Takeda v. Granules Pharmaceuticals: Colchicine IP Dispute Voluntarily Dismissed
Takeda Pharmaceutical filed suit in Delaware against Granules Pharmaceuticals over five patents protecting Colcrys (colchicine, USP) 0.6 mg tablets — a branded gout therapy. The action ran for nearly five years before Takeda voluntarily dismissed under Rule 41(a)(1)(A)(i), before the defendant had answered the complaint or filed for summary judgment.
Five Colchicine Patents, Nearly Five Years, No Merits Ruling
On 16 June 2020, Takeda Pharmaceutical Co., Ltd. initiated an infringement action in the District of Delaware (Case No. 1:20-cv-00812) against Granules Pharmaceuticals, Inc., asserting five U.S. patents — US8093298B2, US8093297B2, US7935731B2, US7964648B2, and US7906519B2 — all directed at Colcrys (colchicine, USP) 0.6 mg oral tablets. The suit was triggered by Granules’ development of a generic 0.6 mg oral colchicine tablet, consistent with a Hatch-Waxman ANDA challenge framework.
The case closed on 16 April 2025 when Takeda filed a notice of voluntary dismissal pursuant to Rule 41(a)(1)(A)(i) of the Federal Rules of Civil Procedure. The dismissal was filed at a stage when Granules had neither answered the complaint nor filed a motion for summary judgment. The public record does not specify whether the dismissal was with or without prejudice, and the Rule 41(a)(1) mechanism — available only before the opposing party answers — leaves that question open without an explicit court order.
The near-five-year duration before a pre-answer dismissal is commercially notable: cases that resolve this late without a merits ruling typically suggest either a negotiated resolution, a change in the commercial landscape, or a strategic recalibration by the patent holder. What drove Takeda’s decision to dismiss at this stage — licensing agreement, generic market entry, patent expiry proximity, or otherwise — is not disclosed in the public record.
Filing to Voluntary dismissal in 1765 days
1,765 days — nearly five years from filing to closure, well above typical ANDA Hatch-Waxman district court timelines
Voluntarily dismissed: what the Rule 41 exit means for both parties
Rule 41(a)(1)(A)(i): dismissal as of right, no court order required
Under Federal Rule of Civil Procedure 41(a)(1)(A)(i), a plaintiff may dismiss an action without a court order at any time before the opposing party serves an answer or a motion for summary judgment. Takeda invoked this right after nearly five years of litigation. The mechanism is self-executing — it requires no judicial approval and generates no ruling on the merits of the infringement claims.
Pre-answer voluntary exitWith or without prejudice? The public record is silent
A Rule 41(a)(1) dismissal is presumed without prejudice unless the notice expressly states otherwise or a prior dismissal of the same claim has been filed (the ‘two-dismissal rule’). However, the publicly available record for this case does not specify either way. This distinction matters: a without-prejudice dismissal leaves open the possibility of refiling, while a with-prejudice dismissal would permanently bar the same claims against Granules.
Prejudice status unconfirmedTakeda exits without a validity or infringement determination
Takeda’s voluntary dismissal means none of its five asserted colchicine patents received a judicial ruling on validity or infringement. The patents remain in force until their expiry dates. Takeda retains the ability to enforce them against other generic challengers, and the dismissal creates no adverse precedent on claim scope or validity that could be weaponised in parallel proceedings.
Patents intact, no adverse rulingGranules avoids adjudication but gains no declaratory clarity
Granules Pharmaceuticals escapes the litigation without a finding against it, but also without a court declaration of non-infringement or invalidity for its generic colchicine product. Any future attempt by Granules to commercialise its 0.6 mg colchicine tablet may still face the same patent portfolio — unless the dismissal was with prejudice or a separate commercial agreement governs the relationship between the parties.
No FTO certainty establishedFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Takeda Pharmaceutical Co., Ltd. | Company | Global pharmaceutical company — holder of five Colcrys colchicine formulation patentsSearch in Eureka ↗ |
| Defendant | Granules Pharmaceuticals, Inc. | Company | Generic pharmaceutical manufacturer developing 0.6 mg oral colchicine tablets referencing ColcrysSearch in Eureka ↗ |
| Plaintiff counsel | Camille 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 | 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 | Faegre Drinker Biddle & Reath LLP | Law Firm | Representing Takeda Pharmaceutical Co., Ltd.Search in Eureka ↗ |
| Defendant counsel | Constance S. Huttner | Attorney | Counsel for Granules Pharmaceuticals, Inc.Search in Eureka ↗ |
| Defendant counsel | Eve H. Ormerod | Attorney | Counsel for Granules Pharmaceuticals, Inc.Search in Eureka ↗ |
| Defendant counsel | James P. Barabas | Attorney | Counsel for Granules Pharmaceuticals, Inc.Search in Eureka ↗ |
| Defendant counsel | Neal C. Belgam | Attorney | Counsel for Granules Pharmaceuticals, Inc.Search in Eureka ↗ |
| Defendant law firm | Smith, Katzenstein, & Jenkins LLP | Law Firm | Representing Granules Pharmaceuticals, Inc.Search in Eureka ↗ |
| Presiding judge | Judge Richard G. Andrews | Judge | Delaware District CourtSearch in Eureka ↗ |
Official order — verbatim text
The dismissal notice invokes Rule 41(a)(1)(A)(i) and expressly notes that Granules had neither answered nor moved for summary judgment — confirming the procedural basis for a unilateral exit. The phrasing generates no ruling on infringement or validity. Because the notice does not specify prejudice, the legal default under Rule 41(a)(1)(B) — that a first dismissal is without prejudice — may apply, though practitioners should verify whether any prior dismissal of the same claims exists before drawing that conclusion.
US8093298B2 and four further patents — Colcrys colchicine 0.6 mg formulations
The five patents asserted in this action — US8093298B2, US8093297B2, US7935731B2, US7964648B2, and US7906519B2 — relate to Takeda’s Colcrys brand, covering formulations and methods associated with oral colchicine 0.6 mg tablets used to treat acute gout flares and familial Mediterranean fever. The application filings span 2010–2011, placing them in a period when colchicine’s regulatory status in the U.S. was undergoing significant change following the FDA’s unapproved drugs initiative. These patents represent Takeda’s primary IP defence against generic entry into the Colcrys market.
Colchicine is an ancient alkaloid therapy, but Colcrys was the first FDA-approved colchicine product under modern standards, giving Takeda a regulatory and IP moat. The five-patent portfolio creates a layered enforcement strategy that any ANDA filer must navigate. With no invalidity finding emerging from this litigation, the patents retain presumptive validity — making them a continued commercial barrier for Granules and any other generic developer with a pending or planned colchicine ANDA.
Should you run an FTO against US8093298B2 and the Colcrys patent family?
Any pharmaceutical company or CDMO developing, manufacturing, or planning to commercialise a generic or branded oral colchicine 0.6 mg tablet in the U.S. market should conduct current freedom-to-operate analysis against all five patents in this family before advancing regulatory submissions. This case’s voluntary dismissal without a validity ruling means none of the patents have been judicially narrowed or invalidated — their claim scope remains as originally granted.
PatSnap Eureka’s FTO Search Agent allows IP and R&D teams to map each of the five Colcrys patents claim-by-claim against a target product or process, identify prior art that could support IPR petitions, and monitor prosecution history for disclaimer arguments. Tracking the adjusted expiry dates of each patent in the family is essential for launch-timing decisions — Eureka’s patent expiry dashboard surfaces this data in one view.
Run a freedom-to-operate analysis on US8093298B2 to assess your product’s exposure
Run FTO in Eureka →Similar Colchicine & Hatch-Waxman Patent Cases in Delaware
Explore related Hatch-Waxman pharmaceutical patent infringement cases involving colchicine formulations and branded small-molecule drugs litigated in the District of Delaware.
What this case signals for the pharmaceutical patent IP landscape
A five-year Hatch-Waxman action ending without a merits ruling raises pointed questions for generic entrants and branded pharma alike.
Pre-answer voluntary dismissals in ANDA cases often signal off-docket resolution
When a plaintiff dismisses under Rule 41(a)(1) after years of litigation, it typically suggests a negotiated outcome — licensing, settlement, or a supply agreement — reached outside the court record. IP teams monitoring Takeda’s colchicine enforcement posture should track any Granules product launches or licence disclosures as a proxy for what drove this exit.
Five asserted patents mean residual risk for any colchicine generic programme
Takeda’s portfolio of five formulation patents (US7906519B2 through US8093298B2) remains valid and enforceable absent expiry or IPR invalidation. Generic developers targeting the 0.6 mg colchicine market — including those not named in this action — should conduct current FTO analysis against each patent individually before advancing ANDA filings.
Takeda v Granules — key questions answered
The public record does not disclose Takeda’s reasons. A Rule 41(a)(1)(A)(i) dismissal filed after years of litigation typically suggests a negotiated resolution — such as a licence, settlement, or commercial agreement — or a change in the strategic value of continued enforcement. No court order or merits ruling was issued.
The dismissal notice does not specify. Under Rule 41(a)(1)(B), a first voluntary dismissal is presumed without prejudice unless the notice states otherwise. However, practitioners should verify the full docket to confirm no prior dismissal of the same claims exists, which could trigger the two-dismissal rule and render the dismissal with prejudice.
Takeda asserted five U.S. patents: US8093298B2, US8093297B2, US7935731B2, US7964648B2, and US7906519B2. All relate to formulations and methods associated with Colcrys (colchicine, USP) 0.6 mg oral tablets. None of these patents received a validity or infringement ruling in this action.
No. A voluntary dismissal without a merits ruling does not affect the validity or enforceability of the asserted patents. All five patents remain in force until their respective expiry dates or until successfully challenged via IPR, reexamination, or subsequent litigation. Other generic developers cannot rely on this dismissal as precedent.
Rule 41(a)(1)(A)(i) permits a plaintiff to dismiss an action as of right — without court approval — provided the opposing party has not yet served an answer or a motion for summary judgment. Takeda’s notice confirms both conditions were met. This procedural vehicle is the fastest and cleanest exit mechanism available to a plaintiff, generating no judicial ruling and no costs order unless otherwise agreed.
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