Patenting - Therapeutics

Intellectual property (IP) broadly refers to the rights given to creators over their inventions. The United States Patent and Trademark Office (USPTO) offers various intellectual property protections such as patents, trademarks, trade secrets, service marks, copyrights, and more.

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, allowing for both a broad range of claims and multiple patents. For instance, biopharmaceutical companies frequently seek patents from the USPTO to protect the creation of a new molecular entity (NME). For more information on NMEs, go to the “Novel drugs” section. After a patent for a drug or biologic/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, with, or without a patent. 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 devices, this application is Premarket Approval (PMA), and for biologics and biosimilars, this application is called Biologic License Application (BLA). For more information on these applications, go to the “Regulatory Path to Market” section.

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