Last updated: February 14, 2026
Case Overview
Recro Gainesville LLC filed suit against Actavis Laboratories FL Inc. on November 4, 2014, in the District Court for the District of Delaware. The complaint alleges patent infringement related to pharmaceutical formulations, specifically asserting infringement of U.S. Patent No. 8,729,107, titled "Oral Controlled Release Formulations." The patent claims a controlled-release oral pharmaceutical composition containing a specific drug and polymer matrix.
Patent Specification
The '107 patent claims a controlled-release formulation of the active ingredient with particular polymer types and release profiles. The patent's priority date is July 16, 2012, and it was granted on May 20, 2014. The patent aims to protect formulations with specific drug release characteristics sustained over a pre-defined period.
Allegations
Recro contends that Actavis's generic version infringes the '107 patent by manufacturing, using, and selling formulations that meet claim elements, including the controlled-release profile and specific polymer composition. Recro seeks injunctive relief, damages, and royalties.
Legal and Technical Claims
The core legal claim involves direct patent infringement under 35 U.S.C. § 271(a). Recro asserts that Actavis's generic products include all elements of the patent claims when used as intended. The technical argument centers on whether Actavis's formulations satisfy the specific polymer composition and release profile limitations set in the patent.
Procedural Timeline
- Complaint filed: November 4, 2014
- Patent asserted: U.S. Patent No. 8,729,107
- Case status (as of the latest update): Pending, with pre-trial motions and potential settlement discussions ongoing.
Key Legal Considerations
- Validity of the patent: The defendant may challenge the patent's novelty or non-obviousness, arguing prior art invalidates the claim.
- Infringement analysis: Established via "all elements" rule; whether the accused product embodies every claim element.
- Statutory defenses: Non-infringement, invalidity, or patent misuse.
Market and Strategic Implications
The case underscores the ongoing patent litigation in the pharmaceutical sector, particularly between brand owners and generic manufacturers. A ruling favoring Recro could lead to an injunction preventing market entry of Actavis's generic, affecting market dynamics and pricing.
Recent Developments
As of the latest update, no final judgment has been issued. The case remains in the pre-trial phase, with discovery and potentially dispositive motions pending.
Analysis
This litigation exemplifies typical patent enforcement efforts in the broad field of controlled-release pharmaceuticals. It highlights the importance of detailed patent drafting, especially regarding polymer compositions and release profiles, which are common points of contention in formulation patent disputes.
The outcome could reinforce or erode the enforceability of formulation patents with specific release characteristics. The defendant's potential invalidity defenses based on prior art could threaten the patent's survival, influencing future patent strategies in this sector.
Key Takeaways
- The case revolves around patent infringement claims targeting pharmaceutical formulation specifics.
- Recro’s patent has a focus on controlled-release profiles and polymer compositions.
- The outcome may impact the market launch of generic versions, affecting pricing strategies.
- Challenges to patent validity remain a significant factor in such disputes.
- The case illustrates the critical importance of precise patent claims and supporting specifications.
FAQs
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What is the core patent involved in this case?
U.S. Patent No. 8,729,107 covers a controlled-release oral pharmaceutical formulation.
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What are the main legal issues?
Infringement of patent claims and potential challenges to patent validity.
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When was the patent granted?
May 20, 2014.
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What products are involved?
Actavis's generic formulations that allegedly replicate the patented controlled-release profile.
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Could the patent be invalidated?
Yes, based on prior art or obviousness arguments raised by the defendant.
Sources
[1] Public court records, District of Delaware.
