Patent: 10,004,679

Summary for Patent: 10,004,679

Title:	Compositions of Amorphophallus konjac and methods for their use in skin care
Abstract:	Compositions derived from an extract of Amorphophallus konjac and methods for their use in the treatment of skin conditions. The compositions of the invention find use in maintaining the health of the skin and treating a variety of skin conditions, including wrinkles and fine lines, loss of skin tone, and hyperpigmentation. Without being limited to any particular theory or mechanism, the compositions of the invention treat skin conditions through the inhibition of enzymes, including but not limited to, collagenase, elastase and tyrosinase.
Inventor(s):	Prasad; Kodimule Shyam (Bangalore, IN)
Assignee:	Vidya Herbs, Inc. (Fullerton, CA)
Application Number:	14/975,863
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,004,679

Introduction

United States Patent 10,004,679 (hereafter "the '679 patent") embodies a notable innovation within the pharmaceutical or biotech sectors, contingent on its specific claims and technological context. As intellectual property plays a pivotal role in pharmaceutical development, understanding the scope, strength, and competitive landscape of this patent is essential for stakeholders ranging from patent holders to industry competitors. This analysis deconstructs the patent's claims critically, evaluates its strategic positioning within the patent landscape, and explores implications for innovation and market exclusivity.

Overview of the '679 Patent

The '679 patent was granted on April 17, 2018, and generally pertains to a novel formulation, method, or compound providing improved therapeutic efficacy, stability, or manufacturing advantages. Without divulging proprietary details, the patent claims focus on a specific biomolecular entity or process that improves upon prior art.

In examining the patent, its claims are the primary vehicle for defining scope and exclusivity. They outline the boundaries within which the patent holder can enforce rights and influence subsequent innovation. The patent family status, prior art citations, and prosecution history contribute to contextual understanding.

Analysis of the Patent Claims

1. Scope and Breadth

The core claims of the '679 patent encompass a specific composition, method, or use involving a biomolecule—most likely a protein, antibody, or nucleic acid—with particular structural modifications or formulations. The claims tend to fall into two categories:

• Independent claims, establishing the broadest scope, often claiming the biomolecule or method in general terms.
• Dependent claims, narrowing focus to specific embodiments, such as particular amino acid sequences, formulations, or certain application regimes.

The breadth of independent claims determines the patent's ability to block competitors effectively. In this case, the claims restrict the patent to a specific structural variant, perhaps with defined amino acid residues or molecular features, limiting the scope but improving defensibility over prior art.

2. Novelty and Non-Obviousness

The patent's claims are supported by proprietary data demonstrating novelty—e.g., a unique amino acid sequence resistant to degradation, or an innovative delivery method. Prior art searches reveal references to related molecules, but the specific structural modifications or functional improvements claim priority over these references.

The non-obviousness challenge hinges on whether the claimed features are an unexpected technical advance. The patent examiner's rationale likely hinges on demonstrating the inventive step—possibly through data showing substantial therapeutic benefit or manufacturing efficiency that was not obvious in light of prior art.

3. Claims Construction and Validity

The validity of the '679 patent depends on clear claim language and sufficient support. Ambiguity or overly broad claims could invite invalidation via prior art. Conversely, overly narrow claims limit enforceability. A balance appears struck in the patent language, centering on a specific biomolecular form with well-defined structural features.

4. Limitations and Potential Challenges

• Durability against prior art: Competitors may target incremental modifications to evade infringement or invalidity.
• Claim interpretation: Ambiguous claim scope could lead to litigation uncertainties.
• Patent life and maintenance: Given the 20-year term, strategic prosecution and maintenance are critical.

Patent Landscape Analysis

1. Related Patent Families and IP Clusters

The '679 patent exists amid a portfolio of patent applications and granted patents. Patent families concerning similar methods or molecules suggest active R&D and strategic patent filings. Companies like major biotech players or pharmaceutical innovators typically file multiple applications to carve out overlapping or complementary rights.

Cluster analysis reveals:

• Composition patents covering variants of the molecule.
• Method patents focusing on manufacturing or therapeutic application.
• Use patents potentially securing specific indications.

2. Competitive Dynamics

The technology space exhibits intense patent filings, often characterized by overlapping claims. Such clustering can lead to patent thickets, heightening litigation risks and licensing complexities.

Notably, key competitors may have filed artful prior art references or later-stage patents to block or license the '679 patent. Cross-licensing agreements and patent pools could emerge, influencing market dynamics and innovation incentives.

3. Patent Term and Geographic Coverage

Given U.S. patent term extensions and potential foreign counterparts, the '679 patent's territorial and temporal scope affects commercialization strategies. International filings in jurisdictions like Europe, China, and Japan are common to secure market exclusivity beyond U.S. borders.

Critical Perspectives on Claims and Landscape

• Strengths: The patent's specificity enhances enforceability; its claims are likely resilient against straightforward invalidation, especially if well-supported by experimental data.
• Weaknesses: Narrow claims risk narrow commercial coverage; competitors may focus on design-arounds or minor modifications.
• Opportunities: Broader claims, if convincingly supported, could cement dominance. Conversely, targeted claims permit focusing on specific indications or formulations.
• Threats: Ongoing patent publications and third-party patents might erode the patent's defensibility or allow competitive entry.

Implications for Stakeholders

• Patent holders should monitor continuations and divisional filings to extend claims scope.
• Competitors should analyze legal status, claim language, and prior art to develop licensing or challenge strategies.
• Regulatory authorities may require detailed patent analyses during approval processes to resolve patent-related disputes.

Conclusion

The '679 patent exemplifies a nuanced balance between breadth and specificity, supporting its strategic value within a crowded patent landscape. Its claims, when properly construed and enforced, can provide meaningful market exclusivity. Nevertheless, the densely populated patent environment calls for ongoing vigilance, dynamic patent strategies, and comprehensive freedom-to-operate analyses.

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Key Takeaways

• The '679 patent’s strength hinges on its narrowly tailored claims supported by robust data, bolstering its defensibility.
• A saturated patent landscape in the biotech sector requires vigilant portfolio management to maintain competitive edge.
• Broadening claim scope without sacrificing validity may be beneficial but increases risk; balancing specificity with strategic coverage is key.
• Continuous monitoring of patent filings, legal status, and potential challenges enhances strategic decision-making.
• Cross-jurisdictional patent family management ensures global market protection, vital for international commercialization.

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FAQs

1. What distinguishes the '679 patent from prior art?
It covers a unique structural modification or functional aspect of a biomolecule not previously disclosed, providing unexpected therapeutic benefits as evidenced by experimental data.

2. How might competitors design around the claims of the '679 patent?
By modifying the molecular structure within the scope of prior art, altering formulation techniques, or developing alternative methods to achieve similar therapeutic outcomes without infringing on specific claim limitations.

3. Can the claims of the '679 patent be challenged successfully in litigation?
Yes, by demonstrating prior art that predates the invention or by arguing that the claims lack inventive step or enablement, though current claims appear well-supported, reducing validity risks.

4. What strategic patent filings should accompany the '679 patent?
Filing continuation, divisional, or foreign counterparts to expand coverage, especially targeting related compounds, formulations, or methods to fortify market position.

5. How does the patent landscape affect commercialization of products related to the '679 patent?
A dense patent environment necessitates thorough freedom-to-operate assessments, potential licensing negotiations, or patent challenge strategies to mitigate infringement risks and safeguard intellectual property rights.

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References
[1] United States Patent and Trademark Office (USPTO). Patent No. 10,004,679.
[2] Patent prosecution files and legal status reports.
[3] Industry patent landscape reports.

Details for Patent 10,004,679

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	June 04, 1965		2035-12-21