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Last Updated: December 25, 2024

Patent: 9,518,057


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Summary for Patent: 9,518,057
Title: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. (Lansdale, PA), Kuduk; Scott (Harleysville, PA)
Assignee: NOVIRA THERAPEUTICS, INC. (Doylestown, PA)
Application Number:14/984,325
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Claims and Patent Landscape of United States Patent 9,518,057

Introduction

United States Patent 9,518,057, like any other patent, is part of a complex and evolving patent landscape. To understand its significance and the challenges it may face, it is crucial to delve into the broader context of U.S. patent law, the procedures for challenging patent validity, and the current trends and issues in the patent system.

The Leahy-Smith America Invents Act (AIA) and Its Impact

The Leahy-Smith America Invents Act (AIA) of 2011 is a pivotal piece of legislation that has significantly shaped the U.S. patent system. It introduced new administrative procedures such as inter partes review (IPR) and post-grant review (PGR), which allow third-party challenges to the validity of patents before the Patent Trial and Appeal Board (PTAB)[1].

The Role of the Patent Trial and Appeal Board (PTAB)

PTAB, established by the AIA, is a tribunal within the U.S. Patent and Trademark Office (USPTO) that hears challenges to the validity of patents. IPR and PGR processes are faster and less expensive than judicial proceedings and require a lower burden of proof to invalidate patents. This makes them attractive options for entities accused of patent infringement[1].

Patent Eligibility Requirements

For a patent to be granted, the invention must satisfy several statutory requirements, including subject matter eligibility, novelty, and non-obviousness. The U.S. Supreme Court's decision in Alice v. CLS Bank introduced a two-part test to determine patentable subject matter, which has been a source of uncertainty for innovators and investors[2].

Subject Matter Eligibility

The Alice/Mayo test involves determining whether the patent claims are directed to ineligible subject matter (such as laws of nature, natural phenomena, or abstract ideas) and whether the claims contain an "inventive concept" that transforms the nature of the claim into a patent-eligible application[1][2].

Novelty Requirement

The claimed invention must be new and not previously disclosed in the prior art. If every element of the claimed invention is already disclosed, no valid patent can be issued[1].

Nonobviousness Requirement

The invention must also be non-obvious, meaning it must be significantly different from existing knowledge and not an obvious combination of prior art elements[1].

Challenges to Patent Validity

Patents like 9,518,057 can be challenged through IPR or PGR at PTAB. These processes are more accessible and less burdensome than court litigation but can also lead to repeated attacks on the same patent, preventing the patent owner from achieving quiet title[2].

The Impact of PTAB on Patent Owners

The ease of challenging patents at PTAB has raised concerns about the stability of the U.S. patent system. Repeated challenges can undermine the confidence of patent owners and investors. Legislation such as the STRONGER Patents Act has been proposed to address these issues but has not yet been enacted[2].

Use of AI in Patent Applications

The increasing use of AI tools in drafting patent applications introduces new complexities. The USPTO has issued guidance requiring the disclosure of AI tool use if it is material to patentability. This includes ensuring that AI contributions do not misrepresent the role of human inventors[5].

Patent Enforcement and Injunctions

Even if a patent is found to be valid and infringed, obtaining an injunction can be challenging. The Supreme Court's decision in eBay Inc. v. MercExchange, L.L.C. made it clear that injunctions are no longer the default remedy, which can weaken the enforceability of patents[2].

Current Trends and Issues in the Patent Landscape

The U.S. patent system faces several challenges, including the need to clarify patent eligibility requirements, strengthen patent enforceability, and address the issues surrounding PTAB. These challenges affect the overall reliability and predictability of the IP ecosystem[2].

Geographical and Technological Trends

Patent filings and trends can vary significantly by geographical region and technological field. For instance, quantum computing patents show a high level of innovation and geopolitical influence, highlighting the importance of patent data in assessing innovation policy[3].

Probability of Receiving a U.S. Patent

The probability of a patent being granted depends on various factors, including the technology field, the origin of the application, and whether the applicant is a large or small entity. Understanding these factors can help applicants navigate the complex patent examination process[4].

Key Takeaways

  • Administrative Challenges: Patents can be challenged through IPR and PGR at PTAB, which are faster and less expensive than court litigation but can lead to repeated attacks.
  • Patent Eligibility: The Alice/Mayo test for subject matter eligibility remains a source of uncertainty and needs clarification.
  • AI in Patent Applications: The use of AI tools must be disclosed if material to patentability, and their contributions must not misrepresent human inventorship.
  • Enforcement Challenges: Obtaining an injunction for patent infringement is difficult due to the eBay Inc. v. MercExchange, L.L.C. decision.
  • Trends and Issues: The U.S. patent system needs to address issues like patent eligibility, enforceability, and the role of PTAB to maintain its reliability and predictability.

FAQs

What is the significance of the Leahy-Smith America Invents Act (AIA) in U.S. patent law?

The AIA introduced new administrative procedures like IPR and PGR, which allow third-party challenges to patent validity before PTAB, aiming to improve patent quality and efficiency.

How does the Alice/Mayo test affect patent eligibility?

The Alice/Mayo test determines whether patent claims are directed to ineligible subject matter and whether they contain an "inventive concept" that makes them patent-eligible, introducing a layer of complexity and uncertainty.

What are the implications of using AI tools in patent applications?

Using AI tools requires disclosure if their contributions are material to patentability, and practitioners must ensure that AI does not misrepresent human inventorship, according to recent USPTO guidance.

Why is it challenging to obtain an injunction for patent infringement?

The Supreme Court's decision in eBay Inc. v. MercExchange, L.L.C. made injunctions no longer the default remedy, making it difficult for patent holders to exclude infringers from the market.

How do IPR and PGR processes differ from court litigation?

IPR and PGR processes are faster, less expensive, and require a lower burden of proof compared to court litigation, but they can also lead to repeated challenges and undermine the stability of patent ownership.

Sources

  1. Congressional Research Service, "The Patent Trial and Appeal Board and Inter Partes Review," May 28, 2024.
  2. Center for Strategic and International Studies, "Four Actions to Strengthen the U.S. Intellectual Property System," August 28, 2023.
  3. Stanford Law School, "Quantum Leap: Decoding Quantum Computing Innovation," accessed December 20, 2024.
  4. Yale Journal of Law and Technology, "What Is the Probability of Receiving a US Patent?" accessed December 20, 2024.
  5. Buchanan Ingersoll & Rooney PC, "U.S. Patent Office Issues Additional Guidance on Use of AI Tools," April 15, 2024.

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Details for Patent 9,518,057

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 2034-12-30
Glaxosmithkline Biologicals ENGERIX-B hepatitis b vaccine (recombinant) Injection 103239 August 28, 1989 ⤷  Subscribe 2034-12-30
Hoffmann-la Roche Inc. PEGASYS COPEGUS COMBINATION PACK peginterferon alfa-2a and ribavirin 125083 June 04, 2004 ⤷  Subscribe 2034-12-30
Schering Corporation A Subsidiary Of Merck & Co., Inc. PEGINTRON/ REBETOL COMBO PACK peginterferon alfa-2b and ribavirin 125196 June 13, 2008 ⤷  Subscribe 2034-12-30
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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