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Last Updated: December 23, 2024

Patent: 10,005,847


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Summary for Patent: 10,005,847
Title:Anti-HER2 glycoantibodies and uses thereof
Abstract: The present disclosure relates to a novel class of anti-HER2 monoclonal antibodies comprising a homogeneous population of anti-HER2 IgG molecules having the same N-glycan on each of Fc. The antibodies of the invention can be produced from anti-HER2 monoclonal antibodies by Fc glycoengineering. Importantly, the antibodies of the invention have improved therapeutic values with increased ADCC activity and increased Fc receptor binding affinity compared to the corresponding monoclonal antibodies that have not been glycoengineered.
Inventor(s): Wong; Chi-Huey (Rancho Santa Fe, CA), Wu; Chung-Yi (New Taipei, TW)
Assignee: ACADEMIA SINICA (Taipei, TW)
Application Number:14/723,181
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive Analysis of the Claims and Patent Landscape for United States Patent 10,005,847

Introduction

Understanding the patent landscape and the validity of specific patent claims is crucial for inventors, businesses, and legal professionals. This analysis will delve into the key aspects of United States Patent 10,005,847, focusing on patent-eligible subject matter, the patentability criteria, recent judicial and administrative developments, and the implications of these factors on the patent's validity and enforcement.

Patent-Eligible Subject Matter

Overview of Section 101 of the Patent Act

The patentability of an invention is governed by Section 101 of the Patent Act (35 U.S.C. ยง101), which defines patent-eligible subject matter as "any new and useful process, machine, manufacture, or composition of matter"[1].

Judicially Developed Exceptions

The Supreme Court has established implicit exceptions to patent-eligible subject matter, including "laws of nature, natural phenomena, and abstract ideas" when claimed as such. Recent Supreme Court decisions, such as Bilski v. Kappos, Mayo Collaborative Servs. v. Prometheus Labs., Association for Molecular Pathology v. Myriad Genetics, and Alice Corp. Pty. v. CLS Bank, have narrowed the scope of patent-eligible subject matter, particularly affecting areas like computer software, business methods, and biotechnology[1].

The Alice/Mayo Framework

Two-Step Test for Patentable Subject Matter

The Supreme Court's decisions have led to the establishment of the Alice/Mayo test, a two-step framework for determining patentable subject matter. The first step assesses whether the patent claims are directed to an ineligible concept (e.g., an abstract idea). If they are, the second step evaluates whether the claims contain an inventive concept that transforms the nature of the claim into a patent-eligible application[1].

Patentability Criteria

Novelty, Nonobviousness, Utility, and Enablement

For a patent to be granted, the invention must meet several criteria:

  • Novelty: The invention must be new and not anticipated by prior art.
  • Nonobviousness: The invention must be significantly different from existing technology.
  • Utility: The invention must have a practical application.
  • Enablement: The patent application must provide sufficient information for a person skilled in the art to make and use the invention[5].

Prior Art Search and Analysis

Importance of Prior Art

A thorough prior art search is essential to determine the novelty and nonobviousness of the invention. This involves reviewing existing patents, publications, and other relevant materials to identify any overlap with the claimed invention. Any overlap can anticipate the novelty or render the claim obvious, affecting the patent's validity[5].

Recent Judicial and Administrative Developments

USPTO Guidance and Federal Circuit Decisions

In 2019, the USPTO issued new guidance to clarify the application of the Alice/Mayo framework, which has been seen to lower Section 101 barriers to patentability, especially for computer-related inventions. However, this guidance is not binding on courts and does not change the legal landscape significantly[1].

The Federal Circuit's decision in In re Cellect highlights the importance of addressing obviousness-type double patenting (ODP) and the need for patent owners to disclaim patent terms to avoid invalidation of subsequent patents. This ruling emphasizes the vigilance required in managing patent portfolios to avoid unintended extensions of patent terms[2].

Stakeholder Views and Implications

Impact on Innovation and Investment

Stakeholders have varying views on whether the current patent-eligible subject matter jurisprudence encourages or discourages innovation. Some argue that the narrowed scope of patent-eligible subject matter hinders investment in emerging technologies, while others see it as a necessary measure to prevent the patenting of abstract ideas and natural phenomena[1].

Case Study: United States Patent 10,005,847

Claim Analysis

To analyze the claims of United States Patent 10,005,847, one must:

  • Review Invention Disclosure: Understand the invention's details and the claims drafted from the disclosure.
  • Perform Prior Art Search: Identify any existing patents or publications that may overlap with the claimed invention.
  • Assess Novelty and Nonobviousness: Determine if the claims are anticipated by prior art or if they are obvious variations of existing technology.
  • Evaluate Utility and Enablement: Ensure the invention has a practical application and that the patent application provides sufficient information for its implementation[5].

Example Analysis

Assuming the patent in question involves a method or device related to computer software or biotechnology, the analysis would focus on:

  • Whether the claims are directed to an abstract idea or natural phenomenon.
  • If the claims contain an inventive concept that transforms the nature of the claim.
  • The presence of any prior art that anticipates the novelty or renders the claim obvious.
  • The utility and enablement of the invention as described in the patent application.

Key Takeaways

  • Patent-Eligible Subject Matter: The scope of what can be patented is defined by Section 101 of the Patent Act and has been narrowed by recent Supreme Court decisions.
  • Alice/Mayo Framework: A two-step test to determine if patent claims are directed to an ineligible concept and if they contain an inventive concept.
  • Prior Art Search: Crucial for determining novelty and nonobviousness.
  • USPTO Guidance and Federal Circuit Decisions: Recent developments that clarify and enforce patentability standards.
  • Stakeholder Views: Varied opinions on the impact of current jurisprudence on innovation and investment.

FAQs

What is the significance of Section 101 of the Patent Act?

Section 101 defines what types of inventions are eligible for patent protection, including processes, machines, manufactures, and compositions of matter.

How does the Alice/Mayo framework impact patent claims?

The Alice/Mayo framework is a two-step test that determines if patent claims are directed to an ineligible concept and if they contain an inventive concept that makes them patent-eligible.

Why is prior art search important in patentability analysis?

A prior art search helps determine the novelty and nonobviousness of an invention by identifying any existing patents or publications that may overlap with the claimed invention.

What is the impact of USPTO guidance on patent applications?

The 2019 USPTO guidance has clarified how to apply the Alice/Mayo framework, potentially lowering barriers to patentability for certain types of inventions, especially those related to computer software.

How does obviousness-type double patenting affect patent validity?

Obviousness-type double patenting can lead to the invalidation of subsequent patents if they are not distinguished from earlier patents or if terminal disclaimers are not filed to avoid extending the patent term unjustly.

Cited Sources

  1. Congressional Research Service, "Patent-Eligible Subject Matter Reform: An Overview," January 3, 2024.
  2. Mintz, "Federal Circuit Puts the Onus on Patent Owners to Disclaim Patent," September 7, 2023.
  3. LexisNexis, "Chisum on Patents," 1978.
  4. Unified Patents Portal, "WO-2010009271-A2," n.d.
  5. InterSECT Job Simulations, "IP: Patentability Analysis," n.d.

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Details for Patent 10,005,847

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Genentech, Inc. HERCEPTIN trastuzumab For Injection 103792 September 25, 1998 10,005,847 2034-05-27
Genentech, Inc. HERCEPTIN trastuzumab For Injection 103792 February 10, 2017 10,005,847 2034-05-27
Genentech, Inc. HERCEPTIN HYLECTA trastuzumab and hyaluronidase-oysk Injection 761106 February 28, 2019 10,005,847 2034-05-27
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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