Alnylam Pharmaceuticals, Inc. has announced that the United States Patent and Trademark Office (USPTO) has allowed claims in a patent application that covers methods for preparing small interfering RNAs, the molecules that mediate RNAi.
The USPTO issued a 'Notice of Allowance' for patent application 10/832,248 in the 'Tuschl II' patent series.
Based on the seminal research by Thomas Tuschl, Ph.D., a founder of Alnylam, the newly allowed claims cover methods of making siRNAs for any target, with or without chemical modifications.
Following a 'Notice of Allowance', the final issuance of a patent involves several administrative steps that typically are completed within three months.
"In my view, this positive evaluation from the U.S. patent office validates the significance of our important findings published in Nature and other scientific journals in 2001," said Thomas Tuschl, Ph.D., Associate Professor, The Rockefeller University.
"Our published studies launched the broad use of RNAi as a tool for post-genomic research and pointed to a clear opportunity for development of RNAi for therapeutic gene silencing."
"It is very gratifying to see the importance of our discovery of key structural features of siRNAs recognized in this way."
"Our exclusive rights to the Tuschl II patent series are a major component of Alnylam's IP leadership," said John Maraganore, Ph.D., President and Chief Executive Officer of Alnylam Pharmaceuticals.
"This U.S. patent represents an important strategic asset for Alnylam, and the allowance of claims by the USPTO solidifies our broad rights relating to the development and commercialization of RNAi therapeutics."
"This will further extend and strengthen our IP position in RNAi, which we have leveraged over the last several years to build significant value through 18 separate collaboration or license agreements with major pharmaceutical companies, biotechnology companies, and research product suppliers."
The allowed Tuschl II patent includes 79 claims that cover the preparation of a double-stranded RNA having key structural elements, including: The presence of 3'-overhangs at one or both ends of the double-stranded molecule; and a length of 19-25 nucleotides.
The claims also cover a siRNA with these structural elements that also incorporates any of various chemical modifications, including the use of phosphorothioates, 2'-O-methyl, and/or 2'-fluoro modifications.
These internal and backbone modifications are believed to be important for achievement of 'drug-like' properties for RNAi therapeutics.
The claims cover siRNAs with the aforementioned structural properties that are directed toward any and all target genes.
The Tuschl II patent series is distinct in inventorship and ownership from the so-called 'Tuschl I' patent series for which Alnylam also holds a license.