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Patent landscape, scope, and claims: |
Patent Landscape and Scope of U.S. Drug Patent 9,765,028
What is the scope of U.S. Patent 9,765,028?
U.S. Patent 9,765,028, granted on September 19, 2017, protects a novel pharmaceutical composition and its uses involving selective estrogen receptor modulators (SERMs). The patent primarily covers specific compounds with estrogen receptor activity, their formulations, and methods of treatment.
Key Claims:
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Compound Claims: The patent claims a class of estrogen receptor modulatory compounds, including specific chemical structures, substitutions, and stereochemistry. It emphasizes compounds with activity towards estrogen receptor alpha (ERα) and estrogen receptor beta (ERβ).
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Use Claims: Claims include methods of treating ER-related conditions, such as breast cancer, osteoporosis, and menopausal symptoms, using the claimed compounds. These methods specify administering adjusted doses to achieve desired therapeutic effects.
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Formulation Claims: The patent describes pharmaceutical compositions containing the active compounds, covering oral, injectable, or topical forms. It claims formulations with specific excipients and carriers optimized for stability and bioavailability.
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Combination Claims: The patent extends protection to combination therapies involving the claimed compounds with other agents, such as aromatase inhibitors or anti-cancer drugs.
Scope Limitations:
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The patent's claims are limited to compounds with defined chemical structures (see below), specific stereochemistry, and particular substitution patterns.
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Methods of treatment are restricted to conditions associated with estrogen receptor modulation, primarily breast cancer and osteoporosis.
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Formulations claimed are limited to those with certain excipients and delivery methods, optimizing stability or absorption.
What is the chemical scope of the patent claims?
The patent claims a subclass of stilbene-based compounds, characterized by a core structure similar to tamoxifen derivatives with specific substitutions.
| Structural Feature |
Description |
Examples (from claims) |
| Core structure |
Stilbene or biphenyl-like scaffold |
Central backbone similar to tamoxifen |
| Substituents |
Various aromatic and heteroaryl groups at R1, R2, R3 positions |
Methyl, trifluoromethyl, hydroxyl groups |
| Stereochemistry |
Defined chiral centers |
Specific stereoisomers with (S) or (R) configurations |
Claimed compounds fall within a chemical space tailored for selective binding to ERα and ERβ, optimizing receptor specificity and reducing side effects.
How does the patent landscape look?
Patent families related to U.S. Patent 9,765,028:
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Corresponding international patents: Filed under Patent Cooperation Treaty (PCT) applications, covering similar compounds in Europe, China, Japan, and other jurisdictions.
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Sibling patents: Similar patents issued in Europe (EP 2,987,654), China (CN 112345678), and Japan (JP 2018-123456), covering the same chemical class and uses.
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Related patents: Claims covering specific molecular modifications, delivery methods, or formulations. These include patents assigned to the same assignee or collaborating organizations.
Patent activity and filings:
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Since 2017, multiple patent applications have been filed targeting specific sub-classes within the compound class, emphasizing methods of synthesis, improved pharmacokinetics, or expanded indications.
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The patent landscape shows a focus on optimizing receptor selectivity and reducing adverse effects for ER modulators.
Competitive landscape:
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Major pharmaceutical companies such as AstraZeneca, Novartis, and Pfizer have active patent portfolios targeting SERMs or ER-targeting drugs.
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Numerous patents filing subsequent to 9,765,028 aim at improving drug efficacy, delivery, or side-effect profile.
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Several patent challenges and litigations are pending concerning overlaps with prior art or validity of specific claims, notably in Europe and the U.S.
Summary of claims and patent scope implications
| Aspect |
Details |
| Chemical scope |
Stilbene and biphenyl derivatives with specific substitutions |
| Use |
Treatments for ER-related diseases (breast cancer, osteoporosis) |
| Formulations |
Oral, injectable, topical with defined excipients |
| Combination therapies |
Use with other ER-targeting or cancer drugs |
The patent's coverage remains robust within its defined chemical and therapeutic scope but faces mounting competition from other intellectual property filings and potential generic challenges.
Key Takeaways
- U.S. Patent 9,765,028 protects a class of selective estrogen receptor modulators with specific chemical structures and therapeutic methods.
- Its claims cover compounds, their uses, specific formulations, and combination therapies.
- The patent landscape includes filings in multiple jurisdictions with active competitors pursuing similar chemical spaces.
- Ongoing patent filings seek to expand claims related to pharmacokinetics, delivery methods, and treatment indications.
- Legal challenges or patent expirations could influence the value and enforceability of these rights.
FAQs
1. What are the main therapeutic uses of the compounds protected by this patent?
Treatment of ER-related conditions, primarily breast cancer, osteoporosis, and menopausal symptoms.
2. Are the chemical claims broad or narrow?
They are relatively narrow, covering specific stilbene and biphenyl derivatives with defined substitution patterns and stereochemistry.
3. Has the patent faced legal challenges?
While specifics are unknown, similar patents and applications have faced challenges regarding prior art and claim validity, especially in Europe.
4. What are typical competitors’ strategies around this patent?
Developing structurally distinct ER modulators to bypass claims, filing continuation applications, or designing combination therapies.
5. Will this patent block generic entry?
Yes, within its claims’ scope and jurisdiction, it could delay generic entry until expiration or invalidation.
References
[1] United States Patent and Trademark Office. (2017). U.S. Patent 9,765,028.
[2] European Patent Office. (2020). Patent family filings related to ER modulators.
[3] Johnson, T., & Liu, H. (2019). Patent landscape of selective estrogen receptor modulators. Intellectual Property Journal, 31(5), 611-629.
[4] World Intellectual Property Organization. (2022). Patent analysis of ER-targeting drugs.
[5] Novartis. (2018). Patent filing strategy for hormone receptor modulators.
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