Last updated: August 4, 2025
Introduction
European Patent EP2968111, titled “Method for producing a pharmaceutical composition,” exemplifies innovation within the pharmaceutical manufacturing sector. Filed by GlaxoSmithKline (GSK), this patent primarily addresses advanced formulations and production processes that optimize drug stability, bioavailability, and manufacturing efficiency. Understanding its scope, claims, and positioning within the patent landscape offers valuable insights for industry stakeholders, R&D strategists, and legal professionals.
Overview of EP2968111
EP2968111 was granted on April 27, 2016, based on the application filed on September 16, 2014. It falls under the European classification A61K (Preparations for medical, dental, or toiletry purposes), specifically targeting pharmaceutical formulation methods (A61K 31/00) and manufacturing processes. The patent claims encompass novel steps in producing specific drug compositions, emphasizing controlled processing conditions, stabilizer incorporation, and optimized excipient interactions.
Scope of the Patent
Core Focus and Innovation
The patent's scope centers on a method to produce a stable, bioavailable pharmaceutical composition, notably involving specific processing parameters such as temperature, pH, and mixing sequences, alongside unique excipient combinations. The invention aims to improve the stability of sensitive APIs—a persistent challenge in formulation science—and to streamline manufacturing workflows.
Key Aspects of the Scope:
- Methodology for preparation: The patent delineates a process involving sequential steps—e.g., dispersing active pharmaceutical ingredients (APIs) within specific excipient matrices, followed by controlled drying and particle size optimization.
- Formulation stability: It claims innovations in stabilizer inclusion that prevent API degradation during production and storage.
- Bioavailability enhancement: The process purportedly enhances solubility and absorption, especially for poorly soluble drugs.
- Manufacturing efficiency: By defining specific processing parameters, the patent aims to enable scalable, reproducible production with minimized batch-to-batch variability.
Limitations and Exclusions
While broad in scope, claims target particular formulations—such as dry powder inhalers, sustained-release tablets, or specific API classes—limiting application to these contexts unless explicitly claimed, thus narrowing the overall patent coverage.
Claims Analysis
The claims structure largely comprises independent and dependent claims that progressively specify processing steps, formulations, and excipient compositions. A detailed breakdown follows:
Independent Claims
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Claim 1 — Defines a method of producing a pharmaceutical composition comprising steps such as:
- Dispersing API in an excipient under specified conditions;
- Controlling parameters like temperature (e.g., below 50°C) and pH (e.g., within 4-7);
- Applying specific drying techniques (e.g., spray-drying) to obtain a stable, free-flowing powder.
This claim sets the broad foundation for the invention, emphasizing process parameters conducive to API stability.
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Claim 10 — Encompasses the pharmaceutical composition produced via the claimed method, characterizing the formulation's particle size distribution, excipient profile, and stability attributes.
Dependent Claims
- Claims 2-5 — Refine the method by specifying excipients such as polyvinylpyrrolidone, lactose, or specific surfactants, and detailed process conditions.
- Claims 6-8 — Address particular API properties, including those with thermosensitivity or low water solubility.
- Claims 11-15 — Define particular applications, such as inhalation powders or sustained-release matrices, narrowing scope to specific drug delivery modalities.
Patent Scope and Limitations
The claims are comprehensive for the described processes and formulations but are confined to those explicitly disclosed. Analogous methods or formulations using different processing parameters, excipients, or APIs outside disclosed ranges likely fall outside the patent’s protection, emphasizing the importance of precise claim scope for strategic freedom-to-operate analyses.
Patent Landscape and Competitive Position
Key Patent Families and Related Patents
EP2968111 exists within a robust landscape of formulations and process patents filed by GSK, citing prior art related to stabilized drug formulations and advanced manufacturing processes [1]. Similar patents like US patents US8679397 and EP2552294 focus on controlled-release systems and inhalable formulations, respectively. GSK’s prior art demonstrates consistent investment in process-based innovations, establishing a strong patent portfolio covering various drug delivery routes.
Competitor Patents
Major pharmaceutical entities such as Novartis, Pfizer, and Teva hold patents targeting similar formulations, including inhalation powders and dissolvable matrices. For example, patents like USRE46407 address stabilizing inhaled corticosteroids, overlapping in scope with GSK’s innovations, potentially resulting in licensing negotiations or litigation if competitive overlaps are significant [2].
Freedom to Operate and Patent Gaps
Assessment reveals that while EP2968111 claims considerable scope, it leaves room in terms of alternative processing routes, emerging excipient compositions, and novel APIs. Strategic R&D can leverage these gaps by designing formulations outside the specified parameters or developing entirely new process paradigms, thereby circumventing patent restrictions.
Implications for Industry Stakeholders
- R&D Teams: Innovation targeting different processing parameters, such as supercritical fluid techniques or alternative stabilizers, may develop competitive formulations while avoiding patent infringement.
- Legal Professionals: Vigilant monitoring of competing patents in the same domain can inform licensing, collaboration, or litigation strategies.
- Manufacturers: Implementing process steps similar to those claimed requires careful licensing or design-around strategies to ensure compliance and avoid infringement.
Conclusion
EP2968111 robustly claims a method for producing stable, bioavailable pharmaceutical compositions through controlled processing steps. Its scope emphasizes process parameters and formulation composition, aligning with GSK’s strategic focus on enhancing drug stability and manufacturability. The broader patent landscape indicates a highly competitive environment, emphasizing the importance of innovation within or outside the claimed scope to maintain freedom to operate.
Key Takeaways
- EP2968111’s claims focus on specific manufacturing processes that enhance drug stability and bioavailability.
- Strategic R&D should explore alternative process parameters and excipients to circumvent patent scope.
- The patent landscape for pharmaceutical formulations remains crowded, necessitating vigilance for overlapping patents and potential licensing opportunities.
- Designing around the patent involves innovative process modifications or formulation strategies outside the predefined parameters.
- Legal due diligence is essential when developing products that potentially fall within the patent’s scope to mitigate infringement risks.
FAQs
1. What types of formulations are covered by EP2968111?
The patent primarily covers dry powder formulations and methods suitable for inhalation or oral administration, emphasizing stability and bioavailability.
2. Can I produce similar compositions using different processing conditions without infringing EP2968111?
Potentially, if the alternative processes differ significantly from the claimed parameters (e.g., higher temperature, different drying techniques), they may circumvent the patent. Legal consultation is advised.
3. How does EP2968111 compare to other GSK patents?
It complements GSK’s wider portfolio of formulations and processes, focusing specifically on certain manufacturing steps. Other patents may cover different delivery routes or drug classes.
4. Is this patent enforceable across the entire European Union?
Yes, as a European patent, it is enforceable in all member states. Enforcement depends on national patent laws and judicial proceedings.
5. What are the strategic implications for competitors?
Competitors can innovate via alternative manufacturing methods, explore APIs outside the scope, or seek licensing agreements to use the covered processes legitimately.
References
[1] European Patent EP2968111, granted April 27, 2016.
[2] USRE46407, "Controlled-release inhalant composition," US patent, assigned to different assignee, demonstrating competitive scope overlaps.
