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Last Updated: December 25, 2024

Details for Patent: 10,137,127


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Which drugs does patent 10,137,127 protect, and when does it expire?

Patent 10,137,127 protects VITRAKVI and is included in one NDA.

This patent has seventy-five patent family members in thirty-seven countries.

Summary for Patent: 10,137,127
Title:Liquid formulations of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyri- midin-3-yl)-3-hydroxypyrrolidine-1-carboxamide
Abstract: A liquid formulation of (S)--N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)-pyrazolo[1,5-a]pyri- midin-3-yl)-3-hydroxypyrrolidine-1-carboxamide, pharmaceutically acceptable salts thereof, or a combination thereof and the use of the liquid formulation in the treatment of pain, cancer, inflammation, and certain infectious diseases are disclosed.
Inventor(s): Reynolds; Mark (Stamford, CT), Smith; Steven A. (Stamford, CT)
Assignee: Loxo Oncology, Inc. (Stamford, CT)
Application Number:15/622,544
Patent Claim Types:
see list of patent claims
Formulation; Compound;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 10,137,127

Introduction

The United States Patent 10,137,127, titled "Liquid formulations of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-4-fluorophenyl)-1,3,4-oxadiazol-2-yl)-N-methyl-2-pyrrolidinylmethyl)pyrazolo[1,5-a]pyrimidine-7-carboxamide," is a patent that covers specific liquid formulations of a pyrazolo[1,5-a]pyrimidine compound. This article will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

The patent, assigned the publication number US10137127B2, discloses liquid formulations of a specific pyrazolo[1,5-a]pyrimidine compound. This compound is asserted to be a Pim-kinase inhibitor, which has potential applications in the treatment of various diseases, including cancer[4].

Claims Analysis

Independent and Dependent Claims

The patent includes both independent and dependent claims. Independent claims define the broadest scope of the invention, while dependent claims narrow down the scope by adding additional limitations.

  • Independent Claims: These claims outline the core components of the liquid formulations, including the specific chemical structure of the pyrazolo[1,5-a]pyrimidine compound and the formulation ingredients.
  • Dependent Claims: These claims build upon the independent claims by specifying particular aspects such as the concentration of the active ingredient, the type of solvents used, and other formulation details.

Claim Scope and Patent Quality

The scope of the claims is crucial in determining the patent's validity and enforceability. Research has shown that narrower claims at publication are associated with a higher probability of grant and a shorter examination process than broader claims. This suggests that the claims in US10137127B2, if narrowly defined, would likely have undergone a more efficient examination process[3].

Patent Scope Metrics

To assess the scope of the patent, metrics such as independent claim length and independent claim count can be used. These metrics help in understanding the breadth and clarity of the patent claims.

  • Independent Claim Length: Longer independent claims often indicate more detailed and specific descriptions of the invention, which can reduce the likelihood of overly broad patents.
  • Independent Claim Count: A higher number of independent claims can suggest a broader scope, but it also increases the complexity and potential for ambiguity in the patent[3].

Patent Landscape and Litigation Trends

Recent Trends in Patent Litigation

The landscape of patent litigation has seen significant changes, particularly with the enactment of the Leahy-Smith America Invents Act (AIA) in 2011. This act introduced changes that affected the number of defendants in patent infringement lawsuits, leading to an increase in the number of lawsuits filed. For instance, from 2007 to 2011, the number of overall defendants in patent infringement lawsuits increased by about 129 percent, with software-related patents accounting for a significant portion of this increase[1].

Role of Nonpracticing Entities (NPEs)

Nonpracticing entities (NPEs), often referred to as "patent trolls," play a significant role in patent litigation. In the period from 2007 to 2011, NPEs brought about a fifth of all patent infringement lawsuits. This trend highlights the importance of carefully drafting and managing patent claims to avoid unnecessary litigation[1].

Reissue Claims and the Original Patent Requirement

In cases where reissue claims are sought, the "original patent" requirement under 35 U.S.C. § 251 is crucial. This requirement mandates that reissue claims must be directed to the invention disclosed in the original patent. Any attempt to broaden the scope of the claims beyond what was originally disclosed can lead to the rejection of the reissue claims, as seen in the case of In Re FLOAT'N'GRILL LLC[5].

Practical Implications for Patent Holders

For patent holders, understanding the scope and claims of their patents is vital for several reasons:

  • Enforceability: Narrow and clear claims are more likely to be enforceable in court.
  • Licensing and Collaboration: Well-defined claims facilitate easier licensing and collaboration agreements.
  • Litigation Avoidance: Clear and specific claims reduce the risk of patent infringement lawsuits.

Regulatory and Examination Process

The U.S. Patent and Trademark Office (USPTO) plays a critical role in the examination and granting of patents. The USPTO has been working to improve patent quality by adapting to developments in patent law and industry. However, there is a need for the USPTO to link trends in patent infringement litigation to internal data on the patent examination process to further enhance the quality of issued patents[1].

Conclusion

Understanding the scope and claims of United States Patent 10,137,127 involves a detailed analysis of the patent's independent and dependent claims, as well as the broader patent landscape. The use of metrics such as independent claim length and count can help in assessing the patent's breadth and clarity. The recent trends in patent litigation, the role of NPEs, and the regulatory environment all contribute to the complexity of managing and enforcing patents.

Key Takeaways

  • Clear and Narrow Claims: These are more likely to be granted and enforced.
  • Patent Litigation Trends: Changes in laws and increased activity by NPEs impact the patent landscape.
  • Regulatory Environment: The USPTO's efforts to improve patent quality are ongoing.
  • Reissue Claims: Must adhere to the "original patent" requirement.
  • Practical Implications: Well-defined claims are crucial for enforceability, licensing, and litigation avoidance.

FAQs

  1. What is the main subject of United States Patent 10,137,127?

    • The patent covers liquid formulations of a specific pyrazolo[1,5-a]pyrimidine compound, which is a Pim-kinase inhibitor.
  2. How do independent and dependent claims differ in a patent?

    • Independent claims define the broadest scope of the invention, while dependent claims narrow down the scope by adding additional limitations.
  3. What metrics can be used to assess the scope of a patent?

    • Metrics such as independent claim length and independent claim count can be used to assess the scope and clarity of the patent claims.
  4. How has the Leahy-Smith America Invents Act (AIA) impacted patent litigation?

    • The AIA has led to an increase in the number of patent infringement lawsuits, particularly by limiting the number of defendants in a single lawsuit.
  5. What is the "original patent" requirement in reissue claims?

    • Reissue claims must be directed to the invention disclosed in the original patent, as mandated by 35 U.S.C. § 251.

Sources

  1. GAO - Assessing Factors That Affect Patent Infringement Litigation
  2. U.S. Patent and Trademark Office (USPTO) | USAGov
  3. Patent Claims and Patent Scope - Search eLibrary :: SSRN
  4. US10137127B2 - Liquid formulations of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-4-fluorophenyl)-1,3,4-oxadiazol-2-yl)-N-methyl-2-pyrrolidinylmethyl)pyrazolo[1,5-a]pyrimidine-7-carboxamide
  5. In Re FLOAT'N'GRILL LLC - Court of Appeals for the Federal Circuit

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Drugs Protected by US Patent 10,137,127

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bayer Healthcare VITRAKVI larotrectinib sulfate SOLUTION;ORAL 211710-001 Nov 26, 2018 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 10,137,127

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 108090 ⤷  Subscribe
Australia 2017246547 ⤷  Subscribe
Australia 2017246554 ⤷  Subscribe
Brazil 112018070017 ⤷  Subscribe
Brazil 112018070304 ⤷  Subscribe
Canada 3019661 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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