What is the role of the FDA in the patent term extension process?

The Food and Drug Administration (FDA) plays a crucial role in the patent term extension process for certain products. Specifically: The FDA assists the USPTO in determining the eligibility of patents for term extension for products requiring regulatory review (excluding veterinary biological products). It is responsible for determining the regulatory review period for these products.…

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What is the process for expunging confidential information from patent term extension applications?

The process for expunging confidential information from patent term extension applications is outlined in MPEP 2760. The key points are: “Otherwise, if a suitable petition to expunge is filed before the issuance of the certificate, the trade secret or confidential information will be expunged from the file and returned to the patent term extension applicant.”…

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Are there any exceptions to the prohibition on third-party participation in patent term extension proceedings?

While MPEP 2763 generally prohibits third-party participation in patent term extension proceedings, there is one potential exception mentioned: “Absent an invitation from the Director, any such submission would be inappropriate.“ This suggests that the Director of the USPTO has the discretion to invite third-party submissions in exceptional circumstances. However, such invitations are likely to be…

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What is the role of examiners in patent term extensions?

According to MPEP 2720, examiners do not make decisions regarding patent term extensions. The MPEP states: “Examiners make no decisions regarding patent term extensions.“ This means that the determination and calculation of patent term extensions are not part of the examiner’s duties during the patent examination process. Instead, these decisions are made by other entities…

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What types of products are eligible for patent term extension?

According to MPEP 2750, the following types of products are eligible for patent term extension under 35 U.S.C. 156: Human drugs Food or color additives Medical devices Animal drugs Veterinary biological products It’s important to note that “Animal drug products which are primarily manufactured through biotechnology are excluded from the provisions of patent term extension.”…

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When does a withdrawal of a patent term extension application become effective?

A withdrawal of a patent term extension application becomes effective when it is acknowledged in writing by the USPTO. According to MPEP 2764: “An express withdrawal pursuant to this section is effective when acknowledged in writing by the Office.” This means that simply submitting a withdrawal request is not sufficient. The withdrawal only takes effect…

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How is the approval date determined for drug products in patent term extension applications?

For drug products, the approval date used in patent term extension applications is determined based on the Food and Drug Administration’s (FDA) communication. According to MPEP 2754.01: “For drug products the approval date is the date of a letter by the Food and Drug Administration indicating that the application has been approved, even if the…

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