United States Patent 11,285,129: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,285,129, titled "Treatment of circadian rhythm disorders," is a significant patent in the pharmaceutical sector, particularly in the treatment of circadian rhythm disorders using melatonin agonists. This article delves into the scope, claims, and the broader patent landscape surrounding this patent.
Background on Circadian Rhythm Disorders
Circadian rhythm disorders are conditions that affect the body's internal clock, leading to sleep disturbances and other health issues. Treatments for these disorders often involve medications that regulate the body's natural sleep-wake cycle.
Overview of the Patent
Title and Abstract
The patent, titled "Treatment of circadian rhythm disorders," involves the use of a melatonin agonist, specifically tasimelteon, in treating these conditions. The abstract highlights the invention's focus on using melatonin agonists to address free-running type non-24-hour sleep-wake disorder and other circadian rhythm disorders[2].
Scope of the Patent
Claim Coverage
The patent claims cover various aspects of using melatonin agonists for therapeutic purposes. Here are some key points:
- Therapeutic Use: The patent claims the use of tasimelteon for treating circadian rhythm disorders, including non-24-hour sleep-wake disorder, which is common in blind individuals.
- Dosage and Administration: The claims specify the dosage and administration methods of tasimelteon, ensuring its efficacy and safety in treating these disorders.
- Exclusion of Certain Combinations: The patent excludes the use of tasimelteon in combination with strong CYP1A2 inhibitors, which could affect its metabolism and efficacy[1].
Claim Structure and Metrics
Independent Claim Length and Count
The scope of the patent can be analyzed using metrics such as independent claim length (ICL) and independent claim count (ICC). These metrics help in understanding the breadth and clarity of the patent claims. Generally, narrower claims with shorter lengths and fewer counts are associated with higher patent quality and a shorter examination process[3].
Patent Expiration Dates
The patent 11,285,129 is part of a larger patent family with various expiration dates. Key expiration dates for related patents include:
- January 25, 2033: Several related patents expire on this date, indicating a significant period of exclusivity for the branded product[5].
- February 12, 2035: Other patents in the family expire on this date, extending the exclusivity period further[5].
Patent Landscape and Litigation
Continuation and Divisional Applications
The pharmaceutical industry often employs a strategy of filing continuation and divisional applications to extend patent protection. This practice allows brand companies to maintain an early priority date and keep patent families alive even if related patents are invalidated. However, this approach can lead to increased litigation costs and uncertainty for generic drug companies[4].
Litigation Examples
The case involving Allergan and Sandoz illustrates the complexities and costs associated with patent litigation in the pharmaceutical sector. Allergan's use of terminal disclaimers and repeated redrafting of claims led to prolonged litigation, costing Sandoz significantly and delaying the launch of generic products[4].
Impact on Generic Drug Development
The extensive use of continuation and divisional applications, along with the practice of terminal disclaimers, can hinder the development and launch of generic drugs. This approach can create a perpetual cycle of litigation, increasing costs and risks for generic drug companies and delaying patient access to affordable medications[4].
Public and Economic Implications
Innovation and Access to Medications
The broad and often unclear claims in pharmaceutical patents can diminish innovation by increasing licensing and litigation costs. This can lead to delayed or blocked generic entries, affecting public health and the economy. The Hatch-Waxman Act aims to provide a clear and efficient path to generic entry, but the current patent landscape often complicates this objective[4].
Regulatory Changes
Proposed regulatory changes, such as those related to terminal disclaimers, aim to mitigate these issues by requiring patentees to overcome obviousness-type double patenting rejections. This could reduce the burden on generic drug companies and the court system, promoting a more efficient and innovative pharmaceutical market[4].
Key Takeaways
- Patent Scope and Claims: The patent 11,285,129 covers the therapeutic use of tasimelteon for circadian rhythm disorders, with specific exclusions and dosage guidelines.
- Patent Metrics: The use of independent claim length and count can help in assessing the quality and breadth of patent claims.
- Patent Expiration Dates: The patent family includes various expiration dates, extending exclusivity periods.
- Litigation and Generic Drug Development: The patent landscape can significantly impact generic drug development and patient access to medications.
- Public and Economic Implications: The current patent practices can affect innovation, public health, and the economy, highlighting the need for regulatory changes.
FAQs
What is the primary focus of United States Patent 11,285,129?
The primary focus of this patent is the use of melatonin agonists, specifically tasimelteon, in treating circadian rhythm disorders.
How do continuation and divisional applications affect patent litigation?
Continuation and divisional applications can extend patent protection but also lead to increased litigation costs and uncertainty for generic drug companies.
What are the implications of broad and unclear patent claims?
Broad and unclear patent claims can diminish innovation by increasing licensing and litigation costs, delaying generic entries, and affecting public health and the economy.
What regulatory changes are proposed to address patent litigation issues?
Proposed changes include requiring patentees to overcome obviousness-type double patenting rejections, which could reduce litigation burdens and promote a more efficient pharmaceutical market.
How do patent expiration dates impact the availability of generic drugs?
Patent expiration dates determine when generic versions of drugs can be launched. Multiple patents with different expiration dates can extend the exclusivity period for branded products, delaying generic entries.
Sources
- FDA Approval Letter for Tasimelteon Capsules: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211601Orig1s000ltr.pdf
- Pharmaceutical drugs covered by patent 11,285,129: https://www.drugpatentwatch.com/p/patent/11285129
- Patent Claims and Patent Scope: https://www.hoover.org/sites/default/files/ip2-wp16001-paper.pdf
- USPTO Comment on Terminal Disclaimer: https://downloads.regulations.gov/PTO-P-2024-0003-0328/attachment_1.pdf
- Generic Hetlioz Availability: https://www.drugs.com/availability/generic-hetlioz.html
