Detailed Analysis of the Scope and Claims of United States Patent 8,491,932
Introduction
United States Patent 8,491,932, titled "Compositions for the oral delivery of corticosteroids," is a significant patent in the pharmaceutical industry, particularly for the treatment of inflammatory diseases of the gastrointestinal tract. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Patent Number and Title
The patent in question is US 8,491,932 B2, titled "Compositions for the oral delivery of corticosteroids." It was granted to Calliditas Therapeutics AB and is associated with the drug TARPEYO® (budesonide) delayed release capsules[1][4].
Scope of the Patent
Disease Targets
The compositions described in this patent are designed for treating inflammatory diseases of the gastrointestinal tract, such as Crohn's disease and ulcerative colitis. This specific scope indicates that the patent is focused on a particular therapeutic area, which is crucial for understanding its relevance and impact[4].
Composition Details
The patent describes specific formulations for the oral delivery of corticosteroids. These compositions include a corticosteroid, such as budesonide, combined with various excipients and release components to achieve a sustained-release profile. The use of materials like ethyl cellulose, hydroxypropyl methyl cellulose, and starch is highlighted to control the release of the active ingredient[4].
Claims of the Patent
Independent and Dependent Claims
The patent includes both independent and dependent claims. Independent claims define the broad scope of the invention, while dependent claims narrow down the scope by adding specific details or limitations.
- Independent Claims: These claims outline the core components of the invention, such as the composition of the corticosteroid and the sustained-release formulation.
- Dependent Claims: These claims provide additional details, such as the specific types of excipients used, the method of preparation, and the dosage forms (e.g., capsules or pellets)[4].
Claim Language and Scope
The claim language is critical in defining the patent's scope. The patent uses specific terms to describe the composition and its components, ensuring clarity and precision. For example, the claims mention the use of "a sustained-release form" and "a release component" to control the release of the corticosteroid[4].
Patent Landscape
Related Patents and Applications
The patent landscape for corticosteroid formulations is extensive. Other patents and applications in this area often focus on different aspects, such as new compounds, alternative delivery methods, or improved formulations. For instance, patents related to heterocyclic compounds (IPC class C07D) and therapeutic activities of chemical compounds (IPC class A61P) are common in the pharmaceutical sector[3].
Patent Classification
The International Patent Classification (IPC) system categorizes patents based on their technological content. US 8,491,932 falls under IPC classes related to pharmaceutical compositions, particularly those involving corticosteroids and sustained-release formulations. The dominant IPC classes in this area include C07D (heterocyclic compounds) and A61P (therapeutic activities of chemical compounds or medicinal preparations)[3].
Patent Quality and Scope Metrics
Independent Claim Length and Count
Research on patent quality often uses metrics such as independent claim length and count to measure the scope of a patent. Narrower claims, as measured by shorter lengths and fewer counts, are generally associated with a higher probability of grant and a shorter examination process. This patent, with its detailed and specific claims, likely underwent a rigorous examination process to ensure its validity and scope[5].
Examination Process
The examination process for US 8,491,932 would have involved a thorough review of the claims to ensure they are clear, concise, and not overly broad. The patent office tends to narrow the scope of patent claims during the examination process, which can result in more focused and defensible patents[5].
Impact on the Pharmaceutical Industry
Innovation and Competition
Patents like US 8,491,932 drive innovation in the pharmaceutical industry by protecting novel formulations and delivery methods. This protection incentivizes companies to invest in research and development, knowing that their inventions will be safeguarded. However, it also creates a competitive landscape where companies must navigate existing patents to develop new treatments[5].
Licensing and Litigation
The scope and claims of this patent can influence licensing agreements and potential litigation. Clear and well-defined claims reduce the likelihood of disputes and make it easier for other companies to understand what is and is not covered by the patent. This clarity is crucial for maintaining a healthy and innovative industry environment[5].
Key Takeaways
- Specific Therapeutic Area: The patent is focused on treating inflammatory diseases of the gastrointestinal tract.
- Detailed Formulations: The compositions include specific excipients and release components for sustained-release profiles.
- Clear Claims: The patent's claims are detailed and specific, ensuring clarity and precision.
- Patent Landscape: The patent is part of a broader landscape involving various IPC classes related to pharmaceutical compositions.
- Impact on Industry: The patent drives innovation, influences competition, and affects licensing and litigation in the pharmaceutical sector.
FAQs
What is the primary use of the compositions described in US 8,491,932?
The primary use is for treating inflammatory diseases of the gastrointestinal tract, such as Crohn's disease and ulcerative colitis.
What are the key components of the sustained-release formulations described in the patent?
The key components include a corticosteroid (e.g., budesonide), excipients like ethyl cellulose and hydroxypropyl methyl cellulose, and release components to control the release of the active ingredient.
How does the patent's scope impact the pharmaceutical industry?
The patent's scope protects novel formulations, driving innovation and investment in research and development. It also influences competition, licensing agreements, and potential litigation within the industry.
What metrics are used to measure the scope of a patent like US 8,491,932?
Metrics such as independent claim length and count are used to measure the scope of a patent. Narrower claims are generally associated with a higher probability of grant and a shorter examination process.
How does the examination process affect the scope of patent claims?
The examination process tends to narrow the scope of patent claims, ensuring they are clear, concise, and not overly broad. This results in more focused and defensible patents.
Sources
- Calliditas Therapeutics AB. Patent Notice – Calliditas Therapeutics AB. Retrieved from https://www.calliditas.se/en/our-products/patent-notice/
- Google Patents. US11896719.pdf. Retrieved from https://patentimages.storage.googleapis.com/ee/35/6f/685df100424ed8/US11896719.pdf
- bioRxiv. A novel approach to understand patents from the drug discovery ... Retrieved from https://www.biorxiv.org/content/10.1101/2023.02.10.527980v3.full.pdf
- Google Patents. US8491932B2 - Compositions for the oral delivery of corticosteroids. Retrieved from https://patents.google.com/patent/US8491932B2/en
- Hoover Institution. Patent Claims and Patent Scope. Retrieved from https://www.hoover.org/sites/default/files/ip2-wp16001-paper.pdf
