How does the “first permitted marketing or use” requirement affect patent term extension eligibility?
The “first permitted marketing or use” requirement is a crucial factor in determining eligibility for patent term extension. According to 35 U.S.C. 156(a)(5) and 37 CFR 1.720(e), the approval for commercial marketing or use must generally be the first permitted under the provision of law under which the regulatory review occurred. For human drug products:…
Read MoreWhen is a regulatory review period determination considered final?
A regulatory review period determination is not considered final until all due diligence petitions and informal hearings, if any, have been resolved. This is important because the USPTO cannot issue a certificate for extension of the term of a patent until the regulatory review period determination is final, unless an interim extension is warranted under…
Read MoreWhen should subsequent applications for interim extension be filed?
For subsequent applications for interim extension, the filing window is different from the first application. According to MPEP 2754.02: “Each subsequent application for interim extension must be filed during the period beginning sixty days before and ending thirty days before the expiration of the preceding interim extension.” This means that for any interim extension after…
Read MoreWhat is the filing window for a first application for interim extension under 35 U.S.C. 156(d)(5)?
The filing window for a first application for interim extension under 35 U.S.C. 156(d)(5) is specified in the MPEP. According to MPEP 2754.02: “A first application for interim extension under 35 U.S.C. 156(d)(5) (to extend the patent term before product approval) must be filed within the period beginning six months and ending fifteen days before…
Read MoreWhat deadlines are set in the Federal Register Notice regarding regulatory review period determinations?
The Federal Register Notice sets two important deadlines: A deadline 180 days after publication for filing written comments or petitions regarding the marketing applicant’s due diligence during the regulatory review period. A deadline 60 days after publication for requesting redetermination if anyone believes the published dates are incorrect. MPEP 2757 states: “The Federal Register Notice…
Read MoreWhat 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.…
Read MoreWhat happens if FDA approval is received during an interim extension?
What happens if FDA approval is received during an interim extension? If FDA approval is received during an interim extension period, the patent holder must notify the USPTO promptly. According to MPEP 2755.01: “The patent owner must immediately notify the Office of any determination by the regulatory agency regarding the application for regulatory approval. After…
Read MoreWhat happens if a patent owner fails to elect a single product for extension when multiple applications are filed?
When a single applicant files multiple applications for patent term extension based on different products’ regulatory review periods, the USPTO provides a period (usually one month) for the patent owner to elect the product for which extension is desired. According to MPEP 2761: “The final determination will indicate that if the patent owner fails to…
Read MoreWhat 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.”…
Read MoreAre 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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