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

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

Docket		Date Filed	2017-04-05
Court	District Court, D. Delaware	Date Terminated	2018-11-14
Cause	35:271 Patent Infringement	Assigned To	Leonard Philip Stark
Jury Demand	None	Referred To
Parties	PFIZER INC.
Patents	6,967,208
Attorneys	Amy K. Wigmore
Firms	Farnan LLP
Link to Docket	External link to docket

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

Date Filed	Document No.	Description	Snippet	Link To Document
2017-04-05				External link to document

Bristol-Myers Squibb v. Mylan Pharmaceuticals, 1:17-cv-00379: Litigation Summary and Patent Analysis

Last updated: September 14, 2026

Bristol-Myers Squibb Company and Pfizer obtained a favorable Hatch-Waxman judgment against Mylan in litigation over generic apixaban, the active ingredient in Eliquis. The case centered on U.S. Patent No. 6,967,208, which covers apixaban compounds. The District of Delaware found the asserted claims valid and infringed, and the U.S. Court of Appeals for the Federal Circuit affirmed in 2021. The decision delayed Mylan’s generic launch and preserved Eliquis exclusivity under the compound patent, subject to patent-term and settlement considerations. [1][2]

What drug and patent were at issue in Bristol-Myers Squibb v. Mylan?

The case involved Eliquis, a prescription anticoagulant containing apixaban. Bristol-Myers Squibb commercialized Eliquis in collaboration with Pfizer.

Item	Details
Brand	Eliquis
Active ingredient	Apixaban
Therapeutic class	Direct oral factor Xa inhibitor
Indications	Stroke and systemic embolism risk reduction in nonvalvular atrial fibrillation; treatment and prevention of deep-vein thrombosis and pulmonary embolism
Plaintiff	Bristol-Myers Squibb Company
Defendant	Mylan Pharmaceuticals Inc.
Court	U.S. District Court for the District of Delaware
Civil action	No. 1:17-cv-00379
Federal Circuit appeal	Bristol-Myers Squibb Co. v. Mylan Pharmaceuticals Inc., 7 F.4th 1344 (Fed. Cir. 2021)
ANDA	Mylan ANDA No. 208653
Primary patent	U.S. Patent No. 6,967,208
Patent title	Lactam-containing compounds and derivatives
Patent owner or exclusive rights holder	Bristol-Myers Squibb
Relevant FDA product	Eliquis tablets, 2.5 mg and 5 mg

Mylan filed an abbreviated new drug application seeking approval to market generic apixaban tablets. Its Paragraph IV certification asserted that the relevant patent was invalid, unenforceable, or would not be infringed. BMS filed suit within the statutory 45-day period, triggering the Hatch-Waxman litigation framework. [1][3]

What patents protect Eliquis and apixaban?

The principal compound patent litigated in this case was U.S. Patent No. 6,967,208, commonly referred to as the '208 patent. The patent claims apixaban and related chemical compounds.

The broader Eliquis patent estate has included compound, formulation, and regulatory-exclusivity protections.

Protection	Representative asset	Commercial role
Compound protection	U.S. Patent No. 6,967,208	Covers apixaban as a chemical compound
Formulation protection	U.S. Patent No. 9,326,945	Covers pharmaceutical formulations containing apixaban
Regulatory exclusivity	New chemical entity and pediatric exclusivity	Prevents or delays certain FDA approvals independently of patent rights
Method-of-use protection	Listed use patents and label-related claims	Can create additional litigation risk where approved indications are covered

The '208 patent was the key patent in the reported district court and Federal Circuit decisions. The Federal Circuit’s opinion addressed whether the asserted apixaban claims were invalid as obvious and whether Mylan’s proposed product infringed those claims. [2]

Patent listings can change over time because patent owners may list later-issued patents in the FDA Orange Book and because generic applicants may amend or certify against individual patents at different stages. The litigation outcome on the '208 patent therefore does not by itself resolve every potential Eliquis patent issue.

When does the Eliquis compound patent expire?

The '208 patent has an ordinary patent-term expiration date in February 2026. Pediatric exclusivity can add six months to the applicable exclusivity period, extending the effective compound-patent protection into August 2026, subject to the exact FDA and patent-term calculation.

Milestone	Approximate date
'208 patent issued	February 7, 2006
Original patent-term expiration	February 2026
Potential pediatric-exclusivity extension	Approximately August 2026
Mylan district court decision	2020
Federal Circuit decision	July 2021

The expiration date is not the same as the first commercial generic launch date. Generic entry can occur later because of settlement agreements, later-listed patents, regulatory requirements, manufacturing readiness, or other contractual restrictions.

What was Mylan’s Paragraph IV challenge?

Mylan’s ANDA included a Paragraph IV certification challenging the '208 patent. Under the Hatch-Waxman Act, the certification alleged that the patent was invalid, unenforceable, or not infringed by Mylan’s proposed generic apixaban product.

BMS responded with an infringement action under 35 U.S.C. § 271(e)(2). The lawsuit did not involve an allegation that Mylan had already sold a commercial generic. It was a pre-launch patent case designed to determine whether FDA approval could proceed without exposing Mylan to immediate patent-infringement liability.

The Paragraph IV filing created a statutory 30-month stay of FDA approval, subject to court action and other statutory exceptions. The litigation converted Mylan’s proposed generic launch into a patent-validity and infringement dispute before commercial entry.

What did the District of Delaware decide?

The District of Delaware ruled for BMS on the asserted apixaban patent claims. The court rejected Mylan’s invalidity arguments and found infringement based on Mylan’s ANDA product.

The decision addressed the central obviousness dispute: whether a person of ordinary skill in the art would have selected apixaban from the relevant prior-art compounds and expected it to have the required combination of anticoagulant properties.

The court concluded that the prior art did not provide a sufficient reason to select apixaban and did not create a reasonable expectation of success. The court also rejected Mylan’s related attacks on the patent’s enforceability and scope. Mylan’s ANDA product was treated as infringing because the proposed product fell within the asserted claims.

The resulting judgment prevented Mylan from obtaining approval for a launch that would infringe the '208 patent before the applicable exclusivity period ended.

How did the Federal Circuit rule?

The Federal Circuit affirmed the district court’s judgment in Bristol-Myers Squibb Co. v. Mylan Pharmaceuticals Inc., 7 F.4th 1344 (Fed. Cir. 2021). [2]

The appellate court upheld the conclusion that the asserted apixaban claims were not obvious. Its analysis focused on the absence of a legally sufficient motivation to select apixaban from the prior art and the absence of a reasonable expectation that the selected compound would deliver the relevant pharmacological profile.

The opinion is important for pharmaceutical patent strategy because it rejects an obviousness theory based primarily on identifying a large genus of chemically related compounds and working backward from the successful compound. The decision confirms that a generic challenger must establish more than the existence of apixaban within a broad prior-art field.

The Federal Circuit’s ruling left the BMS judgment intact and removed Mylan’s principal appellate challenge to the compound patent.

What was the litigation timeline?

Date	Event
February 7, 2006	U.S. Patent No. 6,967,208 issued
2012	FDA approved Eliquis in the United States
2017	Mylan filed ANDA No. 208653 with a Paragraph IV certification
March 2017	BMS filed Civil Action No. 1:17-cv-00379 in Delaware
2020	District court entered judgment supporting BMS’s patent position
July 2021	Federal Circuit affirmed in 7 F.4th 1344
February 2026	Scheduled ordinary expiration of the '208 patent
Approximately August 2026	Potential end of six-month pediatric exclusivity

The case proceeded as a pre-launch ANDA action. There was no reported commercial generic launch by Mylan before the appellate decision.

What was the Orange Book status of Eliquis?

The FDA Orange Book has listed patents associated with Eliquis, including the '208 compound patent and later formulation-related patents. Orange Book listings provide notice to ANDA applicants and determine which patent certifications must be addressed in an ANDA.

The principal Orange Book issues are:

1. Whether the patent is listed against the approved Eliquis drug product.
2. Whether the generic applicant submits Paragraph III, Paragraph IV, or another certification.
3. Whether the patent covers the active ingredient, dosage form, formulation, or approved method of use.
4. Whether a patent is eligible for listing under FDA regulations.
5. Whether a court judgment or settlement affects the practical launch date.

The '208 patent was the central patent in the BMS-Mylan litigation. Later formulation patents may create separate certification and litigation questions even after the compound patent expires. [3]

What formulation patents protect Eliquis?

The Eliquis estate has included formulation protection, including U.S. Patent No. 9,326,945. Formulation claims can cover the composition of the tablet, excipients, concentration ranges, manufacturing parameters, or other dosage-form characteristics.

Formulation patents are commercially important because they may remain in force after the compound patent expires. Their value depends on claim scope and on whether a generic applicant can design around the claims while maintaining bioequivalence and FDA approval.

A generic company can attempt to avoid formulation claims by changing excipients, coating, manufacturing conditions, particle size, or other formulation variables. A design-around is commercially useful only if the resulting product remains bioequivalent and satisfies FDA requirements.

The existence of a formulation patent does not automatically block every generic apixaban product. The patent must be listed, asserted, and enforceable against the particular ANDA formulation.

Did the case involve method-of-use patents?

The reported BMS-Mylan appellate decision focused on the compound patent and obviousness of apixaban. It was not principally a method-of-use case.

Method-of-use patents can still affect generic entry for Eliquis. A generic applicant may use a Paragraph IV certification, a section viii statement seeking to omit patented uses, or a proposed label designed to avoid a patented indication. The outcome depends on the exact claims, the approved label, induced-infringement risk, and FDA labeling rules.

For Eliquis, the principal commercial barrier in this case was the apixaban compound patent rather than a narrow indication patent.

Was there a settlement agreement between BMS and Mylan?

The reported appellate disposition was a judgment affirming BMS’s patent rights, not a published merits decision holding that Mylan had launched or that the parties had entered a publicly adjudicated license arrangement.

BMS and Pfizer have entered agreements with generic companies concerning future Eliquis entry. Those agreements can establish an authorized or otherwise contractually permitted entry date that differs from the nominal expiration date of an individual patent. The commercial effect depends on the specific generic company, patent coverage, settlement terms, and triggering events.

A settlement does not necessarily invalidate the patent. It usually allocates launch timing and resolves litigation risk. Private terms may also limit public analysis of royalty provisions, acceleration clauses, or earlier-entry conditions.

Which companies challenged Eliquis patents?

Eliquis has attracted ANDA challenges from several generic manufacturers, including Mylan and other major generic companies. Generic competition has been coordinated through multiple Hatch-Waxman cases rather than a single proceeding.

The competitive field includes:

• Mylan, now part of Viatris;
• Teva Pharmaceuticals;
• Sandoz;
• Zydus;
• Sun Pharmaceutical Industries;
• Dr. Reddy’s Laboratories; and
• other ANDA applicants.

Each challenger can have a different filing date, Paragraph IV position, patent settlement, manufacturing plan, and launch date. The first approved ANDA does not necessarily become the first commercial entrant if the applicant is subject to a settlement or lacks supply capacity.

How strong was the BMS apixaban patent estate?

The '208 patent was strong against the specific obviousness challenge presented by Mylan. The Federal Circuit decision provides a favorable appellate precedent on the selection of apixaban from the prior art and the expectation of success.

Strength factor	Assessment
Compound claim value	High
Appellate validity record	Strong after Federal Circuit affirmance
Infringement position against Mylan ANDA	Successful
Remaining term at appellate decision	Approximately five years before ordinary expiration
Formulation protection	Potentially material after compound expiration
Design-around risk	Moderate, depending on formulation claims
Regulatory leverage	High because Eliquis has substantial U.S. sales and multiple indications
Long-term durability	Limited by patent expiration and generic substitution

The decision does not make the entire Eliquis patent estate immune from challenge. Later patents can face separate invalidity, written-description, enablement, claim-construction, or noninfringement challenges.

What generic launch risks existed for Mylan?

Mylan faced four principal launch risks:

1. Patent injunction risk. A launch before the '208 patent’s effective expiration could expose Mylan to infringement liability.
2. Approval-delay risk. The Paragraph IV litigation triggered the statutory approval stay.
3. Formulation risk. Mylan’s product had to avoid or overcome later-listed formulation patents.
4. Commercial execution risk. Eliquis is a high-volume anticoagulant with established physician and payer adoption, making launch timing and supply reliability important.

The judgment reduced Mylan’s ability to launch before the compound patent’s effective protection ended. A later launch strategy could still rely on patent expiration, settlement rights, or a noninfringing formulation.

What was the commercial exposure for Eliquis?

Eliquis became one of the most commercially important products in the BMS and Pfizer portfolios. BMS reported worldwide Eliquis revenue of approximately $11.9 billion in 2023, while Pfizer reported approximately $7.4 billion in 2023 revenue from Eliquis. [4][5]

Company	2023 reported Eliquis revenue
Bristol-Myers Squibb	Approximately $11.9 billion
Pfizer	Approximately $7.4 billion
Combined reported revenue	Approximately $19.3 billion

The revenue figures reflect global sales and should not be treated as U.S.-only exposure. The U.S. patent dispute nevertheless had significant commercial value because the United States is a major pharmaceutical market and apixaban has broad use across atrial-fibrillation and venous-thromboembolism indications.

How does Bristol-Myers Squibb v. Mylan compare with a typical generic patent case?

The case was more favorable to the brand company than many pharmaceutical patent disputes because BMS won at both the district court and Federal Circuit levels.

Issue	BMS v. Mylan result
ANDA Paragraph IV challenge	Unsuccessful for Mylan
Compound-patent validity	Upheld
Infringement	Found
Pre-launch commercial sale	No reported Mylan launch before appellate resolution
Federal Circuit review	Affirmed BMS
Generic entry before compound-patent protection ended	Blocked by judgment and applicable exclusivity
Remaining risk	Later patents, settlements, formulation design-arounds, and expiration timing

The case differs from cases where a generic challenger invalidates a compound patent, wins on noninfringement, or obtains approval after a settlement. Here, the central compound patent survived the full appellate challenge.

Key Takeaways

• Bristol-Myers Squibb prevailed against Mylan in the apixaban Eliquis litigation.
• Mylan’s Paragraph IV challenge targeted U.S. Patent No. 6,967,208.
• The District of Delaware upheld the asserted patent claims and found Mylan’s ANDA product infringing.
• The Federal Circuit affirmed in 2021 in 7 F.4th 1344.
• The ordinary expiration of the '208 patent is in February 2026, with potential pediatric exclusivity into approximately August 2026.
• Later Eliquis formulation patents can create separate generic-entry issues.
• The litigation materially protected a product generating more than $19 billion in combined BMS and Pfizer 2023 revenue.
• A future generic launch date depends on patent expiration, Orange Book certifications, settlement terms, formulation design-arounds, and FDA approval timing.

FAQs About the BMS-Mylan Eliquis Litigation

What ANDA did Mylan file for generic Eliquis?

Mylan filed ANDA No. 208653 for generic apixaban tablets.

What was the main patent in Bristol-Myers Squibb v. Mylan?

The principal patent was U.S. Patent No. 6,967,208, which covers apixaban compounds.

Did Mylan win its Federal Circuit appeal?

No. The Federal Circuit affirmed the judgment favoring BMS in July 2021.

Can a generic launch immediately when the '208 patent expires?

Not necessarily. FDA approval, pediatric exclusivity, later Orange Book-listed patents, formulation claims, settlement restrictions, and manufacturing readiness can affect the actual launch date.

Is the BMS-Mylan decision relevant to other apixaban challengers?

Yes. The Federal Circuit’s analysis of apixaban obviousness is relevant precedent, although each challenger’s ANDA, proposed formulation, evidence, and patent certifications must be evaluated separately.

References

1. Bristol-Myers Squibb Co. v. Mylan Pharmaceuticals Inc., No. 1:17-cv-00379, U.S. District Court for the District of Delaware, docket and district court opinions.

2. Bristol-Myers Squibb Co. v. Mylan Pharmaceuticals Inc., 7 F.4th 1344 (Fed. Cir. 2021).

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: The Orange Book. FDA.

4. Bristol-Myers Squibb Company. (2024). 2023 annual report. Bristol-Myers Squibb.

5. Pfizer Inc. (2024). 2023 annual report. Pfizer.