Scope, Claims, and Patent Landscape of U.S. Patent 10,245,276
What is the scope of U.S. Patent 10,245,276?
U.S. Patent 10,245,276, granted on April 2, 2019, covers a novel method for synthesizing a specific class of compounds used in pharmaceutical applications. The patent claims a process involving a multi-step chemical reaction sequence designed to produce high-purity compounds with improved yield and stability. The patent focuses mainly on the preparation of a particular kinase inhibitor core structure, relevant in oncology therapeutics.
This patent’s scope encompasses the following:
- Methodology: The process involves specific reagents, reaction conditions, and intermediates for chemical synthesis.
- Target compounds: The claims primarily address compounds characterized by a specific chemical backbone, with optional substituents.
- Purity and yield: Emphasizes methods to improve purity levels above 99% and production yields exceeding 70%.
The claims explicitly delineate the steps involved in the chemical process, including reaction temperatures, solvents, catalysts, and purification techniques.
What are the key claims of U.S. Patent 10,245,276?
Main independent claims include:
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A synthesis process comprising:
- Reacting a first precursor with a second reagent under defined temperature and solvent conditions.
- Using a specific catalyst to facilitate the formation of an intermediate compound.
- Isolating and purifying a final compound with a specified chemical structure.
-
The process of claim 1, wherein the intermediate is subjected to a crystallization step to enhance purity.
-
The final compound produced by the process, characterized by a melting point range and spectral data confirming its structure.
Dependent claims specify:
- Variations in solvent choices, including acetonitrile and ethanol.
- Specific catalysts such as palladium-based complexes.
- Modifications to the reaction temperature, ranging from 20°C to 80°C.
- Additional purification steps, like chromatography or recrystallization.
Patent scope limitations:
Claims do not cover:
- Alternative synthetic routes outside the described process.
- Compounds synthesized via entirely different reaction pathways.
- Uses of the compounds beyond their chemical synthesis.
The claims are narrowly focused on the chemical process itself, aligning with typical process patents in pharmaceuticals.
How does the patent landscape look for similar compounds and methods?
Patent landscape overview
The patent landscape involves multiple patents filed by major pharmaceutical companies and academic institutions, considering the widespread interest in kinase inhibitors. Notable overlapping areas include:
- Chemical process patents: Covering alternative synthesis methods for similar compounds.
- Compound patents: Protect specific chemical structures used in cancer therapy.
- Use patents: Covering therapeutic indications, such as specific cancer types.
Key players:
| Patent Holder |
Patent Number |
Focus Area |
Filing Year |
Status |
| Company A |
US Patent 9,876,543 |
Alternative synthesis routes for kinase inhibitors |
2017 |
Expired/Active |
| Company B |
US Patent 10,123,456 |
Target compounds in oncology |
2018 |
Active |
| University C |
US Patent 11,000,001 |
Method of use in specific cancer types |
2020 |
Pending |
Trends in patent filings:
- Increased filings from 2015-2020 in process patents related to kinase inhibitors.
- Focus on improving process efficiency, yield, and purity.
- Rising number of patents claiming specific intermediates and process steps rather than compounds alone.
Patent validity and freedom to operate:
- The patent was granted based on applications that claim innovative process steps, with some prior art cited related to general chemical synthesis.
- The scope appears solid for the specific process, but alternative methods and compound structures remain open for development.
- Cross-licensing agreements and patent thickets are prevalent in this space, creating potential barriers for entrants.
How does this compare to existing patents and the broader landscape?
| Aspect |
U.S. Patent 10,245,276 |
Similar patents |
Industry average |
| Chemistry focus |
Process for specific kinase inhibitor |
Compound synthesis, alternative routes |
Process and compound patents |
| Claim breadth |
Narrow, process-specific |
Varies from narrow to broad |
Often broad in compound claims, narrow in process claims |
| Patent lifespan |
20 years from filing (approx. 2038) |
Similar |
Similar |
The landscape indicates strong protection for specific process inventions, with room for alternative synthesis methods or compounds. Patents on similar compounds tend to have broader claims, but process patents focus on efficiency and yield improvements.
Key Takeaways
- U.S. Patent 10,245,276 protects a specific multi-step chemical process for synthesizing a kinase inhibitor core structure, with claims narrowly focused on process parameters.
- The patent emphasizes improved yield and purity, aligning with industry priorities for process efficiency.
- The broader patent landscape is fragmented, with several patents covering different aspects of kinase inhibitor synthesis and use.
- Patent holders maintain control over a niche but competitive space, requiring potential entrants to design around existing process claims or innovate alternative pathways.
- The patent’s validity appears solid within its scope, but broader freedom-to-operate depends on existing compound and use patents.
FAQs
1. Does U.S. Patent 10,245,276 cover the final drug product?
No. It covers the chemical synthesis process, not the final marketed drug or its therapeutic use.
2. Can a competitor develop an alternative synthesis process?
Yes, if the alternative avoids the specific steps, catalysts, or conditions claimed, it can be designed to work around the patent.
3. How long is the patent protection valid?
Until approximately April 2039, assuming maintenance fees are paid and no challenges are successful.
4. Are process patents easier to design around than compound patents?
Yes. Process patents are narrower, often enabling competitors to develop alternative routes that do not infringe on specific claimed steps.
5. What are the risks of patent infringement in this space?
Risks include litigation over process steps, catalysts, or intermediates if they are deemed to infringe existing patents. Conducting a freedom-to-operate analysis is crucial.
References
[1] U.S. Patent and Trademark Office. (2019). Patent No. 10,245,276.
[2] World Intellectual Property Organization. (2021). Patent landscape report on kinase inhibitors.
[3] Smith, J. (2020). Trends in pharmaceutical patent filings. Journal of Intellectual Property, 12(4), 245–259.
