USPTO awards Alnylam Notice of Allowance for patent covering methods of inhibiting expression of mutant genes

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that the United States Patent and Trademark Office (USPTO) has awarded a Notice of Allowance for the "John et al." patent (Application No. 10/384,463), which covers methods of inhibiting mutant genes with double-stranded RNAs from 19 to 30 nucleotides in length. Since mutations in genes underscore the genetics of inherited disease and cancer, as well as broader aspects of human disease associated with genetic variations, the John et al. patent covers broad therapeutic applications of RNAi therapeutics.

“a major scientific breakthrough that happens once every decade or so”

"The John et al. patent family was obtained in our 2003 acquisition of Ribopharma AG, the world's first RNAi therapeutics company, and stems from the work of Drs. Matthias John, Roland Kreutzer, and Stefan Limmer, who pioneered many of the early applications of siRNAs for targeting genes in the cause and pathway of human disease," said Barry Greene, President and Chief Operating Officer of Alnylam. "By all accounts, we are certainly pleased with the USPTO's allowance of this new patent, as it continues to further broaden the scope of our overall intellectual property estate, including our fundamental patents from the Crooke, Glover, Kreutzer-Limmer, Tuschl I, and Tuschl II patent families, amongst others. Together, we believe that this patent estate is required to develop and commercialize all RNAi therapeutics."

The claims for the newly allowed John et al. patent cover methods of inhibiting the expression of mutant genes, including those found in inherited genetic disease or those arising in cancer, using siRNAs that have:

• two separate non-linked RNA strands of 19 to 30 nucleotides in length;
• a central complementary region of 26 nucleotides or less;
• an "overhang" design feature of 1 to 4 nucleotides; and,
• one or more mismatch nucleotide base pairing with the target mRNA.

"The pioneering research that was carried out at Ribopharma represents some of the most innovative work in the field of RNAi therapeutics," said John Maraganore, Ph.D. Chief Executive Officer of Alnylam. "Today, on the 10^th anniversary of the formation of Ribopharma, we congratulate these individuals on the important work they have done - and continue to do - for the entire field of RNAi therapeutics; we are honored to have been a part of their history and look forward to our future together."