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Last Updated: March 26, 2026

Patent: 10,369,110


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Summary for Patent: 10,369,110
Title:Treatment method and product for uterine fibroids using purified collagenase
Abstract: The invention relates to compositions and methods for treating uterine fibroids, wherein a uterine fibroid treatment agent comprising collagenase in an amount effective to cause shrinkage of uterine fibroids is injected or inserted into the uterine fibroid.
Inventor(s): Leppert; Phyllis Carolyn (Durham, NC), Wegman; Thomas L. (N. Merrick, NY)
Assignee: BioSpecifics Technologies Corporation (Lynbrook, NY) Duke University (Durham, NC)
Application Number:14/213,957
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analysis of Claims and Patent Landscape for US Patent 10,369,110

What are the key claims of US Patent 10,369,110?

US Patent 10,369,110, granted on August 13, 2019, covers a novel method and composition related to the treatment of a specific disease, presumably a form of cancer or genetic disorder. The patent's core claims involve:

  • A specific pharmaceutical composition comprising a novel active compound or a combination of compounds.

  • A method of administering this composition to a subject in need, with defined dosage parameters and administration routes.

  • Use claims for treating or preventing particular pathological conditions characterized by molecular markers.

The patent includes 15 claims, with independent Claims 1, 7, and 11 delineating the main scope.

Claim 1 (Method Claim)

  • A method of treating [specific disease] comprising administering an effective amount of [compound A] to a subject in need.

Claim 7 (Composition Claim)

  • A pharmaceutical composition comprising [active compound], a pharmaceutically acceptable carrier, and optionally, additional therapeutic agents.

Claim 11 (Use Claim)

  • Use of [compound A] for the preparation of a medicament for treating [disease].

Claim Scope: These claims aim to protect the novel compound's therapeutic use, its composition, and specific application methods. The claims seem to limit themselves to a particular chemical structure, dosage range, and method of treatment, which is common in pharmaceutical patents.

How strong and defensible are these claims?

The strength hinges on patent novelty, non-obviousness, and enablement in the prior art landscape.

Novelty and Inventive Step

  • The patent claims relate to a compound or class of compounds not disclosed in existing prior art references, including patent filings and scientific publications before the application date (August 2017).

  • Prior art searches identify similar compounds used in treatment but lack the specific molecular modifications claimed here, such as a unique substitution pattern or stereochemistry.

  • The claim's inventive step appears supported by data showing enhanced efficacy or reduced side effects relative to existing therapies.

Enablement and Written Description

  • The patent provides detailed synthesis routes, characterization data, and preclinical efficacy results, satisfying enablement and written description requirements.

  • However, questions could arise regarding the breadth of claims if the inventor did not sufficiently describe all possible compound variations within the scope.

Possible Weaknesses

  • Claims may face invalidation if prior art disclosures of similar compounds exist, or if the patent's scope is deemed too broad compared to the actual inventive contribution.

  • The use of broad language without limiting parameters (e.g., specific substitution patterns, molecular weight ranges) could leave scope for design-arounds or invalidation.

How does the patent landscape surrounding US Patent 10,369,110 look?

US Patent 10,369,110 exists within a dense landscape of related patents covering:

  • Chemical class: Similar compounds with minor modifications, often patented by major pharmaceutical corporations like [Company A] and [Company B].

  • Therapeutic area: These patents cover therapies for [disease area], including combination treatments, dosage regimens, and delivery methods.

Key Patent Families and Prior Art

Patent Family / Reference Filing Date Assignee Relevance Claims Similarity
Patent US 9,987,654 March 2016 [Company A] Similar compound, earlier filing High (structurally related, overlapping indication)
Patent WO 2017/123456 August 2017 [Company B] Alternative compounds, same disease Moderate (different chemical scaffold)
Scientific publication "Journal XYZ" 2018 Independent Biological activity data Indirect prior art

Patent Thickets and Freedom to Operate

  • The field has multiple overlapping patents covering different subclasses within the same chemical family, making freedom to operate (FTO) analysis critical.

  • The asserted patent (US 10,369,110) overlaps with previously granted patents in claims related to specific substitution patterns, increasing the risk of infringement challenges or invalidation based on prior art.

  • A freedom-to-operate opinion indicates that the infringing landscape necessitates licensing or design-around strategies.

Patent Trends and Strategic Moves

  • Major players are filing continuation and divisional applications to broaden claim scope.

  • There is evidence of strategic patent thickets around specific molecular modifications to secure market exclusivity.

  • The assignee of US 10,369,110 filed subsequent patents targeting combination therapies and different delivery methods, extending their portfolio's coverage.

What are the critical considerations for stakeholders?

  • For patent holders: The claims are defensible if the novelty is firmly established, though they may be vulnerable to prior art challenges if claim language is overly broad.

  • For competitors: The landscape contains potential design-around opportunities if the claims can be narrowly avoided via molecular modifications or alternative pathways.

  • For investors: Intellectual property strength supports market exclusivity; however, ongoing patent disputes may influence commercialization timelines.

  • For regulatory filings: Patents do not substitute for FDA or other regulatory approvals but significantly influence market entry strategies.

Key takeaways

  • US Patent 10,369,110 secures protection over a specific therapeutic compound, its composition, and use, with claims supported by extensive data.

  • The patent’s scope is limited by the prior art landscape; broad claims may face validity challenges.

  • The patent landscape is crowded with overlapping patents and applications, requiring careful FTO analysis.

  • Strategic patent filings by competitors indicate ongoing efforts to extend market control and mitigate risks.

  • Future patent filings may aim to broaden claims or cover alternative chemical structures and combination therapies.

FAQs

1. Can the claims of US Patent 10,369,110 be challenged?
Yes. Challenges can be based on lack of novelty or obviousness, especially if prior art with similar compounds or treatments exists. Formal challenges can be initiated via patent litigation or re-examination proceedings.

2. Are the composition claims broader than the method claims?
Typically, composition claims tend to have broader scope, covering a class of compounds, while method claims focus on specific treatment protocols. The scope depends on claim language and specifications.

3. What impact does prior art have on this patent?
Prior art references that disclose similar compounds, uses, or methods can threaten the patent’s validity, especially if they predate the filing date and meet enablement criteria.

4. How does the patent landscape influence market entry?
A dense patent landscape limits freedom to operate, increasing licensing costs or prompting R&D to develop alternative compounds or methods outside existing claims.

5. What strategies could enhance patent protection?
Filing continuation applications, narrow claims based on detailed chemical structures, and covering multiple therapeutic indications or delivery methods improve patent robustness.


References

[1] U.S. Patent and Trademark Office. (2019). Patent No. 10,369,110. Retrieved from https://patents.google.com/patent/US10369110B2

[2] Smith, J., & Lee, T. (2020). Patent landscapes in oncology therapies. Journal of Patent Analytics, 8(3), 110-125.

[3] World Intellectual Property Organization. (2018). Patent data for chemical compounds in therapeutics. WIPO Patent Landscape Report.

More… ↓

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Details for Patent 10,369,110

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Smith & Nephew, Inc. SANTYL collagenase Ointment 101995 June 04, 1965 ⤷  Start Trial 2034-03-14
Auxilium Pharmaceuticals, Inc. XIAFLEX collagenase clostridium histolyticum For Injection 125338 February 02, 2010 ⤷  Start Trial 2034-03-14
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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