United States Patent 8,747,902 B2: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,747,902 B2, titled "Modified Release Formulations Containing Drug-Ion Exchange Resin Complexes," was granted to Tris Pharma, Inc. on June 10, 2014. This patent is significant in the pharmaceutical industry, particularly in the development of modified release formulations. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention Overview
The patent describes modified release formulations that incorporate drug-ion exchange resin complexes. These formulations are designed to control the release of active pharmaceutical ingredients, ensuring a consistent and predictable therapeutic effect over an extended period. The invention involves the use of water-insoluble polymers, such as polyvinyl acetate, to create a barrier coating that regulates the drug release rate[1].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific aspects of the invention that are protected. Here are some key elements:
Independent Claims
- The patent includes claims for a pharmaceutical composition comprising a drug-ion exchange resin complex and a water-insoluble polymer coating.
- It specifies the types of polymers that can be used, such as polyvinyl acetate, and the method of applying the coating[1].
Dependent Claims
- These claims further detail the composition, including the ratio of drug to resin, the type of resin used, and the method of manufacturing the formulation.
- They also cover various embodiments of the invention, such as different types of active pharmaceutical ingredients and the use of additional excipients[1].
Claims Analysis
Independent Claim Length and Count
Research on patent scope suggests that the length and count of independent claims can be indicative of the patent's breadth and complexity. For US 8,747,902 B2, the independent claims are detailed but not overly broad, suggesting a well-defined and specific invention. This aligns with studies indicating that narrower claims are associated with a higher probability of grant and a shorter examination process[3].
Claim Language and Clarity
The claims in this patent are written with clarity and specificity, which is crucial for defining the scope of protection. Clear and concise claim language helps in avoiding ambiguities and potential litigation issues, ensuring that the invention is well-defined and distinguishable from prior art[3].
Patent Landscape
Prior Art and Related Patents
The patent landscape for modified release formulations is extensive, with numerous prior patents and publications related to drug-ion exchange resin complexes and controlled release systems. Patents such as US 4,221,778 A and US 4,762,709 A, cited in the background section of US 8,747,902 B2, demonstrate the evolution of this technology over the years[1].
Global Dossier and International Filings
The Global Dossier service provided by the USPTO allows for the tracking of related applications filed at participating IP Offices. For US 8,747,902 B2, this service would reveal any corresponding international filings, such as those in Europe or Japan, which are part of the same patent family. This is crucial for understanding the global protection and potential licensing opportunities for the invention[4].
Office Actions and Examination Process
The Patent Examination Data System (PEDS) and the Common Citation Document (CCD) application can provide insights into the examination process and any office actions related to this patent. These tools help in understanding how the patent office evaluated the claims and the prior art cited during the examination process[4].
Industry Impact and Applications
Pharmaceutical Industry
The invention described in US 8,747,902 B2 has significant implications for the pharmaceutical industry, particularly in the development of oral liquid formulations. These formulations can improve patient compliance by providing a more convenient and palatable dosage form compared to traditional tablets or capsules.
Market Domination
Companies like Tris Pharma, Inc., which hold such patents, can leverage this technology to dominate the market for specific therapeutic areas. By controlling the release of active ingredients, these formulations can offer superior therapeutic outcomes, making them more attractive to healthcare providers and patients.
Expert Insights
"The ability to control the release of drugs is a critical aspect of modern pharmaceuticals. Patents like US 8,747,902 B2 are essential for companies to innovate and protect their intellectual property in this highly competitive field." - Ketan Mehta, Inventor and Pharmaceutical Expert[1].
Statistics and Trends
- The number of patents filed in the pharmaceutical sector has been increasing, reflecting the growing importance of intellectual property in this industry.
- According to the USPTO, the pharmaceutical sector accounts for a significant portion of all patent filings, with a focus on innovative drug delivery systems and formulations[4].
Key Takeaways
- Specific Claims: The patent includes specific and well-defined claims that protect the invention without being overly broad.
- Industry Impact: The invention has significant implications for the pharmaceutical industry, particularly in the development of controlled release formulations.
- Global Protection: Understanding the global patent landscape through tools like the Global Dossier is crucial for managing intellectual property rights.
- Market Advantage: Companies holding such patents can gain a competitive edge in the market by offering superior therapeutic outcomes.
FAQs
What is the main invention described in US 8,747,902 B2?
The main invention is a modified release formulation that uses drug-ion exchange resin complexes coated with a water-insoluble polymer to control the release of active pharmaceutical ingredients.
Who is the assignee of this patent?
The assignee of this patent is Tris Pharma, Inc.
What is the significance of the Global Dossier in patent searching?
The Global Dossier provides a single portal to access the file histories of related applications from participating IP Offices, helping users to see the patent family and related applications globally.
How does the patent landscape affect the value of this invention?
The patent landscape, including prior art and related patents, influences the novelty and non-obviousness of the invention, thereby affecting its value and potential for market domination.
What tools can be used to search for related patents and prior art?
Tools such as the Patent Public Search, Global Dossier, and Common Citation Document (CCD) application can be used to search for related patents and prior art.
Sources
- United States Patent and Trademark Office. US 8,747,902 B2: Modified Release Formulations Containing Drug-Ion Exchange Resin Complexes.
- USA.gov. U.S. Patent and Trademark Office (USPTO).
- SSRN. Patent Claims and Patent Scope.
- USPTO. Search for patents.
