Understanding the Scope and Claims of United States Patent 8,278,485
Introduction to Patent 8,278,485
United States Patent 8,278,485, hereafter referred to as the '485 patent, is a crucial intellectual property asset held by Newron Pharmaceuticals S.p.A. This patent is part of a broader portfolio related to the treatment of Parkinson's Disease, particularly focusing on the use of safinamide and other related compounds.
Patent Overview
Issuance and Expiration
The '485 patent was issued on October 2, 2012, and is set to expire on June 8, 2027[4][5].
Inventors and Assignees
The inventors listed for this patent include Fariello Ruggero, Cattaneo Carlo, Salvati Patricia, and Benatti Luca. The assignee is Newron Pharmaceuticals S.p.A.[5].
Claims and Scope
Method of Treatment
The '485 patent describes methods for treating idiopathic Parkinson's Disease. The claims are centered around the administration of safinamide, safinamide derivatives, or monoamine oxidase B (MAO-B) inhibitors in combination with other Parkinson's Disease treatments, such as levodopa or dopamine agonists[5].
Key Claim Terms
- Stable Dose of Levodopa: A critical term in the patent is "stable dose of levodopa." This term has been subject to interpretation in legal proceedings. Plaintiffs have argued that it means a dose that neither increases nor decreases, ensuring a consistent therapeutic regimen[2][3].
Combination Therapy
The patent emphasizes the combination of safinamide with a stable dose of levodopa. This combination is designed to enhance the therapeutic efficacy in treating Parkinson's Disease. The claims specify the oral dosage schedule for safinamide, typically ranging from about 0.5 mg/kg/day to about 5 mg/kg/day[2].
Legal and Regulatory Context
Claim Construction
The construction of claims in the '485 patent has been a subject of legal dispute. The court relies on intrinsic evidence, including the claims themselves, the specification, and the prosecution history of the patent, to determine the legally operative meaning of claim language. This approach ensures that the claims are interpreted in a manner consistent with the intent of the inventors and the scope of the invention[1][2].
Indefiniteness
The '485 patent must comply with the definiteness requirement under Section 112 of Title 35 of the U.S. Code. This means the claims must be written in a way that clearly defines the subject matter of the invention, providing notice to the public about the extent of the legal protection afforded by the patent[1].
Patent Landscape and Analytics
Patent Coverage Matrix
To understand the full scope of protection offered by the '485 patent, companies often use a Claim Coverage Matrix. This tool categorizes patents by claims and overarching scope concepts, helping to identify which patents and claims are actively protecting the intellectual property. It also highlights gaps or opportunities in the patent landscape[3].
Claim Charts
Interactive claim charts generated by software like ClaimScape® can be used to review patent coverage. These charts help technical experts determine whether a particular scope concept is applicable to a target product or method, ensuring that there are no gaps in the current coverage and highlighting future design opportunities[3].
Market and Competitive Impact
Generic Availability
The expiration of the '485 patent on June 8, 2027, will open the door for generic versions of safinamide. This could significantly impact the market dynamics, as generic drugs often reduce the cost and increase the accessibility of treatments for Parkinson's Disease[4][5].
Therapeutic Equivalence
The FDA has determined that generic versions of safinamide tablets are bioequivalent and therapeutically equivalent to the reference listed drug. This ensures that patients will have access to effective and affordable treatment options once the patent expires[4].
Conclusion
The '485 patent is a vital component of Newron Pharmaceuticals' intellectual property portfolio, providing a specific method for treating Parkinson's Disease through the combination of safinamide and levodopa. Understanding the scope and claims of this patent is crucial for both the company and its competitors, as it defines the boundaries of legal protection and future development opportunities.
Key Takeaways
- The '485 patent describes methods for treating Parkinson's Disease using safinamide in combination with levodopa.
- The term "stable dose of levodopa" is critical and has been subject to legal interpretation.
- The patent expires on June 8, 2027, which will impact the market availability of generic versions of safinamide.
- Patent analytics tools are essential for managing and understanding the patent landscape.
FAQs
Q: What is the main subject matter of the '485 patent?
A: The '485 patent focuses on methods for treating idiopathic Parkinson's Disease using safinamide in combination with other treatments like levodopa.
Q: When does the '485 patent expire?
A: The '485 patent is set to expire on June 8, 2027.
Q: What is the significance of the term "stable dose of levodopa" in the patent?
A: The term "stable dose of levodopa" refers to a consistent therapeutic regimen where the dose of levodopa does not increase or decrease, ensuring a stable treatment regimen.
Q: How does the expiration of the '485 patent affect the market?
A: The expiration of the patent will allow for the introduction of generic versions of safinamide, potentially reducing costs and increasing accessibility of the treatment.
Q: What tools are used to analyze and manage the patent landscape for the '485 patent?
A: Tools such as Claim Coverage Matrix and interactive claim charts generated by software like ClaimScape® are used to analyze and manage the patent landscape.
Sources
- IN THE UNITED STATES DISTRICT COURT - District of Delaware. Retrieved from https://www.ded.uscourts.gov/sites/ded/files/opinions/21-843.pdf
- Intrinsic Evidence Decodes Disputed Claim Terms. Retrieved from https://vlex.com/vid/intrinsic-evidence-decodes-disputed-953839755
- Patent Analytics | Intellectual Property Law. Retrieved from https://www.slwip.com/services/patent-analytics/
- US FOOD & DRUG - accessdata.fda.gov. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215945Orig1s000TA_ltr.pdf
- Generic Xadago Availability - Drugs.com. Retrieved from https://www.drugs.com/availability/generic-xadago.html
