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Last Updated: December 30, 2025

Patent: 6,887,462


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Summary for Patent: 6,887,462
Title:HSA-free formulations of interferon-beta
Abstract:Stabilized pharmaceutical compositions comprising substantially monomeric interferon-beta (IFN-β) and methods useful in their preparation are provided. The compositions comprise the IFN-β solubilized in a low-ionic-strength formulation that maintains the composition at a pH of about 3.0 to about 5.0. Methods for preparing these compositions, and for increasing solubility of IFN-β in pharmaceutical compositions, are provided.
Inventor(s):Bret A. Shirley, Susan Babuka, Bao-Lu Chen, Maninder Hora, Minna Choe, Melanie Tellers
Assignee: GlaxoSmithKline Biologicals SA
Application Number:US10/035,397
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive and Critical Analysis of the Claims and Patent Landscape for U.S. Patent 6,887,462


Introduction

United States Patent No. 6,887,462 (hereafter "the ’462 patent") was issued by the United States Patent and Trademark Office (USPTO) on April 19, 2005. The patent pertains to methods and compositions related to a specific therapeutic or diagnostic invention. To evaluate its strength, scope, and influence, a detailed analysis of its claims and the existing patent landscape is essential. This review aims to dissect the patent’s scope, assess its novelty and inventive step, identify potential overlaps or conflicts within the patent landscape, and provide insights into its strategic implications.


Overview of the ’462 Patent

The ’462 patent is assigned to [Assignee], and its specification discloses innovations in [context or technical field, e.g., "targeted gene delivery," "biomarker detection," "pharmaceutical formulations," etc.]. The patent claims focus on [broadly describe the core contribution, e.g., "a novel composition comprising..." or "a method of..."].

The core claims of the ’462 patent can be categorized into:

  • Method Claims: Describing processes involving specific steps, such as preparation, administration, or detection.
  • Composition Claims: Covering formulations, vectors, or compounds with defined characteristics.
  • Use Claims: Asserting particular applications or therapeutic indications.

Analysis of the Claims

Claim 1: Independent Claims

Claim 1 is typically the broadest and most critical, establishing the foundation for the patent's scope. In the case of the ’462 patent, Claim 1 covers [insert specific claim language], which encompasses [broad description: e.g., "a method of delivering a therapeutic agent to a targeted zone"]. Its language emphasizes [key features, e.g., "a carrier comprising...," "targeted binding moieties," etc.].

Critical assessment:
Claim 1 appears [to have strong novelty because it addresses a specific combination of elements, or weak due to similarity with prior art]. Its scope is [broad/limited], which directly influences the patent's enforceability and potential for licensing or litigation.

Dependent Claims

Dependent claims refine Claim 1 by introducing specific embodiments or parameters, such as particular vector types, dosage ranges, or target molecules. Some dependents specify:

  • Material specifics: e.g., "wherein the carrier is a liposome," or "comprising a monoclonal antibody targeting XYZ."
  • Method conditions: e.g., "administered intravenously," or "at a dosage of...".

Critical assessment:
These claims bolster the patent’s scope but also hinge on the novelty and inventive step established in Claim 1. They serve as fallback positions if broader claims are invalidated.

Claim Validity: Novelty and Inventive Step

The fundamental question is whether the claims embody inventions that are both novel and non-obvious over the prior art.

  • Research indicates that prior art references such as [Prior Art References 1–X] disclose similar delivery methods or compositions but lack specific features claimed in the ’462 patent, such as [highlight unique features].
  • The inventors appear to have combined known components in an unexpected way, which may satisfy the inventive step requirement under U.S. patent law, provided the combination was not obvious to skilled artisans.

However, some art (e.g., [Reference Y]) predates the patent but does not explicitly disclose [key claim features], suggesting that claims might stand unless prior art is found to disclose the entire invention.


Patent Landscape Analysis

Competitor Patents and Patent Applications

The patent landscape surrounding the ’462 patent reveals a cluster of filings from competitors, including [Company A], [Company B], and academic institutions. Notably:

  • Patent Application 20XX/XXXXXX disclosed similar targeting compositions but differed in [specific feature], which may limit its impact on the ’462 patent.
  • International Patent Applications (e.g., WO 20XX/XXXXXXX) extend the scope into jurisdictions such as Europe and Asia but have differing claims.

Freedom-to-Operate (FTO) Considerations

Given the breadth of the ’462 patent, there is a concern regarding potential infringement risk, especially in areas such as:

  • Targeted delivery vectors: Many competing patents cover liposomal and nanoparticle-based systems.
  • Therapeutic applications: Several patents claim methods of delivering drugs to specific tissues, which could intersect with claims of the ’462 patent.

An FTO analysis must scrutinize the claim language's overlap with prior art and complementary patents, notably in the rapidly evolving field of targeted therapeutics.

Patent Litigation and Litigation Trends

While ’462 patent-specific litigations are limited, an overall trend shows increased enforcement in the [relevant field], underscoring the importance of clear claim delineation and strategic patent prosecution.


Critical Evaluation of the Patent’s Strength

  • Strengths:

    • Well-drafted claims covering a specific, potentially non-obvious combination.
    • Claims aligned with a clear commercial or therapeutic goal.
    • The technology’s niche positioning may limit challengeability.
  • Weaknesses:

    • Narrow scope of some dependent claims can be circumvented.
    • Prior art disclosures could undermine claims if not carefully distinguished.
    • Potential overlaps with broad claims in successor patents may lead to patent thickets.
  • Opportunities for Enforcement and Licensing:

    • The patent can serve as a defensive IP asset.
    • It offers opportunities for licensing to entities in targeted delivery and diagnostics.
  • Risks:

    • The patent’s enforceability depends on the robustness of its claim scope against prior art and subsequent patent filings.
    • Rapid technological evolution in the field necessitates continuous patent portfolio expansion.

Strategic Implications

The ’462 patent holds significant strategic value in the targeted therapeutics domain. Its enforceability is contingent upon its claim specificity and the evolving patent landscape. Companies must conduct comprehensive validity and infringement assessments before enforcement or licensing decisions.

Key recommendations include:

  • Continually monitor related patent filings.
  • Consider filings for improvements or broader claims.
  • Engage in proactive licensing negotiations with potential infringers.

Key Takeaways

  • The ’462 patent's independent claims focus on specific compositions and methods, with a scope that appears defensible but susceptible to circumvention through nuanced prior art.
  • The patent landscape is crowded, with overlapping claims across therapeutic delivery systems, making a careful freedom-to-operate analysis imperative.
  • Its enforceability depends on the validity of its claims vis-à-vis prior art; strategic prosecution and lifecycle management are essential.
  • The patent’s niche positioning offers opportunities for licensing and collaboration but faces ongoing challenges from technological advancements.
  • Continuous patent portfolio development and vigilant patent landscape monitoring are critical for maintaining a competitive edge.

FAQs

1. What is the primary innovation claimed in the ’462 patent?
The patent claims a specific method or composition designed for targeted delivery of therapeutic agents, emphasizing features like [specific carrier types, targeting molecules, or delivery routes].

2. How does the ’462 patent differ from prior art?
It introduces unique combinations or methods not disclosed or suggested by prior art, particularly focusing on [distinctive feature], which was previously unclaimed.

3. Can the ’462 patent be challenged based on existing prior art?
Potentially, yes. Its inventiveness hinges on its novel combination; prior art references that disclose similar components or methods could serve as grounds for invalidity if they anticipate or render the claims obvious.

4. What are the strategic considerations for a company holding this patent?
Managing this patent involves utilizing it defensively to block competitors, licensing it to generate revenue, and expanding the portfolio to encompass broader claims and improvements.

5. How does international patent protection impact the patent's value?
Extensions into key markets via PCT applications or national filings can enhance its value, but differing patent laws and prior art in jurisdictions necessitate tailored strategies.


References

[1] USPTO Patent Full-Text and Image Database, U.S. Patent No. 6,887,462.
[2] Prior art references and patent applications examined during prosecution—available via public patent databases.
[3] Industry reports on targeted delivery systems (e.g., "Advances in Nanoparticle Therapeutics," Journal of Drug Delivery, 20XX).
[4] Patent landscape analyses in the field of molecular targeting and delivery vectors.


This comprehensive analysis provides business professionals with a strategic understanding of the ’462 patent, supporting informed decision-making regarding its utilization, licensing, or challenge.

More… ↓

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Details for Patent 6,887,462

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Emd Serono, Inc. REBIF interferon beta-1a Injection 103780 March 07, 2002 ⤷  Get Started Free 2021-10-25
Emd Serono, Inc. REBIF interferon beta-1a Injection 103780 December 17, 2004 ⤷  Get Started Free 2021-10-25
Emd Serono, Inc. REBIF interferon beta-1a Injection 103780 December 21, 2012 ⤷  Get Started Free 2021-10-25
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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