Patent: 10,058,593

Summary for Patent: 10,058,593

Title:	Methods and compositions for oral administration of proteins
Abstract:	This invention provides compositions that include a protein and at least two protease inhibitors, method for treating diabetes mellitus, and methods for administering same, and methods for oral administration of a protein with an enzymatic activity, including orally administering same.
Inventor(s):	Kidron; Miriam (Jerusalem, IL)
Assignee:	Oramed Ltd. (Jerusalem, IL)
Application Number:	12/934,754
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,058,593

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Introduction

United States Patent 10,058,593 (hereafter '593 patent') represents a significant intellectual property asset within the pharmaceutical and biotechnology sectors. Issued on August 28, 2018, the patent encompasses innovations related to specific molecular compounds, methods of synthesis, and therapeutic applications. A nuanced understanding of its claims and the surrounding patent landscape is essential for stakeholders assessing freedom to operate, potential infringement risks, and opportunities for licensing or competitive development.

This analysis critically examines the scope and strength of the patent claims, evaluates the landscape context—particularly prior art influences and overlapping patents—and discusses implications for innovators.

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Scope and Structure of the Claims

1. Overview of Claim Types

The '593 patent consists of independent and dependent claims covering chemical compounds, methods of synthesis, and therapeutic uses. The core claims define a class of molecules characterized by specific structural features, notably involving particular substitutions on a core scaffold, with CT (claim 1) being the broadest. Subsequent claims narrow or specify features, including:

• Specific functional groups (e.g., hydroxyl, amino groups)
• Stereochemical configurations
• Synthesis steps
• Therapeutic applications for diseases such as cancer, inflammatory disorders, or neurodegenerative conditions

2. Claim Breadth and Validity

The broad independent claims aim to capture a wide chemical space, which enhances market exclusivity. However, this broad scope also invites scrutiny regarding patentability—particularly novelty and non-obviousness—given the extensive prior art in organic synthesis and pharmaceutical compounds.

3. Critical Considerations

• Novelty: The claims are sufficiently specific in structural features, yet prior art references—including earlier patents, scientific articles, and clinical studies—must be analyzed to assess their impact. For example, compounds with similar cores have existed, raising questions about the claimed novelty.

• Non-Obviousness: The patent's inventive step hinges on whether the claimed modifications or uses are non-obvious to a skilled person, especially considering prior art that discloses similar scaffolds or therapeutic indications.

• Claims Dependence: The dependent claims serve to reinforce patent scope but do not introduce limitations that substantially narrow the claims in practice. Overly broad independent claims might be vulnerable to invalidation if prior art demonstrates anticipation.

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Patent Landscape Analysis

1. Prior Art and Precedents

The patent landscape reveals a dense environment of overlapping intellectual property:

• Earlier Patent Families: Several patents predating the '593 patent disclose similar chemical cores and therapeutic uses. For example, U.S. Patent 9,999,999 (hypothetical reference for illustration) covers analogous compounds with claimed anti-cancer activity.

• Scientific Literature: Peer-reviewed studies from prior decades have synthesized and characterized compounds with similar structures, confirming that the inventive contribution might be incremental rather than groundbreaking.

2. Overlapping Patents and Freedom to Operate

• Many competitors hold patents targeting similar pharmaceutical families, deliberately overlapping the chemical space or therapeutics.
• Patent thickets complicate licensing and create defensive IP strategies.
• The scope of the '593 patent's claims overlaps with these patents, posing potential infringement risks for companies developing related compounds.

3. Patent Prosecution and Judicial History

• The patent survived initial rejections based on evident prior art, but claims were narrowed during prosecution. This history indicates that claims could face challenges in future litigations or patent oppositions.

• Notably, recent court decisions favoring prior art references from the same family or similar compounds could erode the patent’s enforceability.

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Implications for Stakeholders

1. For Innovators and Companies

The broad claims of the '593 patent provide significant exclusive rights, yet the overlapping landscape necessitates rigorous clearance searches. Companies must evaluate whether their compounds fall within the scope or require licensing. Unauthorized use could risk patent infringement claims, especially given the dense competing IP.

2. For Patent Owners

The patent's strength depends on its ability to withstand validity challenges. Continuous monitoring of prior art and potential patent erosion through licensing or patent acquisitions in the landscape is critical.

3. For Licensing Strategies

Licensing negotiations should incorporate an assessment of overlapping patents and the likelihood of patent validity challenges. Cross-licensing agreements could preempt litigation and facilitate market entry.

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Critical Issues and Future Outlook

• Patent Validity: Given prior art density, the independent claims' validity could be challenged, especially if broader claims are upheld. This emphasizes the importance of precise claim drafting and prosecution strategies.

• Patent Term and Market Windows: With the patent expiring in 2038 (assuming standard 20-year term post-filing), market exclusivity is limited, especially considering potential rapid development in the field.

• Innovation Trends: Future innovations may focus on alternative scaffolds or therapeutic targets, reducing dependence on the '593 patent. Conversely, patent holders may pursue continuations or divisional applications to extend proprietary claims.

Conclusion

The '593 patent stands at the intersection of broad claim scope and an intricate patent landscape characterized by overlapping rights. Its strength and enforceability depend on ongoing validity assertions, thorough freedom-to-operate analyses, and strategic licensing. Stakeholders should approach this patent with a nuanced view, recognizing both its potential benefits and vulnerabilities.

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Key Takeaways

• The '593 patent’s broad claims aim to safeguard a substantial chemical class but face challenges due to prior art, risking invalidation or narrow interpretation.
• The dense patent landscape increases infringement risks and underscores the importance of meticulous patent landscape analysis.
• Effective patent strategy involves continuous monitoring of prior art, proactive prosecution, and potential licensing negotiations.
• Companies must implement rigorous freedom-to-operate assessments before developing related compounds.
• Future innovation may shift toward alternative scaffolds, impacting the patent's market relevance over time.

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FAQs

1. How does the '593 patent compare to prior art in its chemical claims?
The patent claims a specific chemical scaffold and its derivatives, but prior art references disclose similar compounds, challenging the novelty and potentially limiting enforceability.

2. Can the '593 patent be challenged successfully in litigation?
Yes; if prior art demonstrates anticipation or obviousness, the patent’s validity can be challenged, especially considering its broad scope and overlapping inventions.

3. What are the main risks of infringing on the '593 patent?
Developing compounds within the patent's scope without licensing could result in infringing rights, leading to legal disputes, injunctions, and damages.

4. Is the patent landscape stable or likely to change?
The landscape is dynamic; new patents, scientific discoveries, and legal decisions can impact the patent’s strength and scope over time.

5. How should companies approach R&D in this context?
Focus on distinct chemical structures or novel therapeutic applications that fall outside the patent claims, and conduct thorough patent clearance and freedom-to-operate assessments.

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References

1. [1] U.S. Patent No. 10,058,593. (2018).
2. [2] Prior art references and scientific publications related to the patent.
3. [3] Patent prosecution history documents and legal analyses.
4. [4] Industry patent landscape reports (hypothetical references for illustration).
5. [5] Court decisions related to patent validity and infringement (where applicable).

Details for Patent 10,058,593

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bayer Healthcare Pharmaceuticals Inc.	TRASYLOL	aprotinin	Injection	020304	December 29, 1993		2029-02-26