United States Patent 8,653,103: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,653,103, issued on February 18, 2014, is a significant patent in the pharmaceutical sector, particularly in the treatment of cystic fibrosis. This patent is assigned to Vertex Pharmaceuticals Incorporated and pertains to a substantially crystalline and free solid state form of a specific chemical compound.
Patent Overview
Title and Description
The patent is titled "Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid." This compound is a key component in the treatment of cystic fibrosis, specifically targeting the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) protein[1].
Claims and Scope
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover the solid state forms of the specified compound, including its crystalline structure, purity, and stability. The claims also encompass pharmaceutical compositions containing this compound and methods for treating CFTR-mediated diseases[1].
Dependent Claims
Dependent claims further specify the characteristics of the solid state forms, such as their physical properties, methods of preparation, and pharmaceutical formulations. These claims provide a detailed description of how the compound can be synthesized, purified, and formulated into a therapeutic agent[1].
Patent Landscape
Assignee and Inventors
The patent is assigned to Vertex Pharmaceuticals Incorporated, a company known for its innovative treatments for cystic fibrosis. The inventors listed include Ali Keshavarz-Shokri, Beili Zhang, and Mariusz Krawiec, all of whom are associated with Vertex Pharmaceuticals[1].
Related Patents
Several related patents exist within the same family, covering various aspects of CFTR modulators and their formulations. For example, patents such as US 7,495,103, US 7,973,038, and US 8,324,242 also relate to modulators of ATP-binding cassette transporters, including CFTR, and their therapeutic applications[2].
Patent Expiration Dates
The patent is set to expire on December 4, 2028. This expiration date is crucial for understanding the timeline for generic versions of the drug to enter the market. Currently, there are no therapeutically equivalent generic versions of the drug available in the United States[2].
Pharmaceutical Applications
Cystic Fibrosis Treatment
The compound described in the patent is used in the treatment of cystic fibrosis, a genetic disorder that affects the lungs and digestive system. The drug works by modulating the CFTR protein, helping to restore its normal function and improve the symptoms of the disease[1].
Combination Therapies
This compound is often used in combination with other drugs, such as ivacaftor, to enhance its therapeutic efficacy. These combination therapies have shown significant improvements in the treatment outcomes for patients with cystic fibrosis[2].
Solid State Forms and Pharmaceutical Compositions
Crystalline Structure
The patent emphasizes the importance of the crystalline structure of the compound, which affects its stability, solubility, and bioavailability. Different solid state forms can have varying physical and chemical properties, impacting the drug's performance[1].
Formulations and Methods of Preparation
The patent details various methods for preparing the solid state forms, including crystallization techniques and formulation strategies. These methods ensure the compound's purity and stability, which are critical for its therapeutic effectiveness[1].
Regulatory and Legal Aspects
Patent Scope and Quality
The scope of the patent is defined by its claims, which have been scrutinized during the patent examination process. The patent's scope is narrowed to ensure clarity and validity, avoiding overly broad claims that could diminish innovation incentives[3].
Generic Availability
As the patent approaches its expiration date, the possibility of generic versions entering the market increases. However, the absence of therapeutically equivalent generics currently means that the original patent holder maintains market exclusivity[2].
Search and Examination Process
USPTO Resources
The United States Patent and Trademark Office (USPTO) provides several resources for searching and examining patents, including the Patent Public Search tool, Global Dossier, and the Patent Examination Data System (PEDS). These tools facilitate a comprehensive analysis of patent scope and claims[4].
International Harmonization
The global patent system is increasingly harmonized, with initiatives like the Common Citation Document (CCD) and Global Dossier aimed at streamlining the patent search and examination process across different jurisdictions[4].
Key Takeaways
- Compound and Application: The patent covers a specific compound used in treating cystic fibrosis by modulating the CFTR protein.
- Claims and Scope: The patent includes detailed claims on the solid state forms, pharmaceutical compositions, and methods of treatment.
- Patent Landscape: Related patents cover various CFTR modulators and their formulations, with expiration dates ranging from 2026 to 2028.
- Pharmaceutical Significance: The compound is crucial in combination therapies for cystic fibrosis, with its solid state forms affecting its therapeutic efficacy.
- Regulatory Aspects: The patent's scope is defined to ensure clarity and validity, with generic availability pending its expiration.
FAQs
What is the primary use of the compound described in US Patent 8,653,103?
The compound is primarily used in the treatment of cystic fibrosis by modulating the CFTR protein.
Who is the assignee of US Patent 8,653,103?
The assignee of US Patent 8,653,103 is Vertex Pharmaceuticals Incorporated.
When is the patent set to expire?
The patent is set to expire on December 4, 2028.
Are there any generic versions of the drug available?
Currently, there are no therapeutically equivalent generic versions of the drug available in the United States.
How does the solid state form of the compound affect its therapeutic efficacy?
The solid state form of the compound affects its stability, solubility, and bioavailability, all of which are critical for its therapeutic efficacy.
Cited Sources
- US Patent 8,653,103: Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid.
- Drugs.com: Generic Orkambi Availability.
- SSRN: Patent Claims and Patent Scope.
- USPTO: Search for patents.
