Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) and Alnylam Pharmaceuticals,
Inc. (Nasdaq: ALNY) announced today that the United States Patent and
Trademark Office (USPTO) has issued a Notice of Allowance for U.S.
patent application (No. 10/078,949) in the “Crooke” patent family, which
broadly covers chemically modified RNA-containing therapeutics.
Specifically, the allowed Crooke application includes 75 claims covering
methods of using chemically modified double-stranded RNA-containing
compounds to activate an RNA nuclease (RNase). The activation of the
endogenous cellular RNase “argonaute 2” by double-stranded small
interfering RNAs (siRNAs) is a central step in RNAi, resulting in the
sequence-specific cleavage of target mRNA.
The Crooke patent family stems from innovative 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 Crooke patents are part of Isis’ overall
patent estate, which includes more than 1,600 issued patents worldwide
that broadly cover the design and use of RNA-targeting drugs. Under an
agreement formed in 2004, the Crooke patent estate and additional
Isis-owned patents are licensed exclusively to Alnylam for
double-stranded RNAi therapeutics.
“We are very pleased that the U.S. Patent Office has acknowledged these
new claims, which will expand the coverage of the Crooke patent series.
This series continues to provide broad protection against competitors
who are developing RNA-based drugs, including siRNAs,” said Stanley
Crooke, M.D., Ph.D., Chairman and Chief Executive Officer of Isis. “With
nearly 1,650 patents issued worldwide, we believe that we have an
unparalleled intellectual property estate in the field of RNA
therapeutics. Because we continue to innovate and advance our
technology, we plan to continue to extend our basic patent protections
on our drugs and our technologies.”
“Alnylam has maintained an ongoing strategy to consolidate all the
intellectual property required to develop and commercialize RNAi
therapeutics,” said John Maraganore, Ph.D., Chief Executive Officer of
Alnylam. “Our patent licenses from Isis, including the Crooke patent
estate, form a key component of Alnylam’s intellectual property position
in the field. The allowance of these new claims in the Crooke patent
estate clearly validates this strategy and strengthens our efforts and
those of our partners to bring RNAi therapeutics to patients.”
Issued patents in the Crooke estate already include U.S. Patent No.
5,898,031 covering chemically modified 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-stranded and double-stranded
(siRNA) antisense compounds but also targeting other RNAs, such as
microRNAs. U.S. Patent No. 7,432,250 covering methods of treating
patients by administering siRNA or single-stranded chemically modified
RNA-like compounds; and claims in U.S. Patent No. 7,432,249 cover
pharmaceutical compositions containing single-stranded chemically
modified RNA-like compounds. U.S. Patent No. 7,629,321 claims methods of
cleaving target mRNA using a single-stranded oligonucleotide having a
plurality RNA nucleosides and at least one chemical modification.
The newly allowed U.S. patent application (No. 10/078,949) covers
methods of activating a double-stranded RNase using a double-stranded
chemically modified RNA-containing compound with the following
two oligonucleotide strands hybridized to each other;
each oligonucleotide strand comprised of 15 to 25 nucleosides; and
at least one strand comprising a plurality of ribose sugar moieties
and at least one chemical modification.
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.