What is the role of the USDA in the patent term extension process?
The United States Department of Agriculture (USDA), specifically its Animal and Plant Health Inspection Service (APHIS), plays a crucial role in the patent term extension process for certain products. According to the MPEP: “The Animal and Plant Health Inspection Service of the United States Department of Agriculture is responsible for assisting the Office in determining…
Read MoreWhat information must be included in a patent term extension application?
According to 35 U.S.C. 156(d)(1), a patent term extension application must contain the following information: The identity of the approved product and the Federal statute under which regulatory review occurred The identity of the patent for which an extension is being sought and the relevant claims Information to determine eligibility for extension and the rights…
Read MoreWhat is the purpose of patent term extension under 35 U.S.C. 156?
The purpose of patent term extension under 35 U.S.C. 156 is to compensate patent owners for time lost during the premarket regulatory review process. As stated in the MPEP: “The statute enables the owners of patents on certain human drugs, food or color additives, medical devices, animal drugs, and veterinary biological products to restore to…
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 does the patent term extension under 35 U.S.C. 154(b) relate to the extension under 35 U.S.C. 156?
The patent term extensions under 35 U.S.C. 154(b) and 35 U.S.C. 156 are separate and can be combined. According to MPEP 2720: “The patent term extension that may be available under 35 U.S.C. 156 for premarket regulatory review is separate from and will be added to any extension that may be available under former and…
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 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.”…
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…
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