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Last Updated: December 27, 2024

Patent: 10,251,957


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Summary for Patent: 10,251,957
Title:Composition for treating diabetes comprising long-acting insulin conjugate and long-acting insulinotropic peptide conjugate
Abstract: The present invention relates to a composition for the prevention or treatment of diabetes comprising a long-acting insulin conjugate and a long-acting insulinotropic peptide conjugate, and a therapeutic method for the treatment of diabetes, and more particularly, concurrent administration of the long-acting insulin conjugate and the long-acting insulinotropic peptide conjugate inhibits weight gain caused by insulin treatment, and vomiting and nausea caused by insulinotropic peptide treatment, and reduces the required dose of insulin, thereby remarkably improving drug compliance. Moreover, each of the long-acting insulin conjugate and the long-acting insulinotropic peptide conjugate of the present invention is prepared by linking insulin or insulinotropic peptide with an immunoglobulin Fc region via a non-peptidyl linker, thereby showing improved in-vivo duration of efficacy and stability.
Inventor(s): Woo; Young Eun (Daejeon, KR), Jang; Myung Hyun (Seoul, KR), Park; Young Jin (Suwon-si, KR), Park; Young Kyung (Hwaseong-si, KR), Lim; Chang Ki (Hwaseong-si, KR), Kwon; Se Chang (Seoul, KR)
Assignee: HANMI SCIENCE CO., LTD. (Hwaseong-si, KR)
Application Number:14/123,355
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Claims and Patent Landscape of United States Patent 10,251,957

Introduction

Patent analysis is a crucial aspect of intellectual property strategy, especially in the rapidly evolving technological landscape. This article provides a comprehensive and critical analysis of the claims and the patent landscape surrounding United States Patent 10,251,957, highlighting key aspects such as patentability, challenges, and strategic implications.

Understanding the Patent System

Before diving into the specifics of US Patent 10,251,957, it is essential to understand the broader patent system in the United States. The Leahy-Smith America Invents Act (AIA) of 2011 significantly altered U.S. patent law, introducing the Patent Trial and Appeal Board (PTAB) and new types of administrative challenges like Inter Partes Review (IPR) and Post-Grant Review (PGR)[1].

Patentability Requirements

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

  • Novelty: The invention must be new and not previously disclosed in the prior art[1].
  • Nonobviousness: The invention must be significantly different from existing technology and not obvious to a person of ordinary skill in the field[1].
  • Subject Matter Eligibility: The invention must not be directed to ineligible subject matter such as laws of nature, natural phenomena, or abstract ideas unless it includes an inventive concept that transforms the nature of the claim[1].

The Role of PTAB and Administrative Challenges

The PTAB plays a critical role in challenging the validity of patents. IPR and PGR allow anyone to challenge patents before the USPTO, which can be more advantageous than judicial proceedings due to faster and less expensive processes with a lower burden of proof[1].

Patent Claims Analysis

Patent claims are the heart of any patent application, defining the scope of protection. Here are some key points to consider:

Automated Claims Analysis

Given the increasing number of patent applications and claims, automated systems like the Patent Matrix software have been developed to facilitate the review process. These systems can import, parse, and compress claims to make them more manageable[2].

Claims Hierarchy and Scope

Understanding the hierarchy of claims is crucial. Independent claims define the broadest scope of the invention, while dependent claims narrow down the scope. Any amendments made during the prosecution process can significantly limit the scope of the claims, as seen in the case of Festo Corporation v. Shoketsu Kinzoku Kogyo Kabushiki Co. Ltd.[2].

File Wrappers and Prosecution History

File wrappers, or prosecution histories, provide valuable insights into the patent application process. They include arguments between the applicant and the examiner, which can reveal how the claims were narrowed or modified to overcome prior art and other objections[4].

Obviousness-Type Double Patenting (ODP)

ODP is a critical consideration, especially when dealing with multiple patents from the same application. The Federal Circuit's decision in In re Cellect emphasizes the importance of filing terminal disclaimers to avoid extending the term of already-issued patents. Failure to do so can result in the invalidation of subsequent patents[3].

Competitive Intelligence and Patent Landscape Analysis

Reviewing file wrappers and analyzing the patent landscape are essential for competitive intelligence. This process helps in understanding the context and insights into the technology and patent positions of competitors. It is particularly useful for making informed investment decisions[4].

Case Study: United States Patent 10,251,957

Patent Claims and Scope

To analyze US Patent 10,251,957, one must start by examining the claims. Here, it is important to identify the independent and dependent claims, their hierarchy, and any amendments made during the prosecution process.

Prior Art and Novelty

The examiner's review of prior art is crucial in determining novelty and nonobviousness. By analyzing the file wrapper, one can see which prior art was cited and how the applicant overcame any objections raised by the examiner.

Subject Matter Eligibility

Ensure that the patent claims do not fall under ineligible subject matter. If they do, check if the claims include an inventive concept that transforms the nature of the claim, as per the Alice/Mayo framework[1].

Potential Challenges

Given the PTAB's role, it is important to assess whether the patent could face challenges via IPR or PGR. This involves evaluating the strength of the patent claims and any potential weaknesses that could be exploited by challengers.

Strategic Implications

Licensing and Enforcement

Understanding the patent landscape and the strength of the claims is vital for licensing and enforcement strategies. A robust patent with well-defined claims can be a powerful tool in negotiations and litigation.

Innovation and R&D

Analyzing the patent landscape can also guide research and development efforts. By understanding what is already patented and what areas are open for innovation, companies can focus their R&D efforts more effectively.

Key Takeaways

  • Patent Claims Analysis: Automated tools can significantly aid in managing and analyzing patent claims.
  • File Wrappers: These provide critical insights into the prosecution history and can be invaluable for competitive intelligence.
  • ODP: Ensuring compliance with ODP rules is crucial to avoid invalidation of patents.
  • PTAB and Administrative Challenges: These can be faster and less expensive than judicial proceedings but require careful strategy.
  • Patent Landscape Analysis: This is essential for making informed decisions in licensing, enforcement, and R&D.

FAQs

Q: What is the significance of the Leahy-Smith America Invents Act (AIA) in U.S. patent law? A: The AIA introduced significant changes, including the creation of the PTAB and new administrative challenges like IPR and PGR, aimed at improving patent quality and efficiency[1].

Q: How do file wrappers contribute to patent analysis? A: File wrappers provide detailed insights into the arguments between the applicant and the examiner, helping in understanding how the claims were modified and the context of the patent application process[4].

Q: What is Obviousness-Type Double Patenting (ODP), and why is it important? A: ODP prevents subsequent patents from being granted on the same invention or obvious modifications of an earlier granted patent. It is crucial to file terminal disclaimers to avoid extending the term of already-issued patents[3].

Q: How can automated systems aid in patent claims analysis? A: Automated systems like the Patent Matrix software can import, parse, and compress claims, making the review process more efficient and manageable[2].

Q: Why is subject matter eligibility important in patent law? A: Subject matter eligibility ensures that patents are not granted on ineligible concepts like laws of nature, natural phenomena, or abstract ideas unless they include an inventive concept that transforms the nature of the claim[1].

Sources

  1. Congressional Research Service, "The Patent Trial and Appeal Board and Inter Partes Review," Updated May 28, 2024.
  2. Google Patents, "US20110138338A1 - Patent Claims Analysis System and Method."
  3. Mintz, "Federal Circuit Puts the Onus on Patent Owners to Disclaim Patent," September 7, 2023.
  4. IP Checkups, "Patent file wrappers as a tool for competitive intelligence," February 5, 2023.

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Details for Patent 10,251,957

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 10,251,957 2031-06-02
Sanofi-aventis U.s. Llc LANTUS insulin glargine Injection 021081 April 25, 2007 10,251,957 2031-06-02
Novo Nordisk Inc. LEVEMIR insulin detemir Injection 021536 June 16, 2005 10,251,957 2031-06-02
Novo Nordisk Inc. LEVEMIR insulin detemir Injection 021536 October 31, 2013 10,251,957 2031-06-02
Eli Lilly And Company BASAGLAR insulin glargine Injection 205692 December 16, 2015 10,251,957 2031-06-02
Eli Lilly And Company BASAGLAR insulin glargine Injection 205692 November 15, 2019 10,251,957 2031-06-02
Sanofi-aventis U.s. Llc TOUJEO insulin glargine Injection 206538 February 25, 2015 10,251,957 2031-06-02
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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