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Last Updated: December 23, 2024

Patent: 10,596,173


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Summary for Patent: 10,596,173
Title:Combination therapy of an HBV capsid assembly inhibitor and an interferon
Abstract:The present invention is directed to compositions and methods for treating hepatitis B virus infection. In particular, the present invention is directed to a combination therapy comprising administration of an HBV capsid assembly inhibitor and an interferon for use in the treatment of hepatitis B virus infections.
Inventor(s):Gao Lu, Najera Isabel, Shen Hong, Shen Fang, Shi Liping, Wildum Steffen, Yang Guang
Assignee:Hoffmann-La Roche Inc.
Application Number:US15970128
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Claims and Patent Landscape of United States Patent 10,596,173

Introduction

Patent 10,596,173, like any other patent, exists within a complex and evolving patent landscape in the United States. This analysis will delve into the key aspects of this patent, including its claims, the broader patent landscape, and the regulatory and legal frameworks that govern it.

Understanding the Patent Claims

To analyze Patent 10,596,173, it is crucial to start with the patent claims themselves. These claims define the scope of the invention and what is protected under the patent.

Claim Structure

Patent claims are typically divided into independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims. The clarity and specificity of these claims are critical for determining the patent's validity and enforceability[2].

Novelty and Nonobviousness

Two fundamental requirements for patentability are novelty and nonobviousness. The claimed invention must be new and not obvious to a person of ordinary skill in the relevant field. If every element of the claimed invention is already disclosed in the prior art, the patent may not be valid[2].

The Broader Patent Landscape

The U.S. patent system is governed by a series of laws, regulations, and administrative procedures.

The Leahy-Smith America Invents Act (AIA)

The AIA, enacted in 2011, is a significant piece of legislation that has shaped the current patent landscape. It introduced the Patent Trial and Appeal Board (PTAB) and procedures like Inter Partes Review (IPR) and Post-Grant Review (PGR), which allow for the challenge of patents post-grant. These mechanisms aim to improve patent quality and provide a more efficient system for challenging patents that should not have been issued[2].

Patent Trial and Appeal Board (PTAB)

PTAB plays a crucial role in the post-grant review process. It hears challenges to the validity of patents and can cancel patent claims if they are found to be invalid. This process is often faster and less expensive than judicial proceedings, making it a popular choice for entities facing patent infringement claims[2].

Patent Quality Initiatives

The U.S. Patent and Trademark Office (USPTO) has been actively working to improve patent quality.

Enhanced Patent Quality Initiative

The USPTO's Enhanced Patent Quality Initiative aims to ensure that patents are correctly issued in compliance with all statutory requirements. This includes developing consistent definitions of patent quality, reassessing examination times, and analyzing the effects of performance incentives on patent quality[1].

Definition of Patent Quality

A key recommendation from the Government Accountability Office (GAO) was for the USPTO to define patent quality consistently. The USPTO has since defined a quality patent as one that is correctly issued in compliance with all the requirements of Title 35 and relevant case law at the time of issuance[1].

Challenges and Controversies

Inter Partes Review (IPR) and Constitutional Questions

IPR has faced constitutional challenges, with some arguing that it usurps the role of the courts. However, the Supreme Court has upheld IPR as a valid mechanism for correcting errors in patent issuance, viewing it as an "error correction mechanism" rather than a substitute for court litigation[5].

Patent Assertion Entities (PAEs)

PAEs, often referred to as "patent trolls," have been a subject of controversy. They acquire patents not to use them in their own products but to assert them against other companies. The FTC has studied PAE behavior, identifying two main models: Portfolio PAEs and Litigation PAEs. These entities can significantly impact the patent landscape, particularly in the tech sector[3].

Regional and Demographic Disparities

Regional Patenting Activity

There are significant regional disparities in patenting activity in the United States. Initiatives such as those proposed under the CHIPS and Science Act aim to improve regional innovative capacity, promoting a more diverse and equitable innovation ecosystem[4].

Inventor Diversity

The patent system also faces issues related to inventor diversity. Men are more likely to be named as inventors on patents than women, and there are racial disparities as well. Proposed legislation aims to address these inequities by collecting demographic data from inventors[4].

Impact on Business and Innovation

Licensing and Litigation

The patent landscape significantly affects business strategies, particularly in terms of licensing and litigation. Companies must navigate complex patent portfolios and potential infringement suits, which can be costly and time-consuming. The prevalence of PAEs adds another layer of complexity[3].

Innovation and Economic Growth

A robust and fair patent system is crucial for innovation and economic growth. Clear and enforceable patents encourage investment in research and development, while poor patent quality can stifle innovation by creating uncertainty and litigation risks[1].

Key Takeaways

  • Patent Claims: The specificity and clarity of patent claims are critical for determining the scope and validity of a patent.
  • Patent Quality Initiatives: The USPTO's efforts to define and improve patent quality are ongoing, with a focus on compliance with statutory requirements.
  • Post-Grant Review: Mechanisms like IPR and PGR provide efficient ways to challenge patent validity, impacting the patent landscape.
  • PAEs and Litigation: PAEs and their litigation strategies can significantly affect the tech sector and other industries.
  • Regional and Demographic Disparities: Addressing regional and demographic disparities is essential for a more equitable and innovative ecosystem.

FAQs

What is the role of the Patent Trial and Appeal Board (PTAB) in the U.S. patent system?

The PTAB is a tribunal within the USPTO that hears administrative challenges to the validity of patents, providing a faster and less expensive alternative to judicial proceedings.

How does the USPTO define patent quality?

The USPTO defines a quality patent as one that is correctly issued in compliance with all the requirements of Title 35 and relevant case law at the time of issuance.

What are the main types of Patent Assertion Entities (PAEs)?

PAEs are generally categorized into two models: Portfolio PAEs, which negotiate licenses over large patent portfolios, and Litigation PAEs, which often precede licensing with patent infringement suits.

Why is Inter Partes Review (IPR) important?

IPR is important as it provides a mechanism for correcting errors in patent issuance, improving patent quality, and offering a more efficient and less costly alternative to court litigation.

How do regional disparities affect patenting activity in the United States?

Regional disparities in patenting activity can lead to uneven economic growth and innovation. Initiatives aimed at improving regional innovative capacity are crucial for promoting a more diverse and equitable innovation ecosystem.

Sources

  1. Government Accountability Office. "Intellectual Property: Patent Office Should Define Quality, Reassess Incentives, and Improve Application Review Process." June 30, 2016.
  2. Congressional Research Service. "The Patent Trial and Appeal Board and Inter Partes Review." Updated May 28, 2024.
  3. Federal Trade Commission. "Patent Assertion Entity Activity: An FTC Study." December 2014.
  4. Congressional Research Service. "Equity in Innovation: Trends in U.S. Patenting and Inventor Diversity." November 30, 2022.
  5. Wyatt, Tarrant & Combs, LLP. "Is Inter Partes Review Unconstitutional?" December 11, 2017.

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Details for Patent 10,596,173

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Merck Sharp & Dohme Llc INTRON A interferon alfa-2b For Injection 103132 June 04, 1986 10,596,173 2038-05-03
Merck Sharp & Dohme Llc INTRON A interferon alfa-2b For Injection 103132 10,596,173 2038-05-03
Merck Sharp & Dohme Llc INTRON A interferon alfa-2b Injection 103132 10,596,173 2038-05-03
Hoffmann-la Roche Inc. ROFERON-A interferon alfa-2a For Injection 103145 June 04, 1986 10,596,173 2038-05-03
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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