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Alnylam Announces Continued Progress on Development of its Intellectual Property Estate Covering RNAi Therapeutics

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Alnylam Pharmaceuticals, Inc. has announced that the European Patent Office has granted the previously allowed Tuschl II patent. The European patent (EP 1407044 or “ '044 Patent”) broadly covers compositions, methods, and uses of small interfering RNAs (siRNAs), the molecules that mediate RNAi.

In addition, the company announced that the German Patent Office has granted a new patent (DE 10066235 or “ ’235 patent”) in the Kreutzer-Limmer I patent series broadly covering methods, uses, and medicaments for siRNAs with a length of 15 to 49 nucleotide pairs expressed via vectors.

“The scope of our intellectual property estate, which we believe is required for the development and commercialization of RNAi therapeutics, will only continue to expand as key Alnylam patents advance through the examination stages in patent offices around the world,” said Barry Greene, President and Chief Operating Officer of Alnylam.

“Importantly, access to our patent estate is enabling the creation of an entire new class of innovative medicines for patients, both through our own proprietary pipeline efforts as well as the efforts of our growing number of pharmaceutical partners and licensees,” continued Greene.

“We’re particularly pleased with our continued progress in the worldwide examination of the Tuschl II patent series, which includes issued or granted patents in several countries to date including the U.S. and European Union,” commented Donna Ward, Ph.D., Vice President of Intellectual Property of Alnylam.

“The Tuschl II patent series stems from work performed by Dr. Tuschl and colleagues while at the Max Planck Society and is exclusively licensed to Alnylam for all therapeutic uses worldwide. This scientific work led to the first peer-reviewed publication on siRNAs and their ability to mediate RNAi in mammalian cells. Further, Dr. Tuschl’s work demonstrated the ability to use siRNAs with a broad range of lengths, chemical modifications and various design motifs, including so-called ‘blunt ends’,” Ward added.

The claims for the newly granted Tuschl II ’044 patent cover compositions, methods, and uses of double-stranded RNAs having key structural elements that are widely recognized as important for the therapeutic activity of siRNAs, including, in general terms:

• a double-stranded region formed from two RNA strands with a length of 19-23 nucleotides;

• one or more 3'-overhangs at the ends of the double-stranded molecule;

• compositions with chemical modifications on the 3'-end of the siRNA to protect against degradation and/or the use of one or more nucleotide modification, such as 2'-O-Me or 2'-F, without any limitation to the number of such modifications; and,

• the use and pharmaceutical compositions of such an siRNA molecule to modulate the function of mammalian or pathogen-derived genes both in vitro and in vivo.

The claims for the newly granted Kreutzer-Limmer ’235 patent cover methods, uses, and medicaments of double-stranded RNAs, including, in general terms:

• a double-stranded RNA with a length of 15 to 49 base pairs expressed in a mammalian cell through a vector; and,

• methods, uses, or medicaments of such siRNAs to inhibit the expression of mammalian target genes, where such genes are oncogenes, cytokine genes, developmental genes, or infectious disease genes.

The claims of the Tuschl II ’044 and Kreutzer-Limmer ’235 patents are provided on the company’s website, together with claims from other Alnylam owned or licensed patents.