The outcome was a vacating of the district court's grant of JMOL and a lot of discussion of drug "skinny labels":
GlaxoSmithKline LLC and SmithKline Beecham
(Cork) Ltd. (collectively, GSK) sued Teva Pharmaceuticals
USA, Inc. in the United States District Court for the District of Delaware for infringement of claims of GSK’s Reissue Patent No. RE40,000. After the jury’s verdict of
infringement and its award of damages,
he district court
granted Teva’s renewed motion for judgment as a matter
of law of noninfringement. GlaxoSmithKline LLC v. Teva
Pharm. USA, Inc., 313 F. Supp. 3d 582 (D. Del. 2018) (Dist.
Ct. Op.). GSK appeals the JMOL, and Teva conditionally
cross-appeals the jury’s damages award. We have jurisdiction under 28 U.S.C. § 1295(a)(1).
For the reasons below,
we vacate the grant of JMOL,
reinstate the jury’s verdict and damages award, and remand for appropriate further proceedings.
Some background
In March 2002, Teva filed an Abbreviated New Drug
Application (ANDA) for FDA approval of its generic carvedilol for all three indications. It certified, under Paragraph
III of the Hatch-Waxman Act,1 that it would not launch its
product until the ’067 patent on the carvedilol compound
expired in March 2007.
(...)
Teva also certified, under Paragraph IV, that the ’069 patent was “invalid, unenforceable,
or not infringed.” See 21 U.S.C. § 355(j)(2)(A)(vii)(IV). On
May 24, 2002, Teva sent GSK a Paragraph IV notice stating that the claims of the ’069 patent are anticipated or
would have been obvious. GSK did not sue Teva upon receipt of the notice, and on November 25, 2003, GSK applied
for reissue of the ’069 patent under 35 U.S.C. § 251. Teva
received FDA “tentative approval” for its ANDA in 2004,
“for treatment of heart failure and hypertension.”
J.A. 7437. The approval was to become effective when the
’067 patent expired in 2007.
On January 8, 2008, the PTO issued Reissue Patent
No. RE40,000, and GSK notified the FDA on February 6,
2008. See J.A. 6880–82. The ’000 patent, asserted in this
case, claims a method of decreasing mortality caused by
CHF by administering carvedilol with at least one other
therapeutic agent.
During a seven-day jury trial, Teva argued the asserted
claims of the ’000 patent were invalid and not infringed.
Teva argued it could not have induced infringement, at
least prior to 2011, because it had “carved out” the indication and prescribing information for treatment of congestive heart failure in its 2007 label under section viii. Teva
also argued that it could not be liable for inducement for
any time period because it did not cause others to infringe
the method claimed in the ’000 patent.
(...)
The district court granted Teva’s renewed motion for
JMOL, stating that substantial evidence did not support
the verdict of induced infringement because GSK failed to
prove that Teva’s alleged inducement, as opposed to other
factors, actually caused physicians to directly infringe by
prescribing generic carvedilol for the treatment of mild to
severe CHF. Dist. Ct. Op. at 591. The district court explained that “[w]ithout proof of causation, which is an essential element of GSK’s action, a finding of inducement
cannot stand.” Id.
The district court also determined no reasonable juror
could have found induced infringement based on the
post-MI LVD indication in Teva’s partial label, which GSK
had argued instructed practice of the claimed method. Id.
at 592 n.9. Although the district court acknowledged there
is some overlap with CHF patients and post-MI LVD patients, it reasoned “the two indications are distinct and require different clinical testing and different FDA approvals
to treat.” Id. It further reasoned infringement required
carvedilol be “prescribed to treat the risk of mortality
caused by CHF.” Id. (emphasis in original). The district
court concluded a reasonable juror could not have found
Teva’s post-MI LVD indication “caused or even encouraged
direct infringement” of this claimed use. Id.
Amici were concerned that our prior decision could be
read to upset the careful balance struck with section viii
carve-outs. The Novartis Brief explained, “Generics could
be held liable for actively inducing infringement if they
marketed a drug with a label describing a patented therapeutic use or if they took active steps to encourage doctors
or patients to use the drug in an infringing manner. But
generics could not be held liable for merely marketing and
selling under a ‘skinny’ label omitting all patented indications, or for merely noting (without mentioning any infringing uses) that FDA had rated a product as therapeutically
equivalent to a brand-name drug.” Novartis Br. at 1–2. We
agree that Novartis accurately stated the law, and we
agreed to rehear this case to make clear how the facts of
this case place it clearly outside the boundaries of the concerns expressed by amici. As this record reflects, in both
time periods, substantial evidence supports that Teva actively induced by marketing a drug with a label encouraging a patented therapeutic use. They did not “omit[] all
patented indications” or “merely note[] (without mentioning any infringing uses) that FDA had rated a product as
therapeutically equivalent to a brand-name drug.” Novartis Br. at 1–2. This is a case in which substantial evidence
supports a jury finding that the patented use was on the
generic label at all relevant times and that, therefore, Teva
failed to carve out all patented indications. This narrow,
case-specific review of substantial evidence does not upset
Some issues
Amici were concerned that our prior decision could be
read to upset the careful balance struck with section viii
carve-outs. The Novartis Brief explained, “Generics could
be held liable for actively inducing infringement if they
marketed a drug with a label describing a patented therapeutic use or if they took active steps to encourage doctors
or patients to use the drug in an infringing manner. But
generics could not be held liable for merely marketing and
selling under a ‘skinny’ label omitting all patented indications, or for merely noting (without mentioning any infringing uses) that FDA had rated a product as therapeutically
equivalent to a brand-name drug.” Novartis Br. at 1–2. We
agree that Novartis accurately stated the law, and we
agreed to rehear this case to make clear how the facts of
this case place it clearly outside the boundaries of the concerns expressed by amici. As this record reflects, in both
time periods, substantial evidence supports that Teva actively induced by marketing a drug with a label encouraging a patented therapeutic use. They did not “omit[] all
patented indications” or “merely note[] (without mentioning any infringing uses) that FDA had rated a product as
therapeutically equivalent to a brand-name drug.” Novartis Br. at 1–2. This is a case in which substantial evidence
supports a jury finding that the patented use was on the
generic label at all relevant times and that, therefore, Teva
failed to carve out all patented indications. This narrow,
case-specific review of substantial evidence does not upset
the careful balance struck by the Hatch-Waxman Act regarding section viii carve-outs.
Induced infringement
When a plaintiff relies on a drug’s label accompanying the
marketing of a drug to prove intent, “[t]he label must encourage, recommend, or promote infringement.” Takeda
Pharm. USA, Inc. v. West-Ward Pharm. Corp., 785 F.3d
625, 631 (Fed. Cir. 2015) (citations omitted).
GSK argues that substantial evidence supports the
jury’s verdict of induced infringement. Throughout the
trial and on appeal, GSK argued there are two indications
on the labels that instruct doctors to prescribe carvedilol
for uses that directly infringe the ’000 patent claims: the
post-MI LVD indication and the congestive heart failure indication. Thus, GSK argues both the partial label and the
full label encourage infringement. We first address the
partial label period and then turn to the full label period.
(...)
The applicant must also submit its proposed label to
the FDA omitting or carving out all methods of use claimed
in a patent. 21 C.F.R. § 314.94(a)(8)(iv). “FDA acceptance
of the carve-out label allows the generic company to place
its drug on the market (assuming the ANDA meets other
requirements), but only for a subset of approved uses—i.e.,
those not covered by the brand’s patents.” Caraco Pharm.
Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 406 (2012).
GSK argues that, despite Teva’s section viii certification purporting to carve out one heart failure indication
and its deletion of the indication from its partial label, substantial evidence supports the jury’s finding that Teva induced doctors to infringe the method of use claimed in the
’000 patent. GSK argues that substantial evidence supports the jury’s verdict that Teva’s partial label encouraged
an infringing use (via the post-MI LVD indication) and that
Teva’s marketing materials encouraged prescribing carvedilol in a manner that would cause infringement of the ’000
patent.
We agree.
A skinny label
The parties dispute whether Teva effected a section viii
carve-out of GSK’s patented methods of use, making Teva’s
label a so-called “skinny label.” Since the jury found infringement, we must assume it decided that question in
GSK’s favor. Williamson v. Consol. Rail Corp., 926 F.2d
1344, 1348 (3d Cir. 1991) (“When reviewing the jury’s finding . . . , we give [plaintiff], as verdict winner, the benefit of
all logical inferences that could be drawn from the evidence
presented, resolve all conflicts in the evidence in his favor
and, in general, view the record in the light most favorable
to him.”). And as a quintessential fact question, we must
uphold the jury’s verdict on that point so long as substantial evidence supports it. GSK provided substantial evidence that Teva’s partial label instructed the method of use
claimed in the ’000 patent and thus was not a skinny label.
At the outset, GSK’s cardiology expert, Dr.
McCullough, explained that doctors, the alleged direct infringers, receive information about generic drug products
from a variety of sources, including the drug labels. J.A.
10612:1–9. He then walked through each element of claim
1 of the ’000 patent and compared it to Teva’s partial label.
He relied on the post-MI LVD indication in Teva’s partial
label, which stated:
Carvedilol is indicated to reduce cardiovascular
mortality in clinically stable patients who have
survived the acute phase of a myocardial infarction
and have a left ventricular ejection fraction of
≤ 40% (with or without symptomatic heart failure)
(see CLINICAL STUDIES [14.1]).
J.A. 5508 (emphasis and brackets in original). Dr.
McCullough testified this description satisfied the “decreasing mortality caused by congestive heart failure in a
patient” limitatio
section (which immediately follows the Indication section
and which says how much and how often to give the carvedilol). The jury was entitled to credit expert testimony regarding the label’s instructions on who should take what
drug, when, why, and how, and to reject the argument that
certain portions of the label were disjointed from others. n.
Cobbling together?
Teva characterizes GSK’s argument as a “cobbl[ing] together” of disparate portions of the partial label. Teva
Principal and Resp. Br. at 48, 50. The dissent appears to
adopt Teva’s characterization, arguing that a jury would
have to “piece[] together” the partial label to arrive at the
infringing use. Dis. at 18–20; see also id. at 33. All of the
claim limitations were contained in the Indication section
(which amounted to a single sentence), the Clinical Study
section (to which doctors were directly referred by the Indication section), and the Dosage and Administration
section (which immediately follows the Indication section
and which says how much and how often to give the carvedilol).
The jury was entitled to credit expert testimony regarding the label’s instructions on who should take what
drug, when, why, and how, and to reject the argument that
certain portions of the label were disjointed from others.
(...)
Teva relies on Dr. Zusman’s testimony that
treating patients to help them survive heart attack is not
treating heart failure. Teva Principal and Resp. Br. at 53
(citing J.A. 11183). But Dr. Zusman also agreed the postMI LVD patients with symptomatic heart failure would be
diagnosed as suffering from congestive heart failure under
the district court’s construction of that term (which has not
been appealed). J.A. 11226:14–19.
It was within the province of the jury to weigh the testimony presented by both
sides and make its finding. See Dardovitch v. Haltzman,
190 F.3d 125, 140 (3d Cir. 1999) (“Credibility determinations are the unique province of a fact finder, be it a jury,
or a judge sitting without a jury.”);
Error by the district court
Critically, the district court erred by treating this fact
question—whether the post-MI LVD indication instructs a
physician to prescribe carvedilol for a claimed use—as
though it were a legal one for it to decide de novo. In a
footnote of the district court’s JMOL decision, it decided the
post-MI LVD portion of Teva’s label was insufficient to find
that the label instructed an infringing use. Dist. Ct. Op. at
592 n.9. The district court erred at JMOL by making a fact
finding, namely, “[w]hile there may be some overlap between populations of patients suffering from CHF – the
treatment of which is within the scope of the ’000 patent’s
claims – and those suffering from post-MI LVD – whose
treatment is outside the scope of the claims – the two indications are distinct and require different clinical testing
and different FDA approvals to treat.” Id. Whether treating post-MI LVD patients with symptomatic heart failure
with carvedilol was within the scope of the claims was a
fact question. It was for the jury, not this court or the district court, to resolve. “In determining whether the evidence is sufficient to sustain [the jury’s finding of] liability,
the court may not weigh the evidence, determine the credibility of witnesses, or substitute its version of the facts for
the jury’s version.” Lightning Lube, Inc. v. Witco Corp., 4
F.3d 1153, 1166 (3d Cir. 1993). The district court erred in
reweighing the evidence and finding against GSK following
the jury’s verdict in its favor.
The FDA is not the final arbiter of patent issues
As Teva acknowledged, GSK’s submissions to the FDA
are “not absolutely dispositive of infringement.” See GlaxoSmithKline LLC v. Teva Pharm. USA, Inc., No. 18-1976
(Feb. 23, 2021), Oral Arg. at 55:49–57:07, available at
http://oralarguments.cafc.uscourts.gov/default.aspx?fl=18-
1976_02232021.mp3. As we have observed, “the FDA is not
the arbiter of patent infringement issues.” AstraZeneca LP
v. Apotex, Inc., 633 F.3d 1042, 1061 (Fed. Cir. 2010). In
fact, the FDA has made clear that use codes in the Orange
Book “are not meant to substitute for the [ANDA] applicant’s review of the patent and the approved labeling.”
(...)
Both FDA experts agreed
that the FDA plays no role in determining patent infringement. The jury heard this evidence and the evidence discussed above as to GSK’s claim that the post-MI LVD
indication infringed the ’000 patent. Thus, substantial evidence supports the jury’s finding that the post-MI LVD indication infringed the ’000 patent
Equitable estoppel?
At oral argument on rehearing, Teva suggested that
GSK’s FDA submission for the Orange Book listing for the
’000 patent, which according to Teva is at odds with GSK’s
infringement allegations, creates equitable estoppel. See
Oral Arg. at 53:56–55:28. There are serious consequences
for filing false or incomplete information to the FDA. See
id. at 55:28–56:04 (Teva explaining the consequences including rejection of the NDA); see also 18 U.S.C. § 1001 (it
is a criminal act to file a false declaration under penalty of
perjury). Teva argues one such consequence ought to be
equitable estoppel, which should preclude GSK’s assertion
of the ’000 patent against Teva at least as to the post-MI
LVD use. GSK’s representations regarding the Orange
Book listing of the ’000 patent, Teva’s reliance, and fairness
go directly to an equitable estoppel defense, which has not
yet been tried to the district court. The district court
acknowledged that Teva raised this defense, but decided
that it was “reserved to be tried to the Court at a later
date.” J.A. 29.
There are factual disputes regarding the estoppel issue
that the district court has not yet had an opportunity to
decide.
(...)
The dissent proposes that this court leapfrog that normal process and resolve these questions of law, equity, and
fact on appeal without any trial. We decline to do so. The
dissent claims it is not focused on estoppel, but rather on
whether “the law” permits an inference of intent from a label in light of GSK’s representations to the FDA. See Dis.
at 19. The dissent would hold that GSK’s representations
to the FDA in its declaration bar a finding of intent by the
jury as a matter of law regardless of the remainder of the
record. But intent is itself a question of fact, and this record contained substantial evidence from which the jury
could find Teva intended to infringe despite GSK’s representation to the FDA. This rule of law the dissent seeks is
exactly the estoppel case made by Teva, which the district
court has yet to try
The majority cited Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545
U.S. 913, 936 (2005)
The matter of press releases as evidence arose
GSK also presented evidence that, prior to the ’000 patent’s issuance, Teva issued two relevant press releases:
one in 2004 and another in 2007. In its 2004 press release,
Teva announced that the FDA granted it “tentative approval” for its carvedilol tablets, with final approval “anticipated upon expiry of patent protection for the brand
product on March 5, 2007.” J.A. 6347. It noted its “Carvedilol Tablets are the AB rated generic equivalent of GlaxoSmithKline’s Coreg® Tablets and are indicated for
treatment of heart failure and hypertension.” Id. (emphasis
added). The dissent suggests that Teva’s “reference to
heart failure” is not evidence that supports the jury’s finding that Teva intended to encourage infringement of GSK’s
claimed method. The entire purpose of this press release
is to announce its approval as a substitute for GSK’s
Coreg® Tablets, and it expressly says that the Teva generic
“tablets are the AB-rated generic equivalent of GlaxoSmithKline’s Coreg® Tablets and are indicated for treatment of heart failure and hypertension.” J.A. 6347. The
press release’s use of “heart failure” does not parse between
congestive heart failure or post-MI LVD.
Self-evident
Though the dissent seems to think the press release is
not evidence of encouragement,
it seems self-evident that a
jury could conclude that Teva’s intent in issuing a press release telling the world it could use Teva’s tablets as a substitute for GSK’s Coreg® tablets to treat congestive heart
failure was to encourage that use. Moreover, Dr.
McCullough testified that he saw the 2004 press release
and that it indicates physicians should prescribe
generic
carvedilol for heart failure. J.A. 11656:1–10; J.A. 11657:6–
10 (testifying that Teva’s press release informed doctors
that “it certainly should be” prescribed for the treatment of
heart failure); J.A. 11659:11–19 (Teva’s press release indicates that doctors should be able to prescribe generic carvedilol for heart failure). Dr. McCullough also testified
that doctors consider press releases so they “know when
drugs are going generic.” J.A. 11655:9–24.
(...)
On
appeal, we review the jury’s verdict for substantial evidence based upon the record;
we cannot hunt outside the
record to find evidence to try to contradict the verdict.
We have acknowledged that, as a matter of law, affirmative acts taken before a patent issues cannot violate
§ 271(b). Nat’l Presto Indus., Inc. v. W. Bend Co., 76 F.3d
1185, 1196 (Fed. Cir. 1996).
Information on your website can be used against you
In this case, the jury was presented with evidence
from which it could infer that Teva’s press releases remained on Teva’s website until at least 2015. J.A. 6353
(2007 press release date stamped “4/14/2015”). Teva’s Director of Marketing testified that Teva added carvedilol
product information to the Teva website as part of its 2007
launch. J.A. 10991:13–22 (Suzanne Collier, Teva’s Director of Marketing Communications and Trade Dress). The
2007 press release given to the jury contains a directory
path showing it was stored on the Teva website as follows:
“Home page>Media>Latest News.” And GSK demonstrated the 2007 Teva press release was available on the
Teva website as late as 2015. The press releases were extensively and repeatedly presented before the jury, with at
least five witnesses discussing them
Footnote 8 states: The jury was even presented evidence that Teva
encouraged doctors to visit its website for information
about its generic drugs when prescribing them. Trial Tr.
at 1245:16–19 (Teva’s expert, Dr. Zusman, acknowledging
that Teva advised doctors to “visit its website” to obtain
product information); Trial Tr. at 1249:12–15 (same); Trial
Tr. at 1251:8–11 (same); Trial Tr. at 1258:12–20 (same).
Though the evidence comes from Teva’s 2012 and 2013
Monthly Prescribing References for doctors (during the full
label period), it was reasonable for the jury to conclude that
Teva intended for doctors to visit its website for prescribing
information about the Teva’s products.
Causation
Teva argues that it
did not cause doctors to actually
prescribe generic carvedilol. Teva argues that, at all relevant times, doctors were prescribing carvedilol for CHF
based on information they had received for GSK’s Coreg®.
Teva points to guidelines from the American College of
Cardiology (ACC), the American Heart Association (AHA),
medical textbooks, and treatises to argue doctors already
knew to treat CHF using carvedilol long before Teva
launched its generic. Teva argues that this information,
not its actions, made physicians aware of all the benefits of
carvedilol for heart failure patients. The district court accepted Teva’s argument as sufficient to overcome the jury’s
verdict in GSK’s favor. Dist. Ct. Op. at 594. We do not
agree.
Judge Prost's dissent begins
GSK’s patent on carvedilol expired in 2007. At the
time, however, it still had a patent on one of carvedilol’s
three FDA-approved uses. Because the FDA cannot authorize a generic version of a drug that would infringe a
patent, this one remaining patented use could have prevented a less-expensive, generic carvedilol from coming to
market altogether—even though the drug itself and other
uses of it were unpatented. Congress saw this problem
coming. It wanted to make sure that one patented use
wouldn’t prevent public access to a generic version of a
drug that also has unpatented uses. See Caraco Pharm.
Labs. Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 415 (2012).
So it created rules for just this situation.
These rules, embodied in the so-called skinny-label provisions of the Hatch-Waxman Act, are straightforward. If
a brand drug company (here, GSK) has a patent on one of
a drug’s uses, it tells the FDA which use is patented. In
fact, it tells the FDA exactly what language from its label
is covered by its patents. The FDA will then permit a generic version of that drug to come to market if the manufacturer “carves out” such use from its drug label by
omitting the language that the brand drug company identified. That’s what happened here. GSK’s sworn FDA filings identified just one use as patented. So Teva carved
out that use and came to market with its “skinny” label. It
played by the rules, exactly as Congress intended. It sold
its generic for years without controversy.
And then, in the seventh year, GSK finally sued. It alleged that, even though Teva’s skinny label carved out the
very use—indeed, the only use—that GSK said was patented, the label showed that Teva intended to encourage
an infringing use. GSK also supported its inducement case
by pointing to two cursory, pre-patent press releases that
announced Teva’s drug’s approval (or “tentative” approval)
and called it the generic equivalent of GSK’s brand drug
Coreg.
The dissent on the website issue
And again: causation. To prove it, GSK first had to
show that Teva made this years-old press release available
on its website during the patent’s term. This should have
been a crucial showing—after all, this press release is one
of the three key pieces of evidence the majority relies on.
Once again, though, direct evidence is missing. And once
again, the majority is untroubled. It simply calls up some
inferences to bridge the gap. In particular, the majority
suggests the inference that, because the 2007 press release
was on Teva’s website, and because Teva had a website
with some information about carvedilol, the 2004 press release must have been there too. Maj. 30–31. GSK, for its
part, never argued any of these inferences to the jury. And
while the majority faults Teva for not showing that the
2004 press release was not there, id. at 31, this is GSK’s
case and its burden—and besides, it’s hard to blame Teva
for not rebutting a fact that GSK never even tried establishing.
(...)
But, for argument’s sake, let’s assume the jury could
have reasonably found that GSK carried its burden on this
point. A further question remains: what is there to suggest
that any doctor saw it—years later on the website—then
relied on that as the basis for his or her infringing prescribing decisions? The answer: nothing. At least, that’s the
answer the majority gives. See id. at 35–37. Nothing in
the record suggested that doctors were in the habit of
searching a generic’s website for old press releases to help
them make life-or-death prescribing decisions. The most
we have is that Dr. McCullough saw the 2004 press release
(timing unspecified) and that it said what it said. The rest
is left to sheer possibility
And indeed, it’s possible that things panned out this
way. Maybe a doctor did search Teva’s website for old
press releases, found this one (assuming it was there), and
then relied on that press release to make his or her prescribing decision (at least three years after the date of this
press release), trumping every medical text along the way.
Maybe every relevant doctor did. Many things are possible.
But “‘[m]ere speculation’ is not substantial evidence.” OSI
Pharms., LLC v. Apotex Inc., 939 F.3d 1375, 1382 (Fed. Cir.
2019) (quoting Intell. Ventures I LLC v. Motorola Mobility
LLC, 870 F.3d 1320, 1331 (Fed. Cir. 2017)).
In sum, the 2004 press release’s description of Teva’s
product as the “AB-rated generic equivalent” of Coreg,
along with its reference to “heart failure,” would be a slender enough reed upon which to rest culpable intent, given
that this communique was distributed years before the patent issued (under materially different regulatory circumstances) and announced an approval that was only
“tentative.” But it’s the causation that truly vexes me. It’s
the notion that, instead of the various medical texts (and
experience, and education), all along it was really the 2004
press release, found years later on the website, that caused
doctors’ CHF prescribing decisions. In the face of uncontroverted evidence of the former, some evidence of the latter should be necessary. But there’s none.
In passing, in the distinct realm of prior art, there is no need to PROVE one of reasonable skill knew of the existence of a particular piece of prior art. Knowledge is presumed. However, here we are dealing with inducing infringement, with an element of intent (unlike direct infringement). In the Teva case, intent is inferred by "publishing" the information on a website.
