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Last Updated: December 22, 2024

Patent: 10,172,922


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Summary for Patent: 10,172,922
Title:Rapid-acting insulin compositions
Abstract: The invention is a composition of human insulin or insulin analog that includes treprostinil and that has faster pharmacokinetic action than commercial formulations of existing insulin analog products.
Inventor(s): Christe; Michael Edward (Pendleton, IN), Hardy; Thomas Andrew (Carmel, IN)
Assignee: Eli Lilly and Company (Indianapolis, IN)
Application Number:15/259,101
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Claims and Patent Landscape of United States Patent 10,172,922

Introduction

United States Patent 10,172,922, like any other patent, must navigate the complex and evolving landscape of patent law in the U.S. This analysis will delve into the key aspects of the patent claims, the current state of patent-eligible subject matter, and the broader patent landscape that influences the validity and enforceability of such patents.

Understanding Patent-Eligible Subject Matter

The U.S. patent system is designed to encourage innovation, but the types of inventions that can be patented are subject to specific criteria. The statutory definition of patent-eligible subject matter under Section 101 of the Patent Act has remained largely unchanged for over two centuries. However, the scope of what is considered patent-eligible has fluctuated based on judicial decisions[1].

Judicially Developed Exceptions

The Supreme Court has established that "laws of nature, natural phenomena, and abstract ideas" are not patentable when claimed as such. These exceptions were further clarified in 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[1].

The Alice/Mayo Framework

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

Impact on Specific Technologies

The Alice/Mayo framework has particularly affected patents in areas such as computer software, business methods, and biotechnology. For instance, patents involving abstract ideas or natural phenomena without a significant inventive step are less likely to be granted or upheld[1].

Stakeholder Views and USPTO Guidance

Stakeholders have varying opinions on the impact of the Alice/Mayo framework on innovation and investment. In response to these concerns, the USPTO issued new guidance in 2019 to clarify how to apply the Alice/Mayo framework, which has been seen as lowering barriers to patentability, especially for computer-related inventions[1].

Patent Quality and Survival Rates

The quality of a patent, defined by its likelihood to survive post-grant validity challenges, is influenced by several factors. Patents prosecuted by large law firms, those with more words per claim, and pharmaceutical patents are more likely to survive inter partes review. Conversely, patents obtained by small entities, those assigned to examiners with higher allowance rates, and those with higher backward citation counts are less likely to survive[2].

Patent Assertion Entities (PAEs)

PAEs, often referred to as "patent trolls," play a significant role in the patent landscape. They can be categorized into Litigation PAEs and Portfolio PAEs, each with distinct business models. Litigation PAEs primarily generate revenue through lawsuits, while Portfolio PAEs negotiate licenses covering large portfolios of patents. PAEs often focus on ICT and software patents, asserting them against a broad range of industries[3].

Objective Application Review

To ensure the strength and defensibility of a patent, an objective application review is crucial. Tools like LexisNexis PatentOptimizer automate the review process, helping to identify clerical errors, ambiguous language, and other critical issues. This objective review can save time, reduce costs, and improve the quality of patent drafts[5].

Specific Analysis of United States Patent 10,172,922

Claim Structure and Subject Matter

To determine the patentability of the claims in U.S. Patent 10,172,922, one must apply the Alice/Mayo framework. If the claims are directed to an abstract idea or natural phenomenon, they must contain an inventive concept that transforms the claim into a patent-eligible application.

Technological Field

The technological field in which the patent operates is critical. For example, if the patent is in the area of computer software or biotechnology, it must comply with the stricter standards set by recent Supreme Court decisions.

Prosecution History

The prosecution history, including the involvement of large law firms and the number of words per claim, can influence the patent's likelihood of surviving post-grant challenges. Patents with more detailed claims and those prosecuted by experienced firms tend to fare better in reviews[2].

Examiner and Allowance Rates

The examiner's allowance rate and the specific technology classification can also impact the patent's survival. Patents assigned to examiners with lower allowance rates and those in technology fields with stricter scrutiny may face additional challenges[2].

Key Takeaways

  • Patent-Eligible Subject Matter: The scope of patent-eligible subject matter is defined by Section 101 and influenced by judicial decisions, particularly the Alice/Mayo framework.
  • Claim Structure: Claims must be carefully crafted to avoid being directed to ineligible concepts and must include an inventive concept if they are.
  • Technological Field: The technological field of the patent significantly affects its patentability and survival rates.
  • Prosecution History: The involvement of large law firms and the detail of claims can enhance a patent's chances of survival.
  • Objective Review: An objective application review using tools like LexisNexis PatentOptimizer is essential for ensuring the quality and defensibility of the patent.

FAQs

Q1: What is the Alice/Mayo framework, and how does it affect patent claims? The Alice/Mayo framework is a two-step test used to determine if a patent claim is directed to an ineligible concept (like an abstract idea or natural phenomenon) and if it contains an inventive concept that makes it patent-eligible.

Q2: How do Patent Assertion Entities (PAEs) impact the patent landscape? PAEs, or "patent trolls," assert patents to generate revenue, often through litigation or licensing large portfolios. They focus on ICT and software patents, affecting various industries.

Q3: What factors influence the quality and survival rate of a patent? Factors include the involvement of large law firms, the number of words per claim, the examiner's allowance rate, and the technological field of the patent.

Q4: Why is an objective application review important for patent drafts? An objective review helps identify errors, ambiguous language, and other issues, ensuring the patent draft is of high quality and defensible, thereby reducing future prosecution delays and costs.

Q5: How has the USPTO's 2019 guidance impacted patent applications? The 2019 guidance has clarified the application of the Alice/Mayo framework, particularly for computer-related inventions, leading to an increase in the allowance rate for such patents.

Sources

  1. Congressional Research Service, "Patent-Eligible Subject Matter Reform: An Overview" (December 4, 2024).
  2. Brian J. Love, Shawn P. Miller & Shawn Ambwani, "Determinants of Patent Quality: Evidence from Inter Partes Review Proceedings," 90 U. Colo. L. Rev. 67 (2019).
  3. Federal Trade Commission, "Patent Assertion Entity Activity: An FTC Study" (2016).
  4. Carley, Hegde, & Marco, "What Is the Probability of Receiving a US Patent?" (Yale Journal of Law and Technology).
  5. LexisNexis IP, "Patent Analysis Tools for Objective Application Review" (September 13, 2021).

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Details for Patent 10,172,922

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Eli Lilly And Company HUMALOG insulin lispro Injection 020563 June 14, 1996 ⤷  Subscribe 2034-05-08
Eli Lilly And Company HUMALOG insulin lispro Injection 020563 August 06, 1998 ⤷  Subscribe 2034-05-08
Eli Lilly And Company HUMALOG insulin lispro Injection 020563 September 06, 2007 ⤷  Subscribe 2034-05-08
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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