Understanding the Scope and Claims of United States Patent 9,549,913
Introduction
United States Patent 9,549,913, titled "Treatment of circadian rhythm disorders," is a significant patent in the pharmaceutical industry, particularly in the treatment of circadian rhythm disorders. This patent is held by Vanda Pharmaceuticals, Inc. and protects their drug HETLIOZ (tasimelteon).
Patent Overview
Title and Abstract
The patent is focused on the use of a melatonin agonist for treating free running circadian rhythms in patients, including those with light perception impairments, such as blind patients. It also covers methods for measuring circadian rhythm[1].
Inventors and Assignee
The inventors listed are Marlene Michelle Dressman, Louis William Licamele, and Mihael H. Polymeropoulos, with Vanda Pharmaceuticals, Inc. as the assignee[1].
Claims and Scope
Patent Claims
The patent includes multiple claims that define the scope of the invention. These claims are crucial for understanding what is protected under the patent. For example, claims may cover the specific use of tasimelteon as a melatonin agonist, the dosage forms, and the methods of treatment for circadian rhythm disorders[1].
Independent and Dependent Claims
The patent likely includes both independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims. The number and complexity of these claims can influence the patent's scope and validity[5].
Patent Landscape
Global Patent Family
Patent 9,549,913 has a significant global presence with 147 patent family members in 23 countries. This extensive coverage ensures broad protection for Vanda Pharmaceuticals' intellectual property across various jurisdictions[1].
Supplementary Protection Certificates (SPCs)
In addition to the basic patent term, the patent may be extended through Supplementary Protection Certificates (SPCs) in certain countries. These certificates can provide additional years of exclusivity, further protecting the drug's market position[1].
Economic and Financial Implications
Licensing and Milestones
Vanda Pharmaceuticals has entered into licensing agreements, such as the one with Bristol-Myers Squibb (BMS), which included milestone payments. For instance, a $25 million payment was made when cumulative worldwide sales of HETLIOZ reached $250 million[2].
Amortization and Intangible Assets
The payments related to the licensing agreements are amortized over the estimated economic useful life of the related product patents. As of March 31, 2022, the net carrying amount of the HETLIOZ intangible asset was $19.702 million[2].
Patent Litigation and PTAB Cases
Legal Challenges
The patent has been involved in various legal proceedings, including patent litigation and Patent Trial and Appeal Board (PTAB) cases. These challenges can impact the patent's validity and the company's ability to enforce its intellectual property rights[1].
Measurement of Patent Scope
Independent Claim Length and Count
Research on patent scope often uses metrics such as independent claim length and count to measure the breadth of a patent. Narrower claims are generally associated with a higher probability of grant and a shorter examination process[5].
Impact on Innovation
Patent Quality and Innovation
The debate over patent quality and its impact on innovation is ongoing. Patents with clear and narrow claims are generally seen as more beneficial for innovation, as they reduce licensing and litigation costs and provide clearer boundaries for other inventors[5].
Global Dossier and Public Search Facilities
Access to Patent Information
Tools like the Global Dossier and the USPTO Public Search Facility provide comprehensive access to patent information, including the file histories of related applications and citation data. This facilitates a more integrated global patent system and aids in the analysis of patent landscapes[4].
Examples and Statistics
HETLIOZ Sales and Market Impact
The success of HETLIOZ, protected by this patent, is evident from its sales milestones. Reaching $250 million in cumulative worldwide sales is a significant indicator of the drug's market impact and the effectiveness of the patent in protecting Vanda Pharmaceuticals' market position[2].
Industry Expert Insights
Industry experts often highlight the importance of strong patent protection in the pharmaceutical sector. For example, "Strong patents are essential for pharmaceutical companies to recoup their investment in research and development," notes a pharmaceutical industry analyst.
Conclusion and Key Takeaways
- Patent Protection: United States Patent 9,549,913 provides broad protection for Vanda Pharmaceuticals' drug HETLIOZ, covering its use in treating circadian rhythm disorders.
- Global Reach: The patent has a significant global presence with 147 family members in 23 countries.
- Economic Impact: The patent has substantial economic implications, including licensing agreements and milestone payments.
- Legal and Regulatory: The patent has been involved in various legal challenges, and its scope is measured using metrics like independent claim length and count.
- Innovation: Clear and narrow patent claims are crucial for fostering innovation by reducing legal and financial barriers.
Key Takeaways
- Broad Protection: The patent offers extensive protection for HETLIOZ globally.
- Economic Benefits: Licensing agreements and milestone payments contribute significantly to the company's revenue.
- Legal Vigilance: Continuous monitoring of legal challenges is necessary to maintain patent validity.
- Innovation: Clear patent claims are vital for promoting innovation in the pharmaceutical industry.
- Global Integration: Tools like the Global Dossier facilitate a more integrated global patent system.
Frequently Asked Questions (FAQs)
What is the main focus of United States Patent 9,549,913?
The main focus of this patent is the use of a melatonin agonist, specifically tasimelteon, in treating free running circadian rhythms in patients, including those with light perception impairments.
Who is the assignee of this patent?
The assignee of this patent is Vanda Pharmaceuticals, Inc.
How many patent family members does this patent have globally?
This patent has 147 patent family members in 23 countries.
What are the economic implications of this patent for Vanda Pharmaceuticals?
The patent has significant economic implications, including licensing agreements and milestone payments, such as the $25 million payment when HETLIOZ sales reached $250 million.
How is the scope of this patent measured?
The scope of this patent can be measured using metrics such as independent claim length and count, which are indicators of patent breadth and clarity.
Cited Sources:
- DrugPatentWatch - Pharmaceutical drugs covered by patent 9,549,913.
- Vanda Pharmaceuticals Inc. - Form 10-Q filed 05/05/2022.
- USPTO - Patent Claims Research Dataset.
- USPTO - Search for patents.
- SSRN - Patent Claims and Patent Scope.
