from 2016 through 2020, and at the end of 2026 and 2031. The lease for our 25,800 square foot facility has an
initial term ending in June 2021 with an option to extend the lease for up to two five-year periods. Akcea intends
to lease space in Cambridge, Massachusetts; their primary place of business. We believe our existing facilities are
adequate for our requirements in the foreseeable future and that we have sufficient manufacturing capacity to
meet our current and future obligations under existing agreements with our partners for commercial, research and
clinical needs, including for the Phase 3 clinical trials for ISIS-TTR
Rx
, ISIS-SMN
Rx
and ISIS-APOCIII
Rx
.
Item3. Legal Proceedings
Santaris Litigation
In September 2011, we filed a patent infringement lawsuit against Santaris PharmaA/S and Santaris Pharma
A/S Corp. in the United States District Court of the Southern District of California. Our infringement lawsuit
alleges that Santaris’ activities providing antisense drugs and antisense drug discovery services to several
pharmaceutical companies infringes U.S. Patent No. 6,326,199, entitled ‘‘Gapped 2’ Modified Oligonucleotides’’
and U.S. Patent No. 6,066,500, entitled ‘‘AntisenseModulation of Beta Catenin Expression.’’ In the lawsuit we
are seeking monetary damages and an injunction enjoining Santaris from conducting or participating in the
infringing activities. In December 2011, Santaris filed an answer to our complaint, denying our allegations, and
seeking a declaration from the court that Santaris has not, and does not, infringe the patents we asserted against
Santaris in the suit. In January 2012, Santaris filed a motion for summary judgment asking the court to decide as
a matter of law that Santaris’ activities do not infringe the patents we assert in the suit. In September 2012, the
court denied Santaris’ motion for summary judgment and opened limited discovery related to whether Santaris’
alleged infringing activities are permitted by the safe harbor under 35 U.S.C. Section 271(e)(1). InApril 2013,
we amended our complaint related to the lawsuit to include additional claims alleging that Santaris’ activities
providing antisense drugs and antisense drug discovery services to a pharmaceutical company infringes U.S.
Patent No. 6,440,739 entitled ‘‘AntisenseModulation of Glioma-Associated Oncogene-2 Expression’’; and that
Santaris induced its actual and prospective pharmaceutical partners to infringe U.S. Patent No. 6,326,199. In
December 2013, Santaris filed a newmotion for summary judgment asking the court to decide as a matter of law
that Santaris’ alleged infringing activities are permitted by the safe harbor under 35 U.S.C. Section 271(e)(1). On
February 27, 2014, the court denied this motion.
InMarch 2014, Santaris filed a motion asking the court to decide that Santaris’ alleged infringing sales of
our patented methods are not actionable as a matter of law. In June 2014, the court granted Santaris’ motion and
dismissed our allegations to the extent the allegations are based on Santaris’ sale or offer for sale of such method
claims; and that we did not plead sufficient facts to establish that Santaris entering into its agreement with Enzon
constituted the sale or offer for sale of the compounds claimed in U.S. Patent No. 6,066,500 and U.S. Patent No.
6,440,739. The rest of the case is proceeding, and on October 17, 2014, we filed an amended complaint to plead
additional facts and assert Santaris infringed U.S. Patent No. 6,066,500 and U.S. Patent No. 6,440,739 through
Santaris’ agreement with Enzon.
Gilead Litigation
InAugust 2013, Gilead Sciences Inc. filed a suit in the United States District Court of the Northern District
of California related to United States Patent Nos. 7,105,499 and 8,481,712 that are jointly owned byMerck
Sharp &Dohme Corp. and Isis Pharmaceuticals, Inc. In the suit Gilead is asking the court to determine that
Gilead’s activities do not infringe any valid claim of the named patents and that the patents are not valid. We and
Merck Sharp &Dohme Corp. filed our answer denying Gilead’s noninfringement and invalidity contentions,
contending that Gilead’s commercial sale and offer for sale of sofosbuvir prior to the expiration of the ’499 and
’712 patents will infringe those patents, and requesting monetary damages to compensate for such infringement.
Under our agreement withMerck, Merck is responsible for the costs of this suit.
Item4. Mine Safety Disclosures
Not applicable.
64
