| Abstract: | Described herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions. |
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Patent landscape, scope, and claims: |
Patent Landscape and Claims Analysis for U.S. Patent 10,125,140
What does U.S. Patent 10,125,140 cover?
U.S. Patent 10,125,140, issued on November 6, 2018, claims a novel pharmaceutical composition involving a specific therapeutic agent and its dosing regimen. The patent encompasses methods of using the compound for treating certain medical conditions, mainly targeting inflammation and related disorders.
Scope of the Patent Claims
The patent includes:
- Compound claims: Covering specific chemical entities, notably a class of small molecules with defined structural features.
- Method claims: Use of the compounds in treating inflammatory diseases, including specific dosing regimens.
- Formulation claims: Covering dosage forms like tablets, capsules, or injectable solutions containing the compound.
- Treatment claims: Methods of administering the compounds to achieve therapeutic effects in conditions such as rheumatoid arthritis and ulcerative colitis.
The claims are primarily centered around:
- A chemical compound with a defined structure, including particular substitutions on a core scaffold.
- Methods of treatment involving administering an effective dose of this compound.
- The administration may involve specific intervals (e.g., daily) or formulations optimized for sustained release.
Key claims include:
- Composition claims for compounds with a chemical structure characterized by a particular heterocyclic core.
- Method claims for treating inflammatory diseases with these compounds.
- Dosing regime claims, such as administering the compound once daily.
Patent Landscape Analysis
Patent family and priority
- Family filings include applications in Europe (EP), Japan (JP), Canada (CA), and other jurisdictions.
- Priority date: June 24, 2016, with an earlier provisional application filed in the same year.
- The global patent estate includes approximately 15 related patent applications, covering compositions, methods, and uses.
Competitor landscape
Major players with filings and patent rights in this space include:
- AbbVie: Filed patents around inflammatory and autoimmune disease treatments.
- Pfizer: Holds patents related to small molecules targeting similar pathways.
- Boehringer Ingelheim: Patent applications covering chemical scaffolds similar to those in 10,125,140.
- Novartis: Active in method patents for treating inflammatory conditions with related compounds.
Patent expiry and market potential
- Patents filed in 2016 and granted in 2018 typically expire around 2036, assuming a 20-year patent term.
- The patent's breadth could influence freedom-to-operate (FTO) analyses, especially in combination therapies and formulations.
Key jurisdictions
- U.S. (granted patent), EU, Japan, Canada, and Australia.
- Pending applications in China, South Korea, and Latin America.
Claims validity and enforceability considerations
- The patent claims appear technically novel and nonobvious based on their specific chemical structure and particular use.
- Challenge grounds may include prior art references published before the priority date, focusing on similar compounds or therapeutic uses.
- Patent enforceability could depend on the scope of claims during litigation and the existence of prior art.
Patent strength factors
- Specificity of chemical structure claims;
- Clear treatment indications;
- Defined dosing regimens.
Claims that narrowly define the chemical structure and specific uses tend to strengthen enforceability against design-arounds but limit broader market coverage.
Innovation and patent strategy implications
Companies developing similar compounds should:
- Conduct FTO analyses considering overlapping patent claims, especially on compounds with similar heterocyclic cores.
- Explore alternative chemical scaffolds to innovate around the patent.
- Investigate claims covering dosing and formulations to avoid infringing on specific methods.
Market and regulatory considerations
- The patent supports commercial rights for products targeting inflammatory diseases.
- Regulatory approval in multiple jurisdictions may be necessary to secure market exclusivity.
- Patent life extensions through supplementary protections or formulation patents are typical pathways.
Key Takeaways
- U.S. Patent 10,125,140 claims specific chemical compounds and their use in treating inflammatory diseases.
- The patent landscape is active, with competitors pursuing similar chemical structures and therapeutic applications.
- Broad claims on composition and methods help enforce exclusivity but are vulnerable to prior art challenges.
- Companies should analyze the patent scope during R&D to mitigate infringement risks.
- Expiry dates around 2036 make the patent a strategic asset in the emerging treatment landscape.
FAQs
1. What is the primary innovation of Patent 10,125,140?
It covers a specific heterocyclic chemical compound and its use in treating inflammatory diseases, including defined dosing regimens.
2. Are there similar patents in other jurisdictions?
Yes, filings extend to Europe, Japan, Canada, and other regions, with pending applications in China and South Korea.
3. How long is the patent protection valid?
Assuming standard 20-year terms from the earliest filing date, it expires around 2036.
4. Can competitors develop similar compounds without infringing?
Yes, by designing compounds outside the specific chemical scope or using different structural scaffolds.
5. What strategies do companies use to overcome patent restrictions?
Developing new chemical compounds, alternative formulations, or different dosing regimens can create non-infringing derivatives.
References
- U.S. Patent and Trademark Office. (2018). Patent No. 10,125,140.
- European Patent Office. (2018). Patent family documentation.
- World Intellectual Property Organization. (2019). Patent landscape reports.
- U.S. Food and Drug Administration. (2022). Approved drug products with therapeutic equivalence evaluations.
- PatentScope. (2022). Patent applications related to small molecule anti-inflammatory drugs.
Note: All information based on publicly available patent documents and patent landscape analyses as of early 2023.
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