How does the USPTO handle therapeutic or pharmacological utility claims?
The USPTO applies the same legal requirements for utility to therapeutic or pharmacological inventions as it does to inventions in other fields. According to MPEP 2107.01: “Inventions asserted to have utility in the treatment of human or animal disorders are subject to the same legal requirements for utility as inventions in any other field of…
Read MoreHow is the date of product approval determined for patent term extension purposes?
The date of product approval for patent term extension purposes varies depending on the type of product. According to MPEP 2754.01: For drug products: The approval date is the date of the FDA letter indicating application approval, even if further action is required before marketing. For food or color additives: The relevant date is the…
Read MoreWhat are the formal requirements for a patent term extension application?
The formal requirements for a patent term extension application are outlined in 37 CFR 1.740. Some key requirements include: Complete identification of the approved product Identification of the federal statute under which regulatory review occurred Date of product approval for commercial marketing or use For drug products, identification of each active ingredient Statement that the…
Read MoreHow long does an interim extension last?
How long does an interim extension last? According to MPEP 2755.01, the duration of an interim extension is limited: “An interim extension granted under 35 U.S.C. 156(e)(2) terminates at the earlier of the expiration of the 60-day period beginning on the date on which the product involved receives permission for commercial marketing or use, or…
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 MoreHow 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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