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Alnylam and Isis Announce the Allowance of First US Patent Covering Human microRNAs

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Alnylam Pharmaceuticals, Inc. and Isis Pharmaceuticals, Inc. have announced that the United States Patent and Trademark Office (USPTO) has allowed claims in a patent application that covers microRNAs (miRNAs) and therapeutic molecules that target these miRNAs.

The USPTO issued a “Notice of Allowance” for patent application 10/490,955, which is derived from the “Tuschl III” patent series licensed co-exclusively to Alnylam and Isis for miRNA therapeutics on a world-wide basis through an agreement with Max-Planck-Innovation GmbH, the licensing agent for the Max Planck Society. Following a “Notice of Allowance,” the companies would expect final issuance of the patent within six months.

miRNAs have been shown to regulate the expression of a large number of genes in the human genome through the RNAi pathway, and many of these miRNAs are believed to be involved in disease processes including cancer, metabolic disease, and viral infection.

The Tuschl III patent series pertains to the discovery of over 120 mammalian miRNAs and stems from research performed by Alnylam founder Thomas Tuschl, Associate Professor of RNA Molecular Biology at The Rockefeller University, while at the Max Planck Society.

The allowed claims cover a disease-associated miRNA, specifically miR-122, which is a liver-specific miRNA that has been shown to be required for hepatitis C virus (HCV) infection.

Isis and Alnylam have demonstrated that in vivo antagonism of miR-122 with antisense drugs is associated with regulation of a discrete set of genes involved in liver metabolism.

“The recent discovery that over 250 human genes encode miRNAs that may control gene expression for as much as one-third of the genome suggests that these small, non-coding RNAs play a major role in human physiology and disease,” said C. Frank Bennett, Ph.D., Senior Vice President, Research for Isis.

“Scientists at Isis and Alnylam have been performing an exciting line of research to identify novel, antisense-based therapeutic approaches for targeting miRNAs, and our collaborative efforts point to significant opportunities for the future,” Bennett added.

“As part of our 2004 agreement with Isis, we have been engaged in consolidating intellectual property in the miRNA field,” said Robert Millman, Ph.D., Chief Intellectual Property Counsel for Alnylam.

“We believe that, in addition to this first allowed U.S. patent covering isolated miRNAs and molecules that are complementary to the miRNA, several other patents will likely result from the Tuschl III patent series because similar claims to each of the over 120 miRNAs are disclosed in the patent application as well as methods of altering the level of the miRNA in a cell,” Millman continued.