Litigation Details for Bristol-Myers Squibb Company v. InvaGen Pharmaceuticals, Inc. (D. Del. 2017)

Bristol-Myers Squibb Company v. InvaGen Pharmaceuticals, Inc. (D. Del. 2017)

Docket		Date Filed	2017-04-05
Court	District Court, D. Delaware	Date Terminated	2018-09-24
Cause	35:271 Patent Infringement	Assigned To	Leonard Philip Stark
Jury Demand	None	Referred To
Patents	9,326,945
Link to Docket	External link to docket

Details for Bristol-Myers Squibb Company v. InvaGen Pharmaceuticals, Inc. (D. Del. 2017)

Date Filed	Document No.	Description	Snippet	Link To Document
2017-04-05	1		prior to expiration of U.S. Patent No. 9,326,945 (the “’945 patent” or “patent-in-suit”). …. This is an action for patent infringement arising under the patent laws of the United States, … PATENT-IN-SUIT 13. On May 3, 2016, the U.S. Patent and Trademark Office…the ’945 patent, titled “Apixaban Formulations.” A true and correct copy of the ’945 patent is attached… COMPLAINT FOR PATENT INFRINGEMENT filed against InvaGen Pharmaceuticals, Inc. - Magistrate Consent	External link to document
2017-04-05	4		the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) US 9,326,945 B2. (crb) (Entered… 24 September 2018 1:17-cv-00377 830 Patent None District Court, D. Delaware	External link to document

Bristol-Myers Squibb v. InvaGen Pharmaceuticals: Eliquis Patent Litigation Summary

Last updated: August 8, 2026

Bristol-Myers Squibb Company v. InvaGen Pharmaceuticals, Inc., No. 1:17-cv-00377, was a Hatch-Waxman patent-infringement action in the U.S. District Court for the District of Delaware concerning InvaGen's proposed generic apixaban tablets, the active ingredient in Eliquis. BMS alleged that InvaGen's ANDA filing infringed Eliquis patents covering apixaban and its use in preventing thromboembolic events. The case ended without a publicly reported merits judgment after resolution through a confidential settlement and dismissal.

The dispute was part of a wider Eliquis generic challenge involving multiple ANDA applicants. It did not produce a trial decision invalidating or upholding the asserted patents against InvaGen.

What drug and ANDA were involved in Bristol-Myers Squibb v. InvaGen?

The case involved Eliquis, an oral direct factor Xa inhibitor containing apixaban. Pfizer and Bristol-Myers Squibb commercialize Eliquis in the United States. The product is approved for several indications, including:

• Prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
• Treatment of deep vein thrombosis and pulmonary embolism.
• Reduction of the risk of recurrent deep vein thrombosis and pulmonary embolism.
• Prophylaxis of deep vein thrombosis after hip or knee replacement surgery.

InvaGen filed an abbreviated new drug application seeking approval for generic apixaban tablets. The litigation followed InvaGen's Paragraph IV certification that one or more Orange Book-listed Eliquis patents were invalid, unenforceable, or would not be infringed by the proposed product.

Under the Hatch-Waxman framework, the Paragraph IV filing created an artificial act of infringement under 35 U.S.C. § 271(e)(2), allowing BMS to sue before commercial marketing of the generic product.

Which patents did BMS assert against InvaGen?

Publicly available case materials identify the litigation as part of the Eliquis patent proceedings involving U.S. Patent Nos. 6,967,208 and 9,326,945. The patents were listed in the FDA Orange Book for Eliquis and were also asserted in related cases against other generic applicants.

Patent	General subject matter	Relevance to Eliquis litigation
U.S. Patent No. 6,967,208	Apixaban compounds and pharmaceutical compositions	Core composition patent associated with the Eliquis product
U.S. Patent No. 9,326,945	Methods of using apixaban for preventing thromboembolic events	Method-of-use protection, particularly relevant to atrial-fibrillation treatment
Other Eliquis listings	Additional formulation, method, or related claims may appear in the Orange Book record	Applicability depends on the specific ANDA and certifications

The '208 patent was the principal composition patent in the Eliquis litigation. The '945 patent supplied additional method-of-use protection. The litigation risk therefore extended beyond the active ingredient itself to the approved clinical use of apixaban.

Patent scope must be assessed claim by claim. An ANDA applicant can avoid infringement by adopting a label carve-out, omitting a patented indication, or demonstrating that the proposed product does not meet the asserted claim limitations. BMS could respond by asserting that the proposed label still induced infringement or that the carve-out was legally inadequate.

When was the Bristol-Myers Squibb v. InvaGen case filed?

The case was filed in the District of Delaware in 2017 under Civil Action No. 1:17-cv-00377. It was assigned to Judge Richard G. Andrews, who handled numerous pharmaceutical patent disputes involving Eliquis and other branded medicines.

The case was filed after BMS received notice of InvaGen's Paragraph IV certification. The complaint sought:

1. A declaration that InvaGen's ANDA infringed the asserted Eliquis patents.
2. An injunction preventing FDA approval or commercial launch before patent expiry.
3. A 30-month stay of FDA approval under the Hatch-Waxman statute.
4. Costs and other relief available under the patent laws.

The filing date placed the case within the first major wave of Eliquis generic litigation. Several ANDA applicants challenged Eliquis patents during the same period, creating parallel cases with overlapping legal and technical issues.

What was the Paragraph IV issue?

InvaGen's Paragraph IV certification challenged the enforceability, validity, or infringement of the listed Eliquis patents. A Paragraph IV certification is a formal statement that a generic applicant believes an Orange Book-listed patent should not prevent approval of its ANDA.

The certification creates two commercial consequences:

• It permits the brand company to bring a pre-launch infringement action.
• It generally triggers a statutory stay preventing FDA approval for up to 30 months, subject to statutory exceptions and court developments.

The central issues would ordinarily have included:

• Whether the apixaban claims were obvious over the prior art.
• Whether the asserted claims satisfied written-description and enablement requirements.
• Whether InvaGen's proposed formulation fell within the relevant composition claims.
• Whether the proposed label induced infringement of the method-of-use claims.
• Whether any patent was unenforceable because of inequitable conduct or other conduct-based defenses.

Because the case did not proceed to a publicly reported merits judgment, the docket does not establish how those issues would have been resolved specifically against InvaGen.

How did the litigation end?

The InvaGen case was resolved without a reported trial verdict or final invalidity ruling. The public record reflects termination through settlement-related dismissal rather than an adjudication on the merits.

The settlement terms were not publicly disclosed in the case record. As a result, the docket does not provide a confirmed InvaGen launch date, royalty rate, license structure, or detailed restrictions on product marketing.

That distinction matters. A dismissal after settlement does not mean that:

• The asserted patents were held valid.
• InvaGen admitted infringement.
• InvaGen received an immediate launch license.
• The FDA approved InvaGen's ANDA.
• The patents were enforceable against all other generic applicants.

The litigation outcome was contractual rather than precedential. Its commercial effect depended on the settlement agreement and the remaining Orange Book patents.

Did Bristol-Myers Squibb win the case?

BMS did not obtain a publicly reported merits judgment against InvaGen. The case should be classified as a settlement resolution, not as a litigated BMS victory.

For patent analytics, the outcome has three separate components:

Issue	Public outcome
Infringement	No reported final merits judgment against InvaGen
Patent validity	No reported final validity ruling in the InvaGen case
Commercial launch rights	Governed by confidential settlement terms
Precedential value	Limited; dismissal did not establish a binding claim-construction or validity rule

Related Eliquis litigation produced more substantive rulings. In separate proceedings involving other generic applicants, the asserted Eliquis patents faced challenges based on obviousness and infringement. Those decisions should not automatically be treated as judgments in the InvaGen case, although they could affect the broader value of the Eliquis patent estate.

What was the Orange Book status of Eliquis?

Eliquis was protected by a combination of composition and method-of-use patents listed in the FDA Orange Book. The principal listed patents associated with the litigation included the '208 and '945 patents.

The Orange Book status had several implications:

• It gave BMS and Pfizer a basis to sue after Paragraph IV certifications.
• It delayed FDA approval through the Hatch-Waxman stay mechanism.
• It created separate infringement issues for product claims and use claims.
• It required generic applicants to evaluate whether a label carve-out could avoid method-of-use infringement.

The regulatory exclusivity period for Eliquis was separate from patent protection. New chemical entity exclusivity expired before the principal patent dates, leaving patents as the main barrier to generic approval.

Patent expiration dates should be taken from the FDA Orange Book record and applicable patent-term-adjustment or pediatric-extension data. For the principal Eliquis patents, public Orange Book records generally placed protection in the 2026 period, although the exact effective date could vary by patent and statutory extension.

What generic entry risks existed for Eliquis?

Eliquis faced substantial long-term generic entry risk because the product was a small-molecule drug with an ANDA pathway. Unlike a biologic, apixaban does not require a biosimilar application under the Biologics Price Competition and Innovation Act.

The main entry scenarios were:

Settlement-authorized entry

A generic applicant could receive a license to market before the latest patent expiry under negotiated terms. Such an agreement could include a fixed launch date, royalties, supply restrictions, or other commercial conditions.

Patent-loss entry

If a court invalidated the asserted patents or found no infringement, the generic applicant could pursue FDA approval without waiting for the full patent term, subject to other listed patents and regulatory requirements.

Post-expiry entry

If no earlier launch right existed, generic apixaban could enter after the final enforceable Orange Book barrier expired.

Label-carve-out entry

An applicant could remove a patented indication from its label. This approach carries litigation risk if the remaining label, product marketing, or prescribing behavior allegedly induces infringement.

How strong was the Eliquis patent estate?

The Eliquis estate had meaningful protection because it combined:

• A composition patent directed to apixaban.
• Method-of-use patents directed to approved therapeutic indications.
• Orange Book listing leverage under Hatch-Waxman.
• A commercially important product with large prescription volume.

Its strength was reduced by the age of the core patent estate and by the predictable obviousness challenges facing pharmaceutical composition patents. Once the principal patents entered the 2026 expiration window, the value of settlement rights and litigation leverage depended heavily on the results of related cases.

The '208 patent was particularly important because a successful invalidity or noninfringement ruling could remove the principal composition barrier for multiple ANDA applicants. Method patents could preserve narrower protection but were more vulnerable to label-carve-out strategies.

What was the commercial significance of the case?

Eliquis became one of the largest products in the U.S. anticoagulant market. BMS and Pfizer reported multibillion-dollar annual worldwide Eliquis sales, making generic entry a major revenue event for both companies. [Bristol Myers Squibb, 2023; Pfizer, 2023]

For BMS and Pfizer, the commercial exposure included:

• Loss of branded apixaban volume after generic entry.
• Price erosion from multiple ANDA approvals.
• Rebate and formulary pressure before launch.
• Potential channel substitution after generic availability.
• Reduced value of future Eliquis cash flows.

For InvaGen, the case was a market-entry investment decision. A settlement could provide a defined launch path while avoiding the cost and uncertainty of a full patent trial. The economic value would depend on the agreed launch date, the number of competing generic entrants, manufacturing capacity, and any royalty obligations.

What does the case mean for current Eliquis patent risk?

Bristol-Myers Squibb v. InvaGen should be treated as a resolved, nonprecedential settlement matter. It does not independently establish that the Eliquis patents were valid or invalid.

The broader Eliquis risk profile is determined by:

1. The current Orange Book listings.
2. Federal court rulings in related ANDA cases.
3. The terms of generic settlements.
4. FDA approval status for individual ANDAs.
5. Any authorized generic or licensing arrangements.
6. The effective expiration dates after patent-term adjustments and extensions.

Because InvaGen's settlement terms were confidential, the case alone does not establish an actionable generic launch date. Competitive forecasts should model InvaGen separately from generic applicants with publicly announced launch licenses.

Key Takeaways

• The case concerned InvaGen's Paragraph IV ANDA for generic apixaban, the active ingredient in Eliquis.
• BMS asserted Eliquis patents including U.S. Patent Nos. 6,967,208 and 9,326,945.
• The case was filed in the District of Delaware in 2017.
• It ended through settlement-related dismissal, not a publicly reported merits judgment.
• No public decision in the case established infringement, validity, or unenforceability.
• The settlement terms and any InvaGen launch date were not publicly disclosed.
• Eliquis is a small-molecule product subject to ANDA litigation, not biosimilar litigation.
• The principal Eliquis patent barriers were generally associated with the 2026 period, subject to the precise Orange Book record and statutory adjustments.
• Related Eliquis cases, rather than the InvaGen docket alone, determine the broader patent-strength assessment.

FAQs About Bristol-Myers Squibb v. InvaGen

Was InvaGen authorized to launch generic Eliquis?

The public case record does not disclose a confirmed InvaGen launch license or commercial launch date. The case ended through a confidential settlement.

Did the FDA approve InvaGen's apixaban ANDA?

Case dismissal does not establish FDA approval. FDA approval status must be evaluated from the agency's ANDA and product records, not from the civil docket.

Was Eliquis protected by a biosimilar patent strategy?

No. Apixaban is a small-molecule active ingredient. Generic applicants use the ANDA pathway rather than the biosimilar pathway.

Could InvaGen challenge Eliquis patents after settlement?

A settlement could resolve or limit particular challenges, depending on its terms. The publicly available docket does not disclose the agreement's detailed restrictions.

Does the InvaGen dismissal protect BMS against other generic applicants?

No. The dismissal resolved the dispute with InvaGen. It did not create a universal injunction or establish the validity of the Eliquis patent estate against unrelated ANDA applicants.

References

1. Bristol-Myers Squibb Company v. InvaGen Pharmaceuticals, Inc., No. 1:17-cv-00377, U.S. District Court for the District of Delaware, docket record.

2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov

3. U.S. Food and Drug Administration. (2024). Eliquis prescribing information. Bristol-Myers Squibb Company and Pfizer Inc.

4. Bristol Myers Squibb. (2023). 2023 annual report. https://www.bms.com

5. Pfizer Inc. (2023). 2023 annual report. https://www.pfizer.com

6. 21 U.S.C. § 355(j).

7. 35 U.S.C. § 271(e)(2).