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Alnylam Receives Issued U.S. Patent Covering RNAi Therapeutics

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Alnylam Pharmaceuticals, Inc. has announced that a key fundamental patent from its exclusively held "Tuschl II" patent series was issued by the United States Patent and Trademark Office (USPTO).

The U.S. patent (U.S. Patent No. 7,056,704) broadly covers methods of making small interfering RNAs, the molecules that mediate RNAi.

The issued patent is exclusively licensed to Alnylam for RNAi therapeutics on a worldwide basis through an agreement with Garching Innovation GmbH, the licensing agent for the Max Planck Society

The patent stems from research published in 2001 in the journal Nature by Thomas Tuschl, Ph.D., a founder of Alnylam.

This work provided the published evidence that RNAi is mediated by small double-stranded RNAs with defined structural features and that synthetic siRNAs, with or without chemical modification, can be used to achieve RNAi in mammalian cells.

"We believe that the issuance of the Tuschl II patent represents a defining event in Alnylam's consolidation of intellectual property that is fundamental to the development and commercialization of RNAi therapeutics," said John Maraganore, Ph.D., President and Chief Executive Officer of Alnylam Pharmaceuticals.

"Importantly, the new patent describes the methods for making siRNAs toward any disease target in a mammalian cell, thereby providing significant scope for RNAi therapeutics."

"As such, the new Tuschl II patent, where we have exclusive, worldwide therapeutic rights, solidifies our leadership position in the field of RNAi and bolsters our ability to build value from the advancement of RNAi therapeutics as a potential new class of drugs."

"We expect that this new patent, together with other Alnylam-held intellectual property assets, will strengthen our continued efforts to create value through partnerships and license agreements with major pharmaceutical companies, biotechnology companies, and research product suppliers," continued Dr. Maraganore.

"Indeed, the strength of our patent estate supports a track record of business execution with over 20 current partners and licensees that have provided in excess of $100 million in funding to date, and a source of committed and sustainable funding for the future."

The claims for U.S. Patent No. 7,056,704 cover the preparation of double-stranded RNAs having key structural elements that are widely recognized as important for the therapeutic activity of siRNAs, including:

- A double stranded region formed from two RNA strands of a length of 19-25 nucleotides; and,

- One or more 3'-overhangs at the ends of the double-stranded molecule.

The claims cover such siRNAs for mediating cleavage of a messenger RNA, or mRNA, in mammalian cells, and therefore cover siRNAs with the above mentioned structural elements that are directed toward any and all target genes expressed in mammalian cells.

"We are gratified that the USPTO has acknowledged the pioneering contributions of Professor Tuschl's work which was performed at the Max Planck Institute and disclosed in the Tuschl II patent series," said Robert Millman, Chief Intellectual Property Counsel of Alnylam Pharmaceuticals.

"Virtually all patent offices around the world have recognized the pioneering nature of the Tuschl II series of patents, and we are optimistic that similar claims will issue in other countries in which the Tuschl II applications are pending."

In addition to the Tuschl II patent, Alnylam's intellectual property estate includes certain "fundamental" patents and patent applications that claim the broad structural and functional properties of synthetic RNAi therapeutic products.

These include the recently allowed claims of a separate Tuschl II series patent application 10/832,248, and other pending applications from the same Tuschl II series.

They also include the Kreutzer-Limmer I and II patents, acquired through the Ribopharma merger: EP Patent No. 1144623, covering methods, medicaments and uses of siRNAs with up to 25 nucleotides complementary to a target gene; EP Patent No. 1214945, covering compositions, methods, and uses of siRNAs with a length between 15 and 49 nucleotides; and EP Patent No. 1352061, covering therapeutic compositions, methods, and uses of siRNA and derivatives directed toward over 125 disease targets.

Additional fundamental patents and patent applications licensed to Alnylam on an exclusive or non-exclusive basis include those of Crooke (U.S. Patent Nos. 5,898,031 and 6,107,094), Fire and Mello (U.S. Patent No. 6,506,559), Glover et al. (EP Patent No. 1230375), and Tuschl et al. (Tuschl I, patent pending), among others.