EPO upholds Alnylam's Tuschl II 1407044 patent

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that the European Patent Office (EPO) has fully upheld its Tuschl II '044 (EP 1407044) patent in oral opposition proceedings held in Munich. Specifically, the originally granted claims of the '044 patent were upheld without any modification and were deemed valid and supported by the EPO. Opponents included Sirna Therapeutics Inc., a subsidiary of Merck & Co., Silence Therapeutics AG, Pfizer Inc., BASF SE, and an anonymous party, who collectively failed in their arguments during the course of multi-day proceedings to revoke the patent.

“a major scientific breakthrough that happens once every decade or so”

"We are extremely pleased with the outcome of these opposition proceedings which resulted in the claims from the Tuschl II '044 patent being fully upheld. This affirms our long-standing and resolute belief in the validity of these claims and the groundbreaking nature of the Tuschl II invention forming the basis of this critical patent family," said Barry Greene, President and Chief Operating Officer of Alnylam. "Tuschl II remains a very important and valuable patent in our overall broad estate of patents important for the development and commercialization of RNAi therapeutics, and a patent family to which we are the exclusive licensee. We look forward to the continued advancement of the Tuschl II patent family worldwide in conjunction with many other Alnylam-held patents and pending patent applications."

The Tuschl II patent series provides broad exclusivity for small interfering RNAs (siRNAs), the molecules that mediate RNAi, in the world's top pharmaceutical markets, which include the U.S. (US 7,056,704 and US 7,078,196), the European Union (EP 1407044), China (CN100523215), and Japan (JP04095895 and JP04494392). Specifically, the European Tuschl II '044 patent broadly covers compositions, methods, and uses of siRNAs that are important for the development and commercialization of RNAi therapeutics. 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.