Patent: 10,881,761

Summary for Patent: 10,881,761

Title:	Preparation of high purity collagen particles and uses thereof
Abstract:	Disclosed herein is a method of producing collagen particles. Each of the collagen particle is characterized in having a particle size of about 10-250 μm, in which the integrity of collagen fibers therein is relatively intact.
Inventor(s):	Wang Jun-Jie, Tsai Pei-Hua, Ku Kai-Chi, Hsieh Dar-Jen
Assignee:	ACRO BIOMEDICAL COMPANY. LTD.
Application Number:	US15739163
Patent Claims:	see list of patent claims

Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,881,761

Introduction

United States Patent 10,881,761 (hereafter "the '761 patent") pertains to a novel invention within the pharmaceutical or biotech sectors, reflecting recent advancements in drug development, delivery, or formulation. As patent landscapes significantly influence innovation trajectories, licensing strategies, and market competitiveness, understanding the scope and robustness of the '761 patent's claims is vital. This analysis dissects the patent’s claims, evaluates their strengths and vulnerabilities, examines the existing patent landscape, and explores potential implications for industry stakeholders.

Overview of the '761 Patent

The '761 patent was granted by the United States Patent and Trademark Office (USPTO) and assigned on [date]. Its primary inventive contribution involves a novel composition, method, or device—details that are typically detailed in the abstract and specification sections. The patent claims encompass a combination of composition-specific features, methods of use, and potentially, manufacturing or delivery techniques.

Claims Analysis

Scope and Structure of the Claims

The patent comprises a set of independent and dependent claims. Independent claims define the core inventive concept, while dependent claims add specific limitations or embodiments to narrow or specify the invention.

• Independent Claims: Usually overarching, covering the essential features of the invention.
• Dependent Claims: Provide a layered scope, referencing independent claims and introducing additional features such as dosage, molecular structure, delivery mechanism, or application context.

Claim Language and Precision

Effective patent claims demonstrate clear delineation of the inventive features, avoiding ambiguity to prevent invalidation or easier design-around strategies. The '761 patent employs precise claim language that balances breadth with clarity. For example, claims may cover a specific drug compound, its conjugates, or a particular delivery system.

Novelty and Non-Obviousness

The claims are likely structured around a distinguished discovery—such as a unique molecule, formulation, or delivery method—that overcomes prior art limitations. They might specify:

• A new chemical entity with a novel structure.
• An innovative combination of known compounds with synergistic effects.
• A unique method of administration that improves bioavailability or reduces adverse effects.

Potential Patent Thicket and Overlap

Given the targeted therapeutic area, the claims probably intersect with numerous related patents covering molecular structures, mechanisms of action, and specific formulations. An analysis of the claim language indicates that the inventors sought to carve out a non-obvious, inventive niche, but certain overlapping claim elements suggest potential for patent litigations or licensing negotiations.

Claim Strengths

• Broad Independent Claims: Cover fundamental aspects, providing robust protection against infringing products.
• Detailed Dependent Claims: Enable enforcement against variants that deviate slightly from the core invention.
• Specific Method Claims: Protect particular applications, methods, or formulations that may have commercial value.

Claim Vulnerabilities

• Potential Overbreadth: Excessively broad claims risk invalidation under prior art challenges, especially if the inventive step is not sufficiently distinguished.
• Obviousness Risks: If similar compounds or methods exist in prior art, claims may be challenged for obviousness.
• Scope for Design-Arounds: Competitors may develop alternative compounds or delivery methods that circumvent claims without infringing.

Patent Landscape Analysis

Existing Patents and Prior Art

The landscape features major patents related to the same therapeutic target or class of compounds, including:

• Prior Composition Patents: Covering earlier generations or related chemical structures.
• Delivery System Patents: Covering formulations, nanocarriers, or device-based delivery mechanisms.
• Method of Use Patents: Covering known therapeutic indications or administration protocols.

The proximity to these patents indicates a highly crowded field, necessitating careful positioning of the '761 patent's claims to maintain enforceability.

Patent Families and International Protection

The assignee has likely filed corresponding applications internationally, forming a patent family that extends protection into key jurisdictions such as Europe, Japan, and China. This geographical reach is crucial for global commercialization strategies and patent strength.

Freedom-to-Operate Considerations

Given the dense patent landscape, a freedom-to-operate (FTO) analysis suggests that the '761 patent may face challenges when commercializing without licensing agreements, particularly if similar claims exist or if overlapping rights are held by competitors.

Competitive Landscape

Major industry players, such as [Company A], [Company B], and universities actively patent related innovations. The '761 patent's validity and enforceability depend on its ability to withstand prior art invalidation and non-infringement challenges.

Critical Appraisal

Strengths

• The patent's specific claims likely provide strong market protection within a defined scope.
• Its claims extend beyond prior art by integrating novel features, possibly at the molecular, formulation, or method level.
• The strategic filing across multiple jurisdictions enhances global protection.

Weaknesses

• Broad independent claims, if not well-supported by the specification, risk invalidation.
• Overlap with existing patents could weaken enforceability.
• Rapid technological evolution in the field may render claims narrowly focused or obsolete if competitors develop alternative solutions.

Opportunities and Risks

• Licensing opportunities exist for those wishing to operate within the patent's protected scope.
• Risks include patent challenges from competitors, especially if prior art is uncovered or claims are deemed obvious.

Implications for Stakeholders

• Innovators: The patent reinforces proprietary rights, but ongoing R&D must account for existing patents to avoid infringement.
• Investors: The strength and breadth of the patent impact valuation, promising exclusivity but also signaling potential litigation risks.
• Legal Counsel: Necessity for vigilant monitoring of the patent landscape for challenges or opportunities to broaden claim scope via continuations.

Conclusion

The '761 patent represents a strategic effort to secure exclusive rights around a significant innovator in its therapeutic class. While its claims demonstrate careful drafting aimed at establishing broad yet defensible protection, vulnerabilities exist in terms of prior art overlap and potential for invalidation. An optimal commercialization and licensing strategy hinges on continuous landscape analysis, proactive defense, and possible claim adjustments to address emerging challenges.

Key Takeaways

• The '761 patent claims balance breadth with specificity, providing robust protection for core inventions within the known patent landscape.
• Competition and prior art necessitate vigilant monitoring; claims may be challenged for obviousness or invalidity.
• The patent’s geographical scope bolsters global market positioning, yet enforcement depends on maintaining claim distinctiveness amidst densely populated prior art.
• Strategic licensing and FTO analyses are essential to mitigate litigation risks and maximize commercial potential.
• Continuous innovation and possibly filing continuation applications are advisable to adapt to evolving legal and technological environments.

FAQs

1. How does the scope of the '761 patent impact competitors?
The patent’s broad independent claims could restrict competitors from developing similar drugs or delivery methods without licensing, but narrow or invalidated claims could open pathways for design-around strategies.

2. Can the '761 patent withstand challenges based on prior art?
Potentially, if the claims are sufficiently novel and non-obvious. However, high-density prior art in the field increases the likelihood of challenges, emphasizing the importance of continuous patent prosecution and prior art searches.

3. What is the significance of international filings for this patent?
International filings extend legal protections beyond the US, enabling broader commercial rights, but also increase costs and complexity, requiring strategic planning.

4. How does the patent landscape influence R&D investment?
A crowded landscape with existing patents may deter investment or necessitate licensing agreements. Conversely, a strong patent can attract funding by establishing a competitive moat.

5. What future actions should patent holders consider?
Proactive patent prosecution (e.g., continuations, divisional applications), landscape monitoring, and strategic licensing are critical to adapt to legal challenges and maximize commercial value.

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Sources

1. USPTO Patent Full-Text and Image Database. Patent No. 10,881,761.
2. WIPO Patentscope Database. Patent family and international filings.
3. Recent legal analyses and patent landscape reports in the specific therapeutic area.

Details for Patent 10,881,761

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Discure Medical, Llc	CHYMODIACTIN	chymopapain	For Injection	018663	November 10, 1982		2036-08-11
Discure Medical, Llc	CHYMODIACTIN	chymopapain	For Injection	018663	August 21, 1984		2036-08-11