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Evenwith funding from corporatepartners, if ourpartners donot effectivelyperform their obligations under our agreements
with them, itwoulddelay or stop theprogress of ourdrugdevelopment programs.
In addition to receiving funding, we enter into collaborative arrangementswith thirdparties to:
conduct clinical studies;
seek andobtain regulatory approvals; and
manufacture,market and sell our drugs.
Oncewe have secured a collaborative arrangement to further develop and commercialize one of our drugdevelopment
programs, such as our collaborationswithAstraZeneca, Biogen Idec, Genzyme, andGSK, these collaborationsmaynot continue or
result in commercialized drugs, ormay not progress as quickly aswe first anticipated.
For example, a collaborator such asAstraZeneca, Biogen Idec, Genzyme, orGSK, could determine that it is in its financial
interest to:
pursue alternative technologies or develop alternative products thatmay be competitivewith the drug that is part of
the collaborationwithus;
pursue higher-priorityprograms or change the focus of its owndevelopment programs; or
choose todevote fewer resources toour drugs than it does for its owndrugs.
If anyof these occur, it could affect our partner’s commitment to the collaborationwithus and coulddelayor otherwise
negatively affect the commercialization of our drugs, includingKYNAMRO, ISIS-APOCIII
Rx
, ISIS-SMN
Rx
and ISIS-TTR
Rx
.
Ifwe donot progress inourprograms as anticipated, the price of our securities coulddecrease.
For planningpurposes, we estimate andmay disclose the timing of a varietyof clinical, regulatory andothermilestones, such
aswhenwe anticipate a certaindrugwill enter the clinic, whenwe anticipate completing a clinical study, orwhenwe anticipate filing
an application formarketing approval.We base our estimates onpresent facts and a varietyof assumptions.Manyunderlying
assumptions are outside of our control. Ifwe donot achievemilestones in accordancewithour or our investors’ expectations,
includingmilestones for additional approvals or sales expectations ofKYNAMROormilestones related to thePhase 3programs for
ISIS-APOCIII
Rx
, ISIS-SMN
Rx
and ISIS-TTR
Rx
, the price of our securities could decrease.
For example, inMarch2013 theCHMPof theEuropeanMedicinesAgencymaintained a negative opinion forGenzyme’s
marketing authorization application forKYNAMRO as a treatment for patientswithHoFH.
Ifwe cannot protect ourpatents or our other proprietary rights, othersmay competemore effectivelyagainst us.
Our success depends to a significant degree uponwhetherwe can continue todevelop and secure intellectual property rights
to proprietaryproducts and services. However, wemay not receive issuedpatents on any of our pending patent applications in the
UnitedStates or in other countries. In addition, the scope of anyof our issuedpatentsmay not be sufficientlybroad toprovide uswith
a competitive advantage. Furthermore, our issuedpatents or patents licensed to usmay be successfully challenged, invalidatedor
circumvented so that our patent rightswouldnot create an effective competitive barrier or revenue source.
Intellectual property litigation couldbe expensive andprevent us frompursuing our programs.
From time to timewe have todefendour intellectual property rights. In the event of an intellectual propertydispute, we
sometimes need to litigate todefendour rights or assert them against others. Disputes can involve arbitration, litigation or proceedings
declaredby theUnitedStates Patent andTrademarkOffice or the International TradeCommissionor foreignpatent authorities.
Intellectual property litigation canbe extremely expensive, and this expense, aswell as the consequences shouldwe not prevail, could
seriouslyharmour business. For example, inSeptember 2011we filed a patent infringement lawsuit against Santaris PharmaA/S and
Santaris PharmaA/SCorp. in theUnitedStatesDistrict Court of theSouthernDistrict ofCalifornia, and inNovember 2013we filed a
patent infringement lawsuit againstGileadSciences Inc. in theUnitedStatesDistrict Court of theNorthernDistrict ofCalifornia.
These lawsuitsmay be costly andmaynot be resolved inour favor.
