United States Patent 10,835,499: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,835,499, issued to Corium Inc., pertains to a novel combination drug therapy for treating resistant depression. This patent is significant in the pharmaceutical sector, particularly in the field of psychiatric treatments. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Patent Title and Assignee
The patent titled "Combination Drug Therapy for Treating Resistant Depression" is assigned to Corium Inc., a company known for its innovative approaches in drug delivery and therapeutic treatments.
Inventors and Filing Date
The patent was filed by the inventors associated with Corium Inc., although specific names are not provided in the publicly available summary. The filing date and the grant date are crucial for understanding the patent's timeline and its position within the patent landscape.
Scope of the Patent
Therapeutic Application
The patent describes a combination drug therapy that combines bupropion and dextromethorphan to treat resistant depression. This combination is designed to address the limitations of single-agent therapies and provide a more effective treatment option for patients who do not respond well to conventional treatments[2].
Mechanism of Action
Bupropion, an antidepressant, and dextromethorphan, an NMDA receptor antagonist, work synergistically to modulate neurotransmitter levels and receptor activity in the brain. This dual-action approach aims to enhance the therapeutic efficacy and reduce the side effects associated with individual drugs.
Claims of the Patent
Independent and Dependent Claims
The patent includes both independent and dependent claims that define the scope of the invention. Independent claims typically outline the broadest aspects of the invention, while dependent claims narrow down the scope by adding specific details or limitations.
- Independent Claims: These claims define the core elements of the combination therapy, including the specific drugs used (bupropion and dextromethorphan) and their therapeutic application in treating resistant depression.
- Dependent Claims: These claims may include specific dosages, administration methods, and formulations that are part of the invention[2].
Patent Landscape
Technology Field
The patent falls under the "Drugs and Medical Instruments" field, one of the six broad technology fields categorized by the National Bureau of Economics Research (NBER) classification scheme used by the USPTO[1].
Current Trends
In recent years, there has been a significant increase in the number of patents filed in the pharmaceutical sector, particularly for combination therapies and novel drug delivery systems. This trend reflects the industry's focus on developing more effective and targeted treatments.
Allowance Rate
The allowance rate for patents in the "Drugs and Medical Instruments" field has decreased over time. According to a study by Carley, Hegde, and Marco, only 55.8% of patent applications in this field were granted without using continuation procedures between 1996 and 2013[1].
Competitive Landscape
Similar Patents
Other recent patents in the pharmaceutical sector include innovations such as transdermal patches and biodegradable polymer microsphere compositions. For example, a patent by Adare Pharmaceuticals USA, Inc. describes an injectable formulation containing an active drug and a mixture of biodegradable polymer and an ethyl cellulose derivative[2].
Market Impact
The combination therapy patented by Corium Inc. has the potential to significantly impact the market for treatments of resistant depression. By offering a more effective and possibly safer alternative, this therapy could capture a substantial share of the market, especially if it gains regulatory approvals and clinical acceptance.
Legal and Regulatory Considerations
Patent Term and Extensions
The patent term for U.S. patents is generally 20 years from the filing date. However, patent term adjustments (PTAs) and extensions can be granted due to delays in the prosecution process or other factors. Understanding these legal aspects is crucial for maintaining the patent's validity and enforcing its claims[4].
Obviousness-Type Double Patenting (ODP)
Patents must also be scrutinized for ODP, which can invalidate claims if they are deemed obvious over earlier patents. This was a key issue in the case of In re Cellect, LLC, where multiple patents were found to be unpatentable due to ODP[4].
Key Takeaways
- Combination Therapy: The patent involves a combination of bupropion and dextromethorphan for treating resistant depression.
- Scope and Claims: The patent includes independent and dependent claims defining the core elements and specific details of the therapy.
- Patent Landscape: The patent is part of a broader trend in pharmaceutical innovations, particularly in combination therapies and novel drug delivery systems.
- Allowance Rate: The allowance rate for patents in the "Drugs and Medical Instruments" field has been decreasing.
- Competitive Landscape: The patent competes with other recent pharmaceutical innovations, such as transdermal patches and biodegradable polymer microsphere compositions.
- Legal and Regulatory Considerations: Understanding patent term adjustments, extensions, and ODP is crucial for maintaining the patent's validity.
FAQs
What is the main therapeutic application of U.S. Patent 10,835,499?
The main therapeutic application is the treatment of resistant depression using a combination of bupropion and dextromethorphan.
Who is the assignee of U.S. Patent 10,835,499?
The assignee is Corium Inc.
What are the key components of the combination therapy described in the patent?
The key components are bupropion and dextromethorphan, which work synergistically to treat resistant depression.
How does the allowance rate for patents in the "Drugs and Medical Instruments" field impact this patent?
The decreasing allowance rate in this field indicates a more stringent review process, which could affect the patent's validity and the likelihood of similar patents being granted in the future.
What legal considerations are important for maintaining the validity of U.S. Patent 10,835,499?
Understanding patent term adjustments, extensions, and obviousness-type double patenting (ODP) is crucial for maintaining the patent's validity.
Sources
- Carley, M., Hegde, D., & Marco, A. (2015). What Is the Probability of Receiving a US Patent? Yale Journal of Law & Technology, 17, 203.
- Neelam Sharma, M.S., & Hemant N. Joshi, Ph.D., MBA. (2021). P.I.N. Points - Patent Innovation News. American Pharmaceutical Review.
- USPTO. (2017). Patent Claims Research Dataset. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- United States Court of Appeals for the Federal Circuit. (2023). In re Cellect, LLC. Retrieved from https://cafc.uscourts.gov/opinions-orders/22-1293.OPINION.8-28-2023_2181381.pdf
