United States Patent 9,763,885: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,763,885, titled "Oral tablet formulation consisting of fixed combination of rosuvastatin and ezetimibe for treatment of hyperlipidemia and cardiovascular diseases," is a significant patent in the pharmaceutical industry. This patent, held by Althera Laboratories Ltd., combines two well-known drugs to treat hyperlipidemia and cardiovascular diseases. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
The patent, issued on September 19, 2017, describes an oral tablet formulation that combines rosuvastatin and ezetimibe. Rosuvastatin is a statin used to lower cholesterol levels, while ezetimibe works by inhibiting the absorption of cholesterol in the small intestine. The combination of these two drugs in a single tablet enhances patient compliance and efficacy in managing hyperlipidemia and cardiovascular diseases[2][4].
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 aspects:
- Fixed Combination: The patent protects a fixed combination of rosuvastatin and ezetimibe in a single oral tablet. This combination is designed to treat hyperlipidemia and cardiovascular diseases[2][4].
- Dosage Form: The invention includes various dosage forms, such as layered tablets, which can be tailored to optimize the release of the active ingredients[4].
- Excipients and Inactive Ingredients: The patent also covers the use of specific excipients and inactive ingredients that are crucial for the stability and efficacy of the formulation[4].
Claims Analysis
The claims of the patent are critical in defining the boundaries of the invention. Here are some key claims:
- Independent Claims: The patent includes independent claims that describe the composition of the tablet, including the specific amounts of rosuvastatin and ezetimibe, and the physical form of the tablet (e.g., layered tablets)[4].
- Dependent Claims: Dependent claims further specify the details of the formulation, such as the types of excipients used and the method of manufacturing the tablets[4].
Patent Claims Metrics
To understand the scope and quality of the patent, metrics such as independent claim length and independent claim count can be useful. These metrics can indicate the breadth and clarity of the patent claims. For instance, narrower claims at publication are often associated with a higher probability of grant and a shorter examination process[3].
Patent Landscape
The patent landscape for Roszet, the drug covered by this patent, is complex and involves multiple patents and legal activities.
- Patent Expiry: The patent is set to expire in May 2033, subject to any changes due to legal activities such as term extensions or amendments to the claims[2].
- Family Patents: Roszet is protected by a family of patents, including US9763885 and US10376470, which cover various aspects of the drug formulation and administration[2].
- International Protection: The patent protection is not limited to the United States; Roszet is protected by patents in multiple countries, which is crucial for strategizing market entry and identifying potential generic entry points[2].
Legal Activities and Updates
Recent legal activities on these patents include changes in power of attorney, correspondence address changes, and payment of maintenance fees. These activities can impact the patent's expiry date and the potential for generic versions[2].
Generic Launch
As of now, there are no approved generic versions of Roszet. The estimated generic launch date is May 1, 2033, pending any changes in the patent landscape[2].
Impact on Innovation and Market
The patent's scope and claims have significant implications for innovation and market competition. The combination of rosuvastatin and ezetimibe in a single tablet enhances patient compliance and treatment efficacy, which can drive market demand. However, the broad scope of the patent claims can also limit competition by preventing other manufacturers from developing similar formulations until the patent expires[3].
Challenges and Critiques
Patents with broad claims can sometimes be criticized for impeding innovation. For instance, software and internet patents have been criticized for having unduly broad and unclear claims, which can lead to increased licensing and litigation costs[3].
Conclusion
United States Patent 9,763,885 is a critical patent in the pharmaceutical industry, protecting a valuable combination of rosuvastatin and ezetimibe for treating hyperlipidemia and cardiovascular diseases. Understanding the scope, claims, and patent landscape is essential for pharmaceutical companies, researchers, and regulatory bodies.
Key Takeaways
- The patent protects a fixed combination of rosuvastatin and ezetimibe in an oral tablet.
- The scope includes specific dosage forms and excipients.
- The patent is set to expire in May 2033, subject to legal activities.
- There are no approved generic versions of Roszet as of now.
- The patent's broad claims can impact innovation and market competition.
Frequently Asked Questions
Q: What is the main invention protected by United States Patent 9,763,885?
A: The main invention is an oral tablet formulation consisting of a fixed combination of rosuvastatin and ezetimibe for treating hyperlipidemia and cardiovascular diseases.
Q: When is the patent set to expire?
A: The patent is set to expire in May 2033, subject to any changes due to legal activities.
Q: Are there any generic versions of Roszet available?
A: As of now, there are no approved generic versions of Roszet.
Q: What are the key claims of the patent?
A: The key claims include the composition of the tablet, specific amounts of rosuvastatin and ezetimibe, and the physical form of the tablet.
Q: How does the patent impact innovation in the pharmaceutical industry?
A: The patent's broad claims can limit competition by preventing other manufacturers from developing similar formulations until the patent expires, but it also drives innovation by protecting a valuable combination that enhances patient compliance and treatment efficacy.
Cited Sources
- US Patent and Trademark Office, "US9763885B2 - Oral tablet formulation consisting of fixed combination of rosuvastatin and ezetimibe for treatment of hyperlipidemia and cardiovascular diseases" [PDF].
- Pharsight - GreyB, "Roszet patent expiration".
- Hoover Institution, "Patent Claims and Patent Scope" [PDF].
