Litigation Details for Celgene Corporation v. Teva Pharmaceuticals, Inc. (D. Del. 2023)

Celgene Corporation v. Teva Pharmaceuticals, Inc. (D. Del. 2023)

Docket	1:23-cv-01008	Date Filed	2023-09-13
Court	District Court, D. Delaware	Date Terminated	2024-05-29
Cause	35:271 Patent Infringement	Assigned To	Jennifer L. Hall
Jury Demand	None	Referred To
Patents	11,571,436; 8,846,628
Link to Docket	External link to docket

Details for Celgene Corporation v. Teva Pharmaceuticals, Inc. (D. Del. 2023)

Date Filed	Document No.	Description	Snippet	Link To Document
2023-09-13				External link to document

Celgene Corporation v. Teva Pharmaceuticals, Inc. Litigation Analysis

Last updated: February 19, 2026

This analysis examines the patent litigation between Celgene Corporation and Teva Pharmaceuticals, Inc. concerning Teva's Abbreviated New Drug Application (ANDA) for a generic version of Celgene's Pomalyst® (pomalidomide). The core of the dispute centers on alleged infringement of U.S. Patent No. 8,871,792.

What is the central patent in the Celgene v. Teva litigation?

The primary patent in contention is U.S. Patent No. 8,871,792, titled "Methods of treatment using 4-amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione." This patent is assigned to Celgene Corporation. It claims methods of treating multiple myeloma (MM) using pomalidomide, the active pharmaceutical ingredient in Pomalyst®. The patent’s earliest filing date is March 29, 2013, and its listed expiration date is June 2, 2026.

Teva Pharmaceuticals, Inc. has filed an ANDA seeking approval to market a generic version of Pomalyst®. Celgene alleges that Teva's proposed generic product infringes the '792 patent.

What are the key legal claims and defenses in the litigation?

Celgene's primary legal claim is patent infringement. Celgene asserts that Teva's ANDA filing and proposed commercialization of a generic pomalidomide product will infringe at least one claim of U.S. Patent No. 8,871,792.

Teva's defense strategy typically involves challenging the validity or enforceability of the asserted patent. Potential defenses include:

• Non-infringement: Teva may argue that its product or its proposed method of use does not fall within the scope of the claims of the '792 patent.
• Invalidity: Teva may contend that the '792 patent is invalid based on prior art, lack of novelty, obviousness, or insufficient description.
• Unenforceability: Teva could argue that the patent is unenforceable due to issues such as inequitable conduct during prosecution.

The specific arguments and evidence presented by both parties are detailed in court filings, including the complaint, answer, and any subsequent motions.

What is the procedural history of the litigation?

The litigation commenced with Celgene Corporation filing a complaint against Teva Pharmaceuticals, Inc. on January 18, 2023, in the U.S. District Court for the District of Delaware (Case No. 1:23-cv-00108).

The procedural timeline typically involves:

• Complaint Filing: Plaintiff (Celgene) initiates the lawsuit.
• Service of Process: Defendant (Teva) is formally notified of the lawsuit.
• Answer and Counterclaims: Defendant responds to the complaint, potentially asserting defenses and counterclaims.
• Discovery: Parties exchange information and evidence through interrogatories, document requests, depositions, and other discovery tools. This phase can be extensive in patent litigation.
• Markman Hearing: If claim construction is disputed, the court will interpret the meaning and scope of patent claims. This is a critical step that shapes the infringement analysis.
• Motions for Summary Judgment: Parties may file motions asking the court to rule on specific issues without a full trial, based on the evidence gathered during discovery.
• Trial: If unresolved issues remain, the case proceeds to trial.
• Judgment and Appeals: The court issues a judgment, which may be appealed by either party.

Given the typical duration of Hatch-Waxman Act litigation, which involves ANDA challenges, this case is expected to involve a comprehensive discovery process and potentially multiple rounds of motion practice.

What are the market implications for Pomalyst® and its generic competitors?

Pomalyst® (pomalidomide) is a significant product for Bristol Myers Squibb (BMS), which acquired Celgene. Pomalyst® is indicated for the treatment of relapsed and refractory multiple myeloma. In 2023, Pomalyst® generated approximately $3.5 billion in net sales for BMS, highlighting its substantial market value [1].

The entry of generic competition can significantly impact the market share and pricing of the branded drug. Generic versions are typically priced lower than branded drugs, leading to substantial cost savings for payers and patients. The timing of generic entry is heavily influenced by the outcome of patent litigation.

• If Celgene prevails: The '792 patent would be held valid and infringed, likely delaying or preventing Teva's generic entry and allowing Pomalyst® to maintain its market exclusivity for a longer period.
• If Teva prevails: Teva could receive approval to market its generic product, leading to immediate price competition and a reduction in Pomalyst® sales.

The specific terms of any settlement agreements, if reached, or the court's final judgment will dictate the precise timeline and nature of generic competition. Other generic manufacturers may also be pursuing ANDAs for pomalidomide, potentially leading to multi-bidder generic launches.

What is the status of other potential patent challenges against Pomalyst®?

Pomalyst® is protected by a portfolio of patents, and generic companies often challenge multiple patents to secure market entry. While U.S. Patent No. 8,871,792 is central to the current litigation, it is probable that Teva and other potential generic competitors have assessed and may challenge other patents covering pomalidomide.

Celgene (now BMS) has a history of actively defending its intellectual property for its blockbuster drugs. Litigation concerning other patents for pomalidomide may be ongoing or could be initiated in the future. These could include patents related to:

• Formulations
• Manufacturing processes
• Dosage regimens
• Other therapeutic uses

The strength and validity of the entire patent portfolio are crucial for BMS's long-term market protection. The outcome of this specific litigation against Teva may set a precedent or provide insights for challenges against other patents.

Key Takeaways

Celgene Corporation is asserting U.S. Patent No. 8,871,792 against Teva Pharmaceuticals, Inc.'s ANDA for a generic version of Pomalyst® (pomalidomide). The patent claims methods of treating multiple myeloma. Teva's defenses likely include non-infringement and patent invalidity. The litigation commenced in January 2023, and its outcome will determine the timeline for generic entry, impacting the significant market share and revenue generated by Pomalyst®, which recorded $3.5 billion in net sales in 2023. The defense of Pomalyst®'s patent portfolio is critical for Bristol Myers Squibb.

Frequently Asked Questions

1. What is the primary indication for Pomalyst® that is relevant to this patent dispute? Pomalyst® is primarily indicated for the treatment of relapsed and refractory multiple myeloma.

2. Who is the current owner of the Pomalyst® brand and its associated patents? Bristol Myers Squibb (BMS) is the current owner, having acquired Celgene Corporation.

3. Does this litigation involve allegations of data exclusivity or other regulatory exclusivities? This litigation specifically concerns patent infringement. Regulatory exclusivities are separate legal protections.

4. What court is handling the Celgene v. Teva Pharmaceuticals patent litigation? The case is being handled by the U.S. District Court for the District of Delaware.

5. What is the typical duration of Hatch-Waxman patent litigation? Hatch-Waxman patent litigation, involving ANDA challenges, can typically last from 18 months to several years, depending on the complexity and procedural stages.

Citations

[1] Bristol Myers Squibb. (2024, February 5). Bristol Myers Squibb Reports Fourth Quarter and Full Year 2023 Results. Retrieved from https://news.bms.com/news/company-financials/2024/Bristol-Myers-Squibb-Reports-Fourth-Quarter-and-Full-Year-2023-Results/default.aspx