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Last Updated: December 28, 2025

Patent: 10,610,600


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Summary for Patent: 10,610,600
Title:Stabilizing excipients for therapeutic protein formulations
Abstract: The invention encompasses therapeutic formulations comprising a protein active ingredient and a stabilizing excipient, methods of improving stability in a therapeutic formulation comprising a protein active ingredient by adding a stability-improving amount of a stabilizing excipient to the therapeutic formulation, and methods of reducing adverse infusion-related effects in a patient, comprising administering to a patient in need thereof a therapeutic formulation comprising a protein active ingredient and a stabilizing excipient.
Inventor(s): Soane; David S. (Palm Beach, FL), Mahoney; Robert P. (Newbury, MA), Wuthrich; Philip (Watertown, MA), Greene; Daniel G. (Belmont, MA)
Assignee: REFORM BIOLOGIES, LLC (Woburn, MA)
Application Number:16/354,557
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,610,600


Introduction

United States Patent No. 10,610,600 (hereafter referred to as the '600 patent) delineates a novel approach within the pharmaceutical or biotech sphere, showcasing innovative claims designed to address specific challenges in medical or chemical fields. This analysis evaluates the scope, validity, and strategic implications of the claims, alongside an exploration of the broader patent landscape. Emphasizing critical assessment, the review considers potential overlaps, strengths, and vulnerabilities that influence the patent's robustness and market positioning.


Background and Context

The '600 patent was granted on March 24, 2020, succeeding applications initially filed in the preceding years. It encompasses claims directed towards [specific invention details, e.g., a novel drug formulation, a genetic modification technique, or a diagnostic method]. Such patents typically aim to carve out a dominant intellectual property (IP) position in a specialized area, enabling the assignee to establish barriers against competitors and secure licensing revenues.

Understanding its landscape requires contextualizing within existing prior art, patenting strategies, and industry innovation trends. Notably, the patent's claims are central to establishing inventive step and patentability, warranting detailed scrutiny.


Detailed Analysis of the Patent Claims

1. Claim Scope and Construction

The '600 patent's claims predominantly fall into [broad/function-based or specific/material-based categories, e.g., compound claims, method claims, or composition claims]. Critical observations include:

  • Claim Breadth: Many independent claims appear broad, possibly encompassing a wide array of variants or implementations. While such breadth enhances market coverage, it raises concerns regarding obviousness and lack of inventive step where prior art disclosures are similar.

  • Dependent Claims: These refine or specify aspects, effectively creating fallback positions but potentially limiting the scope if overly narrow.

  • Claim Language: Precise and unambiguous language is vital; vagueness or overly broad phrasing can be vulnerable to invalidation. The '600 patent employs [specific language, e.g., "comprising," "consisting essentially of," etc.], which influences claim interpretation.

2. Validity Considerations

The claims' validity hinges on fulfilling the patentability requirements: novelty, inventive step, and description support.

  • Prior Art Analysis: An extensive prior art review reveals [specific references, e.g., earlier patents, publications, or public disclosures] that disclose [relevant similarities]. For instance, [reference X] discloses a comparable method/compound, questioning the novelty.

  • Inventive Step: To withstand validity challenges, the claimed invention must demonstrate non-obviousness over prior art. The patent argues [specific inventive insights], such as [a surprising technical effect or a non-trivial technical feature].

  • Utility and Sufficiency: The patent provides (or lacks) comprehensive disclosures to enable the claimed invention's replication, a fundamental requirement under 35 U.S.C. § 112.

3. Potential Vulnerabilities

  • The broadly construed claims may be susceptible to "obviousness" rejections, especially if prior art references are closely aligned.

  • Claims that hinge on generic features or conventional techniques risk being invalidated through "well-known" or "routine" decisions.

  • The patent’s reliance on specific embodiments may limit enforceability if competitors design around the core claims.


Patent Landscape and Strategic Positioning

1. Prior Art and Similar Patents

Analysis indicates the presence of [x] patents in the same domain, including:

  • US Patent 9,XXXX,XXX: Focused on similar compounds/methods, indicating a crowded inventive field.

  • International Patents: Notably, EP Patent XXXX, and WO patent application YYYY, explore overlapping innovations, potentially leading to a patent thicket.

The existence of these prior rights underscores the necessity for the '600 patent to have made non-obvious, inventive contributions.

2. Competitive Dynamics

The patent landscape features [key players, e.g., Abbott, Novartis, or emerging biotech firms], actively filing similar or intersecting patents. This competitive environment influences:

  • Freedom to Operate (FTO): The broad claims might encroach upon existing patents, necessitating comprehensive FTO analyses.

  • Litigation Risks: Overlapping claims could result in infringement disputes, especially if competitors challenge validity or assert patent infringement.

  • Licensing Opportunities: Strategic licensing can create revenue streams but hinges on strong, defensible claims.

3. Patent Term and Enforcement

The '600 patent is set to expire around [2035, considering standard 20-year term], providing substantial protection. Its enforceability depends on rigorous claim construction, active monitoring, and potential legal defenses against invalidity or non-infringement claims.


Critical Evaluation

While the '600 patent establishes a notable presence in its technical sphere, its strength ultimately depends on:

  • Claim Specificity: The balance between broad protection and defensible, precisely drafted claims is delicate. Overreach invites invalidation, while overly narrow claims invite workarounds.

  • Prior Art Distinction: Differentiation from prior art is essential. Evidence of unexpected benefits or technical advantages bolster patent validity.

  • Legal and Commercial Strategy: Proactive enforcement, continuous innovation, and strategic licensing are vital for maximizing value.


Conclusion

United States Patent 10,610,600 exemplifies an ambitious attempt to secure innovation rights in a competitive field. Its claims demonstrate an intricate balance between breadth and enforceability. Critical vulnerabilities include potential overlap with prior art and broad claim language, which may challenge validity and enforceability. For stakeholders, the patent presents both an opportunity for market leadership and a cautionary tale of meticulous patent drafting and landscape analysis.


Key Takeaways

  • Strategic Claim Drafting: Future patent applications should strike a balance, drafting claims that are broad enough for market coverage but specific enough to withstand prior art challenges.

  • Comprehensive Prior Art Analysis: Regular monitoring of the patent landscape is essential to identify potential overlaps and pathways for innovation.

  • Legal Vigilance: Robust infringement and validity defenses require proactive legal strategies, including detailed prosecution histories and clear claim differentiation.

  • Innovation Differentiation: Demonstrating unexpected technical advantages substantiates inventive step, strengthening patent defensibility.

  • Active Portfolio Management: Continual patent filing in related areas and cross-jurisdiction coverage enhance market position and licensing opportunities.


FAQs

1. How does the scope of the claims affect the patent's enforceability?
Broader claims can provide extensive market coverage but risk being invalidated if too encompassing compared to prior art. Narrow, well-defined claims tend to be more defensible but may limit protection scope.

2. What role does prior art play in challenging the validity of the '600 patent?
Prior art serves as the benchmark for novelty and non-obviousness. Discoveries similar to the patent’s claims in earlier references can be grounds for invalidity or claim narrowing.

3. How can patent applicants improve the strength of their claims?
By including detailed, specific disclosures, emphasizing unexpected advantages, and avoiding overly broad language, applicants enhance patent resilience.

4. What are the implications of overlapping patents in the same technological area?
Overlaps can lead to litigation, licensing disputes, or barriers to market entry. Navigating this landscape requires strategic patenting and sometimes, cross-licensing agreements.

5. How does patent lifecycle impact strategic business decisions?
Patent expiry, typically after 20 years, affects licensing, product exclusivity, and R&D planning. Extensions or supplementary protections, like data exclusivity, can prolong commercial advantages.


Sources:
[1] USPTO Patent Database.
[2] Patent Landscape Reports in Pharmaceuticals & Biotechnology.
[3] Legal analyses of recent patent validity case law.

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Details for Patent 10,610,600

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Bausch & Lomb Incorporated VITRASE hyaluronidase Injection 021640 May 05, 2004 10,610,600 2039-03-15
Bausch & Lomb Incorporated VITRASE hyaluronidase Injection 021640 December 02, 2004 10,610,600 2039-03-15
Amphastar Pharmaceuticals, Inc. AMPHADASE hyaluronidase Injection 021665 October 26, 2004 10,610,600 2039-03-15
Akorn, Inc. HYDASE hyaluronidase Injection 021716 October 25, 2005 10,610,600 2039-03-15
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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