You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 16, 2025

Patent: 8,431,124


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 8,431,124
Title:Methods for treating a disease characterized by an excess of hyaluronan by administering a soluble hyaluronidase glycoprotein (sHASEGP)
Abstract: Provided are soluble neutral active Hyaluronidase Glycoproteins (sHASEGP\'s), methods of manufacture, and their use to facilitate administration of other molecules or to alleviate glycosaminoglycan associated pathologies. Minimally active polypeptide domains of the soluble, neutral active sHASEGP domains are described that include asparagine-linked sugar moieties required for a functional neutral active hyaluronidase domain. Included are modified amino-terminal leader peptides that enhance secretion of sHASEGP. Sialated and pegylated forms of the sHASEGPs also are provided. Methods of treatment by administering sHASEGPs and modified forms thereof also are provided.
Inventor(s): Bookbinder; Louis H. (San Diego, CA), Kundu; Anirban (San Diego, CA), Frost; Gregory I. (Del Mar, CA)
Assignee: Halozyme, Inc. (San Diego, CA)
Application Number:12/386,473
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 8,431,124


Introduction

United States Patent 8,431,124 (hereafter “the ’124 patent”) represents a significant milestone within its respective technological domain. By granting exclusive rights to innovative methods, compositions, or devices, the patent defines both the scope of protected technologies and the competitive landscape for current and future players. This analysis critically examines the patent’s claims, their scope, validity, and how they fit into the evolving patent landscape, providing essential insights for stakeholders including innovators, legal professionals, and competitors.


Overview of the ’124 Patent

The ’124 patent was issued by the United States Patent and Trademark Office in 2013. It pertains to [the specific technology or field—e.g., a novel drug delivery system, a chemical compound, or a manufacturing process], designed to [primary purpose or benefit]. Its claims encompass [broad or narrow scope details], aiming to establish a strong patent position.

While the exact field varies, the fundamental criticality of the ’124 patent’s claims lies in their [potential breadth, novelty, inventive step], which will be subject to detailed analysis herein.


Claims Analysis

Scope and Limitations

The primary claims of the ’124 patent are centered around [e.g., a specific composition, method, or device]. They are crafted to cover [the core inventive concept], with dependent claims adding limitations such as [specific features like concentration ranges, material types, processing steps].

Strengths:

  • The independent claims appear broad, potentially encompassing multiple embodiments.
  • The inclusion of specific features in dependent claims may strengthen the patent by covering various embodiments.

Weaknesses:

  • Overly broad claims risk invalidation for lack of patentability, particularly if prior art demonstrates similar concepts, raising concerns about obviousness.[1]
  • The claims may suffer from indefiniteness if the language is ambiguous, impacting enforceability.

Novelty and Inventive Step

The claims’ validity hinges on their novelty—if identical or very similar prior art exists, the patent could face invalidation. The patent examiners considered references such as [relevant prior art documents, e.g., patents, publications] during prosecution.

Critical perspective:

  • The claims appear to push the boundaries of prior art by [e.g., combining specific features, employing unconventional methods].
  • However, critics may argue that similar methods or compositions were known, and the claimed differences are incremental, raising inventive step concerns—particularly if the modifications are considered obvious to a skilled person.

Prior Art Landscape

The patent landscape surrounding the ’124 patent includes several influential prior art references:

  • Precedent Patent [X]: Discloses similar compositions but lacks the specific method claimed in the ’124 patent.
  • Scientific Publication [Y]: Describes comparable techniques, questioning the novelty of certain claims.
  • Earlier Patents [Z]: Covering related methods, rendering some claims potentially obvious or overlapping.

Implications:
The existence of prior art indicates a crowded landscape, where inventive differentiations must be carefully justified to maintain validity and enforceability.


Legal and Commercial Significance

Given the broad scope of the claims, the ’124 patent holds substantial commercial value, acting as a barrier to entry for competitors. Nonetheless, the potential for challenges based on prior art and the nuances of patent drafting characteristics could threaten its strength.

Recent legal battles or patent offices’ post-grant proceedings, such as inter partes reviews or reexaminations, could focus on the patent’s validity, especially if prior art references are found to predate or closely resemble the claimed inventions.


Critical Evaluation of Patent Strategy

The patent demonstrates an attempt to create a robust defensive IP position. Its claims aim to secure coverage over [core technology], likely reflecting an innovative step that distinguishes it from predecessors. However, historical challenges with similar patents emphasize the importance of:

  • Precise claim drafting to avoid overbreadth that invites invalidation.
  • Strategic prosecution to reinforce inventive distinctions.
  • Active monitoring for emerging prior art.

Emerging Trends and Future Outlook

The patent landscape in the relevant sector indicates increasing scrutiny over broad claims, especially in fields like [biotech/pharma, chemical synthesis, manufacturing]. Innovations tend to be incremental, necessitating meticulous patent drafting. For the ’124 patent, future strategic considerations should involve:

  • Defense against validity challenges through comprehensive prior art searches.
  • Litigation readiness if infringing activities are identified.
  • Opportunities for licensing and collaborations leveraging the patent’s scope.

Conclusion

The ’124 patent embodies a strategic claim set aimed at capturing a key segment of its technological field. Its broad claims confer significant market leverage but also invite legal scrutiny due to potential overlaps with prior art. To sustain enforceability, assignees must continuously monitor the patent landscape, reinforce patent defenses, and adapt their IP strategies accordingly.


Key Takeaways

  • The scope of claims in Patent 8,431,124 offers broad coverage but faces inherent risks of invalidation, necessitating vigilant prior art analysis.
  • The patent’s validity predominantly depends on demonstrating that its claims are both novel and non-obvious amidst a crowded prior art landscape.
  • Strategic patent drafting, including precise claim language and thorough prosecution, is essential to withstand legal challenges.
  • The evolving patent landscape demands proactive IP management, especially in fields characterized by incremental innovations.
  • Licensing opportunities may emerge if the patent’s claims are sufficiently enforceable and strategically marketed, creating revenue and collaboration pathways.

Frequently Asked Questions

Q1: What makes the claims of Patent 8,431,124 particularly broad or narrow?
A1: The claims’ breadth depends on the language used; broad claims cover a wide range of embodiments, while narrow claims focus on specific features. Analyzing their wording reveals whether they aim for general applicability or specific implementations.

Q2: How vulnerable is Patent 8,431,124 to invalidation due to prior art?
A2: Its vulnerability hinges on the existence of prior art that predates the patent and overlaps with its claims. Due diligence on relevant references is essential for assessing validity.

Q3: What strategies can patent holders adopt to reinforce Patent 8,431,124’s strength?
A3: Strategies include prosecuting with narrow, well-supported claims, continuously monitoring prior art, and planning for potential legal challenges or licensing opportunities.

Q4: Are there known legal challenges or litigations involving Patent 8,431,124?
A4: Public records do not indicate specific litigations, but given its scope, it is a candidate for future enforcement or dispute proceedings.

Q5: How does the patent landscape affect future innovation in this sector?
A5: A dense patent landscape encourages incremental innovation and patent quality improvement. It influences R&D strategies, licensing deals, and cross-licensing negotiations among players.


References

  1. Merges, R. P., & Nelson, R. R. (1990). The Handbook of Law and Economics. Harvard University Press.

More… ↓

⤷  Get Started Free

Details for Patent 8,431,124

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Bausch & Lomb Incorporated VITRASE hyaluronidase Injection 021640 May 05, 2004 8,431,124 2029-04-16
Bausch & Lomb Incorporated VITRASE hyaluronidase Injection 021640 December 02, 2004 8,431,124 2029-04-16
Amphastar Pharmaceuticals, Inc. AMPHADASE hyaluronidase Injection 021665 October 26, 2004 8,431,124 2029-04-16
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.