Alnylam Pharmaceuticals (NSDQ: ALNY) was granted a China patent on a crucial short interfering RNAs (siRNAs) patent, the Tuschl II series. This patent includes 44 claims covering compositions, methods, uses, and systems for siRNAs, the molecules that mediate RNAi. Previously, Alnylam was awarded a patent for the Tuschl II claims in the US, Europe, Japan and Australia. Alnylam licensed the patents from Max Planck Innovation GmbH, the licensing agent for the Max Planck Society.
Alnylam’s broad siRNA patent portfolio includes issued or granted patents from the Crooke, Kreutzer-Limmer, Tuschl I, and Kay & McCaffrey patent estates, among other patent applications pending.
The claims for the Chinese Tuschl II patent cover the compositions, methods, uses, and systems of double-stranded RNAs having key structural elements that are widely recognized as important for the therapeutic activity of siRNAs, including:
- a double stranded region formed from two RNA strands with a length of 19-25 nucleotides;
- one or more 3’-overhangs at the ends of the double-stranded molecule;
- compositions with chemical modifications on the 3’-end of the siRNA to protect against degradation and/or the use of one or more nucleotide modification, such as 2’-O-Me or 2’-F, without any limitation to the number of such modifications; and,
- the use and pharmaceutical compositions of such an siRNA molecule to modulate the function of mammalian or pathogen-derived genes both in vitro and in vivo.
In March 2008, Shanghai GenePharma became the first China biotech to sign a non-exclusive license with Alnylam for the Kreutzer-Limmer siRNA patents. The license gave Shanghai GenePharma the right to manufacture RNAi reagent products for worldwide research use.