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Alnylam and UMass Medical School announce Tuschl I patent upheld in European opposition proceedings

Cambridge, Mass., and Worcester, Mass., March 1, 2012 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, and the University of Massachusetts Medical School (UMMS) reported today that the European Patent Office (EPO) has upheld the Tuschl I '726 patent (EP 1309726) in oral opposition proceedings held in Munich, Germany. The requested claims of the '726 patent were upheld without any modification. Opponents included Sanofi-Aventis Deutschland GmbH, Silence Therapeutics AG, and BASF SE.

Inventors on the patent are David P. Bartel, PhD, a Howard Hughes Medical Institute Investigator and professor of biology at the Massachusetts Institute of Technology; Phillip A. Sharp, PhD, Institute Professor at the Koch Institute for Integrative Cancer Research at the Massachusetts Institute of Technology and a 1993 Nobel Laureate; Thomas Tuschl, PhD, a Howard Hughes Medical Institute Investigator and professor at Rockefeller University; and Phillip D. Zamore, PhD, a Howard Hughes Medical Institute Investigator and the Gretchen Stone Cook Professor of Biomedical Sciences at the University of Massachusetts Medical School, where he co-directs the RNA Therapeutics Institute.

"The Tuschl family of patents defines key discoveries central to the advancement of RNAi therapeutics to patients," said James P. McNamara, PhD, executive director, Office of Technology Management, University of Massachusetts Medical School. "The Tuschl I patent is a critical invention by Professors Tuschl, Zamore, Bartel, and Sharp regarding the RNAi mechanism. We are pleased to see this patent fully upheld in Europe in these opposition proceedings."

"We are very pleased with the outcome of these opposition proceedings which resulted in the claims from the Tuschl I '726 patent being fully upheld. This decision by the EPO affirms our belief in the validity of these claims, and the novelty of the Tuschl I invention, and supports the relevance of Tuschl I for the development and commercialization of RNAi therapeutics," said Laurence Reid, PhD, senior vice president and chief business officer of Alnylam. "Alnylam continues to leverage its leading patent estate for the advancement of innovative medicines to patients and also continues to enable the entire RNAi therapeutics field with over 30 license agreements formed to date."

"The research discoveries that form the basis for this patent were a significant milestone in the explication of the basic science of RNAi and the path to the world of RNA therapeutics," said Zamore. "The affirmation of the intellectual basis of these discoveries by the EPO will accelerate the opportunities for laboratories and research organizations around the world to use this science to work toward therapeutics to treat human disease."

Alnylam is the co-exclusive licensee of the Tuschl I '726 patent which is owned by the Max Planck Society, the Massachusetts Institute of Technology, the Whitehead Institute for Biomedical Research, and the University of Massachusetts Medical School. This patent is a key component to Alnylam's fundamental intellectual property estate that comprises numerous issued or granted patents and a large number of pending patent applications that together broadly cover RNAi therapeutics, including small interfering RNAs, or siRNAs, the molecules that mediate RNAi. The Tuschl I '726 patent consists of 14 claims broadly covering RNAi methods, including methods of reducing the expression of a gene, with double stranded RNAs between 21 and 23 nucleotides in length of mammalian or viral origin. The patent also includes claims covering methods of examining the function of a gene, as well as the use of both unmodified and chemically modified double stranded RNAs.

About RNA Interference (RNAi)

RNAi (RNA interference) is a revolution in biology, representing a breakthrough in understanding how genes are turned on and off in cells, and a completely new approach to drug discovery and development. Its discovery has been heralded as "a major scientific breakthrough that happens once every decade or so," and represents one of the most promising and rapidly advancing frontiers in biology and drug discovery today which was awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi is a natural process of gene silencing that occurs in organisms ranging from plants to mammals. By harnessing the natural biological process of RNAi occurring in our cells, the creation of a major new class of medicines, known as RNAi therapeutics, is on the horizon. Small interfering RNAs (siRNAs), the molecules that mediate RNAi and comprise Alnylam's RNAi therapeutic platform, target the cause of diseases by potently silencing specific mRNAs, thereby preventing disease-causing proteins from being made. RNAi therapeutics have the potential to treat disease and help patients in a fundamentally new way.


Contact: Mark Shelton
University of Massachusetts Medical School

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