United States Patent 10,959,976: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,959,976, titled "Methods and compositions for treating excessive sleepiness," is a significant patent in the pharmaceutical sector, particularly in the treatment of sleep disorders. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent, granted to Axsome Therapeutics, Inc., focuses on carbamoyl phenylalaninol compounds and their methods of use in treating disorders associated with excessive sleepiness. This includes conditions such as narcolepsy, sleep apnea, and shift work sleep disorder[5].
Scope of the Patent
Therapeutic Use
The patent covers the therapeutic use of carbamoyl phenylalaninol compounds, which are designed to modulate the brain's neurotransmitter systems to reduce excessive sleepiness. These compounds are part of a broader class of drugs aimed at improving wakefulness and alertness[5].
Chemical Composition
The invention specifically relates to the synthesis, formulation, and administration of these compounds. It includes various salts, esters, and other derivatives that are pharmaceutically acceptable. The chemical structure and synthesis methods are detailed to ensure the compounds' efficacy and stability[1].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover:
- The carbamoyl phenylalaninol compounds themselves.
- Methods of treating excessive sleepiness using these compounds.
- Pharmaceutical compositions containing these compounds.
- Specific dosing regimens and administration methods[1].
Dependent Claims
Dependent claims further specify the independent claims by detailing:
- Particular salts and esters of the compounds.
- Specific dosages and treatment durations.
- Combination therapies involving other drugs.
- Methods for maintaining therapeutic effects over time[1].
Patent Landscape
Related Patents
The patent landscape surrounding US 10,959,976 includes a multitude of related patents, many of which are also held by Axsome Therapeutics. These patents cover various aspects of the same therapeutic area, including other compounds and methods for treating sleep disorders. For example, patents such as US 11,839,598 and US 11,850,226 are part of the same family and cover similar but distinct inventions[2].
Litigation and Challenges
The patent has been subject to legal challenges, particularly from generic drug manufacturers seeking to market similar products before the patent's expiration. Hetero Labs, for instance, has filed Paragraph IV certifications alleging that the claims of US 10,959,976 are invalid, unenforceable, or not infringed by their proposed product[2].
Global Patent System
The patent is part of a global patent family, with corresponding patents filed in other jurisdictions. Tools like the Global Dossier provided by the USPTO facilitate the management and analysis of these international patent families, allowing stakeholders to track office actions, citations, and other relevant data across different patent offices[4].
Impact on the Pharmaceutical Industry
Innovation and Competition
The patent represents a significant innovation in the treatment of sleep disorders, offering new therapeutic options for patients. However, it also creates a competitive landscape where generic manufacturers and other pharmaceutical companies must navigate the patent's claims to avoid infringement or challenge its validity[2].
Market Dominance
Axsome Therapeutics, by holding this patent, gains a competitive advantage in the market for sleep disorder treatments. This can lead to higher market share and revenue until the patent expires or is successfully challenged.
Challenges and Controversies
Generic Challenges
Generic drug manufacturers often challenge patents like US 10,959,976 to enter the market earlier. These challenges can lead to lengthy legal battles and significant legal costs for both parties involved[2].
Patient Access
The patent's exclusivity period can impact patient access to affordable treatments. Generic versions of the drug, which are typically cheaper, cannot be marketed until the patent expires or is invalidated.
Key Takeaways
- Therapeutic Focus: The patent is centered on treating excessive sleepiness using carbamoyl phenylalaninol compounds.
- Chemical and Method Claims: It includes detailed claims on the chemical composition, synthesis, and administration methods.
- Litigation: The patent is subject to legal challenges from generic manufacturers.
- Global Implications: Part of a global patent family, managed through tools like the Global Dossier.
- Market Impact: Provides Axsome Therapeutics with a competitive advantage in the sleep disorder treatment market.
FAQs
What is the primary focus of United States Patent 10,959,976?
The primary focus is on methods and compositions for treating excessive sleepiness using carbamoyl phenylalaninol compounds.
Which company holds this patent?
Axsome Therapeutics, Inc. holds this patent.
What are the key claims of the patent?
The key claims include the carbamoyl phenylalaninol compounds themselves, methods of treating excessive sleepiness, pharmaceutical compositions, and specific dosing regimens.
Why is this patent significant in the pharmaceutical industry?
It represents a significant innovation in treating sleep disorders and provides Axsome Therapeutics with a competitive advantage in the market.
What challenges has the patent faced?
The patent has faced legal challenges from generic drug manufacturers seeking to market similar products before the patent's expiration.
How does the patent impact patient access to treatments?
The patent's exclusivity period can limit patient access to affordable generic versions of the drug until the patent expires or is invalidated.
Sources
- US10959976B2 - Methods and compositions for treating excessive sleepiness - Google Patents
- Case 2:24-cv-03999 Document 1 Filed 03/19/24 - Insight.RPXcorp
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- Pharmaceutical drugs covered by patent 10,959,976 - DrugPatentWatch
