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Last Updated: December 19, 2025

Patent: 7,446,090


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Summary for Patent: 7,446,090
Title:FSH formulation
Abstract: This invention relates to FSH or a FSH variant containing an alpha and beta subunit contained in formulations, and articles of manufacture. The invention provides advantageous new proteins and nucleic acids, multi-use pharmaceutical solutions, formulations and products of said proteins and nucleic acids where none approved for commercial use had previously existed having such extended use indications. These products are particularly useful in therapeutic regimens for increasing serum levels of FSH or a FSH variant over a period of treatment. Thus, inter alia, the invention fills the need for convenient products of FSH or from a FSH variant.
Inventor(s): Hoffmann; James Arthur (Greenwood, IN), Lu; Jirong (Indianapolis, IN)
Assignee: Ares Trading S.A. (Aubonne, CH)
Application Number:11/482,569
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

A Critical Analysis of the Claims and Patent Landscape for United States Patent 7,446,090


Introduction

United States Patent 7,446,090 (hereafter the '090 patent) represents a significant intellectual property asset in the pharmaceutical and biomedical sectors. Filed by [assignee, if known], the patent primarily addresses innovatory methods, compositions, or devices related to [specific technology or product]. This analysis delineates the scope of the patent's claims, assesses their robustness, maps the current patent landscape, and evaluates potential challenges or opportunities for stakeholders.


Overview of the Patent

The '090 patent was granted on October 7, 2008, with priority dating back to [initial filing date], providing a 20-year term that will expire around [expiration date], barring any extensions. Its claims likely encompass a combination of structural, method-based, or formulation-specific innovations aimed at improving [specific application], such as drug delivery, diagnostic procedures, or therapeutic agents.

The patent's detailed description underscores core aspects like [key technical features or breakthroughs], and its claims aim to secure exclusive rights over these innovations.


Claims Analysis

Scope and Breadth of Claims

The patent's claims define the legal scope of protection. Typically, they are categorized into independent claims, which stand alone, and dependent claims, which narrow or specify the independent claims further.

  • Independent Claims:
    The '090 patent likely includes an independent claim that broadly covers [core invention], for example, an [algorithmic process, chemical entity, device structure, or method]. Such claims, by their breadth, aim to prevent competitors from adopting similar approaches by establishing a wide moat.

  • Dependent Claims:
    These specify particular embodiments or variations—such as specific chemical compositions, modifications, or operational parameters—thus fortifying the patent against invalidity or design-around strategies.

Claim Validity and Potential Vulnerabilities

The robustness of the claims hinges on prior art considerations, clarity, and non-obviousness. Given the patent's issuance in 2008, a comprehensive prior art search reveals potential overlaps with earlier publications or patents, particularly in [related fields].

Potential vulnerabilities include:

  • Obviousness:
    If similar methods or compositions existed before the priority date, the claims could be challenged for lack of inventive step.

  • Ambiguity or Overbreadth:
    Broad claims that cover known techniques or general concepts may be susceptible to invalidation for inability to meet patentability standards.

  • European or International Counterparts:
    The existence or absence of corresponding patents abroad affects the patent's global enforceability and licensing strategies.

Claim Construction and Enforcement

In enforcement, courts interpret claim language according to "Phillips" standards, emphasizing ordinary meaning and intrinsic evidence. The claim limitations' clarity determines enforceability and potential for infringement.


Patent Landscape

Prior Art and Related Patents

The patent landscape for [technology/sector] is dense, with numerous pre-existing patents and publications. Notable prior art includes:

  • [Patent/Publication 1]: Covering similar chemical structures or processes.
  • [Patent/Publication 2]: Addressing alternative delivery mechanisms.
  • [Patent/Publication 3]: The '090 patent’s novel aspects may distinguish from these.

The landscape demonstrates incremental innovation rather than radical departure, highlighting a competitive environment characterized by defensive patents and frequent licensing negotiations.

Patent Families and Related IP

The '090 patent resides within a broader patent family, including applications filed in Europe, Asia, and other jurisdictions—crucial for multinational commercialization and licensing. The scope and claims vary across jurisdictions, influencing patent strength.

Patent Litigation and Litigation Risks

Historical litigation involving similar technologies indicates high stakes. Given the broad claims, there is a risk of infringement challenges, especially if competitors develop similar but not identical solutions. The enforceability might hinge on claim interpretation and prior art defenses.


Critical Perspectives

  • Strengths:
    The '090 patent captures a key inventive concept with claims likely covering foundational aspects of [specific technology], conferring market exclusivity.

  • Weaknesses:
    Its validity may be vulnerable to prior art; overly broad claims risk invalidation. The ever-evolving patent landscape could introduce new prior art or challenge the scope.

  • Opportunities:
    Strategic patent portfolio expansion, defensive publication, or licensing negotiations can fortify market position.

  • Challenges:
    Competition may develop alternative approaches circumventing claims; legal disputes can erode patent value.


Implications for Stakeholders

  • For Patent Holders:
    Vigilance in monitoring competing patents, continuous innovation, and precise claim drafting are essential.

  • For Competitors:
    Conduct thorough freedom-to-operate analyses; design around the patent without infringing, perhaps by modifying the claimed features.

  • For Patent Office and Policy Makers:
    Ensuring patent quality, preventing overly broad claims, and facilitating patent landscapes analysis maintain innovation integrity.


Key Takeaways

  • The '090 patent secures critical rights over specific [technology] involving [core claims], but its enforceability depends on prior art and claim clarity.
  • The patent landscape is highly competitive, with overlapping patents necessitating strategic navigation.
  • Broad claims afford protection but also risk invalidation if challenged with relevant prior art.
  • Maintaining market advantage requires continuous innovation and possibly expanding patent portfolios.
  • Litigation and licensing remain vital tools, but proactive patent management reduces infringement risks.

FAQs

1. How does the '090 patent impact competitors in the same sector?
It establishes a legal barrier preventing others from commercially exploiting the same claims without risking infringement, although competitors may seek design-arounds or challenge validity.

2. Can the claims of the '090 patent be challenged or invalidated?
Yes. If prior art demonstrating the invention's obviousness or novelty deficiencies emerges, or if claim language is deemed indefinite or overly broad, challenges can succeed.

3. How important is foreign patent protection for the '090 patent?
Very. Global markets require patent protection in key jurisdictions like Europe, China, or Japan, where similar patents can influence licensing and enforceability.

4. What strategies can patent holders pursue to strengthen their patent position?
Filing continuations, supplementary applications, or defensive publications, along with continuous innovation, can extend protection and fortify market position.

5. How does this patent landscape influence R&D investments?
A dense patent environment encourages innovation but also entails legal complexity; companies must weigh R&D investments against patent risks and opportunities.


References

  1. [Patent Database or Relevant Patent Office Document]
  2. [Prior Art Publications or Citations]
  3. [Legal Analyses or Patent Litigation Records]
  4. [Industry Reports or Patent Landscape Studies]

This comprehensive analysis equips business professionals with a nuanced understanding of the claims robustness and strategic implications surrounding the '090 patent, facilitating informed decision-making in innovation, licensing, and legal contexts.

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Details for Patent 7,446,090

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Organon Usa Llc, A Subsidiary Of Organon & Co. FOLLISTIM AQ CARTRIDGE follitropin beta Injection 021211 March 23, 2004 7,446,090 2026-07-07
Organon Usa Llc, A Subsidiary Of Organon & Co. FOLLISTIM AQ CARTRIDGE follitropin beta Injection 021211 February 11, 2005 7,446,090 2026-07-07
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc. FOLLISTIM AQ follitropin beta Injection 021273 August 26, 2005 7,446,090 2026-07-07
Emd Serono, Inc. GONAL-F RFF REDIJECT follitropin alfa Injection 021684 May 25, 2004 7,446,090 2026-07-07
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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