Johnson and Johnson 2015 Annual Report Download - page 80

Johnson & Johnson acquired the prostate cancer business of Aragon Pharmaceuticals, Inc. (Aragon), including ARN-509,
a compound being tested for treatment of prostate cancer, in September 2013. Prior to the acquisition, in May 2011,
Medivation, Inc. (Medivation) had sued Aragon and the University of California seeking rights to ARN-509. In December
2012, the State Court granted summary judgment to Aragon on Medivation’s claims, awarding the rights of the ARN-509
compound to Aragon, and in January 2013, the Court dismissed the case against Aragon. Medivation has appealed.
REMICADE®Related Cases
In September 2013, JBI and NYU Langone Medical Center (NYU Medical Center) received an Office Action from the
United States Patent and Trademark Office (USPTO) rejecting the claims in U.S. Patent No. 6,284,471 relating to
REMICADE®(the ‘471 patent) in a reexamination proceeding instituted by a third party. The ‘471 patent is co-owned by
JBI and NYU Medical Center, and NYU Medical Center granted JBI an exclusive license to NYU Medical Center’s rights
under the patent. Currently, the ‘471 patent in the United States expires in September 2018. JBI responded to that
rejection in December 2013 and in August 2014, JBI and NYU Medical Center received a further rejection. JBI responded
to the rejection by filing a further amendment and in November 2014, JBI’s petition to enter the amendment was granted.
The application was returned to the examiner for issuance of a new Office Action, which occurred in February 2015,
further rejecting the patent. JBI responded to that rejection and in April 2015, the USPTO issued a further action
maintaining its rejection of the ‘471 patent. In May 2015, JBI filed a notice of appeal to the USPTO’s Patent Trial and
Appeal Board, and the appeal is currently pending. The ‘471 patent remains a valid and enforceable patent as it
undergoes reexamination at the USPTO. JBI will continue to defend the patent and, if necessary, will pursue all available
appeals.
In August 2014, Celltrion filed for FDA approval to make and sell its own biosimilar version of REMICADE®. In March
2015, JBI filed a lawsuit in the United States District Court for the District of Massachusetts against Celltrion and Hospira
seeking a declaratory judgment that their biosimilar product for which they are seeking FDA approval under the new
Biologics Price Competition and Innovation Act (the BPCIA) infringes or potentially infringes six JBI patents. JBI is also
seeking a declaratory judgment that defendants have failed to comply with certain procedural requirements of the BPCIA.
In addition, JBI has moved for a preliminary and permanent injunction to prohibit Celltrion and Hospira from launching their
biosimilar product until 180 days after they have given JBI a Notice of Commercial Marketing, such notice not to be given
before FDA approval of Celltrion’s product. Also in March 2015, JBI moved to stay all proceedings in the District Court
with respect to the ‘471 patent, pending the USPTO re-examination proceeding. In August 2015, JBI also filed a motion
seeking the District Court’s permission to file a patent infringement lawsuit asserting U.S. Patent No. 7,598,083 (the ‘083
patent) against Celltrion and the manufacturer of the cell culture media that Celltrion uses to make its biosimilar product.
Although the ‘083 patent is already asserted in the existing lawsuit, this would expand the claims to include any use of the
cell media made in the United States to manufacture Celltrion’s biosimilar. In February 2016, Celltrion and Hospira agreed
not to launch their biosimilar product before June 30, 2016 and the ‘471 and ‘083 patents will be the two remaining
patents in the lawsuit. In light of this representation, and because the Federal Circuit Court of Appeals is expected to
decide this issue in an unrelated but similar case before June 29th, the Court denied JBI’s motion for preliminary injunction,
but noted that JBI may renew its motion following the Court of Appeals decision, if necessary, or if the Court of Appeals
fails to decide the issue by June 29th. In addition, in February 2016, Celltrion and Hospira filed a motion for
summary judgment of invalidity of the ‘471 patent.
In March 2013, Hospira Healthcare Corporation (Hospira) filed an impeachment proceeding against The Kennedy Institute
of Rheumatology (Kennedy) challenging the validity of a Canadian patent related to REMICADE®(a Feldman patent),
which is exclusively licensed to Janssen Biotech, Inc. (JBI). In October 2013, Kennedy, along with JBI, Janssen Inc. and
Cilag GmbH International (both affiliates of JBI), filed a counterclaim for infringement against Celltrion Healthcare Co., Ltd.,
Celltrion Inc. (together, Celltrion) and Hospira. The counterclaim alleges that the products described in Celltrion’s and
Hospira’s marketing applications to Health Canada for their subsequent entry biologics (SEB) to REMICADE®would
infringe the Feldman patents owned by Kennedy. Discovery in the patent action is ongoing. Trial has been scheduled for
September 2016.
In January 2014, Health Canada approved Celltrion’s SEB to REMICADE®, allowing Celltrion to market its biosimilar
version of REMICADE®in Canada, regardless of the pending patent action. In June 2014, Hospira received approval for
its SEB to REMICADE®. In July 2014, Janssen Inc. (Janssen) filed a lawsuit to compel the Canadian Minister of Health to
withdraw the Notice of Compliance for Hospira’s SEB because Hospira did not serve a Notice of Allegation on Janssen to
address the patent listed by Janssen on the Patent Register. In March 2015, the parties entered into a settlement
agreement whereby Health Canada agreed to a Consent Judgment setting aside Hospira’s Notice of Compliance, subject
to Health Canada’s right to appeal, which appeal was filed in June 2015. Nevertheless, Hospira began marketing a
biosimilar version of REMICADE®as a distributor under Celltrion’s Notice of Compliance.
68 •Johnson & Johnson 2015 Annual Report