Last updated: July 28, 2025
Introduction
The litigation between Collegium Pharmaceutical, Inc. (“Collegium”) and Teva Pharmaceuticals USA, Inc. (“Teva”) represents a significant patent dispute within the pharmaceutical industry, centered on patent infringement allegations and intellectual property rights associated with controlled-release formulations. Initiated in early 2018 in the District of Delaware, the case highlights the ongoing tension between innovator companies and generic manufacturers over patent protections and market entry strategies.
Case Overview
Parties
- Plaintiff: Collegium Pharmaceutical, Inc., a biopharmaceutical company specializing in developing and commercializing prescription medications with controlled-release formulations.
- Defendant: Teva Pharmaceuticals USA, Inc., one of the world's leading generic drug manufacturers, with extensive portfolios across therapeutic categories.
Legal Action
Filed on February 6, 2018, Collegium alleges that Teva infringed upon U.S. Patent No. 9,889,308 (the ’308 patent), which protects a specific formulation and method of making its controlled-release oxycodone product aimed at managing pain with reduced abuse potential.
Claims
- Patent infringement of the ’308 patent under 35 U.S.C. § 271.
- Unjust patent assertion, seeking injunctive relief, damages, and attorneys’ fees.
Patent Details
The core patent in question, the ’308 patent, broadly claims a controlled-release oxycodone formulation characterized by specific release profile parameters, excipient compositions, and manufacturing processes. Collegium’s product, Xtampza ER, utilizes this patented technology, aiming at providing effective pain relief with tamper-resistant features.
Teva’s proposed generic, alleged to be a bioequivalent formulation, challenges Collegium’s patent rights, asserting invalidity and non-infringement. The dispute positioned the validity of the patent as central to market competition and generics’ market entry.
Procedural History
- Initial Complaint: Filed by Collegium in February 2018, asserting patent infringement.
- Pleadings & Motions: Teva responded with motions to dismiss and to invalidate the patent based on obviousness and other grounds.
- Discovery & Inter Partes Review: Both parties engaged in discovery, with Teva challenging the patent’s validity via inter partes review (IPR) proceedings instituted at the Patent Trial and Appeal Board (PTAB).
- Summary Judgment & Trial: The case did not proceed to a jury trial; instead, dispositive motions, including motions for summary judgment on validity and infringement, played pivotal roles.
- Settlement Negotiations: While settlement efforts occurred, no formal resolution was publicly disclosed as of the latest filings.
Legal Significance
The case underscores critical issues in pharmaceutical patent law:
- The scope of patent claims protecting controlled-release formulations.
- The validity of formulation patents challenged through IPR proceedings.
- The strategic use of patent litigation and IPR to delay generic market entry.
- The importance of detailed patent claims covering manufacturing processes to defend against generic challenges.
Collegium sought to preserve its market exclusivity and prevent Teva from entering with a potentially infringing generic. Conversely, Teva aimed to invalidate the patent claims, facilitating generic competition aligned with the Hatch-Waxman framework.
Outcome and Current Status
As of the most recent docket entries, the case remains unresolved, with significant proceedings ongoing at the PTAB regarding patent validity. The district court proceedings were stayed pending resolution of the IPR, consistent with practices to conserve judicial resources when validity is contested before the PTAB.
The outcome depends heavily on the PTAB’s decision—if the patent claims are upheld, Collegium gains a robust defense against generic infringement; if invalidated, Teva could proceed to market its generic oxycodone product, impacting Collegium’s market position.
Legal and Business Implications
This case exemplifies strategic patent management in the heavily regulated and patent-rich pharmaceutical industry. Patent holders must craft claims that withstand validity challenges while differentiating their formulations to maintain market exclusivity. Simultaneously, generic manufacturers leverage IPRs to challenge patents early, potentially reducing litigation duration and associated costs.
Successful defense of the ’308 patent reinforces Collegium’s market dominance with Xtampza ER, emphasizing the importance for innovator companies to enforce patent rights vigorously. Conversely, a successful invalidation or settlement favoring Teva would demonstrate the value of patent challenges in expanding generic access.
Key Legal Considerations
- Patent Invalidity via IPR: The PTAB's decisions can significantly influence district court outcomes, underscoring the importance of early validity challenges.
- Claim Construction: Precise claim interpretation is vital for establishing infringement or invalidity.
- Patent Term & Market Exclusivity: The timing of litigation and patent filings impacts market exclusivity strategies under Hatch-Waxman.
- Formulation Patents vs. Method Patents: Broad claims covering formulations are generally more defensible than narrow process patents, but both require clarity and durability.
- Settlement and Patent Litigation Strategy: Resolving disputes can involve patent licenses, settlement agreements, or further litigation.
Conclusion
The litigation of Collegium Pharmaceutical, Inc. v. Teva Pharmaceuticals illustrates contemporary patent challenges in the pharmaceutical industry. The case’s resolution hinges on PTAB validity findings and their acceptance in district courts, influencing market dynamics significantly. Such disputes underscore the importance of strategic patent drafting, proactive validity defenses, and the utilization of IPR proceedings to secure or contest market exclusivity.
Key Takeaways
- Effective patent claim drafting is essential to withstand validity challenges.
- Inter partes review proceedings play a crucial role in pharmaceutical patent disputes.
- Strategic litigation combined with PTAB validity determinations influences market exclusivity periods.
- Innovator companies must enforce patent rights vigorously to defend against generic entry.
- The ultimate resolution impacts pricing, access, and competition in the pharmaceutical market.
FAQs
1. What is the significance of the ’308 patent in Collegium’s defense?
It is the primary patent protecting Collegium’s Xtampza ER formulation, crucial for maintaining market exclusivity against generics like Teva.
2. How does inter partes review (IPR) affect patent litigation?
IPR allows the PTAB to assess patent validity early in the litigation process, often serving as a pivotal battleground that can lead to patent invalidation and influence district court rulings.
3. Why do pharmaceutical companies litigate over formulation patents?
Formulation patents are often central to controlling market share because they can be broad and difficult for generics to design around, providing a strategic advantage.
4. Can a patent challenged in IPR be upheld?
Yes. The PTAB can uphold the patent if the claims are found to be valid based on the evidence presented.
5. What are the commercial implications if Teva successfully invalidates the patent?
Teva could launch a generic version of Xtampza ER, potentially reducing revenue for Collegium and increasing healthcare affordability through increased competition.
Sources
- Collegium Pharmaceutical, Inc. v. Teva Pharmaceuticals USA, Inc., District of Delaware, Case No. 1:18-cv-00300, Potentially available via PACER or legal databases.
- U.S. Patent No. 9,889,308.
- PTAB decision records regarding inter partes review proceedings initiated by Teva.
- Court docket updates and legal analyses of the case proceedings.
