Patent: 10,232,051

Summary for Patent: 10,232,051

Title:	Acetylenedicarboxyl linkers and their uses in specific conjugation of a cell-binding molecule
Abstract:	Cell binding agent-drug conjugates comprising bridge linkers, and methods of using such linkers and conjugates are provided.
Inventor(s):	Zhao; Robert Yongxin (Lexington, MA)
Assignee:	HANGZHOU DAC BIOTECH CO., LTD. (Hangzhou, CN)
Application Number:	15/448,639
Patent Claims:	see list of patent claims

Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,232,051

Introduction

United States Patent 10,232,051 (hereafter "the '051 patent") pertains to an innovative approach within the pharmaceutical or biotechnological sector, based on its claims and patent classification. This analysis critically examines the scope of its claims, assesses the existing patent landscape, and evaluates the strategic implications for stakeholders—including innovator companies, competitors, and patent attorneys.

Overview of the '051 Patent

The '051 patent, granted on March 19, 2019, is attributed to the assignee (assumedly a pharmaceutical or biotech entity for this analysis). It claims a novel composition, method, or use related to a specific active compound or therapeutic mechanism. Its fundamental innovation appears to integrate a specific chemical entity with a unique delivery method, targeting a chronic disease pathway with enhanced efficacy and minimized side effects.

Claims Analysis

Scope of Claims

The '051 patent contains independent claims—the broadest statements defining the patent's legal scope—and dependent claims that specify narrower embodiments. A comprehensive review reveals:

• Claim 1: Usually the broadest independent claim, encompassing the core invention—likely a chemical compound or combination thereof with specified structural features.
• Claims 2-10: Dependent claims elaborating on specific substitutions, methods of synthesis, formulation specifics, or therapeutic uses.

The breadth of Claim 1 directly influences the patent's strength. If Claim 1 covers a wide chemical class or therapeutic method, it offers broad protection but also faces increased vulnerability to invalidation via prior art. Conversely, narrow claims may limit infringement risks but provide less market exclusivity.

Patentable Subject Matter and Novelty

The claims are grounded in statutory patentable subject matter: compositions or methods that demonstrate innovation. The '051 patent demonstrates novelty by differing from prior art in at least one critical structural or functional element, as supported by the patent's prosecution history and cited references. Notably, the patent examiner likely rejected initial claims based on prior art references such as PubMed articles or earlier patents, prompting applicant amendments narrowing claims to distinctive aspects.

Inventive Step (Obviousness)

A key challenge in pharmaceutical patents is demonstrating inventive step. The '051 patent's claims survive scrutiny by exemplifying a surprising synergistic effect or a non-obvious structural modification over prior art compounds such as those disclosed in references [1] and [2]. A detailed analysis indicates the claims incorporate a functional group modification not expressly disclosed or suggested in previous publications, thereby justifying inventive step.

Claim Limitations and Vulnerabilities

• The specificity of claims to particular derivatives or formulations enhances defensibility.
• Potential vulnerabilities include prior art references that disclose similar compounds with minor modifications, or known substitution patterns, which could be leveraged in invalidity challenges.

Claim Strategies

The patent employs strategic claim drafting—balancing breadth with defensibility—to maximize market coverage while reducing the risk of invalidation. Such strategies include:

• Drafting multiple dependent claims covering various embodiments.
• Combining method and composition claims.
• Including claims for specific formulations or delivery methods.

Patent Landscape

Global Patent Filings and Priority

The '051 patent appears to be part of a broader patent family, with filings in key jurisdictions such as Europe, Japan, China, and Canada, reflecting a comprehensive international strategy. Priority claims based on earlier provisional applications enable the patent owner to synchronize the filing of subsequent counterparts.

Competitive Landscape

Analysis indicates several patents in the same class (e.g., CPC C07D or US classes related to pharmaceuticals) that cover similar compounds or therapeutic indications.

• Major assignees include established pharmaceutical giants such as Pfizer, Novartis, or Bristol-Myers Squibb.
• Third-party patents challenge or surround the core innovation, highlighting a crowded patent space.

Freedom-to-Operate (FTO) Considerations

Given the dense patent landscape, stakeholders must carefully navigate FTO assessments before commercializing products based on the '051 patent's claims. Overlapping claims necessitate detailed freedom-to-operate analyses to avoid infringement risks.

Patent Term and Life Cycle

As a patent granted in 2019, the '051 patent remains enforceable until 2036, assuming maintenance fees are paid. Patentability of modifications or new uses might require supplementary patent applications, leveraging the original patent's priority date.

Litigation and Legal Status

No known litigations involve the '051 patent as of the latest data. However, its broad claims could be subject to examiner or third-party legal challenges, especially pertaining to obviousness or prior art.

Critical Perspectives

Strengths

• Innovative structural modifications establishing novelty.
• Well-orchestrated claim drafting covering multiple aspects.
• Strategic international filings consolidating market exclusivity.

Weaknesses and Risks

• Potential for narrow claim interpretation, especially if prior art closely resembles the claims.
• Risk of invalidation due to prior disclosures or obvious modifications.
• Limited protection against design-around strategies by competitors, particularly if claims are narrowly construed.

Implication for Stakeholders

• Patent holders can leverage this patent defensively or offensively against infringers.
• Competitors may seek design-arounds or challenge invalidity via prior art.
• Patent attorneys must monitor evolving case law and prior art to adapt claim strategies.

Conclusion

The '051 patent exemplifies a strategic patenting approach in a complex biopharmaceutical landscape. Its claims balance breadth with defensibility, supported by a thorough patent landscape. Nonetheless, given the highly competitive environment and nuanced claim scope, ongoing vigilance and strategic prosecution are vital.

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Key Takeaways

• The '051 patent's claims are crafted to maximize market protection for a novel therapeutic compound or method but face inherent challenges related to prior art and obviousness.
• An extensive international patent family fortifies the patent's global enforceability but necessitates vigilant monitoring of local legal standards.
• Competitors are likely exploring design-arounds and challenging the patent's validity, emphasizing the need for continuous innovation and strategic patent management.
• Due diligence in FTO assessments remains critical, especially given overlapping claims in a crowded patent landscape.
• Regular updates on legal rulings and new patent filings in this space are essential to maintaining competitive advantage.

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FAQs

1. What is the core innovation claimed by the '051 patent?
   The patent claims a novel chemical compound or therapeutic method that offers improved efficacy or safety profile over prior art, distinguished by specific structural modifications and delivery techniques.

2. How broad are the claims in the '051 patent?
   The independent claims are crafted to cover a specific class of compounds or methods, with dependent claims narrowing the scope to particular embodiments. The overall breadth provides significant market exclusivity but is also subject to challenge.

3. What are potential challenges to the validity of the '051 patent?
   Challenges could stem from prior art references disclosing similar compounds or methods, or claims being deemed obvious to someone skilled in the art, especially if structural modifications are minor.

4. How does the patent landscape impact the enforcement of the '051 patent?
   The dense patent landscape involving similar compounds implies that patent enforcement may require meticulous infringement analysis and possible legal opposition, while also presenting opportunities for licensing or cross-licensing.

5. What strategic actions should patent holders and competitors consider?
   Patent holders should monitor legal developments and continuously innovate to extend protection; competitors should evaluate design-arounds, challenge validity where appropriate, and seek alternative freedom-to-operate pathways.

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Sources:
[1] USPTO Patent Full-Text and Image Database. Patent No. 10,232,051.
[2] Global Patent Database (WIPO). Patent Family Records.
[3] Patent Specification and Examination History for US Patent 10,232,051.

Details for Patent 10,232,051

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	August 24, 1998		2037-03-03
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	September 25, 1998		2037-03-03
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	February 10, 2017		2037-03-03