The United States Patent and Trademark Office (USPTO) has issued notices of allowance for three patent applications from the Alnylam Pharmaceuticals' exclusively held Tuschl II patent estate. The USPTO has allowed claims in patent applications 12/537,602 , 12/683,081 and 12/838,786 which cover compositions, methods, and uses of small interfering RNA (siRNA) that are important for the development and commercialization of RNAi therapeutics.

These newly allowed claims are the first to emerge from the US prosecution of the Tuschl II patent series that include composition of matter for siRNA, the molecules that mediate RNAi. 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.

"We are very pleased with continued advancement of our Tuschl II patent estate through the USPTO, which further extends Alnylam's leadership on intellectual property for RNAi therapeutics in the world's largest pharmaceutical market," said Laurence Reid, PhD., senior vice president, chief business officer at Alnylam. "We believe that our unparalleled intellectual property estate will protect the innovative medicines we advance to the market as part of our 'Alnylam 5x15' product strategy. In the near term, Alnylam continues to realize value from this estate through our partnering efforts."

"We are gratified that the USPTO has decided to allow these new composition of matter, method, and use claims from the Tuschl II patent estate," said Dr Joern Erselius, managing director, Max Planck Innovation GmbH. "The continued successful worldwide examination of the Tuschl II patent series highlights that this invention is seminal for RNAi, demonstrating the importance of the work performed by Professor Tuschl and other co-inventors at the Max Planck Institute."

Patent applications 12/537,602, 12/683,081 and 12/838,786 include claims broadly covering compositions, methods, and uses for double-stranded RNAs having key structural elements that are widely recognised as important for the therapeutic activity of siRNA, including: two RNA strands with a length of 19-23 or 19-25 nucleotides; at least one strand forms a single-stranded 3' overhang from 1-3 or 1-5 nucleotides; with or without chemical modifications; and the double-stranded RNA molecule cleaves a target mRNA at a single site.

The prosecution of these cases has been handled by the law firm of Lando & Anastasi, LLP.

Alnylam's intellectual property position is comprised of fundamental, chemistry, delivery, and target patents and patent applications that the company believes are necessary for the development and commercialization of RNAi therapeutics. In aggregate, Alnylam owns or has in-licensed over 1,800 active patent cases, of which over 700 have issued or been granted worldwide, and over 300 have issued or been granted in the US, Europe, or Japan, the world's largest pharmaceutical markets.

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.

Alnylam is a biopharmaceutical company developing novel therapeutics based on RNA interference, or RNAi.