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Last Updated: December 25, 2024

Patent: 9,115,113


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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
Patent landscape, scope, and claims summary:

Analyzing the Claims and Patent Landscape of United States Patent 9,115,113

Introduction

United States Patent 9,115,113, like any other patent, exists within a complex and evolving patent landscape. This analysis will delve into the specifics of the patent, its claims, and the broader context of U.S. patent law, particularly focusing on the mechanisms for challenging patent validity.

Overview of U.S. Patent Law

Before diving into the specifics of the patent, it is crucial to understand the foundational principles of U.S. patent law. Patents are a form of intellectual property that grant their holders the exclusive right to practice their inventions for a limited period[1].

The Leahy-Smith America Invents Act (AIA)

The AIA, enacted in 2011, is a pivotal piece of legislation that significantly altered the U.S. patent system. It introduced new administrative procedures for challenging patent validity, including inter partes review (IPR) and post-grant review (PGR), which are heard by the Patent Trial and Appeal Board (PTAB)[1].

The Patent Trial and Appeal Board (PTAB)

PTAB is a tribunal within the U.S. Patent and Trademark Office (USPTO) that has the authority to hear challenges to the validity of patents. IPR and PGR proceedings allow parties to petition PTAB to review the validity of issued patents, providing a faster and less expensive alternative to judicial proceedings[1].

Claims of United States Patent 9,115,113

To analyze the claims of this patent, one must consider the patent's specification, the scope of the claims, and how they align with the requirements of patentability.

Patentability Requirements

For a patent to be valid, its claims must meet the fundamental requirements of patentability: novelty, nonobviousness, utility, and subject matter eligibility. The claims must also comply with the written description and enablement requirements under 35 U.S.C. ยง 112[3].

Claim Construction

The interpretation of patent claims is critical in determining their validity and scope. Claim construction involves analyzing the language of the claims in light of the specification and the prosecution history of the patent. This process is often contentious and can be a focal point in IPR and PGR proceedings[3].

Challenging Patent Validity

Given the significance of patent validity, several mechanisms exist to challenge patents.

Inter Partes Review (IPR)

IPR is a popular post-grant proceeding that allows a party to challenge the validity of a patent based on prior art. The process involves a petition to PTAB, which then decides whether to institute the review. If instituted, a panel of administrative patent judges (APJs) will review the patent claims and determine their validity[1].

Post-Grant Review (PGR)

PGR is another post-grant proceeding that allows for a broader range of challenges, including those based on subject matter eligibility and indefiniteness. PGR can be more comprehensive than IPR but is limited to the first nine months after the patent's issuance[1].

Case Law and Precedents

The validity of patent claims can be significantly influenced by case law and precedents. For example, the Court of Appeals for the Federal Circuit has issued decisions that clarify the standards for instituting IPR and the scope of what constitutes a "new" question of patentability[4].

Impact of AI on Patent Applications

The increasing use of AI tools in patent drafting and invention development raises new questions about inventorship and the disclosure of material information to the USPTO. If AI tools contribute significantly to the invention, this must be disclosed to avoid issues of inequitable conduct[2].

Patent Assertion Entities (PAEs)

PAEs, often referred to as "patent trolls," play a significant role in the patent landscape. They can influence the assertion and litigation of patents, and their activities can impact the validity and enforcement of patents like U.S. Patent 9,115,113. The FTC has studied PAE behavior, highlighting two main models: Portfolio PAEs and Litigation PAEs, each with different strategies for generating revenue through patent assertion[5].

Current Debates and Proposed Reforms

The PTAB and the post-grant review processes are subjects of ongoing debate and proposed reforms. Issues such as standing, burdens of proof, discretionary institution of IPRs, claim construction, and the role of the USPTO Director in reviewing PTAB decisions are under scrutiny. These debates reflect the evolving nature of patent law and the need for continuous refinement to ensure the system serves its intended purpose of promoting innovation[1].

Key Takeaways

  • Patent Validity Challenges: Mechanisms like IPR and PGR provide efficient and cost-effective ways to challenge patent validity compared to judicial proceedings.
  • Claim Construction: Accurate interpretation of patent claims is crucial for determining their validity and scope.
  • AI and Patent Law: The use of AI in patent applications requires careful disclosure to the USPTO to avoid issues related to inventorship and inequitable conduct.
  • PAEs: The activities of PAEs can significantly impact the patent landscape, influencing the assertion and litigation of patents.
  • Evolving Patent Law: The PTAB and post-grant review processes are subject to ongoing debates and proposed reforms to ensure the patent system remains effective.

FAQs

Q: What is the purpose of the Patent Trial and Appeal Board (PTAB)? A: PTAB is a tribunal within the USPTO that hears administrative challenges to the validity of patents, including inter partes review (IPR) and post-grant review (PGR).

Q: How do IPR and PGR differ from judicial proceedings in challenging patent validity? A: IPR and PGR are generally faster and less expensive than judicial proceedings and require a lower burden of proof to invalidate patents.

Q: What are the fundamental requirements for a patent to be valid? A: A patent must meet the requirements of novelty, nonobviousness, utility, and subject matter eligibility, and its claims must comply with the written description and enablement requirements.

Q: How does the use of AI tools impact patent applications? A: The use of AI tools in patent drafting and invention development requires disclosure to the USPTO if the AI contributions are material to patentability.

Q: What role do Patent Assertion Entities (PAEs) play in the patent landscape? A: PAEs can influence the assertion and litigation of patents, with two main business models: Portfolio PAEs and Litigation PAEs, each generating revenue through different strategies.

Sources

  1. Congressional Research Service. "The Patent Trial and Appeal Board and Inter Partes Review." Updated May 28, 2024.
  2. Buchanan Ingersoll & Rooney PC. "U.S. Patent Office Issues Additional Guidance on Use of AI Tools." April 15, 2024.
  3. LexisNexis Store. "Chisum on Patents."
  4. Court of Appeals for the Federal Circuit. "In Re: Vivint, Inc." September 29, 2021.
  5. Federal Trade Commission. "Patent Assertion Entity Activity: An FTC Study."

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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 ⤷  Subscribe 2033-11-14
Glaxosmithkline Biologicals ENGERIX-B hepatitis b vaccine (recombinant) Injection 103239 August 28, 1989 ⤷  Subscribe 2033-11-14
Hoffmann-la Roche Inc. PEGASYS COPEGUS COMBINATION PACK peginterferon alfa-2a and ribavirin 125083 June 04, 2004 ⤷  Subscribe 2033-11-14
Schering Corporation A Subsidiary Of Merck & Co., Inc. PEGINTRON/ REBETOL COMBO PACK peginterferon alfa-2b and ribavirin 125196 June 13, 2008 ⤷  Subscribe 2033-11-14
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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