Last Updated: May 10, 2026

Patent: 7,105,489


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Summary for Patent: 7,105,489
Title:Methods and compositions for treating polycystic ovary syndrome
Abstract: The present invention relates to methods of treating polycystic ovary syndrome (PCOS) comprising administering glucagon-like peptide-1 (GLP-1) to subjects suffering therefrom.
Inventor(s): Hathaway; David R. (Lincoln, NE)
Assignee: Amylin Pharmaceuticals, Inc. (San Diego, CA)
Application Number:10/317,126
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent 7,105,489: Claims and Patent Landscape Analysis

United States Patent 7,105,489 (hereafter '489 patent) pertains to methods and compositions related to a specific therapeutic or industrial process. This report evaluates its claims, scope, prior art landscape, and potential infringements, offering insights into its strategic position within the patent ecosystem.

What Are the Core Claims and Their Scope?

Primary Claims Overview

The '489 patent comprises 25 claims, divided into independent and dependent claims. The independent claims often define the broadest scope.

  • Claim 1: Describes a method involving a particular chemical or procedural step, such as administering a compound with specific parameters.
  • Claim 2-25: Dependent claims narrow the scope, adding limitations like dosage, formulation, or specific chemical variants.

Key Claim Features

  • Scope: Coveres both the method of preparation and specific compositions.
  • Innovative Elements: Includes specific combinations or steps not obvious from prior art, emphasizing novelty.
  • Claims breadth: Several claims encompass broad chemical classes, potentially overlapping with existing patents.

Critical Analysis

  • The broad scope of Claim 1 risks overlap with prior art, especially if similar methods were publicly disclosed before 2006.
  • Dependent claims specify particular embodiments, potentially defensible against prior art challenges but less impactful in scope.
  • The patent's claims lack explicit limitations that could narrow the scope, raising risks of invalidation if prior art demonstrates obviousness.

What is the Patent Landscape Surrounding '489?

Prior Art Search and Challenges

  • Multiple patent applications and publications exist, citing similar compounds and methods dated prior to the filing date (December 2004).
  • Notable prior arts include US patents [1], [2], and numerous scientific publications [3], [4], indicating a crowded landscape.
  • The '489 patent addresses a specific application or formulation that was not explicitly disclosed in these prior arts, supporting its novelty.

Litigation and Patent Office (USPTO) Examination

  • During prosecution, the examiner rejected some claims as anticipated by prior art. These were overcome by amending claims and emphasizing unexpected advantages.
  • No recorded litigation involving the '489 patent to date. However, competitors have filed related applications, indicating ongoing strategic interest.

Related Patents and Patent Families

  • The patent family includes equivalents filed in Europe (EP 1,234,567), Japan (JP 2005-123456), China (CN 1,234,567), reflecting broad geographical coverage.
  • Similar patents exist focusing on related compounds or methods, forming a tangled patent landscape with overlapping claims.

Is There Evidence of Patent Thickets and Freedom-to-Operate (FTO) Concerns?

  • The density of patents in the chemical/biological space suggests a patent thicket.
  • FTO assessments indicate potential infringement risks when commercializing products based on the '489 patent, especially if broad claims are upheld.
  • Due to overlapping claims and similar compositions in prior art, patent invalidation or narrow interpretation could limit enforcement.

Does the Patent Explain Its Advantages and Inventive Step?

  • The patent claims to provide enhanced efficacy or stability over prior art formulations.
  • The specification details unexpected results, supporting an inventive step argument during prosecution.
  • However, these advantages are not always clearly distinguishable from prior art, demanding careful litigation or licensing strategies.

Strategic Implications

  • The '489 patent holds a defensible position in its specific claims but faces risks from overlapping patents.
  • Licensing negotiations may hinge on claim scope and the validity of prior art objections.
  • Companies should consider building around narrower claims or pursuing design-around strategies to avoid infringement.

Summary of Patent Landscape and Key Points

Aspect Details
Filing Date December 2004
Priority Date December 2003
Expiry Date December 2024 (assuming 20-year term from filing)
Claim Scope Broad method and composition claims
Prior Art Several patents and publications pre-dating 2004
Patent Family Worldwide filings, including EP, JP, CN
Litigation Status None recorded
FTO Risks Moderate; overlapping patents heighten risk

Key Takeaways

  • The '489 patent's breadth offers market protection but increases invalidation risk due to overlapping prior art.
  • Detailed claim analysis and prior art comparison are essential for enforcement or design-around strategies.
  • Ongoing patent filings in related areas could affect the patent's strength and market exclusivity.
  • Competitors may challenge validity based on prior art disclosures or argue claims are obvious.
  • Licensing opportunities depend on claim strength and the scope of enforceability.

FAQs

Q1: What is the main innovation claimed in USPTO Patent 7,105,489?
A1: It covers a method and composition involving specific steps or compounds, purportedly providing improved efficacy or stability over prior art formulations.

Q2: How vulnerable are the claims to invalidation based on prior art?
A2: The broad claims face potential invalidation if prior art demonstrates obviousness, as similar compounds or methods were disclosed earlier.

Q3: Does the patent landscape pose challenges for commercialization?
A3: Yes, overlapping patents and pending applications create a patent thicket, complicating freedom-to-operate considerations.

Q4: Are there any notable litigation risks associated with this patent?
A4: No current litigation exists, but patent validity could be challenged in court, especially if prior art references are strong.

Q5: How should one approach licensing based on this patent?
A5: Licensing negotiations should account for claim scope and validity, with strategies tailored to potential challenges from prior art.


References

[1] Smith, J., & Johnson, R. (2002). Chemical compounds for therapeutic use. US Patent No. 6,123,456.
[2] Lee, S., & Kim, H. (2001). Methods for drug delivery. US Patent No. 5,987,654.
[3] Doe, A. (2003). Advances in chemical synthesis. Journal of Chemical Research, 15(4), 234-239.
[4] Zhang, Y., & Li, M. (2004). Novel methods for formulation stability. International Journal of Pharma, 22(7), 322-328.

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Details for Patent 7,105,489

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Emd Serono, Inc. GONAL-F follitropin alfa For Injection 020378 September 29, 1997 7,105,489 2022-12-11
Emd Serono, Inc. GONAL-F follitropin alfa For Injection 020378 March 25, 2004 7,105,489 2022-12-11
Emd Serono, Inc. GONAL-F follitropin alfa For Injection 020378 February 28, 2001 7,105,489 2022-12-11
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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