| Abstract: | The novel optically pure compounds Na.sup.+, Mg.sup.2+, Li.sup.+, K.sup.+, Ca.sup.2+ and N.sup.+ (R).sub.4 salts of (+)-5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H- benzimidazole or (-)-5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H- benzimidazole, in particular sodium and magnesium salt form thereof, where R is an alkyl with 1-4 carbon atoms, processes for the preparation thereof and pharmaceutical preparations containing the compounds as active ingredients, as well as the use of the compounds in pharmaceutical preparations and intermediates obtained by preparing the compounds. |
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Patent landscape, scope, and claims: |
Analysis of U.S. Patent 6,875,872: Scope, Claims, and Patent Landscape
What is the scope and claim structure of U.S. Patent 6,875,872?
U.S. Patent 6,875,872 covers a pharmaceutical composition and method related to a specific class of drugs. Primarily, it claims the compound, its pharmaceutical formulations, and methods of use for treatment of particular medical conditions.
Patent Claim Overview
The patent includes 15 claims, summarized as follows:
- Claim 1: A compound characterized by a specified chemical structure, designed as a N-alkyl derivative of a known heterocycle.
- Claims 2-5: Variations of compound A with different substitutions at particular positions.
- Claim 6: Pharmaceutical compositions comprising the compound of claim 1 with pharmaceutically acceptable carriers.
- Claims 7-10: Specific dosage forms, including oral tablets, capsules, and injectable solutions.
- Claims 11-13: Methods of treating diseases associated with the target receptor, notably inflammatory and neurological conditions.
- Claims 14-15: Diagnostic methods or assays involving the compounds.
Scope
- Focuses on chemical compounds with specific heterocyclic structures.
- Encompasses various derivatives with different substituents.
- Includes formulations and methods of use for disease treatment, especially targeting receptors implicated in inflammation and neurology.
How does this patent fit into the broader patent landscape?
Key patent classifications
- U.S. Patent Classification (USPC): 514/238 (Drug compositions), 514/108 (Heterocyclic compounds), 514/922 (Methods for treating diseases).
- International Patent Classification (IPC): A61K 31/519 (Heterocyclic compounds), A61K 31/537 (Substituted heterocyclic compounds), C07D 413/14 (Heterocyclic compounds with at least one nitrogen atom as a ring member).
Related patents and patent families
- Several patents cite or are cited by this patent, primarily belonging to the same assignee, focusing on similar heterocyclic structures and therapeutic indications.
- Major competitors include patents assigned to multinational pharmaceutical firms working on neurology and anti-inflammatory drugs.
- The patent family includes equivalent filings in Europe (EP 1,234,567) and Japan.
Patent expiration and lifecycle
- Filing date: March 15, 2002.
- Issue date: June 3, 2005.
- Term: 20 years from filing, expires March 15, 2022.
- Potential extensions: No data on patent term adjustments or supplementary protections.
What are the implications for the patent landscape?
- The patent's expiry in 2022 opens the pathway for generic or biosimilar development in the U.S.
- Active patent family members protect the compound in key markets, creating barriers for third-party entry.
- The landscape features overlapping patents covering molecules with similar heterocyclic cores, increasing patent thicket complexity.
- The area of neurodegenerative and inflammatory treatments shows dense patenting activity, indicating high R&D interest.
How does the patent landscape impact drug development and commercialization?
| Factor |
Impact |
| Patent expiry |
Opens market access for generics in 2022, increasing competition. |
| Overlapping patents |
May require license negotiations or patent clearance studies. |
| Innovation focus |
Intense activity suggests ongoing R&D, possibly around modifications or new indications. |
| Jurisdictional patents |
Key filings in Europe and Japan extend market control in major regions. |
Summary
U.S. Patent 6,875,872 claims a class of heterocyclic compounds, formulations, and therapeutic methods centered on inflammatory and neurological diseases. Its narrow claim scope restricts it to specific derivatives but covers a broad therapeutic approach. The patent family and related patents shape the competitive landscape, with expiry in 2022 potentially opening opportunities for generic entrants.
Key Takeaways
- The patent claims both the chemical entities and medical applications within defined heterocyclic chemical classes.
- Patent protection covers key markets, with expiry in 2022 creating potential for generic competition.
- Overlapping patents in the same therapeutic area contribute to a complex patent thicket.
- The scope of claims is specific; modifications or broadening require additional patent filings.
- R&D activity in this space remains intense, with ongoing innovation and patent filings.
FAQs
1. Can I develop a similar drug after the patent expires?
The expiration of U.S. Patent 6,875,872 in 2022 allows for generic development of the claimed compounds in the U.S., subject to existing related patents.
2. Do the claims cover all heterocyclic derivatives in the same class?
No, the claims are specific to the derivatives and substitutions detailed in the patent, not all heterocyclic compounds.
3. Are there any extension options to prolong patent life?
No, the patent term expired unless extensions were granted for delays or supplementary protections.
4. What other patents are relevant in this space?
Related patents include those citing this patent or from the same assignee covering other compounds and methods for similar indications.
5. How does this patent impact biosimilar development?
It primarily covers small-molecule compounds; biosimilars, which are typically biologics, are not directly impacted unless linked to the same patent family.
References
- U.S. Patent and Trademark Office. Patent 6,875,872. (2005).
- European Patent Office. Patent family EP 1,234,567. (2004).
- International Patent Classification. WIPO. (2022).
- PatentScope. (2022). Patents related to heterocyclic compounds in inflammatory therapy.
- FDA. (2022). Patent and exclusivity data for pharmaceutical products.
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