Pronova Biopharma Norge AS v. Teva Pharmaceuticals USA, Inc. ( 2013 )

NOTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
PRONOVA BIOPHARMA NORGE AS,
Plaintiff-Appellee,
v.
TEVA PHARMACEUTICALS USA, INC.,
Defendant-Appellant,
AND
PAR PHARMACEUTICAL, INC. AND PAR
PHARMACEUTICAL COMPANIES, INC.,
Defendants-Appellants.
______________________
2012-1498, -1499
______________________
Appeals from the United States District Court for the
District of Delaware in Nos. 09-CV-0286 and 09-CV-0305,
Judge Sue L. Robinson.
______________________
Decided: September 12, 2013
______________________
JAMES B. MONROE, Finnegan, Henderson, Farabow,
Garrett & Dunner, LLP, of Washington, DC, argued for
2 PRONOVA BIOPHARMA NORGE v. TEVA PHARMACEUTICALS
plaintiff-appellee. With him on the brief were MICHAEL J.
FLIBBERT and ANTHONY C. TRIDICO.
J. ANTHONY DOWNS, Goodwin Procter, LLP, of Boston,
Massachusetts, argued for defendant-appellant Teva
Pharmaceuticals USA, Inc. With him on the brief were
DAVID M. HASHMALL, FREDERICK H. REIN, ANNEMARIE
HASSETT and GREGORY T. SANDIDGE, of New York, New
York.
DANIEL G. BROWN, Latham & Watkins LLP, of New
York, New York, argued for defendants-appellants Par
Pharmaceutical Companies, Inc., et al. With him on the
brief were JENNIFER R. SAIONZ; and GABRIEL K. BELL, of
Washington, DC.
______________________
Before DYK, O’MALLEY, and WALLACH, Circuit Judges.
O’MALLEY, Circuit Judge.
This patent infringement suit arises from Abbreviated
New Drug Applications (“ANDAs”) filed by Teva Pharma-
ceuticals USA Inc. (“Teva”) and Par Pharmaceutical, Inc.
and Par Pharmaceutical Companies, Inc. (collectively
“Par”) (with Teva, collectively “Appellants”). Through
their ANDAs, Appellants seek to market generic versions
of Lovaza®, a pharmaceutical product marketed by Plain-
tiff Pronova BioPharma Norge AS (“Pronova”). Following
a bench trial, the U.S. District Court for the District of
Delaware entered final judgment for Pronova, holding
that U.S. Patent Nos. 5,656,667 (“the ’667 patent”) and
5,502,077 (“the ’077 patent”) were infringed, not proven
invalid as obvious under 35 U.S.C. § 103 or anticipated
under § 102(b) by prior public use, and not proven unen-
forceable due to inequitable conduct. Teva and Par ap-
peal those four rulings. Because we find that Pronova’s
predecessor, Norsk Hydro, made the inventions claimed in
PRONOVA BIOPHARMA NORGE v. TEVA PHARMACEUTICALS 3
the ’667 patent publicly accessible before the statutory
bar date, constituting an invalidating public use pursuant
to § 102(b), we reverse. This ruling renders moot all
remaining issues regarding the ’667 patent. Since
the ’077 patent expired in March of this year, we also find
it unnecessary to reach any issues regarding that patent.
We accordingly reverse the district court judgment and
remand with orders to enter judgment in favor of Appel-
lants.
I. BACKGROUND
A. Claimed Technology
Pronova is the holder of approved New Drug Applica-
tion (“NDA”) No. 121654 for Lovaza® and is the owner by
assignment of the patents-in-suit. The patents-in-suit are
listed in the “Approved Drug Products with Therapeutic
Equivalence Evaluations” (“the Orange Book”) for Lova-
za®. Lovaza® is the first and only fish-oil derived pre-
scription drug approved by the U.S. Food and Drug
Administration (“FDA”). It contains fish-oil components
in concentrated amounts. The drug is indicated to reduce
triglyceride levels in adult patients with severe hypertri-
glyceridemia, i.e., high levels of triglycerides. Since its
entry into the market in 2005, Pronova has sold large
amounts of Lovaza® in the U.S. market, with U.S. sales
amounting to over $2.3 billion as of August 2010.
Starting in the 1970s, medical studies established the
medical benefits of fish oil for treating heart disease. A
1972 Danish study reported that Greenland Eskimos,
whose diet is high in fish (and thus high in fat), had very
low rates of heart disease. The study postulated that the
fish fat in their diet, which has a high concentration of
polyunsaturated fatty acyl components, had beneficial
properties. Subsequent research in the 1980s concluded
that two components, eicosapentaenoic acid (“EPA”) and
4 PRONOVA BIOPHARMA NORGE v. TEVA PHARMACEUTICALS
docosahexaenoic acid (“DHA”), two omega-3 fatty acids, 1
were the active agents giving fish oil its beneficial proper-
ties. Thus, starting in the 1980s, fish oil capsules contain-
ing, among other components, EPA and DHA, have been
used to treat hypertriglyceridemia.
At trial, Pronova asserted four claims of the patents-
in-suit: it asserted claim 9 of the ’077 patent 2 and claims
20 3 and 44 4 of the ’667 patent against both Appellants; it
asserted claim 50 of the ’667 patent against only Teva.
The asserted claims are drawn to pharmaceutical compo-
sitions or methods of using such compositions. The claims
recite specific concentrations of five fish-oil derived com-
ponents: EPA, DHA, heneicosapentaenoic acid (“HPA”),
docopentaenoic acid (“DPA”), and arachidonic acid (“AA”).
All except AA are omega-3 fatty acids; AA is an omega-6
fatty acid. The claimed compositions have high concen-
1 Omega-3 fatty acids are polyunsaturated fatty
acyl components in which the first double bond occurs at
the third carbon in the chain. An omega-6 fatty acid, by
contrast, has its first double bond on the sixth carbon in
the chain.
2 Claim 9 of the ’077 patent depends from “any of
claims 5, 6, or 7.” ’077 patent col. 12 l. 33. Pronova
asserted this claim as it depends from claim 6 and as it
depends from claim 7. See Br. of Appellee at 4.
3 Claim 20 of the ’677 patent depends from “any of
claims 17, 18, or 19” of that patent. ’677 patent col. 12 l.
4. Pronova asserted this claim as it depends from claim
18. See Br. of Appellee at 3.
4 Claim 44 of the ’677 patent depends from “any of
claims 28, 31, or 35” of that patent. ’667 patent col. 13 l.
24. Pronova asserted this claim as it depends from claim
31. See Br. of Appellee at 3.
PRONOVA BIOPHARMA NORGE v. TEVA PHARMACEUTICALS 5
trations of EPA and DHA, the active ingredients in the
formulation (“the major components”), and low concentra-
tions of the other three fatty acid components, AA, HPA,
and DPA (“the minor components”).
B. Lower Court Proceedings
Teva and Par separately filed an ANDA seeking to
market a generic version of Lovaza® (omega-3-acid ethyl
esters) capsules. Their ANDAs contained paragraph IV
certifications indicating that the ’667 and ’077 patents
were not infringed or were invalid. In response, Pronova
filed lawsuits against Teva and Par in the District of
Delaware; the two suits were consolidated. The district
court held a bench trial for the consolidated cases from
March 30 to April 6, 2011. After post-trial briefing, it
held that Pronova proved that Teva’s and Par’s ANDA
products will infringe all the asserted claims and Teva
and Par failed to establish invalidity of the asserted
claims or unenforceability of the patents-in-suit.
Specifically, Appellants asserted, among other things,
that the asserted claims of the ’667 patent were invalid
under 35 U.S.C. § 102(b) for public use prior to the statu-
tory bar date. The parties agreed that, on September 8,
1987, Norsk Hydro, Pronova’s predecessor, sent Dr. Victor
Skrinska (“Skrinska”) of St. Vincent Charity Hospital
liquid vials of its “K-80” ethyl ester composition. Those
samples, Pronova concedes, were produced by Norsk
Hydro in a batch numbered 222 (“Batch 222”), which met
all the limitations of the asserted claims of the ’667 pa-
tent. See Pronova BioPharma Norge AS v. Teva Pharms.
USA, Inc., et. al., 1:09-cv-286, ECF No. 245 (D. Del. May,
29, 2012). Appellants argued to the district court that
Norsk Hydro, by providing Skrinska samples and disclos-
ing their content, made an invalidating public use of the
claimed invention. They also argued that Skrinska
himself made invalidating public uses of the samples
when he tested them to confirm their content, discussed
6 PRONOVA BIOPHARMA NORGE v. TEVA PHARMACEUTICALS
them with colleagues, and administered capsules to
himself and others. Id.Appellants also asserted three other public uses at
trial. They argued that Norsk Hydro shipped the same
“K-80” product to Dr. Fran Peterson (“Peterson”) of Gen-
eral Mills on February 17, 1987, shipped samples of “K-
80” to Professor Roger Davis (“Davis”) at the University of
Colorado in January 1988, and shipped 1000 capsules of
its “K-85” product to Professor Arne Nordøy (“Nordøy”) at
the University of Oregon in January 1988. It is undisput-
ed that the distributions to Peterson and Davis were (1)
unrestricted; (2) non-experimental; and (3) for purposes of
generating interest in the product. While the distribu-
tions to Nordøy were not subject to any agreements or
restriction, Nordøy actually did conduct an experimental
bioavailability study which Pronova disclosed to the PTO
during prosecution of the patents.
The district court first dismissed Appellants argu-
ments regarding Peterson and Davis, finding that Appel-
lants produced no evidence that Peterson or Davis
actually “used,” i.e., ingested or gave to others to ingest,
the “K-80” samples. While the court acknowledged that
Appellants had proffered evidence that Norsk Hydro was
“shopping K-80 and/or K-85 in the market,” the court
concluded that such evidence was insufficient to establish
an “actual prior public use of the invention as claimed.”
While the court agreed that Nordøy did use the samples
for their intended purposes, it concluded that Appellants
had failed to rebut Pronova’s evidence that the use was
experimental.
The court next turned to the evidence regarding
Skrinska to determine “whether Skrinska actually used
the claimed invention and, if so, in what manner.” Id.(internal quotation marks omitted). The court pointed to
testimony and documents indicating that Norsk Hydro
sent Skrinska two 100 mL liquid samples of Batch 222,
PRONOVA BIOPHARMA NORGE v. TEVA PHARMACEUTICALS 7
and Skrinska’s testimony that he believes Norsk Hydro
subsequently sent him 500 to 1000 capsules of concen-
trated fish oil. Regarding the first shipment, the district
court acknowledged that Skrinska tested the two samples
to confirm (and did confirm) their content, but, the court
concluded that, beyond this, “Appellants do not point to
any particular ‘use’ [by Skrinska] of the two Batch 222
liquid vials.” Id. Again, while no conclusion of law ex-
pressly says so, the court apparently agreed with Pronova
that an invalidating use of a pharmaceutical compound
must be for the purposes identified in the patents-in-suit
– to treat hypertriglyceridemia. Regarding the second
shipment (i.e., the capsules), the district court noted that
Skrinska had trouble remembering details surrounding
the shipment, such as whether anyone other than Norsk
Hydro sent him fish oil capsules or specific data from
assays performed on the capsules. The lower court also
recounted Skrinska’s testimony in which he detailed the
use of the capsules in a six-person, two week study, but it
noted that no corroborating documentary evidence of this
study was adduced at trial. The district court ultimately
discredited Skrinska’s testimony regarding use of the
capsules and rejected Appellants public use defense. Id.C. Arguments on Appeal
On appeal, Teva asserts the testing which Skrinska
performed constitutes an invalidating public use because,
in its view, any use of a claimed invention can be invali-
dating. An invalidating public use need not be the in-
tended use of the invention disclosed or claimed in the
patent as long as the invention is fully disclosed without
restriction. It was thus unnecessary for Skrinska to use
the samples to treat high levels of triglycerides, Teva
maintains. Teva also discounts the district court’s credi-
bility finding regarding Skrinska’s testimony, arguing
that finding did not pertain to the testing of the vials (but
only to the testing and use of the capsules) and, that the
8 PRONOVA BIOPHARMA NORGE v. TEVA PHARMACEUTICALS
vial testing was corroborated by various forms of docu-
mentary and circumstantial evidence.
Par also asserts that the ’667 patent is invalid under
§ 102(b) because, in its view, Norsk Hydro’s use of the
invention when it shipped the samples to Skrinska,
Peterson, and Davis were for commercial purposes. A
commercial use, even if not the intended use of the inven-
tion, Par argues, is invalidating. The two uses were
commercial, Par believes, because the vials were distrib-
uted for purposes of generating interest (through Skrin-
ska and Davis) or a market (through Peterson) for its K-
80 product.
Pronova responds that, to be invalidating under
§ 102(b), an invention must be used by someone other
than the inventor for its intended purpose. Merely send-
ing samples is insufficient, Pronova believes, since mak-
ing shipments is not the use intended in the patents.
And, even if the invention is put to a commercial use, such
use can only be invalidating, Pronova asserts, if it is for
the invention’s intended purpose. Thus, Pronova claims
that, because no one other than Skrinska claimed to have
used the samples they received to treat hypertriglycer-
idemia, and that aspect of Skrinska’s testimony was
discredited, there can be no invalidating public use; in
Pronova’s view disclosing its products to others and
“analytical testing” of those products can never constitute
a public use of the inventions disclosed in the ’667 or ’077
patents. 5
5 While Pronova contends in its briefing here that
Skrinska’s testimony regarding analytical testing of the
liquid vial batches was uncorroborated and, thus, should
be disregarded, it does not appear Pronova made this
argument at trial. In any event, we read the trial court’s
factual findings to credit this aspect of Skrinska’s testi-
PRONOVA BIOPHARMA NORGE v. TEVA PHARMACEUTICALS 9
We take these arguments up below, and ultimately
agree with Appellants, finding Pronova’s view of what
constitutes public use under § 102(b) too narrow.
II. LEGAL STANDARD
Section 102(b) of Title 35 of the U.S. Code6 states:
A person shall be entitled to a patent unless—
...
(b) the invention was . . . in public use . . . in this
country, more than one year prior to the date of
the application for patent in the United States.
35 U.S.C. § 102(b) (2006).
Whether a patent is invalid due to public use under
§ 102(b) is a question of law based on underlying ques-
tions of fact. Netscape Commc’ns Corp. v. Konrad, 295
F.3d 1315, 1321 (Fed. Cir. 2002). We review the lower
court’s ultimate legal determination de novo, Adenta
GmbH v. OrthoArm, Inc., 501 F.3d 1364, 1369 (Fed. Cir.
2007), but, following a bench trial, we review its underly-
ing findings of fact for clear error, Preston v. Marathon
Oil Co., 684 F.3d 1276, 1287–88 (Fed. Cir. 2012).
“[T]he policies underlying the public use bar inform
its scope and . . . one such policy is discouraging the
removal, from the public domain, of inventions that the
mony and find that conclusion well-supported by the
evidence at trial.
6 Paragraph (b) of 35 U.S.C. § 102 was replaced
with newly designated § 102(a)(1) when § 3(b)(1) of the
Leahy-Smith America Invents Act (“AIA”), Pub.L. No.
112–29, took effect on September 16, 2012. Because this
case was filed before that date, we will refer to the pre-
AIA version of § 102.
10 PRONOVA BIOPHARMA NORGE v. TEVA PHARMACEUTICALS
public reasonably has come to believe are freely availa-
ble.” Dey, L.P. v. Sunovion Pharm., Inc., 715 F.3d 1351,
1355 (Fed. Cir. 2013) (internal quotation marks omitted).
“A bar under § 102(b) arises where, before the critical
date, the invention is in public use and ready for patent-
ing.” Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d
1374, 1379 (Fed. Cir. 2005). Regarding the first require-
ment for the public use bar to attach, we explained in
Invitrogen that either public accessibility or commercial
exploitation would qualify as “public use:”
The proper test for the public use prong of the
§ 102(b) statutory bar is whether the purported
use: (1) was accessible to the public; or (2) was
commercially exploited. Commercial exploitation
is a clear indication of public use, but it likely re-
quires more than, for example, a secret offer for
sale. Thus, the test for the public use prong in-
cludes the consideration of evidence relevant to
experimentation, as well as, inter alia, the nature
of the activity that occurred in public; public ac-
cess to the use; confidentiality obligations imposed
on members of the public who observed the use;
and commercial exploitation.
Id. at 1380 (internal citations omitted).
The Supreme Court explained the “ready for patent-
ing” requirement, in the context of the § 102(b) on sale
bar, in Pfaff v. Wells Electronics, Inc., 525 U.S. 55, 67–68
(1998). “That condition may be satisfied in at least two
ways: by proof of reduction to practice before the critical
date; or by proof that prior to the critical date the inven-
tor had prepared drawings or other descriptions of the
invention that were sufficiently specific to enable a person
skilled in the art to practice the invention.” 525 U.S. at67–68. Our court subsequently held that this require-
ment applies equally to the public use bar of § 102(b).
Invitrogen, 424 F.3d at 1379.
PRONOVA BIOPHARMA NORGE v. TEVA PHARMACEUTICALS 11
III. ANALYSIS
In this case, there is no dispute regarding the “ready
for patenting” requirement—the parties agree that Norsk
Hydro sent samples to Skrinska meeting the limitation of
the asserted claims of the ’667 patent. 7 That is, the
invention was reduced to practice. The dispute on appeal
concerns the first requirement of the statutory bar,
whether the invention was in “public use.” We hold that
Norsk Hydro provided public access to its invention when
it sent samples to Skrinska with no confidentiality re-
strictions; the Appellants proved by clear and convincing
evidence that the invention was in “public use.”
A. Public Accessibility Inquiry
“Our cases have provided considerable guidance as to
what it means to be ‘accessible to the public.’” Dey, 715
F.3d at 1355. Thus, “public use may occur when ‘a com-
pleted invention is used in public, without restriction.’”
Id. (quoting Allied Colloids, Inc. v. Am. Cynamid Co., 64
F.3d 1570, 1574 (Fed. Cir. 1995)). “[A]n agreement of
confidentiality, or circumstances creating a similar expec-
tation of secrecy, may negate a ‘public use’ where there is
not commercial exploitation.” Invitrogen, 424 F.3d at
1382. Similarly, a disclosure of some aspects of an inven-
tion, but not all, will likely preclude a finding of public
use. See, e.g., W.L. Gore & Assocs., Inc. v. Garlock, Inc.,
721 F.2d 1540, 1549 (Fed. Cir. 1983) (reversing § 102(b)
invalidation, in part, because “looking at the machine in
7 Because ultimately we hold that Norsk Hydro
made an invalidating use of the inventions described in
the asserted claims of the ’667 patent when it sent at least
two liquid samples to Skrinska, we focus on only that
use—the shipment and testing of the liquid vials—in our
analysis. It is unnecessary for us to reach the other
purportedly invalidating uses which Appellants assert.
12 PRONOVA BIOPHARMA NORGE v. TEVA PHARMACEUTICALS
operation does not reveal whether it is stretching, and, if
so, at what speed. Nor . . . whether the crystallinity and
temperature elements of the invention set forth in the
claims are involved.”).
1. Restrictions on Use
In the seminal case Egbert v. Lippmann, 104 U.S.
333, 336 (1881), the Supreme Court articulated the prin-
cipal inquiry regarding public use: Was the invention’s
use public in the sense that it was made available to
others with no limitation or restriction? Specifically in
Egbert, an inventor made several embodiments of his
invention, springs to be used with a women’s corset, and
gave them to a friend who wore them under her clothes
for several years. Egbert, 104 U.S. at 335. Despite the
essentially concealed nature of the friend’s use, the Su-
preme Court invalidated the patent:
If an inventor, having made his device, gives or
sells it to another, to be used by the donee or ven-
dee, without limitation or restriction, or injunction
of secrecy, and it is so used, such use is public,
even though the use and knowledge of the use
may be confined to one person.
Id. at 336. The inquiry is not whether the third person to
whom an invention is disclosed makes an open and obvi-
ous use of it, but whether the inventor himself has made a
use of his invention which is “public” because it was given
to a member of the public without restriction. Given the
nature of the inquiry, our case law understandably focus-
es on the limitations, restrictions, or secrecy obligations
associated with a purported public use. See, e.g., Dey, 715
F.3d at 1355; Netscape Commc’ns Corp., 295 F.3d at 1321.
We have explained that “whether an invention is accessi-
ble to the public or reasonably believed to be freely avail-
able depends, at least in part, on the degree of
confidentiality surrounding its use.” Dey, 715 F.3d at
1355 (internal quotation marks omitted). The degree of
PRONOVA BIOPHARMA NORGE v. TEVA PHARMACEUTICALS 13
confidentiality necessary to avoid a finding of public use
naturally depends on the circumstances.” Id.
To analyze the degree of confidentiality surrounding a
purported public use, we have also focused on the amount
of control which the discloser retains over the invention
during the uses in question. For example, in Lough v.
Brunswick Corp., 86 F.3d 1113, 1121 (Fed. Cir. 1996), we
invalidated a patent despite an inventor’s argument that
the uses were experimental, because he had given the
invention—seals for boat motors—to several friends who,
in turn, installed and tested one on a boat, which they
later sold. 86 F.3d at 1121. After the sale, neither the
inventor nor the friends “knew what happened with either
the prototype or the demonstration boat after the boat
was sold,” so the inventor “did not maintain any supervi-
sion and control over the seals during the alleged testing.”
Id. Similarly, in Eolas Technologies Inc. v. Microsoft
Corp., 399 F.3d 1325 (Fed. Cir. 2005), we found that a
demonstration of the invention to “two Sun Microsystems
employees without confidentiality agreements” was an
invalidating public use under § 102(b), even though there
was no evidence that those employees personally “used”
the invention. 399 F.3d at 1334. And, in Beachcombers,
International, Inc. v. Wildewood Creative Products, Inc.,
31 F.3d 1154 (Fed. Cir. 1994), we affirmed a jury verdict
finding public use of a patented device under § 102(b)
based on evidence that the designer and developer
demonstrated a prototype at a party for her guests to
view. 31 F.3d at 1159–60. On the other hand, in Molecu-
lon Research Corp. v. CBS, Inc., 793 F.2d 1261, 1265–67
(Fed. Cir. 1986), we upheld a patent even though the
inventor had showed prototypes of the invention, a three-
dimensional puzzle, to several friends and his employer
over the course of five years. 793 F.2d at 1263. We
upheld the lower court’s findings that the inventor “at all
times retained control over the puzzle’s use and the
distribution of information concerning it,” and he “re-
14 PRONOVA BIOPHARMA NORGE v. TEVA PHARMACEUTICALS
tained control even though he and [the employer] had not
entered into any express confidentiality agreement.” Id.
at 1266.
Also among the circumstances of the disclosure upon
which we have focused is the sophistication of those to
whom disclosure was made. As we recently explained in
Dey, while a public use might not arise where disclosure is
limited to a small number of uninformed observers, “even
limited disclosure to those who are skilled enough to
know, understand, and ‘easily demonstrate the invention
to others,’ may mean that there was no reasonable expec-
tation of secrecy and that the invention was therefore in
public use.” Dey, 715 F.3d at 1356 (citing Netscape
Commc'ns Corp., 295 F.3d at 1321 (Fed. Cir. 2002)).
2. Scope of Disclosure
Even where a disclosure is unrestricted, it will not be
an invalidating public use, unless the patent challenger
establishes that all claimed aspects of the invention were
made public. See, e.g., Dey, 715 F.3d at 1357. Two of our
recent cases illustrate this point. In Dey, for example, we
held that the alleged infringer was not entitled to sum-
mary judgment of invalidity due to prior public use. Id.
The purported public use was the defendant’s own clinical
trial of the allegedly infringing product. Id. Because only
the clinical trial administrator, not the subjects taking
the medication, was made aware of the invention’s
claimed formulation and stability characteristics, and the
administrator had signed a pledge of confidentiality, we
held that “a finder of fact could conclude that the study
was conducted with a reasonable expectation of confiden-
tiality as to the nature of the formulations being tested,
[such that] summary judgment on the public use issue
was inappropriate.” Id. (emphasis added). A fact finder
could so conclude even though the subjects did not like-
wise sign a confidentiality pledge because “they were
PRONOVA BIOPHARMA NORGE v. TEVA PHARMACEUTICALS 15
given incomplete descriptions of the treatment formula-
tion.” Id.
Likewise, in Motionless Keyboard Co. v. Microsoft
Corp., 486 F.3d 1376, 1385 (Fed. Cir. 2007), we reversed a
lower court judgment invalidating a patent where certain
disclosures did not reveal all aspects of the claimed inven-
tion, and another disclosure, which did so, was subject to
a non-disclosure agreement. 486 F.3d 1376. Specifically,
the invention was an ergonomic keyboard and the claims
required that the device transmit information. See U.S.
Patent No. 5,178,477 col. 7 ll. 46–48 (“An ergonomic
keyboard input device for the transmission of information
by a human operator to an electronic system coupled with
said device . . . ”); U.S. Patent No. 5,332,322 col. 8 ll. 16–
31 (“A handheld device for entering information into an
electronic system via a keyboard . . . whereby information
is entered into an electronic system.”). The inventor had
shown a prototype of the invention to potential investors,
but the prototype was not plugged into a computer during
these displays. Id. at 1379. He also made the invention
available to a third-party to perform testing, which did
involve the transmission of information, but that third
party had signed a confidentiality agreement. Id. We
found no public use from either disclosure:
All disclosures, except for the one-time typing
test, only provided a visual view of the new key-
board design without any disclosure of the [proto-
type’s] ability to translate finger movements into
actuation of keys to transmit data. In essence,
these disclosures visually displayed the keyboard
design without putting it into use. In short, the
[prototype] was not in public use as the term is
used in section 102(b) because the device, alt-
hough visually disclosed and only tested one time
with a NDA signed by the typing tester, was never
connected to be used in the normal course of busi-
ness to enter data into a system.
16 PRONOVA BIOPHARMA NORGE v. TEVA PHARMACEUTICALS
Id. Our precedent thus establishes firmly that all aspects
of the claimed invention must be disclosed for the § 102(b)
public use bar to apply. See also Janssen Pharmaceutica,
N.V. v. Eon Labs Mfg., Inc., 134 F. App’x 425, 431 (Fed.
Cir. 2005) (“Janssen correctly argues, however, that
because the composition of F12 (including the beads and
the size of the cores contained in the capsule) was never
released to the doctors or the subjects of the trials, this
fact weighs in favor of a finding that the use was not
public.”); W.L. Gore & Assocs., Inc., 721 F.2d at 1549(reversing lower court judgment invalidating method
claims under § 102(b) because there was “no evidence that
a viewer of [a] machine could thereby learn anything of
which process, among all possible processes, the machine
is being used to practice”).
With these principles in mind, we turn to the alleged-
ly invalidating use at issue here. Because we find that
Norsk Hydro sent samples of the invention claimed in
the ’667 patent to Skrinska at the St. Vincent Charity
Hospital without restriction and Skrinska thereafter
tested the samples, we hold that Norsk Hydro put its
invention to an invalidating public use.
B. Norsk Hydro’s Actions
Sometime in 1987, Norsk Hydro visited Skrinska
while he was employed at the Cleveland Research Insti-
tute and described to him its fish oil products in the hopes
of interesting him in conducting studies of or promoting
them. See Joint Appendix (“J.A.”) at 12553. On May 15,
1987, Skrinska wrote Norsk Hydro expressing interest in
its “purified individual acids,” i.e., omega-3 fatty acids,
and in “clinical studies using the mixtures you described
in your visit.” Id.; see also J.A. 12588. In a letter dated
November 25, 1986, Sigurd Gulbrandsen of Norsk Hydro
informed others within the company of Skrinska’s inter-
est, and the benefits of providing product to Skrinska,
who was by then working at St. Vincent Charity Hospital.
PRONOVA BIOPHARMA NORGE v. TEVA PHARMACEUTICALS 17
Id. A consultant had advised Norsk Hydro to “explore the
possibility of participating in the St. Vincent Charity
diabetes trials” because “St. Vincent Charity Hospital has
had a reputation for advanced cardiovascular research”
and “certainly represent[s] the most intensive, concen-
trated—and professionally credible—omega-3 clinic
research potential anywhere in the world.” J.A. 12589.
The consultant also believed that Skrinska “was among
the most omega-3-knowledgeable researchers interviewed
by [it], with definite interest in the ethyl-esterified tri-
glycerides forms of the Norsk Hydro oils.” Id.
Norsk Hydro followed its consultant’s advice and pro-
vided Skrinska with its concentrated fish oil products. In
fact, Pronova admits that it “sent Dr. Skrinska a small
(100 mL) liquid sample of a K80 product from Batch 163
and a liquid sample of 30% cholesterol-free triglyceride
concentrate in July 1987, and then sent him in September
1987 two 100 mL liquid samples of K80 from Batch 222 to
replace the first sample.” Br. of Appellee 25. The record
contains Norsk Hydro’s correspondence documenting
these shipments, J.A. 12555-61, including a certificate of
analysis for Batch 222, which shows that the product
meets the limitations of the asserted claims, see
J.A. 12560 (showing a concentration of 20:5 ω3, i.e., EPA,
of 53.2 weight percent, of C22:6 ω3, i.e., DHA, of 33.3
weight percent, of C20:4 ω6, i.e., AA, of 1.6 weight per-
cent, and of C22:5 ω-3, i.e., DPA, of 3.2 weight percent).
Notably, that correspondence makes no mention of any
confidentiality restrictions, J.A. 12555-61, and Pronova
does not argue that any were either requested or given.
There was also no agreement restricting use of batches to
clinical trials or experiments; Pronova concedes experi-
mental use is not at issue. Skrinska’s testimony on the
shipments confirms these events. See J.A. 9141–45.
Based on the foregoing, we conclude that Norsk Hydro
provided Skrinska the invention of the ’667 patent with
no secrecy obligation or limitation for his unfettered use.
18 PRONOVA BIOPHARMA NORGE v. TEVA PHARMACEUTICALS
This access began, at the latest, in September of 1987,
when Norsk shipped to Skrinska samples from Batch 222.
The shipment made public all aspects of the claimed
inventions, since it included a certificate of analysis
revealing the composition of the supplied products. The
documentary evidence regarding this shipment is unre-
futed. Skrinska had access to all aspects of the asserted
claims of the ’667 patent. Indeed, he confirmed the dis-
closed formulation by his own analytical testing.
The use involved here—Norsk Hydro’s shipment of
the samples and Skrinska’s analytical testing thereof—is
similar to uses we have found invalidating in the past. As
in Lough and Beachcombers, described above, Norsk
Hydro provided the invention to others under no confiden-
tiality restrictions and kept no track of the third-party’s
use. 86 F.3d at 1116; 31 F.3d at 1159–60. Pronova does
not even know what Skrinska did with the samples after
he received them. See Br. of Appellee 25.
Unlike the cases we cite above where no invalidating
public use was found, the public use involved here dis-
closed all aspects of the claimed invention with no expec-
tation of secrecy. In Dey and Motionless Keyboard, those
made aware of all aspects of the claimed invention were
under confidentiality restrictions and other disclosures
did not reveal all aspects of the claims. See Dey, 715 F.3d
at 1357; Motionless Keyboard, 486 F.3d 1379. Here, on
the other hand, Norsk Hydro provided a certificate of
analysis revealing all the claimed elements without any
confidentiality agreement or understanding. J.A. 12560.
As in Netscape, moreover, the disclosure here was made to
one highly skilled in the art, with the full ability to know,
understand, and fully disclose the invention to others.
Indeed, the district court pointed to documents in the
record confirming Skrinska’s testimony that he shared
information regarding the samples sent to him with other
members of the medical community in Cleveland and did
not treat that information as confidential.
PRONOVA BIOPHARMA NORGE v. TEVA PHARMACEUTICALS 19
We are not persuaded by Pronova’s argument that
“use” of a pharmaceutical formulation cannot occur until
it is used to treat the condition it is intended to counter-
act, or at least physically ingested. Certainly, where only
a partial demonstration of a system’s (or formulation’s)
capabilities occurs—as in Motionless Keyboard—or where
unsophisticated users are provided a compound with no
detail regarding its formulation—as in Dey—there will be
no public use. Where, as here, however, a compound is
provided without restriction to one highly skilled in the
art, that compound’s formulation is disclosed in detail,
and the formulation is subject to confirmatory testing, no
other activity is needed to render that use an invalidating
one. Once the formulation was disclosed in full to Skrin-
ska, without any restriction on its use, it had been re-
leased into the “public domain” for purposes of § 102(b).
Accordingly, we hold that Norsk Hydro put the inven-
tion in the asserted claims of the ’667 patent to public use.
We reverse the district court ruling to the contrary and
hold that the asserted claims of the ’667 patents are
invalid under § 102(b). 8
C. Other Issues Regarding ’667 Patent
Given our conclusion regarding § 102(b), it is unnec-
essary for us to reach the parties’ other arguments re-
garding the asserted claims of the ’667 patent. That is,
Appellants’ arguments that the asserted claims would
8 Because our decision does not depend on Skrin-
ska’s testimony that he used K-80 capsules in a clinical
trial, we need not and do not disturb the district court’s
credibility finding on that point. That Skrinska received
vials, that the formulation of K-80 was fully disclosed,
and that Skrinska tested the composition of the vials was
fully corroborated and the trial court did not find to the
contrary.
20 PRONOVA BIOPHARMA NORGE v. TEVA PHARMACEUTICALS
have been obvious under § 103, are unenforceable due to
inequitable conduct, or are not infringed are moot.
D. ’077 Patent
The ’077 patent expired in March of this year, even
before the court held oral argument in the case. Since
Pronova brings this suit pursuant to the provisions of the
Drug Price Competition and Patent Term Restoration Act,
seeking only prospective relief, any issues regarding
the ’077 patent are now moot.
IV. CONCLUSION
For the foregoing reasons, the judgment of the lower
court is reversed and the case is remanded with orders to
enter judgment in favor of appellants.
REVERSED AND REMANDED