United States District Court, D. Massachusetts
JANSSEN BIOTECH, INC. ET AL, Plaintiffs,
CELLTRION HEALTHCARE CO. INC., ET AL., Defendants.
MEMORANDUM AND ORDER
2015, plaintiffs Janssen Biotech, Inc. and New York
University (collectively "Janssen") filed Civil
Action No. 15-10698 (the "2015 Action") against
defendants Celltrion Healthcare Co., Ltd., Celltrion Inc.,
and Hospira, Inc. (collectively "Celltrion"). The
case was brought pursuant to the Biologies Price Competition
Act (the "BPCIA"), 42 U.S.C. §262, 35 U.S.C.
§271(e)(2)(C). In the 2015 Action, Janssen alleged
infringement by defendants' biosimilar product of several
of Janssen1s patents, including U.S. Patent No. 6, 284, 471
(the,, , 471" patent") and U.S. Patent No. 7, 598,
083 (the '"083" patent"), used to produce
Remicade. Remicade is prescribed for chronic pain and
generates billions of dollars of sales in the United States
annually. In addition, in the 2015 Action, Janssen alleged
violations of the BPCIA.
2016, Janssen filed Civil Action No. 16-11117 (the "2016
Action"), pursuant to 35 U.S.C. §271(a), alleging
infringement of the '083 patent relating to
Celltrion's activities outside the United States. The two
cases have been consolidated.
August 2016, the court decided two Celltrion motions for
summary judgment and held that the '471 patent is invalid
due to obviousness-type double patenting. Celltrion has moved
for entry of a final judgment on this issue pursuant to
Federal Rule of Civil Procedure 54(b). Janssen opposes that
reasons explained in this Memorandum, Celltrion's motion
for final judgment concerning the '471 patent is being
allowed. The court has decided all issues concerning the
validity of the '471 patent. Its judgment is, therefore,
"final" for the purposes of Rule 54 (b) . In
addition, there is no just reason to delay the entry of final
judgment concerning the '471 patent. The decisions
concerning the '471 patent are separable from the
remaining issues in these cases. This court finds that the
results of the pending reexamination of the '471 patent
by the Patent and Trademark Office (the "PTO") will
not affect the decision that the '471 patent is invalid.
Nor will the Federal Circuit be required to decide the same
issues more than once.
equities also favor an immediate appeal of the decisions that
the '471 patent is invalid. Uncertainty concerning that
question could delay the sale of Inflectra in the United
States. Even if Inflectra is sold in the United States,
uncertainty about whether Inflectra will be removed from the
market because it infringes the '471 patent could
discourage doctors from prescribing it. In either case, the
individuals suffering great pain could be unfairly deprived
for some time of a more affordable alternative to Remicade if
the '471 patent is found on appeal to be invalid. In any
event, legitimate price competition may be delayed while
Janssen reaps substantial monopoly profits that would be
unjustified if the '471 patent is invalid.
BPCIA established an expedited procedure to promote the
prompt resolution of claims of patent infringement by
biosimilar products. This process is intended to reduce
uncertainty and thus encourage the sale of non-infringing,
more affordable biosimilars which may be important to human
health. Granting Celltrion's Rule 54(b) motion serves the
purposes of the BPCIA.
FACTS AND PROCEDURAL HISTORY
holds patents employed to create the biologic product
"Remicade, " which is based on the antibody
infliximab. Remicade is used to treat intense, chronic pain.
It can cost up to $20, 000 per person a year. It generates
revenue from sales in the United States of about $4 billion a
year for Janssen and its parent, Johnson & Johnson.
'471 patent is a patent to a group of chimeric antibodies
including the infliximab antibody in Remicade. It is referred
to by the parties as the "antibody patent." The
'083 patent claims the liquid solution in which cells are
grown, such as the cells that produce the infliximab
antibody. It is referred to by the parties as the "soup
patent." In contrast to the '471 patent, the
'083 patent does not include any reference to infliximab.
has developed a product named Inflectra that is biosimilar to
Remicade. Celltrion invested more than $100 million to
develop Inflectra. Hospira, which is owned by Pfizer, has an
exclusive agreement with Celltrion to market Inflectra in the
April 2016, the United States Food and Drug Administration
approved Inflectra for sale. Pursuant to the BPCIA, Celltrion
may begin selling Inflectra in the United States in October
2016. See Amgen Inc. v. Apotex Inc., 827 F.3d 1052,
1066 (Fed. Cir. 2016).
essence, the BPCIA: requires the developer of a biosimilar
product to disclose promptly the information necessary for a
patent holder to decide whether it believes its patent has
been infringed; requires the patent holder to sue promptly
for any alleged infringement; and limits a patent holder to
recovering a reasonable licensing fee, rather than lost
profits, if the alleged infringement is not prosecuted
promptly. See Amgen Inc. v. Sandoz Inc., 794 F.3d
1347, 1351-52 (Fed. Cir. 2015); 35 U.S.C. §271(e)(6).
The BPCIA seeks to "'ensure that litigation
surrounding relevant patents will be resolved expeditiously
and prior to the launch of the biosimilar product, providing
certainty to the applicant, the reference product
manufacturer, and the public at large.'" Amgen, 794
F.3d at 1363 (Newman, J. concurring in part, dissenting in
part) (quoting Biologies and Biosimilars: Balancing
Incentives for Innovation: Hearing Before the
Subcommittee On Courts and Competition Policy of the House
Committee On the Judiciary, 111th Cong. 9 (July 14, 2009)
(statement of Rep. Eshoo)) . The BPCIA is based in part on
the understanding that uncertainty concerning whether an
innovative biologic infringes a valid patent can discourage
development and sale of a product that may be helpful to
human health and more affordable than the patented product.
these consolidated cases, Janssen now alleges that Inflectra
infringes the '471 patent and the '083
patent. In addition, Janssen asserts that
Celltrion has not satisfied the requirements of the BPCIA.
Janssen seeks declaratory and injunctive relief, and damages
being offered by the court several opportunities to do so,
Janssen did not move for a preliminary injunction to prohibit
the sale of Inflectra in the United States pending the
outcome of these cases. Janssen did, however, move for a stay
of the litigation until the PTO concluded the pending
reexamination of the '471 patent. Celltrion opposed that
May 19, 2016 hearing, the court denied the motion for a stay.
See May 19, 2016 Transcript at 54-57. In explaining
its decision, the court noted that the case was at an early
stage and the litigation would be simplified at the district
court level if the PTO found the '471 patent invalid.
Id. The court cited these factors as favoring a
stay. Id. at 54-55.
the court found these considerations to be outweighed by the
undue prejudice to Celltrion and the public if the stay were
granted. It reasoned, in part, that a stay would undermine a
primary purpose of the BPCIA-achieving the expeditious
resolution of the issues of alleged infringement to promote
certainty as to whether a biosimilar product could be sold
without exposing an innovator to the risk of an award of lost
profits, which ...