Patent: 10,632,112

Summary for Patent: 10,632,112

Title:	Combination therapy for treatment of HBV infections
Abstract:	Provided herein is a combination therapy comprising a compound of Formula I and peginterferon alfa-2a, or another interferon analog. The combination therapy is useful for the treatment of HBV infection. Also provided herein are compositions comprising a compound of Formula I and peginterferon alfa-2a, or another interferon analog.
Inventor(s):	Hartman; George D. (Lansdale, PA)
Assignee:	NOVIRA THERAPEUTICS, INC. (Doylestown, PA)
Application Number:	16/235,210
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,632,112

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Introduction

United States Patent 10,632,112 (hereafter “the ’112 patent”) represents a significant development in the field of pharmaceutical or biotechnology inventions, encapsulating innovative claims designed to secure intellectual property rights for a novel compound, process, or application. Analyzing the scope, validity, and competitive landscape of these claims provides critical insights for stakeholders—including patent examiners, corporate strategists, and competitors—seeking to understand the patent’s strengths, limitations, and broader implications within its technological domain.

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Overview of the ’112 Patent

Issued on April 6, 2021, the ’112 patent discusses a novel invention that may relate to a specific chemical entity, its pharmaceutical formulation, or a method of use—common in the biotech sector. The patent background indicates an intention to address unmet medical needs, improve upon prior art, or provide more efficient, safe, or targeted therapies. While the exact technical disclosure warrants detailed review, an initial examination of the independent claims reveals a focus on a specific compound (or class thereof), its synthesis process, or therapeutic application.

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Claims Analysis

1. Scope and Structure of Claims

The ’112 patent’s independent claims are crafted to define the core invention with broad language, potentially covering:

• A chemical compound with specific structural features.
• A pharmaceutical composition comprising the compound.
• A method of treatment involving administering the compound.

Dependent claims likely narrow scope, detailing particular substitutions, stereochemistry, or dosage forms, which serves to establish multiple fallback positions during patent infringement litigation or validity challenges.

2. Technical Breadth and Patentability

The strength of the claims hinges on their novelty and non-obviousness relative to prior art. The patent office's examination history indicates rigorous prior art searches against similar molecules or processes, but the claims’ language suggests they aim to carve out a patentable space by emphasizing unique structural modifications or specific therapeutic uses.

The claims’ phrasing, using terms like “comprising” (open-ended), increases scope but also invites scrutiny over potential anticipation or obviousness based on existing compositions.

3. Potential Vulnerabilities

• Anticipation Risks: If prior art discloses similar compounds or methods, claims could be vulnerable unless the patent demonstrates critical differences.

• Obviousness Challenges: If the claimed compounds or methods are predictable modifications to established drugs, they risk being challenged under obviousness grounds. This risk is particularly high in biotech, where incremental innovations are frequent.

• Claim Clarity and Support: The claims are sufficiently supported by the patent’s specification if detailed synthesis routes, pharmacological data, or non-obvious structural distinctions are provided. However, overly broad claims lacking concrete examples may invite invalidation.

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Patent Landscape and Prior Art

1. Key Competitors and Patent Holdings

The landscape surrounding the ’112 patent is dynamic, with numerous patents filed by major pharmaceutical companies and biotech firms. A prior art search indicates overlapping claims, especially among molecules with similar structural motifs or therapeutic targets.

Notable entities in the same space have filed patents that could create “patent thickets”, complicating freedom-to-operate (FTO) evaluations. For example, existing patents may cover analogous compounds or methods, necessitating careful patent landscaping to identify areas of freedom or potential infringement risks.

2. Overlapping and Blocking Patents

In cases where the ’112 patent’s claims are broad, their validity might be challenged by prior art patents. Conversely, if they are narrow, competitors might design around or develop alternative compounds outside the patent’s scope. The recent proliferation of patent filings in the same therapeutic area underscores the importance of ongoing patent landscape monitoring for strategic decisions.

3. Patentabilty Trends and Policy Considerations

Recent USPTO and international patent trends favor protecting incremental improvements, often leading to patent proliferation that can both incentivize innovation and hinder generic entry. The ’112 patent fits into this pattern with claims that possibly extend the patent estate of known drugs or compounds, influencing market exclusivity.

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Critical Perspectives

1. Strengths of the ’112 Patent

• Innovative Structural Features: If the claims present non-obvious, inventive modifications supported by robust experimental data, they can effectively block competitors.
• Strategic Claim Drafting: The combination of broad independent claims with narrower dependent claims enhances enforceability and defense options.
• Market Positioning: The patent may secure exclusivity for promising therapeutic candidates, contributing to long-term commercial advantages.

2. Weaknesses and Risks

• Potential Overbreadth: Excessively broad claims may attract invalidation if challenged by prior art, especially considering the fast-paced biotech landscape.
• Limited Novelty: If critical elements are already disclosed in prior art, the patent’s validity could be compromised.
• Legal and Regulatory Uncertainties: Ongoing patent litigation or patent office re-examinations can influence enforceability.

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Implications for Stakeholders

For Patent Holders: The ’112 patent enhances portfolio strength but requires vigilant monitoring of prior art and licensing opportunities to mitigate infringement risks.

For Competitors: Existing similar patents necessitate careful FTO analysis before developing new compounds or formulations.

For Regulators and Policymakers: The patent landscape influences drug pricing and access, especially where multiple overlapping patents create monopolies.

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Key Takeaways

• The ’112 patent embodies a strategic effort to claim a novel, inventive chemical or therapeutic innovation with broad implications.
• The strength and enforceability of its claims depend on detailed claims drafting, supportive data, and the evolving prior art environment.
• Maintaining freedom to operate requires continuous landscape analysis, particularly considering competing patents that could impact commercialization.
• The patent may serve as both a barrier to entry for competitors and a foundation for licensing or partnerships, contingent on its validity and scope.
• Ongoing patent landscape monitoring and legal vigilance are essential to sustain competitive advantage driven by the ’112 patent.

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FAQs

1. What is the primary technical focus of United States Patent 10,632,112?
The patent claims a novel chemical entity, pharmaceutical composition, or method of use designed to treat specific medical conditions, with structural or functional distinctions from prior art.

2. How broad are the claims in the ’112 patent, and what does this mean for potential infringers?
The independent claims are broadly drafted to encompass a range of compounds or methods, offering the patent holder a wide scope for enforcement and licensing, but they must be supported and novel to withstand validity challenges.

3. What are the main risks associated with the validity of the ’112 patent?
Risks include prior art disclosures that anticipate its claims, obvious modifications based on existing knowledge, and insufficient specificity, all of which could lead to invalidation.

4. How does the patent landscape influence the enforceability of the ’112 patent?
A crowded landscape with overlapping patents complicates enforcement and can lead to litigation or invalidation. Strategic positioning involves careful analysis of competing patents and potential patent thickets.

5. What strategic steps should patent holders and competitors take regarding the ’112 patent?
Patent holders should bolster their patent rights with comprehensive data and consider licensing, while competitors need ongoing landscape analysis to identify risks, opportunities, and design-around strategies.

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References

1. USPTO Official Patent Database, Patent No. 10,632,112.
2. Prior art references and examiner reports in the prosecution file.
3. Patent landscape reports from industry intelligence providers.
4. Recent legal analyses of similar biotech patents.
5. Scientific publications related to the patent’s technology area.

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In conclusion, the ’112 patent exemplifies strategic patenting within a competitive biotech landscape, with claims designed to secure a competitive edge. Its value, however, depends on robust validity, clear claim scope, and vigilant landscape management—elements that collectively determine its role in driving innovation, protecting market share, and shaping future patent filings.

Details for Patent 10,632,112

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Kadmon Pharmaceuticals Llc	INFERGEN	interferon alfacon-1	Injection	103663	October 06, 1997	10,632,112	2038-12-28
Biogen Inc.	PLEGRIDY	peginterferon beta-1a	Injection	125499	August 15, 2014	10,632,112	2038-12-28