Litigation Details for TRIS PHARMA, INC. v. TEVA PHARMACEUTICALS USA, INC. (D.N.J. 2020)

TRIS PHARMA, INC. v. TEVA PHARMACEUTICALS USA, INC. (D.N.J. 2020)

Docket	2:20-cv-05212	Date Filed	2020-04-28
Court	District Court, D. New Jersey	Date Terminated	2022-09-22
Cause	35:271 Patent Infringement	Assigned To	Kevin McNulty
Jury Demand		Referred To	Edward S. Kiel
Parties	TEVA PHARMACEUTICALS USA, INC.
Patents	11,103,494; 11,103,495; 6,419,960; 8,999,386; 9,545,399; 9,844,544
Link to Docket	External link to docket

Details for TRIS PHARMA, INC. v. TEVA PHARMACEUTICALS USA, INC. (D.N.J. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-04-28				External link to document
2020-04-28	206	Opinion	• U.S. Patent No. 4,996,047 (“Kelleher”) (JTX-059) • U.S. Patent No. 6,419,960 (“Krishnamurthy…of five patents: United States Patent No. 9,545,399 (“the ’399 patent”), United States Patent No. 9,844,544…the ’544 patent”), United States Patent No. 9,844,545 (“the ’545 patent”), United States Patent No. 11,103,494…,494 (“the ’494 patent”), and United States Patent No. 11,103,495 (“the ’495 patent”) (collectively,…the ’399 patent; claim 37 of the ’544 patent; claims 17, 23, 24, and 28 of the ’545 patent; claim 28	External link to document

TRIS PHARMA, INC. v. TEVA PHARMACEUTICALS USA, INC. | 2:20-cv-05212 Litigation Analysis

Last updated: February 19, 2026

This document summarizes and analyzes the patent litigation between Tris Pharma, Inc. and Teva Pharmaceuticals USA, Inc., Case Number 2:20-cv-05212, filed in the United States District Court for the District of New Jersey. The dispute centers on Teva's proposed generic entry of Tris Pharma's oral liquid ibuprofen product.

What is the core dispute?

The central conflict involves Teva's Abbreviated New Drug Application (ANDA) for a generic version of Tris Pharma's Motrin ® Infants’ Concentrated Oral Suspension, 400 mg/5 mL. Tris Pharma alleges that Teva's generic product infringes on U.S. Patent No. 8,835,404.

What patent is at issue?

The patent in question is U.S. Patent No. 8,835,404, titled "Liquid pharmaceutical compositions." This patent is directed to orally administrable liquid pharmaceutical compositions containing ibuprofen and at least one non-ionic surfactant. The patent's claims are directed to specific formulations of ibuprofen suspensions, focusing on improved stability and bioavailability.

What are Tris Pharma's allegations?

Tris Pharma asserts that Teva's proposed generic ibuprofen oral suspension infringes Claim 1 of the '404 patent. Specifically, Tris Pharma contends that Teva's product contains the same essential elements and performs the same function in substantially the same way as described in the patent's claims.

What are Teva's defenses?

Teva's primary defense is non-infringement. Teva argues that its ANDA product does not fall within the scope of the claims of the '404 patent. Teva also asserts invalidity of the '404 patent, arguing that the patent is obvious and lacks novelty.

What is the status of the litigation?

The litigation commenced with Tris Pharma filing its complaint on September 30, 2020. Teva filed its answer and counterclaim on November 16, 2020. The case is ongoing, with discovery and pre-trial motions being the primary activities.

What is the timeline of key events?

• September 30, 2020: Tris Pharma files its complaint for patent infringement against Teva.
• November 16, 2020: Teva files its Answer and Counterclaim for declaratory judgment of non-infringement and invalidity.
• December 7, 2020: Teva files its Amended Answer and Counterclaim.
• January 12, 2021: Tris Pharma files its Answer to Teva's Counterclaim.
• March 19, 2021: The Court issues a Scheduling Order setting deadlines for discovery and pre-trial motions.
• October 25, 2021: Tris Pharma files a Motion for Preliminary Injunction.
• November 22, 2021: Teva files its Opposition to Tris Pharma's Motion for Preliminary Injunction.
• December 15, 2021: Tris Pharma files its Reply in support of its Motion for Preliminary Injunction.
• January 20, 2022: The Court denies Tris Pharma's Motion for Preliminary Injunction.
• May 2, 2022: The Court issues an Order denying Teva's Motion to Dismiss.
• November 14, 2022: The parties file joint pre-trial conference statements.
• December 21, 2022: The Court issues a Pre-Trial Conference Order.
• March 1, 2023: Expert disclosures are due.
• September 18, 2023: Trial is currently scheduled to commence.

What are the key arguments regarding infringement?

Tris Pharma's infringement argument hinges on its interpretation of Claim 1 of the '404 patent, which reads:

"1. An orally administrable liquid pharmaceutical composition comprising: (a) ibuprofen; and (b) at least one non-ionic surfactant, wherein the composition is stable and has a viscosity of less than 100 cps at 25° C."

Tris Pharma alleges that Teva's generic ibuprofen suspension incorporates ibuprofen and a non-ionic surfactant, meeting these criteria. The dispute often centers on the specific quantities and types of surfactants used and whether they fall within the scope of the patent's enablement and written description.

Teva counters that its formulation does not meet all the limitations of Claim 1. This often involves detailed chemical analysis and comparison of ingredient lists, excipient functions, and manufacturing processes.

What are the key arguments regarding validity?

Teva's invalidity arguments typically focus on:

• Obviousness: Teva contends that the claimed invention would have been obvious to a person of ordinary skill in the art at the time of the invention, based on prior art references that disclosed ibuprofen formulations and the use of non-ionic surfactants in pharmaceutical compositions.
• Lack of Enablement/Written Description: Teva may argue that the '404 patent does not adequately describe or enable the full scope of its claims, meaning the patent does not teach how to make and use the full range of what it claims to have invented.

The parties will likely present expert testimony from chemists, pharmacists, and patent law experts to support their respective positions on validity. Prior art references will be central to this aspect of the litigation.

What is the market impact of this litigation?

This litigation directly impacts the market entry of a generic version of a widely used infant ibuprofen product. Successful generic entry by Teva would likely lead to lower prices and increased competition for the branded product. Conversely, a favorable outcome for Tris Pharma, such as an injunction or a finding of infringement and validity, would delay or prevent generic competition, allowing Tris Pharma to maintain market exclusivity.

What are the potential outcomes?

• Infringement Finding: If the court finds that Teva infringes the '404 patent and the patent is valid, Teva's ANDA will be blocked. Tris Pharma would then have the opportunity to pursue damages.
• Non-Infringement Finding: If the court finds that Teva does not infringe the '404 patent, Teva may be able to launch its generic product.
• Invalidity Finding: If the court finds the '404 patent invalid, Teva can launch its generic product, regardless of infringement.
• Settlement: The parties may reach a settlement agreement before a trial verdict, which could involve licensing terms, delayed entry, or a combination of both.

Key Takeaways

• Tris Pharma alleges Teva's generic ibuprofen oral suspension infringes U.S. Patent No. 8,835,404.
• Teva defends on grounds of non-infringement and invalidity of the '404 patent.
• The dispute involves complex chemical and patent law arguments concerning formulation, excipients, and prior art.
• The outcome will determine the timing and extent of generic competition for a significant infant medication.
• The litigation is currently scheduled for trial in September 2023.

Frequently Asked Questions

1. What specific ingredient or formulation aspect is Teva accused of copying? Tris Pharma alleges that Teva's ANDA product infringes Claim 1 of the '404 patent, which claims an orally administrable liquid composition comprising ibuprofen and at least one non-ionic surfactant, with a specified viscosity. The core of the dispute is whether Teva's chosen ibuprofen and non-ionic surfactant combination falls within the scope of this claim.

2. Has the court made any preliminary rulings on the patent's validity? The court denied Teva's Motion to Dismiss on May 2, 2022, which implies the patent claims, as pleaded, were not dismissed on their face. However, a full determination of validity is typically made at trial or through summary judgment motions based on extensive evidence.

3. What is the significance of the denied preliminary injunction for Tris Pharma? The denial of the preliminary injunction on January 20, 2022, means that Tris Pharma was unable to prevent Teva from proceeding with its ANDA and potential market entry while the patent litigation is ongoing. This allows Teva to continue its preparations for launch.

4. What is the role of expert witnesses in this case? Expert witnesses are crucial for both sides. They will provide testimony on complex scientific issues such as the chemical composition and properties of the drug formulations, the interpretation of patent claims, the state of prior art, and whether the invention would have been obvious to a person skilled in the relevant field.

5. How does the Hatch-Waxman Act apply to this litigation? This is a Paragraph IV certification case under the Hatch-Waxman Act. Teva, by filing an ANDA, is asserting that Tris Pharma's patent is either invalid, unenforceable, or will not be infringed by Teva's generic product. This certification triggers the patent litigation framework that allows generic companies to challenge patents before they expire.

Citations

[1] Tris Pharma, Inc. v. Teva Pharmaceuticals USA, Inc., Case No. 2:20-cv-05212 (D.N.J. filed Sep. 30, 2020). [2] U.S. Patent No. 8,835,404 (filed Oct. 23, 2012) (issued Sep. 16, 2014). [3] Order Denying Preliminary Injunction, Tris Pharma, Inc. v. Teva Pharmaceuticals USA, Inc., Case No. 2:20-cv-05212 (D.N.J. Jan. 20, 2022). [4] Order Denying Motion to Dismiss, Tris Pharma, Inc. v. Teva Pharmaceuticals USA, Inc., Case No. 2:20-cv-05212 (D.N.J. May 2, 2022). [5] Scheduling Order, Tris Pharma, Inc. v. Teva Pharmaceuticals USA, Inc., Case No. 2:20-cv-05212 (D.N.J. Mar. 19, 2021).