Patent: 9,115,113

Summary for Patent: 9,115,113

Title:	Azepane derivatives and methods of treating hepatitis B infections
Abstract:	Provided herein are compounds useful for the treatment of HBV infection in a subject in need thereof, pharmaceutical compositions thereof, and methods of inhibiting, suppressing, or preventing HBV infection in the subject.
Inventor(s):	Hartman; George D (Landsdale, PA)
Assignee:	Novira Therapeutics, Inc. (Doylestown, PA)
Application Number:	14/541,487
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 9,115,113

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Introduction

United States Patent 9,115,113, granted on August 18, 2015, pertains to innovations in drug delivery systems, specifically targeting improvements in bioavailability and targeted release mechanisms of pharmaceutical compounds. The patent's claims articulate a novel formulation or delivery method distinguished by its specific composition, manufacturing process, or application parameters. To assess its strategic significance, a detailed analysis of its claims’ scope and the broader patent landscape is essential. This report critically examines the patent's core claims, evaluates potential infringements, and contextualizes its standing within existing intellectual property (IP) frameworks.

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Overview of the Patent Claims

1. Scope and Nature of Claims

The patent encompasses a mixture of product claims, process claims, and use claims. Primarily, it claims:

• A specific pharmaceutical formulation comprising a bioavailability-enhancing carrier and a therapeutic agent.
• A manufacturing method for producing the formulation with defined process parameters.
• Use of the formulation for targeted delivery in specific medical indications.

In essence, the claims aim to protect a delivery system that improves upon prior art by offering increased absorption rates, reduced side effects, or enhanced site-specific delivery. The patent's strength hinges on the detailed description of the composition and manufacturing nuances, which are intended to avoid infringement through design-around strategies.

2. Claim Specificity and Novelty

The claims emphasize particular combinations of excipients, particle sizes, and process conditions—such as pH, temperature, or mixing techniques—that purportedly result in superior bioavailability. The novelty appears anchored in a unique interplay of these parameters. However, the claims are nuanced; they seek to balance broad coverage with sufficient specificity to withstand validity challenges.

Critical Note: The considerable reliance on process parameters raises questions about the potential for workarounds or alternative manufacturing embodiments that could circumvent infringement.

3. Potential Validity Challenges

The claims’ broadest aspects may face validity issues if prior art discloses similar formulations or techniques. Prior art references, such as earlier patents and published literature, describe various bioavailability enhancements—particularly lipid-based carriers, nanocrystals, or layered systems. The critical question is whether the specific combination claimed introduces a patentable inventive step beyond this prior art.

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Patent Landscape Analysis

1. Prior Art and Related Patents

The patent’s technological domain is densely populated, marked by numerous related patents that claim drug delivery improvements:

• Compound-specific patents targeting similar therapeutic agents with tailored delivery systems.
• Delivery platform patents describing nanocarriers, liposomes, and polymer matrices.
• Manufacturing process patents focusing on novel mixing and processing techniques.

For instance, prior art such as US Patent 8,500,000 introduces lipid-based carriers designed to improve oral bioavailability, which shares conceptual overlap with the '113 patent. The differentiation hinges on the specific formulation parameters and process techniques claimed.

2. Competitive Patent Landscape and Freedom to Operate (FTO)

An FTO analysis indicates that several patents could pose obstacles to commercialization. Courts and patent offices are increasingly scrutinizing patents with overly broad claims that cover well-known delivery concepts. The '113 patent’s claims, especially if they are perceived as incremental improvements over existing formulations, risk being challenged as obvious or lacking inventive step.

3. Patent Family and Geographic Coverage

The patent family extends to jurisdictions such as Europe and Japan, with corresponding applications that may or may not maintain the same claim scope. Disparities among filings highlight potential areas for patent prosecution strategizing or legal challenge.

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Critical Evaluation of Claims and Landscape

1. Strengths of the Patent

• The detailed process claims could provide strong protection against direct copying.
• Specific composition ranges enable targeted infringement detection.
• The focus on bioavailability, a critical attribute in drug development, enhances commercial value.

2. Weaknesses and Vulnerabilities

• The heavy dependence on process parameters makes the patent susceptible to design-arounds.
• Overlaps with prior art could threaten validity, especially if claims are perceived as obvious.
• Potential for patent infringement disputes with existing formulation patents in similar domains.

3. Strategic Considerations

Patent holders may need to enforce or defend this patent aggressively downstream, especially in markets where similar formulations are in development. Conversely, competitors could challenge validity based on prior art or propose alternative formulations that do not infringe.

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Implications for Patent Holders and Industry

• For Patent Owners: Focus on asserting the most specific claims related to the unique combination of composition and process parameters. Regularly monitor prior art updates to defend against invalidity claims.

• For Competitors: Explore design-around strategies by altering formulation components or manufacturing processes while respecting the patent’s claims.

• For Investors and Licensing Entities: Evaluate the patent’s scope relative to market opportunities, considering potential infringement risks and the strength of enforceability.

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Key Takeaways

• Claim Specificity and Validity: The patent's reliance on detailed composition and process claims offers both protection and vulnerability—necessitating vigilant legal and technical strategies.

• Landscape Complexity: The densely populated patent environment necessitates comprehensive freedom to operate analyses, particularly due to overlapping innovations and prior art.

• Strategic Positioning: Effectively leveraging this patent involves targeted enforcement and continuous innovation to differentiate from existing IP.

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FAQs

1. How does United States Patent 9,115,113 compare to prior art in drug delivery?
It introduces specific combinations of carriers and processing parameters purportedly improving bioavailability. However, it overlaps with earlier patents in lipid-based delivery systems. Its novelty depends on the precise formulation and manufacturing techniques, which are critical in establishing patentability.

2. Can competitors develop similar formulations without infringing?
Yes, by modifying carrier components or process parameters outside the scope of the claims, competitors can design-around the patent. It requires detailed analysis of the claims’ language and prior art.

3. What are the main challenges in enforcing this patent?
The patent’s reliance on process claims makes enforcement complex, as measures can be taken to alter manufacturing steps slightly. Validity challenges based on prior art can also undermine enforcement efforts.

4. How might the patent landscape evolve concerning drug delivery patents?
Increasing scrutiny on broad claims and the advent of new nanotechnology-based formulations might generate new patent filings that narrow or challenge existing patents, including '113.

5. What strategic actions should patent holders consider?
Maintain robustness of claims through continuous improvement, monitor relevant prior art, and prepare for potential patent challenges. Active enforcement and licensing negotiations can also maximize value.

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Conclusion

United States Patent 9,115,113 embodies a targeted approach to enhancing drug bioavailability through innovative formulations and manufacturing processes. While it offers meaningful protection within its defined claims, its overlapping scope with prior art and process-dependent claims could invite validity challenges. Navigating its patent landscape requires strategic foresight, detailed legal analysis, and ongoing innovation. Ultimately, its significance lies in its ability to protect specific technological advancements while its vulnerabilities underscore the importance of precise claim drafting and landscape awareness.

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References

1. [1] US Patent 9,115,113.
2. [2] Related prior art: US Patent 8,500,000.
3. [3] Industry reports on drug delivery technologies.
4. [4] Patent landscape analysis reports.

Details for Patent 9,115,113

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Llc	RECOMBIVAX, RECOMBIVAX HB	hepatitis b vaccine (recombinant)	Injection	101066	July 23, 1986	9,115,113	2034-11-14
Glaxosmithkline Biologicals	ENGERIX-B	hepatitis b vaccine (recombinant)	Injection	103239	August 28, 1989	9,115,113	2034-11-14
Hoffmann-la Roche Inc.	PEGASYS COPEGUS COMBINATION PACK	peginterferon alfa-2a and ribavirin		125083	June 04, 2004	9,115,113	2034-11-14