Alnylam Pharmaceuticals, Inc, a leading RNAi therapeutics company, announced that the German Patent Office has upheld the 'Kreutzer-Limmer I' '235 (DE 10066235) patent in oral proceedings held before the Opposition Board. The patent was upheld in an amended form and the opponents' request to revoke the patent was rejected. The '235 patent stems from the broader Kreutzer-Limmer I patent family, which is exclusively owned by Alnylam, and in this particular case includes broad claims covering methods of silencing disease genes with vector-expressed small interfering RNAs, or 'siRNAs', the molecules that mediate RNAi.
The maintenance of key granted claims in the Kreutzer-Limmer '235 patent reinforces the strength of Alnylam's overall intellectual property (IP) estate which is believed by the company to be needed for the development and commercialization of RNAi therapeutics. The '235 patent was challenged by Silence Therapeutics plc, Pfizer Inc, and sanofi-aventis, whose collective request to revoke the patent was denied.
"We are gratified with the German Patent Office's decision to support the '235 patent from our Kreutzer-Limmer I patent family. This patent family has broad and significant claims related to RNAi therapeutics, and stems from the pioneering work of some of Alnylam's founding scientists," said Barry Greene, president and chief operating officer of Alnylam. "This ruling continues to affirm Alnylam's overall IP estate as a required component for development and commercialization of all RNAi therapeutics. Alnylam has leveraged this IP estate to enable the field with freedom to operate for RNAi therapeutics as evidenced by more than 25 licensing agreements which have yielded over $675 million in realized cash funding, and we expect this to continue in the future."
Alnylam's IP position is comprised of fundamental, chemistry, delivery, and target patents and patent applications that the company believes are 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 over 300 have issued or been granted in the US, Europe, or Japan, the world's largest pharmaceutical markets.
RNAi (RNA interference) is a revolution in biology, representing a breakthrough in understanding how genes are turned on and off in cells, and a completely new approach to drug discovery and development.
Alnylam is a biopharmaceutical company developing novel therapeutics based on RNA interference, or RNAi.