Takeda Pharmaceuticals U.S.A., Inc. v. West-Ward Pharmaceutical Corporation et al
Filing
21
MEMORANDUM ORDER granting 5 MOTION for Temporary Restraining Order and Preliminary Injunction filed by Takeda Pharmaceuticals U.S.A., Inc. ORDER Setting Teleconference: Counsel for Takeda to initiate the call.( A Telephone Conference is set for 10/14/2014 at 01:00 PM before Judge Sue L. Robinson). Signed by Judge Sue L. Robinson on 10/9/2014. (nmfn)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
TAKEDA PHARMACEUTICALS
USA, INC.,
Plaintiff,
)
)
)
)
)
v.
) Civ. No. 14-1268-SLR
)
WEST-WARD PHARMACEUTICAL
)
CORPORATION, HIKMA AMERICAS )
INC., and HIKMA PHARMACEUTICALS)
PLC,
)
)
Defundan~.
)
MEMORANDUM ORDER
At Wilmington this 9 1h day of October, 2014, having conferred with counsel and
having reviewed the papers filed in connection with plaintiff's motion for a temporary
restraining order ("TRO");
IT IS ORDERED that said motion (D.I. 5) is granted, for the reasons that follow:
1. Background. Plaintiff Takeda Pharmaceuticals U.S.A., Inc. ("Takeda") has
requested a TRO to preserve the status quo while the parties more fully brief (and the
court considers) Takeda's motion for a preliminary injunction. Takeda is the owner of
the asserted patents, 1 all of which cover methods of administering colchicine products
1
U.S. Patent Nos. 7,964,648 ("the '648 patent"); 7,981,938 ("the '938 patent");
8,097,655 ("the '655 patent"); 8,440,722 ("the '722 patent"); and 7,964,647 ("the '647
patent") (collectively, "the asserted patents"). The '655, '648 and '722 patents are
directed to methods for administering reduced doses of colchicine for the prophylaxis of
gout flares in patients who are concomitantly taking clarithromycin ('655 patent),
ketoconazole ('648 patent), or verapamil ('722 patent). The '938 patent is directed to a
for the treatment of acute gout flares, as well as for concomitant administration of
colchicine with other drugs for prophylaxis (prevention) of gout flares. Defendants
West-Ward Pharmaceutical Corporation, Hikma Americas Inc., and Hikma
Pharmaceuticals PLC (collectively referred to as "Hikma") have launched a branded
product, Mitigare TM, an oral single-ingredient colchicine product, "indicated for
prophylaxis of goutflares in adults" (D.I. 1, ex. Hat 1). and intends to launch a generic
version of such as early as Friday, October 10, 2014 at a price significantly below that
of Takeda's pricing structure. Although Mitigare™ has the same active ingredient, route
of administration, and strength as Takeda's colchicine product (Colcrys®), Hikma did
not file its application with the FDA as an ANDA. Moreover, in its proposed label,
Hikma has omitted specific mention of uses for which Takeda has patent protection.
2. Standard of review. "The decision to grant or deny ... injunctive relief is an
act of equitable discretion by the district court." eBay, Inc. v. MercExchange, LLC, 547
U.S. 388, 391 (2006). The grant of such relief is considered an "extraordinary remedy"
that should be granted only in "limited circumstances." See Kos Pharma, Inc. v. Andrx
Corp., 369 F.3d 700, 708 (3d Cir. 2004) (citation omitted). A party seeking preliminary
injunction relief must demonstrate: (1) a reasonable likelihood of success on the
merits; (2) the prospect of irreparable harm in the absence of an injunction; (3) that this
harm would exceed harm to the opposing party; and (4) the public interest favors such
relief. See, e.g., Scie/e Pharma Inc. v. Lupin Ltd., 684 F.3d 1253, 1259 (Fed. Cir.
method of treating a gout flare using a specific low-dose regiment in patients already
undergoing prophylactic treatment with colchicine. The '647 patent is directed to a
method of treating a gout flare using a low-dose regiment of colchicine.
2
2011); Antares Pharma, Inc. v. Medac Pharma, Inc., Civ. No. 14-270, 2014 WL
3374614, at *2 (D. Del. July 10, 2014). A request for a TROis governed by the same
general standards that govern the issuance of a preliminary injunction. In re
Cyclobenzaprine, 2011 WL 1980610, at *1 (D. Del. May 20, 2011).
3. Analysis. I start with the recognition that this dispute did not proceed through
the statutory regime established to vet patent infringement issues before drugs enter
the stream of commerce. 2 This is so because defendants did not note the asserted
patents as having any relevance to their product Mitigare TM. Because the infringement
analysis need not reflect the artificial construct of ANDA litigation, 3 I in turn am not
confined to the principle that "section 271(e)(2)(A) lies only against a patented use that
has been approved by the FDA." Bayer Schering Parma AG v. Lupin, Ltd., 676 F.3d
1316, 1319 (Fed. Cir. 2012). To put the point differently, I can consider the record in
light of the realities of the marketplace in which the parties compete.
4. In this regard, as I have noted before, "off-label prescribing -the prescription
of a medication in a manner different from that approved by the FDA - is legal and
common." Stafford, "Regulating Off-Label Drug Use- Rethinking the Role of the FDA,"
The New England Journal of Medicine (April 3, 2008) ("Stafford") at 1427. See
generally Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 350-351 and n.5
2
35 U.S.C. § 271 (e)(2).
3
The court in /G/ Laboratories, Inc. v. Mallinckrodt LLC, 2014 WL 1652790 (D.
Del. April 22, 2014), in addressing counterclaims under 35 U.S.C. § 271(e)(2)(A),
described this section "as creating a highly artificial act of infringement ... so that
courts could promptly resolve infringement and validity disputes before the ANDA
applicant had engaged in the traditional statutorily defined act of infringement." /d. at *1
(citing AstraZeneca Pharm. LP v. Apotex Corp., 669 F.3d 1370, 1377 (Fed. Cir. 2012)).
3
(2001 ). Indeed, it has been suggested that the FDA itself has a "permissive attitude
toward the promotion of off-label uses of drugs." See Stafford at 1428. Therefore, the
fact that the Mitigare TM label does not instruct users to perform the patented method is
not dispositive. And, indeed, the label does contain relevant information regarding use
of Mitigare TM with other drugs:
Co-administration of P-gp or CYP3A4 inhibitors or inhibitors of both
P-gp and CYP3A4 (e.g., clarithromycin or cyclosporine) have been
reported to lead to colchicine toxicity. The potential for drug-drug
interactions must be considered prior to and during therapy.
Concomitant use of MITIGARE™ and inhibitors of CYP3A4 or P-gp
should be avoided if possible. If co-administration of MITIGARE™
and an inhibitor of CYP3A4 or P-gp is necessary, the dose of
MITIGARE™ should be reduced and the patient should be monitored
carefully for colchicine toxicity.
(D.I. 1, ex. Hat 1)
5. To prove infringement, the patentee must show that the accused method
meets every claim limitation either literally or under the doctrine of equivalents. Pfizer,
Inc. v. Teva Pharms., USA, Inc., 429 F.3d 1364, 1376 (Fed. Cir. 2005). To establish
inducement, the patentee must show "direct infringement, and that the alleged infringer
'knowingly induced infringement and possessed specific intent to encourage another's
infringement."' i4i Ltd. P'ship v. Microsoft Corp., 598 F.3d 831, 851 (Fed. Cir. 2010).
6. Having reviewed the record, including the claim charts prepared by Takeda
(D.I. 9, exs. M, 0, and P), I conclude that Takeda has carried its burden to prove a
likelihood of success on the merits with respect to direct and induced infringement. 4
4
Hikma has not taken any steps to challenge the validity of the asserted patents,
as would be contemplated in, e.g., a Paragraph IV notice under the ANDA regime.
4
More specifically, prescribing and filling prescriptions (by doctors and pharmacists) and
use (by patients) of Mitigare ™ for prophylaxis of gout flares will directly infringe
representative claims of the '655, '648, and '722 patents. Based on the listing of these
patents in the FDA's Orange Book, the parties' previous litigation history related to other
colchicine patents, 5 and Hikma's instructions in the product labeling for Mitigare TM, I
conclude that Hikma knew about the patents and that the prescription or use of
Mitigare™ infringes those patents. See AstraZeneca LP v. Apotex, Inc., 633 F.3d
1042, 1060 (Fed. Cir. 201 0) (a finding of specific intent is justified when the language of
the accused infringer's product labeling "would inevitably lead some customers to
practice the claimed method.").
7. With respect to the '938 and '647 patents, the pharmacological properties of
Takeda's branded drug Colcrys® and Mitigare TM are identical. (0.1. 7, 1'[12) Although
Mitigare ™ is approved for a more limited use than is Colcrys® - the latter is approved
for treatment and prophylaxis of gout flares, while the former is approved only for
prophylaxis- the record indicates that it is likely that some patients may use the same
medication they use for prophylaxis to treat an acute gout flare when it occurs, because
the dosing is similar (administration of "0.6 mg (one capsule) once or twice daily"). (D.I.
1, ex. Hat 1; see D.l. 7, 1'[1'[10-14) Consistent with the claim chart provided by Takeda
(D.I. 9, ex. S), I conclude that Takeda has carried its burden of proof to demonstrate
direct infringement. Furthermore, by providing patients using colchicine for prophylaxis
5
Takeda previously asserted several patents against Hikma relating to the
concomitant administration of colchicine with other drugs for the prophylaxis of gout
flares. (0.1. 9, ex. I)
5
of gout flares with the same 0.6 mg colchicine that is used to treat acute gout flares,
with knowledge of the patents and the dosing recommendations specified by the FDA in
the Orange Book, there is sufficient evidence of a specific intent on Hikma's part to
induce infringement. By selling Mitigare rM, Hikma is providing a 0.6 mg colchicine
product to gout patients who will likely need to treat acute gout attacks and can readily
do so by taking Mitigare rM consistent with the use of colchicine as recommended by the
FDA and disclosed by the '983 and '647 patents. Indeed, the limited market for
Mitigare ™'s approved use - prophylaxis only -further demonstrates a specific intent to
induce infringement, as the vast majority of gout patients using colchicine for
prophylaxis also suffer acute gout flares. (D. I. 7,
1f 13)
8. I also conclude that Takeda has carried its burden to demonstrate the
remaining prerequisites for preliminary relief. There is sufficient record evidence to
demonstrate that the generic launch will significantly impact Takeda's market share of
colchicine products, as well as impair goodwill, pricing, and research and development
efforts. (D.I. 8) Further, it is my impression that Hikma has effectively side-stepped the
ANDA regime in an effort to get its generic product to market without appropriate legal
underpinnings. For these reasons, the balance of hardships (maintaining the status
quo for 14 days) and the public interest weigh in Takeda's favor.
9. Conclusion. For the reasons stated above, Takeda's motion for a temporary
restraining order is granted.
IT IS FURTHER ORDERED that defendants shall maintain the status quo with
6
respect to the launch of their generic colchicine product as of the date of this order, 6
and may be sanctioned if they have moved forward with their launch in bad faith despite
the pendency of these proceedings. A telephonic status conference shall be conducted
on Tuesday, October 14 at 1:00 p.m., with counsel for Takeda initiating the call.
Takeda shall take the laboring oar in preparing a more detailed form of order for review
by defendants and the court.
6
ln other words, if defendants have launched so that their generic product is in
the stream of commerce and, ostensibly, out of their custody or control, defendants
must demonstrate that they have reached out to their customers and presented this
order to them in order to stay any further distribution of the generic.
7
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
Why Is My Information Online?