United States Patent 7,229,982: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,229,982, titled "Pharmaceutical Formulation," is a significant patent in the pharmaceutical industry, particularly in the field of cardiovascular health. This patent, assigned to Schering Corporation (now part of Merck & Co., Inc.), involves a novel formulation combining a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor and a cholesterol absorption inhibitor.
Background of the Invention
The patent addresses the need for effective and convenient treatments for hypercholesterolemia and other cardiovascular diseases. It combines simvastatin, an HMG-CoA reductase inhibitor marketed under the tradename ZOCOR, with ezetimibe, a cholesterol absorption inhibitor marketed under the tradename ZETIA[1].
Scope of the Patent
The scope of the patent is broad, covering both the bulk pharmaceutical composition and oral pharmaceutical dosage units. The formulation includes simvastatin and ezetimibe, or their pharmaceutically acceptable salts, solvates, or hydrates. This combination is designed to provide a synergistic effect in reducing cholesterol levels, making it a more effective treatment option compared to using either drug alone[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
- Claim 1: A pharmaceutical composition comprising a combination of simvastatin and ezetimibe.
- Claim 2: The composition of claim 1, where the simvastatin and ezetimibe are in a specific ratio.
- Claim 3: A method of treating hypercholesterolemia using the composition of claim 1.
- Claim 4: A pharmaceutical dosage unit containing the composition of claim 1[1].
Methods of Making the Compounds
The patent also describes methods for making simvastatin and ezetimibe, referencing earlier patents such as U.S. Pat. Nos. 4,444,784; 4,916,239; and 4,820,850 for simvastatin, and U.S. Pat. Nos. 5,631,365; Re. 37,721; and 5,846,966 for ezetimibe[1].
Patent Landscape
Related Patents and Applications
The patent is part of a larger family of patents related to simvastatin and ezetimibe. It claims the benefit of earlier applications, including U.S. Provisional Application No. 60/398,691 and U.S. Application No. 10/625,004, now U.S. Pat. No. 7,229,982. This indicates a continuous development and refinement of the formulation over several years[1].
International Aspects
The patent is also linked to international patent applications and grants. For instance, the Global Dossier service provided by the USPTO allows users to view the file histories of related applications from participating IP Offices, including the IP5 Offices. This helps in understanding the global patent family and the status of related applications[4].
Competitive Landscape
The combination of simvastatin and ezetimibe has been a significant advancement in the treatment of hypercholesterolemia. Other pharmaceutical companies, such as Ranbaxy Laboratories, have also developed similar formulations, as seen in patent applications like WO-2009024889-A2[5].
Impact on the Pharmaceutical Industry
The patent has had a substantial impact on the pharmaceutical industry by providing a more effective and convenient treatment option for patients with high cholesterol. The combination therapy has been widely adopted and has contributed to the development of similar combination therapies in the field.
Legal and Regulatory Considerations
The patent's validity and enforcement are subject to various legal and regulatory considerations. For instance, the USPTO's Patent Claims Research Dataset can provide insights into the scope and claims of patents, helping in the analysis of patent validity and potential infringement issues[3].
Expert Insights
Industry experts and legal practitioners often analyze such patents to understand their implications on the market and potential legal challenges. For example, a study by the Administrative Conference of the United States (ACUS) on small claims patent courts highlights the need for efficient mechanisms to resolve patent disputes, which can affect the enforcement of patents like U.S. Patent 7,229,982[2].
Statistics and Trends
The USPTO's economic research datasets, such as the Patent Claims Research Dataset, provide valuable statistics on patent claims and scope. These datasets can help in understanding trends in pharmaceutical patent filings and the impact of combination therapies on the market[3].
Key Takeaways
- Combination Therapy: The patent involves a novel combination of simvastatin and ezetimibe, enhancing the treatment of hypercholesterolemia.
- Broad Scope: The patent covers both bulk composition and oral dosage units.
- International Significance: The patent is part of a global patent family, with related applications in various IP Offices.
- Industry Impact: The combination therapy has significantly influenced the development of similar treatments in the pharmaceutical industry.
- Legal Considerations: The patent's validity and enforcement are subject to legal and regulatory scrutiny.
FAQs
Q: What are the main components of the pharmaceutical formulation described in U.S. Patent 7,229,982?
A: The main components are simvastatin, an HMG-CoA reductase inhibitor, and ezetimibe, a cholesterol absorption inhibitor.
Q: What is the significance of combining simvastatin and ezetimibe?
A: The combination provides a synergistic effect in reducing cholesterol levels, making it a more effective treatment option compared to using either drug alone.
Q: How does the Global Dossier service relate to this patent?
A: The Global Dossier service allows users to view the file histories of related applications from participating IP Offices, helping in understanding the global patent family.
Q: What is the impact of this patent on the pharmaceutical industry?
A: The patent has contributed to the development of combination therapies for treating hypercholesterolemia and has been widely adopted in clinical practice.
Q: How can the USPTO's Patent Claims Research Dataset be useful in analyzing this patent?
A: The dataset provides detailed information on claims and scope, helping in the analysis of patent validity and potential infringement issues.
Cited Sources
- United States Patent and Trademark Office, "United States Patent 7,718,643 B2," May 18, 2010.
- Administrative Conference of the United States, "U.S. Patent Small Claims Court," 2022.
- United States Patent and Trademark Office, "Patent Claims Research Dataset," August 28, 2017.
- United States Patent and Trademark Office, "Search for patents," October 18, 2018.
- PubChem, "Pharmaceutical composition comprising a hmg-coa reductase inhibitor and ezetimibe," WO-2009024889-A2.
