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 18, 2016, allowing defendants
Celltrion Healthcare Co., Ltd., Celltrion, Inc., and Hospira,
Inc.'s, Motion For Summary Judgment Of Invalidity Of
Claims 1, 3, 5, 6, 7 of The '471 patent For
Obviousness-Type Double Patenting In Light Of The Claims In
The '195 And '272 patents (the "Reexam
Motion"). The Memorandum adds citations and some text,
and clarifies 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 defendants
Celltrion Healthcare Co., Ltd., Celltrion, Inc., and Hospira,
Inc. (collectively "Celltrion") have infringed
these patents by filing an abbreviated Biologic License
Application for a product that is "biosimilar" to
Remicade, which is named Inflectra.
have moved for summary judgment of invalidity on one of the
patents at issue in this case, U.S. Patent Number 6, 284, 471
(the "471 patent" or '"471"). They
argue that claims 1, 3, 5, 6 and 7 of the '471 patent are
invalid under the doctrine of obviousness-type double
patenting over the claims in two now-expired patent
previously held by plaintiffs, U.S. Patent Nos. 5, 656, 272
(the "'272 patent") and 5, 698, 195 (the
reasons explained in this Memorandum, the Reexam Motion is
being allowed. In summary, the court finds that the '471
patent is not protected by the safe harbor provided by 35
U.S.C. §121. The court also finds that the one-way test
for obviousness-type double patenting, rather than the
two-way test, applies in this case. As the plaintiffs concede
for present purposes, the claims in the '471 are obvious
in view of the earlier-issued claims in the '195 and
'272. Assuming, without finding, that the two-way
obviousness test should be applied, there may be disputed
facts concerning whether the United States Patent and
Trademark Office (the "PTO") was solely responsible
for any delay that caused the '195 patent and '272
patent to issue before the '471 patent. However, any such
disputes would not be material because the claims of the
'471 patent are also obvious under the two-way test.
February 19, 2016, defendants filed their initial Motion for
Partial Summary Judgment on the '471 patent (Docket No.
127) (the "Gilead Motion"), which
plaintiffs opposed. The court subsequently allowed defendants
to file a second motion for summary judgment, the Reexam
Motion, which plaintiffs also opposed.
August 16, 2016, the court heard oral argument on the Reexam
Motion. On August 18, 2016, the court issued an oral decision
allowing the Reexam Motion. On August 19, 2016, the court
issued an order summarizing the reasons for that decision.
Like the August 18, 2016 transcript, this Memorandum provides
a fuller explanation of those reasons.
Rule of Civil Procedure 56(a) provides that the court
"shall grant summary judgment if the movant shows that
there is no genuine dispute as to any material fact and the
movant is entitled to judgment as a matter of law." A
factual dispute, therefore, precludes summary judgment if it
is "material" and "genuine." See
Anderson v. Liberty Lobby, 477 U.S. 242, 247-48 (1986).
is "material" if, in light of the relevant
substantive law, "it has the potential of determining
the outcome of the litigation." Maymi v. Puerto Rico
Ports Auth., 515 F.3d 20, 25 (1st Cir. 2008);
Martinez-Rodriguez v. Guevara, 597 F.3d 414, 419
(1st Cir. 2010). "Only disputes over facts that might
affect the outcome of the suit under the governing law
properly preclude the entry of summary judgment."
Anderson, 477 U.S. at 248.
party moving for summary judgment "bears the initial
responsibility of informing the district court of the basis
for its motion, and identifying those portions of [the
record] which it believes demonstrate the absence of a
genuine issue of material fact." Celotex Corp. v.
Catrett, 477 U.S. 317, 323 (1986). However, the moving
party's burden "may be discharged by
'showing' . . . that there is an absence of evidence
to support the nonmoving party's case." Id.
at 325. Summary judgment is, therefore, mandated "after
adequate time for discovery and upon motion, against a party
who fails to make a showing sufficient to establish the
existence of an element essential to that party's case,
and on which that party will bear the burden of proof at
trial." Id. at 322; Gorski v. New Hampshire
Dep't of Corr., 290 F.3d 466, 475-76 (1st Cir.
2002); Smith v. Stratus Computer, Inc., 40 F.3d 11,
12 (1st Cir. 1994).
OBVIOUSNESS-TYPE DOUBLE PATENTING
issued patent is presumed valid and can only be proven
invalid by clear and convincing evidence." Biogen
Idec MA Inc. v. Trustees of Columbia Univ. in City of New
York, 332 F.Supp.2d 286, 296 (D. Mass. 2004) (citing 35
[35 U.S.C. §101] precludes more than one patent on the
same invention .... Section 101, however, only prohibits a
second patent on subject matter identical to an earlier
patent. Thus, applicants can evade this statutory requirement
by drafting claims that vary slightly from the earlier
(Therefore, courts have] fashioned a doctrine of nonstatutory
double patenting (also known as "obviousness-type"
double patenting) to prevent issuance of a patent on claims
that are nearly identical to claims in an earlier patent.
This doctrine prevents an applicant from extending patent
protection for an invention beyond the statutory term by
claiming a slight variant.
Id. (quoting Geneva Pharm., Inc. v.
GlaxoSmithKline PLC, 349 F.3d 1373, 1377-78 (Fed. Cir.
later claim that is not patentably distinct from, ' i.e.,
'is obvious over[ ] or anticipated by, ' an earlier
claim is invalid for obviousness-type double patenting."
Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611
F.3d 1381, 1385 (Fed. Cir. 2010) (quoting Eli Lilly v.
Barr Labs, 251 F.3d 955, 968 (Fed. Cir. 2001)). The
doctrine of obviousness-type double patenting is primarily
intended "to prevent unjustified timewise extension of
the right to exclude granted by a patent no matter how the
extension is brought about." In re Hubbell, 709
F.3d 1140, 1145 (Fed. Cir. 2013) (quoting In re Van
Ornum, 686 F.2d 937, 943 (C.C.P.A. 1982)). "The
obviousness-type double patenting analysis involves two
steps." Abbvie Inc. v. Mathilda and Terence Kennedy
Institute of Rheumatology Trust, 764 F.3d 1366,
1374 (Fed Cir. 2014).
"First, the court 'construes the claim[s] in the
earlier patent and the claim[s] in the later patent and
determines the differences.' Second, the court
'determines whether those differences render the claims
patentably distinct.'" Sun Pharm. Indus., Ltd.
v. Eli Lilly & Co., 611 F.3d 1381, 1385 (Fed. Cir.
2010) (alteration in original) (quoting Pfizer, Inc. v.
Teva Pharm. USA, Inc., 518 F.3d 1353, 1363 (Fed. Cir.
2008)). "'A later claim that is not patentably
distinct from, ' i.e., 'is obvious over[ ] or
anticipated by, 'an earlier claim is invalid for
obviousness-type double patenting." Id. at 1385
(alteration in original) (quoting Eli Lilly, 251
F.3d at 968).