United States Patent 5,908,850: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,908,850, titled "Method of treating attention deficit disorders with d-threo methylphenidate," is a significant patent in the pharmaceutical industry, particularly in the treatment of Attention Deficit Disorder (ADD) and Attention Deficit Hyperactivity Disorder (ADHD). This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent, filed on December 4, 1995, and granted on June 8, 1999, pertains to methods of treating certain Central Nervous System (CNS) disorders using d-threo methylphenidate, a specific enantiomer of methylphenidate[1].
Scope of the Patent
The scope of the patent is focused on the therapeutic use of d-threo methylphenidate for treating ADD and ADHD. This includes the administration of the drug in various forms and dosages to achieve optimal therapeutic effects while minimizing side effects.
Therapeutic Use
The patent describes the use of d-threo methylphenidate as a more effective and safer alternative to the racemic mixture of methylphenidate, which is commonly used in treatments for ADD and ADHD. The d-threo enantiomer is highlighted for its superior pharmacokinetic profile and reduced abuse potential[1].
Dosage and Administration
The patent details various methods of administering d-threo methylphenidate, including immediate release and sustained release formulations. This flexibility in dosage forms allows for tailored treatment plans to suit different patient needs[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- The method of treating ADD or ADHD using d-threo methylphenidate.
- Specific dosage forms, such as immediate release tablets or capsules.
- Sustained release formulations designed to provide a prolonged therapeutic effect[1].
Dependent Claims
- Various dosages and administration schedules.
- Combination therapies involving d-threo methylphenidate and other CNS active compounds.
- Methods for reducing the abuse potential of methylphenidate by using the d-threo enantiomer exclusively[1].
Patent Landscape
The patent landscape surrounding U.S. Patent 5,908,850 is complex and involves several key aspects:
Related Patents
- Other patents related to methylphenidate formulations, such as U.S. Patent Nos. 6,355,656 and 6,252,325, which also pertain to chronic, bolus administration and formulations with diminished abuse potential[1].
- These patents collectively form a robust intellectual property portfolio for the treatment of ADD and ADHD using methylphenidate and its enantiomers.
Litigation and Infringement
The patent has been involved in several legal disputes, particularly under the Hatch-Waxman Act, which governs the approval process for generic pharmaceuticals. For instance, Novartis, the marketer of FOCALIN IR (a product containing d-threo methylphenidate), has filed lawsuits against generic manufacturers alleging patent infringement[2].
Regulatory Environment
The Hatch-Waxman Act plays a crucial role in the patent landscape by allowing generic manufacturers to file Abbreviated New Drug Applications (ANDAs) while also providing a framework for resolving patent disputes. This act has been instrumental in the legal battles surrounding U.S. Patent 5,908,850[2].
Economic Value of the Patent
The economic value of U.S. Patent 5,908,850 can be significant, given its impact on the treatment of ADD and ADHD. Here are some insights into the valuation of such patents:
Valuation Methods
- The cost approach, which considers the development costs of the patent.
- The income approach, which evaluates the future benefits derived from the patent.
- The market approach, which looks at what similar patents have sold for in the market[4].
Market Transactions
- Transactions involving large patent portfolios, such as the sale of Nortel's patents to Rockstar Bidco for $4.5 billion, highlight the substantial value that can be attributed to pharmaceutical patents[4].
Impact on the Pharmaceutical Industry
U.S. Patent 5,908,850 has had a notable impact on the pharmaceutical industry:
Innovation in Treatment
- The patent has driven innovation in the development of more effective and safer treatments for ADD and ADHD.
- It has encouraged further research into the therapeutic uses of enantiomers, which can offer improved pharmacological profiles compared to racemic mixtures[1].
Market Competition
- The patent has influenced market competition by setting a standard for the use of d-threo methylphenidate in therapeutic applications.
- Generic manufacturers must navigate the patent landscape carefully to avoid infringement, which can lead to significant legal and financial consequences[2].
Key Takeaways
- Therapeutic Use: U.S. Patent 5,908,850 is focused on the therapeutic use of d-threo methylphenidate for treating ADD and ADHD.
- Claims and Scope: The patent includes claims related to dosage forms, administration methods, and combination therapies.
- Patent Landscape: The patent is part of a broader intellectual property portfolio and has been involved in significant legal disputes.
- Economic Value: The patent holds substantial economic value, as evidenced by its impact on the pharmaceutical industry and market transactions.
- Industry Impact: The patent has driven innovation and influenced market competition in the treatment of CNS disorders.
FAQs
What is the main subject of U.S. Patent 5,908,850?
The main subject of U.S. Patent 5,908,850 is the method of treating Attention Deficit Disorder (ADD) and Attention Deficit Hyperactivity Disorder (ADHD) using d-threo methylphenidate.
What are the key claims of the patent?
The key claims include the method of treating ADD or ADHD using d-threo methylphenidate, specific dosage forms, and sustained release formulations.
How has the patent been involved in legal disputes?
The patent has been involved in legal disputes under the Hatch-Waxman Act, particularly with generic manufacturers alleging patent infringement.
What is the economic value of such patents?
The economic value can be significant, with valuation methods including cost, income, and market approaches. Market transactions involving similar patents can also indicate substantial value.
How has the patent impacted the pharmaceutical industry?
The patent has driven innovation in treatment options for ADD and ADHD, set standards for therapeutic use, and influenced market competition among pharmaceutical companies.
What is the significance of the Hatch-Waxman Act in this context?
The Hatch-Waxman Act streamlines the approval process for generic pharmaceuticals and provides a framework for resolving patent disputes, which is crucial for the legal battles surrounding U.S. Patent 5,908,850.
Sources
- US5908850A - Method of treating attention deficit disorders with d-threo methylphenidate - Google Patents
- NOT FOR PUBLICATION UNITED STATES DISTRICT COURT - GovInfo
- Patent Claims Research Dataset - USPTO
- The value of a patent - Perpetual Motion Patents
