as the parties specify. Here, each side bears its own costs. No appellate judgment was entered, meaning no precedent was created and the lower court record stands as the last substantive ruling on the merits.
No merits adjudicationPublic record is silent on prejudice designation
A voluntary dismissal under Rule 42(b) can be structured with or without prejudice to refiling or to the underlying claims. The Federal Circuit order in this case does not specify either designation. Without prejudice would preserve Lilly’s ability to re-assert the nine patents in future proceedings; with prejudice would extinguish the appeal permanently. IP professionals should treat the prejudice status as unconfirmed until further public filings clarify the position.
Prejudice status unconfirmedAppeal withdrawn — underlying patent portfolio remains live
Lilly exits the Federal Circuit without an adverse precedential ruling against its CGRP antibody patents. The nine patents — covering both method-of-treatment and antibody composition claims — retain whatever enforceability they held after the district court proceedings. Lilly retains optionality to assert these patents against other market entrants in the CGRP migraine biologics space, subject to any covenants agreed privately with Teva.
Patent portfolio intactTeva clears appellate risk — commercial certainty for Ajovy
Teva avoids a Federal Circuit ruling that could have validated or strengthened Lilly’s CGRP patent claims. The mutual cost-bearing and joint stipulation structure suggests Teva secured commercial certainty — likely continued market access for Ajovy (fremanezumab) — without requiring a full appellate win on the merits. Any undisclosed licensing terms would be key to understanding the true scope of Teva’s freedom to operate going forward.
Ajovy market position stabilisedFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Eli Lilly & Company | Company | Pharmaceutical innovator and biologics developer — holder of US9890210B2 and 8 further anti-CGRP patentsSearch in Eureka ↗ |
| Defendant | Teva Pharmaceutical Industries, Ltd. | Company | Global generic and biosimilar pharmaceutical company; developer of the Ajovy (fremanezumab) anti-CGRP migraine biologicSearch in Eureka ↗ |
| Co-Defendant | Teva Pharmaceuticals USA, Inc. | Company | Search in Eureka ↗ |
| Plaintiff counsel | J. Michael Jakes | Attorney | Counsel for Eli Lilly & CompanySearch in Eureka ↗ |
| Plaintiff law firm | Finnegan, Henderson, Farabow, Garrett & Dunner, LLP | Law Firm | Representing Eli Lilly & CompanySearch in Eureka ↗ |
| Defendant counsel | Kevin P. Martin | Attorney | Counsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗ |
| Defendant law firm | Goodwin Procter LLP | Law Firm | Representing Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | Court of Appeals for the Federal CircuitSearch in Eureka ↗ |
Official order — verbatim text
The Federal Circuit order gives effect to a joint stipulation under Fed. R. App. P. 42(b), resulting in dismissal without any merits ruling. The order’s silence on prejudice designation is notable — practitioners cannot assume either with-prejudice finality or without-prejudice preservation from the face of the order alone. The cost-neutrality provision (each side bearing its own costs) is consistent with a negotiated commercial resolution rather than a unilateral withdrawal, suggesting neither party conceded the underlying legal arguments.
US9890210B2 — Anti-CGRP antagonist antibody methods for migraine treatment
The nine patents asserted in this case — anchored by US9890210B2 (application US15/588432) and extending to earlier grants including US8597649B2 and US8586045B2 — protect methods of treating migraine and other headache disorders using antagonist antibodies directed against calcitonin gene-related peptide (CGRP) or its receptor. CGRP is a neuropeptide central to migraine pathophysiology; antibody-mediated blockade represents the mechanistic basis of the approved anti-CGRP biologic class. The patent family spans both method-of-treatment and antibody composition claims, providing layered protection.
This patent portfolio sits at the commercial core of Eli Lilly’s Emgality (galcanezumab) franchise, one of the leading approved anti-CGRP monoclonal antibodies for preventive migraine treatment. The breadth of nine patents covering overlapping claim sets — filed across application years from US13/179846 through US15/588512 — creates a durable enforcement barrier against biosimilar developers and follow-on biologic entrants. Any company advancing an anti-CGRP antibody into clinical development must conduct rigorous freedom-to-operate analysis against this family, particularly given that no appellate ruling has narrowed or invalidated any claim.
Should you run an FTO against US9890210B2 and the Lilly CGRP antibody family?
Any R&D or product team developing an anti-CGRP monoclonal antibody, CGRP receptor antagonist biologic, or related headache treatment platform should treat this nine-patent family as a primary FTO target. The voluntary dismissal means no claim was invalidated or narrowed at the Federal Circuit — each patent retains full enforceability as last established in the district court record. Method-of-treatment claims in this family may capture a broad range of CGRP-pathway therapeutic approaches, not just direct Emgality analogues.
PatSnap Eureka’s FTO Search Agent enables structured claim mapping across all nine patents simultaneously, surfacing prior art, claim scope boundaries, and prosecution history estoppel that may affect enforceability. Eureka’s litigation intelligence layer also tracks Lilly’s broader enforcement history in the CGRP space, helping you identify whether your specific antibody sequence, dosing method, or indication falls within or outside the asserted claim language — before you reach clinical or regulatory milestones.
Run a freedom-to-operate analysis on US9890210B2 to assess your product’s exposure
Run FTO in Eureka →Similar Federal Circuit Anti-CGRP and Migraine Biologics Patent Appeals
Federal Circuit appeals involving anti-CGRP antibody patents and migraine biologics — cases tracking similar method-of-treatment claim disputes and voluntary dismissal outcomes.
What this case signals for the anti-CGRP biologics IP landscape
Nine CGRP antibody patents, a 664-day Federal Circuit appeal, and a mutual walk-away — the IP dynamics here extend well beyond Lilly and Teva.
CGRP patent thickets remain a key barrier to biosimilar and follow-on entry
Lilly’s nine-patent portfolio covering anti-CGRP antibody methods signals the density of IP protection around this migraine biologics class. Competitors and biosimilar developers should map the full claim scope of these patents — particularly US8597649B2 and the method-of-treatment claims — before advancing CGRP-pathway products toward clinical or commercial stages.
Mutual cost-bearing dismissals at the Federal Circuit often mask licensing deals
When both parties in a high-value biologics appeal agree to bear their own costs and jointly dismiss, the most commercially plausible explanation is a negotiated resolution — often a cross-licence, market-access agreement, or royalty arrangement. IP teams monitoring competitive CGRP landscapes should watch for Teva’s subsequent regulatory filings and Lilly’s future enforcement posture as indirect indicators of deal terms.
Eli v Teva — key questions answered
The parties jointly stipulated to dismiss Appeal No. 24-1149 under Fed. R. App. P. 42(b) on 8 September 2025, after 664 days of appellate proceedings. No merits ruling was issued. Each side bears its own costs. The appeal concerned nine Eli Lilly patents covering anti-CGRP antagonist antibody methods for treating migraine headache.
Nine U.S. patents were asserted: US9890210B2, US9340614B2, US9266951B2, US9346881B2, US9884908B2, US8597649B2, US9884907B2, US9890211B2, and US8586045B2. All cover methods of treating migraine and headache using anti-CGRP antagonist antibodies or related antibody compositions, forming the IP backbone of Lilly’s Emgality franchise.
The Federal Circuit order does not specify whether the dismissal was with or without prejudice. The voluntary dismissal under Rule 42(b) is silent on this point in the public record. IP practitioners should treat the prejudice designation as unconfirmed until additional public filings — such as district court orders or Teva’s regulatory submissions — shed further light.
The dismissal leaves all nine Lilly CGRP patents with their pre-appeal enforceability intact. No Federal Circuit ruling narrowed, invalidated, or limited any claim. Lilly retains the ability to assert this portfolio against other CGRP-pathway competitors unless restricted by any undisclosed covenants or licences agreed with Teva as part of the settlement.
Mutual cost-bearing in a joint stipulated dismissal — particularly after 664 days of appellate litigation — typically signals a negotiated commercial resolution rather than a unilateral withdrawal. It suggests both parties gained something of value, consistent with a cross-licence, market-access agreement, or royalty arrangement. The true terms remain undisclosed on the public record.
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