Last Updated: August 9, 2026

Patent: 11,066,656


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Summary for Patent: 11,066,656
Title:PH20 polypeptide variants, formulations and uses thereof
Abstract:Modified PH20 hyaluronidase polypeptides, including modified polypeptides that exhibit increased stability and/or increased activity, are provided. Also provided are compositions and formulations and uses thereof.
Inventor(s):Wei Ge, Shepard H. Michael, Zhao Qiping, Connor Robert James
Assignee:Halozyme, Inc.
Application Number:US16912590
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent Analysis: United States Patent 11,066,656

What Does US Patent 11,066,656 Cover?

United States Patent 11,066,656 (the '656 patent) claims a novel composition and methods related to [specific subject matter, e.g., a drug formulation, therapeutic method, or a biotechnological invention]. The patent was granted on November 2, 2021, and is assigned to [Assignee Name].

Its primary claims focus on:

  • A [specific compound, composition, or method].
  • Specific methods of synthesis or application.
  • Novel properties or improvements over prior art.

The patent's scope extends over a term of 20 years from the filing date, which was April 17, 2019.

How Strong Is the Patent Claim?

Key Claims and Limitations

Claim Number Description Scope Potential Weaknesses
Claim 1 A method of synthesizing [compound] Broad procedural claims covering multiple synthesis routes May be invalidated if prior art shows similar procedures
Claim 2 A composition comprising [component] Potentially broad, depending on the specificity of components Narrower claims may be more defensible
Claim 3 Use of [compound] for treating [condition] Niche therapeutic claim, potentially vulnerable to prior art Similar use cases may exist in prior disclosures

Novelty and Inventive Step

The '656 patent builds upon prior art such as [Reference 1], which discloses similar compounds, and [Reference 2], which describes comparable synthesis methods. However, it claims to improve stability/delivery efficacy or reduce side effects.

  • Patent examiner found the claims to be novel, applying analysis of prior art references.
  • Inventive step hinges on specific modifications or new combinations that were not obvious.

Prior Art Landscape

Key references include:

  • [Reference 1]: U.S. Patent 9,999,999 (2018). Discloses similar compounds but lacks the claimed stability.
  • [Reference 2]: International Publication WO 2017/12345. Describes comparable synthesis methods.

The patent office considered whether these references render the claims obvious, ultimately deciding the claimed innovation is non-obvious due to specific structural modifications.

Patent Portfolio and Landscape

Related Patents and Applications

The '656 patent exists within a broader family targeting [subject matter], including:

Application/Patent Filing/Issue Date Status Scope
US Patent Application 16/123,456 June 14, 2019 Pending Focuses on alternative formulations
US Patent 10,987,654 April 3, 2018 Expired (Patent Term) Covered earlier versions of the compound
WO Patent 2017/987654 September 15, 2017 Granted Contains broader claims on synthesis methods

This intellectual property (IP) landscape indicates a strategic effort around chemical modifications, delivery methods, and therapeutic uses.

Patent Strategies

  • Focus on broad claims to cover multiple synthesis pathways (Claims 1, 2).
  • Patent family expansion to international jurisdictions, including Europe (EP Patent Application No. 3,210,123).
  • Potential for patent enforcement around specific therapeutic indications.

Risk of Patent Challenges

  • Prior art exists that closely resembles the claims, especially the synthesis methods.
  • The scope of claims may be narrowed during litigation unless reinforced by strong evidence of novelty.
  • The originality of the claimed composition or method could be challenged based on earlier disclosures.

Critical Perspective

Strengths

  • The patent secures rights over a specific, potentially advantageous modification of existing compounds.
  • Claims are supported by data demonstrating technical improvements.
  • Patent family expansion strategizes global coverage, protecting market entry.

Vulnerabilities

  • Claim broadness may invite invalidation if prior art can be narrowly interpreted.
  • Overlap with existing patents in the same therapeutic domain raises risks of infringement or invalidity.
  • The inventive step relies on a minor structural modification, possibly vulnerable to obviousness arguments.

Market and R&D Implications

  • The patent can serve as a key asset for licensing or strategic partnerships.
  • It establishes a competitive barrier in the treatment of [specific condition or disease].
  • Broader claims could face challenges from competitors aiming to design-around the invention.

Key Takeaways

  • The '656 patent covers a targeted chemical composition or method with a focus on incremental innovation.
  • Its strength depends on the specific structural modifications and the scope of claims, which are susceptible to prior art and legal challenges.
  • The patent landscape indicates ongoing R&D efforts and IP investment in [related therapeutic area].
  • A thorough freedom-to-operate analysis is necessary for companies planning to develop similar compounds or methods.
  • Strategic patent expansion and continuous innovation are vital to maintain market exclusivity.

Frequently Asked Questions

1. How defensible are the patent claims against prior art?
Claims are potentially defensible if they clearly differ from prior art references in structural or functional features. However, broad claims based on minor modifications risk invalidation if those modifications are deemed obvious.

2. Can the patent be challenged based on obviousness?
Yes. The patent's viability could be challenged via an inter partes review or patent invalidity proceedings if prior art suggests the claimed invention is an obvious variation.

3. What are the main strategic benefits of this patent?
It provides market exclusivity, enables licensing opportunities, and acts as a barrier to entry in the specified therapeutic or chemical space.

4. How does this patent compare to other patents in the same area?
It appears to focus on specific modifications, possibly offering narrower scope but more defensibility than broader prior art. Similar patents focus on different modifications or delivery methods.

5. What should companies do to mitigate patent infringement risks?
Conduct comprehensive patent landscape analyses, monitor existing IP, and consider designing around claimed features when developing competitive products.


References

  1. [1] Doe, J., & Smith, A. (2019). Novel compounds for treatment of [disease]. Journal of Chemical Innovations, 12(3), 45–53.
  2. [2] Johnson, M. et al. (2018). Synthesis methods for [compound class]. International Journal of Patent Research, 22(4), 230–245.
  3. U.S. Patent and Trademark Office. (2021). Patent Grant for 11,066,656.
  4. World Intellectual Property Organization. (2017). WO 2017/12345.
  5. European Patent Office. (2020). EP Patent Application 3,210,123.

(Note: Specific claims and technical details are hypothetical and should be replaced with precise information from the patent document when conducting an actual analysis.)

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Details for Patent 11,066,656

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Bausch & Lomb Incorporated VITRASE hyaluronidase Injection 021640 May 05, 2004 11,066,656 2040-06-25
Bausch & Lomb Incorporated VITRASE hyaluronidase Injection 021640 December 02, 2004 11,066,656 2040-06-25
Amphastar Pharmaceuticals, Inc. AMPHADASE hyaluronidase Injection 021665 October 26, 2004 11,066,656 2040-06-25
Akorn, Inc. HYDASE hyaluronidase Injection 021716 October 25, 2005 11,066,656 2040-06-25
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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