Alnylam Pharmaceuticals, Inc, a leading RNAi therapeutics company, announced that the European Patent Office (EPO) has ruled in favour of the opposing parties in oral proceedings before the European Opposition Board related to the '945 (EP 1214945) patent in its Kreutzer-Limmer patent estate. This ruling does not affect other granted claims of the Kreutzer-Limmer patent series, nor does it affect the ongoing examination of other applications in this patent family, which the company expects will result in new granted patents. In addition, the ruling of this opposition hearing is not considered final and can be appealed.

The '945 patent is only one of a number of patents in the Kreutzer-Limmer estate. Other distinct patents in the family include EP 1550719, or '719, which covers siRNAs comprising 15-21 nucleotides in length stabilized by chemical linkages. In addition, patents from the Kreutzer-Limmer patent family have been granted in other countries, including Germany (DE 10080167 and DE 10066235) with claims covering siRNAs with lengths of 15-49 nucleotides. Many additional patents from the Kreutzer-Limmer patent family are pending in the US, Japan, and other countries.

"Notwithstanding the current outcome for the '945 patent in the European Opposition Proceedings, Alnylam maintains an unparalleled intellectual property position that we believe is needed for the development and commercialization of all RNAi therapeutics. In addition, we strongly believe in the inventive matter described in the '945 patent and we intend to take the next step and appeal the decision made today through the EPO's appeal process," said Barry Greene, president and chief operating officer of Alnylam. "The Kreutzer-Limmer patent family is broad and is comprised of numerous pending applications for which we expect new patent grants and issuances to emerge. Of course, no single patent or patent family defines the full breadth of Alnylam's intellectual property position. We have a clear track record of leveraging our intellectual property estate to enable the field with freedom to operate for RNAi therapeutics as evidenced by more than 25 licensing agreements which have yielded over $660 million in realized cash funding, and we expect this to continue in the future."

"We believe that the EPO will recognize the importance of these early discoveries in the RNAi field and that consideration of parallel filings will continue to yield significant patents, such as the new '719 patent announced recently," said Roland Kreutzer, head of Roche's Center of Excellence for RNA Therapeutics in Kulmbach, Germany, and an inventor on the Kreutzer-Limmer patent series. "We are very excited about the progress being made in the field of RNAi research and are absolutely committed to advancing RNAi therapeutics to patients. Clearly, a strong IP estate is critical for the success of such an endeavour, and Alnylam and its partners, such as Roche, uniquely enjoy this benefit."

Alnylam's intellectual property (IP) position is comprised of fundamental, chemistry, and target IP that the company believes is necessary for the development and commercialization of RNAi therapeutics. In aggregate Alnylam owns or has in-licensed over 1,800 active patent cases, of which over 700 have issued or been granted worldwide, and 317 have issued or been granted in the US, Europe, or Japan, the world's largest pharmaceutical markets; together, these define the company's IP estate for RNAi therapeutics. In addition to the Kreutzer-Limmer patent family, Alnylam's fundamental IP estate includes exclusive licenses to the Crooke, Glover, and Tuschl II patent families, and the Li & Kirby, Pachuk I, and Giordano patent families obtained from its acquisition of the patent assets from Nucleonics, Inc. It also includes a co-exclusive license to the Tuschl I patent family and a non-exclusive license to the Fire & Mello patent.

Alnylam's IP estate includes issued, allowed, or granted fundamental patents in many of the world's major pharmaceutical markets that claim the broad structural and functional properties of RNAi therapeutic products.

Alnylam is a biopharmaceutical company developing novel therapeutics based on RNA interference, or RNAi.