Alnylam Pharmaceuticals, Inc. has announced that a key fundamental patent from its exclusively held “Tuschl II” patent estate has received Rule 51(4) EPC notification from the European Patent Office (EPO); this notification is equivalent to a “Notice of Allowance” by the United States Patent and Trademark Office.
It is expected that the patent will be granted by the EPO within the next six months. The European patent (EP 1407044 or “’044 Patent”) broadly covers compositions, methods, and uses of small interfering RNAs (siRNAs), the molecules that mediate RNAi. Alnylam also announced that the Tuschl II patent has been granted in Australia (AU2002235744).
The Tuschl II patent family is exclusively licensed to Alnylam for RNAi therapeutics on a worldwide basis through an agreement with Max Planck Innovation GmbH, the licensing agent for the Max Planck Society.
The ’044 patent stems from research published in 2001 in the journal Nature by Thomas Tuschl, Ph.D., a founder of Alnylam, together with other co-inventors in work performed at the Max Planck Institute in Goettingen, Germany. This research led to the first peer-reviewed published evidence that RNAi is mediated by small double-stranded RNAs with defined structural features and that synthetic siRNAs, with or without chemical modification, can be used to achieve RNAi in mammalian cells.
Patents stemming from the Tuschl II patent series have been issued or granted in many countries across the world, including the U.S. (U.S. Patent No. 7,056,704 and U.S. Patent No. 7,078,196), New Zealand (NZ525888), South Africa (ZA2003/3929), and Singapore (SG96891); additional applications are pending worldwide, including certain divisional applications in the U.S.
The Tuschl II patent series is distinct in ownership and inventorship from the so-called “Tuschl I” patent series that has yet to issue and for which Alnylam also has a license.
“With growing interest across the entire biopharmaceutical industry in the development of RNAi therapeutics as a potential new class of innovative medicines, the very unique position of Alnylam’s intellectual property estate is yet again extended with the advancement today of the Tuschl II patent in Europe and Australia,” said John Maraganore, Ph.D., President and Chief Executive Officer of Alnylam Pharmaceuticals.
“Importantly, the new patents include claims covering compositions, methods, and uses of siRNAs, thereby providing significant scope for intellectual property needed for development and commercialization of RNAi therapeutics.”
The claims for the European ’044 patent cover the compositions, methods, and uses 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 19-23 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
• The use and pharmaceutical compositions of such a siRNA molecule to modulate the function of mammalian or pathogen-derived genes both in vitro and in vivo.
The claims of the Tuschl II ’044 patent are provided on the company’s website, together with other granted, allowed or issued claims from other Alnylam owned or licensed patents.