United States Patent 8,314,117: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,314,117, titled "CGRP Receptor Antagonists," is a significant patent in the field of pharmaceuticals, particularly for the treatment of calcitonin gene-related peptide (CGRP) related disorders. This patent, assigned to Bristol-Myers Squibb Company, was issued on November 20, 2012. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Scope of the Patent
Overview
The patent disclosure generally relates to novel compounds of formula I, which are CGRP receptor antagonists. These compounds, including their pharmaceutically acceptable salts, are designed to treat various CGRP-related disorders[4].
Therapeutic Applications
The patent covers a wide range of therapeutic applications, including:
- Migraine and other headaches
- Neurogenic vasodilation
- Neurogenic inflammation
- Thermal injury
- Circulatory shock
- Flushing associated with menopause
- Airway inflammatory diseases such as asthma and chronic obstructive pulmonary disease (COPD)[4].
Claims of the Patent
Compound Structure
The patent claims novel compounds of formula I, which include specific structural elements such as hydrogen, pyridin, difluorophenyl, and cyclohepta groups. These compounds are synthesized through various chemical methods and can exist in stereoisomeric and tautomeric forms[4].
Pharmaceutical Compositions
The claims also extend to pharmaceutical compositions that include these compounds, either alone or in combination with other active ingredients. These compositions can be formulated in various forms, such as tablets, capsules, or solutions, and may include a range of pharmaceutically acceptable salts like succinate, sulfate, and tartrate[4].
Methods of Use
The patent includes methods for using these compounds in the treatment of CGRP-related disorders. This encompasses administering the compounds to patients in need, either as a single dose or as part of a treatment regimen[4].
Patent Claims Analysis
Independent and Dependent Claims
The patent contains 18 claims, which include both independent and dependent claims. Independent claims define the broad scope of the invention, while dependent claims narrow down the scope by adding specific limitations. For example, Claim 1 defines the general structure of the compounds, while subsequent claims specify particular substituents or pharmaceutical compositions[4].
Claim Language and Scope
The language used in the claims is crucial for determining the patent's scope. Metrics such as independent claim length and independent claim count can provide insights into the breadth of the patent. Generally, narrower claims are associated with a higher probability of grant and a shorter examination process[3].
Patent Landscape
Related Patents
The patent landscape surrounding US 8,314,117 includes other patents related to CGRP receptor antagonists. For instance, Patent 11,083,724, assigned to Biohaven Pharmaceutical Ireland DAC, also deals with methods of treating CGRP-related disorders using rimegepant, a specific CGRP receptor antagonist. This patent was issued on August 10, 2021, and expires on March 25, 2039[5].
Litigation and Infringement
The patent has been involved in litigation, particularly regarding infringement claims. For example, Pfizer Inc. has been involved in legal disputes concerning the infringement of related patents, such as the '372 patent and the '724 patent, by other companies. These disputes highlight the importance of patent protection in the pharmaceutical industry[2].
Pharmaceutical and Commercial Implications
Drug Exclusivity and Patent Expiration
The patent assigns exclusive legal rights to the patent holder, which in this case is Bristol-Myers Squibb Company. The patent expires 20 years from the date of filing, but this can be variable due to factors such as the development of new formulations and patent infringement litigation. Additionally, the FDA grants exclusivity periods that can run simultaneously with the patent, providing further market protection[5].
Market Impact
CGRP receptor antagonists, such as those covered by US 8,314,117, have significant market impact due to their efficacy in treating migraine and other CGRP-related disorders. The approval of drugs like NURTEC ODT (rimegepant sulfate) has expanded treatment options for patients, highlighting the commercial importance of these patents[2].
Conclusion
The United States Patent 8,314,117 is a pivotal patent in the field of CGRP receptor antagonists, covering a broad range of therapeutic applications and pharmaceutical compositions. Understanding the scope and claims of this patent, as well as the broader patent landscape, is crucial for pharmaceutical companies and researchers working in this area.
Key Takeaways
- CGRP Receptor Antagonists: The patent covers novel compounds that act as CGRP receptor antagonists.
- Therapeutic Applications: It includes treatments for migraine, neurogenic vasodilation, neurogenic inflammation, and other CGRP-related disorders.
- Pharmaceutical Compositions: The patent claims various pharmaceutical compositions and methods of use.
- Patent Landscape: Related patents and ongoing litigation highlight the complex and competitive nature of the pharmaceutical industry.
- Commercial Implications: The patent and associated exclusivity periods provide significant market protection and commercial advantages.
FAQs
Q1: What is the primary focus of the United States Patent 8,314,117?
The primary focus is on novel compounds that act as CGRP receptor antagonists for treating various CGRP-related disorders.
Q2: Who is the assignee of the United States Patent 8,314,117?
The assignee is Bristol-Myers Squibb Company.
Q3: What are some of the therapeutic applications covered by this patent?
The patent covers treatments for migraine, neurogenic vasodilation, neurogenic inflammation, thermal injury, circulatory shock, and other CGRP-related disorders.
Q4: How long does the patent protection last?
The patent protection typically lasts 20 years from the date of filing but can be variable due to factors like new formulations and litigation.
Q5: Are there other related patents in the same field?
Yes, there are other related patents, such as Patent 11,083,724 assigned to Biohaven Pharmaceutical Ireland DAC, which also deals with CGRP receptor antagonists.
Sources
- US8314117B2 - CGRP receptor antagonists - Google Patents
- in the united states district court - RPX Insight
- Patent Claims and Patent Scope - SSRN
- (12) United States Patent (10) Patent No.: US 8,314,117 B2 - Patent Images
- Generic Nurtec ODT Availability - Drugs.com
