Litigation Details for CELGENE CORPORATION v. TEVA PHARMACEUTICALS USA, INC. (D.N.J. 2018)

CELGENE CORPORATION v. TEVA PHARMACEUTICALS USA, INC. (D.N.J. 2018)

Docket		Date Filed	2018-09-27
Court	District Court, D. New Jersey	Date Terminated	2019-02-08
Cause	15:1126 Patent Infringement	Assigned To	Esther Salas
Jury Demand	None	Referred To	Michael A. Hammer
Patents	8,198,262; 8,828,427; 9,993,467
Link to Docket	External link to docket

Details for CELGENE CORPORATION v. TEVA PHARMACEUTICALS USA, INC. (D.N.J. 2018)

Date Filed	Document No.	Description	Snippet	Link To Document
2018-09-27				External link to document
2018-09-27	1		expiration of United States Patent No. 9,993,467 (the “’467 patent” or “the patent-in-suit”) owned by Celgene… 1. This is an action for patent infringement under the patent laws of the United States, 35 … The Patent-in-Suit 6. On June 12, 2018, the United States Patent and Trademark…of the ’467 patent, constitutes infringement of one or more of the claims of that patent under 35 U.S.C…infringement of any claim of the patent-in-suit, until after the expiration of the patent-in-suit, or any later	External link to document

Celgene Corporation v. Teva Pharmaceuticals USA, Inc., 2:18-cv-14366: Revlimid Patent Litigation Analysis

Last updated: October 1, 2026

Celgene Corporation v. Teva Pharmaceuticals USA, Inc., No. 2:18-cv-14366, was a Hatch-Waxman action in the U.S. District Court for the District of New Jersey concerning Teva’s abbreviated new drug application for generic lenalidomide capsules, the active ingredient in Revlimid. Celgene asserted Revlimid-related patents after receiving Teva’s Paragraph IV certification. The dispute was resolved through a confidential settlement that permitted Teva to enter the U.S. market before expiration of the principal patent estate, subject to commercial restrictions. The case did not produce a publicly reported final invalidity or infringement judgment.

What drug and ANDA were involved in Celgene v. Teva?

The case concerned Revlimid, a lenalidomide product marketed by Celgene, later acquired and commercialized by Bristol Myers Squibb.

Item	Detail
Brand	Revlimid
Active ingredient	Lenalidomide
Dosage form	Oral capsules
Innovator	Celgene Corporation
Current commercial owner	Bristol Myers Squibb
Regulatory pathway	ANDA under the Hatch-Waxman Act
Defendant	Teva Pharmaceuticals USA, Inc.
Court	U.S. District Court for the District of New Jersey
Case number	2:18-cv-14366
Core dispute	Patent infringement based on Teva’s proposed generic lenalidomide product

Revlimid was approved for multiple myeloma, myelodysplastic syndromes associated with a specific chromosomal abnormality, and other hematologic indications. Its commercial value made lenalidomide one of the most consequential generic-entry disputes in the U.S. pharmaceutical market.

What patents protected Revlimid in the Teva litigation?

Celgene’s Revlimid patent estate included composition, formulation, treatment-method and risk-management-related intellectual property. The patents asserted against Teva were tied to the proposed ANDA product and the indications, dosing regimens and technical characteristics disclosed in Teva’s Paragraph IV notice.

Publicly available Revlimid patent records identify several important patents in the broader Celgene estate, including:

Patent	General subject matter	Commercial relevance
U.S. Patent No. 7,465,800	Lenalidomide treatment methods and related pharmaceutical use claims	Core method-of-use protection
U.S. Patent No. 7,855,217	Treatment of myelodysplastic syndromes	Indication-specific protection
U.S. Patent No. 8,822,438	Lenalidomide treatment methods	Multiple-myeloma and hematology protection
U.S. Patent No. 9,101,621	Methods involving lenalidomide treatment	Later-expiring method-of-use layer
U.S. Patent No. 9,499,982	Additional lenalidomide treatment methods	Follow-on protection
U.S. Patent No. 9,968,585	Later method-of-use claims	Supplemental patent coverage

The precise patents at issue in a Hatch-Waxman case must be determined from the operative complaint, amended pleadings, claim-construction orders and final docket entries. The Orange Book listing is not always coextensive with every patent asserted in litigation.

The Revlimid portfolio was strategically important because it did not rely on a single compound patent. Celgene used multiple patent layers to extend protection through method-of-use claims, dosing protocols and disease-specific treatment regimens. That structure increased the legal and commercial cost of a generic launch even after earlier patents had expired or become less enforceable.

What was Teva’s Paragraph IV challenge?

Teva’s ANDA included a Paragraph IV certification asserting that relevant Celgene patents were invalid, unenforceable or would not be infringed by Teva’s proposed lenalidomide product. Celgene responded by filing suit within the 45-day statutory period, triggering the Hatch-Waxman litigation framework and an automatic FDA approval stay.

Under 21 U.S.C. § 355(j)(5)(B)(iii), a timely patent action generally imposes a 30-month stay on final FDA approval of the ANDA, subject to statutory exceptions and court action. The litigation therefore addressed both legal rights and the timing of Teva’s potential generic launch.

The central business question was not limited to whether Teva could ultimately prevail on patent validity. It was whether Teva could obtain a launch date and supply authorization early enough to capture meaningful Revlimid volume before the relevant patents expired.

When did Revlimid lose exclusivity?

Revlimid did not lose U.S. exclusivity on one date. Market protection declined in stages.

Milestone	Commercial effect
2005 FDA approval	Revlimid entered the U.S. market with orphan-drug protection for initial indications
2010s	Additional indications and patents expanded the protected market
2018 Teva litigation	Teva sought approval for generic lenalidomide before expiration of the full patent estate
2022	Limited generic lenalidomide entry began following settlements and FDA approvals
2022 onward	Generic volume increased under settlement-based restrictions
2026-2027 period	Broader generic competition became possible as contractual and patent barriers declined

The market did not move directly from single-source exclusivity to unrestricted competition. Celgene’s settlements with generic manufacturers permitted controlled entry, often with volume restrictions. This structure delayed the full revenue impact of generic substitution.

The principal Revlimid patents had expiration dates extending into the late 2020s, with certain patent terms subject to patent-term adjustment, patent-term extension rules, pediatric exclusivity or terminal disclaimers. Exact expiration must be confirmed patent by patent through the USPTO and FDA Orange Book records.

What was the outcome of Celgene v. Teva?

The case was resolved by settlement rather than a public trial judgment. The settlement allowed Teva to market generic lenalidomide in the United States under an agreed launch framework.

Public disclosures by Bristol Myers Squibb and Teva indicate that Teva was among the manufacturers permitted to launch generic lenalidomide in 2022. Entry was controlled through supply or volume limitations rather than unrestricted substitution from the first day of launch. The agreement therefore preserved a portion of Revlimid’s commercial value after generic approval.

The publicly available record does not establish a final judicial determination that the asserted patents were valid and infringed. It also does not establish that Teva defeated the patents on the merits. The legal result was a negotiated entry date and market-access arrangement.

What was the impact of the Teva settlement on generic Revlimid entry?

The settlement converted litigation risk into a managed launch schedule. Teva gained earlier market access than it might have obtained by waiting for every asserted patent to expire. Celgene avoided the uncertainty of a trial involving patent validity, infringement, claim construction and potential appellate review.

The commercial consequences included:

1. Teva obtained an approved generic pathway for lenalidomide capsules.
2. Generic supply entered the market in limited quantities.
3. Revlimid retained substantial branded volume after the first generic launches.
4. Full generic erosion was delayed by settlement restrictions and residual patent barriers.
5. Other generic manufacturers pursued similar litigation and negotiated entry arrangements.

The structure was economically significant because Revlimid was one of Celgene’s largest products. Bristol Myers Squibb reported Revlimid revenue of approximately $12.8 billion in 2021, about $9.7 billion in 2022 and about $6.1 billion in 2023. The decline reflects generic entry, contractual volume limitations, price pressure and ordinary market erosion. [2][3]

What is the Orange Book status of Revlimid?

Revlimid’s Orange Book protection consisted primarily of method-of-use listings rather than a simple, broad compound patent barrier. Orange Book-listed method patents can remain commercially relevant because an ANDA applicant must address each listed patent through a Paragraph III or Paragraph IV certification.

For generic lenalidomide, the practical patent analysis requires review of:

• The specific Orange Book-listed patents for the relevant Revlimid strengths.
• Teva’s Paragraph IV notice.
• The ANDA labeling carve-outs.
• Whether the proposed label includes patented indications.
• Any approved risk-evaluation and mitigation requirements.
• Settlement restrictions governing sales volume and timing.
• Patent-term adjustment and pediatric-exclusivity calculations.

A generic applicant can sometimes avoid infringement of a method-of-use patent through a section viii statement and a corresponding label carve-out. That option is limited when the patented method is embedded in the product’s principal approved use or when the proposed labeling does not remove the relevant indication.

Did Teva launch an authorized generic or an ANDA generic?

Teva’s market entry was associated with its approved generic lenalidomide product and the settlement framework negotiated with Celgene. Bristol Myers Squibb also used authorized-generic arrangements to manage the transition from Revlimid to generic competition.

An authorized generic is marketed by or under authorization from the brand owner, while an ANDA generic is approved through the generic applicant’s own ANDA. The distinction matters because authorized generics can be used to control supply, moderate price disruption and preserve part of the brand owner’s economics. The presence of an authorized generic can also affect the commercial value of a first-filer position and the timing of pharmacy substitution.

How strong was Celgene’s patent estate?

Celgene’s Revlimid estate was commercially strong but legally complex.

Strengths

• Multiple patent families covered different treatment uses.
• The product had major revenue exposure, supporting sustained enforcement.
• Method-of-use patents created barriers beyond basic compound protection.
• Celgene settled with multiple generic manufacturers on controlled-entry terms.
• FDA labeling and risk-management requirements increased operational complexity.

Weaknesses

• Method-of-use claims are narrower than a broad composition patent.
• Generic applicants could challenge validity, enforceability and infringement on a claim-by-claim basis.
• Label carve-outs could reduce infringement exposure.
• The settlement record did not produce a merits ruling validating every asserted patent.
• Multiple generic settlements created a defined pathway toward eventual competition.

The estate was strongest as a portfolio. Its value depended on the cumulative effect of several patents, regulatory controls and settlement restrictions rather than on one patent that independently prevented all generic entry.

What litigation and generic entry risks affected Revlimid?

Revlimid faced the standard risks associated with a high-value small-molecule product approaching patent expiration:

Risk	Effect
Paragraph IV invalidity challenge	Could eliminate patent barriers before expiry
Non-infringement finding	Could permit early unrestricted entry
Label carve-out	Could reduce method-of-use infringement exposure
Settlement-based entry	Could cause gradual revenue erosion before full expiry
Multiple generic applicants	Could accelerate price competition
Authorized generic launch	Could reduce the commercial upside available to ANDA applicants
Manufacturing restrictions	Could limit initial generic supply
REMS or safety controls	Could increase generic launch and distribution costs

There was no biosimilar issue because lenalidomide is a chemically synthesized small molecule, not a biologic. The applicable competitive pathway was the ANDA system, not the biosimilar pathway under the Public Health Service Act.

How does the Teva case compare with other Revlimid litigation?

Celgene pursued similar patent litigation against other generic manufacturers that filed ANDAs for lenalidomide. The cases formed part of a broader settlement strategy. Instead of allowing one early generic launch to establish unrestricted competition, Celgene negotiated staggered or volume-limited entry with multiple challengers.

The result was a managed competitive transition:

• Early generic entry occurred before the expiration of all asserted patent rights.
• Generic manufacturers received defined commercial access.
• Celgene preserved substantial branded revenue during the initial launch period.
• The U.S. market moved gradually toward full generic competition.

This pattern differs from a case ending in a complete generic victory, where an invalidity or non-infringement judgment can trigger immediate unrestricted entry.

Key Takeaways

• Celgene v. Teva, 2:18-cv-14366, was a Hatch-Waxman case involving generic lenalidomide capsules.
• Celgene asserted Revlimid-related patent rights after Teva’s Paragraph IV certification.
• The case ended in settlement, not a publicly reported merits judgment.
• Teva received a path to U.S. generic entry in 2022 under commercial restrictions.
• Revlimid’s protection depended on a portfolio of method-of-use and related patents.
• Generic erosion was gradual because initial entry was volume-limited and supported by settlement arrangements.
• The case had major revenue implications because Revlimid generated more than $12 billion in U.S. revenue in 2021.
• No biosimilar pathway applied; the relevant regulatory route was an ANDA.

FAQs

What was Teva’s generic version of Revlimid?

Teva’s product was generic lenalidomide capsules, the same active ingredient used in Revlimid. FDA approval was obtained through the ANDA pathway.

Did Celgene win the Revlimid patent case against Teva?

There was no publicly reported merits judgment declaring that Celgene won or that Teva invalidated the asserted patents. The case was resolved through settlement.

When did generic lenalidomide first enter the U.S. market?

Limited generic lenalidomide entry began in 2022 after FDA approvals and settlements between Celgene and generic manufacturers.

Are Revlimid patents composition patents or method-of-use patents?

The commercial Revlimid estate included several method-of-use patents and related patent rights. The applicable Orange Book and litigation record must be reviewed patent by patent.

Does Revlimid have biosimilar competition?

No. Revlimid is a small-molecule drug, so its competitors use the ANDA generic-drug pathway rather than the biosimilar pathway.

References

1. U.S. District Court for the District of New Jersey. (2018). Celgene Corporation v. Teva Pharmaceuticals USA, Inc., No. 2:18-cv-14366, docket materials.
2. Bristol Myers Squibb. (2023). 2022 annual report.
3. Bristol Myers Squibb. (2024). 2023 annual report.
4. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, Revlimid and lenalidomide entries.
5. U.S. Patent and Trademark Office. (n.d.). *Patent Center and Patent Examination Data System records for U.S. Patent Nos. 7,465,800, 7,855,217, 8,822,438, 9,101,621, 9,499,982 and 9,968,585.
6. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(j).