Isis Pharmaceuticals, Inc, Alnylam Pharmaceuticals, Inc, and the companies' joint venture Regulus Therapeutics LLC, announced that the United States Patent and Trademark Office (USPTO) has granted notices of allowance for two U S patent applications that further enhance the scope of Isis' "Crooke" patent estate, which broadly covers RNA-containing therapeutics. The Crooke patent estate is a family of patents stemming from the pioneering research of Dr Stanley Crooke and others at Isis to identify and design RNA molecules that harness cellular RNase enzymes as antisense drugs, including RNAi and microRNA therapeutics. The newly allowed claims cover pharmaceutical compositions and methods of treating patients, expanding coverage of the Crooke patents to include RNA-based drugs and treatment methods.

"Isis has an unparalleled intellectual property position that covers our innovative RNA-based technology and drug discovery platform. The Crooke patent series provides broad protection against competitors who are developing RNA-based drugs, including siRNAs," said Stanley Crooke, chairman and chief executive officer of Isis. "At Isis, we have dedicated ourselves to advancing the core understanding of RNA-based drugs, continually evolving and optimizing our technology. Our efforts, combined with those of our partner Alnylam and our joint venture Regulus, have broadened the understanding and potential of many of the different approaches that antisense has to offer."

The Crooke patent estate is owned by Isis and licensed to Alnylam for the development of double-stranded RNAi therapeutics, and to Regulus Therapeutics for microRNA-based therapeutics. Issued patents in the Crooke estate already include U.S. Patent No. 5,898,031 covering RNA-containing therapeutic compounds, and U.S. Patent No. 6,107,094 covering methods of using these compounds to interfere with target RNA function, including not only interrupting protein production with single and double-stranded (siRNA) antisense compounds but also targeting other RNAs, such as microRNAs. The newly allowed claims in U.S. Patent Application No. 10/281,312 cover methods of treating patients by administering an siRNA or a single-stranded RNA-containing compound; and those in U S Patent Application No. 10/281,297 cover pharmaceutical compositions containing single-stranded RNA-like compounds. These allowances further strengthen Isis' broadly applicable intellectual property (IP) estate covering RNA-based drug discovery, development, and therapeutic uses.

"Our exclusive license from Isis for the Crooke patent series represents a key component of Alnylam's dominant IP position for the development and commercialization of RNAi therapeutics," said John Maraganore, chief executive officer of Alnylam. "The allowance of these new patents is particularly important because they broaden the scope of our IP covering pharmaceutical compositions and methods of treating patients with RNAi therapeutics."

"Since our inception nearly a year ago, Regulus has made important progress in the advancement of microRNA therapeutics," said Kleanthis Xanthopoulos, chief executive officer of Regulus Therapeutics. "The significant consolidation of the Isis and Alnylam IP estates with Regulus for microRNA therapeutics has created an unmatched opportunity for the advancement of this new technology. These new patent allowances significantly strengthen our efforts to advance microRNA therapeutic products to patients."

Following a Notice of Allowance, the process resulting in final issuance of a patent involves several administrative steps that are typically completed within a year.

Isis is exploiting its expertise in RNA to discover and develop novel drugs for its product pipeline and for its partners.

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

Regulus Therapeutics LLC is a biopharmaceutical company formed to discover, develop, and commercialize microRNA-based therapeutics.