What is the regulatory agency’s role in determining the length of the regulatory review period?
The regulatory agency is responsible for determining the length of the regulatory review period for the approved product on which a patent term extension application is based. This determination is made based on the application and official regulatory agency records for the approved product. According to MPEP 2757, “Under 35 U.S.C. 156, the regulatory agency…
Read MoreHow does the paragraph IV certification process relate to USPTO disclosures?
The paragraph IV certification process, typically associated with generic drug applications to the FDA, can generate information material to patentability that should be disclosed to the USPTO. According to MPEP 2015: “Consequently, to assist USPTO staff in evaluating patentability effectively and efficiently, the party receiving a paragraph IV certification should review such documents to determine…
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 MoreCan an examiner require information submitted to other government agencies?
Yes, an examiner can require information submitted to other government agencies under certain circumstances. The MPEP states: “This requirement could include statements made or information submitted to other Government agencies such as the FDA.” For example, when examining a claim related to a drug manufacturing process filed more than a year after FDA approval, an…
Read MoreWhat are the duties of disclosure and reasonable inquiry in dealings with other government agencies?
Individuals with a duty to disclose or parties with a duty of reasonable inquiry must ensure consistency in statements made to the USPTO and other government agencies regarding claimed subject matter. The MPEP 2015 states: “Each individual with a duty to disclose, or party with a duty of reasonable inquiry, should ensure that the statements…
Read MoreWhat are the disclosure requirements for information related to regulatory review, such as FDA submissions?
Information submitted to regulatory review bodies, such as the U.S. Food & Drug Administration (FDA), may be material to pending patent applications or reexamination proceedings and should be disclosed to the USPTO. The MPEP states: “Where relevant documentation is submitted to a regulatory review body, such as the U.S. Food & Drug Administration (FDA), and…
Read MoreWhat are the consequences of withholding material information from the USPTO?
Withholding material information from the USPTO while providing it to other government agencies can lead to serious consequences, including findings of inequitable conduct. The MPEP 2015 cites a relevant case: “In Bruno Independent Living Aids, Inc. v. Acorn Mobility Services, Ltd., 394 F.3d 1348, 1354, 73 USPQ2d 1593, 1598 (Fed. Cir. 2005), the U.S. Court…
Read MoreHow is the regulatory review period for an animal drug determined?
For animal drugs where the New Animal Drug Application (NADA) components were submitted to FDA in a phased review, the approval phase begins on the date of the submission of the administrative NADA. As stated in MPEP 2757: “To determine the regulatory review period for an animal drug where the New Animal Drug Application (NADA)…
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