The evolving landscape of biotech patent law presents ongoing challenges, particularly for innovations involving recombinant nucleic acids and biological sequences. A recent ruling in REGENXBIO v. Sarepta Therapeutics by the US District Court for the District of Delaware highlights these issues, as Judge Richard Andrews ruled that merely combining natural AAV sequences with heterologous non-AAV sequences in a cultured host cell—without further modifications—does not satisfy patent eligibility under 35 U.S.C. § 101.
On Tuesday, April 15, WilmerHale Partner Omar Khan will join Christen DiPetrillo, Head of Intellectual Property, and Kevin Marks, Chief Legal Officer at the Parker Institute for Cancer Immunotherapy, for Biocom California’s joint meeting of the IP and Cellular Gene Therapy Committees. Together, they will lead a discussion exploring the history of biotech patent eligibility, the reasoning behind the REGENXBIO court’s decision (including its reliance on the Funk Brothers precedent), and implications for innovation in gene therapy and biotech patent strategies.
