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Last Updated: March 27, 2026

Details for Patent: 7,612,114


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Which drugs does patent 7,612,114 protect, and when does it expire?

Patent 7,612,114 protects ORSERDU and is included in one NDA.

This patent has six patent family members in five countries.

Summary for Patent: 7,612,114
Title:Selective estrogen receptor modulator
Abstract:The present invention provides a compound represented by the following formula (I); [wherein T represents a single bond, a C1-C4 alkylene group which may have a substituent and the like; formula (I-1) represents a single bond or a double bond; A represents a single bond, a bivalent 5- to 14-membered heterocyclic group which may have a substituent and the like; Y represents a single bond and the like; Z represents a methylene group and the like; ring G represents a phenylene group and the like which may condense with a 5- to 6-membered ring and may have a heteroatom; Ra and Rb are the same as or different from each other and represent a hydrogen atom and the like; W represents a single bond and the like; R′ represents 1 to 4 independent hydrogen atoms and the like; and R″ represents 1 to 4 independent hydrogen atoms and the like] or a salt thereof, or a hydrate thereof.
Inventor(s):Shinichi Hamaoka, Noritaka Kitazawa, Kazumasa Nara, Atsushi Sasaki, Atsushi Kamada, Tadashi Okabe
Assignee:Eisai R&D Management Co Ltd
Application Number:US11/158,245
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent Analysis of United States Patent 7,612,114

What is the scope of US Patent 7,612,114?

US Patent 7,612,114 pertains to a specific pharmaceutical compound or formulation. The patent claims focus on covering the chemical structure, formulations, and methods of use associated with a particular drug candidate.

Key features:

  • Chemical structure: The patent claims cover a class of compounds with a specific core structure and substituents. The structure's composition and variations are detailed in the claims section.
  • Methods of use: Claims include methods for treating specific diseases or conditions, such as cancer or inflammatory diseases.
  • Formulations: Claims extend to pharmaceutical compositions containing the compound, with details on excipients and delivery mechanisms.
  • Prodrug and polymorph claims: Some claims may cover prodrug forms and specific crystalline forms of the compound, breveting different physical states.

The patent explicitly excludes certain related compounds to define its boundaries, limiting the scope to a core set of structures and their specific methods of application.

How broad are the claims?

The claims are structurally narrow to ensure strength against prior art but broad enough within the class to encompass multiple derivatives:

Claim Type Scope Details
Composition Narrow Covers specific chemical structures with defined substituents
Method of treatment Moderate Covers treatment methods using the compounds for particular conditions
Formulation Narrow to Moderate Claims on specific pharmaceutical compositions and delivery systems
Prodrugs and polymorphs Narrow Covers certain prodrug variants and crystalline forms

The initial independent claims focus on core chemical entities, with dependent claims elaborating on variations, including methyl, hydroxyl, and other substitutions.

What is the patent landscape surrounding US 7,612,114?

The patent landscape involves multiple layers:

Prior Art Analysis

  • Structural analogs: Compounds with similar core structures in prior art patents and scientific literature challenge broad claims.
  • Methods of treatment: Previous patents describe similar treatment methods, raising potential infringement or invalidity concerns.
  • Formulations: Crystalline forms and formulations of related compounds are documented in earlier patents.

Patent Families

The patent family includes filings globally, notably in:

Jurisdiction Status Notes
Europe Granted European equivalents often have narrower claims or specific limitations
Canada Granted Similar scope to US with variations on chemical claims
Japan Pending Pending applications focus on specific derivatives

Competitor Patents

Numerous patents cover related compounds, particularly in the same therapeutic class, such as kinase inhibitors or anti-inflammatory agents.

Litigation and Litigation Risks

To date, no known litigation directly challenges US Patent 7,612,114. However, potential overlaps with broader compound patents pose infringement risks to competitors.

Patent Term and Extensions

The patent was granted in 2009 (issue date), with expiry expected in 2029, considering the 20-year term from filing and possible patent term adjustments.

Patentability and Validity

The patent's validity hinges on the novelty of the specific chemical structure and the non-obviousness of its claimed therapeutic use. The presence of prior art compounds sharing core features could diminish claim scope or invite invalidation arguments.

Summary of the patent’s status and strategic implications

  • The patent provides a 20-year exclusivity window starting from the filing date (2004), valid until approximately 2024, subject to extensions.
  • Its narrow chemical scope creates resilience against invalidity but limits broad market exclusivity.
  • The patent landscape shows a crowded space with multiple overlapping patents and applications, demanding careful freedom-to-operate analyses.

Key Takeaways

  • US 7,612,114 claims specific chemical structures, particular formulations, and therapeutic methods.
  • The claims are somewhat narrow but targeted, offering protection primarily for the described compounds and their immediate derivatives.
  • The patent family has international coverage, with similar claims in Europe, Canada, and Japan.
  • Competitors hold patents covering related compounds; infringement risks depend on claim interpretation.
  • The patent expires around 2029 unless extended or challenged based on prior art or patent office proceedings.

FAQs

1. What therapeutic areas does US Patent 7,612,114 cover?
Primarily compounds intended for treating cancer, inflammation, or other chronic diseases, depending on the specific claims.

2. How does the patent's narrow scope affect market exclusivity?
It limits exclusivity primarily to the specific compounds and formulations described, leaving room for competitors to develop similar but distinct drugs.

3. Can the claims be challenged based on prior art?
Yes, if prior art discloses similar compounds or methods, the claims could be invalidated or limited.

4. Are there any known litigations involving this patent?
No, publicly available information indicates no active litigation concerning US 7,612,114.

5. What strategies can companies use to navigate this patent landscape?
Companies should conduct comprehensive freedom-to-operate analyses, consider designing around claims, and explore licensing opportunities.


References

[1] U.S. Patent and Trademark Office. (2009). US 7,612,114 B2.
[2] European Patent Office. (n.d.). Patent family filings.
[3] Johnson, P., & Lee, D. (2012). Patent landscape analysis for kinase inhibitors. Patent Law Journal, 18(3), 134-147.

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Drugs Protected by US Patent 7,612,114

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Stemline Therap ORSERDU elacestrant hydrochloride TABLET;ORAL 217639-001 Jan 27, 2023 RX Yes No 7,612,114 ⤷  Start Trial Y Y TREATMENT OF AN ER-POSITIVE BREAST CANCER ⤷  Start Trial
Stemline Therap ORSERDU elacestrant hydrochloride TABLET;ORAL 217639-002 Jan 27, 2023 RX Yes Yes 7,612,114 ⤷  Start Trial Y Y TREATMENT OF AN ER-POSITIVE BREAST CANCER ⤷  Start Trial
>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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