THERMOLIFE INTERNATIONAL LLC, BOARD OF TRUSTEES OF THE LELAND STANFORD JUNIOR UNIVERSITY, Plaintiffs-Appellants
GNC CORPORATION, GENERAL NUTRITION CENTERS, INC., GENERAL NUTRITION CORPORATION, Defendants HI-TECH PHARMACEUTICALS, INC., VITAL PHARMACEUTICALS, INC, Defendants-Appellees
Appeals from the United States District Court for the
Southern District of California in Nos.
3:13-cv-01015-JLS-MDD, Judge Janis L. Sammartino.
J. Gajarsa, Latham & Watkins LLP, Washington, DC, argued
for plaintiff-appellant ThermoLife International LLC. Also
represented by Gabriel Bell; Gregory Blain Collins, Eric
Hull, Cara Molly Louise Rogers, Kercsmar & Feltus PLLC,
William P. Atkins, Pillsbury Winthrop Shaw Pittman LLP,
McLean, VA, argued for plaintiff-appellant Board of Trustees
of the Leland Stanford Junior University. Also represented by
Benjamin Lee Kiersz.
F. Parsley, Miller & Martin PLLC, Chattanooga, TN, argued
for defendant-appellee Hi-Tech Pharmaceuticals, Inc. Also
represented by David M. Barnes.
Francis DiGiovanni, Drinker Biddle & Reath LLP,
Wilmington, DE, argued for defendant-appellee Vital
Pharmaceuticals, Inc. Also represented by Michael Curt
Lambert, Thatcher Rahmeier; Marc Kesten, Vital
Pharmaceuticals, Inc., Parkland, FL.
Taranto, Bryson, and Stoll, Circuit Judges.
Taranto, Circuit Judge.
International, LLC exclusively licensed four patents from the
Board of Trustees of the Leland Stanford Junior University.
It filed infringement suits, asserting selected claims of
four patents, against numerous defendants, including Hi-Tech
Pharmaceuticals, Inc. and Vital Pharmaceuticals, Inc. After
Stanford became a co-plaintiff of ThermoLife's, a bench
trial was held involving Hi-Tech, Vital, and a trio of
companies from the GNC family as defendants (all other
defendants having settled). The district court held all
asserted claims invalid. That ruling ended the cases on the
merits and is not at issue here.
us is the court's later grant of Hi-Tech's and
Vital's motions for attorney's fees under 35 U.S.C.
§ 285, which authorizes an award of fees to a prevailing
party (like Hi-Tech and Vital) in "exceptional"
cases. The district court found the cases exceptional, but
not based on an assessment of the validity position taken by
plaintiffs ThermoLife and Stanford or how they litigated
validity. Rather, the court relied on its conclusion that
plaintiffs were unjustified in alleging infringement in the
first place, having failed to do an adequate pre-filing
and Stanford appeal the district court's award of fees,
challenging the determination that these were
"exceptional" cases, not the amounts the court
awarded after finding the cases exceptional. We recognize
that these are unusual cases in that the basis for the fee
award had nothing to do with the only issues litigated to
reach the judgment on the merits: Infringement had not been
adjudicated in reaching the final judgment, and even
discovery on infringement had been postponed early in the
proceedings so that validity could be litigated first.
Nevertheless, we see no abuse of discretion in the district
court's determination of exceptionality based on
plaintiffs' inadequate pre-suit investigation of
infringement in these and related cases. We therefore affirm.
owns U.S. Patent Nos. 5, 891, 459, 6, 117, 872, 6, 646, 006,
and 7, 452, 916, which claim methods and compositions
involving the amino acids arginine and lysine, to be ingested
to enhance vascular function and physical performance.
See, e.g., '459 patent, Abstract. The
'459 patent, the '916 patent, and the relevant claims
of the '006 patent share a priority date of June 11,
1993, and expired on June 11, 2013. The '872 patent has a
priority date of June 23, 1998, and expired on June 23, 2018.
All asserted claims of the '459, '872, and '916
patents are method claims, whereas all asserted claims of the
'006 patent are composition claims.
of the '459 patent, the only claim of that patent
asserted against Hi-Tech and Vital, includes a requirement of
efficacy in producing physiological results. It recites:
1. A method of improving vascular NO activity of the vascular
system of a human host by enhancing endothelial NO, said
administering orally as a dietary supplement to said host in
accordance with a predetermined regimen a prophylactic dose
in an amount sufficient to enhance endogenous endothelial
NO, L-arginine or L-arginine hydrochloride, as other
than a natural food source and in the absence of other amino
acids and polypeptides as other tha[n] dietary supplements,
to enhance the level of endogenous NO in the vascular system.
Id., col. 26, lines 39-49 (emphasis added). As
originally filed, claim 1 included L-arginine and all
physiologically acceptable salts thereof, but it was amended
during prosecution to exclude salts other than L-arginine
of the '872 patent requires particular amounts of
identified amino acids. It reads:
1. A method for enhancing physical performance of a mammal
prior to said physical performance, said method comprising:
administering to said mammal prior to said physical
performance as the active ingredient an amino acid
composition consisting of at least one amino acid selected
[from] the group consisting of arginine and lysine
of at least about 60 mg/kg/day within 24 h of said
'872 patent, col. 11, line 55, through col. 12, line 6
(emphasis added). Claims 4 and 5 depend on claim 1 and thus
also require at least about 60 mg/kg/day of arginine or
ly-sine. Id., col. 12, lines 11-16. Claims 7, 8, and
12 all require "at least about 2 g per day" of
arginine or lysine. Id., col. 12, lines 19-31,
45-51. Claim 10 depends on claim 7 and additionally requires
"about 2 to 12 g per day" of arginine or lysine.
Id., col. 12, lines 34-36.
of the '916 patent includes both efficacy and amount
requirements for L-arginine or any physiologically acceptable
salt (not just the hydrochloride salt). It reads:
1. A method of enhancing nitric oxide production comprising
orally administering to a human host in need thereof a
composition comprising L-arginine or a physiologically
acceptable salt thereof, wherein (i) said composition
includes an amount of L-arginine or its physiologically
acceptable salt sufficient to increase the level of nitric
oxide production in said human host and (ii) said
composition is a dietary or food supplement or a
pharmaceutical composition in a form suitable for oral
administration selected from the group consisting of a pill,
a powder, a liquid, and a capsule, wherein said administering
provides a daily amount ranging from 1 to 12 grams of
L-arginine or its physiologically acceptable salt and
wherein the composition further comprises at least one
additional compound associated with production of nitric
oxide other than L-arginine or a physiologically acceptable
'916 patent, col. 26, lines 38-53 (emphases added). Claim
2, another independent claim, and claim 6, which depends on
claim 2, likewise require both "an amount of L-arginine
or its physiologically acceptable salt sufficient to increase
the level of nitric oxide production" and "a daily
amount ranging from 1 to 12 grams of L-arginine or its
physiologically acceptable salt." See id., col.
26, lines 54-67; id., col. 28, lines 6-8.
apart from the other asserted claims are three claims of the
'006 patent, which claim compositions comprising
L-arginine and any physiologically acceptable salt but do not
include either amount or efficacy requirements. Claim 3
3. A composition comprising L-arginine or a
physiologically acceptable salt thereof and at least one
additional compound associated with production of nitric
oxide other than L-arginine or a physiologically acceptable
salt thereof, said composition excluding other amino acids
which are not precursors of nitric oxide, wherein said
composition is in a form suitable for oral administration
selected from the group consisting of a pill, a powder, a
liquid, and a capsule.
'006 patent, col. 27, lines 40-47 (emphasis added). Claim
5, another independent claim, and claim 14, which depends on
claim 5, similarly do not, on their face, contain any amount
or efficacy limitations. See id., col. 27, lines
52-61; id., col. 28, lines 20-22.
originally granted exclusive licenses to the '459,
'872, '006, and '916 patents to Cooke Pharma,
Inc., which eventually became Unither Pharma, Inc. In 2002
and 2003, Unither and Stanford filed several infringement
suits involving some of those patents in the Northern
District of California. One of those cases resulted in a
November 2005 district court decision that construed
"amount sufficient" in the '459 patent to mean
"an amount typically administered to a subset of
mammalian organisms for the purpose of the
administration." Unither Pharma, Inc. v. Daily
Wellness Co., No. 02-cv-05284, 2005 WL 6220096, at *10
(N.D. Cal. Nov. 30, 2005). Unither terminated its license
with Stanford in September 2012.
months later, in February 2013, Stanford exclusively licensed
the four patents to ThermoLife. From March 19, 2013, to
December 11, 2013, ThermoLife filed a total of eighty-one
infringement suits, including suits against Hi-Tech and
Vital, in the Southern District of California. Although
separate suits were filed, see 35 U.S.C. § 299
(broadly requiring separate filings), the district court,
beginning in August 2013, consolidated the cases before it
for pre-trial purposes. Eventually, in January 2015, Stanford
was added as a plaintiff, through the filing of an amended
complaint against all defendants, to resolve a dispute about
ThermoLife's standing to proceed alone.
alleged that Hi-Tech and Vital each directly infringed the
four patents-for the composition claims, by making or selling
the accused products, and for the method claims, by
administering the accused products to end users-and also
indirectly infringed, by inducing or contributing to end
users' directly infringing use of the accused products.
ThermoLife pointed to Hi-Tech's and Vital's labels
and advertisements in support of its allegations. ThermoLife
sought damages, including enhanced damages, and injunctive
relief. The January 2015 amended complaint is similar.
to applicable local rules for patent cases, ThermoLife
notified the defendants of specific infringement contentions
shortly after the suits were filed. In its December 12, 2013
amended infringement contentions, ThermoLife identified
specific Hi-Tech products and the corresponding allegedly
infringed patent claims: Anavar ('459 patent-claim 1); NO
Overload ('459 patent-claim 1; '872 patent-claims 1,
4, 5, 7, 8, 10, 12; '916 patent-claims 1, 2, 6); Zencore
Plus ('459 patent-claim 1; '006 patent- claims 3, 5);
Mesomorph (APS Nutrition) ('006 patent- claim 3);
SizeMatters (HealthSource) ('459 patent-claim 1; '006
patent-claims 3, 5, 14); and StaminaRx ('459 patent-claim
1; '006 patent-claims 3, 5, 14). The same day, ThermoLife
made more limited allegations against Vital products: AEX NO
('872 patent-claim 12; '916 patent- claims 1, 2, 6);
and NO Shotgun V3, NO Shotgun MHF-1, and NO Synthesize
('459 patent-claim 1).
January 2014, with dozens of cases before it, the district
court had set a schedule in which discovery was to begin for
claim construction, invalidity, unenforceability, and
standing-but not for infringement. In March 2014, the parties
filed a joint report stating that they had agreed to
"phased discovery": "discovery should be
coordinated and initially limited to issues concerning
standing, claim construction, patent invalidity and/or
unenforceability." J.A. 215. "If necessary,"
the report added, "discovery should then proceed as
issues unique to each Defendant and each case, namely[, ]
infringement and damages." Id. The report
explained that "[t]his will facilitate the fair and
efficient conduct of discovery and dispositive motion
practice in this matter, and will ...