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Last Updated: May 20, 2025

Details for Patent: 10,323,001


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Which drugs does patent 10,323,001 protect, and when does it expire?

Patent 10,323,001 protects KLISYRI and is included in one NDA.

This patent has thirty-four patent family members in thirteen countries.

Summary for Patent: 10,323,001
Title:Compositions for modulating a kinase cascade and methods of use thereof
Abstract: The invention relates to compositions comprising 2-(5-(4-(2-morpholinoethoxy)phenyl) pyridin-2-yl)-N-benzylacetamide and its mesylate and dihydrochloride salts. The invention provides an efficient process for the synthesis of 2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl)-N-benzylacetamide and its mesylate and dihydrochloride salts and methods for modulating one or more components of a kinase cascade using the compositions of the invention. The present invention also provides a novel polymorph of the mesylate salt of 2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl)-N-benzylacetamide (Form A), characterized by a unique X-ray diffraction pattern and Differential Scanning Calorimetry profile, as well as a unique crystalline structure.
Inventor(s): Hangauer, Jr.; David G. (Lancaster, NY), Patra; Debasis (Manlius, NY), Cody; Jeremy A. (Clifton Springs, NY), Palmer; Grant J. (Nashville, TN), Isbester; Paul K. (Castleton on Hudson, NY), Salsbury; Jonathon (Madison, WI)
Assignee: Athenex, Inc. (Buffalo, NY)
Application Number:15/387,322
Patent Claim Types:
see list of patent claims
Composition; Compound;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 10,323,001

Introduction

United States Patent 10,323,001, titled "Compositions for modulating a kinase cascade and methods of use thereof," was granted to Athenex in June 2019. This patent is a significant development in the field of pharmaceuticals, particularly in the area of kinase modulation. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape.

Patent Overview

Patent Title and Assignee The patent, assigned to Athenex, focuses on compositions and methods for modulating kinase cascades. Kinases are enzymes that play crucial roles in various cellular processes, and their dysregulation is often associated with diseases such as cancer and inflammatory disorders[5].

Scope of the Patent

Technical Field The patent falls within the technical field of biochemistry and pharmacology, specifically targeting the modulation of kinase cascades. This involves the development of compositions that can either activate or inhibit specific kinases to achieve therapeutic effects.

Background of the Invention The background section of the patent highlights the importance of kinases in cellular signaling pathways and the need for targeted therapies to modulate these pathways. It also discusses existing challenges and limitations in current treatments, setting the stage for the innovative solutions presented in the patent.

Claims of the Patent

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 typically describe the core components of the invention, such as the specific compositions and methods for modulating kinase cascades.
  • Dependent Claims: These build upon the independent claims by specifying particular aspects, such as the types of kinases targeted, the dosage forms of the compositions, and the methods of administration.

Claim Language and Scope

Metrics for Measuring Patent Scope Research has shown that the scope of a patent can be measured using metrics such as independent claim length and independent claim count. Narrower claims, as indicated by shorter lengths and fewer counts, are often associated with a higher probability of grant and a shorter examination process[3].

Examination Process

Patent Examination Data System (PEDS) The examination process for Patent 10,323,001 can be analyzed using the Patent Examination Data System (PEDS), which provides public access to bibliographic data for patent applications. This system allows users to track the progression of the patent application, including any office actions and responses[4].

Patent Landscape

Prior Art and Citation Data To understand the patent landscape surrounding Patent 10,323,001, it is crucial to analyze prior art and citation data. Tools like the Common Citation Document (CCD) and the Global Dossier provide comprehensive views of prior art cited by various patent offices, helping to identify the novelty and non-obviousness of the invention[4].

Competitors and Related Patents A thorough search of existing patents in the same field can reveal competitors and related inventions. Databases such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO) are invaluable resources for this purpose[4].

International Patent Considerations

Global Patent System Given the global nature of pharmaceutical research and development, it is essential to consider the international patent landscape. The Global Dossier and other international patent databases help in assessing the patent family for a specific application, including related applications filed at participating IP offices[4].

Litigation and Enforcement

Small Claims Patent Court In the event of disputes or infringement, the concept of a small claims patent court, as studied by the Administrative Conference of the United States (ACUS), could provide a more streamlined and cost-effective mechanism for resolving patent issues. This would be particularly beneficial for smaller entities and individual inventors[2].

Economic and Social Impact

Innovation and Licensing Costs The quality and scope of patents, including Patent 10,323,001, can significantly impact innovation and licensing costs. Narrower, clearer patents tend to reduce licensing and litigation costs, thereby encouraging further innovation in the field[3].

Expert Insights

Industry Experts' Views Industry experts and legal practitioners, such as those involved in the ACUS study, emphasize the importance of well-defined patent scope and clear claim language. For example, Andrei Iancu, former Undersecretary of Commerce for IP and Director of the USPTO, has highlighted the need for high-quality patents that do not overly broaden the scope of protection[2].

Conclusion

Understanding the scope and claims of United States Patent 10,323,001 involves a detailed analysis of the patent's technical field, claim language, and the broader patent landscape. This includes examining the metrics for measuring patent scope, the examination process, and international patent considerations.

Key Takeaways

  • Patent Scope: Measured using metrics like independent claim length and count.
  • Claim Language: Narrower claims are associated with higher grant probabilities and shorter examination processes.
  • Patent Landscape: Analyze prior art and citation data using tools like CCD and Global Dossier.
  • International Considerations: Assess the global patent family and related applications.
  • Litigation and Enforcement: Potential benefits of a small claims patent court for dispute resolution.
  • Economic Impact: Clearer patents reduce licensing and litigation costs, promoting innovation.

FAQs

Q1: What is the main focus of United States Patent 10,323,001? The main focus of this patent is on compositions and methods for modulating kinase cascades, particularly for therapeutic applications.

Q2: How can the scope of a patent be measured? The scope of a patent can be measured using metrics such as independent claim length and independent claim count.

Q3: What tools are available for searching prior art and citation data? Tools like the Common Citation Document (CCD) and the Global Dossier are available for searching prior art and citation data.

Q4: Why is the clarity of patent claims important? Clear patent claims reduce licensing and litigation costs, thereby encouraging innovation by providing clear boundaries of protection.

Q5: What is the potential benefit of a small claims patent court? A small claims patent court could provide a more streamlined and cost-effective mechanism for resolving patent disputes, particularly beneficial for smaller entities and individual inventors.

Sources

  1. BitLaw: Patent Law in the United States.
  2. ACUS: U.S. Patent Small Claims Court.
  3. Hoover Institution: Patent Claims and Patent Scope.
  4. USPTO: Search for patents.
  5. Golden: US Patent 10323001 Compositions for modulating a kinase cascade and methods of use thereof.

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Drugs Protected by US Patent 10,323,001

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Almirall KLISYRI tirbanibulin OINTMENT;TOPICAL 213189-001 Dec 14, 2020 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
>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 10,323,001

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2007340350 ⤷  Try for Free
Australia 2008254500 ⤷  Try for Free
Canada 2673974 ⤷  Try for Free
Canada 2686267 ⤷  Try for Free
China 101616915 ⤷  Try for Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.