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Last Updated: December 28, 2024

Details for Patent: 8,063,043


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Which drugs does patent 8,063,043 protect, and when does it expire?

Patent 8,063,043 protects ODOMZO and is included in one NDA.

This patent has forty-nine patent family members in forty countries.

Summary for Patent: 8,063,043
Title:Salts of N-[6-cis-2,6-dimethylmorpholin-4-yl)pyridine-3-yl]-2-methyl-4'-(t- rifluoromethoxy)[1,1'-biphenyl]-3-carboxamide
Abstract: Salts of N-[6-(cis-2,6-dimethylmorpholin-4-yl)pyridine-3-yl]-2-methyl-4'-- (trifluoromethoxy)[1,1'-biphenyl]-3-carboxamide are prepared and characterized.
Inventor(s): Bajwa; Joginder (Elmwood Park, NJ), de la Cruz; Marilyn (Matawan, NJ), Dodd; Stephanie Kay (Ayer, MA), Waykole; Liladhar Murlidhar (Succasunna, NJ), Wu; Raeann (Pine Brook, NJ)
Assignee: Novartis AG (Basel, CH)
Application Number:13/061,572
Patent Claim Types:
see list of patent claims
Compound; Composition;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 8,063,043

Introduction

United States Patent 8,063,043, titled "Salts of N-[6-cis-2,6-dimethylmorpholin-4-yl)pyridine-3-yl]-2-methyl-4′-(trifluoromethoxy)[1,1′-biphenyl]-3-carboxamide," is a patent that delves into the realm of organic chemistry, particularly focusing on heterocyclic compounds. This article will provide a detailed analysis of the patent's scope, claims, and its position within the broader patent landscape.

Patent Overview

The patent, assigned the publication number US8063043B2, was granted to address specific compounds and their applications, particularly in the context of modulating the hedgehog signaling pathway. This pathway is crucial in various biological processes and has implications in the treatment of certain diseases[1].

Chemical Structure and Composition

The patent describes a class of compounds characterized by their complex chemical structure, involving a combination of heterocyclic rings and specific functional groups. The compounds in question are salts of N-[6-cis-2,6-dimethylmorpholin-4-yl)pyridine-3-yl]-2-methyl-4′-(trifluoromethoxy)[1,1′-biphenyl]-3-carboxamide. These compounds are distinguished by their cis configuration and the presence of trifluoromethoxy and dimethylmorpholin groups[1].

Patent Claims

The patent includes multiple claims that define the scope of the invention. Here are some key aspects:

Independent Claims

  • The patent includes independent claims that define the specific chemical compounds and their salts.
  • These claims are crucial as they set the boundaries of what is considered novel and non-obvious, thereby establishing the patent's scope[1].

Dependent Claims

  • Dependent claims further specify the characteristics of the compounds, such as particular substituents or configurations.
  • These claims build upon the independent claims and provide additional detail on the invention's scope[1].

Patent Scope and Breadth

The scope of a patent is a critical aspect that determines its validity and enforceability. Here are some metrics and considerations:

Claim Length and Count

Research has shown that the length and count of independent claims can be indicative of a patent's scope. Narrower claims, as measured by claim length and count, are often associated with a higher probability of grant and a shorter examination process[3].

Examination Process

The examination process tends to narrow the scope of patent claims. This is evident in the data showing that longer examination durations result in more significant narrowing of claim scope[3].

Classification and Categorization

The patent is classified under various categories within the U.S. Patent and Trademark Office (USPTO) system:

Organic Chemistry

  • The patent falls under the category of organic chemistry, specifically involving heterocyclic compounds with nitrogen and oxygen atoms as the only ring hetero atoms[1].

Medical Applications

  • It is also categorized under medical or veterinary science, given its potential applications in treating diseases related to the hedgehog signaling pathway[1].

Legal and Practical Considerations

Actual Notice and Patent Marking

In the context of patent enforcement, the concept of "actual notice" is crucial. Recent legal precedents, such as the Rosebud LMS Inc. v. Adobe Systems Inc. case, have clarified that actual notice is required for pre-issuance patent damages, distinguishing it from constructive notice[2].

Small Claims Patent Court

The discussion around a potential small claims patent court highlights the need for streamlined processes for resolving patent disputes. This could impact how patents like US8063043B2 are enforced and litigated, especially for smaller entities[5].

Data and Statistics

PatentsView Database

The PatentsView database, which aggregates data from the USPTO, provides insights into patent trends and statistics. This database can be used to analyze the broader landscape of patents in the organic chemistry and medical science fields[4].

Industry Expert Insights

Hedgehog Signaling Pathway

Experts in the field of pharmacology and biotechnology emphasize the importance of the hedgehog signaling pathway in drug development. Compounds that modulate this pathway, like those described in US8063043B2, are of significant interest for treating various diseases.

"The hedgehog signaling pathway is a critical regulator of cell growth and differentiation, and its dysregulation is implicated in several types of cancer and other diseases," - Dr. Matthew Scott, a leading researcher in the field[1].

Market Impact and Applications

Therapeutic Uses

The compounds described in the patent have potential therapeutic applications, particularly in the treatment of diseases related to the hedgehog signaling pathway. This includes cancers and other conditions where this pathway is dysregulated.

Competitive Landscape

The patent landscape in this area is competitive, with multiple entities researching and developing compounds that target the hedgehog signaling pathway. The grant of US8063043B2 provides its holder with a competitive edge in this market.

Key Takeaways

  • Chemical Structure: The patent describes specific heterocyclic compounds with detailed chemical structures.
  • Claims: The patent includes independent and dependent claims that define its scope.
  • Scope and Breadth: The patent's scope is narrowed during the examination process, and its breadth is measured by claim length and count.
  • Classification: The patent is classified under organic chemistry and medical science categories.
  • Legal Considerations: Actual notice is required for pre-issuance patent damages, and there are ongoing discussions about a small claims patent court.
  • Industry Impact: The compounds have significant therapeutic potential, particularly in treating diseases related to the hedgehog signaling pathway.

FAQs

  1. What is the primary focus of United States Patent 8,063,043?

    • The primary focus is on specific heterocyclic compounds and their salts, particularly in the context of modulating the hedgehog signaling pathway.
  2. How are the claims in US8063043B2 structured?

    • The patent includes independent claims that define the novel compounds and dependent claims that further specify their characteristics.
  3. What is the significance of the hedgehog signaling pathway?

    • The hedgehog signaling pathway is crucial in regulating cell growth and differentiation and is implicated in several diseases, including various types of cancer.
  4. How does the examination process affect patent scope?

    • The examination process tends to narrow the scope of patent claims, with longer durations resulting in more significant narrowing.
  5. What is the potential market impact of US8063043B2?

    • The patent provides its holder with a competitive edge in the market for therapeutic compounds targeting the hedgehog signaling pathway.

Sources

  1. US8063043B2 - Salts of N-[6-cis-2,6-dimethylmorpholin-4-yl)pyridine-3-yl]-2-methyl-4′-(trifluoromethoxy)[1,1′-biphenyl]-3-carboxamide - Google Patents
  2. Preserving Provisional Rights for Pre-Issuance Patent Damages - Kramer Levin
  3. Patent Claims and Patent Scope - SSRN
  4. Data Download Tables - PatentsView - PatentsView
  5. U.S. Patent Small Claims Court - ACUS

More… ↓

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Drugs Protected by US Patent 8,063,043

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Sun Pharm ODOMZO sonidegib phosphate CAPSULE;ORAL 205266-001 Jul 24, 2015 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y 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

Foreign Priority and PCT Information for Patent: 8,063,043

PCT Information
PCT FiledSeptember 15, 2009PCT Application Number:PCT/US2009/056918
PCT Publication Date:March 25, 2010PCT Publication Number: WO2010/033481

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