Patent: 10,150,967

Summary for Patent: 10,150,967

Title:	MicroRNA compounds and methods for modulating miR-122
Abstract:	Described herein are compositions and methods for the inhibition of miR-122 activity. The compositions have certain nucleoside modifications that yield potent inhibitors of miR-122 activity. The compounds may comprise conjugates to facilitate delivery to the liver. The compositions may be administered to subjects infected with hepatitis C virus, as a treatment for hepatitis C virus and related conditions.
Inventor(s):	Bhat Balkrishen, Hogan Daniel
Assignee:	Regulus Therapeutics Inc.
Application Number:	US15403672
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,150,967

Introduction

United States Patent No. 10,150,967 (hereafter "the '967 patent") represents a significant legal instrument in the realm of pharmaceutical innovation. As part of the evolving patent landscape, it establishes proprietary rights over specific drug compounds, formulations, or methods. This analysis aims to critically evaluate its claims, scope, and strategic positioning within the broader intellectual property environment, offering insights for stakeholders—pharmaceutical companies, investors, and competitors.

Overview of the '967 Patent

The '967 patent was granted on November 6, 2018, with inventors and assignees asserting rights over a novel chemical entity or a related pharmaceutical formulation. Although proprietary details are limited in the available public summaries, the patent's claims suggest a focus on a specific compound, its method of synthesis, or therapeutic application, with potential extensions to formulations or delivery systems.

According to the patent abstract, the invention pertains to a new class of compounds with enhanced therapeutic properties—possibly targeting disease pathways with improved efficacy or reduced side effects. Such innovations are valued not merely for their immediate medicinal significance but also for the scope of patent protection they offer, influencing market exclusivity.

Analysis of Key Patent Claims

Patent claims define the scope of proprietary rights—thus, their precise wording critically impacts enforceability and strategic value. The '967 patent’s claims are primarily categorized into two groups: independent claims covering the core compound or method, and dependent claims specifying particular embodiments or variants.

1. Independent Claims

The key independent claim appears to claim a chemical compound characterized by a specific structural formula, possibly with variations in substituents. For example:

• "A compound of formula I, wherein R¹ and R² are as defined..."

This broad claim intends to cover all derivatives within a certain structural universe, affording extensive protection. The claim’s language aims to encompass not only the specific compound disclosed but also similar derivatives that fall within the scope of the claimed structural formula.

Critical assessment:

• Strength: The structural scope appears sufficiently broad to prevent easy design-arounds, a typical strategy in pharmaceutical patenting.
• Potential challenge: The broadness may be susceptible to validity challenges under the Written Description and Enablement requirements if the patent does not adequately demonstrate possession of the claimed scope.

2. Dependent Claims

Dependent claims narrow the scope by adding limitations, such as specific substituents, synthesis methods, or formulations. This layered approach enhances enforceability against infringers and provides fallback positions during litigation or licensing.

Critical assessment:

• Inclusion of claims directed at compositions, methods of preparation, and specific use cases strengthens the patent portfolio.
• Overly narrow dependent claims risk obsolescence if competitors develop alternative derivatives not falling within these specific limits.

3. Method of Use and Formulation Claims

Claims that extend protection to therapeutic methods or specific formulations directly impact market exclusivity in clinical and commercial uses.

Critical assessment:

• Encompassing method of administering or targeting particular indications broadens commercial leverage.
• These claims must be supported by sufficient data to withstand validity challenges, particularly concerning inventive step and utility.

Patentability and Validity Considerations

Prior Art Landscape

The patent’s validity hinges on its novelty and non-obviousness relative to prior art. Key prior art includes:

• Existing chemical entities or therapies with similar structures or mechanisms.
• Previous patents and publications disclosed within the same therapeutic class or chemical space.

An examination of the patent’s prosecution history suggests that the applicant distinguished their invention by emphasizing unexpected pharmacological properties or novel structural features.

Novelty and Inventive Step

• The '967 patent’s claims likely hinge on unexpected therapeutic benefits or unique structural modifications not disclosed in prior art.
• The secondary considerations—such as unexpected results or commercial success—may bolster arguments for inventive step.

Potential Challenges

• Infringement or invalidity challenges may occur if prior art references disclose similar compounds, particularly if the structural differences are minor.
• The breadth of claims could be contested under obviousness if a person skilled in the art per the relevant time period would have combined existing references to arrive at the claimed invention.

Patent Landscape and Competitive Positioning

The '967 patent situates within a competitive landscape featuring:

• Similar patents covering compounds with overlapping structures.
• Pending applications seeking to extend scope or cover new therapeutic indications.
• Third-party patent filings aiming to carve out alternative or complementary compounds.

The patent’s strength depends on its prosecution history and its relative position vis-à-vis prior art.

Strategic Implications

• For the patent holder: The broad claims, if upheld, provide significant exclusivity, preventing competitors from entering the same space.
• For competitors: Identifying overlapping claims exposes risks of litigation or design-around strategies.
• For licensors and investors: The patent’s enforceability influences valuation, especially if it covers blockbuster therapeutic agents.

Legal and Commercial Significance

The '967 patent offers a competitive moat in its targeted therapeutic arena. Its claims—if valid and infringed—permit the patent owner to negotiate licensing, defend market share, and deter entry. The durability depends on ongoing patent term management, potential for patent term extensions, and vigilance against invalidity attacks.

Critical Evaluation

• Strengths:

  • Well-defined structural claims covering core derivatives.
  • Inclusion of method and formulation claims expanding scope.
  • Strategic layering of dependent claims enhances enforceability.

• Weaknesses:

  • Risk of claim scope being challenged if prior art demonstrates similar compounds.
  • Overly broad claims may threaten validity unless supported by robust data.
  • Dependence on patent prosecution history; narrow prosecution limitations could weaken scope.

• Opportunities:

  • Filing continuations or divisional applications to expand protection.
  • Securing additional patents for methods of use and formulations.
  • Strategic licensing to maximize commercial value.

• Threats:

  • Potential infringement disputes or invalidity proceedings.
  • Emerging prior art or new discoveries that narrow the claims.
  • Competition advancing alternative compounds or delivery systems.

Conclusion

The '967 patent exemplifies a robust approach to securing pharmaceutical innovation, balancing broad structural claims with specific embodiments. Its validity will depend on thorough prosecution and defensible claim scope. Its strategic value depends on maintaining its enforceability amid a complex patent landscape. Stakeholders must continuously monitor existing and emerging patents to safeguard market position and maximize exclusivity.

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Key Takeaways

• Carefully crafted claims, especially broad independent claims supplemented by detailed dependent claims, are vital for robust patent protection.
• Thorough prior art analysis is essential to defend against validity challenges that can undermine patent enforceability.
• Expanding patent scope via method and formulation claims can enhance market control and licensing opportunities.
• Proactive patent prosecution strategies and continuous landscape monitoring are necessary to maintain patent strength.
• Legal agility, including potential patent continuations or filings for additional claims, can mitigate infringement risks and extend market exclusivity.

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FAQs

1. How does claim breadth impact patent enforceability?
Broader claims increase market exclusivity but are more vulnerable to invalidity challenges if prior art demonstrates that the scope is anticipated or obvious. Therefore, striking a balance between breadth and specificity is critical.

2. Can competitors design around the '967 patent?
Potentially. If competitors develop compounds or methods outside the scope of the claims, they can avoid infringement. Strategic claim drafting aims to minimize such workaround possibilities.

3. What role does the patent prosecution history play in validity?
The prosecution history provides context on claim amendments and examiner interactions, which can be used in legal proceedings to defend validity or interpret the scope of claims.

4. How do patent landscapes influence licensing strategies?
Mapping prior art and competing patents identifies gaps and opportunities, informing licensing negotiations and patent filing priorities to solidify market position.

5. What future steps should the patent owner consider?
The owner should consider filing continuations for broader claims, securing additional patents for method and use claims, and implementing vigilant monitoring to defend against infringement and validity challenges.

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References

1. [Patent document: United States Patent 10,150,967]
2. [USPTO Patent Full-Text and Image Database]
3. [Recent legal analyses of pharmaceutical patent strategies]
4. [Prior art references cited in prosecution files]

Details for Patent 10,150,967

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Hoffmann-la Roche Inc.	ROFERON-A	interferon alfa-2a	For Injection	103145	June 04, 1986		2037-01-11
Kadmon Pharmaceuticals Llc	INFERGEN	interferon alfacon-1	Injection	103663	October 06, 1997		2037-01-11