United States Patent 4,663,318: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,663,318, titled "Method of treating Alzheimer's disease," is a significant patent that has played a crucial role in the treatment of Alzheimer's disease. This patent, granted on May 5, 1987, revolves around the use of galanthamine, a cholinesterase inhibitor, for treating Alzheimer's disease.
Background and Invention
The patent describes a novel method of treating Alzheimer's disease using galanthamine, a naturally occurring compound found in certain plants like the snowdrop and the daffodil. Galanthamine works by inhibiting the enzyme acetylcholinesterase, which breaks down the neurotransmitter acetylcholine. By preventing this breakdown, galanthamine increases the concentration of acetylcholine in the brain, thereby alleviating some symptoms of Alzheimer's disease[1][4].
Claims of the Patent
The patent includes several claims that outline the specific methods and compositions for treating Alzheimer's disease with galanthamine. Key claims include:
- The use of galanthamine or its pharmaceutically acceptable salts for treating Alzheimer's disease.
- Specific dosage forms and administration methods.
- The therapeutic efficacy of galanthamine in improving cognitive functions in patients with Alzheimer's disease[1][4].
Patent Term and Extensions
The original expiration date of the patent was January 15, 2006. However, due to regulatory review periods, the patent term was extended under 35 U.S.C. § 156. The extension period was calculated to be 1,064 days, extending the patent's validity until a new expiration date[2].
Regulatory Approval and Commercial Use
The patent covers the human drug product REMINYL® (galantamine hydrobromide), which was approved by the FDA. REMINYL® was marketed by Janssen and later known as Razadyne®. This approval and subsequent commercial use underscore the patent's significance in clinical practice[2][5].
Patent Infringement Litigation
The patent was involved in several litigation cases, particularly when generic drug manufacturers filed abbreviated new drug applications (ANDAs) with the FDA. Janssen, the holder of the approved new drug application (NDA) for galanthamine hydrobromide, sued these manufacturers for patent infringement. The defendants conceded infringement of certain claims, and the court addressed issues of anticipation, obviousness, and enablement[5].
Patent Landscape for Alzheimer's Disease Treatments
The patent landscape for Alzheimer's disease treatments is highly active, with numerous patent filings since 2000. According to a patent analytics report, there have been 3,881 unique patent families related to Alzheimer's disease treatment and diagnostic technologies. Major players include Merck Sharp & Dohme (MSD), Roche, AstraZeneca, Pfizer, Elan Pharmaceuticals, and Taisho Pharmaceuticals. The United States, Japan, and the United Kingdom are among the top countries in terms of patent filings in this area[3].
Global Patent Filing Trends
The use of the Patent Cooperation Treaty (PCT) route is prevalent for patent applications related to Alzheimer's disease. This allows for a unified filing date across 148 contracting states and facilitates global patent protection. The report highlights a gradual decrease in patent filings since 2006 but notes continued significant activity, especially in pharmaceuticals, biologics, and genetic engineering[3].
Top Applicants and Regions
The top applicants in the Alzheimer's disease patent landscape include pharmaceutical giants and research institutions. The United States leads in the number of patent families, followed by Japan and the United Kingdom. Other significant contributors include European countries like Germany, Sweden, and France, as well as Asian countries such as China and South Korea[3].
Collaboration and Innovation
The patent landscape indicates strong collaboration among various entities, including academic institutions and pharmaceutical companies. This collaboration drives innovation and the development of new treatments and diagnostic tools for Alzheimer's disease. For example, the Chinese Academy of Sciences, Seoul National University, and the Korean Institute of Science and Technology are among the active contributors[3].
Impact on Treatment and Research
The patent has significantly impacted the treatment of Alzheimer's disease by providing a clinically approved method using galanthamine. It has also spurred further research into cholinesterase inhibitors and other therapeutic approaches. The commercial success of REMINYL® and Razadyne® has demonstrated the viability of galanthamine as a treatment option, encouraging continued innovation in the field[1][4].
Key Takeaways
- Galanthamine as a Treatment: The patent introduced galanthamine as a viable treatment for Alzheimer's disease.
- Patent Term Extension: The patent term was extended due to regulatory review periods.
- Commercial Use: The patent covered the FDA-approved drug REMINYL® (galantamine hydrobromide).
- Litigation: The patent was involved in significant litigation regarding generic drug applications.
- Global Patent Landscape: The patent is part of a highly active landscape with major pharmaceutical companies and research institutions contributing to Alzheimer's disease treatments.
FAQs
Q: What is the primary compound used in the treatment method described in US Patent 4,663,318?
A: The primary compound is galanthamine, a cholinesterase inhibitor.
Q: When was US Patent 4,663,318 granted?
A: The patent was granted on May 5, 1987.
Q: What is the commercial name of the drug covered by this patent?
A: The commercial name is REMINYL® (later known as Razadyne®).
Q: Why was the patent term extended?
A: The patent term was extended due to the regulatory review period under 35 U.S.C. § 156.
Q: Who are the major players in the Alzheimer's disease patent landscape?
A: Major players include Merck Sharp & Dohme (MSD), Roche, AstraZeneca, Pfizer, Elan Pharmaceuticals, and Taisho Pharmaceuticals.
Cited Sources:
- US4663318A - Method of treating Alzheimer's disease - Google Patents
- NOTICE OF FINAL DETERMINATION - USPTO
- Patent Analytics Report: Alzheimer's Disease - IP Australia
- US Patent for Method of treating Alzheimer's disease - Justia Patents
- In re `318 Patent Infringement Litigation - Casetext
