Alnylam Pharmaceuticals, Inc. has announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for claims in the Manoharan et al. patent application 13/693,478. The '478 patent application includes newly allowed claims directed to compositions including those comprising a modified RNA agent linked to a biantennary or triantennary ligand.
Specifically, the allowed application includes claims that broadly cover single-stranded or double-stranded, chemically modified RNA therapeutics conjugated with an N-acetylgalactosamine (GalNAc) ligand independent of length, sequence, or disease target.
The allowance of this patent application represents a major advance in Alnylam's intellectual property (IP) estate, since GalNAc-siRNA conjugates enable potent and durable silencing of liver-expressed disease genes with subcutaneous dose administration and a wide therapeutic index. Importantly, this delivery approach is a key component of the company's execution on its "Alnylam 5x15" and broader genetic medicine product strategy.
"These newly allowed claims from the Manoharan '478 patent recognize the pioneering work of Alnylam scientists in the advancement of conjugates as a delivery platform for RNA therapeutics. We are gratified that the USPTO has acknowledged these innovations by allowance of broad claims from this patent application," said Laurence Reid, Ph.D., Senior Vice President and Chief Business Officer of Alnylam.
Reid continued, "Our conjugate delivery platform - specifically utilizing GalNAc-siRNA conjugates - enables subcutaneous dosing of RNAi therapeutics with potent and durable effects and a wide therapeutic index. With our Enhanced Stabilization Chemistry (ESC) conjugates, we believe that once-monthly and possibly once-quarterly subcutaneous dosing regimens can be achieved in our clinical pipeline programs. Based on this progress, we believe that GalNAc-conjugates are now the industry-leading delivery approach for RNA therapeutics targeting liver-expressed genes, and this patent allowance will reinforce Alnylam's central role in value creation based on therapeutics linked to this technology."
The allowed claims of the Manoharan '478 patent application, as well as other granted, Alnylam-owned or -licensed patents, are provided on the company's website, and in aggregate broadly cover delivery of RNAi therapeutics, including those that employ GalNAc-siRNA conjugate technology; additional claims from this and other patent families are pending.
In addition, Alnylam's owned or licensed patents broadly cover siRNAs and their use in a wide range of lengths from 15 to 49 nucleotides, and chemical modifications with naturally or non-naturally occurring nucleotides, including, for example, acyclic nucleotides such as "unlocked nucleoside analogs." Alnylam's IP estate also includes patents that broadly cover siRNAs toward a wide range of disease targets.