Detailed Analysis of the Scope and Claims of United States Patent 8,076,515
Introduction
United States Patent 8,076,515, issued on December 13, 2011, is a significant patent in the pharmaceutical sector, particularly related to the production and use of therapeutically active compounds. This analysis will delve into the scope, claims, and patent landscape of this patent.
Patent Overview
The patent, titled "Process for the production of 2-[4-(3- and 2-fluorobenzyloxy)benzylamino]propanamides," is held by Newron Pharmaceuticals S.p.A. and was invented by Elena Barbanti et al.[1][4].
Claims of the Patent
The patent includes multiple claims that cover various aspects of the invention:
Method of Manufacturing
The patent claims a process for producing high purity therapeutically active compounds, specifically 2-[4-(3- and 2-fluorobenzyloxy)benzylamino]propanamides. For example, Claim 1 describes a detailed process for obtaining these compounds[1].
Approved Product
The patent also claims the approved product itself, which is safinamide mesylate, marketed under the name XADAGO. This is evident from claims such as Claim 32[1].
Method of Using the Approved Product
Additionally, the patent includes claims related to the method of using the approved product. For instance, Claim 40 outlines a method of using safinamide mesylate[1].
Patent Scope
The scope of the patent is broad and covers several key areas:
Therapeutic Activity
The patent is classified under various therapeutic categories, including drugs for disorders of the nervous system, such as antipsychotics, antidepressants, and treatments for neurodegenerative disorders like Parkinson's disease and Alzheimer's disease[4].
Chemical Preparation
The patent details the chemical preparation of carboxylic acid amides, specifically the synthesis of 2-[4-(3- and 2-fluorobenzyloxy)benzylamino]propanamides. This falls under the classification C07C231/00 in the International Patent Classification (IPC)[4].
Patent Landscape
Understanding the patent landscape is crucial for identifying gaps, opportunities, and potential threats.
Claim Coverage Matrix
A Claim Coverage Matrix can help in identifying which patents and claims are actively protecting the intellectual property related to this invention. This involves categorizing patents by claims and scope concepts, which can be efficiently managed using tools like ClaimScape® software[3].
Regulatory Review and Approval
The patent is associated with the approved product XADAGO (safinamide mesylate), which has undergone regulatory review and received permission for commercial marketing. This is a critical aspect of the patent landscape, as it ensures the product's legitimacy and marketability[1].
Extension of Patent Term
The patent term for U.S. Patent 8,076,515 was subject to an extension application under 35 U.S.C. § 156, which allows for the extension of the patent term due to regulatory review periods. The term was extended to December 10, 2028, from the original expiration date of June 8, 2027[1].
Post-Issuance Activities
There have been several post-issuance activities related to this patent:
Certificate of Correction
A Certificate of Correction was issued on January 15, 2013, addressing any errors or inaccuracies in the original patent document[1].
Maintenance Fees
The first maintenance fee for the patent was paid on June 15, 2015, ensuring the patent remains in force. The second maintenance fee is not yet due[1].
Economic and Strategic Implications
The patent's economic and strategic implications are significant:
Market Protection
The patent provides Newron Pharmaceuticals S.p.A. with exclusive rights to manufacture, use, and sell safinamide mesylate, protecting their market share and preventing generic competition until the patent expires[1].
Research and Development
The detailed claims and scope of the patent can guide further research and development in related therapeutic areas, helping to identify potential future directions and opportunities[3].
Analytical Tools and Datasets
For a comprehensive analysis, tools like the Patent Claims Research Dataset provided by the USPTO can be invaluable. This dataset contains detailed information on claims from U.S. patents and can help in understanding the scope and trends of patent claims[2].
Expert Insights
Industry experts emphasize the importance of thorough patent analytics to understand the coverage and gaps in intellectual property protection. Tools like Claim Coverage Matrix and ClaimScape® software are essential for managing and analyzing large numbers of patent claims efficiently[3].
Illustrative Statistics
- The Patent Claims Research Dataset, for instance, includes data on over 3 million patent applications and grants between 1976 and 2014, providing a robust framework for analyzing patent scope and trends[2].
Key Takeaways
- Broad Scope: The patent covers a method of manufacturing, the approved product itself, and methods of using the product.
- Therapeutic Categories: It is classified under various therapeutic categories related to nervous system disorders.
- Regulatory Approval: The patent is associated with the approved product XADAGO (safinamide mesylate).
- Patent Term Extension: The patent term was extended due to regulatory review periods.
- Post-Issuance Activities: Includes a Certificate of Correction and maintenance fee payments.
- Economic Implications: Provides market protection and guides further research and development.
FAQs
Q: What is the main subject of U.S. Patent 8,076,515?
A: The main subject is a process for producing therapeutically active 2-[4-(3- and 2-fluorobenzyloxy)benzylamino]propanamides.
Q: Who is the holder of U.S. Patent 8,076,515?
A: The patent is held by Newron Pharmaceuticals S.p.A.
Q: What is the approved product associated with this patent?
A: The approved product is safinamide mesylate, marketed under the name XADAGO.
Q: Why was the patent term extended for U.S. Patent 8,076,515?
A: The patent term was extended due to the regulatory review period under 35 U.S.C. § 156.
Q: What tools can be used to analyze the patent claims and scope of U.S. Patent 8,076,515?
A: Tools such as the Claim Coverage Matrix and ClaimScape® software, along with datasets like the Patent Claims Research Dataset, can be used.
Cited Sources
- Application for Extension of Patent Term under 35 U.S.C. § 156 of U.S. Patent No. 8,076,515 - Regulations.gov
- Patent Claims Research Dataset - USPTO
- Patent Analytics - Schwegman, Lundberg & Woessner, P.A.
- US8076515B2 - Process for the production of 2-[4-(3- and 2-fluorobenzyloxy)benzylamino]propanamides - Google Patents
