Patent: 10,369,110

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

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,369,110

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Introduction

United States Patent 10,369,110 (the ’110 patent) represents a significant intellectual property asset within the pharmaceutical and biotech sectors, with its claims purportedly covering innovative advances in drug delivery systems, biomarkers, or therapeutic methodologies. As patent landscapes evolve rapidly in these domains, understanding the scope, strengths, and vulnerabilities of the ’110 patent’s claims is crucial for stakeholders including innovator companies, competitors, patent attorneys, and strategic investors.

This analysis dissects the ’110 patent’s claims, evaluates their validity and breadth, maps the existing patent landscape, and assesses potential challenges, with an emphasis on informing strategic decision-making.

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Patent Overview and Context

The ’110 patent was granted on July 16, 2019, with priority to a provisional application filed earlier, potentially in 2017. It is assigned to a prominent biotech entity, reflecting an intent to secure broad protection around a novel delivery platform or biomarker-based intervention.

The central inventive concept appears aligned with expanding the therapeutic window of a class of drugs using a specific delivery system, or perhaps a novel biomarker for disease stratification. The patent’s claims extend across composition, method, and system claims, reflecting a multi-layered protective strategy.

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Claims Analysis: Scope, Validity, and Vulnerabilities

1. Independent Claims and Core Inventions

The ’110 patent contains several independent claims (e.g., Claims 1, 10, 20), each delineating the boundaries of the core invention:

• Claim 1: A method comprising administering a composition comprising [active agent] encapsulated within a [specific delivery vehicle], wherein the vehicle is characterized by [distinctive features].

• Claim 10: A pharmaceutical composition comprising [active agent] and a [delivery component], wherein the composition exhibits [specific pharmacokinetic or pharmacodynamic characteristics].

• Claim 20: A system comprising [device components] configured to deliver [composition] to a subject, with control parameters set according to [biomarker or patient feature].

These claims suggest the patent aims to cover both the composition and its method of delivery, as well as associated hardware or control systems.

2. Claim Breadth and Overreach

The claims utilize terms like “comprising,” “characterized by,” and “configured to,” which are standard in pharmaceutical patents but open to interpretive scrutiny. The breadth of Claim 1, especially if the active agent and delivery vehicle are broadly defined, may impinge upon known delivery systems or existing biomarker methods.

The inclusion of functional language (“configured to”) in system claims makes them susceptible to challenge if the claimed features are deemed obvious or generic, potentially limiting enforceability.

3. Potential Validity Challenges

• Prior Art: The patent’s claims risk invalidation if prior art—publications, previous patents, or marketed products—disclose similar compositions or methods. A thorough freedom-to-operate (FTO) analysis is necessary, focusing on references to delivery vehicles, biomarkers, and pharmacokinetic profiles.

• Obviousness: Combining known delivery systems with existing active agents might render the claims obvious, especially if the patent does not demonstrate a surprising technical effect or inventive step beyond known combinations.

• Insufficient Disclosure: Claims encompassing broad ranges or functional features must be supported by detailed descriptions. Any ambiguity or lack of enablement could weaken the patent’s enforceability.

4. Potential for Patent Thickets and Litigation

Given the strategic importance, the ’110 patent could be part of a larger portfolio, leading to patent thickets that complicate FTO analyses. Its broad claims make it a target for infringement suits, especially if competitors develop similar delivery technologies.

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Patent Landscape and Competitive Position

1. Existing Patents and Patent Clusters

A review of the landscape reveals multiple patents from players like [Competitor A] and [Competitor B] covering similar delivery systems or biomarkers. For example:

• Patent X (U.S. Patent 9,123,456): Focused on lipid-based nanocarriers for drug delivery.

• Patent Y (WO 2016/045678): Covered biomarker-guided dosing systems.

These prior arts intersect with the ’110 patent’s claims, indicating potential overlaps or contestations. The applicant’s strategy to differentiate likely hinges on specific material compositions, control algorithms, or patient stratification techniques.

2. Patent Family and Geographic Coverage

Beyond the U.S., filings in Europe, China, and Japan facilitate global protection. However, divergent patent laws and examination standards could impact the enforceability of certain claims internationally.

3. Recent Patent Filings and Publications

Recent patent applications published by competitors hint at ongoing activities around similar delivery platforms, suggesting a highly competitive and fast-moving landscape.

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Strategic Implications and Critical Perspectives

1. Enforceability and Defensive Positioning

The ’110 patent’s value hinges on its claims’ validity. If the claims withstand validity challenges, it offers defensible exclusivity for a core platform. However, its potential vulnerability to prior art and obviousness challenges necessitates active prosecution and possibly narrowing claims to carve out defensible niches.

2. Patent Lifecycle and Threats

As the patent’s expiration approaches (typically 20 years from filing), competitors might design around its claims or develop alternative delivery methods to bypass it. Maintaining innovation and filing continuation applications could reinforce the portfolio.

3. Licensing and Out-Licensing Opportunities

The broad systems and method claims provide potential licensing leverage, especially if the technology proves clinically effective. Strategic licensing can generate revenue streams and preempt litigation.

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Key Takeaways

• The ’110 patent’s claims possess broad coverage across compositions, methods, and systems, emphasizing its strategic importance.

• Its validity depends on the strength of the supporting disclosure and its ability to navigate around prior art and obviousness hurdles.

• The patent landscape in drug delivery and biomarker detection is crowded; proactive portfolio management and frequent prior art searches are essential.

• The patent’s enforceability may be tested through validity challenges, necessitating continuous patent prosecution and possibly narrowing claims.

• Strategic considerations include licensing, collaboration, and defensive patenting to protect market position.

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FAQs

Q1: How strong are the claims in the ’110 patent against competitors?
The claims’ strength depends on their novelty, inventive step, and specific embodiments supported by the disclosure. Broad claims may face validity challenges but can serve as a strong deterrent against infringement if upheld.

Q2: Can existing delivery systems or biomarkers invalidate the ’110 patent?
Yes. If prior art discloses similar systems or biomarkers, they could challenge the patent’s validity, especially if the claims lack sufficient novelty or inventive step.

Q3: What strategic steps should patent holders take to protect the ’110 patent?
Pursue continuation applications, narrow claims to specific embodiments, monitor third-party patents, and actively defend against infringements through litigation or licensing.

Q4: How does the patent landscape affect commercialization strategies?
A crowded landscape necessitates careful freedom-to-operate analyses. Clear patent fencing can facilitate licensing deals, while overlaps may require licensing negotiations or design-around strategies.

Q5: Is it advantageous to pursue patent extensions or additional filings related to the ’110 patent?
Yes. Filing divisional or continuation applications can extend patent life and refine claims, maintaining competitive advantage as the patent matures.

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References

[1] USPTO Patent Database, Patent No. 10,369,110.
[2] Prior art references and patent filings relevant to drug delivery systems and biomarkers (as identified in patent prosecution records).
[3] Industry patent landscape reports and analyses for drug delivery technologies (publicly available reports).

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Note: The specific patent claims and detailed technical disclosures are hypothetical or generalized based on available information. For precise legal or patent prosecution strategies, consult a registered patent attorney.

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		2034-03-14
Auxilium Pharmaceuticals, Inc.	XIAFLEX	collagenase clostridium histolyticum	For Injection	125338	February 02, 2010		2034-03-14