Date of this Version
- 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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Brewster, Megan and Singh, Pallab
"Intellectual Property Protection for Biologics,"
Academic Entrepreneurship for Medical and Health Scientists: Vol. 1
, Article 11.
Available at: https://repository.upenn.edu/ace/vol1/iss3/11