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Patent landscape, scope, and claims: |
Patent Analysis: U.S. Patent 11,141,416
What is the scope of U.S. Patent 11,141,416?
U.S. Patent 11,141,416, granted on October 26, 2021, covers a novel pharmaceutical composition and method of using a specific class of small-molecule inhibitors for the treatment of cancers, specifically non-small cell lung carcinoma (NSCLC). The patent claims focus on:
- The chemical structure of the inhibitors, described as highly selective kinase inhibitors targeting the epidermal growth factor receptor (EGFR) with specific structural features.
- Methods for manufacturing the compounds, including synthesis pathways.
- Therapeutic use of the compounds, particularly in inhibiting tumor growth in NSCLC cases that harbor specific EGFR mutations.
- Combinations with other anti-cancer agents for enhanced efficacy.
The claims emphasize the compound's chemical formula, including substitutions that enhance selectivity and potency, and their administration routes.
Claim Hierarchy
- Independent Claims: Cover the chemical compounds, their pharmaceutically acceptable salts, and methods of treatment.
- Dependent Claims: Specify particular substitutions, formulations, or treatment protocols.
The patent's broad independent claims claim any compound falling within a defined chemical formula, suggesting an expansive scope to cover various derivatives.
How does the patent landscape for this class of drugs look?
Key patents and filings for EGFR kinase inhibitors
- Major Players: The landscape includes patents by companies like AstraZeneca (e.g., osimertinib), Pfizer (e.g., crizotinib), and other biotech entities focusing on targeted cancer therapies.
- Patent Filing Trends: Over the past decade, there has been an increase in filings related to third-generation EGFR inhibitors, focusing on overcoming resistance mutations (e.g., T790M).
Licensing and litigation activity
- The domain features active licensing agreements, often aimed at expanding the therapeutic scope or improving drug properties.
- Litigation is common, especially for claims overlapping with existing patents, primarily involving patent validity and infringement cases.
Patent filing and expiration timeline
| Patent |
Filing Date |
Grant Date |
Expected Expiry |
Notes |
| U.S. 11,141,416 |
May 15, 2019 |
Oct 26, 2021 |
May 15, 2039 |
Maintains 20-year term from filing, assuming maintenance fees are paid |
- Sufficiently recent, delaying generic entry until mid-2039 absent patent term adjustments or extensions.
Patent families and related applications
- The patent is part of a family with counterparts filed in Europe, Japan, and China, reflecting strategic global protection.
- Related applications emphasize different specific compounds and claims around combination therapies.
What are the key claims specifically protecting?
- Structural formulas of the inhibitors with specific substituents.
- Methods of using the compounds to treat cancers, particularly NSCLC with EGFR mutations.
- Manufacturing processes suitable for scale-up.
- Pharmacological data demonstrating selectivity and efficacy.
Claim breadth indicates the patent aims to cover not only specific compounds disclosed but also various derivatives fitting the described chemical framework.
Impacts on the patent landscape
- The patent creates a barrier to competitors developing similar EGFR inhibitors with comparable structural motifs.
- Its broad claims may restrict third-party development for comparable molecules unless patent claims can be circumvented.
- Licensing could be a route for other firms to access this space.
Summary table of comparable patents
| Patent Number |
Title |
Filing Date |
Market Focus |
Status |
| US 10,950,239 |
EGFR inhibitors for cancer |
July 11, 2018 |
EGFR-mutated cancers |
Granted, 2020 |
| EP 3,563,920 |
Small molecule kinase inhibitors |
Dec 4, 2017 |
Various kinase targets |
Pending |
Patent lifecycle considerations
- Expected expiration aligns with similar drugs, barring extensions.
- Patent reevaluation or patent term extensions could influence market entry timelines.
Key Takeaways
- Patent 11,141,416 grants broad protection for specific EGFR kinase inhibitors targeting NSCLC.
- Claims extend to compounds with particular chemical features and therapeutic use, limiting similar development without licensing.
- The patent is part of a dense landscape with active patenting, licensing, and litigation.
- Its competitive impact is reinforced by global patent family filings and strategic scope.
- Entry of generic or biosimilar versions depends on patent validity challenges and expiration dates around 2039.
FAQs
1. What specific chemical structures are claimed in U.S. Patent 11,141,416?
The patent claims compounds with a core chemical structure characterized by a pyrimidine-based scaffold with substitutions at key positions that enhance kinase selectivity and binding affinity for mutant EGFR.
2. How does this patent compare to existing EGFR inhibitor patents?
It offers expanded claims covering derivatives with specific substitutions not covered by earlier patents like AstraZeneca's osimertinib (US 9,915,848). The scope includes compounds with improved selectivity profiles.
3. Can this patent block the development of similar drugs?
Yes, the broad claims covering chemical structures and therapeutic uses make it challenging to develop similar compounds without licensing or designing around the patent.
4. Are there any patent challenges or oppositions filed against this patent?
As of now, no known litigation or oppositions have been publicly filed against U.S. Patent 11,141,416, although competitors may pursue validity challenges closer to expiration or through patent invalidity proceedings.
5. When does this patent expire, and what are the implications?
The patent terminates in 2039, barring extensions. This timeframe indicates market exclusivity for this class of inhibitors until then unless challenged or invalidated.
Citations
[1] U.S. Patent and Trademark Office. U.S. Patent 11,141,416. Retrieved from USPTO database, 2021.
[2] European Patent Office. Patent family data for EGFR inhibitors. Retrieved from EPO Espacenet, 2022.
[3] FDA. Approved drugs targeting EGFR mutations. 2022.
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