RNAi Litigation

Archive for March, 2010

By John Leavitt and Scott Lloyd

The Max Planck Society (Max Planck) and Alnylam Pharmaceuticals (Alnylam) have filed a multiple-count complaint against the Whitehead Institute for Biomedical Research (Whitehead) and the University of Massachusetts (UMass) that questions the legality of several business dealings among the parties as well as the intellectual property (IP) rights to seminal small interfering RNA (siRNA) technologies.

The outcome of this trial will determine if Alnylam retains exclusive rights to the trigger IP for therapeutic “siRNA”, e.g. therapeutic siRNA-mediated gene silencing (Tuschl II patent estate). Large and small biotech and pharmaceutical companies, patent attorneys, and technology transfer offices will be following the this litigation. There are other “work-around” gene silencing technologies, but it’s generally believed, given the current state of the art, that Alnylam’s Tuschl II (siRNA) invention provides the most efficient approach to therapeutic RNAi-mediated gene silencing.

But who invented “siRNA”? … if it comes up.

If Tuschl, Elbashir and Lendeckel can show how and when they determined the optimal structure of dsRNA for facilitating therapeutic gene silencing (siRNA with 3′-overhangs) from their notebooks prior to October 25, 2000 or better yet, before Brenda Bass’ review in Cell (April 2000) where she speculated on the role of RNase III which produces 3′-overhangs, this may settle the issue. Because Bass merely speculated on this, it appears that no experiments such as those conducted by Tuschl’s group at Max-Planck and incorporated into Tuschl II were publicly known (Bass is a leading RNase III expert who would likely be aware of any such publications).

By contrast, if Zamore can show he reduced to practice the benefit of 3′-overhangs for efficient gene silencing prior to the Tuschl II inventors, then this may undermine the Tuschl II patent estate. So Zamore would have to show in his notebooks that he discovered the benefit of 3′-overhangs on 21-23 nucleotide dsRNA molecules for gene silencing before the priority date of Tuschl II (December 1, 2000), or that Zamore and Tuschl actually collaborated on the inventive matter of Tuschl II. A ‘Catch-22′ here is that if Elbashir and Lendeckel’s inventorship on Tuschl I or Zamore’s inventorship on Tuschl II was mishandled, this could invalidate one or both of the Tuschl patent estates (I and II). Read the rest of this entry »