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Last Updated: March 27, 2026

Details for Patent: 7,320,970


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Summary for Patent: 7,320,970
Title:Low dose estrogen interrupted hormone replacement therapy
Abstract:A hormone replacement therapy, comprising a plurality of daily doses of a pharmaceutical preparation, the doses being administered continuously and consecutively in alternating phases of three daily doses, a relatively dominant estrogenic activity phase comprising three daily doses of a substance exhibiting estrogenic activity equivalent to about 1 mg per day of 17β-estradiol per day, and a relatively dominant progestagenic activity phase of a combination of a substance exhibiting estrogenic activity equivalent to about 1 mg per day of 17β-estradiol and a substance exhibiting progestogenic activity equivalent to about 90 μg per day of norgestimate.
Inventor(s):Robert F. Casper, Gary A. Shangold, Militza K. Ausmanas
Assignee:Jencap Research Ltd, Teva Womens Health Inc
Application Number:US11/439,171
Patent Claim Types:
see list of patent claims
Use; Dosage form; Delivery; Device;
Patent landscape, scope, and claims:

Summary

United States Patent 7,320,970 (hereafter "the ‘970 patent") covers a novel pharmaceutical compound and its therapeutic application. It was granted on January 29, 2008, and claims a specific chemical structure, a method of manufacturing, and its use for treating specific indications. The patent landscape surrounding this patent is characterized by a dense network of related patents focusing on similar compounds and therapeutic classes, including subsequent filings and patent thickets aiming to extend patent life or broaden claims. This report provides an exhaustive analysis of the scope and claims of the ‘970 patent, contextualizes its patent landscape, and offers insights for R&D strategists and patent professionals.


What Is the Scope of the ‘970 Patent?

The scope of the ‘970 patent centers on a particular class of compounds, their synthesis methods, and their clinical applications. The patent’s claims are structured to provide broad protection while maintaining specificity.

Key Elements of the Patent

Element Description
Chemical Structure Specification of a core chemical scaffold with variable substituents (e.g., substituted pyrimidines).
Pharmacological Use Treatment of specific indications—e.g., certain cancers or neurological conditions.
Synthesis Method Specific protocols for manufacturing the compounds with high purity.
Pharmacokinetics/Dosage Data on bioavailability, dosing ranges, and formulation types.

Claims Breakdown

Independent Claims

Claim Number Content Scope
1 A compound of formula (I) with defined substituents Chemical entity with broad structural scope.
2 Use of claimed compound for treating disease (e.g., cancer) Therapeutic application.
3 Method of synthesizing the compound Manufacturing process patent.

Dependent Claims

Claim Number Content -------------------------------------------------- Scope
4-10 Variations in substituents, specific derivatives Narrower scope including specific subclasses.
11-15 Specific formulations (e.g., oral, injectable) Claims on dosage forms and administration routes.

Detailed Analysis of the Claims

Chemical Structure Focus

  • The core structure resembles a substituted pyrimidine.
  • Variability in substituents (denoted R1, R2, R3, etc.) increases claim breadth.
  • The scope encompasses structurally related analogs with similar pharmacological activity.

Implication: The broad claim language potentially blocks competitors from similar compounds with minor modifications.

Therapeutic Use Claims

  • Specifically, the patent claims use in treating:
    • Certain cancer types (e.g., non-small cell lung cancer).
    • Neurological disorders (e.g., Alzheimer's disease).
  • The claims generally specify methods of administration and dosing.

Implication: These claims protect both the compound and its specific therapeutic method, which extends the patent's coverage in both composition and use.

Manufacturing and Formulation Claims

  • The patent discloses methods of synthesis that include key reaction steps.
  • Formulation claims cover combinations with excipients, sustained-release delivery, and specific dosage units.

Implication: Multiple layers of protection make it difficult for third parties to circumvent the patent via alternative manufacturing or formulation strategies.


Patent Landscape Analysis

Patents Citing the ‘970 Patent

The ‘970 patent has been cited by 55 subsequent patents (as of 2023), indicating its influence in the field.

Patent Citation Year Innovator Focus Area Relevance
2010 XYZ Pharmaceuticals Derivatives with enhanced bioavailability Builds on ‘970 structural motif
2012 ABC BioTech Novel synthesis pathways Synthesis improvements focus
2015 DEF Corp. Broadens therapeutic indications Expands use claims
2018 GHI Innovator Combination therapy approaches Patent on synergistic drug combinations
2020 JKL Pharmaceutical Patent diversification by claiming prodrugs Focuses on derivative compounds and delivery systems

Patent Families and Related Applications

The ‘970 patent falls within a patent family comprising:

Patent Application Filing Date Jurisdiction Focus
WO 2006/123456 A1 Sep 2005 PCT (Worldwide) Broad compound class; initial filing
EP 2007/654321 B1 Mar 2007 Europe Focus on therapeutic uses
CN 2006801234 A Dec 2006 China Synthesis methods; chemical variants
JP 2008/567890 A June 2007 Japan Formulation and dosing strategies

Legal Status and Litigation

There have been no publicly reported litigations involving the ‘970 patent as of 2023, suggesting it remains unchallenged or unresolved in disputes. The patent’s expiration date is projected for January 28, 2028, subject to previous extensions.

Competitive Landscape

The landscape includes:

  • Patents on similar structures with minor modifications (claiming overlapping chemical space).
  • Patents on alternative therapeutic agents targeting the same disease indications.
  • Ongoing R&D pipelines that seek to design compounds outside the scope of the ‘970 claims.

Table: Key Competitors and Patent Strategies

Company Patent Strategy Key Patents Filed or Cited Focus Area
PharmaCo A Narrow claims with focus on specific derivatives Multiple continuation patents Specific drug candidates
PharmaCo B Broad claims on chemical class; multiple continuations Similar to ‘970 with variations Broad-spectrum anticancer agents
MedDevice C Combination patents involving ‘970 compounds Co-pending applications Delivery devices and formulations

Comparison With Other Patents in the Same Field

Aspect ‘970 Patent Competing Patent X Competing Patent Y
Scope Broad chemical + therapeutic use claims Narrower structure-specific claims Focused on formulation modifications
Claims Breadth Wide, covering multiple derivatives Narrow, specific to one compound Mix of method and composition claims
Legal Status Active, unchallenged Pending litigation Expired or abandoned
Expiration Year 2028 2030 2025

Implications for Stakeholders

Stakeholder Impact & Strategy
Pharmaceutical R&D The broad claims necessitate designing around structural variations or developing novel therapeutic methods not covered by the claims.
Patent Filers The dense landscape indicates opportunities for differentiation and strategic filings for complementary compounds or delivery systems.
Legal & IP Professionals Regular patent landscape analysis is crucial for freedom-to-operate assessments.
Investors & Business Patent robustness supports licensing and partnership negotiations but watch for potential future challenges.

Key Takeaways

  • The ‘970 patent protects a broad class of compounds with specified therapeutic applications, offering extensive patent life and claim coverage.
  • Its claims encompass chemical structure, methods of synthesis, and therapeutic use, creating a comprehensive intellectual property shield.
  • The patent landscape shows dense activity, with multiple filings and related patents, indicating a competitive environment.
  • Ongoing patent filings and citations suggest that the patent remains highly relevant in the field, with potential for extensions or carve-outs.
  • Strategies to navigate the landscape include designing structurally distinct analogs, applying for method-specific patents, and monitoring competitor filings.

FAQs

1. What are the key chemical features claimed in the ‘970 patent?

The patent claims a substituted pyrimidine core with variable R-group substituents, designed to target specific therapeutic pathways, primarily in anticancer or neurological indications.

2. How does the ‘970 patent impact competitors developing similar compounds?

It creates a patent thicket that requires competitors to design novel compounds outside its scope, such as different core scaffolds or alternative mechanisms of action, to avoid infringement.

3. Are there known patent challenges to the ‘970 patent?

As of 2023, no publicly reported legal challenges have been filed against the ‘970 patent. It remains in force, with its expiration date in early 2028.

4. What strategies could be used to design around the ‘970 patent?

Developing compounds with distinct chemical scaffolds, using different synthesis methods, or targeting alternative indications can circumvent its claims.

5. How does the patent landscape influence R&D investments?

A dense patent landscape can both hinder and inspire innovation, depending on the ability to develop novel, non-infringing compounds, and secure complementary patents.


References

[1] US Patent 7,320,970 B2, issued Jan 29, 2008.
[2] Patent citation data obtained from USPTO and WIPO databases (as of 2023).
[3] Patent Office reports, legal status records, and industry analyses.

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Drugs Protected by US Patent 7,320,970

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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