GlaxoSmithKline LLC et al v. Glenmark Generics Inc. USA

Filing 38

REPORT AND RECOMMENDATIONS recommending Granting in part D.I.(18 in 1:14-cv-00877-LPS-CJB) MOTION to Dismiss for Failure to State a Claim filed by Glenmark Generics Inc. USA, and D.I. (20 in 1:14-cv-00878-LPS-CJB) MOTION to Dismiss f or Failure to State a Claim filed by Teva Pharmaceuticals USA Inc.. Please note that when filing Objections pursuant to Federal Rule of Civil Procedure 72(b)(2), briefing consists solely of the Objections (no longer than ten (10) pages) an d the Response to the Objections (no longer than ten (10) pages). No further briefing shall be permitted with respect to objections without leave of the Court. Objections to R&R due by 5/11/2015. Signed by Judge Christopher J. Burke on 4/22/2015. Associated Cases: 1:14-cv-00877-LPS-CJB, 1:14-cv-00878-LPS-CJB(dlk)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE

GLAXOSMITHKLINE LLC and
SMITHKLINE BEECHAM (CORK)
LIMITED,
Plaintiffs,
V.

GLENMARK GENERICS INC., USA,
Defendant.

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Civil Action No. 14-877-LPS-CJB

GLAXOSMITHKLINE LLC and
SMITHKLINE BEECHAM (CORK)
LIMITED,

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Plaintiffs,
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v.
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TEVA PHARMACEUTICALS USA, INC., )
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Defendant.
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Civil Action No. 14-878-LPS-CJB

REPORT AND RECOMMENDATION

Presently pending in these two related patent infringement cases are Defendant Glenmark
Generics Inc., USA's ("Glenmark") and Teva Pharmaceuticals USA, Inc. 's ("Teva")
(collectively, "Defendants") motions to dismiss Plaintiffs GlaxoSmithKline LLC ("GSK") and
SmithKline Beecham (Cork) Limited's (collectively, "Plaintiffs") First Amended Complaints
("FAC"), pursuant to Federal Rule of Civil Procedure 12(b)( 6) (the "Motions"). (Civil Action
No. 14-877-LPS-CJB, D.I. 18; Civil Action No. 14-878-LPS-CJB, D.I. 20) 1 For the reasons set
The allegations in the respective FACs are very similar; as to the key issues at
play in the Motions, the FACs are at times nearly identical. The parties' respective briefs are, in
tum, very similar across the two cases. For this reason, the Court resolves both Motions together

forth below, the Court recommends that Defendants' Motions each be GRANTED-IN-PART and
DENIED-IN-PART.
I.

BACKGROUND
A.

Factual Background

The patent-in-suit, U.S. Patent No. RE40,000 (the "Asserted Patent" or the "'000 Patent")
relates to the chemical compound carvedilol. Carvedilol belongs to a class of chemical
compounds known as beta-blockers, which are drugs that, among other things, may be used to
treat patients with high blood pressure, or hypertension. (Civil Action No. 14-877-LPS-CJB, D.I.
14 at~ 8; Civil Action No. 14-878-LPS-CJB, D.I. 16 at~ 8) Approximately two decades ago,
GSK filed New Drug Application ("NDA") No. 20-297 with the United States Food and Drug
Administration ("FDA") on carvedilol tablets for management of hypertension, and in September
1995, it received approval to market the drug for that purpose. (Id) However, GSK did not
launch carvedilol then, in part due to the "crowded hypertensive treatment market[.]" (Id.)
Instead, GSK pursued promising research suggesting that carvedilol could be used to successfully
treat chronic heart failure ("CHF"); eventually, this led to the FDA's May 1997 approval of
carvedilol for the treatment of CHF. (Civil Action No. 14-877-LPS-CJB, D.I. 14 at~~ 8-17;
Civil Action No. 14-878-LPS-CJB, D.I. 16 at~~ 8-17) Thereafter, GSK began marketing and
selling carvedilol 3.125 mg, 6.25 mg, 12.5 mg and 25 mg tablets (referred to herein as
"carvedilol tablets") under the brand name COREG® ("COREG"). (Civil Action No. 14-877LPS-CJB, D.I. 14 at~ 18; Civil Action No. 14-878-LPS-CJB, D.I. 16 at~ 18)
By the year 2003, COREG had received FDA approval for multiple indications: for

in this single Report and Recommendation.
2

management of hypertension, for treatment of mild-to-severe CHF and for a third use-treatment
of left ventricular dysfunction following myocardial infarction in clinically stable patients ("left
ventricular dysfunction"). (Civil Action No. 14-877-LPS-CJB, D.I. 14 at iii! 8, 17, 22-24; Civil
Action No. 14-878-LPS-CJB, D.I. 16 at

iii! 8, 17, 22-24)

Despite this, GSK has only ever

marketed COREG in the United States for the CHF indication (and has never marketed it for any
other indication). (Civil Action No. 14-877-LPS-CJB, D.I. 14 at iii! 18, 25; Civil Action No. 14878-LPS-CJB, D.I. 16 at iii! 18, 25)
GSK also obtained United States Patent No. 5,760,069 ("'069 Patent"), issued in June
1998, on a method of treatment using carvedilol to decrease the risk of mortality caused by CHF.
(Civil Action No. 14-877-LPS-CJB, D.I. 14 at i! 28; Civil Action No. 14-878-LPS-CJB, D.I. 16
at ii 28) In January 2008, that patent reissued as the Asserted Patent, which is listed in the FDA's
"Approved Drug Products with Therapeutic Equivalence Evaluations" (the "Orange Book") as
covering COREG. (Civil Action No. 14-877-LPS-CJB, D.I. 14 at iii! 28-33; Civil Action No. 14878-LPS-CJB, D.I. 16 at iii! 28-33) The key claim of the Asserted Patent (and its only
independent claim) is claim 1, which reads:

1. A method of decreasing mortality caused by congestive
heart failure in a patient in need thereof which comprises
administering a therapeutically acceptable amount of carvedilol in
conjunction with one or more other therapeutic agents, said agents
being selected from the group consisting of an angiotensin
converting enzyme inhibitor (ACE), a diuretic, and digoxin,
wherein the administering comprises administering to said
patient daily maintenance dosages for a maintenance
period to decrease a risk of mortality caused by congestive
heart failure, and said maintenance period is greater than
six months.
(Civil Action No. 14-877-LPS-CJB, D.I. 14, ex. E ("'000 Patent"), col. 8:30-40 (emphasis in

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original)) The italicized portion of the claim above is the portion that was added to the claim
during the reissue proceeding.
Teva holds Abbreviated New Drug Application ("ANDA") No. 76-373 for generic
carvedilol tablets. (Civil Action No. 14-878-LPS-CJB, D.I. 16 at~ 44) Although Teva had
originally submitted a Paragraph IV certification asserting that the '069 Patent was invalid,
eventually Teva sought FDA approval under 21 U.S.C. § 355G)(2)(A)(viii) (a "Section viii carve
out") to label its generic carvedilol tablets only for uses not covered by the patent-i.e., treating
hypertension and left ventricular dysfunction. (Id. at~~ 38-44; D.I. 22, ex. C) 2 Teva received
this FDA approval on or about September 5, 2007 and launched its generic COREG tablets in the
United States immediately thereafter. (Civil Action No. 14-878-LPS-CJB, D.I. 16 at~ 44) In
May 2011, however, Teva amended its label to fully conform with and be identical (for all
relevant purposes) to GSK's label for COREG, such that Teva's label now expressly included the
CHF indication. (Id.

at~~

45-46 & ex. G)

Glenmark holds Abbreviated New Drug Application ("ANDA") No. 78-251 for generic
carvedilol tablets. (Civil Action No. 14-877-LPS-CJB, D.I. 14 at~ 40) It filed its application
with a Section viii carve out, i.e., without those portions of the label relating to the CHF
indication. (Id. at~ 42) On or about September 5, 2007, the FDA granted approval for
Glenmark's ANDA, and Glenmark immediately launched its generic COREG tablets in the
United States. (Id.) Thus, at the time of this launch, Glenmark's label promoted use for two

2

In resolving a Rule 12(b)(6) motion, the Court can consider the content of Teva's
label from this time period, (Civil Action No. 14-878-LPS-CJB, D.I. 22, ex. C), although it is not
attached to the FAC, since the document is integral to the FAC, (id., D.I. 16 at~~ 44-45). See In
re Burlington Coat Factory Sec. Litig., 114 F.3d 1410, 1426 (3d Cir. 1997).
4

indications-treating hypertension and left ventricular dysfunction. (Id.) However, it is alleged
that at least between about August 2009 and about August 2010, Glenmark revised its label for
generic carvedilol tablets to fully conform with and be identical (for all relevant purposes) to
GSK's label for COREG, such that the label now expressly included the CHF indication. (Id. at
~~

43-44 & ex. G) Thereafter, it appears that Glenmark switched back to the version of the label

that it had utilized prior to about August 2009. (Id.; see also D.I. 21 at 5)

B.

Procedural Background

Plaintiffs commenced these actions on July 3, 2014, alleging indirect infringement claims
against the Defendants concerning the Asserted Patent. (Civil Action No. 14-877-LPS-CJB, D.I.
1; Civil Action No. 14-878-LPS-CJB, D.I. 1) Soon after, Defendants moved to dismiss the
Complaints for failure to state a claim, pursuant to Rule 12(b)(6). (Civil Action No. 14-877LPS-CJB, D.I. 10; Civil Action No. 14-878-LPS-CJB, D.I. 10) In response, on September 22,
2014, Plaintiffs filed the FACs. (Civil Action No. 14-877-LPS-CJB, D.I. 14; Civil Action No.
14-878-LPS-CJB, D.I. 16) On October 16, 2014, Chief Judge Leonard P. Stark referred these
cases to the Court to hear and resolve all pretrial matters, up to and including the resolution of
case-dispositive motions. (Civil Action No. 14-877-LPS-CJB, D.I. 16; Civil Action No. 14-878LPS-CJB, D.I. 18)
Defendants then filed the instant Motions, in lieu of answering the F ACs, on October 23,
2014. (Civil Action No. 14-877-LPS-CJB, D.I. 18; Civil Action No. 14-878-LPS-CJB, D.I. 20)
The Motions were fully briefed as of November 20, 2014. (Civil Action No. 14-877-LPS-CJB,
D.I. 22; Civil Action No. 14-878-LPS-CJB, D.I. 25) On April 13, 2015, at the request of all

5

parties, the Court heard oral argument on the Motions. 3 (Civil Action No. 14-877-LPS-CJB, D.I.
36 ("Tr.")) On April 15, 2015 and April 17, 2015, the parties filed supplemental letter briefs,
which the Court has also considered. (Civil Action No. 14-877-LPS-CJB, D.I. 33, 34; Civil
Action No. 14-878-LPS-CJB, D.I. 34, 35)

II.

STANDARD OF REVIEW
The sufficiency of pleadings for non-fraud cases is governed by Federal Rule of Civil

Procedure 8, which requires "a short and plain statement of the claim showing that the pleader is
entitled to relief." Fed. R. Civ. P. 8(a)(2). When presented with a Rule 12(b)(6) motion to
dismiss for failure to state a claim, a court conducts a two-part analysis. Fowler v. UPMC
Shadyside, 578 F.3d 203, 210 (3d Cir. 2009). First, the court separates the factual and legal

elements of a claim, accepting "all of the complaint's well-pleaded facts as true, but
[disregarding] any legal conclusions." Id. at 210-11. Second, the court determines "whether the
facts alleged in the complaint are sufficient to show that the plaintiff has a 'plausible claim for
relief."' Id. at 211 (quoting Ashcroft v. Iqbal, 556 U.S. 662, 679 (2009)). "A claim has facial
plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable
inference that the defendant is liable for the misconduct alleged." Iqbal, 556 U.S. at 678 (citing
Bell At!. Corp. v. Twombly, 550 U.S. 544, 556 (2007)). In assessing the plausibility of a claim,

the court must "'accept all factual allegations as true, construe the complaint in the light most
favorable to the plaintiff, and determine whether, under any reasonable reading of the complaint,
the plaintiff may be entitled to relief."' Fowler, 578 F.3d at 210 (quoting Phillips v. Cnty. of

3

The Court heard argument in conjunction with holding a Case Management

Conference.

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Allegheny, 515 F.3d 224, 233 (3d Cir. 2008)).

III.

DISCUSSION
The FA Cs allege that Defendants have indirectly infringed the Asserted Patent by

inducement of infringement under 35 U.S.C. § 27l(b) (Count I) and contributory infringement
under 35 U.S.C. § 27l(c) (Count II). The Motions seek dismissal of both Counts, and the Court
will address the arguments as to each Count in turn.

A.

Induced Infringement

Pursuant to 35 U.S.C. § 271(b), "[w]hoever actively induces infringement of a patent
shall be liable as an infringer." In order to prove induced infringement, the patentee "must show
direct infringement, and that the alleged infringer knowingly induced infringement and possessed
specific intent to encourage another's infringement." Toshiba Corp. v. Imation Corp., 681 F.3d
1358, 1363 (Fed. Cir. 2012) (internal quotation marks and citations omitted); Symantec Corp. v.
Computer Assocs. Int'/, Inc., 522 F.3d 1279, 1292-93 (Fed. Cir. 2008) ("Thus, 'inducement
requires evidence of culpable conduct, directed to encouraging another's infringement, not
merely that the inducer had knowledge of the direct infringer's activities.'") (emphasis added)
(citation omitted).
Plaintiffs' claims for induced infringement are based on two general sets of
allegations-that Defendants induced infringement: (1) during the time periods when their labels
did not contain a CHF indication (i.e., for Teva, from approximately January 2008 through May
2011, and for Glenmark, from approximately January 2008 through August 2009 and postAugust 2010) and (2) during the time periods when their labels were amended to include the
CHF indication and were thus essentially identical to the COREG label (i.e., for Teva, after

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approximately May 2011, and for Glenmark, from approximately August 2009 to August 2010).
The parties have separately addressed the vitality of the claims in these two sets of time periods,
and the Court will do the same below.

1.

Time Periods When Defendants' Labels Did Not Include the CHF
Indication

With regard to the time periods in which Defendants' labels for their generic carvedilol
tablets did not include the CHF indication, Plaintiffs focus on two paragraphs in the Background
section of the FACs, arguing that they provide the requisite factual specificity to withstand the
Motions. (Civil Action No. 14-877-LPS-CJB, D.I. 21 at 12-13; Civil Action No. 14-878-LPSCJB, D.I. 24 at 12-13) Those paragraphs state:
[53. I 55.] In addition, even prior to its labeling change,
[Teva/Glenrnark] caused its generic carvedilol ... tablets to be
listed in the Orange Book with a therapeutic equivalence rating of
"AB," which indicates that its generic copies are considered
therapeutically equivalent to COREG® on all indications approved
for the generic drug. On information and belief, since the approval
of its ANDA . .. [Teva/Glenmark] has actively promoted the "AB"
rating of its generic carvedilol tablets and marketed them as
therapeutically equivalent to and fully substitutable for GSK 's
COREG® tablets indicated for treatment ofCHF. Although the
Orange Book states explicitly that an AB rating is limited to what is
on the generic's approved label ... [Teva/Glenrnark] never
informed the public that its generic carvedilol was not approved by
the FDA for the CHF indication when it touted its generic copy as
AB-rated and fully substitutable for COREG®.
[54. I 56.] On information and belief, [Teva/Glenrnark] knew that
when an AB-rated generic drug is available, many states and/or
third party payers of prescription drugs (e.g., health insurance plans,
Medicare and Medicaid programs) have adopted policies to
encourage or require the substitution of the AB-rated generic drugs
for the branded drugs, regardless of whether the generic drug label
includes all the indications contained in the branded drug label.
[Teva/Glenrnark] also knew that unless informed otherwise, the
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market would assume that, like most-AB-rated generic drugs,
[Teva' s/Glenmark' s] generic carvedilol tablets were labeled
identically to COREG® and included the CHF indication. As a
result, by promoting its generic carvedilol tablets as AB-rated and
fully substitutable for CO REG® without informing the market that
its generic carvedilol tablets were not approved for the CHF
indication, [Teva/Glenmark] knew and intended that its generic
carvedilol tablets would be substituted for COREG® for patients
prescribed the drug for treatment of congestive heart failure in the
direct infringement of the '000 [P]atent.
(Civil Action No. 14-877-LPS-CJB, D.I. 14 at iii! 53-54 (emphasis added); Civil Action No. 14878-LPS-CJB, D.I. 16 at iii! 55-56 (emphasis added))
Much of these paragraphs focus on what Defendants knew or what they did not do (or, in
some cases, what those other than Defendants did). But, as the Federal Circuit has recognized, a
claim for induced infringement requires more: "mere knowledge of possible infringement by
others does not amount to inducement; specific intent and action to induce infringement must be
proven. Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1364 (Fed. Cir. 2003) (emphasis
added); see also Novartis Pharm., Corp. v. Wockhardt USA LLC, Civil Action No. 12-cv-3967,
2013 WL 5770539, at *9 (D.N.J. Oct. 23, 2013) (noting that inducement involves the taking of
"'affirmative steps'") (internal citation omitted) (citing DSU Med. Corp. v. JMS Co., Ltd., 471
F.3d 1293, 1305-06 (Fed. Cir. 2006)). The law requires the patent holder to plead facts that
plausibly suggest that Defendants "promote[d] or encourage[ d] doctors to infringe the ...
patent." Warner-Lambert Co., 316 F.3d at 1364 (emphasis added).
When it comes to actions taken by Defendants that might be argued to amount to
inducement of infringement, these key paragraphs say far less. The paragraphs do allege that
Defendants "caused [their] generic carvedilol ... tablets to be listed in the Orange Book with a

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therapeutic equivalence rating of' AB,' [indicating that their] generic copies are considered
therapeutically equivalent to COREG® on all indications approved for the generic drug." But as
the FACs themselves note, the "Orange Book states explicitly that an AB rating is limited to
what is on the generic's approved label[.]" It is hard to conclude that Defendants' obtaining an
AB rating in the Orange Book for their product, standing alone, could amount to sufficient
"action" to encourage infringement of a patented use not listed on their label-when the Orange
Book affirmatively instructs that a generic drug product is the therapeutic equivalent of a branded
drug only for those uses listed on the Defendants' label. 4
In the end, the claims will sink or swim based on the FACs' content regarding the
sentences rendered in italics above, particularly the allegations that Defendants "actively ...
marketed" and "promot[ed]" their generic drugs as "A-B rated" and as "therapeutically
equivalent to" and "fully substitutable for ... COREG[.]" Plaintiffs seem to acknowledge this,
as in their answering brief, they refer to these sentences as specifying the "actual actions by the
defendants to encourage infringement" and assert that these allegations render their induced
infringement claims plausible. (Civil Action No. 14-877-LPS-CJB, D.I. 21 at 13-15 (emphasis
omitted); Civil Action No. 14-878-LPS-CJB, D.I. 25 at 13-15 (emphasis omitted)) Yet these key
sentences suffer from a particular lack of any meaningful factual content. What type of
"market[ing]" and "promoting" are Defendants alleged to have engaged in that gives rise to the
claim? Is it simply the act of causing their drugs and accompanying drug labels to be sent out

4

Cf Novartis Pharm., Corp., 2013 WL 5770539, at *9 (dismissing, in an ANDA
case, an induced infringement claim where defendants' proposed labels did not seek approval to
market their generic drug to treat osteoporosis, a use protected by plaintiffs patent and approved
by the FDA); see also AstraZeneca Pharm. LP v. Apotex Corp., 669 F .3d 13 70, 13 80 (Fed Cir.
2012).
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into the market? Or does it refer additionally to other acts, such as web-based or person-toperson marketing that is asserted to have confused the public into thinking that Defendants'
drugs should be used for the patented form of treatment? 5 And if it is the latter, what is at least
the general nature or scope of that alleged conduct said to be?
These key paragraphs of the FA Cs are silent as to these important questions, the answers
to which could have an impact as to whether the claims here are plausible. As a result, they leave
Defendants to guess at what the contours of these induced infringement allegations are. Without
any further factual detail, Plaintiffs' "market[ing]" and "promoting" allegations are not much of a
step up from a blanket statement that "Defendants have encouraged infringement"-i.e., a
parroting back of the elements of the claim. Such allegations are insufficient to meet the
requirements of Twombly and Iqbal that "enough facts" be pleaded to "state a claim to relief that
is plausible on its face." Twombly, 550 U.S. at 570.

2.

Time Periods When Defendants' Labels Did Include the CHF
Indication

With regard to the time periods in which Defendants' labels for their generic carvedilol
tablets included the CHF indication (in other words, time periods in which the generics' labels
were essentially identical to GSK's COREG label), Defendants' main argument for dismissal is
narrowly focused. That is, Plaintiffs have alleged (and it is not disputed) that during these time

At oral argument, counsel for Plaintiffs suggested that Plaintiffs do in fact have
such evidence, and that this evidence is what motivated the inclusion of these rather generalized
allegations in the FA Cs. (Tr. at 64, 81-82 (Plaintiffs' counsel explaining that "we go to a website
and the products are listed ... with their [AB] rating. And ... sometimes there's a link to the
branded drug's label that's utilized. So [the generic's website] will say compare [COREG], so
you are encouraging people to go to the place that has the indication [for the patented use]")) Of
course, no such conduct is set out in any level of detail in the FA Cs.
11

periods, Defendants' labels included, as one approved indication, treatment to decrease a risk of
mortality caused by CHF. (Civil Action No. 14-877-LPS-CJB, D.I. 14 at if 43; Civil Action No.
14-878-LPS-CJB, D.I. 16 at ii 45) And there is no question that statements "in a package insert
that encourage infringing use of a drug product are alone sufficient to establish intent to
encourage direct infringement" for purposes of an induced infringement claim. Bone Care Int 'l,
L.L.C. v. Roxane Labs., Inc., C.A. No. 09-cv-285 (GMS), 2012 WL 2126896, at *9 (D. Del. June

11, 2012) (internal quotation marks and citation omitted); see also AstraZeneca LP v. Apotex,
Inc., 633 F.3d 1042, 1060 (Fed Cir. 2010) (noting that the "pertinent question" as to whether a

proposed label can provide evidence of a pharmaceutical company's specific intent to induce
infringement is "whether the proposed label instructs users to perform the patented method" and
"would inevitably lead some consumers to practice the claimed method"). Defendants' challenge
here, however, is that the FACs do not sufficiently allege induced infringement because their
labels could not be plausibly read to encourage administration of carvedilol to treat CHF for (as
the Asserted Patent requires) a "maintenance period [of] greater than six months." ('000 Patent,
col. 8:39-40 (emphasis added)) For the reasons set forth below, the Court disagrees with
Defendants.
First, as Plaintiffs allege, Defendants' labels stated that Defendants' tablets were
'"indicated for the treatment of mild-to-severe chronic heart failure"'-i.e., a malady that by
definition persists for a lengthy period of time or is constantly recurring. (Civil Action No. 14877-LPS-CJB, D.I. 14 at ii 44 (quoting ex. G at§ 1.1) (emphasis added); Civil Action No. 14878-LPS-CJB, D.I. 16 at ii 46 (quoting ex. G at§ 1.1) (emphasis added)) And in advising
patients as to use of carvedilol, the labels at issue caution that '" [p]atients should not interrupt or
12

discontinue using carvedilol tablets without a physician's advice"' and warn that '"[i]fyou stop
taking carvedilol tablets suddenly, you could have chest pain and/or a heart attack."' (Civil
Action No. 14-877-LPS-CJB, D.I. 14 atii 46 (quoting ex. G at§§ 17.1, 17.2); Civil Action No.
14-878-LPS-CJB, D.I. 16 at ii 48 (quoting ex. G at§§ 17.1, 17.2); see also Civil Action No. 14877-LPS-CJB, D.I. 14, ex. G at "Dosage and Administration" section (instructing patients taking
carvedilol for heart failure to start at 3.125 mg and increase to 6.25, 12.5, and then 25 mg over
two-week intervals, and to "[m}aintain lower doses ifhigher doses are not tolerated" (emphasis
added); Civil Action No. 14-878-CJB, D.I. 16, ex. G at "Dosage and Administration" section
(same)) If one encourages a drug's use for a chronic disease, and one strongly encourages those
taking the drug to continue to take it for an open-ended period (absent a doctor's advice
otherwise), it is at least a plausible conclusion that one is encouraging the drug's administration
for more than six months. These pleaded facts are probably enough, on their own, to support a
claim of induced infringement. 6 But more is alleged.
Plaintiffs further note that portions of Defendants' labels promote data from many clinical
studies in which carvedilol was taken by patients with mild to severe heart failure. Plaintiffs
explain that "[a]ll the treatment durations mentioned in this section [of the labels] are greater
than 6 months." (Civil Action No. 14-877-LPS-CJB, D.I. 14 at iiii 47-48; Civil Action No. 14878-LPS-CJB, D.I. 16 at iiii 49-50) Indeed, these sections tout the beneficial results patients

6

Plaintiffs also plead that FDA regulations (21 C.F.R. § 201.57(c)(3)(i)(F))
establish that the "Dosage and Administration" section of Defendants' labels were required to
state "'[t]he usual duration of treatment when treatment duration should be limited"'; they note
that in that section, the labels do "not identify a limitation on treatment duration for the CHF
indication." (Civil Action No. 14-877-LPS-CJB, D.I. 14 at ii 45 (emphasis added); Civil Action
No. 14-878-LPS-CJB, D.I. 16 at ii 47 (emphasis added))
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obtained when taking carvedilol for CHF "during an average follow-up of 7 months" or "over 18
to 24 months" or where "[t]he mean duration of follow-up was 4.8 years" or where "[t]he trial
was stopped after a median follow-up of 10 months [due to a large reduction in mortality.]"
(Civil Action No. 14-877-LPS-CJB, D.I. 14, ex. G at§ 14.1; Civil Action No. 14-878-LPS-CJB,
D.I. 16, ex. G at§ 14.1) The labels also indicate that "[a]pproximately 60% of the total treated
population in placebo-controlled clinical trials received carvedilol for at least 6 months and 30%
received carvedilol for at least 12 months"-and it is further alleged that much of the remainder
of the population (i.e., the other 40%) stopped participating in the studies before six months not
because they (or their physician) independently determined to stop the therapy, but instead due to
the trials' early termination or the patients' death. (Civil Action No. 14-877-LPS-CJB, D.I. 14 at
~

48 (quoting ex. G at§ 6.1); Civil Action No. 14-878-LPS-CJB, D.I. 16 at~ 50 (quoting ex. G at

§ 6.1)) Thus, the inclusion of this data, describing many examples of the drugs' administration
for more than six months to treat CHF (and the beneficial effects thereof), could be seen to
encourage just that same type of administration in the future.
And lastly, the allegations here are not that Defendants' labels were created and existed in
a vacuum. Instead, Plaintiffs assert that Defendants distributed the labels (and their generic drug
products) at the same time that GSK was simultaneously actively using the identical label in a
widespread fashion to promote the approved use of CO REG in a manner that would meet the
claim's limitations. (Civil Action No. 14-877-LPS-CJB, D.I. 14 at~~ 43-48; Civil Action No.
14-878-LPS-CJB, D.I. 16 at~~ 45-50)
In the end, while the labels at issue during these time periods did not flatly state
"carvedilol should be administered for a maintenance period of greater than six months," there is
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no requirement that Defendants need to have mimicked the precise wording of claim 1. Instead,
the question is whether the allegations, when considered in their entirety and in context, plausibly
suggest an intent and actions to encourage administration of carvedilol in a manner that would
meet the claim limitations. See In re Bill of Lading Transmission & Processing Sys. Patent
Litig., 681 F.3d 1323, 1342-43 (Fed. Cir. 2012). For the reasons set out above, the Court finds
that they do. Cf JG/ Labs., Inc. v. Mallinckrodt LLC, Civil Action No. 13-2044-RGA, 2014 WL
1652790, at *1-2 (D. Del. Apr. 22, 2014) (denying a motion to dismiss induced infringement
counterclaims, where the patents at issue covered "using diclofenac for treating osteoarthritis of
the knee via applying the diclofenac, waiting for it to dry, and applying either a second
medication, sunscreen or insect repellant" and the plaintiffs label "instructs the reader to ' [w ]ait
until the treated area is dry before applying sunscreen, insect repell[e]nt, lotion, moisturizer,
cosmetics, or other topical medication"'); Bone Care Int 'l, 2012 WL 2126896, at* 11 (finding
that a labeling instruction to administer a drug "for the treatment of secondary
hyperparathyroidism ['SHPT'] in patients with chronic kidney disease on dialysis" would induce
infringement of a patent claiming use of the drug for both treatment of SHPT and end stage renal
disease, because a majority of patients with end stage renal disease have SHPT). 7

7

Glenmark additionally argues that Plaintiffs' induced infringement claims fail due
to the absence of facts pied to support a claim of direct infringement of the Asserted Patent, a
required element of inducement of infringement. (Civil Action No. 14-877-LPS-CJB, D.I. 19 at
2, 14, 19; D.I. 22 at 2-3, 10) As set out above, claim 1 of the '000 Patent requires the
administration of carvedilol "in conjunction with one or more therapeutic agents ... selected
from the group consisting of an angiotensin converting enzyme inhibitor (ACE), a diuretic, and a
digoxin." ('000 Patent, col. 8:32-36) Glenmark asserts that "the patent claims a combination of
two drugs and there are zero allegations of any combination use." (Civil Action No. 14-877LPS-CJB, D.I. 22 at 10 (emphasis in original); see also id. at 2-3; D.I. 19 at 2, 14, 19) With
respect to the time period when Glenmark's label included the CHF indication, portions of that
label make it clear that carvedilol is "usually" taken with one of these other three possible drugs,
15

B.

Contributory Infringement

Under 35 U.S.C. § 27l(c), a patentee must demonstrate that an alleged contributory
infringer has sold, offered to sell or imported into the United States a component of a material or
apparatus for use in practicing a patented process "knowing the same to be especially made or
especially adapted for use in an infringement of such patent, and not a staple article or
commodity of commerce suitable for substantial noninfringing use." See also Lucent Techs., Inc.
v. Gateway, Inc., 580 F.3d 1301, 1320 (Fed. Cir. 2009); Walker Digital, LLC v. Facebook, Inc.,

852 F. Supp. 2d 559, 566 (D. Del. 2012). Here, Defendants' challenge to Count II is that the
FAC does not sufficiently allege facts indicating that the carvedilol tablets at issue have no
"substantial noninfringing uses." (Civil Action No. 14-877-LPS-CJB, D.I. 19 at 9-10; Civil
Action No. 14-878-LPS-CJB, D.I. 21at10-11) A noninfringing use is "substantial" ifit is "not
unusual, far-fetched, illusory, impractical, occasional, aberrant, or experimental." Vita-Mix
Corp. v. Basic Holding, Inc., 581F.3d1317, 1327 (Fed. Cir. 2009).
It is not disputed that there are non-infringing uses for Defendants' carvedilol, including

its use to treat hypertension, its use to treat left ventricular dysfunction, and its administration to

(see, e.g., id., D.I. 14, ex. G at§§ 1.1, 1.3, 5.4, 14.1), and Plaintiffs note this in the FAC, (id. at~
44). Thus, it is plausible that Glenmark's label specifically encourages the use of carvedilol
together with one of these other medications (for a period of more than six months). The issue is
less clear with respect to the time periods when Glenmark's label did not include the CHF
indication. Even so, during that time frame, portions of GSK's label and the Asserted Patent
establish that carvedilol was often taken with one of these add-on drugs, (see, e.g., Civil Action
No. 14-877-LPS-CJB, D.I. 14, ex.Fat§§ 1.1, 1.3, 5.4, 14.1; '000 Patent, col. 1:31-41)-leading
to the fair inference that if Glenmark was inducing the administration of carvedilol for CHF in
these periods, it was encouraging individuals to do so in the way that drug is often administered
(i.e., in conjunction with one of these other drugs). If Plaintiffs amend their claims with respect
to these time periods (as the Court recommends they be given the opportunity to do at the
conclusion of this Report and Recommendation), they can make this allegation relating to direct
infringement even clearer in the amended complaint.

16

CHF patients for a maintenance period of six months or less. 8 Indeed, the FACs make repeated
reference to these non-infringing uses, (see, e.g., Civil Action No. 14-877-LPS-CJB, D.I. 14 at~~
8, 23, 24, 48; Civil Action No. 14-878-LPS-CJB, D.I. 16 at~~ 8, 23, 24, 50), some of which were
the only FDA-approved indications on Defendants' labels for certain time periods relevant to this
case.
Instead, the question is whether the carvedilol tablets at issue were used in a more than
"occasional" manner for these three purposes. And in the key portions of the FA Cs, Plaintiffs
plead facts suggesting that they were not. 9

8

Defendants suggest a fourth non-infringing use in their reply briefs: use of
carvedilol during periods of up-titration. (Civil Action No. 14-877-LPS-CJB, D.I. 22 at 3-4;
Civil Action No. 14-878-LPS-CJB, D.I. 25 at 3) Up-titration is an initial period, lasting a few
weeks, in which the drug is given to patients for the purpose of calibrating the size of the
appropriate maintenance dosage, before thereafter being administered to the patient at that nowidentified appropriate dosage level. (Civil Action No. 14-877-LPS-CJB, D.I. 14, ex. G at§ 2.1;
Civil Action No. 14-878-LPS-CJB, D.I. 16, ex. G at§ 2.1) The Court is not convinced that
administration of carvedilol to treat CHF during this time period is necessarily a separate "use"
of the drug that is different from its use to treat CHF during the maintenance period referred to in
claim 1. Indeed, it appears this is a legal issue that may be further debated later in the case
during the claim construction stage. (See Tr. at 19-20 (Teva' s counsel acknowledging that "once
we start talking about an up-titration period versus maintenance period, we start to push into an
issue of claim construction"); id. at 72-73 (Plaintiffs' counsel noting that whether the up-titration
period is a separate period that cannot be combined with the maintenance period is "a claim
construction issue at some level"))
9

As a result, the allegations here are unlike those ordered dismissed in Palmetto
Pharm. LLC v. AstraZeneca Pharm. LP, No. 2:11-cv-00807-SB-JDA, 2012 WL 484907 (D.S.C.
Jan. 4, 2012), report and recommendation adopted by 2012 WL 484848 (D.S.C. Feb. 14, 2012).
In Palmetto, the patent claimed only a method for treating non-hyperlipidemic persons, and the
plaintiff did not dispute (and pleaded facts in its Amended Complaint that affirmatively
established) that for a period of seven years, the defendant's accused drug product (CRESTOR)
had been "widely prescribed" for the treatment ofhyperlipidemic persons. Id. at *2, *7 (citing
D.I. 27 at~~ 13-14, 25)). In contrast, here the FACs do not admit that Defendants' carvedilol
tablets (or those manufactured by any other entity) were "widely prescribed" for any of the noninfringing uses discussed above. Indeed, Plaintiffs hotly dispute that fact, and pleaded facts in
the FACs that set out at least a plausible basis to believe that no such widespread prescription
17

For example, as to carvedilol's use to treat hypertension, Plaintiffs assert that
"[h]ypertensive treatment is a crowded market in which many treatment options are available."
(Civil Action No. 14-877-LPS-CJB, D.I. 14 at if 25; Civil Action No. 14-878-LPS-CJB, D.I. 16
at if 25) As a way to suggest that carvedilol was not actually used often in the relevant time
periods to treat hypertension, Plaintiffs cite to a 2014 report (or "guideline") commissioned by
the United States Department of Health and Human Services that: (1) recommended four classes
of other drugs for initial treatment of hypertension and (2) specifically stated that beta-blockers
(like carvedilol) were not recommended for the initial treatment of hypertension, due to poor
study results and the lack of credible clinical trial data suggesting beta-blockers' effectiveness for
this purpose. (Civil Action No. 14-877-LPS-CJB, D.I. 14 at if 25 & ex. D; Civil Action No. 14878-LPS-CJB, D.I. 16 at if 25 & ex. D) As to carvedilol's treatment for left ventricular
dysfunction, Plaintiffs allege that "a much smaller population of patients suffer from" that
malady than do the 5.1 million persons in the United States who suffer from CHF. (Civil Action
No. 14-877-LPS-CJB, D.I. 14 at ifif 9, 26; Civil Action No. 14-878-LPS-CJB, D.I. 16 at

ifif 9, 26)

Lastly, as noted in the subsection above, much of the thrust of the FACs explains why the "vast
majority" of those who have used carvedilol to treat CHF have done so for a period of "more
than six months." (See, e.g., Civil Action No. 14-877-LPS-CJB, D.I. 14 at if 27; Civil Action No.
14-878-LPS-CJB, D.I. 16 at if 27)
As was noted by at least one Defendant, Plaintiffs' allegations in this regard could be seen
to "raise more questions than they answer[.]" (Civil Action No. 14-878-LPS-CJB, D.I. 25 at 1)
The facts alleged certainly could be more full, for example, and they contain no actual data as to

occurred.
18

how many Americans were taking carvedilol in the time periods at issue here for any of these
non-infringing uses. (See Tr. at 63 (Plaintiffs' counsel asserting that Plaintiffs intend to seek out
such data during discovery)) Moreover, carvedilol clearly was approved to treat hypertension
and left ventricular dysfunction for many years prior to and subsequent to COREG's launch. 10
And indeed, Defendants argue that certain portions of the materials that Plaintiffs attach to their
FACs might even help Defendants rebut the claim of contributory infringement. (See, e.g., Civil
Action No. 14-878-LPS-CJB, D.I. 21 at 12) 11
However, "questions" about a party's liability need not be definitively "answer[ed]" at the

10

However, the Court is not prepared to conclude that, as a legal matter, the sole
fact that a drug is FDA-approved for a non-infringing use renders a plaintiff unable to
successfully assert that the drug has no "substantial" non-infringing uses. (See Tr. at 12 (Teva's
counsel explaining that "Teva isn't arguing and I'm not getting up here and saying that just
because [uses of carvedilol for the treatment of hypertension and the treatment of left ventricular
dysfunction] are FDA-approved they must be substantial[] uses")); see also Novartis Pharm.,
Corp., 2013 WL 5770539, at *10 (rejecting defendants' argument that "'[a]n FDA approved
indication is necessarily [a] substantial' [non-infringing use, where] Plaintiffs previously sought
approval for [the FDA-approved indication and] conducted clinical trials for this indication[,
one] for which the FDA deemed the product safe and effective") (internal citation omitted).
Presumably, such FDA approval would, on average, make it more difficult to prevail on this type
of contributory infringement claim. But the Court is not aware of precedent suggesting that it
makes such a claim impossible to bring or renders that claim de facto implausible.
11

For example, Defendant Teva notes that the 2014 guideline referenced above is
attached to the FAC, and that a table within the report references at least two other guidelines
issued between 2010-2014 that recommended that beta-blockers be used to treat certain adults
who suffer from hypertension. (See, e.g., Civil Action No. 14-877-LPS-CJB, D.I. 14, ex. D at
518; Civil Action No. 14-878-LPS-CJB, D.I. 16, ex. D at 518) And it is true that these facts
might help combat Plaintiffs' claim. But it is also worth noting that even when looking at this
particular table, the record is not as one-sided as Defendants suggest. The table lists seven
guidelines in total, and the other five guidelines (one from 2010, one from 2011, one from 2012,
one from 2013 and the 2014 guideline cited in the FACs) did not recommend use ofbetablockers to initially treat hypertension at all. (Id.) And even as to those two guidelines in which
beta-blockers were recommended, beta-blockers as a class were recommended only for particular
subsets of the general population, and even then, were recommended along with a number of
other drug treatment options. (Id.)
19

pleading stage. Instead, all Plaintiffs must do at this stage is point to sufficient facts that render it
plausible that their claims could succeed. Here, the allegations may fall fairly close to the
plausibility line. But the key paragraphs cited above, and the entirety of the 70+ paragraph
FACs, contain enough factual specificity to put Defendants on notice of the claim of contributory
infringement, and to sufficiently suggest that any non-infringing use of carvedilol was occasional
and non-substantial. Cf Novartis Pharm., Corp., 2013 WL 5770539, at *IO (denying a motion
to dismiss a contributory infringement claim where the FDA-approved uses for the drug at issue
included a non-infringing use (the treatment of Paget's disease), since it was plausible that any
such use was occasional, where 0.3% of the drug's use was to treat Paget's disease, amounting to
treatment of"' at least hundreds and hundreds of cases of Paget' s with [the drug] every year'")
(internal citation omitted); Braintree Labs., Inc. v. Nephro-Tech., Inc., 31 F. Supp. 2d 921, 92425 (D. Kan. 1998) (denying the defendant's motion to dismiss a contributory infringement claim
and explaining that the issue of whether the defendant's product is capable of being sold for a
substantial noninfringing use is a question of fact more appropriately resolved at a later stage in
the case, such as summary judgment or trial).

C.

Nature of Dismissal

With regard to the claims for induced infringement during the time periods where the
CHF indication was not on Defendants' labels, the Court recommends that the dismissal be
without prejudice. Defendants argue that because Plaintiffs have already amended their initial
Complaint once, the dismissal should be with prejudice, because further amendments would be
"futile." (Civil Action No. 14-877-LPS-CJB, D.I. 19 at 20; Civil Action No. 14-878-LPS-CJB,
D.I. 21 at 20) Yet this is the first instance in which a court has found Plaintiffs' allegations
20

wanting and where Plaintiffs would now be attempting to overcome those identified deficiencies
(if it is possible to do so). And, as noted above, it appears that there is additional factual content
that Plaintiffs could add to these induced infringement allegations that would, at a minimum,
make their argument against dismissal far stronger.

It is within the Court's discretion to grant leave to amend, see Foman v. Davis, 371 U.S.
178, 182 (1962), and amendment should be allowed "when justice so requires[,]" Fed. R. Civ. P.
15(a)(2). In light of that, and because it is not clear to the Court that amendment would be futile,
the Court recommends that Plaintiffs be given leave to file further amended complaints
addressing the identified deficiencies regarding the claims recommended for dismissal. See, e.g.,

Abrams v. Wainscott, Civil Action No. 11-297, 2012 WL 3614638, at *4 (D. Del. Aug. 21,
2012).
IV.

CONCLUSION
For the foregoing reasons, the Court recommends that Defendants' Motions each be

GRANTED-IN-PART and DENIED-IN-PART. More specifically, the Court recommends that
the Motions be GRANTED as to Plaintiffs' claims regarding induced infringement during the
time periods where the CHF indication was not on Defendants' labels, and that they be DENIED
as to Plaintiffs' claims regarding induced infringement during the time periods where the CHF
indication was on Defendants' labels, and as to Plaintiffs' claims for contributory infringement.
The Court also recommends that if the District Court affirms this Report and Recommendation
as to dismissal of the afore-mentioned induced infringement claims, that: (1) Plaintiffs be given
fourteen (14) days from the date of affirmance to file further amended complaints; and (2) failure
to do so shall give rise to dismissal with prejudice of those claims.

21

This Report and Recommendation is filed pursuant to 28 U.S.C. § 636(b)(l)(B), Fed. R.
Civ. P. 72(b)(l), and D. Del. LR 72.1. The parties may serve and file specific written objections
within fourteen (14) days after being served with a copy of this Report and Recommendation.
Fed. R. Civ. P. 72(b). The failure of a party to object to legal conclusions may result in the loss
of the right to de novo review in the district court. See Henderson v. Carlson, 812 F.2d 874, 87879 (3d Cir. 1987); Sincavage v. Barnhart, 171 F. App'x 924, 925 n.1 (3d Cir. 2006).
The parties are directed to the Court's Standing Order for Objections Filed Under Fed. R.
Civ. P. 72, dated October 9, 2013, a copy of which is available on the District Court's website,
located athttp://www.ded.uscourts.gov.

Dated: April 22, 2015
Christopher J. Burke
UNITED STATES MAGISTRATE JUDGE

22