Litigation Details for Bristol-Myers Squibb Company v. Indoco Remedies Ltd. (D. Del. 2017)

Bristol-Myers Squibb Company v. Indoco Remedies Ltd. (D. Del. 2017)

Docket		Date Filed	2017-04-10
Court	District Court, D. Delaware	Date Terminated	2018-12-11
Cause	35:271 Patent Infringement	Assigned To	Leonard Philip Stark
Jury Demand	None	Referred To
Parties	BRISTOL-MYERS SQUIBB COMPANY
Patents	6,967,208; 9,326,945
Attorneys	Sri K. Sankaran
Firms	Klehr Harrison Harvey Branzburg & Ellers
Link to Docket	External link to docket

Details for Bristol-Myers Squibb Company v. Indoco Remedies Ltd. (D. Del. 2017)

Date Filed	Document No.	Description	Snippet	Link To Document
2017-04-10				External link to document

Litigation summary and analysis for: Bristol-Myers Squibb Company v. Indoco Remedies Ltd. (D. Del. 2017)

Last updated: June 17, 2026

Bristol-Myers Squibb v. Indoco Remedies (1:17-cv-00404): Litigation Summary, Claims at Issue, and Patent Expiration Risk

Bristol-Myers Squibb Company (BMS) sued Indoco Remedies Ltd. in 2017 in U.S. District Court under the Hatch-Waxman Act framework to block a generic entry tied to BMS’s branded product(s). The case is docketed as 1:17-cv-00404. The litigation’s enforceability and entry-blocking posture depends on which BMS patents Indoco challenged (typically Orange Book-listed patents tied to drug product, formulation, method-of-use, and/or manufacturing). Without the case docket’s final order set and the specific patent numbers asserted and challenged, a complete, decision-grade infringement and validity analysis cannot be produced.

What happened in Bristol-Myers Squibb Company v. Indoco Remedies Ltd. 1:17-cv-00404?

Summary answer: The matter is a branded-versus-generic patent infringement dispute filed in 2017 and handled through the Paragraph IV litigation track typical of U.S. generic approvals.

What court and timing define 1:17-cv-00404?

• Case name: Bristol-Myers Squibb Company v. Indoco Remedies Ltd.
• Docket number: 1:17-cv-00404
• Year filed: 2017

What issues does a Hatch-Waxman Paragraph IV case like this usually litigate?

• Infringement of asserted Orange Book patents by the proposed generic product
• Invalidity (for example, anticipation/obviousness, lack of novelty, non-infringement)
• Enforceability (inequitable conduct and related theories) where pleaded
• Remedies tied to a potential 30-month stay expiration or carve-outs via stipulations

Which patents were asserted in 1:17-cv-00404?

Summary answer: The asserted patent list must be taken from the complaint and any amended pleadings, and the Paragraph IV notice must be taken from the Notice of Certification and the Orange Book reference product listing. This information is not included in the prompt, so a specific claim-by-claim or patent-by-patent breakdown cannot be provided.

Which patents did Indoco challenge (Paragraph IV certifications) in 1:17-cv-00404?

Summary answer: Paragraph IV certifications are identified through the FDA approval context, the statutory notice, and the patent numbers listed as “challenged” in the infringement complaint. The patent number set is not provided, so the analysis cannot be completed.

What is the litigation posture and outcome for Bristol-Myers Squibb v. Indoco Remedies 1:17-cv-00404?

Summary answer: A complete outcome requires docket-level facts: trial scheduling orders, claim construction rulings, summary judgment orders, and any final judgment or settlement documentation. These are not in the prompt, so the final posture and resolution cannot be stated.

Key docket artifacts needed for a decision-grade litigation read

• Complaint and amended complaint (asserted patents and theories)
• Indoco’s answer and any counterclaims (invalidity and non-infringement)
• Markman/claim construction orders
• Summary judgment decisions
• Final judgment (infringement and invalidity determinations)
• Settlement orders (consent judgments, stipulated dismissal, agreed launch dates)

How strong is the BMS patent estate in this case, and what drove the litigation?

Summary answer: Litigation strength depends on (1) which patent classes were asserted (drug substance, composition/formulation, method of use, or device/administration), (2) the claim scope and claim construction outcomes, and (3) validity findings. The prompt does not provide those determinants.

How to interpret strength in the Hatch-Waxman context

• If the court construed claims narrowly, infringement risk usually increases for the generic.
• If invalidity was found on a foundational claim, remaining dependent claims may fall via invalidity propagation.
• If the case ended in settlement, the legally relevant signal is the scope of the allowed “design-around” and any agreed stipulations that affect launch.

What generic entry risks exist for Indoco (and other filers) tied to this case?

Summary answer: Entry risk is linked to the remaining unexpired patents after the litigation and the regulatory timeline tied to the FDA approval. Without the Orange Book patent list and the case outcome, no ranked launch risk can be produced.

What drives “entry risk” after Paragraph IV litigation

• Patent expiration dates for asserted and unasserted Orange Book patents
• Whether a court decision invalidated a core patent
• Whether settlement included launch timing restrictions
• Whether FDA approval was blocked by remaining patents with unexpired status

What is the Orange Book status of BMS’s patents implicated by 1:17-cv-00404?

Summary answer: Orange Book status requires the exact BMS reference product and the specific patent numbers asserted. Those identifiers are not provided in the prompt.

How Orange Book timing maps to litigation strategy

• Drug substance patents often expire later than formulation or method-of-use patents depending on priority dates.
• 30-month stay dynamics can shift generic launch schedules even without a final merits ruling.

Which companies could be impacted by the 1:17-cv-00404 litigation outcome?

Summary answer: Competitors impacted are other generic and authorized generic applicants referencing the same BMS NDA. This requires the NDA number, reference product, and the patent list tied to the Paragraph IV notice. None are in the prompt.

How does Indoco’s likely “design-around” path compare with other generic challengers?

Summary answer: A design-around assessment requires knowledge of the claim elements at issue and the proposed generic’s formulation and dosing regimen. Without those, the comparison cannot be executed.

What manufacturing or formulation barriers typically remain after Hatch-Waxman litigation like this?

Summary answer: Post-litigation barriers often include:

• Residual formulation and method-of-use patents
• Requirements to avoid claimed active ingredient ratios, excipient compositions, or dissolution/particle-size parameters
• Process patents if asserted (less common than composition and formulation, but possible) The specific barriers for this case cannot be identified without the patent claims.

Could there be FDA regulatory consequences (including labeling and exclusivity) stemming from 1:17-cv-00404?

Summary answer: FDA consequences flow from the court’s outcome and any settlement/consent judgment tied to the statutory framework. Without the litigation outcome and the NDA context, FDA labeling and approval status cannot be analyzed.

What should investors and litigators track next for 1:17-cv-00404?

Summary answer: The next actionable items are docket-level and Orange Book-level:

• Whether any claims survive on appeal (if applicable)
• Whether a final judgment triggered immediate launch authorization or continued injunction
• Which patents remain enforced post-disposition
• Whether other defendants filed parallel Paragraph IV cases with different challenged patent sets

---

Key Takeaways

• 1:17-cv-00404 is a BMS v. Indoco Hatch-Waxman patent infringement case filed in 2017, but the prompt does not include the asserted patent numbers, the challenged Orange Book patents, or the final docket outcome.
• A complete litigation summary and patent-expiration-driven risk analysis requires docket and Orange Book specifics that are not present in the provided information.
• A decision-grade view must map: (1) asserted patents and claim scope → (2) court rulings → (3) settlement/final outcome → (4) remaining patent expiries and FDA approval consequences. None of the needed identifiers are included here.

---

FAQs

1. What does a Paragraph IV case like 1:17-cv-00404 typically require the brand to prove?
2. How do claim construction rulings usually shift infringement risk in Hatch-Waxman litigations?
3. What launch date constraints usually appear in settlements of BMS v. generic company patent cases?
4. How do method-of-use patents affect label design after a generic wins or settles?
5. What unasserted Orange Book patents can still delay generic entry after resolution of a single patent suit?

---

References

1. United States District Court docket for Bristol-Myers Squibb Company v. Indoco Remedies Ltd., 1:17-cv-00404.