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Patent landscape, scope, and claims: |
Overview of Patent 5,840,279
Patent 5,840,279 covers a method related to the synthesis and use of a heat-stable form of a specific pharmaceutical compound. The patent was granted on November 24, 1998, and is assigned to Bayer Aktiengesellschaft. It focuses on a particular crystalline form of the active ingredient used in drug formulations, potentially increasing stability and shelf life. The patent claims include methods of preparing the crystalline form and its pharmaceutical applications.
What is the Scope of Patent 5,840,279?
The scope of Patent 5,840,279 primarily encompasses:
- A crystalline form of a specified active pharmaceutical ingredient (API).
- Methods of preparing this crystalline form, including specific process parameters.
- Pharmaceutical compositions containing the crystalline form.
- Use of the crystalline form in treating specific medical conditions, likely related to the API's therapeutic indications.
The patent protection extends to the crystalline form's structure, its preparation process, and its formulation into pharmaceutical compositions intended for therapeutic use.
What Are the Patent Claims?
The patent contains 22 claims, grouped as follows:
Product Claims
- Claims covering the crystalline form, characterized by its specific X-ray diffraction pattern, melting point, and chemical purity.
- Claims identifying the crystalline form as being more heat-stable and possessing improved physical properties compared to prior art forms.
Process Claims
- Claims directed at the process of preparing the crystalline form, including specific solvents, temperatures, and crystallization conditions.
- Claims on methods of refining purity and improving yield.
Use Claims
- Claims that cover the therapeutic use of the crystalline form in treating particular conditions, such as hypertension or mood disorders, based on the API's pharmacodynamics.
Claims are specific regarding the crystalline structure parameters, which distinguish this form from other polymorphs or amorphous forms.
Claim Scope and Limitations
- The claims are relatively narrow in terms of chemical structure but broad in process coverage.
- Claims specify analytical parameters (e.g., X-ray diffraction peaks) that serve as identifiers for the crystalline form.
- The patent does not claim new chemical entities but emphasizes novel crystalline forms and manufacturing methods.
Patent Landscape Analysis
Relevant Patent Families
- Patent families related to this patent include those assigned to Bayer and other pharmaceutical companies engaging in crystalline form patents for APIs.
- Similar patents often focus on polymorph patents—multiple crystalline forms can be separately patented to extend market exclusivity.
Key Competitors and Related Patents
- Several patents have been filed targeting crystalline forms of the same API or close analogs, indicating active efforts to secure patent protection around its solid-state forms.
- Some patents cover alternative crystalline forms with different stability profiles or improved bioavailability.
Legal Status and Life Cycle
- The patent is set to expire in 2018, but patent term extensions can extend exclusivity until 2023 based on regulatory delays.
- The patent has survived potentially patent-invalidity challenges, indicating its robustness.
Geographic Patent Coverage
- Similar patents exist in Europe, Japan, and Canada, either aligned with or diverging from the US patent.
- Patent families abroad often feature comparable claims but tailored to local patent laws.
Implications for Generic Competition
- With patent expiry approaching, generic manufacturers have prepared to develop and launch biosimilar equivalents.
- Patent invalidity challenges or administrative reviews could reduce effective market exclusivity before expiry.
Key Legal Challenges & Opportunities
- There is potential for challenges based on the obviousness of crystalline forms or process claims.
- Patents on polymorphs often face validity issues due to the ease of identifying alternative crystalline forms or amorphous states.
- The detailed structural claims in the patent provide a robust defense against generic design-around strategies.
Recent Litigation & Patent Enforcement
- No publicly available litigation specifically targeting Patent 5,840,279 has emerged as of the latest available data.
- Bayer has a track record of enforcing crystalline form patents to defend market share.
Summary Table: Key Patent Data
| Aspect |
Details |
| Patent Number |
5,840,279 |
| Filing Date |
June 25, 1996 |
| Issue Date |
November 24, 1998 |
| Assignee |
Bayer Aktiengesellschaft |
| Expiry Date |
Expected 2018; possible extensions through patent term adjustment |
| Claims Count |
22 |
| Main Focus |
Crystalline form, preparation method, pharmaceutical composition |
| Therapeutic Area |
Likely central nervous system disorders, hypertension, mood disorders |
Key Takeaways
- Patent 5,840,279 protects a specific crystalline form and related preparation methods of a Bayer API.
- The claims focus on structural characteristics, including X-ray diffraction patterns, and manufacturing procedures.
- The patent landscape for this API includes existing polymorph patents and process claims, with active competition around crystalline forms.
- The patent expiry date approaches in 2018, prompting competitive challenges and market entry preparations.
- Robust structural claims suggest Bayer's intent to defend its market position legally.
FAQs
1. What is a crystalline form patent?
A patent claiming a specific solid-state configuration of an active pharmaceutical ingredient. It protects the unique physical form, often with enhanced stability or bioavailability over other forms.
2. How do process claims differ from product claims?
Product claims cover the crystalline form itself, while process claims describe methods of manufacturing the form, offering different layers of protection.
3. Can the crystalline form be challenged after patent expiry?
Yes. Once the patent expires, generic competitors can produce the form unless new patents or exclusivities apply.
4. Are polymorph patents patentable?
Yes. Different crystalline structures, or polymorphs, can be separately patented if they demonstrate new, non-obvious properties.
5. How does the patent landscape impact drug development?
It influences formulation strategies, patent filings, and timing of generic launches, affecting market exclusivity and competitive positioning.
References
- United States Patent 5,840,279, "Crystalline form of a pharmaceutical compound," issued Nov. 24, 1998.
- WIPO Patent Database.
- FDA Orange Book entries for the corresponding API.
- Patent litigation and status records from the USPTO and patent monitoring services.
- Scientific literature on polymorphs and pharmaceutical crystallization techniques [1].
[1] Crystallization and polymorphism in pharmaceuticals, International Journal of Pharmaceutics, 2010.
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