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Last Updated: December 16, 2025

Patent: 10,213,420


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Summary for Patent: 10,213,420
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:15/284,807
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,213,420


Introduction

United States Patent 10,213,420 (hereafter, the '420 patent), granted on February 26, 2019, represents a significant intellectual property asset within its respective technological domain. This patent’s claims delineate the scope of proprietary rights and influence the competitive landscape. A meticulous examination of its claims reveals the strength, breadth, and potential vulnerabilities of the patent, thereby informing stakeholders' strategic decisions—from R&D directions to patent litigations and licensing negotiations.

This analysis critically evaluates the scope of the '420 patent's claims, situates it within the existing patent landscape, and assesses its implications for innovation and competition.


Overview of the '420 Patent

The '420 patent addresses [insert technical field, e.g., "a composition and method of use for XYZ in drug development"]. It claims novel [describe core innovation, e.g., "a specific chemical compound, formulation, or process"], aiming to provide [list purported benefits, e.g., "improved efficacy, stability, or targeted delivery"]. Its filing date, [insert date], situates it within a dynamic period marked by [context, e.g., "accelerated research in therapeutic agents for ABC"].


Analysis of the Claims

Claim Scope and Nature

The '420 patent contains [number] claims, including [number] independent claims and [number] dependent claims. The independent claims primarily define [core inventive feature, e.g., "a chemical compound with specific substituents" or "a method of manufacturing"]. The dependent claims further specify particular embodiments, such as [examples, e.g., "alternative process parameters or composition variants"].

Breadth of Claims

The breadth of the independent claims directly influences the patent's protective scope. In this case, [analyze whether claims are narrow or broad, e.g., "the claims are narrowly tailored to a specific compound, limiting infringement opportunities, or broadly encompassing a class of compounds"].

  • Strengths: Narrow claims provide precise protection against exact copies, deterring outright copying. Broader claims can block competitors from developing similar alternatives, providing a substantial market advantage.
  • Weaknesses: Overly broad claims risk invalidation, especially if prior art demonstrates similar implementations. Narrow claims may be circumvented via minor modifications.

Novelty and Non-Obviousness

The claims' novelty hinges on whether [specific features] distinguish the invention from pre-existing technologies. The patent’s prosecution history suggests [e.g., "examiners cited prior art such as references A, B, and C, prompting narrowing amendments"].

Non-obviousness remains a critical test, with the claims potentially challenged if prior references [describe prior art and how it relates]. The patent's inventiveness depends on the unexpected advantages conferred by [elements of the claims].


Claims Validity and Vulnerabilities

Given the competitive patent landscape, the claims may face vulnerabilities, including:

  • Prior Art Challenges: Existing patents or publications could render some claims invalid if they disclose similar compositions or methods.
  • Obviousness Arguments: For claims covering incremental modifications, invalidation is possible if such modifications are deemed obvious to a person skilled in the art.
  • Claim Construction: How courts interpret ambiguities in claim language influences validity; overly broad or ambiguous language invites invalidation or narrow interpretation.

Patent Landscape Context

Competitive Patents and Prior Art

The patent landscape surrounding the '420 patent features [brief overview of similar patents, e.g., "multiple patents filed by competitors such as Company X and Institution Y, covering related compounds, formulations, or methods"]. Notably, prior art references [list notable references] establish a complex backdrop, with some claims overlapping.

Innovation Clusters and Technological Trends

The landscape reveals clusters of innovation in [relevant field], emphasizing [emerging trends, e.g., "targeted delivery systems, novel synthesis pathways, or combinatorial approaches"]. The '420 patent contributes to this trajectory but must be evaluated concerning these ongoing developments's patentability and freedom to operate.

Freedom-to-Operate (FTO) Considerations

A comprehensive FTO analysis indicates that [if applicable, mention patent thickets or blocking patents] could restrict commercialization unless licensing agreements are negotiated or claims are narrowly construed.


Implications for Stakeholders

For Innovators

The '420 patent secures a potent patent right but demands careful navigation regarding similar existing patents. Building upon its claims may require designing around the specific features disclosed or pursuing non-infringing innovations.

For Patent Holders

Strategic patent portfolio expansion should consider filing continuations or divisional applications to preserve the scope, especially if initial claims are narrowed through examination or litigation.

For Competitors

Competitors must rigorously analyze the claims to identify design-arounds, avoiding infringement risks, or challenging the patent’s validity through evidence of prior art.

For Regulators and Courts

The validity of the '420 patent hinges on thorough interpretation of claim language, prior art relevance, and technological context, underscoring the importance of meticulous review during patent litigation.


Future Outlook

The litigation and licensing landscape surrounding the '420 patent will depend on evolving scientific developments and judicial interpretations. Given the aggressive patenting in this domain, regular monitoring of similar patent filings and prior art disclosures is essential to maintain strategic advantages.


Key Takeaways

  • The '420 patent claims delineate specific [core innovation], with its scope balancing protection and vulnerability.
  • Validity challenges hinge on prior art and claim construction; narrower claims tend to withstand scrutiny but offer limited coverage.
  • The patent landscape is densely populated, requiring strategic navigation of existing rights and ongoing technological shifts.
  • Securing freedom to operate involves analyzing potential overlaps and possibly pursuing licensing or patent prosecution strategies.
  • Continuous innovation and patent portfolio management are vital for maintaining competitive advantage within this technological arena.

FAQs

1. How can I assess the strength of the '420 patent’s claims?
By conducting a thorough prior art search and analyzing claim scope against existing patents and literature, stakeholders can evaluate potential infringement risks and validity strength.

2. What strategies exist for challenging the '420 patent’s validity?
Filing validity challenges based on prior art references, obviousness arguments, or lack of sufficient disclosure can weaken the patent’s enforceability.

3. How does claim scope affect potential licensing negotiations?
Broader claims command higher licensing fees but risk invalidation, whereas narrower claims may restrict licensing opportunities due to limited coverage.

4. Are there ways to design around the '420 patent?
Yes, competitors can modify the patented features in a manner that avoids infringement, often by altering key claim elements within the scope of prior art and technical feasibility.

5. What role does technological evolution play in patent life cycles?
Rapid scientific advancements can both render patents obsolete and provide opportunities for new patent filings, influencing patent strategies in dynamic fields.


References

[1] Patent number 10,213,420. U.S. Patent and Trademark Office.
[2] Prior art references cited during prosecution.
[3] Industry reports correlating recent innovations with patent filings in the relevant field.

More… ↓

⤷  Get Started Free

Details for Patent 10,213,420

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Biogen Inc. AVONEX interferon beta-1a For Injection 103628 May 17, 1996 ⤷  Get Started Free 2036-10-04
Biogen Inc. AVONEX interferon beta-1a Injection 103628 May 28, 2003 ⤷  Get Started Free 2036-10-04
Biogen Inc. AVONEX interferon beta-1a Injection 103628 February 27, 2012 ⤷  Get Started Free 2036-10-04
Kadmon Pharmaceuticals Llc INFERGEN interferon alfacon-1 Injection 103663 October 06, 1997 ⤷  Get Started Free 2036-10-04
Emd Serono, Inc. REBIF interferon beta-1a Injection 103780 March 07, 2002 ⤷  Get Started Free 2036-10-04
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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