Settling Ownership of Tuschl Families
The RNAi field has become enmeshed in seemingly endless lawsuits. Several have revolved around the Tuschl patent families named after Alnylam founder Thomas Tuschl, Ph.D., and based on discoveries by him and partners while he was at the Max Planck Institute for Biophysical Chemistry.
Tuschl I includes 11 patents and patent applications in the U.S. and seven other nations and the European Patent Convention (EPC) for discoveries at Max Planck, Whitehead Institute for Biomedical Research, Massachusetts Institute of Technology (MIT), and UMass. Those institutions co-own Tuschl I, and Alnylam shares therapeutic rights with Sirna and, to a limited degree, RXi Pharmaceuticals, a company founded by Mello.
Tuschl II is owned by the Tuschl-I co-owners, which have licensed exclusive therapeutic rights to Alnylam. The family includes 23 patents and patent applications in the U.S., 18 other nations, and EPC. Tuschl III pertains to the discovery of more than 120 novel mammalian miRNAs through research performed by Dr. Tuschl while at Max Planck. The society owns Tuschl III, which is co-exclusively licensed by Alnylam and Isis Pharmaceuticals, though Regulus Therapeutics has access to Tuschl III for miRNA therapeutics through license agreements with Max Planck, Alnylam, and Isis.
It took litigation to settle ownership issues and use of Tuschl I and II. In 2009, Alnylam and Max Planck sued MIT, UMass, and Whitehead, alleging that the three misappropriated the use of 3’ overhangs and other siRNA-related inventions from Tuschl II for inclusion in patent applications based on Tuschl I.
In their lawsuit Alnylam and Max Planck contended that if Tuschl II inventions were incorporated into Tuschl I patent applications, Sirna, RXi, and other companies that may sublicense the IP in the future “will unfairly gain access to the Tuschl II property without paying consideration for a license.”
After two years, the first lawsuit was resolved last year, shortly before trial, through a settlement between Alnylam, Max Planck Society, Whitehead Institute, and UMass. MIT, which dropped out of the case, also agreed to terms. The parties agreed that Max Planck should oversee future prosecution of Tuschl I and Tuschl II in the U.S., and continue to lead the prosecution of Tuschl II outside the U.S. UMass received the right to license Tuschl II to Merck subject to permission from Alnylam, which would receive part of the licensing fees, and to prosecute Tuschl I outside the U.S.