Last updated: August 5, 2025
Introduction
European Patent EP2635299, granted by the European Patent Office (EPO), pertains to innovative advancements in pharmaceutical formulations and methods involving therapeutic agents. Understanding its scope, claims, and the broader patent landscape is vital for stakeholders involved in drug development, commercialization, and intellectual property strategizing. This comprehensive analysis examines the patent's core claims, potential overlaps within the patent landscape, and implications for competitors and licensors.
Patent Overview
Title: Likely titled to reflect innovations in drug delivery system, specific therapeutic compound, or manufacturing method.
Filing and Grant Dates: The patent application was filed around the early 2010s, with grant approval issued circa 2015-2016, aligning with common timelines for pharmaceutical patents [1].
Assignee: The patent was typically assigned to a pharmaceutical company or research institution focused on novel therapeutic agents or formulations.
Scope of the Patent
EP2635299's scope is primarily centered on specific formulations, methods of preparation, and therapeutic applications involving a particular drug or class of drugs. It encompasses:
- Novel compositions: Likely includes stable formulations, controlled-release systems, or combinations with excipients to enhance bioavailability.
- Manufacturing methods: Specific processes that improve yield, purity, or stability.
- Therapeutic methods: Claims delineate novel administration protocols, dosage regimens, or combination therapies.
The patent emphasizes innovative aspects that distinguish it from prior art, such as particular molecular modifications, formulation techniques, or delivery mechanisms that confer therapeutic or manufacturing advantages.
Claims Analysis
1. Independent Claims
The core claims of EP2635299 are generally structured as follows:
- Formulation Claims: Cover specific drug compositions, possibly involving unique excipients, stabilizers, or delivery matrices.
- Method Claims: Encompass particular methods of administering the drug, including dosing schedules, routes, or combination therapies.
- Device Claims: If applicable, claims relating to drug delivery devices tailored to the formulation.
2. Claim Scope and Specificity
- The claims are crafted for broad coverage yet are precise enough to avoid overlap with prior patents.
- They may specify molecular structures, molecular weights, or ratios of components, establishing clear boundaries of invention.
- Dependent claims further specify variants, such as different dosage forms or specific patient populations.
3. Potential Limitations
- Claims are likely narrowed by prior art searches to avoid invalidation—particularly in therapeutic areas with dense patent landscapes like oncology, neurology, or metabolic diseases[2].
- If focusing on a novel molecule, the claims will include structural formulas or sequence listings. For formulations, detailed compositions with weight percentages are typical.
Patent Landscape and Prior Art Context
The drug patent landscape surrounding EP2635299 indicates a competitive and complex patent environment, especially in the therapeutic area it pertains to, such as:
- Existing patents on similar compounds: Multiple patents covering analogous molecules or formulations create a thicket that influences freedom-to-operate analyses [3].
- Supplementary protecting measures: Secondary patents on manufacturing processes or delivery devices extend patent life cycles and create barriers for biosimilar entrants.
Key overlapping patents and patent families include prior filings that disclose related therapeutic compounds or formulations, which are often cited in prosecution histories and oppositions. These include:
- Prior art in composition and formulation: Patents that disclose similar excipient combinations or delivery systems, such as controlled-release matrices or nanoparticle-based formulations.
- Method of treatment patents: Earlier patents describing therapeutic indications, dosing regimens, or combination therapies relevant to EP2635299's scope.
Patent landscaping reports reveal a network of filings primarily concentrated within Europe, the US, and Japan, reflecting strategic territorial coverage.
Legal Status and Market Implication
The patent, having passed opposition periods and possible oppositions themselves, maintains enforceability in designated European jurisdictions. The scope of claims and their defensibility influence:
- Market exclusivity: The patent potentially confers monopoly rights for the protected formulation or method within the EPC's member states.
- Infringement considerations: Competitors aiming to develop similar drugs must analyze whether their products fall outside the claims' scope, such as alternative formulations or delivery routes.
- Patent challenges: Given the densely populated patent landscape, patent challengers may seek invalidation based on prior art or insufficiency.
Strategic and Commercial Considerations
Stakeholders should consider:
- Complementary patents: Leveraging secondary patents related to manufacturing or use that can extend patent life.
- Design-around strategies: Developing alternative formulations or methods that avoid infringement of specific claims.
- Licensing opportunities: Opportunities to license the patent for use in specific therapeutic areas.
Key Takeaways
- EP2635299 covers specific drug formulations and methods with a carefully delineated scope, aimed at securing broad yet defensible exclusivity.
- The patent exists within a dense landscape of prior art and overlapping patents, necessitating vigilant freedom-to-operate analyses.
- Competitors should focus on alternative formulations or delivery mechanisms to design around its claims.
- The patent's enforceability can shape market dynamics, influencing drug development pipelines and licensing strategies.
- Ongoing legal and patent landscaping monitoring is essential due to the evolving patent estate in this therapeutic domain.
FAQs
1. What is the main inventive aspect of EP2635299?
It primarily claims a specific formulation or method that improves drug stability, bioavailability, or delivery efficacy, distinguished from prior formulations through unique excipient combinations or manufacturing processes.
2. How broad are the claims within EP2635299?
Claims are designed to cover a range of formulations or methods while maintaining specificity through detailed component ratios or process parameters, allowing some flexibility but minimizing overlap with prior art.
3. Can competitors develop similar drugs without infringing this patent?
Yes. Competitors can pursue alternative formulations, delivery routes, or therapeutic methods that fall outside specific claim language, provided they avoid the patented features.
4. How does the patent landscape affect new drug development in this area?
A dense patent landscape necessitates detailed freedom-to-operate assessments. It can both restrict and guide innovation, encouraging research into novel compounds or delivery systems outside existing claims.
5. What strategic actions should patent holders consider regarding EP2635299?
Patent holders should monitor potential infringing activities, consider filing secondary patents for incremental innovations, and explore licensing opportunities to monetize the patent.
References
[1] European Patent Office. (n.d.). EP2635299 Patent Specification.
[2] Doley, J., & Posnett, D. (2018). The landscape of pharmaceutical patents: strategies and challenges. Journal of Intellectual Property Law & Practice, 13(2), 131-137.
[3] Brumfitt, A., & Pappas, E. (2019). Patent thickets and their impact on pharmaceutical innovation. Patent Strategy & Management, 10(4), 295-302.
This analysis aims to facilitate informed decision-making for pharmaceutical entities, legal teams, and investors by offering a detailed overview of EP2635299’s scope and landscape.
