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Alnylam Announces Allowance in Europe of New Fundamental Patent Broadly Covering RNAi Therapeutics in Oncology

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Alnylam Pharmaceuticals, Inc. has announced that the European Patent Office (EPO) has issued a notification of intent to grant for a patent in the Kreutzer-Limmer III patent series (EP Application No 02702247.4). This patent series stems from the pioneering RNAi research performed by scientists at Ribopharma AG, which was acquired by Alnylam in 2003.

The Kreutzer-Limmer III patent series extends the scope and breadth of 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.

“We are pleased with the EPO’s decision to grant claims from Kreutzer-Limmer III, an early filed patent in RNAi therapeutics research that described many applications for siRNAs and their use in oncology indications,” said Barry Greene, President and Chief Operating Officer of Alnylam Pharmaceuticals. “The grant of this new patent series in the EU continues to expand the scope of our fundamental IP estate that also includes issued or granted patents from the Crooke, Kreutzer-Limmer, Tuschl I, Tuschl II, and Kay & McCaffrey patent estates, among other patent applications pending.”

“We are gratified that the EPO continues to recognize the importance and patentability of our early discoveries in the RNAi field,” said Roland Kreutzer, Ph.D., Head of Roche’s Center of Excellence for RNA Therapeutics in Kulmbach, Germany, and an inventor on the Kreutzer-Limmer patent series. “There has already been great progress in the advancement of RNAi therapeutics and we remain committed to this continued effort. A strong IP estate is critical for the success of such an endeavor, and Alnylam and its partners, such as Roche, uniquely enjoy this benefit.”

The new patent includes 22 claims covering methods and medicaments for use of an RNAi therapeutic in oncology applications. The methods claims cover the use of siRNAs to inhibit anti-apoptotic genes in malignant cells. The corresponding medicament claims cover siRNA compositions that are less than 25 nucleotides in length having a 3’ nucleotide “overhang” on the antisense strand and also cover “hairpin” siRNAs which have an overhang at the 3’ end of the molecule.

Alnylam’s IP position is comprised of fundamental, chemistry, and target IP that the company believes is 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 U.S., Europe, or Japan, the world’s largest pharmaceutical markets.