SC CTSI | Patenting - Drugs & Biologics

Intellectual property (IP) broadly refers to the rights given to creators over their inventions. The United States Patent and Trademark Office (USPTO) offers a range of protections for intellectual property, including patents, trademarks, trade secrets, service marks, copyrights, and additional mechanisms for safeguarding inventions. It is important to understand the distinctions between the protections provided by a patent and the exclusivity from a marketing application. Patents protect intangible, non-physical property assets.

The USPTO can grant these patents at various stages of the medical product development process, enabling a broad range of claims and the possibility of obtaining multiple patents. For example, biopharmaceutical companies often seek patents from the USPTO to protect the development of a new molecular entity (NME). For more information on NMEs, go to the “Novel drugs” section. After a patent for a drug, biologic, or biosimilar is approved by the USPTO, the FDA is required by law to list the patent number and expiration date in online databases for each medical product.

Unlike patents, marketing exclusivity refers to the marketing rights granted by the FDA upon the approval of the medical product, regardless of whether a patent exists. The FDA grants varying durations of marketing exclusivity to promote innovation in new treatments and encourage healthy competition. Companies receive exclusivity through FDA approval of a marketing application. For pharmaceuticals or drugs, these applications include New Drug Application (NDA) and Abbreviated New Drug Application (ANDA). For more information on these applications, go to the “Regulatory Paths to Market” section.