United States Patent 8,367,102: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,367,102, titled "Pharmaceutical semi-solid composition of isotretinoin," is a significant patent in the field of pharmaceuticals, particularly for the treatment of skin disorders such as acne. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
Isotretinoin is a well-known retinoid used primarily for the treatment of severe acne and other skin conditions. The patent in question focuses on a specific semi-solid composition of isotretinoin, which enhances its stability, efficacy, and patient compliance.
Scope of the Patent
The scope of US Patent 8,367,102 is defined by its claims, which outline the specific composition and its components. Here are the key aspects:
Composition
The patent describes a semi-solid composition containing isotretinoin, which is stabilized by the inclusion of specific ingredients such as antioxidants, chelating agents, and pharmaceutical carriers. The composition is designed to be applied topically, improving the treatment of skin disorders like acne[4].
Active Ingredients
- Isotretinoin: The primary active ingredient, known for its efficacy in treating acne and other skin conditions.
- Antioxidants: Included to prevent the degradation of isotretinoin.
- Chelating Agents: Used to stabilize the composition and prevent oxidation.
- Pharmaceutical Carriers: Such as fatty acid esters, glycerine, and propylene glycol, which enhance the stability and application of the composition[4].
Claims
The patent includes several claims that define the invention and its boundaries:
Independent Claims
- Claim 1: Describes the semi-solid composition containing isotretinoin, an antioxidant, a chelating agent, and a pharmaceutical carrier.
- Claim 2: Specifies the types of antioxidants and chelating agents that can be used.
- Claim 3: Details the pharmaceutical carriers, including fatty acid esters and glycerine[4].
Dependent Claims
These claims further specify the composition by detailing the proportions of the ingredients, the types of fatty acids, and the inclusion of additional components like polysorbate and sodium laurylsulphate[4].
Patent Landscape
Understanding the patent landscape is crucial for assessing the novelty, non-obviousness, and potential infringement of the patent.
Prior Art
The patent cites several prior art references, including European Patent EP 0184942, which describes similar compositions of isotretinoin. However, the current patent distinguishes itself by the specific combination and proportions of ingredients used[4].
International Patent Offices
The invention is part of a broader global patent family. Searching international patent databases, such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO), can reveal related patents and applications in other jurisdictions[1].
Related Patents and Applications
Using tools like the USPTO's Patent Public Search or the Common Citation Document (CCD) application, one can identify related patents and applications that cite or are cited by US Patent 8,367,102. This helps in understanding the broader context and potential overlaps or conflicts with other intellectual property[1].
Classification
The patent is classified under the International Patent Classification (IPC) system as follows:
- A61K31/00: Medicinal preparations containing organic active ingredients.
- A61K31/185: Acids; Anhydrides, halides or salts thereof.
- A61K31/20: Carboxylic acids having a carboxyl group bound to a chain of seven or more carbon atoms[4].
Legal Status
As of the last update, the patent is listed as active, but it is important to note that the legal status can change. It is always advisable to conduct a thorough legal analysis or consult with a patent attorney for the most current and accurate information[4].
Practical Implications
For pharmaceutical companies and researchers, understanding the scope and claims of this patent is essential for developing new treatments or formulations that do not infringe on existing patents. Here are some practical considerations:
Licensing and Collaboration
Companies may need to consider licensing agreements or collaborations to use the patented composition. This can involve negotiating with the patent holder to secure the necessary rights.
Research and Development
Researchers should be aware of the existing patent landscape to avoid unintentional infringement. Conducting thorough patent searches using resources like the USPTO's Patent Public Search or international databases can help in identifying potential conflicts early in the development process[1].
Regulatory Compliance
Ensuring compliance with regulatory requirements is crucial. This includes submitting necessary documentation and undergoing the appropriate approval processes before bringing a new product to market.
Key Takeaways
- Composition: The patent describes a semi-solid composition of isotretinoin stabilized by antioxidants, chelating agents, and pharmaceutical carriers.
- Claims: The patent includes independent and dependent claims that define the specific ingredients and their proportions.
- Patent Landscape: Understanding related patents and applications is crucial for assessing novelty and potential infringement.
- Classification: The patent is classified under A61K31/00 and related subclasses.
- Legal Status: The patent is currently active, but its status can change.
FAQs
Q: What is the primary active ingredient in the patented composition?
A: The primary active ingredient is isotretinoin, a retinoid used for treating skin disorders like acne.
Q: What are the key components that stabilize the isotretinoin composition?
A: The composition is stabilized by antioxidants, chelating agents, and pharmaceutical carriers such as fatty acid esters and glycerine.
Q: How can one search for related patents and applications?
A: Using tools like the USPTO's Patent Public Search, the Common Citation Document (CCD) application, and international patent databases such as those provided by the EPO and WIPO.
Q: What is the classification of the patent under the IPC system?
A: The patent is classified under A61K31/00 and related subclasses, specifically A61K31/185 and A61K31/20.
Q: Why is it important to understand the patent landscape?
A: Understanding the patent landscape helps in assessing the novelty and non-obviousness of the invention and in avoiding potential infringement of existing patents.
Sources
- USPTO: Search for patents - USPTO. Retrieved from https://www.uspto.gov/patents/search
- PubChem: Pharmaceutical semi-solid composition of isotretinoin - Patent US-2013158119-A1. Retrieved from https://pubchem.ncbi.nlm.nih.gov/patent/US-2013158119-A1
- USPTO: Patent Claims Research Dataset - USPTO. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents: US8367102B2 - Pharmaceutical semi-solid composition of isotretinoin. Retrieved from https://patents.google.com/patent/US8367102B2/en
