United States Patent 8,101,599: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,101,599, titled "Pharmaceutical composition containing anti-hypertensive agents," is a significant patent in the field of pharmaceuticals, particularly focusing on the treatment of hypertension and related cardiovascular diseases. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention Overview
The patent, filed by the inventors and assigned to various pharmaceutical companies, pertains to a combination of organic compounds that act as anti-hypertensive agents. These compounds include amlodipine, valsartan, and hydrochlorothiazide, among others, which are known for their complementary modes of action in reducing blood pressure[1][2].
Scope of the Invention
The scope of this patent is broad, covering various aspects of pharmaceutical compositions and their applications:
- Combination Therapy: The patent emphasizes the combination of different anti-hypertensive agents to achieve a synergistic effect in treating hypertension and other cardiovascular conditions.
- Pharmaceutical Compositions: It includes formulations such as tablets, capsules, and other dosage forms that contain the specified anti-hypertensive agents.
- Therapeutic Uses: The patent covers the treatment of a wide range of diseases, including hypertension, heart failure, renal insufficiency, and various other cardiovascular and renal disorders[1].
Claims of the Patent
The claims of the patent are detailed and extensive, outlining the specific combinations of anti-hypertensive agents, their dosages, and the pharmaceutical compositions:
- Independent Claims: These claims define the core invention, including the specific combinations of amlodipine, valsartan, and hydrochlorothiazide, and their respective dosages.
- Dependent Claims: These claims build upon the independent claims, specifying various formulations, dosage forms, and methods of administration.
- Method Claims: The patent also includes claims related to the methods of treating hypertension and other diseases using these combinations of anti-hypertensive agents[1][2].
Key Components and Combinations
The patent highlights several key components and their combinations:
- Amlodipine: A calcium channel blocker that helps relax blood vessels.
- Valsartan: An angiotensin II receptor antagonist that blocks the action of a natural chemical that narrows blood vessels.
- Hydrochlorothiazide: A diuretic that helps the body get rid of excess salt and water, reducing blood volume and pressure[1].
Therapeutic Applications
The therapeutic applications of this patent are diverse and include:
- Hypertension: The primary focus is on treating high blood pressure.
- Heart Failure: The combination is also effective in managing heart failure.
- Renal Insufficiency: It addresses kidney function issues related to hypertension.
- Other Cardiovascular Diseases: The patent covers a range of other cardiovascular conditions, including angina pectoris, atherosclerosis, and peripheral vascular disease[1].
Patent Landscape
Understanding the patent landscape is crucial for navigating the intellectual property rights and potential gaps or opportunities:
- Claim Coverage Matrix: This tool helps in categorizing patents by claims and scope concepts, making it easier to analyze large numbers of patent claims concurrently. It identifies which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist[3].
- Competing Patents: Other patents in the same field, such as those related to endothelin receptor antagonists or other anti-hypertensive agents, need to be considered to understand the competitive landscape[4].
- Expiry and Maintenance: The patent has expired due to fee-related issues, which affects its current legal status and the protection it offers. This is a critical aspect to consider in the patent landscape[1].
Impact on Pharmaceutical Industry
The impact of this patent on the pharmaceutical industry is significant:
- Combination Therapy: It has set a precedent for combination therapies in treating hypertension and related diseases, which has been a trend in modern pharmacology.
- Research and Development: The patent has influenced further research into the development of new anti-hypertensive agents and their combinations.
- Market Competition: The expiration of the patent has opened up opportunities for generic formulations and new market entrants, increasing competition in the anti-hypertensive drug market[1].
Challenges and Opportunities
The patent landscape presents both challenges and opportunities:
- Generic Competition: With the patent expired, generic versions of the combination therapy can be developed, posing a challenge to the original patent holders but offering cost-effective alternatives to patients.
- Innovation: The expiration also presents opportunities for innovation, as new combinations and formulations can be developed without infringing on the expired patent[1].
Conclusion
The United States Patent 8,101,599 is a pivotal patent in the field of anti-hypertensive medications, offering a comprehensive approach to treating hypertension and related cardiovascular diseases through combination therapy. Understanding its scope, claims, and the broader patent landscape is essential for pharmaceutical companies, researchers, and healthcare professionals.
Key Takeaways
- The patent covers combinations of anti-hypertensive agents like amlodipine, valsartan, and hydrochlorothiazide.
- It includes various pharmaceutical compositions and therapeutic uses.
- The patent has expired, affecting its current legal status and protection.
- The expiration opens up opportunities for generic formulations and new market entrants.
- The patent has significantly influenced the trend of combination therapies in pharmacology.
Frequently Asked Questions (FAQs)
Q: What are the main components of the pharmaceutical composition described in US Patent 8,101,599?
A: The main components are amlodipine, valsartan, and hydrochlorothiazide.
Q: What is the primary therapeutic application of this patent?
A: The primary application is the treatment of hypertension.
Q: Has the patent expired?
A: Yes, the patent has expired due to fee-related issues.
Q: What impact does the expiration of this patent have on the pharmaceutical industry?
A: The expiration allows for the development of generic versions of the combination therapy, increasing market competition.
Q: How does this patent influence research and development in the pharmaceutical industry?
A: It sets a precedent for combination therapies, influencing further research into new anti-hypertensive agents and their combinations.
Cited Sources
- US Patent 8,101,599B2 - Pharmaceutical composition containing anti-hypertensive agents.
- US Patent for Pharmaceutical composition containing anti-hypertensive agents - Justia Patents.
- Patent Analytics - SLWIP.
- United States Patent 11,174,247 B2 - Combinations of a 4-pyrimidinesulfamide derivative with active ingredients for the treatment of endothelin-related diseases.
