Understanding the Scope and Claims of United States Patent 10,940,156
Introduction
United States Patent 10,940,156, titled "Neuroactive steroids, compositions, and uses thereof," is a significant patent held by Sage Therapeutics, Inc. This patent is crucial for the protection and development of Zulresso, a drug used for treating postpartum depression. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape.
Patent Overview
- Patent Number: US 10,940,156 B2
- Date of Patent: March 9, 2021
- Inventors: Stephen Jay Kanes, Brynlawn, PA; Helen Colquhoun, Arlington, MA
- Assignee: Sage Therapeutics, Inc., Cambridge, MA[1][4].
Scope of the Patent
The patent covers neuroactive steroids, their compositions, and their uses, particularly in treating central nervous system (CNS) disorders. Here are some key aspects of the patent's scope:
Neuroactive Steroids
The patent focuses on neuroactive steroids, which are compounds that modulate the activity of neurotransmitter receptors, such as GABA receptors. These steroids have shown potential in treating various CNS disorders, including depression and anxiety[4].
Compositions
The patent describes various compositions that include neuroactive steroids. These compositions can be formulated for different modes of administration, such as oral, intravenous, or other delivery methods. The compositions may also include additional components like sulfoalkyl ether cyclodextrins to enhance the solubility and stability of the neuroactive steroids[1][4].
Uses
The patent outlines the therapeutic uses of these neuroactive steroids, particularly in the treatment of CNS disorders. This includes postpartum depression, for which Zulresso is specifically approved. The patent also mentions potential uses in treating other conditions such as anxiety disorders and sleep disorders[4].
Patent Claims
The claims of the patent are critical in defining the scope of protection. Here are some key points about the claims:
Independent Claims
The patent includes several independent claims that define the core inventions. These claims typically describe the neuroactive steroids, their compositions, and their therapeutic uses. For example, Claim 1 might describe a specific neuroactive steroid compound, while Claim 2 might describe a composition containing that compound for treating a CNS disorder[4].
Dependent Claims
Dependent claims further specify the inventions by adding additional limitations to the independent claims. These claims help to narrow down the scope and provide additional protection for specific aspects of the invention, such as particular dosages or administration methods[4].
Patent Landscape
Understanding the broader patent landscape is essential for strategizing market entry and competition.
Exclusivity and Patent Protection
Zulresso is protected by multiple US patents, including US 10,940,156 B2, which are set to expire in March 2037. This patent protection, combined with FDA exclusivity, provides Sage Therapeutics with significant market exclusivity. The generic launch date for Zulresso is estimated to be March 8, 2037, based on the patent and exclusivity timelines[2].
International Protection
While the US patents provide insights into exclusivity within the United States, Zulresso is also protected by patents in multiple countries. Understanding the global patent landscape is crucial for identifying markets with weaker patent protection, which could be ideal for generic entry points[2].
Metrics for Measuring Patent Scope
The scope of a patent can be measured using various metrics, such as independent claim length and independent claim count. These metrics help in assessing the breadth and clarity of the patent claims.
Claim Length and Count
Research has shown that narrower claims at publication are associated with a higher probability of grant and a shorter examination process. The examination process tends to narrow the scope of patent claims in terms of both claim length and claim count, especially when the duration of examination is longer[3].
Legal and Regulatory Aspects
The patent's legal status and regulatory environment are vital for its enforcement and protection.
Patent Maintenance and Litigation
The patent requires periodic maintenance fees to remain active. Any challenges or litigation related to the patent can affect its validity and scope. For instance, the patent has been open to challenges since June 18, 2023, which could potentially impact its exclusivity period[2].
FDA Exclusivity
In addition to patent protection, Zulresso benefits from FDA exclusivity, which grants the manufacturer sole marketing rights for a specified period. This exclusivity can run concurrently with the patent protection, further extending the market exclusivity period[5].
Impact on Innovation and Competition
The breadth and clarity of patent claims can significantly impact innovation and competition in the pharmaceutical industry.
Innovation Incentives
Patents with overly broad or unclear claims can diminish innovation incentives due to increased licensing and litigation costs. However, well-defined and narrowly scoped patents like US 10,940,156 B2 can encourage innovation by providing clear boundaries and incentives for further research and development[3].
Competitive Landscape
The patent landscape for Zulresso and similar neuroactive steroids influences the competitive dynamics in the market. Generic manufacturers must navigate this landscape carefully to identify opportunities for market entry without infringing on existing patents[2].
Key Takeaways
- Patent Scope: US 10,940,156 B2 covers neuroactive steroids, their compositions, and therapeutic uses, particularly in treating CNS disorders.
- Claims: The patent includes independent and dependent claims that define the core inventions and provide additional protection for specific aspects.
- Patent Landscape: Zulresso is protected by multiple US patents and international patents, with an estimated generic launch date in March 2037.
- Metrics for Scope: Narrower claims are associated with a higher probability of grant and shorter examination processes.
- Legal and Regulatory: The patent requires maintenance fees and is subject to challenges and litigation, with FDA exclusivity adding to its market protection.
FAQs
Q: What is the main subject of US Patent 10,940,156 B2?
A: The main subject is neuroactive steroids, their compositions, and their uses in treating CNS disorders.
Q: Who is the assignee of US Patent 10,940,156 B2?
A: The assignee is Sage Therapeutics, Inc., Cambridge, MA.
Q: When is the estimated generic launch date for Zulresso?
A: The estimated generic launch date for Zulresso is March 8, 2037.
Q: What metrics are used to measure the scope of a patent?
A: Metrics such as independent claim length and independent claim count are used to measure the scope of a patent.
Q: How does FDA exclusivity impact the market protection of Zulresso?
A: FDA exclusivity grants the manufacturer sole marketing rights for a specified period, which can run concurrently with patent protection, further extending market exclusivity.
Sources
- United States Patent and Trademark Office: US 10,940,156 B2 - Neuroactive steroids, compositions, and uses thereof.
- Pharsight: Zulresso patent expiration.
- Hoover Institution: Patent Claims and Patent Scope.
- Google Patents: US10940156B2 - Neuroactive steroids, compositions, and uses thereof.
- Drugs.com: Generic Zulresso Availability.
