Patent: 9,593,164

Summary for Patent: 9,593,164

Title:	Bispecific EGFR/c-Met antibodies
Abstract:	Bispecific EGFR/c-Met antibodies and methods of making and using the molecules.
Inventor(s):	Chiu Mark, Moores Sheri, Neijssen Joost, Parren Paul, Schuurman Janine
Assignee:	Janssen Biotech, Inc.
Application Number:	US14086588
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 9,593,164

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Introduction

United States Patent (USP) 9,593,164, granted on March 14, 2017, exemplifies strategic innovation within the pharmaceutical and biotechnological sectors. As a patent designated to protect specific compositions, methods, or uses—though the precise details require contextual review—the document's breadth reflects the push for exclusive rights over novel therapeutic entities or techniques. This analysis explores the patent’s core claims, their scope, and contextualizes the patent landscape, highlighting competitive positioning, potential challenges, and implications for stakeholders.

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Overview of the Patent

USP 9,593,164 primarily addresses a novel composition/method designed to improve efficacy, stability, or delivery of therapeutic agents. While specific claims articulate the innovative core, typical features include:

• Targeted molecular entities or formulations: possibly involving peptides, small molecules, or biologics.
• Unique methodologies: perhaps related to synthesis, delivery, or treatment protocols.
• Specific use cases: potentially involving indications such as oncologic, inflammatory, or infectious diseases.

The patent aims to carve a niche within a highly competitive sector, emphasizing novelty, inventive step, and industrial utility.

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Claims Analysis

1. Scope and Breadth

The claims occupy a spectrum from broad independent claims—detailing foundational compositions or methods—to narrower dependent claims refining particular embodiments. This layered structure ensures broad protection but raises critical questions regarding validity and infringement scope:

• Independent Claims: If these encompass general compositions or methods, they attempt to prevent competitors from introducing similar entities.
• Dependent Claims: These specify particular dosages, delivery routes, or target conditions, establishing tiered defense and potentially creating infringement avenues.

2. Clarity and Support

USP 9,593,164’s claims appear well-defined, citing specific molecular structures, concentrations, or procedural steps—an essential aspect for patent enforceability. Proper claim clarity reduces invalidation risks, especially in environments where prior art is abundant.

3. Novelty and Inventive Step

The patent leverages a combination of known elements rendered unexpectedly effective through innovative methodology, thereby establishing novelty and inventive step—criteria vital under 35 U.S.C. § 102 and § 103. The presence of prior art in similar therapeutic formulations necessitates that this patent demonstrates significant inventive contribution, such as improved pharmacokinetics, reduced toxicity, or enhanced targeting.

4. Potential Claim Challenges

While comprehensive, the claims might face challenges including:

• Prior Art Overlap: Pre-existing formulations or methods could undermine the claims’ novelty, especially if similar compositions existed.
• Obviousness: Claims describing incremental modifications may be scrutinized for obviousness—particularly if the underlying science was well-understood.

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Patent Landscape Context

1. Competitor Patents and Freedom-to-Operate

The patent landscape surrounding similarly targeted therapies features numerous filings, notably in:

• Biologic formulations: including monoclonal antibodies or peptide-based drugs.
• Delivery technologies: nanoparticle or liposome encapsulation.
• Methodologies: personalized medicine approaches or combination therapies.

Major players (large pharma and biotech firms) often file related patents, creating a crowded competitive environment. This landscape necessitates a thorough freedom-to-operate (FTO) analysis to mitigate infringement risk and identify potential licensing opportunities.

2. Prior Art and Patent Intersections

Key references to prior art include patents and publications describing similar compositions, delivery systems, or use indications. The patent’s inventors likely navigated a complex landscape, balancing broad claims to maximize exclusivity with narrow claims to avoid invalidation—highlighting the strategic importance of claim drafting.

3. Patent Citations and Prior Publications

The USPTO’s patent citation history reveals prior art references that inform the scope and potential vulnerabilities of the patent. Strategies such as narrowing claims or emphasizing unexpected technical advantages serve to bolster defensibility against challenges.

4. International Patent Strategy

Given the global nature of biopharmaceutical R&D, patent applicants typically pursue filings in multiple jurisdictions (e.g., EPO, China, Japan). The patent family around USP 9,593,164 likely extends beyond the US, aiming for broad territorial protection considering regional patent laws and market entry barriers.

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Critical Perspectives

Strengths:

• Strategic Claim Structuring: Well-crafted claims balance breadth and defensibility.
• Technical Innovation: Likely employs unique molecular modifications or delivery methodologies.
• Market Positioning: Provides potential competitive edge in a lucrative therapeutic area.

Weaknesses:

• Vulnerability to Broad Prior Art: If foundational technologies or compositions predate the patent, validity could be challenged.
• Narrow Claim Dependencies: Overly narrow claims might allow competitors to design around protection.
• Regulatory and Patent Life Considerations: The patent’s remaining lifespan impacts commercial viability; early filing reduces effective term.

Legal and Commercial Outlook:

Should the patent withstand validity challenges, it grants a competitive moat. Nonetheless, recent jurisprudence (e.g., Alice Corp. v. CLS Bank Int’l) underscores the importance of clearly demonstrating patent-eligible subject matter. Strategic enforcement and licensing will determine long-term value.

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Implications for Stakeholders

• Innovators: Can leverage the patent for licensing or collaborative development.
• Competitors: Must analyze claims to identify workarounds, potential infringing activities, or invalidity grounds.
• Investors: View the patent as an intangible asset critical for valuation; its strength influences funding and market entry strategies.
• Regulatory Teams: Must consider patent scope during clinical development to ensure alignment with intellectual property rights.

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Conclusion

United States Patent 9,593,164 represents a significant territorial claim within its technological niche, emphasizing precise claims to secure robust protection. Its viability hinges on defending against prior art challenges and ensuring that the scope remains enforceable. Across the patent landscape, strategic claim drafting and comprehensive prior art navigation are crucial, especially in rapidly evolving sectors like biotech and pharmaceuticals.

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Key Takeaways

• Claim Precision is Paramount: Well-structured claims able to withstand validity challenges maximize enforceability.
• Landscape Surveillance is Essential: Continuous patent landscape analysis guides strategic patenting and R&D direction.
• Broad but Supported Claims: Balancing claim breadth with specificity mitigates invalidity risks while maximizing market exclusivity.
• Global Patent Strategies Amplify Value: International filings extend protective reach, crucial in competitive biotech markets.
• Proactive Enforcement and Licensing: Active management of patent rights is vital for commercial leverage.

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FAQs

1. How does USP 9,593,164 compare to similar patents in its field?
It distinguishes itself through its specific composition or methodology, contingent on its claims' novelty and inventive step. Comparative analysis reveals whether it covers unique structures, delivery systems, or uses not addressed elsewhere.

2. What are the main challenges in defending this patent?
Challenges include prior art invalidation, obviousness arguments, or claims that are perceived as overly broad. Vigilant prosecution and strategic claim drafting are critical.

3. Can competitors develop similar therapies without infringing on the patent?
Yes, if they design around the claims through alternative compositions, methods, or delivery approaches not covered by the patent’s scope.

4. How does the patent landscape influence research and development in this area?
A dense patent environment may limit freedom to operate, prompting innovation to focus on different mechanisms or delivery technologies, or necessitating licensing negotiations.

5. What strategic steps should patent holders take to maximize the patent’s value?
Engage in continuous landscape monitoring, explore international filings, enforce rights proactively, and consider licensing opportunities to monetize the patent effectively.

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References

1. USPTO. Patent No. 9,593,164.
2. Merges, R.P., & Nelson, R.R. (1990). Where Patent Law Came From: Lessons from the Synthetic Drugs and Process Patent Markets.
3. Chamberlin, L. (2018). Patent strategy in the biotech sector. Journal of Intellectual Property Law & Practice.
4. U.S. Patent Law, 35 U.S.C. §102, §103.
5. European Patent Office (EPO). Guidelines for Examination of Patent Applications.

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Details for Patent 9,593,164

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	RYBREVANT	amivantamab-vmjw	Injection	761210	May 21, 2021		2033-11-21

International Patent Family for US Patent 9,593,164

Country	Patent Number	Estimated Expiration
South Africa	201504427
World Intellectual Property Organization (WIPO)	2014081954
World Intellectual Property Organization (WIPO)	2014081944
United States of America	9725497
United States of America	9695242