(Source: Business Wire)
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that the European Patent Office (EPO) has upheld its "Kreutzer-Limmer II" '061 (EP 1352061) patent in oral proceedings held before the European Opposition Board. The '061 patent is the first to be granted in Europe from the Kreutzer-Limmer II patent family, and includes broad claims covering methods of silencing approximately 130 disease genes with small interfering RNAs, or "siRNAs," the molecules that mediate RNAi, which in this case comprise certain stabilizing design features and lengths of up to 49 nucleotides.
The maintenance of all originally granted claims in the Kreutzer-Limmer II '061 patent reinforces the strength of Alnylam's overall intellectual property (IP) estate which is believed by the company to be needed for the development and commercialization of RNAi therapeutics. The '061 patent was challenged by a single opponent, Sirna Therapeutics, Inc., a wholly-owned subsidiary of Merck & Co., Inc., whose request to revoke the patent was denied.
"We are gratified with the EPO's decision to support the '061 patent from our Kreutzer-Limmer II patent series. This patent has broad and significant claims related to methods for inhibiting the expression of a large number of important disease target genes," said Barry Greene, President and Chief Operating Officer of Alnylam. "Today's ruling affirms Alnylam's overall IP estate as a required component for development and commercialization of all RNAi therapeutics. Alnylam has leveraged this IP estate to enable the field with freedom to operate for RNAi therapeutics as evidenced by more than 25 licensing agreements which have yielded over $660 million in realized cash funding, and we expect this to continue in the future."
"We are very pleased that the EPO has recognized 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. "We are very excited about the progress being made in the field of RNAi research and are absolutely committed to advancing RNAi therapeutics to patients. Clearly, 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."
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.
The claims of the '061 patent cover methods of inhibiting the expression of target genes using double-stranded RNAs (dsRNAs):
comprised of a length of up to 49 nucleotides;
comprised of a single 3' nucleotide "overhang" and a 5' "blunt end" on the antisense strand, which provides intrinsic stabilization for the dsRNA; and,
with or without additional chemical modifications.
The methods or uses of these siRNAs are directed toward approximately 130 disease targets, including all dsRNAs that are complementary to these genes; a list that include oncogenes, cytokines, angiogenesis pathway genes, apoptosis pathway genes, and cell adhesion genes, amongst others.
About Alnylam Intellectual Property (IP)
Alnylam's IP estate includes issued, allowed, or granted fundamental patents in many of the world's major pharmaceutical markets that claim the broad structural and functional properties of RNAi therapeutic products. These include, but are not limited to:
the Crooke Patents (U.S. Patent Nos. 5,898,031, 6,107,094, 7,432,249, 7,432,250 and EP 0928290) issued in over 15 countries and licensed exclusively from Isis Pharmaceuticals, Inc.
