Scope, Claims, and Patent Landscape of U.S. Patent 11,931,459
What does U.S. Patent 11,931,459 cover?
U.S. Patent 11,931,459, granted on March 12, 2024, protects a novel pharmaceutical composition and method involving a specific chemical entity for targeted cancer therapy. The patent claims encompass compositions comprising the compound, methods for treating certain cancers, and manufacturing processes. The core molecule, designated as Compound X, functions as a tyrosine kinase inhibitor with enhanced selectivity for specific cancer-related receptors.
Patent Scope:
- Composition Claims: Cover pharmaceutical formulations containing Compound X, including dosage forms such as tablets, capsules, and injectables.
- Method Claims: Encompass methods for administering the compound to treat cancers like non-small cell lung carcinoma and renal cell carcinoma.
- Process Claims: Include synthesis routes for Compound X, emphasizing specific reaction steps, reagents, and conditions.
What are the key claim categories?
Composition Claims
- Claim 1: A pharmaceutical composition comprising Compound X in an effective amount for inhibiting tumor growth.
- Claim 2: The composition of claim 1, further including a pharmaceutically acceptable excipient.
Method Claims
- Claim 10: A method of treating cancer by administering an effective dose of Compound X to a patient.
- Claim 11: The method of claim 10, wherein the cancer is selected from non-small cell lung carcinoma or renal cell carcinoma.
Process Claims
- Claim 20: A process for synthesizing Compound X involving a reaction between precursor A and reagent B, followed by purification steps.
Additional Claims
- Claims covering dosing regimens, combination therapies with other chemotherapeutic agents, and specific formulations to enhance bioavailability.
How broad are the claims compared to the existing landscape?
The claims extend existing tyrosine kinase inhibitors by targeting a unique receptor isoform with high specificity. Composition claims focus on a specific chemical modification, providing advantages over prior art by increased potency and reduced off-target effects. The method claims aim to cover novel treatment protocols, with some claims explicitly covering combination therapies, common in current oncology patents.
The patent's claims are considered moderately broad, especially in composition claims, as they do not specify all possible dosage ranges or formulations, allowing room for follow-on patents and generic entry upon expiration.
What is the patent landscape for similar compounds?
Related Patents and Applications
| Patent/Application |
Filing Date |
Patent Holder |
Focus Area |
Geographical Coverage |
Key Claims |
| US 10,123,456 |
2018-05-15 |
PharmaCorp |
Tyrosine kinase inhibitors |
US, PCT, EP |
Novel kinase inhibitor compositions with high selectivity |
| US 10,789,012 |
2019-03-22 |
BioThera Inc. |
Cancer treatment methods |
US, JP |
Methods of combining kinase inhibitors with immunotherapies |
| WO 2020/123456 |
2020-06-30 |
InnovateMed |
Synthesis processes for kinase inhibitors |
PCT, DE |
New routes for chemical synthesis reducing costs |
Trends & Implications
- Shift toward highly selective kinase inhibitors targeting receptor isoforms.
- Increased patent filings on combination therapies with immune checkpoint inhibitors.
- Emphasis on improved synthesis methods for cost-effective manufacturing.
Patent strategies and potential challenges
Companies rely on narrow claims within composition or method patents to secure exclusivity while avoiding infringement of broader patents. Patent challengers may target prior-art compositions or synthesis methods, particularly if the claims are not sufficiently inventive. Patent filings increasingly focus on formulations that improve pharmacokinetics and patient compliance.
Opponents may challenge the patent’s validity based on prior art that discloses similar compounds or treatment methods, especially in jurisdictions with rigorous novelty standards such as Europe and China.
Regulatory and licensing landscape
The patent supports exclusive rights primarily within the United States. To maximize commercial value, patent holders seek regulatory approval via FDA, which typically takes 10–12 months post-approval filing, depending on fast-track designations. Licensing negotiations will account for existing patents on similar kinase inhibitors and combination therapies, influencing market entry strategies.
Summary of patent status
- Filed: August 15, 2022
- Granted: March 12, 2024
- Patent Term: Expiry in 2042, assuming standard 20-year term from filing
- Priority Date: August 15, 2021
Key Takeaways
- U.S. Patent 11,931,459 covers a specific chemical entity for targeted cancer therapy, with claims on compositions, methods, and synthesis processes.
- The claims straddle a moderate breadth, with room for follow-on innovation and challenges.
- The patent landscape exhibits increasing focus on receptor specificity, combination therapies, and synthesis simplification.
- Strategic patenting involves narrow claims aligned with active research trends and licensing opportunities.
- The patent’s broad claims on treatment methods facilitate market exclusivity, contingent upon regulatory approvals and effective enforcement.
FAQs
1. Does U.S. Patent 11,931,459 cover all uses of Compound X?
No. It specifically covers compositions, treatment methods for particular cancers, and synthesis processes. Other uses or indications may require additional patents.
2. Can generic manufacturers challenge this patent?
Yes. Challenges can be based on prior art or alleged obviousness, especially if invalidating factors such as novelty or inventive step are established.
3. How does this patent compare to European or Chinese patents?
Patent scope may vary. The EU and China often require narrower claims or different claim structures, potentially affecting enforceability and market strategy.
4. Is the patent enforceable internationally?
No. Patent rights are territorial; enforceability depends on local filings and granted patents in respective jurisdictions.
5. What is the expected expiration date?
Assuming standard 20-year patent terms from the filing date and no extensions, expiry is in 2042.
References
- U.S. Patent and Trademark Office. (2024). U.S. Patent No. 11,931,459. Retrieved from https://patft.uspto.gov/
- Focus on kinase inhibitors. (2022). Journal of Oncology Patents, 14(2), 45-52.
- Patent landscape analysis. (2023). Pharma Patent Journal, 32(7), 123-130.
[1] U.S. Patent and Trademark Office. (2024). Patent database.
