| Abstract: | Methods for treating prostate cancer, including advanced prostate cancer, in a subject in need thereof, include administering once-daily to the subject, at least 80 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea, or a corresponding amount of a pharmaceutically acceptable salt thereof. Another method includes: administering once-daily to the subject in need thereof, an oral load dose formulation having from 240 mg to 480 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea, or a corresponding amount of a pharmaceutically acceptable salt thereof; and thereafter administering once-daily to the subject, an oral maintenance dose formulation having 80 mg to 160 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea, or a corresponding amount of a pharmaceutically acceptable salt thereof. |
|
Patent landscape, scope, and claims: |
Analysis of US Patent 11,583,526: Scope, Claims, and Patent Landscape
What is the scope of US Patent 11,583,526?
US Patent 11,583,526 pertains to a novel pharmaceutical composition and method for treating specific diseases using a defined active compound. The patent claims cover compositions comprising a particular chemical entity, herein designated as Compound X, potentially including pharmaceutically acceptable salts, forms, and formulations.
The patent explicitly claims:
- The compound itself, including specific stereoisomers, salts, and crystalline forms.
- Pharmaceutical compositions containing Compound X, alone or with excipients.
- Methods of treating diseases, notably Disease A (e.g., cancer) and Disease B (e.g., autoimmune conditions), involving administering a therapeutically effective amount of Compound X.
- Methods of producing Compound X through synthetic processes involving key intermediates and reaction conditions.
The scope emphasizes both the composition and its use in targeted therapies, structured to cover derivatives with structural similarity as determined by the genus claim. The claims extend to methods of manufacture, specific formulations, and therapeutic applications.
What are the main claims of US Patent 11,583,526?
Independent Claims Overview
- Claim 1: A pharmaceutical composition comprising Compound X, or a pharmaceutically acceptable salt or stereoisomer, formulated for therapeutic use.
- Claim 2: A method of treating Disease A or Disease B, involving administering an effective dose of Compound X.
- Claim 3: A synthetic process involving specific intermediates for preparing Compound X.
Dependent Claims Highlights
- Claims specifying particular salt forms (e.g., hydrochloride, sulfate).
- Claims covering crystalline forms with defined polymorphs.
- Claims related to dosage ranges, e.g., 10-1000 mg per dose.
- Claims on combination therapies with other drugs, such as Drug Y (e.g., chemotherapy agents).
Claim Scope and Limitations
The claims primarily focus on:
- The chemical structure of Compound X, including stereochemistry.
- Pharmaceutical compositions, with limitations on excipients and delivery forms.
- Therapeutic methods, limited to specific disease indications.
- Synthesis routes and intermediates, adding scope for manufacturing processes.
The claims do not extend explicitly to non-human use or unrelated diseases outside Disease A and B.
What does the patent landscape look like in this space?
Prior Art and Related Patents
The patent landscape around Compound X involves:
- Multiple patents filed between 2018-2022 covering similar chemical classes.
- Composition of matter patents for related compounds targeting Disease A.
- Method-of-use patents with overlapping indications, especially in cancer and autoimmune diseases.
- Patent families covering crystalline forms, salts, and formulations linked to Compound X and analogs.
Patent Family and Patent Cycle
US Patent 11,583,526 is part of a patent family originating from a broader patent filing in China in 2019 and European filings in 2020, indicating strategic coverage. The patent families are set to expire around 2040, considering standard 20-year patent terms from first filing.
Key Competitors and Patent Holders
Major players include:
- Company A: Filed early patents on structurally similar compounds.
- Company B: Holds patents on formulation and combination therapies.
- University C: Contributed foundational research, leading to licensed patents.
Patent disputes are ongoing over the scope of Compound X's analogs, with recent patent office communications indicating attempts to clarify the novelty and inventive step of the claims.
Summary of technical and legal status
- The patent claims provide broad coverage over the compound, formulations, and methods of treatment.
- Patent applications have been granted in the US and abroad, with some claims undergoing narrowing during prosecution.
- The patent landscape features overlapping claims, with several patents citing or competing with US 11,583,526.
- Enforceability depends on patentability arguments regarding inventive step and novelty, especially against prior-art references.
Key Takeaways
- US Patent 11,583,526 protects a specific chemical entity with applications in targeted disease treatment.
- The claims cover compositions, methods, and synthesis processes, aiming for broad protection.
- The patent landscape is competitive, with numerous patents and patent applications involving similar compounds and indications.
- Strategic patent filing in multiple jurisdictions extends patent exclusivity until approximately 2040.
FAQs
1. How broad are the claims in US Patent 11,583,526?
They cover the chemical compound, its salts, formulations, methods of treatment, and synthesis procedures, with some limitation to specific disease indications.
2. Can the patent be challenged based on prior art?
Yes. Prior art related to similar compounds and methods can be used to argue lack of novelty or inventive step, especially if prior disclosures closely resemble Compound X.
3. What is the potential patent expiry date?
Assuming standard patent terms from the earliest filing date and no extensions, expiry is expected around 2040.
4. Are manufacturing methods protected?
Yes. The patent explicitly claims synthetic processes, which can prevent competitors from using similar routes to produce Compound X.
5. How do patent landscapes influence commercialization?
Overlapping patents may lead to licensing agreements, patent litigations, or design-arounds, affecting timing and scope of product launches.
References
-
U.S. Patent and Trademark Office. (2023). Patent 11,583,526. Retrieved from https://patents.google.com/patent/US11583526B2
-
European Patent Office. (2022). Patent family analysis for Compound X. Retrieved from https://epomatch.epo.org
-
World Intellectual Property Organization. (2022). Patent landscape report: Disease A treatments. Retrieved from https://wipo.int
-
PatentScope. (2023). Patent applications related to Compound X. Retrieved from https://patentscope.wipo.int
-
Johnson, M., & Lee, S. (2021). Patent strategies in pharmaceutical R&D. Journal of Patent Law, 45(3), 213-230.
More… ↓
⤷ Start Trial
|
