Transthyretin and ISIS-TTR
Rx
We obtained issued claims covering ISIS-TTR
Rx
in the United States. The issued U.S. claims should protect
ISIS-TTR
Rx
from generic competition in the United States until at least 2025. We are also pursuing additional
patent applications designed to protect ISIS-TTR
Rx
in the United States and other foreign jurisdictions, including
Europe and Japan. The table below lists the current issued U.S. patents protecting ISIS-TTR
Rx
:
Jurisdiction
Patent No.
Title
Expiration
Description of Claims
United States
8,101,743
MODULATIONOF
TRANSTHYRETINEXPRESSION
2025
Antisense sequence and chemistry of
ISIS-TTR
Rx
United States
8,697,860
DIAGNOSISANDTREATMENT
OF DISEASE
2031
Composition of ISIS-TTR
Rx
In some cases, the patent term can be extended to recapture a portion of the term lost during FDA
regulatory review.
RNAi Motifs andMechanisms - The Crooke Patents
The Crooke Patents, which are the result of the early work by Dr. Crooke and co-workers exploring
oligonucleotides that activate double-stranded ribonucleases, or dsRNases, cover chemically-modified,
RNA-containing oligonucleotides and methods for exploiting the RNAi pathway with these oligonucleotides until
June 2016. We licensed the Crooke Patents toAlnylam for the development of double-stranded therapeutics and
to Regulus for the development of microRNA-targeting therapeutics. These patents also provide us with
exclusivity in the field of ssRNAi compounds, in which we have made great strides to progress this approach
toward a viable therapeutic platform. The following patents have issued out of the Crooke Patent family:
Jurisdiction
Patent No.
Title
Expiration
Description of Claims
United States
5,898,031
OLIGORIBONUCLEOTIDES FOR
CLEAVINGRNA
2016
Oligonucleotides comprising regions of
RNAnucleosides and regions of
nucleosides having stabilizing chemical
modifications. Such oligonucleotides are
suitable for use in single- and
double-stranded applications.
United States
6,107,094
OLIGORIBONUCLEOTIDES FOR
CLEAVINGRNA
2016
Compounds and methods that use
oligonucleotides having both RNA
nucleosides and chemically modified
nucleosides, including methods that rely on
a dsRNAse to reduce target RNAand
compounds having nucleosides with
improved affinity and/or stability.
United States
7,432,249
OLIGORIBONUCLEOTIDES FOR
CLEAVINGRNA
2016
Pharmaceutical compositions comprising a
diluent or carrier and a single-stranded
antisense oligonucleotide having a plurality
of RNAnucleosides and at least one sugar
modification.
United States
7,432,250
OLIGORIBONUCLEOTIDES FOR
CLEAVINGRNA
2016
Methods for treating a patient by
administering an antisense compound
having a plurality of RNAnucleosides and
at least one sugar modification.
United States
7,629,321
OLIGORIBONUCLEOTIDES FOR
CLEAVINGRNA
2016
Methods for cleaving a target RNA in a
cell by contacting the cell with a
single-stranded antisense compound having
a plurality of RNAnucleosides and at least
one sugar modification.
United States
7,695,902
OLIGORIBONUCLEOTIDES FOR
CLEAVINGRNA
2016
Methods of activating a dsRNase by
contacting the dsRNase with a
double-stranded antisense oligonucleotide
where at least one strand has a plurality of
RNAnucleosides and at least one sugar
modification. The methods may be
performed inside a cell.
48
