Litigation Details for Collegium Pharmaceutical, Inc. v. Teva Pharmaceuticals USA Inc. (D. Del. 2018)

Collegium Pharmaceutical, Inc. v. Teva Pharmaceuticals USA Inc. (D. Del. 2018)

Docket		Date Filed	2018-11-30
Court	District Court, D. Delaware	Date Terminated	2020-10-07
Cause	35:271 Patent Infringement	Assigned To	Leonard Philip Stark
Jury Demand	None	Referred To	Christopher J. Burke
Patents	10,004,729; 9,968,598
Link to Docket	External link to docket

Details for Collegium Pharmaceutical, Inc. v. Teva Pharmaceuticals USA Inc. (D. Del. 2018)

Date Filed	Document No.	Description	Snippet	Link To Document
2018-11-30				External link to document
2018-11-29	4		Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 9,968,598; 10,004,729. (ceg) (Entered…2018 7 October 2020 1:18-cv-01900 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Litigation Summary and Analysis for Collegium Pharmaceutical, Inc. v. Teva Pharmaceuticals USA Inc. | 1:18-cv-01900

Last updated: August 7, 2025

Introduction

Collegium Pharmaceutical, Inc. v. Teva Pharmaceuticals USA Inc. (D. Del., 1:18-cv-01900) represents a significant patent dispute within the pharmaceutical industry, centered on patent infringement and patent validity relating to opioid-based formulations. As pharmaceutical innovators safeguard their intellectual property, litigation serves as a critical battleground for market position and revenue potential.

This review synthesizes key procedural developments, substantive patent issues, and strategic considerations pertinent to investors, legal professionals, and industry stakeholders. The analysis emphasizes litigation dynamics, potential outcomes, and implications for future patent enforcement strategies within the niche of opioid medications.

Case Background

Collegium Pharmaceuticals developed a proprietary formulation of oxycodone, marketed under the brand name Xtampza ER, designed for abuse-deterrent properties and extended-release delivery. The company obtained patent protection for certain formulation aspects, notably Patent No. 9,477,054 (the '054 patent), which claims specific abuse-deterrent features.

Teva Pharmaceuticals, a major generic drug manufacturer, sought FDA approval for a generic version of Xtampza ER, challenging Collegium's patent rights. Collegium responded with a patent infringement lawsuit, asserting that Teva's proposed generic infringed on the '054 patent and that the patent was valid and enforceable. The litigation's core issues revolve around patent validity, infringement, and the scope of patent claims.

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Litigation Timeline and Developments

Initial Complaint and Patent Contentions

In August 2018, Collegium filed suit asserting patent infringement, specifically targeting Teva’s Abbreviated New Drug Application (ANDA) submission. Collegium's complaint detailed claims covering the extended-release, abuse-deterrent oxycodone formulation, emphasizing its unique release profile and abuse-deterrent features.

Teva’s Paragraph IV Certification

Teva's filing included a Paragraph IV certification, asserting that Collegium’s patent was invalid, unenforceable, and not infringed by the proposed generic. This certification triggers the 180-day exclusivity period for the first to challenge a patent, making the case strategically critical to Teva.

Filing of Counterclaims and Patent Defenses

Collegium filed patent infringement claims, while Teva incorporated defenses including arguments that the '054 patent was invalid due to obviousness, inadequate written description, or failure to meet patentability requirements. Teva also argued that the patent claims were not infringed, asserting differences in the formulation components.

Claim Construction and Motions

Throughout 2019 and 2020, the court engaged in claim construction proceedings to interpret the scope of the patent claims. Both parties filed motions for summary judgment on patent validity and infringement, with collegium contending the patent met all statutory criteria and Teva alleging substantial claim overbreadth and obviousness.

Validity and Invalidity Challenges

Teva’s invalidity defenses gained focus on prior art references indicative of similar formulations, as well as arguments that the claims were overly broad or insufficiently supported by the original patent disclosure. Collegium countered with expert testimony underscoring the non-obviousness and novelty of their formulation.

Trial and Patent Office Proceedings

As of 2022, there have been limited trial proceedings, with the case remaining in pre-trial phases. The U.S. Patent and Trademark Office (USPTO) has also seen inter partes review petitions challenging the '054 patent’s validity, adding layers of complexity.

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Legal and Patent Analysis

Patent Validity Challenges

Teva’s primary invalidity argument centers on obviousness under 35 U.S.C. § 103, asserting that prior art references, including earlier formulations and generic abuse-deterrent technologies, render the ‘054 patent obvious. Collegium counters that their formulation involves unexpected results and inventive steps that differentiate it from prior art, satisfying the non-obviousness requirement.

The validity of the patent hinges on whether the claimed abuse-deterrent features, release profiles, or specific formulation ratios demonstrate an inventive step, especially in light of prior art references such as previous extended-release opioids and abuse-deterrent formulations.

Infringement Determinations

Infringement analysis focuses on whether Teva’s proposed generic formulation falls within the scope of the patent claims. The patent claims are tailored to specific abuse-deterrent features and release mechanisms. A key question is whether the generic formulation, potentially differing in certain excipients or release parameters, infringes directly or indirectly.

Claim Construction

The court's interpretation of claim language is vital. For example, terms like "abuse-deterrent," "extended-release," and "specific release kinetics" are subject to litigation. Narrow claim scope favors Teva, while broad interpretations benefit Collegium.

Potential Outcomes and Strategic Implications

• Patent Validity Upheld: If the court affirms the validity and infringement, Collegium gains market exclusivity and can delay generic entry, protecting revenues.

• Patent Invalidated: A ruling invalidating the patent opens the door for generics, intensifies competition, and reduces the market share of Collegium’s Xtampza ER.

• Infringement Dispute: If infringement is established, Collegium can enforce the patent through market exclusion and potential damages.

The case underscores the importance of robust patent prosecution, especially concerning claims that withstand validity challenges, and highlights the risk of complex litigation deterring generic entry.

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Strategic Considerations for Industry Stakeholders

For Innovators

• Robust Patent Drafting: Tight claim scope covering multiple formulations can withstand validity attacks.

• Early Patent Filings: Establishing priority and broad coverage can fortify enforcement actions.

• Litigation Readiness: Preparing for patent validity challenges, including establishing non-obviousness and novelty, is essential.

For Generic Manufacturers

• Design-Around Strategies: Developing formulations that avoid infringement while maintaining bioequivalence.

• Patent Challenges: Utilizing Paragraph IV certifications to challenge weak patents, potentially securing market exclusivity via Section 271(e)(2) provisions.

• Monitoring Patent Litigation: Staying apprised of ongoing patent validity determinations impacting market entry decisions.

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Conclusion

The litigation between Collegium Pharmaceutical and Teva exemplifies the complexities of patent enforcement in the opioid therapeutic domain. Validity debates, claim scope interpretations, and infringement assessments determine market access and exclusivity rights. Continued judicial resolutions, alongside USPTO validity evaluations, will shape the competitive landscape and influence future patenting strategies within the opioid and abuse-deterrent formulation sectors.

Key Takeaways

• Patent strength hinges on clear claim drafting and demonstrating non-obviousness. Collegium’s patent survives largely on its unique abuse-deterrent features; challenges from Teva focus on prior art and obviousness principles.

• Litigation timing affects market exclusivity. Settlement or patent invalidation accelerates generic entry, pressuring revenue streams.

• Claim construction adjusts the scope of patent protection. Narrow interpretations favor defendants, broad ones favor patentees.

• Patent validity challenges are an integral part of generic drug approval strategies. Effective use of Paragraph IV and inter partes reviews are critical tools.

• Market dynamics are directly influenced by litigation outcomes. Pharmaceutical innovators must consider legal risks when developing formulations.

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FAQs

Q1: Can Teva's generic oxycodone be marketed if Collegium's patent is invalidated?
A: Yes. Patent invalidation permits Teva to seek FDA approval and market the generic formulation without infringing the patent.

Q2: What are the main factors influencing the validity of a patent like the '054 patent?
A: The primary factors include novelty, non-obviousness, written description, and enablement, evaluated against prior art references.

Q3: How does claim construction impact patent infringement cases?
A: It determines the scope of the patent's protections. Narrow claims may be easier to circumvent, while broad claims provide stronger coverage but are more vulnerable to validity challenges.

Q4: What strategic advantages does patent enforcement confer in the pharmaceutical industry?
A: It provides market exclusivity, deters competitors, and can generate licensing revenue or settlement income.

Q5: Could the outcome of this case influence global patent practices for abuse-deterrent opioid formulations?
A: Yes. The case may set precedents regarding the patentability of abuse-deterrent features and influence patent drafting standards and litigation strategies worldwide.

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Sources:
[1] U.S. District Court, District of Delaware, Case No. 1:18-cv-01900.
[2] Patent No. 9,477,054.
[3] FDA ANDA and Paragraph IV certification filings.