United States District Court, N.D. Illinois, Eastern Division
TORRENT PHARMACEUTICALS LIMITED and TORRENT PHARMA INC., Plaintiffs,
DAIICHI SANKYO, INC. and DAIICHI SANKYO CO., LTD., Defendants. MYLAN PHARMACEUTICALS INC., Intervenor-Defendant. ALEMBIC PHARMACEUTICAS LIMITED, Plaintiff,
DAIICHI SANKYO CO., LTD., Defendant. MYLAN PHARMACEUTICALS INC., Intervenor-Defendant. AUROBINDO PHARMACEUTICALS, LIMITED and AUROBINDO PHARMA, INC. Plaintiffs,
DAIICHI SANKYO, INC. and DAIICHI SANKYO CO., LTD., Defendants. MYLAN PHARMACEUTICALS INC., Intervenor-Defendant.
Aurobindo Pharmaceuticals Limited, Plaintiff, represented by
Stephen Arthur Wood, Chuhak & Tecson, P.C. & Kristen
Elizabeth Hudson, Chuhak & Tecson, P.C..
Aurobindo Pharma, Inc., Plaintiff, represented by Stephen
Arthur Wood, Chuhak & Tecson, P.C., Steven J. Moore, Withers
Bergman LLP, pro hac vice & Kristen Elizabeth Hudson, Chuhak
& Tecson, P.C..
Sankyo, Inc., Defendant, represented by David C. Van Dyke,
Howard & Howard & Emily Elizabeth Bennett, Howard & Howard
Daiichi Sankyo Co., Ltd.,, Defendant, represented by David C.
Van Dyke, Howard & Howard, C. Austin Ginnings, Fitzpatrick
Cella Harper & Scinto, pro hac vice, Christopher Paul
Borello, Fitzpatrick Cella Harper & Scinto, pro hac vice,
Dominick A. Conde, Fitzpatrick Cella Harper & Scinto, pro hac
vice, Emily Elizabeth Bennett, Howard & Howard Attorneys,
PLLC & Nina Shreve, Fitzpatrick Cella Harper & Scinto, pro
Pharmaceuticals Inc., Intervenor Defendant, represented by
James B. Coughlan, Perkins Coie LLP, Shannon M. Bloodworth,
Perkins Coie Llp, pro hac vice, Autumn N. Nero, Perkins Coie
Llp, pro hac vice, David R. Pekarek Krohn, Perkins Coie LLP &
Maria Alice Stubbings, Perkins Coie LLP, pro hac vice.
MEMORANDUM OPINION AND ORDER
REBECCA R. PALLMEYER, District Judge.
three manufacturers of generic drugs, are seeking a
declaratory judgment, which they believe would give them the
green light to produce a generic form of Defendants'
popular blood pressure medicine, BenicarÂ® (olmesartan
medoxomil), at the earliest possible date. As explained here,
however, this court lacks jurisdiction over Defendants.
Accordingly, the case is dismissed without prejudice.
Daiichi Sankyo Co., Ltd. ("DS Japan"), a Japanese
pharmaceutical company, owns certain patents, including
United States Patent No. 6, 878, 703 ("the '703
patent"), concerning the pharmaceutical drug product
BenicarÂ®. Defendant Daiichi Sankyo, Inc. ("DS
USA"), DS Japan's United States subsidiary, is
incorporated in Delaware and has its principal place of
business in New Jersey. DS USA markets and sells BenicarÂ®
throughout the United States and holds the United States New
Drug Application ("NDA") for the
drug. Plaintiffs Torrent Pharmaceuticals
Limited and Torrent Pharma Inc. ("Torrent"),
Alembic Pharmaceuticals Limited ("Alembic"), and
Aurobindo Pharmaceuticals Limited and Aurobindo Pharma Inc.
("Aurobindo") are all seeking approval from the
United States Food and Drug Administration ("FDA")
to market and sell their own generic versions of BenicarÂ®.
Each has brought separate suits in this district seeking a
declaratory judgment that their applications for FDA
approval, as well as the sale and marketing following such
approval, would not infringe the '703
patent. Without such a judgment, Plaintiffs
insist that Intervenor-Defendant Mylan Laboratories Limited
("Mylan") will have the exclusive right to market a
generic version of BenicarÂ® for a 180-day period beginning
October 25, 2016. Under federal law, Mylan is entitled to
this exclusivity period because it was the first generic
manufacturer to challenge the '703 patent. Plaintiffs
assert that a declaratory judgment of non-infringement in
this case would result in Mylan's forfeiting the
exclusivity period. Unless this court enters the judgment
they seek, Plaintiffs contend, they will be deprived of sales
revenue for the 180-day period, and the public will be
deprived of the benefits of a competitive market for generic
versions of BenicarÂ®.
have filed motions for summary judgment (, Alembic
Pharm. Ltd. v. Daiichi Sankyo Co., 16 C 3956 ,
Aurobindo Pharm. Ltd. v. Daiichi Sankyo Inc., 16 C
4876 ), contending that Plaintiffs' products, as a
matter of law, could not infringe the '703 patent because
Defendants have already disclaimed the patent. Mylan has
filed a motion for judgment on the pleadings , arguing
that the court lacks subject matter jurisdiction. Mylan
insists the declaratory judgment Plaintiffs seek would not
redress their asserted injuries because it would not cause
Mylan to forfeit its exclusivity period as Plaintiffs
contend. In addition, Mylan argues that there is no case or
controversy regarding infringement of the '703 patent
because Daiichi has already disclaimed it. Defendants, for
their part, contend that the court lacks personal
jurisdiction over them and should therefore dismiss
Plaintiffs' complaints in their entirety. For the reasons
discussed below, the court agrees with Defendants and grants
their motions to dismiss (, Alembic, No. 16 C
3956 , Aurobindo, No. 16 C 4876 ) for lack
of personal jurisdiction.
is drug approved by the FDA for the treatment of
/ucm215245.htm (last visited July 20, 2016). To obtain FDA
approval to market and sell BenicarÂ®, Defendants listed two
patents in the FDA's published list of Approved Drug
Products with Therapeutic Equivalence Evaluations
(commonly referred to as the "Orange Book"). (Pl.
Torrent's Compl. For Decl. J. (hereinafter "Torrent
Compl.")  at 28.); see 21 U.S.C. Â§ 355(b)(1)
(requiring applicants to list patents "with respect to
which a claim of patent infringement could reasonably be
asserted if a person not licensed by the owner engaged in the
manufacture, use or sale of the drug"). United States
Patent No. 5, 616, 599 ("the '599 patent) covers the
drug's active ingredient, olmesartan medoxomil, while the
'703 patent covers methods of treatment. Apotex, Inc.
v. Daiichi Sankyo, Inc., 781 F.3d 1356, 1358 (Fed. Cir.
2015). The '703 patent remains listed in the Orange Book
though Daiichi disclaimed every term of the patent on July
11, 2006. ( Id. Â¶Â¶ 24, 29.) With the '703
patent disclaimed, approved generic manufacturers would
ordinarily be able to begin marketing a version of the drug
when the '599 patent expired on April 25, 2016.
Defendants, however, qualify for a six-month extension of
their market exclusivity for the drug because they submitted
certain data concerning the drug's effects on children.
See 21 U.S.C. Â§ 355a(b)(1)(B)(i); Apotex,
781 F.3d at 1358. As a result, FDA cannot approve any generic
version of BenicarÂ® until October 25, 2016, six months after
the expiration of the '599 patent. (Torrent Compl. Â¶ 32.)
manufacturers who seek FDA approval to market and sell
generic versions of previously-approved drugs may do so by
submitting abbreviated new drug applications
("ANDAs"). See 21 U.S.C. Â§ 355(j).
Plaintiffs have submitted ANDAs with respect to their own
generic versions of BenicarÂ®. In doing so, they certified
under 21 U.S.C. Â§ 355(j)(2)(A)(vii)(IV) that the '703
patent will not be infringed by the manufacture, use, or sale
of their generic products. Though each Plaintiff filed an
ANDA containing such a "Paragraph IV" certification
concerning the '703 patent, Intervenor-Defendant Mylan
was the first generic manufacturer to do so. As a result,
Mylan is presumptively entitled to a 180-day period,
beginning once it enters in the market, in which it is the
only generic manufacturer that can market and sell the drug.
See 21 U.S.C. Â§ 355(j)(5)(B)(iv). Plaintiffs
point out, however, that the first ANDA filer's 180-day
exclusivity may be forfeited under certain conditions.
(Torrent Compl. Â¶ 26.) They assert that if the FDA grants
tentative approval for another ANDA filer and that filer
obtains a non-appealable court judgment of non-infringement,
the first ANDA filer would be required to market the drug
within 75 days of the court judgment or else forfeit the
exclusivity. See 21 U.S.C. Â§
355(j)(5)(D)(i)(l)(bb)(AA). Each Plaintiff claims
that a declaratory judgment of non-infringement in this case,
as long as it is entered (or, if appealed, affirmed) at least
75 days before October 25, 2016, would trigger forfeiture of
Mylan's 180-day exclusivity period. (Torrent Compl. Â¶ 46;
Pl. Aurobindo's Compl. for Decl. J.  Â¶ 44,
Aurobindo, No. 16 C 4876 (hereinafter
"Aurobindo Compl."); Pl. Alembic's Compl. for
Decl. J. of Patent Non-infringement of U.S. Patent No. 6,
878, 703  Â¶ 94, Alembic, No. 16 C 3956
(hereinafter "Alembic Compl.").)
earlier lawsuit in this district, another manufacturer of a
generic version of BenicarÂ® sought the same declaratory
judgment of non-infringement of patent '703 that
Plaintiffs seek here. See Apotex, Inc. v. Daiichi Sankyo,
Inc., No. 12 C 9295, 2014 WL 114127, at *1 (N.D. Ill.
Jan. 9, 2014). In that case, the district court initially
concluded that the case did not present a case or controversy
and dismissed it for lack of subject-matter jurisdiction.
Id. at *4. The Federal Circuit reversed that
decision on appeal, finding that the parties' dispute
over the plaintiff's ability to sell the patented drug
involved sufficiently concrete and substantial stakes.
SeeApotex, 781 F.3d at 1361-62. On remand,
the district court granted the generic manufacturer's
motion for summary judgment of non-infringement. Apotex,
Inc. v. Daiichi Sankyo, Inc., No. 12 C 9295, 2016 WL
98572, at *4 (N.D. Ill. Jan. 8, 2016). The court ruled that
non-infringement follows as a matter of law from the fact
that the '703 patent had been formally disclaimed.
Id. Defendants have appealed that ruling, and the
case is now pending again before the Federal Circuit.
Plaintiffs suggest that for the same reason the court entered
summary judgment in Apotex, this court should grant