Takeda v. Mylan: 17-Patent Colchicine Dispute Ends in Confidential Settlement
Takeda Pharmaceutical filed suit against Mylan Pharmaceuticals in Delaware, asserting 17 patents covering its Colcrys® colchicine 0.6 mg tablet franchise. The parties also exchanged counterclaims for breach of a pre-existing license agreement. After 1,963 days of litigation, the action was dismissed with prejudice under a confidential settlement — with each side bearing its own legal costs.
A 17-patent colchicine fortress meets a generic challenger — and settles
On December 2, 2019, Takeda Pharmaceutical Co., Ltd. filed suit in the District of Delaware against Mylan Pharmaceuticals Inc., asserting infringement of 17 U.S. patents tied to its Colcrys® (colchicine, USP) 0.6 mg oral tablet product. Mylan’s filing of an ANDA seeking approval to market a generic 0.6 mg oral colchicine tablet triggered the action. The patent portfolio at issue spans formulation, composition, and related colchicine-specific IP, reflecting Takeda’s strategy of layering multiple defensive patents around the Colcrys® franchise.
The case concluded on April 17, 2025, when the parties filed a joint stipulation of dismissal with prejudice, disclosing that they had reached a confidential settlement agreement. All of Takeda’s infringement and breach-of-license claims, as well as Mylan’s counterclaims for breach of the license agreement and its invalidity defenses, were dismissed with prejudice. The court retained jurisdiction to enforce the settlement. Each party will bear its own attorneys’ fees and costs — a common feature of negotiated pharmaceutical patent settlements that suggests neither side extracted a clear fee-shifting concession.
At 1,963 days, the litigation ran notably long, consistent with the complexity of defending a 17-patent portfolio through ANDA litigation. The presence of mutual breach-of-license counterclaims — suggesting a pre-existing commercial relationship between the parties — may have created settlement leverage on both sides beyond the patent merits alone. The confidential nature of the agreement leaves undisclosed any market entry date Mylan may have secured, royalty terms, or any authorised-generic arrangement, all of which are commercially material to the colchicine market.
Filing to Dismissed with Prejudice in 1963 days
1,963 days — approximately 5.4 years, above the median for multi-patent Hatch-Waxman disputes in D. Del.
Dismissed with prejudice: what the confidential settlement means for both parties
Dismissed with prejudice under a confidential settlement
A dismissal with prejudice is a final adjudication on the merits — Mylan cannot be sued again on the same patents for the same ANDA product. The court retains jurisdiction to enforce the confidential settlement agreement, meaning either party may return to court if the other breaches the agreed terms. This is standard practice in Hatch-Waxman settlements involving future market-entry commitments.
Rule 41(a) — with prejudiceTakeda secures settlement; licence dispute resolved on confidential terms
Takeda’s infringement claims and its breach-of-licence counterclaims are extinguished, suggesting the commercial relationship with Mylan has been restructured rather than litigated to a merits finding. The confidential settlement likely governs if and when Mylan may enter the colchicine market, but those terms are not public. Takeda’s 17-patent portfolio was never adjudicated on validity or infringement, leaving it formally intact.
Portfolio unadjudicatedMylan avoids validity ruling; market entry timeline remains undisclosed
Mylan’s ANDA challenge did not produce a public invalidity or non-infringement ruling, which would have benefited other generic filers under Hatch-Waxman’s first-filer exclusivity rules. The dismissal with prejudice bars Mylan from re-litigating these specific patent claims. Any authorised-generic rights, royalty obligations, or consent market-entry date secured in settlement remain confidential.
No public invalidity finding17 colchicine patents survive unchallenged; subsequent ANDA filers face full portfolio
Because no patent was held invalid or not infringed, subsequent generic applicants for colchicine 0.6 mg tablets must independently challenge all 17 asserted patents. The mutual breach-of-licence claims suggest the parties had a prior licensing relationship — a dynamic that may influence how other would-be generic entrants approach Takeda’s colchicine IP. The own-costs ruling provides no fee-shifting signal for future litigants.
Strong IP deterrent remainsFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Takeda Pharmaceutical Co., Ltd. | Company | Global pharmaceutical company — holder of US7915269B2 and 16 further Colcrys® patentsSearch in Eureka ↗ |
| Defendant | MylanPharmaceuticals Inc. | Company | Generic pharmaceutical manufacturer seeking ANDA approval for 0.6 mg oral colchicine tabletsSearch in Eureka ↗ |
| Plaintiff counsel | Alan Richard Silverstein | Attorney | Counsel for Takeda Pharmaceutical Co., Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Camile Y. Turner | Attorney | Counsel for Takeda Pharmaceutical Co., Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Edgar H. Haug | Attorney | Counsel for Takeda Pharmaceutical Co., Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Francis DiGiovanni | Attorney | Counsel for Takeda Pharmaceutical Co., Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Jonathan Herstoff | Attorney | Counsel for Takeda Pharmaceutical Co., Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Nicholas F. Giove | Attorney | Counsel for Takeda Pharmaceutical Co., Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Porter F. Fleming | Attorney | Counsel for Takeda Pharmaceutical Co., Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Thatcher A. Rahmeier | Attorney | Counsel for Takeda Pharmaceutical Co., Ltd.Search in Eureka ↗ |
| Plaintiff law firm | Connolly Gallagher LLP | Law Firm | Representing Takeda Pharmaceutical Co., Ltd.Search in Eureka ↗ |
| Plaintiff law firm | Faegre Drinker Biddle & Reath LLP | Law Firm | Representing Takeda Pharmaceutical Co., Ltd.Search in Eureka ↗ |
| Defendant counsel | Cortlan S. Hitch | Attorney | Counsel for MylanPharmaceuticals Inc.Search in Eureka ↗ |
| Defendant counsel | David S. Steuer | Attorney | Counsel for MylanPharmaceuticals Inc.Search in Eureka ↗ |
| Defendant counsel | Elham F. Steiner | Attorney | Counsel for MylanPharmaceuticals Inc.Search in Eureka ↗ |
| Defendant counsel | Jessica L. Margolis | Attorney | Counsel for MylanPharmaceuticals Inc.Search in Eureka ↗ |
| Defendant counsel | Kenneth Laurence Dorsney | Attorney | Counsel for MylanPharmaceuticals Inc.Search in Eureka ↗ |
| Defendant counsel | Nicole W. Stafford | Attorney | Counsel for MylanPharmaceuticals Inc.Search in Eureka ↗ |
| Defendant counsel | Sheryl S. Bassin | Attorney | Counsel for MylanPharmaceuticals Inc.Search in Eureka ↗ |
| Defendant counsel | Shyamkrishna Palaiyanur | Attorney | Counsel for MylanPharmaceuticals Inc.Search in Eureka ↗ |
| Defendant law firm | Morris James LLP | Law Firm | Representing MylanPharmaceuticals Inc.Search in Eureka ↗ |
| Presiding judge | Judge Richard G. Andrews | Judge | Delaware District CourtSearch in Eureka ↗ |
Official order — verbatim text
The stipulated order confirms a fully negotiated exit: all claims and counterclaims dismissed with prejudice, the settlement terms kept confidential, and each party absorbing its own costs. The ‘with prejudice’ designation is significant — it forecloses any future action by Takeda on these same patents against Mylan’s same ANDA product, and extinguishes Mylan’s breach-of-licence counterclaims. The court’s retention of enforcement jurisdiction is a structural feature suggesting the settlement contains ongoing obligations — most likely a future market-entry date or royalty arrangement — whose breach could be adjudicated without fresh pleadings.
US7915269B2 and 16 further patents — Colcrys® colchicine 0.6 mg tablet portfolio
The 17 asserted patents collectively form a dense IP thicket around Colcrys® (colchicine, USP) 0.6 mg oral tablets — a product with a complex regulatory history given that colchicine itself is an ancient alkaloid only recently brought under formal FDA approval. The portfolio spans composition-of-matter, formulation, and related pharmaceutical method claims, with application dates ranging across multiple filing windows, suggesting a deliberate continuation and divisional strategy to maximise patent term and coverage breadth around the approved drug product.
For competitors in the generic pharmaceutical sector, Takeda’s layered portfolio strategy is a textbook example of lifecycle management applied to a formerly unpatented active ingredient. Because the FDA’s 2009 enforcement initiative effectively reset the colchicine approval landscape, Takeda was able to obtain patent protection that a generic entrant must now challenge claim-by-claim. With no validity or claim construction rulings emerging from this litigation, the strategic value of each of the 17 patents remains formally undiminished — a significant commercial barrier for any subsequent ANDA applicant.
Should you run an FTO against Takeda’s colchicine patent portfolio?
Any company developing, formulating, or seeking ANDA approval for oral colchicine tablets at any dose should treat Takeda’s 17-patent Colcrys® portfolio as a live enforcement risk. This litigation confirms Takeda’s willingness to assert the full portfolio aggressively and to pursue breach-of-licence claims in parallel. R&D teams working on colchicine compositions, formulations, or dosing regimens — including combination products or new indications — should commission an FTO analysis before committing to development spend.
PatSnap Eureka’s FTO Search Agent can map each of the 17 asserted patents against your proposed product design, identify relevant prior art that was not litigated in this case, and flag continuation applications that may extend coverage beyond currently issued claims. Because no claim construction positions entered the public record here, Eureka’s claim analysis tools are particularly valuable for modelling the scope risk of each patent independently — helping your team prioritise design-around investment and invalidity argument development.
Run a freedom-to-operate analysis on US7915269B2 to assess your product’s exposure
Run FTO in Eureka →Similar colchicine and ANDA patent cases in Delaware District Court
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What this case signals for the pharmaceutical patent IP landscape
A 17-patent settlement with licence counterclaims illustrates the multi-layered defensive strategies shaping generic drug market access.
Multi-patent ANDA stacking creates settlement leverage even without trial
Takeda’s 17-patent assertion meant Mylan faced cumulative litigation costs and uncertainty across a wide validity landscape. This volume strategy — common in Hatch-Waxman — frequently pressures generic challengers toward settlement before any merits ruling, preserving the innovator’s commercial position without risking a single adverse validity finding.
Mutual licence counterclaims signal a pre-existing commercial relationship worth monitoring
Mylan’s counterclaims for breach of a licence agreement indicate a prior contractual relationship with Takeda. When both parties hold litigation leverage through contract claims, resolution typically involves renegotiated licence terms rather than a clean patent victory — making the confidential settlement terms commercially significant to anyone tracking colchicine market dynamics.
Takeda v MylanPharmaceuticals — key questions answered
Takeda asserted 17 U.S. patents in this action, including US7915269B2, US7601758B1, US8093297B2, US7964648B2, US8415396B1, US7906519B2, US8093296B2, US7820681B1, US8415395B1, US8093298B2, US7935731B2, US8097655B2, US7964647B2, US7619004B1, US8440722B2, US7981938B2, and US8440721B2. All patents relate to the Colcrys® (colchicine, USP) 0.6 mg oral tablet product and were asserted in response to Mylan’s ANDA filing.
The case was dismissed with prejudice on April 17, 2025, pursuant to a confidential settlement agreement between the parties. All of Takeda’s patent infringement and breach-of-licence claims, and all of Mylan’s counterclaims for breach of the licence agreement, were dismissed. The Delaware District Court retained jurisdiction to enforce the settlement agreement. Each party agreed to bear its own attorneys’ fees and costs.
Because the settlement is confidential and no patents were adjudicated for validity or infringement, subsequent ANDA filers for colchicine 0.6 mg tablets receive no public invalidity findings or claim construction positions from this case. They must independently challenge all 17 Takeda patents from scratch, without the benefit of any publicly litigated prior art record or non-infringement arguments tested before the court.
Mylan’s breach-of-licence counterclaims suggest the parties had a pre-existing licence or supply agreement relating to colchicine products before the litigation commenced. The specific terms and alleged breach are not detailed in the public record. The mutual existence of contract claims on both sides likely created bilateral negotiating leverage that contributed to the eventual confidential settlement, potentially involving renegotiated commercial terms beyond the patent infringement dispute alone.
The case ran for 1,963 days — approximately 5.4 years — from filing on December 2, 2019 to closure on April 17, 2025. This duration is consistent with complex multi-patent Hatch-Waxman litigation in the District of Delaware, where cases involving large patent portfolios, ANDA challenges, and parallel contract claims typically proceed through extensive fact and expert discovery before resolution.
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