Understanding the Scope and Claims of United States Patent 9,233,077
Introduction
United States Patent 9,233,077, titled "Delayed release cysteamine bead formulation, and methods of making and using same," is a patent that addresses a specific pharmaceutical formulation and its production and application methods. This analysis will delve into the details of the patent, including its scope, claims, and the broader patent landscape it operates within.
Patent Overview
Invention Description
The patent describes a delayed release cysteamine bead formulation designed to deliver cysteamine to the small intestine, reducing the frequency of dosing and improving the efficacy of the treatment. Cysteamine is used to treat conditions such as cystinosis, a rare genetic disorder that causes the accumulation of cystine within cells[4].
Key Components
- Delayed Release Formulation: The patent focuses on an enterically-coated cysteamine composition that ensures the drug is released in the small intestine rather than the stomach, enhancing its absorption and reducing side effects.
- Bead Formulation: The cysteamine is formulated into beads, which are then coated to achieve the desired delayed release profile.
- Methods of Making and Using: The patent includes detailed methods for preparing the bead formulation and the procedures for its administration.
Scope of the Patent
Claims
The patent includes several claims that define the scope of the invention. These claims can be categorized into:
- Composition Claims: These claims describe the specific formulation of the cysteamine beads, including the enteric coating and the dosage form.
- Method Claims: These claims outline the processes for making the bead formulation and the methods for its use in treating medical conditions.
- Apparatus Claims: Though not explicitly mentioned, any apparatus or equipment necessary for the production or administration of the formulation could be implied under the broader method claims.
Claim Examples
For instance, Claim 1 might describe the composition of the cysteamine beads, including the specific materials used for the enteric coating and the dosage form. Claim 2 could detail the method of preparing these beads, and Claim 3 might describe the method of administering the formulation to achieve the desired therapeutic effect[4].
Patent Landscape
Technology Area
This patent falls under the category of pharmaceuticals and biotechnology, which is one of the significant technology areas tracked by the USPTO. According to the USPTO's classification system, patents related to chemistry and pharmaceuticals are part of the broader technology areas that include instruments and other fields[1].
Trends in Pharmaceutical Patents
The number of pharmaceutical patents has seen significant growth over the years, driven by advancements in biotechnology and the need for innovative treatments for various diseases. The USPTO data indicates that patents in the chemistry and pharmaceutical fields make up a substantial portion of the total patents granted, reflecting the ongoing research and development in these areas[1].
Legal and Regulatory Context
Patent Term and Protection
The patent term for U.S. patents, including pharmaceutical patents like US 9,233,077, is 20 years from the effective filing date, as amended by the Uruguay Round Agreements Act (URAA) in 1995. This change was intended to promote timely disclosure of innovations and align U.S. patent law with international standards[2].
Restriction Requirements
In the process of patent examination, the USPTO may issue restriction requirements if the application includes multiple independent and distinct inventions. This was a point of contention in cases like Hyatt v. United States Patent and Trademark Office, where the applicant's failure to disclose claims to separate inventions led to the imposition of a restriction requirement[2].
Economic and Practical Implications
Market Impact
Patents like US 9,233,077 can have significant market implications, particularly in the pharmaceutical industry. They can provide exclusive rights to the patent holder, allowing them to market and sell the formulation without competition for the duration of the patent term. This exclusivity can drive innovation but also affects the availability and cost of treatments.
Research and Development
The detailed information on claims and patent scope, as provided by datasets like the USPTO's Patent Claims Research Dataset, can help researchers and developers understand the existing landscape and identify areas for further innovation. This dataset includes detailed information on claims from U.S. patents and applications, which can be crucial for strategic planning and R&D activities[3].
Future Directions and Challenges
Small Claims Patent Court
There is ongoing discussion about the feasibility of a small claims patent court, which could impact how disputes related to patents like US 9,233,077 are handled. Such a court would aim to provide a more streamlined and cost-effective process for resolving patent disputes, particularly for smaller entities[5].
Global Comparisons
In the global context, the trends in patenting, including those in the pharmaceutical sector, vary significantly. The USPTO's data on international patents, classified under the WIPO's 35 technical fields, provides insights into how different countries and regions focus on various technology areas. This can be crucial for companies looking to expand their intellectual property protection globally[1].
Key Takeaways
- Patent Scope: US 9,233,077 covers a specific delayed release cysteamine bead formulation and its production and application methods.
- Claims: The patent includes composition, method, and potentially apparatus claims that define its scope.
- Technology Area: It falls under the pharmaceutical and biotechnology category, a significant area in the USPTO's classification system.
- Legal Context: The patent term is 20 years from the effective filing date, and restriction requirements can be imposed if multiple distinct inventions are included.
- Economic Impact: The patent can significantly impact the market by providing exclusivity and driving innovation.
FAQs
Q: What is the primary focus of United States Patent 9,233,077?
A: The primary focus is on a delayed release cysteamine bead formulation designed to deliver cysteamine to the small intestine.
Q: How does the patent term for US 9,233,077 work?
A: The patent term is 20 years from the effective filing date, as per the Uruguay Round Agreements Act (URAA).
Q: What are the implications of restriction requirements in patent applications?
A: Restriction requirements can be imposed if the application includes multiple independent and distinct inventions, which can complicate the patent examination process.
Q: How does the USPTO classify patents in the pharmaceutical sector?
A: The USPTO classifies patents under the World Intellectual Property Organization (WIPO) classification system, which includes 35 technical fields.
Q: What is the significance of the Patent Claims Research Dataset in understanding patent scope?
A: The dataset provides detailed information on claims from U.S. patents and applications, helping researchers and developers understand the existing patent landscape and identify areas for further innovation.
