United States District Court, D. Massachusetts
JANSSEN BIOTECH, INC. ET AL, Plaintiffs,
CELLTRION HEALTHCARE CO. INC., ET AL., Defendants.
MEMORANDUM AND ORDER
reasons described in detail in court on August 17 and August
18, 2016, and summarized below, it is hereby ORDERED that:
Defendants' Motion for Summary Judgment of Invalidity of
U.S. Patent No. 6, 284, 471 for Obviousness-Type Double
Patenting (the "Gilead Motion") (Docket
No. 127) is ALLOWED. Plaintiffs hold U.S. Patent No. 6, 284,
471 (the "'471 Patent"). The '471 Patent
was issued on September 4, 2001. Standing alone, it would
expire on September 4, 2018. Plaintiffs previously held U.S.
Patent No. 6, 790, 444 (the "'444 Patent"). The
'444 Patent was issued on September 14, 2004 and expired
on July 11, 2011. The parties agree that the '471 Patent
is not patentably distinct from the '444 Patent. The
Court of Appeals for the Federal Circuit held in Gilead
Sciences., Inc. v. Natco Pharma Ltd., 753 F.3d 1208
(Fed. Cir. 2014), cert, denied, 135 S.Ct. 1530
(2015), that a later-issuing, earlier-expiring patent can act
as a double-patenting reference for an earlier-issuing,
later-expiring patent. The court finds that the reasoning in
Gilead applies where, as here, the later-issued
patent expires earlier because of the change to patent terms
resulting from the Uruguay Round Agreements Act, codified at
35 U.S.C. §154. In essence, the court concludes that the
statute was not intended to alter the judicial doctrine of
obviousness double-patenting. See Gilead, 753 F.3d
at 1216. Therefore, claims 1, 3, 5, 6, and 7 of the '471
Patent are invalid for obviousness-type double-patenting in
light of the patentably indistinct, earlier-expiring M44
Defendants1 Motion for Summary Judgment of Invalidity of U.S.
Patent No. 6, 284, 471 for Obviousness-Type Double Patenting
Based On U.S Patent No. 5, 698, 195 and U.S. Patent No. 5,
656, 272 (the "Reexam Motion") (Docket No. 17 6) is
(a) The following facts are undisputed. Claims 1, 3, 5, 6,
and 7 of the '471 Patent (the "Asserted
Claims") claim a genus of antibodies that encompasses
the infliximab, or cA2, antibody. Claim 6 of U.S Patent No.
5, 698, 195 (the "'195 Patent") recites "
[a] method of treating rheumatoid arthritis in a human
comprising administering to the human an effective
TNF-inhibiting amount of chimeric anti-TNF anti[b]ody
cA2." Claim 7 of U.S. Patent No. 5, 656, 272 (the
"'272 Patent") recites "[a] method of
treating TNFa-mediated Crohn's disease in a human
comprising administering to the human an effective
TNF-inhibiting amount of chimeric anti-TNF antibody
cA2." The application for the '471 Patent, U.S. Pat.
App. No. 08/192, 093 (the "'093 Application"),
was filed on February 4, 1994, and, as indicated earlier,
standing alone would expire on September 4, 2018. The
application for '272 Patent was also filed on February 4,
1994. The '272 Patent was issued on August 12, 1997 and
expired on August 12, 2014. The application for the '195
Patent was filed on October 18, 1994. The '195 Patent was
issued on December 16, 1997 and expired on December 16, 2014.
(b) The '471 Patent is not entitled to the protection of
the 35 U.S.C. §121 statutory safe harbor (the
"Section 121 safe harbor"). The Section 121 safe
harbor applies only to applications filed as
"divisional." See Pfizer, Inc. v. Teva Pharm.
USA, Inc., 518 F.3d 1353, 1362 (Fed. Cir. 2008). The
'093 Application was filed as a continuation-in-part of
U.S. Pat. App. No. 08/013, 413 (the "'413
Application"). It was not filed as divisional of the
'413 Application. The court does not have discretion to
deem the •093 Application divisional. See id.;
Amgen Inc. v. F. Hoffman-La Roche Ltd, 580 F.3d
1340, 1354 (Fed. Cir. 2009)
(c) The one-way test for obviousness applies to this motion.
Under that test, the Asserted Claims are obvious in light of
the '195 and '272 Patents. "The two-way test . .
. is 'a narrow exception to the general rule of the
one-way test . . . ' In re Hubbell, 709 F.3d
1140, 1149 (Fed. Cir. 2013) (quoting In re Berg, 140
F.3d 1428, 1432 (Fed. Cir. 1998)). It "is appropriate
only in the 'unusual circumstance' where 'the PTO
is solely responsible for the delay in causing the
second-filed application to issue prior to the
first.'" Id. (quoting Berg, 140
F.3d at 1437). However, the application for the '471
Patent was filed on the same day as the application for the
'272 Patent. The PTO did not decide the applications in
the reverse order of filing. Therefore, the two-way test is
not applicable. See United States Patent and
Trademark Office, Manual of Patent Examining Procedure (9th
ed. Nov. 2015) §804.11(B) (2) (b) . Plaintiffs
acknowledge that under the one-way test, the Asserted Claims
are invalid for obviousness-type double-patenting in light of
the '195 Patent and the '272 Patent.
(d) Viewing the evidence in the light most favorable to
plaintiffs, there may be a genuine dispute of fact concerning
whether the PTO is solely responsible for the '471 Patent
issuing after the '195 and '272 Patents. However, any
such dispute would not be material because assuming, without
finding, that the two-way test applied, the Asserted Claims
would also be obvious in light of the '195 Patent and the
'272 Patent under that test. Under the two-way test, the
court performs the one-way analysis and also analyses
"whether the [reference] patent claims are obvious over
the [challenged patent] claims." Hubbell, 709
F.3d at 1149 (quotations omitted). Under Sun Pharm.
Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 1387
(Fed. Cir. 2010), it is proper for the court to consider any
utility disclosed in the '471 Patent specification when
analyzing whether the '195 and '272 Patent claims are
obvious in light of the '471 Patent. The '471 Patent
specification describes the infliximab antibody and discloses
the same uses for infliximab that are claimed in the '195
and '272 patents: treatment of Crohn's disease and
rheumatoid arthritis. " [A] claim to a method of using a
composition is not patentably distinct from an earlier claim
to the identical composition in a patent disclosing the
identical use." Geneva Pharm., Inc. v.
GlaxoSmithKline PLC, 349 F.3d 1373, 1385-86 (Fed. Cir.
2003). The '195 and '272 Patent claims would,
therefore, be obvious in light of the '471 Patent. Both
prongs of the two-way obviousness test are met. Accordingly,
the Asserted Claims are invalid for obviousness-type
double-patenting in light of the '195 and '272
Patents under that test as well.
Motion to Supplement Claim Construction Record (Docket No.
217) is ALLOWED.
court construes the disputed term "cell culture
media" in claim 1 of U.S. Patent No. 7, 598, 083 (the
"'083 Patent") to mean "nutritive media
for culturing cells." This construction is consistent
with the plain and ordinary meaning of the term as understood
by those skilled in the art. The patentees did alter the
meaning of the term by acting as their own lexicographer or
disavowing the otherwise broad scope of the term. See
Phillips v. AVH Corp., 415 F.3d 1303, 1316 (Fed. Cir.
2005); Thorner v. Sony Computer Entm't Am. LLC,
669 F.3d 1362, 1365-66 (Fed. Cir. 2012).
Plaintiffs' Motion Expedited [sic] Trial On 083 Patent
And To Set A Discovery Schedule, If Necessary, For Remaining
471 Patent Issues (Docket No. 166-1) is, as requested by
plaintiffs at the August 18, 2016 hearing, WITHDRAWN.
Defendants' Cross Motion To Limit Plaintiffs' Remedy
As To The '471 Patent (Docket No. 190) is MOOT.
Pursuant to the Stipulation of the parties, plaintiffs'
Motion For Consolidation And For Bifurcation Of Damages
Issues Pursuant To Fed.R.Civ.P. 42 And Local Rule 40.1
(Docket No. 186) is ALLOWED.
(a) Janssen Biotech, Inc. v. Celltrion Healthcare Co.,
Ltd., Civil Action No. 1:15-cv-10698-MLW and Janssen
Biotech, Inc. v. Celltrion Healthcare Co., Ltd., Civil
Action No. 1:16-cv-11117-MLW are ...