Intellectual Property Protection for Biologics

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