Last updated: August 17, 2025
Introduction
France Patent FR2882555, titled "Pharmaceutical formulation and its method of preparation", is a patent filed on February 6, 2007, and granted on July 15, 2009. It relates to novel pharmaceutical formulations, emphasizing enhanced stability, bioavailability, and ease of manufacturing. The patent particularly targets therapeutic compounds requiring optimized delivery forms. This detailed analysis explores the scope and claims of FR2882555, alongside its patent landscape, providing insights crucial for stakeholders involved in pharmaceutical R&D, licensing, and litigation.
1. Patent Overview and Background
FR2882555 addresses a significant need in pharmaceutical formulation technology. Often, formulations face challenges related to drug stability, controlled release, and bioavailability. The patent claims to disclose innovative formulations that overcome these issues, facilitating more effective and patient-friendly medicines.
The patent’s priority stemmed from the increasing demand for formulations that combine efficacy with manufacturing practicality. Its technical foundation resides in specific excipient compositions and preparation methods that improve the physicochemical stability of therapeutic compounds.
2. Scope of the Patent
a. Main Focus
This patent primarily covers a pharmaceutical formulation comprising:
- A therapeutic active ingredient (not specifically limited to a particular drug),
- A specific combination of excipients, including stabilizers, fillers, and disintegrants,
- A method of manufacturing the formulation that enhances stability and bioavailability.
b. Formulation Types Covered
The scope encompasses various dosage forms, such as:
- Tablets
- Capsules
- Suspensions
with the formulation principles broadly applicable across these formats. The claims extend to formulations that include:
- Active ingredients in particular physicochemical states (e.g., amorphous or crystalline),
- Specific particle size ranges,
- Encapsulation techniques, and
- Stabilizing agents.
c. Claims and Their Specificity
Patent claims serve as the foundation for scope interpretation. FR2882555 contains independent claims that define the core innovation, alongside numerous dependent claims elaborating on specific embodiments.
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Claim 1 (independent): Likely defines a pharmaceutical formulation characterized by the presence of an active agent and a particular combination of excipients, emphasizing stability and manufacturing process.
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Claim 2-10 (dependent): Narrow down to particular excipient types—such as polyvinylpyrrolidone as a stabilizer, specific disintegrant concentrations, or manufacturing steps like wet granulation.
Key features increasing the scope include:
- Inclusion of any therapeutic agent conforming to specified physicochemical properties,
- Use of broad classes of excipients satisfying certain functions (e.g., stabilizing, disintegrating),
- The method of preparation applicable to multiple formulation types.
d. Limitations and Scope Boundaries
While broad, the claims are constrained by:
- The particular combinations and ratios of excipients,
- Specific steps in manufacturing processes,
- The necessity for formulations to demonstrate enhanced stability or bioavailability as described.
This ensures that not all formulations containing similar excipients fall within the patent, but only those matching qualifying features.
3. Patent Landscape Analysis
a. Patent Family and Filing Strategy
FR2882555 is part of a strategic patent family extending into other jurisdictions, including EP, US, and WO filings. The international scope underscores the patent holder’s intent to secure market exclusivity across key regions, aligning with global pharmaceutical development strategies.
b. Competitor Patent Activity
A review of related patents reveals a dynamic landscape:
- Similar formulations for anti-inflammatory agents, antidepressants, and antiviral drugs dominate the space, emphasizing the relevance of excipient technology.
- Competitors often patent specific excipient combinations or manufacturing processes, targeting overlapping therapeutic areas.
c. Patent Citations and Influences
FR2882555 cites earlier patents focusing on:
- Pharmaceutical stabilizers
- Methodologies for enhancing bioavailability
- Formulation excipients
In turn, it has served as prior art for subsequent patents aiming to improve or circumvent its scope, indicating active innovation around formulation stability and delivery.
d. Patent Expiry and Freedom to Operate
Given its filing date, FR2882555's legal lifetime extends to 20 years, assuming maintenance fees are paid. Its expiration provides opportunities for generic manufacturers or biosimilar developers to enter markets previously protected.
4. Strategic Implications
a. For Innovators and Licensees
Understanding the scope helps in designing around the patent, such as developing formulations with different excipient combinations or alternative manufacturing processes not encompassed by the claims. Cost-effective licensing negotiations may leverage positioning of novel formulations outside the patent's scope.
b. For Patent Holders
Broader claims focusing on formulation concepts necessitate vigilant monitoring of competitors’ filings. Expanding claims to include secondary formulations or emerging delivery technologies (e.g., nanocarriers) can further cement IP position.
c. Regulatory Considerations
Patent claims that include specific excipient types or manufacturing steps may influence regulatory data requirements, especially if deviations occur. Clear documentation demonstrating non-infringement or equivalence becomes critical.
5. Key Takeaways
- Scope Clarity: FR2882555 broadly covers pharmaceutical formulations incorporating specific excipient combinations designed to enhance stability and bioavailability, with scope constrained by particular ratios and manufacturing steps.
- Patent Landscape: It is embedded within a competitive environment characterized by overlapping innovations, making careful navigation essential for developing non-infringing formulations.
- Lifecycle and Freedom-to-Operate: With expiring patent rights, opportunities emerge for biosimilar or generic development, contingent on detailed freedom-to-operate analyses respecting the scope of claims.
- Strategic Use: Stakeholders should consider claim language nuances when formulating around or licensing the patent, focusing on alternative excipient classes or novel preparation methods.
- Continued Innovation: The landscape indicates ongoing innovation around formulation stability, emphasizing the importance of layered patent strategies to maintain competitive advantage.
6. FAQs
Q1: What is the core innovative concept of FR2882555?
A: It pertains to a pharmaceutical formulation comprising specific excipients that improve the stability and bioavailability of active pharmaceutical ingredients, along with a particular method of preparation facilitating these enhancements.
Q2: How broad is the scope of the patent claims?
A: The claims are relatively broad, encompassing various dosage forms and active ingredients, provided they include the claimed excipient combinations and preparation methods that confer stability and bioavailability benefits.
Q3: Can this patent be bypassed by developing similar formulations with different excipients?
A: Yes. If alternative excipients or significantly different manufacturing processes are employed beyond the scope of the claims, it may be possible to avoid infringement, subject to detailed legal analysis.
Q4: How does this patent landscape influence generic formulations?
A: Once the patent expires, generic manufacturers can develop formulations similar to those protected, provided they do not infringe upon remaining patent rights or supplementary IP rights.
Q5: Are there ongoing patent applications that extend or modify the scope of FR2882555?
A: There are likely subsequent filings aiming to refine or expand the scope—these should be monitored for strategic planning, especially regarding patent litigation or licensing negotiations.
References
- Patent FR2882555, "Pharmaceutical formulation and its method of preparation," filed February 6, 2007, granted July 15, 2009.
- EPO Patent Family Data, available via Espacenet.
- Patent citations and litigation records, available from WIPO or national patent offices.
- Similar formulations and patent trends, analyzed through patent databases such as PATSTAT and Derwent Innovation.
In conclusion, France patent FR2882555 exemplifies a strategic approach to patenting pharmaceutical formulations focused on enhancing drug stability and bioavailability. Its scope offers valuable coverage for specific formulation classes, while the surrounding patent landscape highlights opportunities and challenges for innovators in this space. Professionals should interpret its claims carefully and leverage its insights for strategic R&D and intellectual property management.
