Overview
Title
Determination of Regulatory Review Period for Purposes of Patent Extension; NEXOBRID
Agencies
ELI5 AI
The FDA decided how long it took to review a special medicine called NEXOBRID, used to help treat burns, and said it was nearly 20 years. They gave the company a chance to ask for more time on their patent so they can keep selling it without others copying it.
Summary AI
The Food and Drug Administration (FDA) has announced the regulatory review period for NEXOBRID, a product used for eschar removal in adults with certain types of burns. This review period is relevant to an application for patent term extension submitted to the U.S. Patent and Trademark Office (USPTO) by MediWound, Ltd. The FDA determined that the total regulatory review period for NEXOBRID was 7,427 days, with a request for a 5-year patent extension being made. The public can submit comments on this determination until February 28, 2025, and may petition the FDA to review whether the applicant acted with due diligence during this period by June 30, 2025.
Abstract
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NEXOBRID and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Keywords AI
Sources
AnalysisAI
The recent notice from the Food and Drug Administration (FDA) regarding NEXOBRID, a drug for eschar removal in adults with specific types of burns, provides critical information about the regulatory review period relevant to its patent extension. MediWound, Ltd., the company behind NEXOBRID, is seeking a 5-year extension on its patent from the U.S. Patent and Trademark Office (USPTO). According to the FDA's determination, the review period spanned a total of 7,427 days, broken down into a testing phase and an approval phase.
General Summary
The document outlines the timeline and procedural details associated with the regulatory review and subsequent patent extension application for NEXOBRID. It specifies the relevant dates including the effective date of the investigational new drug application, the submission date of the biologics license application, and the product's approval date. Additionally, the notice invites public comments and petitions, specifying deadlines for submissions.
Significant Issues or Concerns
One point of concern is the complexity of the instructions for submitting comments and petitions. The detailed requirements might pose challenges for individuals unfamiliar with legal or regulatory processes. Furthermore, the document mentions statutory limitations applied by the USPTO in calculating patent extension but does not elucidate these limitations. This omission may confuse readers who are not well-versed in regulatory terminology or procedures.
Potential Impact on the Public
For the general public, the document represents an opportunity to engage in the bureaucratic process by submitting comments or petitions. Such participation can ensure transparency and due diligence by the FDA in its processes. However, the dense nature of the instructions for participation could deter public engagement.
Impact on Specific Stakeholders
For MediWound, Ltd., the stakeholder directly involved, the determination by the FDA and potential patent extension is vital, adding years of market exclusivity to a valuable product. This extension can significantly affect their revenue and ability to fund research and development for future products. On the other hand, competitors might view the extension as a hindrance to market entry with similar or alternative treatments.
For patients and healthcare providers, the availability of NEXOBRID as a treatment option adds diversity to therapeutic tools for managing certain types of burns. However, the patent extension could potentially affect pricing and accessibility, depending on how MediWound prices the drug during the extended patent period.
In summary, while the document provides a pathway for public participation and regulatory clarity for NEXOBRID's patent extension, its complexity may hamper broader understanding and involvement. The outcomes of this process have implications for various stakeholders, including industry competitors, healthcare providers, and patients, highlighting the essential balance between innovative drug availability and competitive market practices.
Issues
• The document does not provide specific information on the costs involved in the regulatory review process or the patent extension application, making it unclear if there is any wasteful spending or financial bias.
• The document's instructions for submitting comments electronically and in written form are detailed but may be considered overly complex due to the amount of information required.
• The process for submitting petitions is dense and could be difficult to comprehend, especially for those unfamiliar with legal or regulatory processes.
• The document mentions statutory limitations applied by the USPTO in the calculation of patent extension, but does not specify what these limitations are, which can be confusing for the reader.
• The regulatory review period of 7,427 days is calculated but not explained in terms of how it compares to typical durations, which could provide context for the reader.