United States District Court, D. Massachusetts
JANSSEN BIOTECH, INC. ET AL, Plaintiffs,
CELLTRION HEALTHCARE CO. LTD., ET AL., Defendants.
MEMORANDUM AND ORDER
Memorandum is based on the transcript of the decision
rendered orally on August 17, 2016, allowing defendants
Celltrion Healthcare Co., Ltd., Celltrion, Inc., and Hospira,
Inc.'s (collectively "Celltrion") Motion for
Summary Judgment of Invalidity of U.S. Patent No. 6, 284, 471
for Obviousness-Type Double Patenting (the
"Gilead Motion"). This Memorandum adds
citations, and clarifies and amplifies some language.
Janssen Biotech, Inc. and New York University, (collectively
"Janssen"), are the holders of patents related to a
biologic medication called Remicade, which is based on an
antibody called infliximab. Plaintiffs allege that Celltrion
has infringed these patents by filing an abbreviated Biologic
License Application for a product that is
"biosimilar" to Remicade.
patents are at issue in this motion for summary judgment
based on obviousness-type double patenting. They are U.S.
Patent Number 6, 284, 471 (the "'471 patent" or
'"471"), and U.S. Patent Number 6, 790, 444
(the "'444 patent" or "'444").
The '471 patent covers a genus, or group, of compounds
that includes infliximab. The '444 patent is for the
infliximab antibody specifically.
concede that the M44 claims are not patentably distinct from
the '471 claims. Both patents are based on an application
filed in 1991, which is sometimes called the "priority
application." The priority date for each patent is 1991.
'471 patent was filed in 1994, and issued on September 4,
2001. If it stood alone, it would expire on September 4, 2018
because it was filed before the 1995 effective date of the
law altering patent terms, the Uruguay Round Agreements Act
(the "URAA"). The URAA is codified at 35 U.S.C.
§154, most pertinently at §154(c)(1). The URAA
provides protection for 20 years from the date of the
original, priority application or 17 years after issuance,
whichever is longer, for applications filed before 1995.
Therefore, if the '471 patent stood alone, it would
expire in 2018. However, for applications filed after 1995,
patent protection extends for 20 years after the date the
original, priority application was filed. The application for
the '444 patent was filed in 2001, after the 1995
effective date of the URAA, and was issued in 2004. As it was
based on a 1991 priority application, it expired 20 years
later, in 2011.
Celltrion's Gilead motion, the defendants seek
summary judgment of invalidity on Claims 1, 3, 5, 6 and 7 of
the '471 patent for obviousness-type double patenting
based on the '444 patent. The only question presented by
the motion is whether, in view of the Federal Circuit's
decision in Gilead Sciences, Inc. v. Mateo Pharma
Limited, 753 F.3d 1208 (Fed. Cir. 2014), the
earlier-expiring '444 patent should be held to be a
double patenting reference that invalidates the '471
Patent. I find that it is such a reference and, therefore,
the '471 patent is invalid.
involved two patents based on applications filed after 1995.
Therefore, it did not implicate the provision of the URAA
that provides patent protection for at least 17 years after
issuance if the application for a patent in dispute was filed
before 1995. As this case is factually different than
Gilead, Gilead is not binding precedent. I
find, however, that in enacting the URAA, Congress and the
President did not intend to alter the judicially-created
doctrine of obviousness-type double patenting or restrict the
power of the courts to apply it to patents resulting from
applications filed before 1995.
find that the Federal Circuit would apply the Gilead
ruling to the circumstances of this case and again find that
a later-issued but earlier-expiring patent can serve as a
reference that renders an earlier-issued but later-expiring
patent invalid for obviousness-type double patenting.
August 16, 2016, the court heard oral argument on the
Gilead Motion. On August 17, 2016, the court issued
an oral decision, allowing the Gilead Motion. On
August 19, 2016, the court issued an order summarizing the
reasons for its oral decision. This Memorandum, like the
August 17, 2016 transcript, more fully explains those
Gilead, 753 F.3d at 1214, the Federal Circuit wrote
that "[i]t is a bedrock principle of our patent system
that when a patent expires, the public is free to use not
only the same invention claimed in the expired patent but
also obvious or patentably indistinct modifications of that
invention." The court explained that "[t]he public
should ... be able to act on the assumption that upon the
expiration of [a] patent it will be free to use not only the
invention claimed in the patent but also [any] modifications
or variants [of it] which would have been obvious to those of
ordinary skill in the art at the time the invention was
made." Id. (citing In re ...