Patenting - Devices

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 offered by a patent and the exclusivity granted through a marketing application. Patents protect intangible, non-physical property assets.

To qualify for a patent, developers must determine whether their device is novel, useful and nonobvious. A novel device would not be substantially equivalent to another medical device on the market. Developers most likely file for utility or design patents. Alternatively, they can pursue a provisional patent to establish a filing date for an invention, giving them a year to decide whether or not to obtain a patent. Ensuring that the invention has not been publicly disclosed by another party and is non-patented, it is essential to conduct a search of all previous public disclosures, including a search of foreign patents and printed publications. USPTO encourages novices to contact their local Patent and Trademark Resource Center (PTRC) for expert guidance in setting a search strategy. Additionally, consulting a registered patent attorney or agent can be invaluable.

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. Companies attain exclusivity through FDA approval of a marketing application. For medical devices, this application is a Premarket Approval (PMA). For more information on the PMA, go to the “Regulatory Paths to Market - Device” section.

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