Overview
Title
Determination of Regulatory Review Period for Purposes of Patent Extension; ROCTAVIAN
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ELI5 AI
The FDA looked at how long it took to check if a medicine called ROCTAVIAN is safe to use and found it took 2,101 days. They are letting people who think the timeline is wrong say so, but the rules for saying this are a bit complicated.
Summary AI
The Food and Drug Administration (FDA) has calculated the regulatory review period for the human biological product ROCTAVIAN. This action is in relation to a request for patent term extension submitted to the U.S. Patent and Trademark Office by BioMarin Pharmaceutical, Inc. The total review period is 2,101 days, divided into 816 days for testing and 1,285 days for approval. The FDA encourages anyone who believes the dates are incorrect to submit comments or petitions by specified deadlines for consideration.
Abstract
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ROCTAVIAN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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.
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Sources
AnalysisAI
Summary of the Document
The document from the Federal Register announces the Food and Drug Administration's (FDA) determination of the regulatory review period for "ROCTAVIAN." This is a human biological product developed by BioMarin Pharmaceutical, Inc., designed for treating severe hemophilia A. The regulatory review period amounts to 2,101 days, with breakdowns of 816 days in the testing phase and 1,285 days in the approval phase. This review period is significant for extending the patent term. The notice invites public comments or petitions if there are discrepancies in the recorded dates.
Significant Issues and Concerns
The document presents several challenges for potential commenters and stakeholders:
Confusing Docket Numbers: The document lists different docket numbers for comments and petitions, which might confuse those unfamiliar with regulatory procedures. Commenters could potentially misdirect their submissions if not careful.
Complex Instructions: The instructions for submitting confidential information are detailed and may overwhelm readers not versed in legal documentation, risking accidental public disclosure of sensitive data.
Lack of Clarity on USPTO Process: There's a lack of detail on how the U.S. Patent and Trademark Office (USPTO) will decide the final patent extension period, which can be crucial for stakeholders seeking the extension.
Technical Legal References: The document refers to specific laws and parts of the Code of Federal Regulations (CFR) without explanations, making it difficult for those not familiar with legal jargon to engage effectively.
These issues could hinder constructive participation from individuals or organizations unfamiliar with regulatory and legal processes.
Impact on the Public
For the general public, this document may seem inaccessible due to its technical language and procedural requirements. While the notice primarily targets experts and stakeholders involved in patent processes or drug manufacturing, it raises broader concerns about the transparency and accessibility of regulatory processes. The public might be indirectly affected by these proceedings if patent extensions influence drug availability or cost.
Impact on Specific Stakeholders
For stakeholders such as BioMarin Pharmaceutical, Inc., granting a patent extension is significant for maximizing returns on their investment in ROCTAVIAN. The lengthy patent could mean prolonged exclusivity in the market, potentially impacting competitors and prices for the treatment.
Regulatory professionals and legal experts might find this document directly relevant, as it outlines procedural expectations for participating in or contesting patent extension decisions. However, the document’s complexity may deter those without specialized knowledge, limiting broader participation.
Overall, the document reflects the complexities of regulatory affairs and highlights the need for clearer communication to involve a wider range of stakeholders effectively.
Issues
• The document references a specific docket number (FDA-2024-E-0440 and FDA-2024-E-0441) for comments, but there is a separate docket number given for petitions (FDA-2013-S-0610), which could be confusing for readers intending to submit different types of documents.
• The instructions for submitting confidential information are detailed but might be complex for individuals unfamiliar with legal or regulatory submissions, potentially discouraging participation or leading to inadvertent public disclosure of confidential information.
• There is a lack of clarity about the specific process and criteria USPTO will use to determine the final patent extension period, which might be important for stakeholders.
• The document contains several references to specific parts of the Code of Federal Regulations (CFR) and public laws without providing summaries or context, which could be confusing for readers not familiar with these legal references.
• The lengthy instructions and legal references scattered throughout the document could be intimidating and difficult to follow for those without legal expertise, potentially hindering stakeholder engagement.