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Last Updated: April 24, 2025

Patent: 10,022,427


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Summary for Patent: 10,022,427
Title:Interferon lambda-antibody complexes
Abstract: The present invention concerns methods and compositions for forming complexes of interferon-.lamda. with an antibody or antigen-binding antibody fragment. In preferred embodiments, the interferon-.lamda. and the antibody or fragment are fusion proteins, each comprising a dimerization and docking domain (DDD) moiety from human protein kinase A or an anchor domain (AD) moiety from an A-kinase anchoring protein (AKAP). In more preferred embodiments, the interferon-antibody complex is more efficacious for treatment of cancer, asthma, Alzheimer\'s disease, multiple sclerosis or viral infection than interferon-.lamda. alone, antibody alone, or the combination of unconjugated interferon-.lamda. and antibody.
Inventor(s): Chang; Chien-Hsing (Downingtown, PA), Goldenberg; David M. (Mendham, NJ), Liu; Donglin (Kendall Park, NJ)
Assignee: IBC Pharmaceuticals, Inc. (Morris Plains, NJ)
Application Number:14/997,843
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Claims and Patent Landscape of United States Patent 10,022,427

Introduction

The United States patent system is a cornerstone of innovation, encouraging the development and protection of new inventions. This analysis will delve into the specifics of United States Patent 10,022,427, examining its claims, the broader patent landscape, and the implications of recent judicial, administrative, and legislative developments.

Understanding Patent-Eligible Subject Matter

To begin, it is crucial to understand what constitutes patent-eligible subject matter. Section 101 of the Patent Act defines four categories of patentable inventions: processes, machines, manufactures, and compositions of matter. However, the Supreme Court has established implicit exceptions, excluding laws of nature, natural phenomena, and abstract ideas from patentability unless they contain an inventive concept that transforms the nature of the claim[1].

The Patent in Question: United States Patent 10,022,427

While the specific details of United States Patent 10,022,427 are not provided here, we can generalize the analysis based on common practices and recent trends in patent law.

Claim Structure and Scope

Patent claims are the heart of any patent application, defining the scope of protection. The claims must be novel, non-obvious, and fully described to meet the requirements of the Patent Act. Recent trends show an increase in the number of claims per application, with some applications containing hundreds or even thousands of claims. This complexity necessitates automated systems for analyzing and managing patent claims, as seen in the development of systems like the Patent Claims Analysis System and Method[2].

Subject Matter Eligibility

Given the evolving landscape of patent-eligible subject matter, any patent must navigate the Alice/Mayo framework. This framework involves a two-step test to determine if a patent claim is directed to an ineligible concept (such as an abstract idea) and whether the claim contains an inventive concept that transforms it into a patent-eligible application. The USPTO's 2019 Guidance aimed to clarify this process, particularly for AI-related inventions, but its impact is still subject to judicial interpretation[1].

Recent Judicial and Administrative Developments

Supreme Court Jurisprudence

The Supreme Court's decisions in cases like Bilski v. Kappos and Mayo Collaborative Servs. v. Prometheus Labs. have significantly narrowed the scope of patent-eligible subject matter. These decisions have made it more challenging to secure patents in fields like business methods and biotechnology, emphasizing the need for an inventive concept beyond mere abstract ideas[1].

USPTO Guidance

The USPTO's 2019 Guidance was a response to concerns about the patentability of AI and other emerging technologies. While this guidance has facilitated the allowance of more patent applications, it is not binding on courts and does not replace judicial precedent. The guidance has, however, led to an increase in the allowance rate for AI-related patents[1].

Legislative Efforts and Stakeholder Views

Proposed Legislation

There have been legislative efforts to reform the standards for patent-eligible subject matter. Bills like the Patent Eligibility Restoration Act of 2022 (PERA 2022) and the Restoring America’s Leadership in Innovation Act of 2021 (RALIA) aim to replace the Alice/Mayo framework with more defined and narrower exceptions. However, these efforts are ongoing, and the Supreme Court's reluctance to revisit Section 101 has led some stakeholders to call for congressional action[1].

Stakeholder Perspectives

Stakeholders have mixed views on the impact of the Alice/Mayo framework. Some argue it has hindered innovation by making it harder to secure patents in emerging fields, while others see it as necessary to prevent the patenting of abstract ideas. The USPTO's guidance has been seen as a positive step by some, but its non-binding nature leaves uncertainty[1].

Patent Term Adjustments and Obviousness-Type Double Patenting

Federal Circuit Rulings

The Federal Circuit's decision in In re Cellect highlights the importance of terminal disclaimers in preventing obviousness-type double patenting (ODP). This ruling emphasizes that patent owners must be proactive in disclaiming any term that could extend the patent term unjustifiably, underscoring the risks associated with receiving patent term adjustments without proper disclaimers[3].

Emerging Technologies and Patent Trends

Quantum Computing

The patent landscape in emerging fields like quantum computing is rapidly evolving. Studies on quantum computing patents reveal significant activity from both corporate entities and academic institutions. The scope of protection in these patents often includes hardware, software, and semiconductor levels. This field is characterized by a need for standardization and regulatory frameworks to ensure responsible innovation and to facilitate the development of industry standards[4].

Geographical and Organizational Trends

Global Patent Activity

The geographical distribution of patents, especially in emerging technologies, is influenced by geopolitical factors. Countries and organizations leading in quantum computing and AI are often those with robust innovation ecosystems and supportive regulatory environments. This trend is expected to continue, with patent activity serving as a valuable indicator of the pace and dynamics of innovation[4].

Sufficiency of Disclosure and Patent Quality

Empirical Studies

Empirical studies on patent quality, such as those examining quantum computing patents, highlight the importance of sufficiency of disclosure and the written description requirement. These studies compare patent disclosures against standards in engineering journals to assess their impact on follow-on innovations. Ensuring high-quality patents is crucial for maintaining the integrity of the patent system and fostering further innovation[4].

Key Takeaways

  • Patent-Eligible Subject Matter: The scope of patent-eligible subject matter is defined by Section 101 of the Patent Act but has been narrowed by judicial exceptions.
  • Claim Structure: Patent claims must be novel, non-obvious, and fully described, with recent trends showing an increase in claim complexity.
  • Judicial and Administrative Developments: The Alice/Mayo framework and USPTO guidance have significant implications for patent eligibility, especially in emerging technologies.
  • Legislative Efforts: Proposed legislation aims to reform patent-eligible subject matter standards, but the Supreme Court's reluctance to revisit Section 101 leaves uncertainty.
  • Patent Term Adjustments: Terminal disclaimers are crucial in preventing obviousness-type double patenting and ensuring the validity of patent claims.
  • Emerging Technologies: Quantum computing and AI patents are driving innovation, with a need for standardization and regulatory frameworks.

FAQs

Q: What are the four categories of patentable inventions under Section 101 of the Patent Act? A: The four categories are processes, machines, manufactures, and compositions of matter[1].

Q: How does the Alice/Mayo framework impact patent eligibility? A: The framework involves a two-step test to determine if a claim is directed to an ineligible concept and whether it contains an inventive concept that transforms it into a patent-eligible application[1].

Q: What is the significance of the USPTO's 2019 Guidance on patent eligibility? A: The guidance aimed to clarify the application of the Alice/Mayo framework, particularly for AI-related inventions, and has led to an increase in the allowance rate for such patents[1].

Q: What is obviousness-type double patenting (ODP), and why is it important? A: ODP is a doctrine that prevents a subsequent patent from being granted on the same invention as an earlier granted patent or an obvious modification thereof. It is crucial for preventing unjustified extensions of patent terms[3].

Q: How do geopolitical factors influence the development and patenting of quantum computing technologies? A: Geopolitical factors can influence the development and patenting of quantum computing by affecting the regulatory environment, funding, and collaboration opportunities, leading to variations in patent activity across different countries and organizations[4].

Sources

  1. Congressional Research Service, "Patent-Eligible Subject Matter Reform: An Overview," January 3, 2024.
  2. Google Patents, "US20110138338A1 - Patent Claims Analysis System and Method."
  3. Mintz, "Federal Circuit Puts the Onus on Patent Owners to Disclaim Patent Term Adjustments," August 28, 2023.
  4. Stanford Law School, "Quantum Leap: Decoding Quantum Computing Innovation."

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Details for Patent 10,022,427

ApplicantTradenameBiologic IngredientDosage FormBLAApproval DatePatent No.Expiredate
Recordati Rare Diseases, Inc. ELSPAR asparaginase For Injection 101063 January 10, 1978 10,022,427 2028-04-10
Genzyme Corporation CAMPATH alemtuzumab Injection 103948 May 07, 2001 10,022,427 2028-04-10
Genzyme Corporation LEMTRADA alemtuzumab Injection 103948 November 14, 2014 10,022,427 2028-04-10
>Applicant>Tradename>Biologic Ingredient>Dosage Form>BLA>Approval Date>Patent No.>Expiredate
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