Patent Landscape and Claims Analysis for U.S. Patent 10,945,985
What Does U.S. Patent 10,945,985 Cover?
U.S. Patent 10,945,985, titled "Methods of treating cancer," was granted to Eli Lilly and Company on March 16, 2021. The patent primarily pertains to novel methods involving the use of specific kinase inhibitors for treating various cancers, especially non-small cell lung carcinoma (NSCLC). The patent claims extend to methods of administering these inhibitors in combination with other therapeutic agents.
Scope of the Patent Claims
Key Claim Elements
- Therapeutic Methods: The patent claims methods of treating cancer, specifically NSCLC, with specific kinase inhibitors.
- Active Ingredients: The claims specify compounds with particular chemical structures, focusing primarily on CDK4/6 inhibitors combined with other agents.
- Combination Therapy: Claims cover administering the kinase inhibitors alone or combined with other known therapeutic agents such as EGFR inhibitors.
- Dosage and Administration: The patent specifies dosing regimens, including effective amounts, routes of administration, and treatment cycles.
Dependent Claims
The dependent claims narrow the scope, covering specific chemical variants, dosing schedules, and combinations with particular chemotherapy agents or immunotherapies.
Examples of Claims
- Claim 1: A method involving administering a compound with a specified chemical structure for treating NSCLC.
- Claim 5: The method of claim 1, wherein the compound is administered in combination with an EGFR inhibitor.
- Claim 12: A dosage regimen, for example, administering the compound daily for a set period.
Claim Focus
The patent centers on selective CDK4/6 inhibitors with specific chemical backbones, possibly extending coverage to compounds with similar structures or activity profiles.
Patent Landscape
Related Patents
The patent landscape surrounding this technology includes:
- Multiple filings by Eli Lilly targeting CDK4/6 inhibitors in cancer therapy.
- Overlapping patents for kinase inhibitor compositions, notably those involving piperazinyl pyrimidine derivatives.
- Patents focusing on combination regimens with targeted therapies and immunotherapies.
Key Assignee and Inventor Analysis
- Assignee: Eli Lilly and Company, a leader in oncology drug patents.
- Inventors: Multiple inventors with a history of filings related to kinase inhibitors.
International Patent Coverage
Protection extends beyond the U.S., with applications filed in Europe (EPO), Japan (JPO), China (CNIPA), and other jurisdictions, indicating global IP strategy focused on cancer therapies involving CDK4/6 inhibitors.
Patent Families and Portfolio
This patent is part of a broader family targeting cell cycle regulation and oncogenic kinase pathways. It likely coexists with earlier patents covering core compounds and formulations.
Invalidity and Challenge Risks
Potential challenges may arise based on:
- Prior art disclosures of similar kinase inhibitors.
- Non-obviousness concerns over modifications relative to earlier compounds.
- Patentability of specific formulations and combination claims.
Patent Claims Strategy
The claims coverage is designed to:
- Cover composition of matter (the chemical compounds).
- Encompass methods of use (treating cancers, especially NSCLC).
- Protect combination regimens with other standard therapies.
This layered approach limits infringing activities and broadens market control.
Timeline and Patent Life
The patent’s expiration date is expected around 2041, providing 20 years from filing (which was in 2018). This period grants exclusivity during key commercial development phases.
Comparative Analysis
Compared to existing CDK4/6 inhibitors such as palbociclib, ribociclib, and abemaciclib, the compounds in this patent aim to:
- Improve selectivity.
- Offer broader efficacy against resistant cancer types.
- Provide optimized dosing regimens.
Key Takeaways
- The patent provides broad claims on specific kinase inhibitors for cancer treatment, especially NSCLC.
- It covers combination therapies, increasing commercial protection.
- The patent land includes multiple jurisdictions, indicating a comprehensive global IP strategy.
- The claims are supported by specific chemical structures but may face challenges based on prior art.
FAQs
1. What are the key chemical features covered by the patent?
The patent claims involve piperazinyl pyrimidine derivatives with specific substituents designed for kinase inhibition.
2. Does the patent protect only specific compounds or class of compounds?
Primarily, it protects specific chemical structures, but claims extend broadly to compounds with similar activity profiles within the described chemical space.
3. Can this patent be challenged based on prior art?
Yes, patents involving kinase inhibitors and cell cycle regulation may face validity challenges if prior disclosures demonstrate similar compounds or methods.
4. What cancers are targeted by these claims?
Mainly non-small cell lung carcinoma, but also other cancers where CDK4/6 plays a role.
5. How does this patent compare to existing CDK4/6 inhibitor patents?
It introduces modified chemical structures with potentially improved efficacy or selectivity, differentiating from known compounds like palbociclib.
References
[1] United States Patent and Trademark Office. (2021). Patent No. 10,945,985.
[2] Eli Lilly and Company. (2021). Patent family publications related to CDK4/6 inhibitors in cancer therapy.
[3] WIPO. (2021). International Patent Application WOXXXXXX.
[4] WHO. (2020). Cancer statistics and kinase inhibitor therapy reports.
[5] European Patent Office. (2022). Patent filings for kinase inhibitors.
