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  • Biologics are a rapidly evolving area within biotechnology, and having the proper intellec­tual property (IP) protection is crucial to safeguarding inventions.

  • IP protection of genetic material can be traced back to the early 1900s, though biologics themselves are fairly new.

  • All forms of IP, including trademarks, copyrights, trade secrets, and patents can protect biologics, though most current issues have to do with patent protection.

  • The U.S. government grants two types of protection against competition: patents through the U.S. Patent and Trademark Office (USPTO), and regulatory exclusivity through the U.S. Food and Drug Administration (FDA).

  • There are many challenges related to obtaining IP protection of biologics, including cost, difficulties in characterization, and the uncertain nature of laws currently in place.

  • Patent attorneys with experience in biotechnology and the university technology transfer office TTO) can work with the inventors to ensure that the biologic is properly protected.

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Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.