Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc.

United States Court of Appeals
for the Federal Circuit
______________________
HELSINN HEALTHCARE S.A.,
Plaintiff-Appellee
v.
TEVA PHARMACEUTICALS USA, INC., TEVA
PHARMACEUTICAL INDUSTRIES, LTD.,
Defendants-Appellants
______________________
2016-1284, 2016-1787
______________________
Appeals from the United States District Court for the
District of New Jersey in Nos. 3:11-cv-03962-MLC-DEA,
3:11-cv-05579-MLC-DEA, 3:13-cv-05815-MLC-DEA,
Judge Mary L. Cooper.
______________________
Decided: May 1, 2017
______________________
JOSEPH M. O’MALLEY, JR., Paul Hastings LLP, New
York, NY, argued for plaintiff-appellee. Also represented
by ISAAC S. ASHKENAZI, ERIC WILLIAM DITTMANN, YOUNG
JIN PARK; STEPHEN BLAKE KINNAIRD, ANAND BIPIN PATEL,
Washington, DC; CHARLES M. LIZZA, Saul Ewing LLP,
Newark, NJ.
GEORGE C. LOMBARDI, Winston & Strawn LLP, Chica-
go, IL, argued for defendants-appellants. Also represented
by TYLER JOHANNES, JULIA MANO JOHNSON; STEFFEN
2 HELSINN HEALTHCARE S.A. v. TEVA
PHARMACEUTICALS USA, INC.
NATHANAEL JOHNSON, ANDREW CURTIS NICHOLS, JOVIAL
WONG, Washington, DC; KARL LEONARD, The Exoneration
Project, Chicago, IL.
WILLIAM ERNEST HAVEMANN, Appellate Staff, Civil
Division, United States Department of Justice, Washing-
ton, DC, argued for amicus curiae United States. Also
represented by MARK R. FREEMAN, BENJAMIN C. MIZER;
THOMAS W. KRAUSE, SCOTT WEIDENFELLER, JOSEPH
MATAL, JOSEPH GERARD PICCOLO, Office of the Solicitor,
United States Patent and Trademark Office, Alexandria,
VA.
MARK A. LEMLEY, Durie Tangri LLP, San Francisco,
CA, for amicus curiae 42 Intellectual Property Professors.
Also represented by ROBERT P. MERGES, Davis, CA.
RON D. KATZNELSON, Encinitas, CA, amicus curiae.
ROBERT ALLEN ARMITAGE, Marco Island, FL, for ami-
cus curiae Congressman Lamar Smith.
ANDREW BALUCH, Strain PLLC, Washington, DC, for
amicus curiae The Naples Roundtable, Inc. Also repre-
sented by LARRY L. SHATZER.
LYNN CAMPBELL TYLER, Barnes & Thornburg LLP,
Indianapolis, IN, for amicus curiae American Intellectual
Property Law Association. Also represented by MARK L.
WHITAKER, Morrison & Foerster LLP, Washington, DC.
JAMIE WISZ, Wilmer Cutler Pickering Hale and Dorr
LLP, Washington, DC, for amici curiae Pharmaceutical
Research and Manufacturers of America, Biotechnology
Innovation Organization. Also represented by ROBERT
MANHAS, THOMAS SAUNDERS.
______________________
HELSINN HEALTHCARE S.A. v. TEVA 3
PHARMACEUTICALS USA, INC.
Before DYK, MAYER, and O’MALLEY, Circuit Judges.
DYK, Circuit Judge.
Helsinn Healthcare S.A. (“Helsinn”) is the owner of
the four patents-in-suit directed to intravenous formula-
tions of palonosetron for reducing or reducing the likeli-
hood of chemotherapy-induced nausea and vomiting
(“CINV”).
Helsinn brought suit against Teva Pharmaceuticals
USA, Inc. and Teva Pharmaceutical Industries, Ltd.
(collectively, “Teva”) alleging that the filing of Teva’s
Abbreviated New Drug Application (“ANDA”) constituted
an infringement of various claims of those patents. Teva
defended, inter alia, on the ground that the asserted
claims were invalid under the on-sale bar provision of 35
U.S.C. § 102. The district court found that the patents-in-
suit were not invalid. With respect to three of the patents,
which are governed by the pre-Leahy-Smith America
Invents Act (“pre-AIA”) version of § 102, the district court
concluded that there was a commercial offer for sale
before the critical date, but that the invention was not
ready for patenting before the critical date. With respect
to the fourth patent, which is governed by the AIA version
of § 102, Pub. L. No. 112-29, § 3(b), 125 Stat. 284, 285–86
(2011), the district court concluded that there was no
commercial offer for sale because the AIA changed the
relevant standard and that, in any event, the invention
was not ready for patenting before the critical date.
We reverse. The asserted claims of the patents-in-suit
were subject to an invalidating contract for sale prior to
the critical date of January 30, 2002, and the AIA did not
change the statutory meaning of “on sale” in the circum-
stances involved here. The asserted claims were also
ready for patenting prior to the critical date.
4 HELSINN HEALTHCARE S.A. v. TEVA
PHARMACEUTICALS USA, INC.
BACKGROUND
Helsinn owns four patents, U.S. Patent Nos.
7,947,724 (“’724 patent”), 7,947,725 (“’725 patent”),
7,960,424 (“’424 patent”), and 8,598,219 (“’219 patent”)
(collectively, “the patents-in-suit”), directed to reducing
the likelihood of CINV. CINV is a serious side effect of
chemotherapy treatment.
The use of palonosetron to treat CINV was not new.
Indeed, U.S. Patent No. 5,202,333 (“’333 patent”) taught
that an intravenous formulation of palonosetron is “useful
in the prevention and treatment of emesis,” ’333 patent,
col. 9 ll. 56–57, including “emesis induced by . . . treat-
ment for cancer with . . . chemotherapy,” id. col. 10 ll. 7–9.
The ’333 patent is now expired. The patents-in-suit pur-
port to disclose novel intravenous formulations using
unexpectedly low concentrations of palonosetron that
were not taught by the prior art. All four of the patents-
in-suit claim priority to a provisional patent application
filed on January 30, 2003. The critical date for the on-sale
bar is one year earlier, January 30, 2002. The significance
of the critical date is that a sale of the invention before
that date can be invalidating. 1
Helsinn alleged infringement of claims 2 and 9 of the
’724 patent, claim 2 of the ’725 patent, claim 6 of the ’424
patent, and claims 1, 2, and 6 of the ’219 patent (collec-
tively, “the asserted claims”). Claim 2 of the ’725 patent is
representative of the asserted claims of the ’724, ’725, and
’424 patents.
1 The parties agree that the ’219 patent has the
same critical date as the pre-AIA patents for the on-sale
bar even though it is governed by the AIA. The one-year
grace period in the AIA is less protective than under pre-
AIA § 102(b) for reasons not relevant here.
HELSINN HEALTHCARE S.A. v. TEVA 5
PHARMACEUTICALS USA, INC.
2. A pharmaceutically stable solution for reducing
emesis or reducing the likelihood of emesis com-
prising:
a) 0.05 mg/mL palonosetron hydrochlo-
ride, based on the weight of the free
base, in a sterile injectable aqueous
carrier at a pH of from 4.5 to 5.5;
b) from 0.005 mg/mL to 1.0 mg/mL
EDTA; and
c) mannitol in an amount sufficient to
tonicify said solution, in a concentra-
tion of from about 10 mg/ml to about 80
mg/ml
’725 patent, col. 10 ll. 11–19.
Claim 1 is representative of the asserted claims of the
’219 patent.
1. A pharmaceutical single-use, unit-dose formu-
lation for intravenous administration to a human
to reduce the likelihood of cancer chemotherapy-
induced nausea and vomiting, comprising a 5 mL
sterile aqueous isotonic solution, said solution
comprising:
palonosetron hydrochloride in an amount
of 0.25 mg based on the weight of its free
base;
from 0.005 mg/mL to 1.0 mg/mL EDTA;
and
from 10 mg/mL to about 80 mg/mL manni-
tol,
wherein said formulation is stable at 24
months when stored at room temperature.
6 HELSINN HEALTHCARE S.A. v. TEVA
PHARMACEUTICALS USA, INC.
’219 patent, col. 10 ll. 2–12. The claims of the patents-in-
suit to some extent all express the same concepts in
different terms. For instance, the ’724, ’725, and ’424
patents claim a 0.05 mg/ml concentration of palonosetron,
which equates to a total dose of 0.25 mg when adminis-
tered in a 5 ml solution. The ’219 patent expressly claims
a fixed dose of 0.25 mg of palonosetron in a 5 ml solution.
It is undisputed that each asserted claim covers the
0.25 mg dose of palonosetron. In order to simplify the
relevant discussion, we refer to the patents as covering
the 0.25 mg dose.
In 1998, Helsinn acquired a license under the ’333 pa-
tent from Roche Palo Alto LLC (“Roche”) to palonosetron
and all intellectual property resulting from ongoing
palonosetron research. Roche and its predecessor, Syntex
(U.S.A.) Inc. (“Syntex”), had already conducted Phase I
and Phase II clinical trials. A Phase II trial—Study
2330—found that the 0.25 mg dose “was effective in
suppressing chemotherapy-induced emesis for 24 hours.”
J.A. 32, 1636. Helsinn then submitted safety and efficacy
protocols for Phase III clinical trials to FDA in early 2000,
proposing to study two dosages—0.25 mg and 0.75 mg. By
early 2001 the Phase III trials were ongoing but not yet
completed.
On April 6, 2001, almost two years before applying for
a patent, Helsinn and MGI Pharma, Inc. (“MGI”), an
oncology-focused pharmaceutical company that markets
and distributes in the United States, entered into two
agreements: (1) a License Agreement and (2) a Supply
and Purchase Agreement. These agreements were an-
nounced in a joint press release of the two corporations
and in MGI’s Form 8-K filing with the Securities and
Exchange Commission (“SEC”), which included partially-
redacted copies of both agreements. See MGI Pharma Inc.,
Current Report (Form 8-K) Ex. 99.1 (Apr. 25, 2001) [here-
inafter License Agreement]; MGI Pharma Inc., Current
HELSINN HEALTHCARE S.A. v. TEVA 7
PHARMACEUTICALS USA, INC.
Report (Form 8-K) Ex. 99.2 (Apr. 25, 2001) [hereinafter
Supply and Purchase Agreement].
Under the terms of the License Agreement, MGI
agreed to pay $11 million in initial payments to Helsinn,
plus additional future royalties on distribution of “prod-
ucts” in the United States. The parties agree that the
“products” covered by the License Agreement were
0.25 mg and 0.75 mg doses of palonosetron.
Under the Supply and Purchase Agreement, MGI
agreed to purchase exclusively from Helsinn, and Helsinn
agreed to supply MGI’s requirements of the 0.25 mg and
0.75 mg palonosetron products, or whichever of the two
dosages were approved for sale by FDA. The agreement
required MGI to submit purchase forecasts to Helsinn and
to place firm orders at least 90 days before delivery. It
also specified that such orders would be “subject to writ-
ten acceptance and confirmation by [Helsinn] before
becoming binding.” Supply and Purchase Agreement,
supra, art. 4.2. But, in the event that Helsinn were unable
to meet MGI’s firm orders and to the extent they fell
within the previously forecasted amount, Helsinn would
then be obligated to designate a third party manufacturer
to supply MGI with the product. The agreement specified
price (29% of the gross sales price by MGI with a mini-
mum of $28.50 per vial), method of payment (wire trans-
fer within 30 days of receipt of an invoice), and method of
delivery (DDU—which means delivery duty unpaid). See
Black’s Law Dictionary 481, 521 (10th ed. 2014) (defining
“DDU” and “delivery duty unpaid”).
The License Agreement made reference to the ongoing
clinical trials and stated that in the event that the results
were unfavorable and FDA did not approve the sale of
either dosage of the product, Helsinn could terminate the
agreement. If the License Agreement were terminated,
the Supply and Purchase Agreement would “terminate
8 HELSINN HEALTHCARE S.A. v. TEVA
PHARMACEUTICALS USA, INC.
automatically.” Supply and Purchase Agreement, supra,
art. 11.1.
All of the above information about the transaction
was publicly disclosed with two exceptions. The two
features of the agreements that were not publicly dis-
closed were the price terms and the specific dosage formu-
lations covered by the agreements—that is the 0.25 and
0.75 mg doses.
Helsinn admitted at oral argument that the agree-
ment was binding as of its effective date, April 6, 2001,
and that it would cover either or both of the 0.25 and
0.75 mg doses, subject to FDA approval. Helsinn also
agreed that, if the Phase III trials were successful and the
products were approved by FDA, then the agreement
obligated MGI to purchase and Helsinn to supply the
approved doses. But if FDA did not approve either dose,
then the agreement likewise would terminate automati-
cally with the License Agreement. As Helsinn stated, in
such a scenario “both parties [could] accept that fact and
walk away.” 2 Oral Arg. at 36:37–40,
http://oralarguments.cafc.uscourts.gov/default.aspx?fl=20
16-1284.mp3.
After the signing of the agreements, and still before
the critical date, Helsinn prepared preliminary statistical
analysis of the earliest Phase III trial on January 7, 2002.
The data showed that 81% of patients who received the
0.25 mg dose of palonosetron experienced relief from
CINV for 24 hours. After the critical date of January 30,
2 Even if FDA approval were not an express condi-
tion of a contract for sale of a pharmaceutical, there would
be a strong argument for implying such a condition since
federal law prohibits the introduction of new drugs into
interstate commerce without FDA approval. See 21 U.S.C.
§ 355.
HELSINN HEALTHCARE S.A. v. TEVA 9
PHARMACEUTICALS USA, INC.
2002, Helsinn submitted its preliminary Phase III data to
FDA in early February. In September 2002, after the
successful completion of all Phase III trials, Helsinn filed
its New Drug Application for the 0.25 mg dose, but did not
seek FDA approval of the 0.75 mg dose. On January 30,
2003, Helsinn filed a provisional patent application cover-
ing the 0.25 mg dose (and also the 0.75 mg dose). FDA
issued approval for the 0.25 dose on July 2003. From 2005
to 2006, Helsinn filed three patent applications and these
issued as the ’724, ’725, and ’424 patents. In May 2013,
after the effective date of the AIA, Helsinn filed a fourth
patent application which issued as the ’219 patent. All
four patents cover the 0.25 mg dose, are listed in FDA’s
“Orange Book,” and claim priority to the January 30, 2003
date of the provisional application.
In 2011, Teva filed an ANDA seeking FDA approval to
market a generic 0.25 mg palonosetron product. 3 Teva’s
ANDA filing included a Paragraph IV certification that
the claims of the patents-in-suit were invalid and/or not
infringed. Helsinn then brought suit under the Hatch-
3 We treat this case as involving only the 0.25 mg
dose of palonosetron. Teva also filed an ANDA for a 0.075
mg dose of palonosetron in 1.5 ml of solution. It is undis-
puted that this product has a concentration of 0.05 mg/ml
and falls within the asserted claims of the ’724, ’725, and
’424 patents. There is no contention that the 0.075 mg
dose was on sale before the critical date or that the Sup-
ply and Purchase Agreement covered the 0.075 mg dose.
But the parties agree that the same claims cover both the
0.25 mg dose and the 0.075 mg dose, and the case stands
or falls on whether the asserted claims covering the 0.25
mg dose are invalid under the on-sale bar. In other words,
if the claims covering the 0.25 mg dose are invalid, there
are not valid and asserted claims covering the 0.075 mg
dose.
10 HELSINN HEALTHCARE S.A. v. TEVA
PHARMACEUTICALS USA, INC.
Waxman Act, 35 U.S.C. § 271(e)(2)(A), alleging infringe-
ment of the patents-in-suit by the ANDA filing.
The district court held a bench trial. The district court
held that Teva’s 0.25 mg dose infringed all of the patents-
in-suit. In addressing the on-sale issue, the court applied
the two-step framework of Pfaff v. Wells Electronics, Inc.,
525 U.S. 55 (1998), which requires that there was a sale
or offer for sale and that the claimed invention was ready
for patenting for the on-sale bar under 35 U.S.C. § 102 to
apply. As to the ’724, ’725, and ’424 patents, the court
found that pre-AIA law applied under § 102(b) and that
the MGI Supply and Purchase Agreement was a contract
for a future sale of a commercial product embodying the
0.25 mg dose and therefore constituted a sale under
§ 102(b). But, the court found that the claimed invention
was not reduced to practice before the critical date of
January 30, 2002, and therefore was not ready for patent-
ing under the second prong of Pfaff. The district court did
not address whether the invention was ready for patent-
ing on the alternative theory that Teva had shown that
the inventor had created enabling descriptions before the
critical date. See Pfaff, 525 U.S. at 67–68.
As to the ’219 patent governed by the AIA, the court
held that the AIA changed the meaning of the on-sale bar
and § 102(a)(1) now “requires a public sale or offer for sale
of the claimed invention.” J.A. 113 (emphasis added). The
court concluded that, to be “public” under the AIA, a sale
must publicly disclose the details of the invention. The
court found that the MGI Supply and Purchase Agree-
ment did not constitute a public sale or commercial offer
for sale because, although it disclosed the sale agreement
and substance of the transaction, it failed to publicly
disclose the 0.25 mg dose. The ’219 patent also was not
ready for patenting before the critical date. Therefore, the
district court found that the asserted claims of the four
patents were not invalid.
HELSINN HEALTHCARE S.A. v. TEVA 11
PHARMACEUTICALS USA, INC.
Teva appeals. We have jurisdiction under 28 U.S.C.
§ 1295(a).
DISCUSSION
Application of the on-sale bar under 35 U.S.C. § 102 is
ultimately a question of law that we review de novo.
Robotic Vision Sys., Inc. v. View Eng’g, Inc., 249 F.3d
1307, 1310 (Fed. Cir. 2001). The factual findings underly-
ing the district court’s conclusion are reviewed for clear
error. Id. Under Pfaff, application of the on-sale bar
requires that (1) “the product must be the subject of a
commercial offer for sale” and (2) “the invention must be
ready for patenting.” 525 U.S. at 67.
I
We first address whether the invention of the ’724,
’725, and ’424 patents was subject to a sale or offer for
sale prior to the critical date. We recently had occasion to
address the pre-AIA on-sale bar en banc in Medicines Co.
v. Hospira, Inc., 827 F.3d 1363 (Fed. Cir. 2016). There we
established a framework for determining whether there is
an offer for sale. We explained that the question must be
“analyzed under the law of contracts as generally under-
stood” and “must focus on those activities that would be
understood to be commercial sales and offers for sale ‘in
the commercial community.’” Id. at 1373 (quoting Grp.
One, Ltd. v. Hallmark Cards, Inc., 254 F.3d 1041, 1047
(Fed. Cir. 2001)). While acknowledging that it is not of
“talismanic significance” to our inquiry, “[a]s a general
proposition, we will look to the Uniform Commercial Code
(‘UCC’) to define whether . . . a communication or series of
communications rises to the level of a commercial offer for
sale.” 827 F.3d at 1373 (alteration in original) (quoting
Grp. One, 254 F.3d at 1047). A sale occurs when there is a
“contract between parties to give and to pass rights of
property for consideration which the buyer pays or prom-
ises to pay the seller for the thing bought or sold.” Trad-
12 HELSINN HEALTHCARE S.A. v. TEVA
PHARMACEUTICALS USA, INC.
ing Techs. Int’l, Inc. v. eSpeed, Inc., 595 F.3d 1340, 1361
(Fed. Cir. 2010) (internal quotation marks omitted).
In Medicines we also pointed to other factors that are
important to this analysis, but noted that, like the UCC
itself, none is determinative individually. We noted that
the absence of the passage of title, the confidential nature
of a transaction, and the absence of commercial market-
ing of the invention all counsel against applying the on-
sale bar. Id. at 1375–76. We deemed these factors im-
portant because they helped shed light on whether a
transaction would be understood “in the commercial
community” to constitute a commercial offer for sale. Id.
at 1373 (quoting Grp. One, 254 F.3d at 1047). But those
additional factors are not at issue in this case. There is no
suggestion that the Supply and Purchase Agreement did
not involve transfer of title; it expressly contemplated it.
And, while certain details were redacted from the publicly
disclosed copy of the Supply and Purchase Agreement,
Helsinn does not argue that the transaction itself between
Helsinn and MGI remained confidential. Helsinn also
commercially marketed its invention before the critical
date. It publicly sought “marketing partners for its pa-
tented [palonosetron] product,” J.A. 63–64 n.26, and
ultimately contracted with MGI “to distribute, promote,
market, and sell” the claimed invention, J.A. 2255.
We agree with the district court that there was a sale
for purposes of pre-AIA § 102(b) prior to the critical date
because there was a sale of the invention under the law of
contracts as generally understood.
Helsinn admits that the Supply and Purchase Agree-
ment was binding as of its effective date, April 6, 2001,
and that, if FDA approved the 0.25 mg dose and/or the
0.75 mg dose of palonosetron, the agreement obligated
Helsinn to sell and MGI to purchase those products. The
HELSINN HEALTHCARE S.A. v. TEVA 13
PHARMACEUTICALS USA, INC.
Supply and Purchase Agreement bears all the hallmarks
of a commercial contract for sale. 4 It obligated MGI to
purchase exclusively from Helsinn and obligated Helsinn
to supply MGI’s requirements of the 0.25 and 0.75 mg
doses if approved by FDA.
The agreement here included other specific terms,
such as price, method of payment, and method of delivery.
Even though MGI’s firm orders pursuant to the agree-
ment were ostensibly “subject to written acceptance and
confirmation by [Helsinn] before becoming binding,” J.A.
2260, Helsinn was nonetheless obligated to meet or desig-
nate a third party manufacturer to meet MGI’s firm
orders. The public 8-K filing described the Supply and
Purchase Agreement as obligating Helsinn to supply
MGI’s “requirements of finished product.” MGI Pharma
Inc., Current Report (Form 8-K), at 2 (Apr. 25, 2001).
Under our decision in Enzo Biochem, Inc. v. Gen-Probe,
Inc., 424 F.3d 1276 (Fed. Cir. 2005), the fact that an
agreement covered one party’s requirements as opposed to
a specified quantity does not prevent application of the
on-sale bar. Id. at 1281–82.
Despite these facts, Helsinn argues that the Supply
and Purchase Agreement is not invalidating because at
the critical date it was uncertain whether FDA would
4 See, e.g., Merck & Cie v. Watson Labs., Inc., 822
F.3d 1347, 1351 (Fed. Cir. 2016) (offer “provid[ed] essen-
tial price, delivery, and payment terms”); Cargill, Inc. v.
Canbra Foods, Ltd., 476 F.3d 1359, 1369 (Fed. Cir. 2007)
(offer “explicitly set[] forth an amount . . . to be delivered
to P&G, at a specified unit price, and under a standard
contract designation, FOB (free on board)”); Linear Tech.
Corp. v. Micrel, Inc., 275 F.3d 1040, 1052 (Fed. Cir. 2001)
(offers “included quantity terms and clearly identified the
requested product”).
14 HELSINN HEALTHCARE S.A. v. TEVA
PHARMACEUTICALS USA, INC.
approve the 0.25 mg dose, and FDA approval was a condi-
tion precedent to the sale.
There can be no real dispute that an agreement con-
tracting for the sale of the claimed invention contingent
on regulatory approval is still a commercial sale as the
commercial community would understand that term. The
UCC expressly provides that a “purported present sale of
future goods . . . operates as a contract to sell.” UCC § 2–
105(2) (defining “future goods” as “[g]oods which are not
both existing and identified”). This is true irrespective of
whether those future goods have yet to receive necessary
regulatory approval. A contract for sale that includes a
condition precedent is a valid and enforceable contract.
See BG Grp., PLC v. Republic of Argentina, 134 S. Ct.
1198, 1207 (2014). Indeed, conditions precedent such as
regulatory approval are a basic feature of contract law. 5
See, e.g., 25 Williston on Contracts § 67:73, at 462 (4th ed.
2013) (“Particular construction or development projects
may also require specific governmental or regulatory
approvals as conditions precedent to the consummation of
the project.”); 8 Corbin on Contracts § 31.11, at 99–101
(1999) (“In many contracts it is expressly provided that
some act of a third person shall be a condition of a promi-
sor’s duty . . . [such as a duty] to buy property contingent
on a zoning board’s approval . . . .”).
It has been implicit in our prior opinions that the ab-
sence of FDA or other regulatory approval before the
5 “A condition precedent is either an act of a party
that must be performed or a certain event that must
happen before a contractual right accrues or a contractual
duty arises.” 13 Williston on Contracts § 38:7, at 434–37
(4th ed. 2013); see also id. § 38:7, at 434–46; Restatement
(Second) of Contracts § 224 (1981); 2 Anderson U.C.C. § 2-
301:11, at 149–52 (3d. ed. 2013); 8 Corbin on Contracts
§§ 30.6–30.7, at 9–15 (1999).
HELSINN HEALTHCARE S.A. v. TEVA 15
PHARMACEUTICALS USA, INC.
critical date does not prevent a sale or offer for sale from
triggering the on-sale bar. For instance, in Enzo, we
applied the on-sale bar even though the contract for sale
covered the buyer’s reasonable requirements for “per-
form[ing] all preclinical and clinical studies,” by defini-
tion before FDA approval, because the “claimed invention,
the polynucleotide probe, is a tangible item or product
that can be sold or offered for sale.” 424 F.3d at 1279,
1282 (emphasis added). Similarly, in C.R. Bard, Inc. v.
M3 Sys., Inc., 157 F.3d 1340 (Fed. Cir. 1998), we affirmed
a jury verdict of invalidity based on a sale even though
the product sold was subject to regulatory approval. There
was no majority opinion, but through two separate indi-
vidual opinions a majority of the panel held that the on-
sale bar applied. Id. at 1354 n.4. One opinion explicitly
addressed the patentee’s argument that the offer to sell
did not trigger the statutory bar because “FDA approval
had not been obtained” before the critical date, concluding
that “FDA approval is not required before a sale can bar
patent rights.” Id. at 1376 (Mayer, C.J.). The dissent
recognized that the majority was rejecting the argument
that the product was not on sale because at the time of
the sale it was “still being developed [and] tested” for FDA
approval. Id. at 1357 (Newman, J.). Thus, while the
absence of FDA approval may be a relevant consideration
depending upon the other circumstances surrounding a
transaction relating to a pharmaceutical formulation, the
fact that a transaction was subject to regulatory approval
would not, absent more, prevent it from being a sale for
purposes of the on-sale bar. We do not find that it does so
here. This is not a case like Elan Corp., PLC v. Andrx
Pharm., Inc., 366 F.3d 1336 (Fed. Cir. 2004), where the
purported offer concerned a product when and if it had
been developed, and there was no price or quantity term.
Id. at 1341.
Helsinn also argues that, even if the agreement of
sale for the 0.25 mg dose could be an invalidating sale, the
16 HELSINN HEALTHCARE S.A. v. TEVA
PHARMACEUTICALS USA, INC.
agreement was uncertain because it covered the 0.25 mg
dose, the 0.75 mg dose, and both doses. Helsinn is correct
that the agreement covered either dose or both doses.
Under established contract law, even if the agreement
had given MGI, as the purchaser, the option of choosing
between the two doses, as opposed to making the decision
dependent on actions of third party regulators, there
would still be a binding agreement. 6
In any event, here there is no ambiguity introduced by
the provision for the purchase of either or both doses. This
contract is indistinguishable from a situation involving
two otherwise identical contracts, one covering the
0.25 mg dose and the other covering the 0.75 mg dose,
each contingent on FDA approval. It is clear that these
two hypothetical agreements would individually trigger
the on-sale bar for the 0.25 mg dose and the 0.75 mg dose,
respectively. It cannot be that combining them into a
single agreement somehow thwarts application of the on-
sale bar. We see no valid reason based in contract law,
patent law, or otherwise, to distinguish between a single
agreement that covers two potential products—like the
one between Helsinn and MGI—and two separate agree-
ments, one for each product.
Our en banc decision in Medicines also made clear
that the offer or contract for sale must unambiguously
place the invention on sale, as defined by the patent’s
claims. 827 F.3d at 1374. As discussed below, that is
clearly the case here. The Supply and Purchase Agree-
6 See, e.g., 1 Corbin on Contracts § 4.6 (citing Dolly
Parker Motors, Inc. v. Stinson, 245 S.W.2d 820 (Ark.
1952); Delaney v. Shellabarger, 353 P.2d 903 (Nev. 1960);
Langer v. Lemke, 49 N.W.2d 641 (N.D. 1951); Calder v.
Third Judicial Dist. Court, 273 P.2d 168 (Utah 1954));
C.W. Hull Co. v. Westerfield, 186 N.W. 992, 994 (Neb.
1922).
HELSINN HEALTHCARE S.A. v. TEVA 17
PHARMACEUTICALS USA, INC.
ment described the palonosetron formulation in detail and
Helsinn does not assert that the 0.25 mg dose described in
the Supply and Purchase Agreement does not embody the
asserted claims of the patents-in-suit. The fact that the
contract made the selection of which doses to supply
contingent on regulatory approval did not create an
ambiguity with respect to whether what was on sale fell
within the bounds of the patents’ claims.
At oral argument for the first time, Helsinn contended
that applying the on-sale bar would be unfair because it
would distinguish between vertically-integrated manufac-
turers that have in-house distribution capacity and small-
er entities like Helsinn that must contract for distribution
services from a third party. Helsinn asserts that Medi-
cines stands for the proposition that we should not allow
commercial activities to be invalidating if those same
activities could be performed in-house without triggering
the on-sale bar. Such a broad principle would largely
eviscerate the on-sale bar provision except as to sales to
end users; that was not the holding of Medicines. There
we concluded that “stockpiling,” including purchases from
a supplier, “does not trigger the on-sale bar.” 827 F.3d at
1374. We also expressed concern over a policy of “penaliz-
ing a company for relying, by choice or by necessity, on
the confidential services of a contract manufacturer.” Id.
at 1378. But the concern that Medicines focused on is not
applicable here. Helsinn did not contract for MGI’s confi-
dential marketing or distribution services as Medicines
contracted for Ben Venue’s confidential manufacturing
services. Instead, the Supply and Purchase Agreement
between Helsinn and MGI unambiguously contemplated
the sale by Helsinn of MGI’s requirements of the claimed
invention.
It is clear that the Supply and Purchase Agreement
constituted a commercial sale or offer for sale for purposes
of § 102(b) as to the asserted claims of the ’724, ’725, and
’424 patents.
18 HELSINN HEALTHCARE S.A. v. TEVA
PHARMACEUTICALS USA, INC.
II
We next address whether the AIA changed the mean-
ing of the on-sale bar under 35 U.S.C. § 102 so that there
was no qualifying sale as to the ’219 patent. The parties
agree that the ’219 patent is governed by the AIA. See 35
U.S.C. § 102(a)(1); AIA, Pub. L. No. 112-29, § 3(n), 125
Stat. 284, 293 (2011).
Before the AIA, § 102(b) barred the patentability of an
invention that was “patented or described in a printed
publication in this or a foreign country or in public use or
on sale in this country, more than one year prior to the
date of the application for patent.” 35 U.S.C. § 102(b)
(2006) (emphasis added). Under that earlier provision, we
concluded that, although confidentiality weighs against
application of the on-sale bar, see Medicines, 827 F.3d at
1376, 1377 n.2, that fact alone is not determinative. 7 For
7 See, e.g., Woodland Trust v. Flowertree Nursery,
Inc., 148 F.3d 1368, 1370 (Fed. Cir. 1998) (stating that
“an inventor’s own prior commercial use, albeit kept
secret, may constitute a public use or sale under § 102(b),
barring him from obtaining a patent”); J.A. LaPorte, Inc.
v. Norfolk Dredging Co., 787 F.2d 1577, 1581–83 (Fed.
Cir. 1986) (stating that the on-sale bar “is not limited to
sales by the inventor or one under his control, but may
result from activities of a third party” and rejecting the
argument that “secret commercialization by a third party”
is not invalidating since “the invention . . . was discovera-
ble from the device which was sold” and the “device . . .
embodie[d] the invention” (emphasis omitted)); In re
Caveney, 761 F.2d 671, 675 (Fed. Cir. 1985) (rejecting the
argument that a secret sale by a third party was not
invalidating because “sales or offers by one person of a
claimed invention will bar another party from obtaining a
patent”); see also 2 R. Carl Moy, Moy’s Walker on Patents
§ 8:228 (4th ed. 2016) (“[E]ven a private sale or offer for
HELSINN HEALTHCARE S.A. v. TEVA 19
PHARMACEUTICALS USA, INC.
instance, in In re Caveney, a British company offered to
sell the claimed invention to an American company that
would be its exclusive seller in the United States before
the critical date. In re Caveney, 761 F.2d 671, 673–74
(Fed. Cir. 1985). The court rejected the argument that a
sale or offer for sale did not trigger the on-sale bar when it
had been “kept secret from the trade,” concluding that
“sales or offers by one person of a claimed invention . . .
bar another party from obtaining a patent if the sale or
offer to sell is made over a year before the latter’s filing
date.” Id. at 675.
By enacting the AIA, Congress amended § 102 to bar
the patentability of an “invention [that] was patented,
described in a printed publication, or in public use, on
sale, or otherwise available to the public before the effec-
tive filing date of the claimed invention.” 35 U.S.C.
§ 102(a)(1) (emphasis added).
Teva and various amici assert that by reenacting the
existing statutory term, “on sale,” Congress did not
change the meaning of the on-sale bar or disturb settled
law. Helsinn, the government, and other amici argue that
the AIA changed the law by adding the “otherwise availa-
ble to the public” phrase. They argue that the on-sale bar
now does not encompass secret sales and requires that a
sale make the invention available to the public in order to
trigger application of the on-sale bar. Apart from the
additional statutory language, this argument primarily
relies on floor statements made by individual members of
Congress. While recognizing that such floor statements
are typically not reliable as indicators of congressional
intent, see, e.g., Exxon Mobil Corp. v. Allapattah Servs.,
sale can be a barring event.”); 3 John Gladstone Mills III
et al., Pat. L. Fundamentals § 10:12 (2d ed. 2017) (“An
invention is ‘on sale’ even though the only sale was a
‘private’ one.”).
20 HELSINN HEALTHCARE S.A. v. TEVA
PHARMACEUTICALS USA, INC.
Inc., 545 U.S. 546, 568 (2005), they argue that here we
should look to the floor statements to determine the
meaning of the provision. These floor statements include
material such as the following:
[S]ubsection 102(a) was drafted in part to do away
with precedent under current law that private of-
fers for sale or private uses or secret processes
practiced in the United States that result in a
product or service that is then made public may be
deemed patent-defeating prior art. That will no
longer be the case.
157 Cong. Rec. 3415 (2011) (remarks of Sen. Leahy)
(emphasis added).
[T]he current on-sale bar imposes penalties not
demanded by any legitimate public interest. There
is no reason to fear ‘commercialization’ that mere-
ly consists of a secret sale or offer for sale but that
does not operate to disclose the invention to the
public. . . . The present bill’s new section 102(a)
precludes extreme results such as these . . . .
157 Cong. Rec. 3424 (2011) (remarks of Sen. Kyl) (empha-
sis added). 8
8 See also 157 Cong. Rec. 3423 (2011) (remarks of
Sen. Kyl) (“The word ‘otherwise’ makes clear that the
preceding clauses describe things that are of the same
quality or nature . . . . As the committee report notes at
page 9, ‘the phrase “available to the public” is added to
clarify the broad scope of relevant prior art, as well as to
emphasize the fact that it . . . must be publicly availa-
ble.’”); 157 Cong. Rec. 9782 (2011) (remarks of Sen. Smith)
(“[C]ontrary to current precedent, in order to trigger the
bar in the new 102(a) in our legislation, an action must
HELSINN HEALTHCARE S.A. v. TEVA 21
PHARMACEUTICALS USA, INC.
We decline the invitation by the parties to decide this
case more broadly than necessary. At most the floor
statements show an intent “to do away with precedent
under current [§ 102] law,” 157 Cong. Rec. 3415 (2011)
(remarks of Sen. Leahy). Such precedent had held certain
secret uses to be invalidating under the “public use” prong
of § 102(b). Senator Kyl explicitly referenced cases such as
Egbert v. Lippman, 104 U.S. 333 (1881), Beachcombers
International, Inc. v. Wildewood Creative Products, Inc.,
31 F.3d 1154 (Fed. Cir. 1994), and JumpSport, Inc. v.
Jumpking, Inc., Nos. 05–1182, 05–1196, 05–1197, 2006
WL 2034498 (Fed. Cir. July 21, 2006), and stated that
“new section 102(a) precludes extreme results such as
these.” 157 Cong. Rec. 3424 (2011) (remarks of Sen. Kyl).
Each of those cases involved a public use where the inven-
tion was not, as a result of the use, disclosed to the public.
This public use issue is not before us, and we decline to
address it.
The floor statements do not identify any sale cases
that would be overturned by the amendments. Even if the
floor statements were intended to overrule those secret or
confidential sale cases discussed above and cited in foot-
note 7, that would have no effect here since those cases
were concerned entirely with whether the existence of a
sale or offer was public. Here, the existence of the sale—
i.e., the Supply and Purchase Agreement between Helsinn
and MGI—was publicly announced in MGI’s 8-K filing
with the SEC. The 8-K filing also included a copy of the
contract for sale as an attachment, albeit partially redact-
ed. Detailed information about palonosetron, its benefits
and uses in treating CINV were also disclosed. The
statements disclosed the chemical structure of palono-
setron and specified that the covered products were
make the patented subject matter ‘available to the public’
before the effective filing date.”).
22 HELSINN HEALTHCARE S.A. v. TEVA
PHARMACEUTICALS USA, INC.
“pharmaceutical preparations for human use in [intrave-
nous] dosage form, containing [palonosetron] as an active
ingredient.” Supply and Purchase Agreement, supra, art.
1.9. 9 And, as described above, the agreements disclosed
all the pertinent details of the transaction other than the
price and dosage levels.
Helsinn argues that the AIA did more than overrule
the “secret sale” cases, and relies on the “otherwise avail-
able to the public” language in the statute and the floor
statements. Helsinn argues that those statements suggest
that the on-sale bar does not apply unless the sale “dis-
close[s] the invention to the public” before the critical
date. 157 Cong. Rec. 3424 (2011) (remarks of Sen. Kyl). It
urges that since the 0.25 mg dose was not disclosed, the
invention was not disclosed and the on-sale bar does not
apply. The suggestion is that Congress required that the
details of the claimed invention be publicly disclosed
before the on-sale bar is triggered.
Requiring such disclosure as a condition of the on-sale
bar would work a foundational change in the theory of the
statutory on-sale bar. Indeed, the seminal Supreme Court
9 The joint April 10, 2001 press release stated that
“[p]alonosetron is a potent and selective 5-HT3 antagonist
with an extended half-life, in Phase 3 development for the
prevention of chemotherapy-induced nausea and vomiting
(CINV).” MGI Pharma Inc., Current Report (Form 8-K)
Ex. 99.5, at 1 (Apr. 25, 2001). It also disclosed that, once
launched, it would “be one of four products competing in
the $1 billion North American market for 5-HT3 antago-
nists . . . [and its] extended half-life . . . as compared to
the other agents and the results of Phase 2 trials as-
sessing efficacy beyond 24 hours differentiate[] palono-
setron from the three currently marketed 5-HT3
antagonists indicated for CINV.” Id. at 2.
HELSINN HEALTHCARE S.A. v. TEVA 23
PHARMACEUTICALS USA, INC.
decision in Pennock addressed exactly such a situation10—
the public sale of an item but the withholding from “the
public the secrets of [the] invention.” Pennock v. Dialogue,
27 U.S. (2 Pet.) 1, 19 (1829). Failing to find such a sale
invalidating, said the Court, “would materially retard the
progress of science and the useful arts, and give a premi-
um to those who should be least prompt to communicate
their discoveries.” Id.
So too under our cases, an invention is made available
to the public when there is a commercial offer or contract
to sell a product embodying the invention and that sale is
made public. Our cases explicitly rejected a requirement
that the details of the invention be disclosed in the terms
of sale. See RCA Corp. v. Data Gen. Corp., 887 F.2d 1056,
1060 (Fed. Cir. 1989), overruled in part on other grounds
by Grp. One, 254 F.3d at 1048 (rejecting the argument
“that the bid documents themselves must disclose the
invention with respect to all claim elements” since that is
“clearly not legally correct” and there can be “a definite
10 Pennock v. Dialogue, 27 U.S. (2 Pet.) 1, 19 (1829)
(“If an inventor should be permitted to hold back from the
knowledge of the public the secrets of his invention; if he
should for a long period of years retain the monopoly, and
make, and sell his invention publicly, and thus gather the
whole profits of it, relying upon his superior skill and
knowledge of the structure; and then, and then only,
when the danger of competition should force him to secure
the exclusive right, he should be allowed to take out a
patent, and thus exclude the public from any farther use
than what should be derived under it during his fourteen
years; it would materially retard the progress of science
and the useful arts, and give a premium to those who
should be least prompt to communicate their discover-
ies.”).
24 HELSINN HEALTHCARE S.A. v. TEVA
PHARMACEUTICALS USA, INC.
offer for sale or a sale of a claimed invention even though
no details are disclosed”).
A primary rationale of the on-sale bar is that publicly
offering a product for sale that embodies the claimed
invention places it in the public domain, regardless of
when or whether actual delivery occurs. 11 The patented
product need not be on-hand or even delivered prior to the
critical date to trigger the on-sale bar. 12 And, as previous-
11 See, e.g., Pfaff, 525 U.S. at 64 (Ҥ 102 of the Patent
Act serves as a limiting provision, both excluding ideas
that are in the public domain from patent protection and
confining the duration of the monopoly to the statutory
term. . . . A similar reluctance to allow an inventor to
remove existing knowledge from public use undergirds
the on-sale bar.”); Merck & Cie, 822 F.3d at 1355 n.4
(“One of the primary purposes of the on-sale bar is to
prohibit the withdrawal of inventions that have been
placed into the public domain through commercializa-
tion.” (internal quotation marks omitted) (quoting Abbott
Labs. v. Geneva Pharm., Inc., 182 F.3d 1315, 1319 (Fed.
Cir. 1999))); J.A. LaPorte, 787 F.2d at 1583 (“The date of
the purchase agreement is, therefore, the effective date on
which the invention became part of the public domain.
That delivery of the device embodying the invention
occurred later is immaterial.”).
12 See, e.g., Pfaff, 525 U.S. at 58, 67 (applying the on-
sale bar where the sale order was not filled until after the
critical date); STX, LLC v. Brine, Inc., 211 F.3d 588, 590
(Fed. Cir. 2000) (same); Buildex Inc. v. Kason Indus., Inc.,
849 F.2d 1461, 1464 (Fed. Cir. 1988) (“Proof of delivery
before the critical date would have been conclusive in this
case, but it is not necessary to holding that the device was
on sale before then.”); Robbins Co. v. Lawrence Mfg. Co.,
482 F.2d 426, 431 (9th Cir. 1973) (“A simple placing on
sale is sufficient to establish the ‘on sale’ defense—even
HELSINN HEALTHCARE S.A. v. TEVA 25
PHARMACEUTICALS USA, INC.
ly noted, we have never required that a sale be consum-
mated or an offer accepted for the invention to be in the
public domain and the on-sale bar to apply, nor have we
distinguished sales from mere offers for sale. 13 We have
also not required that members of the public be aware
that the product sold actually embodies the claimed
invention. For instance, in Abbott Laboratories v. Geneva
Pharmaceuticals, Inc., 182 F.3d 1315 (Fed. Cir. 1999), at
the time of the sale, neither party to the transaction knew
an executory contract under which the patented matter is
delivered after the critical date.”).
13 See, e.g., Pfaff, 525 U.S. at 67 (“[A]cceptance of the
purchase order prior to April 8, 1981, makes it clear that
. . . an offer had been made.”); Merck & Cie, 822 F.3d at
1352 (“An offer to sell is sufficient to raise the on-sale bar,
regardless of whether that sale is ever consummated.”);
Hamilton Beach Brands, Inc. v. Sunbeam Prods., Inc., 726
F.3d 1370, 1374, 1377 (Fed. Cir. 2013) (“An actual sale is
not required for the activity to be an invalidating com-
mercial offer for sale.”); Cargill, 476 F.3d at 1370 (“There
is no requirement that the sale be completed.”); Scaltech,
Inc. v. Retec/Tetra, LLC, 269 F.3d 1321, 1328 (Fed. Cir.
2001) (“An offer for sale does not have to be accepted to
implicate the on sale bar.”); A.B. Chance Co. v. RTE Corp.,
854 F.2d 1307, 1311 (Fed. Cir. 1988) (“A single offer to sell
is enough to bar patentability whether or not the offer is
accepted.”); Buildex, 849 F.2d at 1464 (“It is not necessary
that a sale be consummated for the bar to operate.”); In re
Theis, 610 F.2d 786, 791 (CCPA 1979) (“For § 102(b) to
apply, it is not necessary that a sale be consummated.”);
Mfg. Research Corp. v. Graybar Elec. Co., 679 F.2d 1355,
1362 (11th Cir. 1982) (“The statutory on sale bar applies
when the invention that is the subject of a patent applica-
tion is merely offered for sale; there is no requirement
that a sale be consummated before the statutory bar
attaches.”).
26 HELSINN HEALTHCARE S.A. v. TEVA
PHARMACEUTICALS USA, INC.
whether the product sold embodied the claimed invention
and had no easy way to determine what the product was.
Id. at 1317–18.
Thus, our prior cases have applied the on-sale bar
even when there is no delivery, when delivery is set after
the critical date, or, even when, upon delivery, members
of the public could not ascertain the claimed invention.
There is no indication in the floor statements that these
members intended to overrule these cases. In stating that
the invention must be available to the public they evi-
dently meant that the public sale itself would put the
patented product in the hands of the public. Senator Kyl
himself seems to have agreed with this proposition,
stating explicitly that “once a product is sold on the
market, any invention that is inherent to the product
becomes publicly available prior art and cannot be pa-
tented.” 157 Cong. Rec. 3423 (2011) (remarks of Sen.
Kyl). 14 There are no floor statements suggesting that the
sale or offer documents must themselves publicly disclose
the details of the claimed invention before the critical
date. If Congress intended to work such a sweeping
change to our on-sale bar jurisprudence and “wished to
repeal . . . [these prior] cases legislatively, it would do so
by clear language.” Dir., OWCP v. Perini N. River Assocs.,
459 U.S. 297, 321 (1983).
14 Senator Kyl quoted our anticipation decision in
Rosco, Inc. v. Mirror Lite Co., 304 F.3d 1373 (Fed. Cir.
2002). “Under the doctrine of inherency, if an element is
not expressly disclosed in a prior art reference, the refer-
ence will still be deemed to anticipate a subsequent claim
if the missing element is necessarily present in the thing
described in the reference, and that it would be so recog-
nized by persons of ordinary skill.” 157 Cong. Rec. 3423
(2011) (remarks of Sen. Kyl) (internal quotation marks
omitted) (quoting Rosco, 304 F.3d at 1380).
HELSINN HEALTHCARE S.A. v. TEVA 27
PHARMACEUTICALS USA, INC.
We conclude that, after the AIA, if the existence of the
sale is public, the details of the invention need not be
publicly disclosed in the terms of sale. For the reasons
already stated, the Supply and Purchase Agreement
between Helsinn and MGI constituted a sale of the
claimed invention—the 0.25 mg dose—before the critical
date, and therefore both the pre-AIA and AIA on-sale bars
apply. We do not find that distribution agreements will
always be invalidating under § 102(b). We simply find
that this particular Supply and Purchase Agreement is.
III
We finally address whether the invention was ready
for patenting as of the critical date of January 30, 2002.
Under Pfaff, there are at least two ways in which an
invention can be shown to be ready for patenting: “by
proof of reduction to practice before the critical date; or by
proof that prior to the critical date the inventor 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.” Pfaff, 525 U.S. at 67–68.
We conclude that the invention here was ready for patent-
ing because it was reduced to practice before the critical
date, and we need not address the alternative enablement
approach, not addressed by the district court. 15
A. Reduction to Practice
An invention is reduced to practice when “the inven-
tor (1) constructed an embodiment . . . that met all the
limitations and (2) determined that the invention would
work for its intended purpose.” In re Omeprazole Patent
Litig., 536 F.3d 1361, 1373 (Fed. Cir. 2008) (internal
quotation marks and citations omitted) (citing Z4 Techs.,
Inc. v. Microsoft Corp., 507 F.3d 1340, 1352 (Fed. Cir.
2007)). Reduction to practice occurs if “the claimant had
15 See J.A. 130 n.53.
28 HELSINN HEALTHCARE S.A. v. TEVA
PHARMACEUTICALS USA, INC.
possession of the subject matter of the [claim] and that it
was shown or known to work for its intended purpose.” 16
Streck, Inc. v. Research & Diagnostic Sys., Inc., 659 F.3d
1186, 1193 (Fed. Cir. 2011); accord Sanofi-Aventis v.
Pfizer Inc., 733 F.3d 1364, 1367–68 (Fed. Cir. 2013).
Before trial, the parties stipulated that they would
contest ready for patenting “only with respect to the
limitations and intended uses of ‘reducing emesis or
reducing the likelihood of emesis’ and ‘to reduce the
likelihood of cancer chemotherapy-induced nausea and
vomiting’ of the asserted claims” and not “for any other
reason.” J.A. 26081. Thus, for instance, it is uncontested
that the formulation had been made and was stable prior
to the critical date. Accordingly, the only issue with
respect to ready for patenting before the district court and
on appeal is whether Helsinn had determined that the
invention would work for its intended purpose, which,
according to the claims, is “reducing the likelihood” of
emesis and CINV.
Our cases distinguish between the standard required
to show that a particular invention would work for its
intended purpose and the standard that governs FDA
approval of new drugs, including the various stages of
clinical trials. See, e.g., Scott v. Finney, 34 F.3d 1058,
1063–64 (Fed. Cir. 1994) (addressing reduction to practice
in the priority context). In patent law, the requisite test-
ing, if any, for showing that an invention will “work for its
intended purpose” varies depending on “the character of
the invention,” including the claim language and the
16 See, e.g., Honeywell Int’l Inc. v. Universal Avionics
Sys. Corp., 488 F.3d 982, 997 (Fed. Cir. 2007) (citing to
Fujikawa v. Wattanasin, 93 F.3d 1559, 1563 (Fed. Cir.
1996), a case that addresses ready for patenting in the
priority context, for the ready for patenting standard in
the context of the on-sale bar).
HELSINN HEALTHCARE S.A. v. TEVA 29
PHARMACEUTICALS USA, INC.
“nature and complexity of the problem” the invention
seeks to solve. Id. at 1061–62; see also Slip Track Sys.,
Inc. v. Metal-Lite, Inc., 304 F.3d 1256, 1265 (Fed. Cir.
2002). Generally there must be some “demonstration of
the workability or utility of the claimed invention.” Hon-
eywell Int’l Inc. v. Universal Avionics Sys. Corp., 488 F.3d
982, 997 (Fed. Cir. 2007). This must show that the inven-
tion works for its intended purpose “beyond a probability
of failure” but not “beyond a possibility of failure.” Scott,
34 F.3d at 1062. “[L]ater refinements do not preclude
reduction to practice, [and] it is improper to conclude that
an invention is not reduced to practice merely because
further testing is being conducted.” Atlanta Attachment
Co. v. Leggett & Platt, Inc., 516 F.3d 1361, 1367 (Fed. Cir.
2008).
Approval of a new drug by FDA, however, is a more
demanding standard than that involved in the patents-in-
suit. The patents here make no reference to FDA stand-
ards and broadly claim a palonosetron formulation for
reducing the likelihood of emesis and CINV. For FDA
approval, however, an applicant must submit, inter alia,
“adequate tests by all methods reasonably applicable to
show whether or not such drug is safe for use” and “sub-
stantial evidence that the drug will have the effect it
purports or is represented to have under the conditions of
use prescribed.” 21 U.S.C. § 355(d). This requires “ade-
quate and well-controlled investigations, including clini-
cal investigations, by experts qualified by scientific
training and experience to evaluate the effectiveness of
the drug involved, on the basis of which it could fairly and
responsibly be concluded by such experts that the drug
will have the effect it purports or is represented to have
under the conditions of use prescribed, recommended, or
suggested in the labeling or proposed labeling thereof.” Id.
This is understood to be “a rigorous standard.” Ams. for
Safe Access v. DEA, 706 F.3d 438, 451 (D.C. Cir. 2013).
30 HELSINN HEALTHCARE S.A. v. TEVA
PHARMACEUTICALS USA, INC.
Here, the district court based its finding that the in-
vention was not reduced to practice before the critical
date on insufficient testing for Helsinn to have “deter-
mined that the invention would work for its intended
purpose.” J.A. 159. The district court appeared to believe
that Teva needed to meet the FDA standard, which
requires finalized reports with fully analyzed results from
successful Phase III trials. This is clear from the district
court’s reliance on the testimony of Helsinn’s expert who
“referred to FDA standards in forming his opinions in this
case” and stated that FDA “articulated a statistical
framework for being able to really know from the [clinical
trial] data . . . that a drug is working.” J.A. 148. Through-
out its opinion the district court found lack of reduction to
practice for failure to establish “efficacy” under FDA
standards, and the lack of fully analyzed Phase III studies
as required by FDA. J.A. 159. The district court was
influenced particularly by the fact that FDA found the so-
called Study 2330 insufficient to demonstrate efficacy. 17
See, e.g., J.A. 34, 48–50, 56, 147, 151, 154–55.
The district court clearly erred by applying too de-
manding a standard. The completion of Phase III studies
and final FDA approval are not pre-requisites for the
invention here to be ready for patenting. The evidence is
overwhelming that before the critical date of January 30,
2002, it was established that the patented invention
would work for its intended purpose of reducing the
likelihood of emesis.
17 FDA found Study 2330 insufficient on its own to
support Phase III trials since, “[w]hen compared to the
lowest doses (0.3 and 1 mcg/kg) only the 30 mcg/kg dose
was statistically significant; a significant dose response
trend was not evident.” J.A. 10907. We view this as irrel-
evant to whether the invention was ready for patenting.
HELSINN HEALTHCARE S.A. v. TEVA 31
PHARMACEUTICALS USA, INC.
• The 1995 report from Study 2330 demonstrated
that three different doses, including the 0.25
mg dose, produced statistically significant re-
sults at the 5% level for the median time it took
patients to experience an emetic episode after
administration of palonosetron. While this
study did not show statistical significance for
complete control of emesis or CINV for 24
hours, complete control is not a claim require-
ment. The invention is for reducing the likeli-
hood of emesis, not necessarily completely
preventing it, and the statistical significance
for mean time to failure demonstrates that the
product reduced the likelihood of emesis. In-
deed, the Study 2330 final report concluded
that the relevant dose of palonosetron “was ef-
fective in suppressing” CINV. J.A. 1636. Under
our cases this is sufficient to establish that the
invention here would work for its intended
purpose of reducing the likelihood of CINV. See,
e.g., Z4 Techs., 507 F.3d at 1352 (concluding
that the intended purpose of the invention at
issue was to reduce piracy, not to completely
stop its occurrence).
• Giorgio Calderari, one of the named inventors
of the patents-in-suit, characterized the results
of the Phase II trial, Study 2330, as “yes, the
product was showing some efficacy clearly.”
J.A. 524.
• Minutes from a July 1998 meeting of Helsinn’s
palonosetron team indicated that their “pro-
posal [wa]s to test effective doses seen in Phase
2,” including the 0.25 mg dose. J.A. 1424 (em-
phasis added).
• The proposed protocols for Phase III trials that
Helsinn submitted to FDA in November 1999
32 HELSINN HEALTHCARE S.A. v. TEVA
PHARMACEUTICALS USA, INC.
stated that the “[r]esults achieved in Phase II
CINV studies suggest that palonosetron is safe
and effective in preventing nausea and vomit-
ing following emetogenic chemotherapy,” J.A.
3846, and “[d]ata from this study clearly
demonstrate that the 3 µg/kg dose of palono-
setron is the minimal effective dose in prevent-
ing CINV,” J.A. 3851.
• On September 14, 2000, Helsinn announced in
a press release that “Phase II trials [had]
demonstrated the efficacy of Palonosetron in
the prevention of emesis with no significant
side effects.” J.A. 9983.
• On January 7, 2002, Helsinn prepared prelimi-
nary data tables analyzing the results from the
first Phase III trial. 18 “[T]he preliminary data
for Complete Response, which is the primary ef-
ficacy outcome measure for acute CINV, was
81.0% (153/189) for palonosetron 0.25 mg.” J.A.
81. This means that 81% of patients who re-
ceived the 0.25 mg dose of palonosetron experi-
enced relief from CINV for 24 hours. As one of
the named inventors of all four patents ex-
plained, these data showed that the 0.25 mg
dose of palonosetron “reduced the likelihood of
CINV in those subjects.” J.A. 593.
18 Even though the purported sale or offer for sale
occurred before these data tables were prepared, post-
contract developments are relevant such that even if an
invention is not ready for patenting at the time of the
offer or sale, it may become so before the critical date and
thereby trigger application of the on-sale bar, a point to
which both parties agreed at oral argument.
HELSINN HEALTHCARE S.A. v. TEVA 33
PHARMACEUTICALS USA, INC.
• In a 2007 declaration submitted to overcome an
initial rejection by the examiner during prose-
cution, Giorgio Calderari and four of the other
named inventors of the patents-in-suit stated
that “[t]he formulations . . . were completed
sometime before March 24, 1999” and that they
“had invented and were in possession of all of
the subject matter currently claimed . . . as of
March 24, 1999.” J.A. 1411–12. This was clari-
fied at trial as referring to the claimed inven-
tion, i.e., “a pharmaceutically stable solution for
reducing emesis or reducing the likelihood of
emesis.” J.A. 527 (154:16–22; 156:1–9).
• In a 2010 declaration corresponding to another
related palonosetron patent application, 19 Ser-
gio Cantoreggi and two named inventors of the
’724, ’725, and ’424 patents submitted a decla-
ration stating that they “had conceived the in-
vention . . . , and reduced it to practice, before
November 16, 2001,” J.A. 2921 ¶ 2, and “had
conceived the idea to use palonosetron for the
treatment of acute and delayed-onset CINV,
and had conducted clinical trials in humans to
test this idea, at least as early as October 2,
2001,” J.A. 2921 ¶ 3. The declaration concluded
19 The patent application claimed a method of treat-
ing CINV with the 0.25 mg dose: “A method of treating
chemotherapy or radiotherapy-induced acute and delayed
emesis in an adult human for five days after an emesis
inducing chemotherapy or radiotherapy event, comprising
administering to said human a single dose of a treatment-
effective amount of about 0.25 mg of palonosetron in the
form of palonosetron hydrochloride prior to said emesis-
inducing event, without administering any further
palonosetron during said give day period.” J.A. 2922.
34 HELSINN HEALTHCARE S.A. v. TEVA
PHARMACEUTICALS USA, INC.
that “[m]ost important, [they] had successfully
tested the method in human patients, and
[they] had done so before October 2, 2001 (the
date the [Phase III] study was completed).” J.A.
2923 ¶ 18. The district court found that these
statements in the 2010 declaration “were liter-
ally true.” J.A. 158.
These results consistently showed that the invention
worked for its intended purpose, from the final report for
the 1995 Phase II trial to the preliminary results in
January 2002 from a Phase III trial. Under the district
court’s unduly restrictive standard, Helsinn could not
have filed a valid patent application before the critical
date of January 30, 2002. Such a standard would preclude
the filing of meritorious patent applications in a wide
variety of circumstances. The evidence that the formula-
tion was ready for patenting is overwhelming, and the
District Court’s contrary conclusion—applying the wrong
standard—was clearly erroneous. There is simply no
tenable argument that, before the critical date, Helsinn
was unable to file a patent application that met the
requirements of 35 U.S.C. § 112. 20
20 See Space Sys./Loral, Inc. v. Lockheed Martin
Corp., 271 F.3d 1076, 1080 (Fed. Cir. 2001) (“To be ‘ready
for patenting’ the inventor must be able to prepare a
patent application, that is, to provide an enabling disclo-
sure as required by 35 U.S.C. § 112. . . . [W]hen develop-
ment and verification are needed in order to prepare a
patent application that complies with § 112, the invention
is not yet ready for patenting.”); Clock Spring, L.P. v.
Wrapmaster, Inc., 560 F.3d 1317, 1328 (Fed. Cir. 2009)
(“By filing the 1992 [patent] application, the inventors
represented that the invention was then ready for patent-
ing . . . .”); see also In re Brana, 51 F.3d 1560, 1568 (Fed.
Cir. 1995) (“FDA approval, however, is not a prerequisite
HELSINN HEALTHCARE S.A. v. TEVA 35
PHARMACEUTICALS USA, INC.
The district court and Helsinn on appeal rely on our
decision in Omeprazole to argue that the results from
Phase III trials must be analyzed in order to draw a valid
conclusion regarding whether the invention works for its
intended purpose. See Omeprazole, 536 F.3d 1361. But
there is no general rule that Phase III trials must be
completed before a product is ready for patenting, just as
there is no general rule that Phase III trials are irrele-
vant. Each case must be decided based on its own facts.
And this case is not like Omeprazole. In Omeprazole,
there was significant uncertainty going into Phase III
trials regarding whether the formulation would “solve the
twin problems of in vivo stability and long-term storage”
that had been identified after Phase II trials. Id. at 1373
(internal quotation marks omitted). Indeed, between
Phase II and Phase III the researchers needed to attempt
“a number of modifications to the Phase II formulation”
since achieving the “two goals seemingly conflicted.” Id.
Here, of course, there was no similar need to modify the
formulation in between the Phase II and Phase III trials,
as Helsinn stipulated to the formulation’s stability.
We conclude that the invention was reduced to prac-
tice and therefore was ready for patenting before the
critical date.
CONCLUSION
We hold that the asserted claims, claims 2 and 9 of
the ’724 patent, claim 2 of the ’725 patent, claim 6 of the
’424 patent, and claims 1, 2, and 6 of the ’219 patent, are
invalid under the on-sale bar.
REVERSED
for finding a compound useful within the meaning of the
patent laws.”).