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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of U.S. Patent 8,809,615
What does U.S. Patent 8,809,615 cover?
U.S. Patent 8,809,615 was granted on August 19, 2014, assigned to Eli Lilly and Company. The patent primarily covers methods of treating conditions related to the calcium channels using a specific class of compounds. Its scope includes composition and methods for treating or preventing diseases involving calcium channel modulation, especially neurological and cardiovascular disorders.
The patent claims focus on a family of pyrimidine derivatives with specific substituents, which act as calcium channel blockers. These compounds are characterized by a core structure with substitutions at certain positions, designed to improve selectivity, potency, or pharmacokinetics.
What are the key claims of U.S. Patent 8,809,615?
Core Claims
- Compound claims: The patent claims specific chemical entities with defined structural formulas, including substitution patterns. These compounds are claimed to selectively inhibit L-type voltage-gated calcium channels.
- Method claims: Treatment methods include administering these compounds to prevent or treat diseases such as hypertension, angina, stroke, neurodegeneration, and certain psychiatric disorders.
- Dosage and formulation claims: The patent describes formulations for delivery, including oral and injectable forms, and specifies dosages suitable for therapeutic effect.
Notable Claim Features
- The compounds are characterized by a pyrimidine ring with specified substituents that influence activity.
- Claims include variations with different side groups at particular positions, offering broad coverage of derivatives.
- The patent emphasizes the pharmacologically active nature of these compounds for selective calcium channel blockade.
Limitations
- The claims are limited to compounds with the specified core structure and substituents.
- Use is restricted to treatment of conditions associated with calcium channel dysfunction.
- No claims cover extended pharmacokinetic modifications beyond the described derivatives.
How broad is the patent coverage?
| Aspect |
Details |
| Chemical scope |
Covers a family of pyrimidine derivatives with specified substitutions. The claims include multiple variations, making the patent’s chemical space broad but structurally focused. |
| Therapeutic applications |
Includes treatment of cardiovascular and neurological disorders. The claims are therapeutic in nature; they do not extend to other disease areas. |
| Patent family |
Related filings include continuation and divisional applications, expanding the family’s scope to cover monitored derivatives and methods. These include applications in Europe (EP), Canada (CA), and other jurisdictions, reinforcing worldwide protection. |
How does it compare to previous calcium channel patents?
| Patent |
Focus |
Similarities |
Differences |
| U.S. Patent 7,722,639 |
General calcium channel blockers |
Targets similar calcium channels |
Broader structural scope; less selective compounds |
| European Patent EP2,503,462 |
Pyrimidine derivatives for calcium channel blockade |
Shares core pyrimidine structure |
Different substitution patterns; different claimed compounds |
| U.S. Patent 8,174,417 |
Specific dihydropyridine calcium channel blockers |
Different core structure |
Dihydropyridines vs pyrimidines |
The 8,809,615 patent narrows focus to specific pyrimidine derivatives with particular substitutions, distinguishing it from broader or different classes of calcium channel blockers.
Patent landscape overview
- Major players: Eli Lilly, Shionogi, and other pharmaceutical companies have filed patents covering calcium channel modulators, including pyrimidines.
- Patent expiration: The patent expires on August 19, 2032, subject to maintenance payments and possible extensions.
- Freedom-to-operate considerations: Several patents cover similar compounds (e.g., dihydropyridines like amlodipine). The narrow chemical claims of 8,809,615 may give clearance but require careful landscape review.
- Research activity: The landscape shows ongoing R&D into selective calcium channel modulators beyond the patent’s scope, including targeting different channel subtypes and disease indications.
Key legal and strategic points
- The patent’s chemical claims are narrow enough to allow competing compounds with different substitutions.
- Therapeutic claims are broad, covering multi-disease applications but depend on specific compounds being used.
- The patent family’s international filings strengthen its global enforcement capability.
- Potential for patent challenge or design-around exists through compounds outside the specific structures claimed.
Summary
U.S. Patent 8,809,615 claims a family of pyrimidine derivatives designed as selective calcium channel blockers, primarily for cardiovascular and neurological indications. The patent covers specific structural variants and methods of treatment, with a scope limited to the compounds' chemical design and therapeutic uses. Its family extends into various jurisdictions, securing broad protection, though the narrow chemical claims create opportunities for competitors with different structures.
Key Takeaways
- The patent focuses on specific pyrimidine compounds with claims centered on chemical structure and therapeutic application.
- Its scope is broad within the chemical class but narrow outside the specifics of the claimed compounds.
- The patent family extends protection internationally, but competitors can develop different structural classes to design around it.
- With expiry in 2032, licensing opportunities or litigation could arise depending on emerging calcium channel modulator research.
FAQs
Q1: Are there any existing drugs on the market based on the compounds claimed in U.S. Patent 8,809,615?
A1: No approved drugs explicitly reference the compounds from this patent. However, calcium channel blockers like amlodipine are structurally different but serve similar therapeutic purposes.
Q2: What diseases could potentially be targeted with these compounds besides hypertension?
A2: The patent mentions neurological disorders such as stroke, neurodegeneration, and psychiatric conditions, indicating broad therapeutic potential.
Q3: How easy is it for competitors to design around this patent?
A3: Design-around is feasible by developing compounds outside the specific pyrimidine scaffolds or substitutions claimed, especially targeting different calcium channel subtypes.
Q4: Can Eli Lilly enforce this patent against generic companies?
A4: Yes, if the compounds or methods infringe the claims, Eli Lilly can pursue enforcement actions before patent expiry in 2032.
Q5: Are any patent challenges likely before the expiration date?
A5: Challenges may focus on obviousness or novelty, particularly if prior art includes similar pyrimidine derivatives, but the narrow chemical claims might limit grounds for invalidation.
References
- U.S. Patent 8,809,615. (2014). Pyrimidine derivatives as calcium channel blockers. Eli Lilly and Company.
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