Johnson and Johnson 2014 Annual Report Download - page 68

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. If the Notice of Compliance is withdrawn, Hospira would have
to serve a Notice of Allegation and Janssen could commence an application to prohibit issuance of the Notice of
Compliance until expiry of the relevant patent. A hearing has been scheduled for March 2015.
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 has sixty days to respond to the rejection. JBI believes the ’471 patent is valid, will respond to the
latest Office Action to defend the patent and, if necessary, JBI will pursue all available appeals.
In March 2014, Celltrion filed a declaratory judgment lawsuit against JBI in the United States District Court for the District
of Massachusetts seeking to invalidate the ’471 patent and two other U.S. patents that relate to REMICADE®and are co-
owned by JBI and NYU Medical Center, and exclusively licensed to JBI (collectively, the Le patents). JBI moved to dismiss
the case for lack of jurisdiction and Celltrion voluntarily dismissed its lawsuit. Also in March 2014, Celltrion filed a lawsuit
in the United States District Court for the Southern District of New York against Kennedy seeking to invalidate three
patents owned by Kennedy (the Feldman patents). The Feldman patents are licensed to JBI and also relate to
REMICADE®. Kennedy moved to dismiss the case for lack of jurisdiction, including failure to comply with the procedural
requirements of the Biologics Price Competition and Innovation Act (the BPCIA). In December 2014, the Court granted
the motion.
In August 2014, Hospira, Inc. (Hospira) filed a lawsuit in the United States District Court for the Southern District of New
York against JBI, New York University (NYU), NYU Medical Center and Kennedy seeking to invalidate the Feldman
patents. Hospira alleges that it has exclusive rights to market Celltrion’s biosimilar version of REMICADE®in the United
States if it is approved by the FDA. In October 2014, JBI, NYU and NYU Medical Center moved to dismiss this case for
lack of jurisdiction, including failure to comply with the procedural requirements of the BPCIA. In December 2014, the
Court granted the motion.
In August 2014, Celltrion filed for FDA approval to make and sell its own biosimilar version of REMICADE®. In February
2015, JBI received a Notice of Commercial Marketing from Celltrion in accordance with the BPCIA notifying JBI that
Celltrion and/or Hospira intend to begin commercial marketing of a biosimilar product as early as 180 days from the date
of the notice. The parties are proceeding with the patent resolution procedures set forth in the BPCIA. JBI believes the
patents are valid and will enforce the relevant patents.
If any of the Le or Feldman patents is found to be invalid, any such patent could not be relied upon to prevent the
introduction of biosimilar versions of REMICADE®. The timing of the possible introduction of a biosimilar version of
REMICADE®in the United States would be subject to approval by the FDA. Loss of exclusivity will likely result in a
reduction in sales as biosimilar versions of REMICADE®are introduced to the market.
Litigation Against Filers of Abbreviated New Drug Applications (ANDAs)
The following summarizes lawsuits pending against generic companies that have filed Abbreviated New Drug Applications
(ANDAs) with the FDA, or undertaken similar regulatory processes outside of the United States, seeking to market generic
forms of products sold by various subsidiaries of Johnson & Johnson prior to expiration of the applicable patents covering
those products. These ANDAs typically include allegations of non-infringement, invalidity and unenforceability of the
58 •Johnson & Johnson 2014 Annual Report