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Last Updated: May 17, 2025

Details for Patent: 10,017,536


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Which drugs does patent 10,017,536 protect, and when does it expire?

Patent 10,017,536 protects KORSUVA and is included in one NDA.

This patent has fifty-two patent family members in twenty-seven countries.

Summary for Patent: 10,017,536
Title:Synthetic peptide amides and dimers thereof
Abstract: The invention relates to synthetic peptide amide ligands of the kappa opioid receptor and particularly to agonists of the kappa opioid receptor that exhibit low P.sub.450 CYP inhibition and low penetration into the brain. The synthetic peptide amides of the invention conform to the structure: ##STR00001## The compounds are useful in the prophylaxis and treatment of pain and inflammation associated with a variety of diseases and conditions.
Inventor(s): Schteingart; Claudio D. (San Diego, CA), Menzaghi; Frederique (Rye, NY), Jiang; Guangcheng (San Diego, CA), Alexander; Roberta Vezza (San Diego, CA), Sueiras-Diaz; Javier (La Jolla, CA), Spencer; Robert H. (New Hope, PA), Chalmers; Derek T. (Riverside, CT), Luo; Zhiyong (New City, NY)
Assignee: Cara Therapeutics, Inc. (Stamford, CT)
Application Number:15/145,901
Patent Claim Types:
see list of patent claims
Use; Composition; Compound;
Patent landscape, scope, and claims:

Analyzing the Scope and Claims of United States Patent 10,017,536

Introduction

United States Patent 10,017,536, titled "Synthetic peptide amides and dimers thereof," is a patent that delves into the realm of synthetic peptide amides, particularly those acting as agonists of the kappa opioid receptor. This analysis will explore the patent's scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

The patent, issued to inventors who have developed synthetic peptide amide ligands, focuses on compounds that interact with the kappa opioid receptor. These receptors are crucial in the body's pain regulation and mood modulation systems. The invention involves the design and synthesis of peptide amides and their dimers, which exhibit agonistic activity on the kappa opioid receptor[1].

Scope of the Patent

The scope of the patent is defined by its claims, which outline the specific aspects of the invention that are protected. Here are some key points:

Novelty, Usefulness, and Nonobviousness

For a patent to be granted, the invention must meet the criteria of being novel, useful, and nonobvious. The synthetic peptide amides and their dimers described in this patent must be new and not previously known, have a practical application, and not be obvious to a person with ordinary skill in the field of peptide chemistry and pharmacology[5].

Claim Structure

The patent claims are structured to define the boundaries of the protected invention. These claims include:

  • Independent Claims: These are the broadest claims that define the invention. For example, claims might include the general structure of the synthetic peptide amides and their dimers.
  • Dependent Claims: These claims are narrower and depend on the independent claims. They might specify particular variations or embodiments of the peptide amides and dimers[5].

Specific Compounds

The patent details specific chemical structures and sequences of the peptide amides and their dimers. These include various moieties and ring structures that are crucial for the agonistic activity on the kappa opioid receptor. The chemical formulas and descriptions provided ensure that the invention is clearly defined and distinguishable from prior art[1].

Claims Analysis

Independent Claim Length and Count

Research on patent scope suggests that the length and count of independent claims can be indicative of the patent's breadth. Patents with narrower claims at publication tend to have a higher probability of grant and a shorter examination process. The claims in this patent would be analyzed for their length and count to understand the scope and potential for future litigation or licensing[3].

Claim Language

The language used in the claims is critical. It must be clear and specific enough to allow someone with ordinary skill in the art to reproduce the invention without undue experimentation. The claims in this patent would need to be scrutinized for clarity and sufficiency to ensure they meet these criteria[5].

Patent Examination Process

The examination process for this patent would have involved several stages:

Filing and Initial Review

The patent application would have been filed with the U.S. Patent and Trademark Office (USPTO), including a detailed description of the invention, drawings, and claims.

Patent Prosecution

During the prosecution phase, the patent examiner would review the application to determine if the invention meets the criteria for patentability. This process can take several years and may involve arguments and amendments to the claims to address any issues raised by the examiner[5].

Grant and Maintenance

If the claims are deemed patentable, the patent would be granted. The patent holder would then need to pay maintenance fees to keep the patent in force. The patent's validity and scope could be challenged through various legal mechanisms, such as reexamination or litigation[5].

Broader Patent Landscape

Related Patents

The patent landscape surrounding synthetic peptide amides and kappa opioid receptor agonists is likely to include other patents related to peptide chemistry, pharmacology, and drug development. These patents might cover different aspects of peptide design, synthesis, and application, and could potentially intersect with the claims of this patent.

Industry Trends

The development of synthetic peptide amides is part of a broader trend in pharmaceutical research, where peptides are being explored for their therapeutic potential. Other companies and researchers may be working on similar or related inventions, which could impact the commercial and legal landscape of this patent[1].

Commercial and Practical Implications

Licensing and Collaboration

The commercial value of this patent could be significant, given the potential therapeutic applications of kappa opioid receptor agonists. The patent holder might engage in licensing agreements or collaborations with pharmaceutical companies to develop and market these compounds.

Regulatory Considerations

Any commercial use of the synthetic peptide amides would need to comply with regulatory requirements, including clinical trials and FDA approval. The patent holder would need to navigate these regulatory pathways to bring the invention to market[5].

Expert Insights

"Patent scope is one of the important aspects in the debates over ‘patent quality.’ The purported decrease in patent quality over the past decade or two has supposedly led to granting patents of increased breadth (or ‘overly broad’ patents), decreased clarity, and questionable validity." - Source: SSRN Paper on Patent Claims and Patent Scope[3]

Statistics and Examples

  • Patent Prosecution Costs: The process of obtaining a patent can be costly, with U.S. non-provisional patent applications ranging from $8,000 to $20,000, and international patents costing several times more[5].
  • Patent Landscape: Companies like Pearl, which have been granted patents for AI-based dental practice data analysis, illustrate the diverse and complex nature of the patent landscape in various fields[4].

Key Takeaways

  • Patent Scope: The scope of the patent is defined by its claims, which must be novel, useful, and nonobvious.
  • Claim Structure: Independent and dependent claims define the boundaries of the protected invention.
  • Examination Process: The patent examination process involves filing, initial review, prosecution, and potential challenges.
  • Commercial Implications: The patent has significant commercial potential, requiring licensing, collaboration, and regulatory compliance.
  • Industry Trends: The patent is part of a broader trend in pharmaceutical research focusing on peptide therapeutics.

FAQs

  1. What is the main focus of United States Patent 10,017,536?

    • The main focus is on synthetic peptide amides and their dimers that act as agonists of the kappa opioid receptor.
  2. What are the criteria for a patent to be granted in the U.S.?

    • A patent must be novel, useful, and nonobvious.
  3. How long does the patent examination process typically take?

    • The process can take two to five years.
  4. What is the significance of independent and dependent claims in a patent?

    • Independent claims define the broadest scope of the invention, while dependent claims are narrower and build upon the independent claims.
  5. What are the potential commercial implications of this patent?

    • The patent has significant commercial potential, including licensing agreements and collaborations with pharmaceutical companies, and requires compliance with regulatory requirements.

Sources

  1. US10017536B2 - Synthetic peptide amides and dimers thereof - Google Patents
  2. U.S. Patent and Trademark Office (USPTO) | USAGov
  3. Patent Claims and Patent Scope - SSRN
  4. Pearl Granted U.S. Patent for Dental Practice Data Analysis AI Technology - HelloPearl
  5. Intellectual Property Protection - KU Office of Research

More… ↓

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Drugs Protected by US Patent 10,017,536

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Cara Therap KORSUVA difelikefalin acetate SOLUTION;INTRAVENOUS 214916-001 Aug 23, 2021 RX Yes Yes 10,017,536 ⤷  Try for Free Y TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD) ⤷  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 10,017,536

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2064228 ⤷  Try for Free 301199 Netherlands ⤷  Try for Free
European Patent Office 2064228 ⤷  Try for Free CA 2022 00045 Denmark ⤷  Try for Free
European Patent Office 2064228 ⤷  Try for Free PA2022522 Lithuania ⤷  Try for Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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