United States Patent 9,669,096: A Detailed Analysis
Overview of the Patent
United States Patent 9,669,096, hereafter referred to as the '096 patent, is a significant intellectual property asset that protects a specific pharmaceutical formulation. This patent is particularly notable for its coverage of RELISTOR, a medication used to treat opioid-induced constipation.
Patent Holder and Coverage
The '096 patent is held by Salix Pharmaceuticals, Inc., and it is included in one New Drug Application (NDA)[2].
International Patent Family
This patent has a substantial international presence, with forty-five patent family members in nineteen countries. This extensive coverage underscores the global importance and protection of the patented formulation[2].
Claims and Scope
Detailed Claims
The '096 patent includes multiple claims that define the scope of the invention. These claims typically outline the specific components, methods of preparation, and uses of the pharmaceutical formulation. Here are some key aspects:
- Composition Claims: These claims specify the exact formulation of RELISTOR, including the active ingredient methylnaltrexone and any excipients or other components.
- Method Claims: These claims describe the methods of preparing the formulation, which can include steps such as mixing, encapsulating, or other manufacturing processes.
- Use Claims: These claims define the therapeutic uses of the formulation, specifically its application in treating opioid-induced constipation[2].
Scope of Protection
The scope of the '096 patent is broad enough to cover various aspects of the pharmaceutical formulation but narrow enough to be specific and enforceable. This balance is crucial for preventing infringement while allowing for innovation in related areas.
Patent Landscape
Related Patents and Family Members
The '096 patent is part of a larger patent family, with numerous related patents and applications in different jurisdictions. This extensive family ensures comprehensive protection across various markets and regions[2].
Expiration and Generic Entry
Understanding the expiration date of the '096 patent is crucial for both the patent holder and potential generic manufacturers. The patent's expiration can open the market to generic versions of the drug, potentially impacting the market dynamics and pricing[2].
Economic and Strategic Significance
Valuation of Patents
Patents like the '096 patent can be highly valuable, as evidenced by significant transactions in the patent market. For instance, the sale of Novell's patents to CPTN Holdings for $510,204.08 per patent and Google's acquisition of Motorola Mobility's patents for a similar price per patent highlight the economic importance of such intellectual property[1].
Market Impact
The '096 patent, by protecting RELISTOR, gives Salix Pharmaceuticals a competitive edge in the market for opioid-induced constipation treatments. This exclusivity can lead to higher revenues and market share until the patent expires.
Litigation and Enforcement
Infringement Actions
Patents like the '096 patent are often the subject of litigation to enforce their claims and prevent infringement. For example, actions for infringement under U.S. patent laws, such as those filed under 35 U.S.C. ยงยง 271 and 281, are common mechanisms for protecting patent rights[5].
Declaratory Judgment
In cases where there is a dispute over the validity or infringement of a patent, parties may seek a declaratory judgment to clarify their rights and obligations. This can be particularly relevant in the pharmaceutical industry, where patent disputes are frequent[5].
Data and Statistics
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents, including those related to pharmaceutical formulations. This dataset can offer insights into the scope and trends of patent claims in the industry[3].
Global Patent Index
Using tools like the Global Patent Index (GPI) from the European Patent Office (EPO), one can conduct detailed searches on worldwide bibliographic, legal event, and full-text data related to patents. This is useful for understanding the global patent landscape and the protection afforded by patents like the '096 patent[4].
Key Takeaways
- Patent Coverage: The '096 patent protects a specific pharmaceutical formulation of RELISTOR, with extensive international coverage.
- Claims and Scope: The patent includes detailed claims on composition, method of preparation, and therapeutic use.
- Economic Significance: Patents like the '096 patent are highly valuable and can significantly impact market dynamics.
- Litigation and Enforcement: The patent is subject to litigation to prevent infringement and protect its claims.
- Data and Statistics: Various datasets and indices provide insights into the scope and trends of patent claims in the pharmaceutical industry.
FAQs
Q: What is the primary use of the formulation protected by the '096 patent?
A: The primary use is for treating opioid-induced constipation.
Q: How many international patent family members does the '096 patent have?
A: The '096 patent has forty-five patent family members in nineteen countries.
Q: What is the significance of the expiration date of the '096 patent?
A: The expiration date marks when the market can be opened to generic versions of the drug, potentially impacting market dynamics and pricing.
Q: How are patents like the '096 patent valued?
A: Patents are valued using methods such as cost, income, and market approaches, with significant transactions often reflecting their high value.
Q: What legal actions can be taken to enforce the '096 patent?
A: Actions for infringement under U.S. patent laws and declaratory judgments are common mechanisms for enforcing patent rights.
Sources
- Perpetual Motion Patents, "The Value of a Patent"
- DrugPatentWatch, "Patent 9,669,096"
- USPTO, "Patent Claims Research Dataset"
- EPO, "Global Patent Index (GPI)"
- GIBBONS P.C., "Litigation Documents"
