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Last Updated: December 22, 2024

Patent: 10,117,909


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Summary for Patent: 10,117,909
Title:Combination of an insulin and a GLP-1 agonist
Abstract: The invention relates to a drug comprising at least one insulin and at least one GLP-1 receptor agonist.
Inventor(s): Werner; Ulrich (Frankfurt am Main, DE), Rotthauser; Barbel (Frankfurt am Main, DE)
Assignee: SANOFI-AVENTIS DEUTSCHLAND GMBH (Frankfurt am Main, DE)
Application Number:15/340,969
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Patent Landscape for United States Patent 10,117,909

Introduction

Patent law in the United States is a complex and evolving field, particularly when it comes to determining what constitutes patent-eligible subject matter. This analysis will delve into the specifics of United States Patent 10,117,909, examining its claims, the broader patent landscape, and the critical factors that influence its validity and enforceability.

Understanding Patent-Eligible Subject Matter

To begin, it is crucial to understand what types of inventions can be patented under U.S. law. Section 101 of the Patent Act (35 U.S.C. ยง101) outlines 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 are transformed into a patent-eligible application[1].

The Alice/Mayo Framework

The Supreme Court's decisions in cases 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 significantly shaped the landscape of patent-eligible subject matter. The Alice/Mayo test is a two-step process:

  • Step 1: Determine if the patent claims are directed to an ineligible concept (law of nature, natural phenomenon, or abstract idea).
  • Step 2: If directed to an ineligible concept, assess whether the claims contain an inventive concept that transforms the nature of the claim into a patent-eligible application[1].

Patent 10,117,909: An Overview

Without specific details on the patent itself, we can still analyze the general principles that would apply. Here are some key points to consider:

Novelty Requirement

For a patent to be granted, the claimed invention must be novel, meaning it must not have been patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention[2].

Nonobviousness Requirement

The invention must also be nonobvious, meaning it must be significantly different from existing technology and not obvious to a person of ordinary skill in the relevant field[2].

Usefulness Requirement

The invention must be useful, which is generally considered a low bar but is still a requirement for patentability[2].

Examination Process

The U.S. Patent and Trademark Office (USPTO) examines patent applications to ensure they meet the requirements of novelty, nonobviousness, and usefulness. The examiner reviews prior art to determine if the claims overcome the technical features disclosed in the prior art. If rejected, the applicant may narrow or limit the scope of the submitted claims to satisfy the examiner's arguments[3].

Inter Partes Review (IPR)

IPR is a post-grant proceeding before the PTAB where a third party can challenge the validity of at least one claim of an issued patent. The grounds for invalidity can be anticipation or obviousness, and the petition must demonstrate a reasonable likelihood of success. IPR proceedings have a lower standard of proof (preponderance of the evidence) compared to district court proceedings (clear and convincing evidence)[5].

Impact of Recent Guidance

In 2019, the USPTO issued new guidance to clarify how to apply the Alice/Mayo framework, which has been perceived as lowering Section 101 barriers to patentability, especially for computer-related inventions. This guidance has led to an increase in the allowance rate for patent applications containing AI-related claims, although it is not binding on courts when issued patents are challenged in litigation[1].

Stakeholder Views

Stakeholders have varying views on the impact of the Alice/Mayo framework on innovation. Some argue it has negatively affected investment in technology by narrowing the scope of patent-eligible subject matter, while others see it as a necessary measure to prevent the patenting of abstract ideas and natural phenomena[1].

Competitive Intelligence and Patent File Wrappers

Reviewing patent file wrappers can provide valuable insights into the patent application process and the examiner's reasoning. This can be particularly useful for competitive intelligence and technology landscape analysis, helping to understand the strengths and weaknesses of a patent application[3].

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 shaped by Supreme Court decisions.
  • Alice/Mayo Framework: A two-step test to determine if a patent claim is directed to an ineligible concept and if it contains an inventive concept.
  • Novelty, Nonobviousness, and Usefulness: Essential requirements for patentability.
  • Examination Process: USPTO examiners review prior art to ensure claims meet patentability requirements.
  • Inter Partes Review: A post-grant proceeding to challenge the validity of issued patent claims.
  • Recent Guidance: The 2019 USPTO guidance has clarified the application of the Alice/Mayo framework, particularly for AI-related inventions.

FAQs

Q: What are the four categories of patentable inventions under U.S. law? A: The four categories are processes, machines, manufactures, and compositions of matter[1].

Q: What is the Alice/Mayo test, and how does it impact patent eligibility? A: The Alice/Mayo test is a two-step process to determine if a patent claim is directed to an ineligible concept and if it contains an inventive concept. It has narrowed the scope of patent-eligible subject matter, particularly in areas like computer software and biotechnology[1].

Q: What is Inter Partes Review (IPR), and how does it differ from district court proceedings? A: IPR is a post-grant proceeding before the PTAB to challenge the validity of issued patent claims. It differs from district court proceedings in its lower standard of proof (preponderance of the evidence) and more limited discovery process[5].

Q: How has the 2019 USPTO guidance impacted patent applications? A: The guidance has clarified the application of the Alice/Mayo framework, leading to an increase in the allowance rate for patent applications containing AI-related claims[1].

Q: What role do patent file wrappers play in competitive intelligence? A: Patent file wrappers provide important context and insights into the patent application process, helping with technology landscape analysis and competitive intelligence[3].

Sources

  1. Congressional Research Service. Patent-Eligible Subject Matter Reform: An Overview. January 3, 2024.
  2. Congressional Research Service. The Patent Trial and Appeal Board and Inter Partes Review. Updated May 28, 2024.
  3. IP Checkups. Patent file wrappers as a tool for competitive intelligence. February 5, 2023.
  4. Supreme Court of the United States. Patent And Trademark Office v. Booking.com B.V. June 30, 2020.
  5. Maier & Maier. Inter Partes Review (IPR). Accessed December 20, 2024.

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Details for Patent 10,117,909

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Sanofi-aventis U.s. Llc LANTUS insulin glargine Injection 021081 April 20, 2000 10,117,909 2028-10-17
Sanofi-aventis U.s. Llc LANTUS insulin glargine Injection 021081 April 25, 2007 10,117,909 2028-10-17
Eli Lilly And Company BASAGLAR insulin glargine Injection 205692 December 16, 2015 10,117,909 2028-10-17
Eli Lilly And Company BASAGLAR insulin glargine Injection 205692 November 15, 2019 10,117,909 2028-10-17
Sanofi-aventis U.s. Llc TOUJEO insulin glargine Injection 206538 February 25, 2015 10,117,909 2028-10-17
Sanofi-aventis U.s. Llc TOUJEO insulin glargine Injection 206538 March 26, 2018 10,117,909 2028-10-17
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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