Overview
Title
Grant of Interim Extension of the Term of U.S. Patent No. 7,534,790; Vernakalant Hydrochloride
Agencies
ELI5 AI
The U.S. government gave more time for a company to keep their special rights to a medicine called vernakalant hydrochloride because the people who check if it's safe haven't finished their work yet. This means the company can still be the only one selling it for a bit longer.
Summary AI
The United States Patent and Trademark Office (USPTO) has granted a one-year interim extension for U.S. Patent No. 7,534,790, which covers the drug vernakalant hydrochloride. The extension was necessary because the regulatory review by the Food and Drug Administration (FDA) will extend beyond the patent's expiration date of March 31, 2021. Correvio International Sàrl, the patent owner, applied for this third interim extension as allowed under U.S. patent law for certain cases where market approval is pending. This extension ensures the patent remains valid while the review process continues.
Abstract
The United States Patent and Trademark Office has issued an order granting interim extension for a one-year interim extension of the term of U.S. Patent No. 7,534,790.
Keywords AI
Sources
AnalysisAI
The document is a notice from the United States Patent and Trademark Office (USPTO) about an interim patent term extension for U.S. Patent No. 7,534,790, which relates to a drug named vernakalant hydrochloride. This patent extension is granted for one additional year beyond its original expiration date because the Food and Drug Administration's (FDA) regulatory review is still ongoing.
General Summary
The patent extension notice highlights the USPTO's decision to grant a one-year interim extension for the patent owned by Correvio International Sàrl. The patent relates to the drug vernakalant hydrochloride, and the extension is necessary due to prolonged regulatory review by the FDA, indicating that the drug is still under consideration for market approval. This step is informed by U.S. patent laws that allow for extensions if regulatory review periods threaten to overlap a patent's expiration, thereby potentially impacting the initial inventor’s term of protection.
Significant Issues or Concerns
There are several notable issues in the document. Firstly, the justification for the interim extension is primarily the continuation of FDA review; however, the document does not detail why this review has been delayed or provide any timeline for completion. This lack of clarity might lead to questions about the efficiency of the regulatory process.
Furthermore, the notice mentions Section 156 of Title 35, United States Code, which outlines the eligibility for patent term extensions. The language used to describe these legal provisions is somewhat complex and might be difficult for individuals without legal expertise to fully understand. Simplifying this portion could make the document more accessible to a broader audience.
Impact on the Public Broadly
The extension of the patent term could have varying impacts on the public. On one hand, it can ensure that the patent holder continues to benefit from exclusive rights to the drug, which can be crucial for recovering investment costs associated with its development. On the other hand, prolonged exclusivity can delay the entry of generic versions into the market, potentially impacting drug prices and accessibility for consumers.
Impact on Specific Stakeholders
For the patent holder, Correvio International Sàrl, the extension provides a safeguard, allowing them to maintain exclusive rights to the drug while awaiting the completion of regulatory approval processes. This can be financially beneficial by allowing more time to potentially market the drug exclusively once approval is granted.
For competitors and the pharmaceutical industry, extended patent protection can delay the potential for entering the market with generic alternatives, thereby influencing competitive dynamics. It also underscores the importance of navigating the patent and regulatory landscape effectively to avoid prolonged delays.
In conclusion, while the extension ensures continued patent protection during regulatory review, more information on the reasons for the review delay and potential economic impacts would be beneficial for understanding the full implications of this decision.
Issues
• The document does not provide a detailed explanation of why the interim extension is necessary beyond stating that regulatory review will continue. More clarity could be provided on this point.
• The explanation of 35 U.S.C. 156 is complex and may not be easily understood by individuals without legal or patent expertise. Simplifying this language could improve accessibility.
• There is no information on the potential impacts of the extension on consumers or the market for vernakalant hydrochloride, which could be relevant for stakeholders.
• No information is provided about the financial implications of the patent extension for the patent holder or the public. This could be useful for understanding any economic impacts.