(Slip Opinion) OCTOBER TERM, 2018 1 

Syllabus 

NOTE: Where it is feasible, a syllabus (headnote) will be released, as is 

being done in connection with this case, at the time the opinion is issued. 

The syllabus constitutes no part of the opinion of the Court but has been 

prepared by the Reporter of Decisions for the convenience of the reader. 

See United States v. Detroit Timber & Lumber Co., 200 U. S. 321, 337. 

SUPREME COURT OF THE UNITED STATES 

Syllabus 

HELSINN HEALTHCARE S. A. v. TEVA 

PHARMACEUTICALS USA, INC., ET AL. 

CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR 

THE FEDERAL CIRCUIT 

No. 17–1229. Argued December 4, 2018—Decided January 22, 2019 

Petitioner Helsinn Healthcare S. A. makes a treatment for chemotherapy-induced nausea and vomiting using the chemical palonosetron. 

While Helsinn was developing its palonosetron product, it entered

into two agreements with another company granting that company the

right to distribute, promote, market, and sell a 0.25 mg dose of 

palonosetron in the United States. The agreements required that the 

company keep confidential any proprietary information received 

under the agreements. Nearly two years later, in January 2003, Helsinn filed a provisional patent application covering a 0.25 mg dose of

palonosetron. Over the next 10 years, Helsinn filed four patent applications that claimed priority to the January 2003 date. Relevant 

here, Helsinn filed its fourth patent application in 2013. That patent

(the ’219 patent) covers a fixed dose of 0.25 mg of palonosetron in a 5 

ml solution and is covered by the Leahy-Smith America Invents Act 

(AIA).

In 2011, respondents Teva Pharmaceutical Industries, Ltd., and 

Teva Pharmaceuticals USA, Inc. (collectively Teva), sought approval 

to market a generic 0.25 mg palonosetron product. Helsinn sued 

Teva for infringing its patents, including the ’219 patent. Teva countered that the ’219 patent was invalid under the “on sale” provision of 

the AIA—which precludes a person from obtaining a patent on an invention that was “in public use, on sale, or otherwise available to the 

public before the effective filing date of the claimed invention,” 35

U. S. C. §102(a)(1)—because the 0.25 mg dose was “on sale” more 

than one year before Helsinn filed the provisional patent application 

in 2003. The District Court held that the AIA’s “on sale” provision

did not apply because the public disclosure of the agreements did not 
2 HELSINN HEALTHCARE S. A. v. TEVA 

PHARMACEUTICALS USA, INC. 

Syllabus 

disclose the 0.25 mg dose. The Federal Circuit reversed, holding that 

the sale was publicly disclosed, regardless of whether the details of

the invention were publicly disclosed in the terms of the sale agreements. 

Held: A commercial sale to a third party who is required to keep the 

invention confidential may place the invention “on sale” under 

§102(a). The patent statute in force immediately before the AIA included an on-sale bar. This Court’s precedent interpreting that provision supports the view that a sale or offer of sale need not make an 

invention available to the public to constitute invalidating prior art. 

See, e.g., Pfaff v. Wells Electronics, Inc., 525 U. S. 55, 67. The Federal Circuit had made explicit what was implicit in this Court’s pre-AIA 

precedent, holding that “secret sales” could invalidate a patent. Special Devices, Inc. v. OEA, Inc., 270 F. 3d 1353, 1357. Given this settled pre-AIA precedent, the Court applies the presumption that when 

Congress reenacted the same “on sale” language in the AIA, it adopted the earlier judicial construction of that phrase. The addition of the 

catchall phrase “or otherwise available to the public” is not enough of

a change for the Court to conclude that Congress intended to alter

the meaning of “on sale.” Paroline v. United States, 572 U. S. 434, 

and Federal Maritime Comm’n v. Seatrain Lines, Inc., 411 U. S. 726, 

distinguished. Pp. 5–9. 

855 F. 3d 1356, affirmed. 

THOMAS, J., delivered the opinion for a unanimous Court. 
 

 

 

_________________ 

_________________ 

Cite as: 586 U. S. ____ (2019) 1 

Opinion of the Court 

NOTICE: This opinion is subject to formal revision before publication in the

preliminary print of the United States Reports. Readers are requested to 

notify the Reporter of Decisions, Supreme Court of the United States, Washington, D. C. 20543, of any typographical or other formal errors, in order

that corrections may be made before the preliminary print goes to press. 

SUPREME COURT OF THE UNITED STATES 

No. 17–1229 

HELSINN HEALTHCARE S. A., PETITIONER v. TEVA 

PHARMACEUTICALS USA, INC., ET AL. 

ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF 

APPEALS FOR THE FEDERAL CIRCUIT 

[January 22, 2019]

 JUSTICE THOMAS delivered the opinion of the Court. 

The Leahy-Smith America Invents Act (AIA) bars a 

person from receiving a patent on an invention that was 

“in public use, on sale, or otherwise available to the public 

before the effective filing date of the claimed invention.” 

35 U. S. C. §102(a)(1). This case requires us to decide 

whether the sale of an invention to a third party who is 

contractually obligated to keep the invention confidential 

places the invention “on sale” within the meaning of 

§102(a).

More than 20 years ago, this Court determined that an

invention was “on sale” within the meaning of an earlier 

version of §102(a) when it was “the subject of a commercial 

offer for sale” and “ready for patenting.” Pfaff v. Wells 

Electronics, Inc., 525 U. S. 55, 67 (1998). We did not further require that the sale make the details of the invention available to the public. In light of this earlier construction, we determine that the reenactment of the 

phrase “on sale” in the AIA did not alter this meaning. 

Accordingly, a commercial sale to a third party who is 

required to keep the invention confidential may place the 
 

2 HELSINN HEALTHCARE S. A. v. TEVA 

PHARMACEUTICALS USA, INC. 

Opinion of the Court 

invention “on sale” under the AIA. 

I 

Petitioner Helsinn Healthcare S. A. (Helsinn) is a Swiss 

pharmaceutical company that makes Aloxi, a drug that 

treats chemotherapy-induced nausea and vomiting. Helsinn acquired the right to develop palonosetron, the active 

ingredient in Aloxi, in 1998. In early 2000, it submitted

protocols for Phase III clinical trials to the Food and Drug 

Administration (FDA), proposing to study a 0.25 mg and a 

0.75 mg dose of palonosetron. In September 2000, Helsinn 

announced that it was beginning Phase III clinical trials 

and was seeking marketing partners for its palonosetron 

product.

Helsinn found its marketing partner in MGI Pharma, 

Inc. (MGI), a Minnesota pharmaceutical company that 

markets and distributes drugs in the United States. 

Helsinn and MGI entered into two agreements: a license

agreement and a supply and purchase agreement. The 

license agreement granted MGI the right to distribute, 

promote, market, and sell the 0.25 mg and 0.75 mg doses

of palonosetron in the United States. In return, MGI 

agreed to make upfront payments to Helsinn and to pay 

future royalties on distribution of those doses. Under the 

supply and purchase agreement, MGI agreed to purchase

exclusively from Helsinn any palonosetron product approved by the FDA. Helsinn in turn agreed to supply MGI 

however much of the approved doses it required. Both 

agreements included dosage information and required 

MGI to keep confidential any proprietary information 

received under the agreements.

Helsinn and MGI announced the agreements in a joint 

press release, and MGI also reported the agreements in its 

Form 8–K filing with the Securities and Exchange Commission. Although the 8–K filing included redacted copies

of the agreements, neither the 8–K filing nor the press 
Cite as: 586 U. S. ____ (2019) 3 

Opinion of the Court 

releases disclosed the specific dosage formulations covered 

by the agreements.

On January 30, 2003, nearly two years after Helsinn

and MGI entered into the agreements, Helsinn filed a 

provisional patent application covering the 0.25 mg and 

0.75 mg doses of palonosetron. Over the next 10 years, 

Helsinn filed four patent applications that claimed priority 

to the January 30, 2003, date of the provisional application. Helsinn filed its fourth patent application—the one

relevant here—in May 2013, and it issued as U. S. Patent 

No. 8,598,219 (’219 patent). The ’219 patent covers a fixed 

dose of 0.25 mg of palonosetron in a 5 ml solution. By

virtue of its effective date, the ’219 patent is governed by

the AIA. See §101(i).

Respondents Teva Pharmaceutical Industries, Ltd., and 

Teva Pharmaceuticals USA, Inc. (Teva), are, respectively,

an Israeli company that manufactures generic drugs and 

its American affiliate. In 2011, Teva sought approval from 

the FDA to market a generic 0.25 mg palonosetron product. Helsinn then sued Teva for infringing its patents, 

including the ’219 patent. In defense, Teva asserted that 

the ’219 patent was invalid because the 0.25 mg dose was 

“on sale” more than one year before Helsinn filed the 

provisional patent application covering that dose in January 2003.

The AIA precludes a person from obtaining a patent on 

an invention that was “on sale” before the effective filing 

date of the patent application: 

“A person shall be entitled to a patent unless . . . the

claimed invention was patented, described in a printed 

publication, or in public use, on sale, or otherwise 

available to the public before the effective filing date

of the claimed invention.” 35 U. S. C. §102(a)(1) (emphasis added). 

See also §102(b)(1) (exception for certain disclosures made 
 

4 HELSINN HEALTHCARE S. A. v. TEVA 

PHARMACEUTICALS USA, INC. 

Opinion of the Court 

within a year before the effective filing date). Disclosures 

described in §102(a)(1) are often referred to as “prior art.” 

The patent statute in effect before the passage of the

AIA included a similar proscription, known as the “on-sale 

bar”: 

“A person shall be entitled to a patent unless—

“(a) the invention was known or used by others in 

this country, or patented or described in a printed

publication in this or a foreign country, before the invention thereof by the applicant for patent, or

“(b) the invention 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 in 

the United States.” 35 U. S. C. §§102(a)–(b) (2006 ed.) 

(emphasis added). 

The District Court determined that the “on sale” provision did not apply. It concluded that, under the AIA, an 

invention is not “on sale” unless the sale or offer in question made the claimed invention available to the public. 

Helsinn Healthcare S. A. v. Dr. Reddy’s Labs. Ltd., 2016 

WL 832089, *45, *51 (D NJ, Mar. 3, 2016). Because the 

companies’ public disclosure of the agreements between 

Helsinn and MGI did not disclose the 0.25 mg dose, the

court determined that the invention was not “on sale” 

before the critical date. Id., at *51–*52. 

The Federal Circuit reversed. 855 F. 3d 1356, 1360 

(2017). It concluded that “if the existence of the sale is 

public, the details of the invention need not be publicly 

disclosed in the terms of sale” to fall within the AIA’s onsale bar. Id., at 1371. Because the sale between Helsinn 

and MGI was publicly disclosed, it held that the on-sale 

bar applied. Id., at 1364, 1371. 

We granted certiorari to determine whether, under the 

AIA, an inventor’s sale of an invention to a third party 
Cite as: 586 U. S. ____ (2019) 5 

Opinion of the Court 

who is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention. 585 U. S. ___ (2018). We conclude 

that such a sale can qualify as prior art. 

II 

A 

The United States Constitution authorizes Congress

“[t]o promote the Progress of Science and useful Arts, by

securing for limited Times to Authors and Inventors the

exclusive Right to their respective Writings and Discoveries.” Art. 1, §8, cl. 8. Under this grant of authority, Congress has crafted a federal patent system that encourages 

“the creation and disclosure of new, useful, and nonobvious advances in technology and design” by granting inventors “the exclusive right to practice the invention for a 

period of years.” Bonito Boats, Inc. v. Thunder Craft 

Boats, Inc., 489 U. S. 141, 151 (1989). 

To further the goal of “motivating innovation and enlightenment” while also “avoiding monopolies that unnecessarily stifle competition,” Pfaff, 525 U. S., at 63, Congress has imposed several conditions on the “limited

opportunity to obtain a property right in an idea,” Bonito 

Boats, supra, at 149. One such condition is the on-sale 

bar, which reflects Congress’ “reluctance to allow an inventor to remove existing knowledge from public use” by 

obtaining a patent covering that knowledge. Pfaff, supra, 

at 64; see also Pennock v. Dialogue, 2 Pet. 1, 19 (1829) 

(explaining that “it would materially retard the progress of

science and the useful arts” to allow an inventor to “sell 

his invention publicly” and later “take out a patent” and

“exclude the public from any farther use than what should 

be derived under it”).

Every patent statute since 1836 has included an on-sale

bar. Pfaff, supra, at 65. The patent statute in force immediately before the AIA prevented a person from receiv-
 

6 HELSINN HEALTHCARE S. A. v. TEVA 

PHARMACEUTICALS USA, INC. 

Opinion of the Court 

ing a patent if, “more than one year prior to the date of the 

application for patent in the United States,” “the invention 

was . . . on sale” in the United States. 35 U. S. C. §102(b) 

(2006 ed., Supp. IV). The AIA, as relevant here, retained 

the on-sale bar and added the catchall phrase “or otherwise available to the public.” §102(a)(1) (2012 ed.) (“A

person shall be entitled to a patent unless” the “claimed

invention was . . . in public use, on sale, or otherwise 

available to the public . . . ”). We must decide whether 

these changes altered the meaning of the “on sale” bar.

We hold that they did not. 

B 

Congress enacted the AIA in 2011 against the backdrop 

of a substantial body of law interpreting §102’s on-sale 

bar. In 1998, we determined that the pre-AIA on-sale bar 

applies “when two conditions are satisfied” more than a

year before an inventor files a patent application. Pfaff, 

525 U. S., at 67. “First, the product must be the subject of

a commercial offer for sale.” Ibid. “Second, the invention 

must be ready for patenting,” which we explained could be

shown by proof of “reduction to practice” or “drawings or

other descriptions of the invention that were sufficiently 

specific to enable a person skilled in the art to practice the 

invention.” Id., at 67–68. 

Although this Court has never addressed the precise

question presented in this case, our precedents suggest 

that a sale or offer of sale need not make an invention 

available to the public. For instance, we held in Pfaff that 

an offer for sale could cause an inventor to lose the right to

patent, without regard to whether the offer discloses each 

detail of the invention. E.g., id., at 67. Other cases focus 

on whether the invention had been sold, not whether the 

details of the invention had been made available to the 

public or whether the sale itself had been publicly disclosed. E.g., Consolidated Fruit-Jar Co. v. Wright, 94 
 

 

Cite as: 586 U. S. ____ (2019) 7 

Opinion of the Court 

U. S. 92, 94 (1877) (“[A] single instance of sale or of use by

the patentee may, under the circumstances, be fatal to the 

patent . . . ”); cf. Smith & Griggs Mfg. Co. v. Sprague, 123 

U. S. 249, 257 (1887) (“A single sale to another . . . would 

certainly have defeated his right to a patent . . . ”); Elizabeth v. Pavement Co., 97 U. S. 126, 136 (1878) (“It is not a

public knowledge of his invention that precludes the inventor from obtaining a patent for it, but a public use or 

sale of it”).

The Federal Circuit—which has “exclusive jurisdiction”

over patent appeals, 28 U. S. C. §1295(a)—has made

explicit what was implicit in our precedents. It has long

held that “secret sales” can invalidate a patent. E.g., 

Special Devices, Inc. v. OEA, Inc., 270 F. 3d 1353, 1357 

(2001) (invalidating patent claims based on “sales for the

purpose of the commercial stockpiling of an invention”

that “took place in secret”); Woodland Trust v. Flowertree 

Nursery, Inc., 148 F. 3d 1368, 1370 (1998) (“Thus 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”).

In light of this settled pre-AIA precedent on the meaning of “on sale,” we presume that when Congress reenacted 

the same language in the AIA, it adopted the earlier judicial construction of that phrase. See Shapiro v. United 

States, 335 U. S. 1, 16 (1948) (“In adopting the language

used in the earlier act, Congress ‘must be considered to 

have adopted also the construction given by this Court to

such language, and made it a part of the enactment’”). 

The new §102 retained the exact language used in its 

predecessor statute (“on sale”) and, as relevant here, 

added only a new catchall clause (“or otherwise available 

to the public”). As amicus United States noted at oral 

argument, if “on sale” had a settled meaning before the 

AIA was adopted, then adding the phrase “or otherwise 

available to the public” to the statute “would be a fairly 
 

8 HELSINN HEALTHCARE S. A. v. TEVA 

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Opinion of the Court 

oblique way of attempting to overturn” that “settled body 

of law.” Tr. of Oral Arg. 28. The addition of “or otherwise 

available to the public” is simply not enough of a change

for us to conclude that Congress intended to alter the

meaning of the reenacted term “on sale.” Cf. Holder v. 

Martinez Gutierrez, 566 U. S. 583, 593 (2012) (determining 

that a reenacted provision did not ratify an earlier judicial

construction where the provision omitted the word on 

which the prior judicial constructions were based). 

Helsinn disagrees, arguing that our construction reads

“otherwise” out of the statute. Citing Paroline v. United 

States, 572 U. S. 434 (2014), and Federal Maritime 

Comm’n v. Seatrain Lines, Inc., 411 U. S. 726 (1973),

Helsinn contends that the associated-words canon requires us to read “otherwise available to the public” to

limit the preceding terms in §102 to disclosures that make

the claimed invention available to the public. 

As an initial matter, neither of the cited decisions addresses the reenactment of terms that had acquired a 

well-settled judicial interpretation. And Helsinn’s argument places too much weight on §102’s catchall phrase.

Like other such phrases, “otherwise available to the public” captures material that does not fit neatly into the 

statute’s enumerated categories but is nevertheless meant 

to be covered. Given that the phrase “on sale” had acquired a well-settled meaning when the AIA was enacted, 

we decline to read the addition of a broad catchall phrase 

to upset that body of precedent. 

III 

Helsinn does not ask us to revisit our pre-AIA interpretation of the on-sale bar. Nor does it dispute the Federal

Circuit’s determination that the invention claimed in the 

’219 patent was “on sale” within the meaning of the preAIA statute. Because we determine that Congress did not 

alter the meaning of “on sale” when it enacted the AIA, we 
Cite as: 586 U. S. ____ (2019) 9 

Opinion of the Court 

hold that an inventor’s sale of an invention to a third 

party who is obligated to keep the invention confidential

can qualify as prior art under §102(a). We therefore affirm the judgment of the Federal Circuit. 

It is so ordered.