Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-15-02064/USCOURTS-ca13-15-02064-0/pdf.json

Parties Involved:
Bayer HealthCare Pharmaceuticals Inc.
Appellee
Bayer Pharma AG
Appellee
Merck & Cie
Appellee
Watson Laboratories Inc.
Appellant

Document Text:

United States Court of Appeals 

for the Federal Circuit ______________________ 

 

MERCK & CIE, BAYER PHARMA AG, BAYER 

HEALTHCARE PHARMACEUTICALS INC.,

Plaintiffs-Appellees

v.

WATSON LABORATORIES, INC.,

Defendant-Appellant

______________________ 

2015-2063, 2015-2064

______________________ 

Appeals from the United States District Court for the 

District of Delaware in Nos. 1:13-cv-00978-RGA, 1:13-cv01272-RGA, Judge Richard G. Andrews.

______________________ 

Decided: May 13, 2016 

______________________ 

 JOHN SCOTT MCBRIDE, Bartlit Beck Herman Palenchar & Scott LLP, Chicago, IL, argued for plaintiffsappellees. Also represented by ADAM MORTARA, REBECCA 

HORWITZ, FAYE PAUL. 

 STEVEN ARTHUR MADDOX, Maddox Edwards, PLLC, 

Washington, DC, argued for defendant-appellant. Also 

represented by JEREMY J. EDWARDS, MATTHEW C. RUEDY,

KAVEH SABA. 

______________________ 

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2 MERCK & CIE v. WATSON LABORATORIES INC. 

Before DYK, MAYER, and HUGHES, Circuit Judges.

MAYER, Circuit Judge.

Watson Laboratories, Inc. (“Watson”) appeals the final 

judgment of the United States District Court for the 

District of Delaware holding that claim 4 of U.S. Patent 

No. 6,441,168 (the “’168 patent”) is not invalid under the 

on-sale bar of 35 U.S.C. § 102(b) (2006).1 See Merck & Cie 

v. Watson Labs., Inc., 125 F. Supp. 3d 503 (D. Del. 2015) 

(“District Court Decision”). For the reasons discussed 

below, we reverse.

BACKGROUND

A. The ’168 Patent

Claim 4, the sole asserted claim of the ’168 patent, is 

directed to a crystalline calcium salt of a tetrahydrofolic 

acid (“MTHF”). Claim 4 recites: “A crystalline calcium 

salt of 5-methyl-(6S)-tetrahydrofolic acid with 2 theta 

values of 6.5, 13.3, 16.8 and 20.1 (Type I) said crystalline 

salt having a water of crystallization of at least one 

equivalent per equivalent of 5-methyltetrahydrofolic 

acid.” ’168 patent, col. 10 ll. 57–61. The application for 

the ’168 patent was filed on April 17, 2000, and it issued 

on August 27, 2002. See Joint Appendix (“J.A.”) 8, 22.

In 1997, Merck KGaA (“Merck”) and Weider Nutrition 

International, Inc. (“Weider”) began “exploring a strategic 

partnership to introduce dietary supplements with Merck 

ingredients into the United States.” District Court Decision, 125 F. Supp. 3d at 508. The first major project 

 

1 Section 102(b) was amended by the Leahy-Smith 

America Invents Act (“AIA”), Pub. L. No. 112-29, § 3(b)(1), 

125 Stat. 284, 285–86 (2011). Because the application for 

the ’168 patent was filed in 2000, however, we apply the 

pre-AIA version of the statute. See In re Giannelli, 739 

F.3d 1375, 1376 n.1 (Fed. Cir. 2014). 

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MERCK & CIE v. WATSON LABORATORIES INC. 3

considered by the parties was a joint venture to market 

and distribute MTHF. J.A. 1287–90, 1434. In February 

1998, Merck and Weider executed a Confidentiality and 

Noncompetition Agreement (the “Confidentiality Agreement”). J.A. 1368–73. Section 5.2 of the Confidentiality 

Agreement provided: “Unless and until such definitive 

agreement regarding a transaction between Weider and 

Merck has been signed by both parties, neither party will 

be under any legal obligation of any kind with respect to 

such a transaction.” J.A. 1371.

In August 1998, Weider notified Merck that it was no 

longer interested in forming a joint venture to market 

MTHF in the United States, explaining that the advertising expenses associated with such a “large-scale” project 

were too high. J.A. 1419. Weider stated, however, that it 

would like to purchase two kilograms of MTHF on a 

stand-alone basis. J.A. 1419, 1446–48. Weider explained 

that “[i]n order to complete the transaction,” it needed 

information on the price for the product. J.A. 1446. 

Weider also informed Merck that it would like to handle 

the purchase of MTHF in a way that was “simplest . . . for 

both companies.” J.A. 1446.

In response, on September 9, 1998, Dr. Roland Martin, a manager in Merck’s Health, Cosmetic and Nutrition 

Business Unit, sent Weider a signed fax stating:

[W]e would like to handle your purchase of 

[MTHF] very simpl[y].

Therefore please send the order to my attention 

and I will arrange everything. In addition we 

need the exact delivery address/person.

The price is 25,000 US$ per kg [of MTHF] free delivered to your R&D center in the U.S. Payment 

terms are 60 days net. With Rick Blair and Richard Bizzaro we discussed a purchase of 2 kg [of 

MTHF]. If you need more, we have no problem for 

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4 MERCK & CIE v. WATSON LABORATORIES INC. 

an immediate[] delivery. After receiving your order you will get the official confirmation of the order.

J.A. 1386.

On September 16, 1998, Gary Jepson, Weider’s purchasing manager, responded to Martin, stating that 

Weider would order two kilograms of MTHF for delivery 

to its Salt Lake City, Utah facility. J.A. 1352. Jepson 

asked Martin to provide the information he needed to 

complete Weider’s purchase order, including the 

“[s]pecification sheet for the raw material outlining physical, analytical, and microbial characteristics” of the 

MTHF product as well as the “material safety data 

sheets.” J.A. 1352. In addition, Jepson asked for a certificate of insurance naming Weider as an additional insured. J.A. 1352.

Shortly thereafter, on September 25, 1998, Martin 

sent Jepson a specification and analytical data sheet for 

the MTHF product. J.A. 1355. Martin informed Jepson 

that Weider would receive a certificate of insurance 

naming it as an additional insured “after dispatch of [the] 

product.” J.A. 1354. Martin reiterated, moreover, that 

the purchase price for the MTHF would be $25,000 per 

kilogram and that it would be delivered, free of charge, to 

Weider’s Utah facility. J.A. 1354. On October 8, 1998, 

Merck sent Weider a letter confirming that it had placed a 

“first order” for two kilograms of MTHF. J.A. 1455.

Merck subsequently met with Whitehall Robins 

(“Whitehall”), a Weider competitor. J.A. 1398, 1461–62. 

Whitehall informed Merck that it was interested in obtaining exclusive rights to market MTHF in the United 

States and Canada. J.A. 1461–62.

In a November 1998 internal memorandum, Weider 

noted that it needed to “track” its MTHF order and “determine [a] delivery date.” J.A. 1438. In December 1998, 

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MERCK & CIE v. WATSON LABORATORIES INC. 5

Merck agreed to try to locate Weider’s MTHF order. J.A. 

1388. Merck contacted Weider in January 1999, inquiring 

about whether its purchase order for MTHF was still 

“active.” J.A. 1428. On January 6, 1999, Preston Zoller, a 

Weider employee, noted in an internal Weider email that 

“Merck wasn’t expecting us to buy any [MTHF] immediately.” J.A. 1428. Zoller further stated that it was his 

“understanding that there wouldn’t be any dire consequences to cancelling [Weider’s purchase order] (if one 

exists) until such time as a new [MTHF] product is actually approved for launch.” J.A. 1428. On January 9, 1999, 

Weider sent Merck an email noting that the parties had 

made a “mutual decision” to cancel Weider’s “existing 

order for [MTHF].” J.A. 1463.

B. The District Court Litigation

In 2013, Bayer Pharma AG, Bayer Healthcare Pharmaceuticals Inc., and Merck & Cie, a Merck subsidiary, 

brought suit against Watson. They accused Watson of 

infringing claim 4 of the ’168 patent by filing Abbreviated 

New Drug Applications seeking approval to manufacture 

and market generic versions of the Safyral® and Beyaz®

oral contraceptive products. See District Court Decision, 

125 F. Supp. 3d at 506. Because Watson stipulated to 

infringement if claim 4 was valid, the only issue for trial 

was validity. Id. at 507.

Following a bench trial, the district court held that 

claim 4 of the ’168 patent was not anticipated, obvious, or 

invalid for lack of adequate written description. Id. at 

511–15. It further held that claim 4 was not invalid 

under the on-sale bar. Id. at 507–10. Although the court 

determined that MTHF was ready for patenting by September 1998, id. at 508, it concluded that there had been 

no invalidating commercial offer for sale or sale of the 

product, id. at 509–10. In the court’s view, the fax Merck 

sent to Weider on September 9, 1998, was not sufficiently 

definite to qualify as a commercial offer because it did not 

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6 MERCK & CIE v. WATSON LABORATORIES INC. 

include “important safety and liability terms.” Id. at 510. 

The court noted, moreover, that under section 5.2 of the 

Confidentiality Agreement any “definitive agreement” 

between Merck and Weider had to be signed by both 

parties. Id. at 509. According to the court, because any 

agreement for the sale of MTHF was not “reduced to 

writing and signed by both parties,” there had been no 

legally binding sale. Id. at 510. 

Watson then filed a timely appeal with this court. 

Watson limits its appeal to the issue of whether the 

district court correctly held that claim 4 of the ’168 patent 

is not invalid due to the on-sale bar. We have jurisdiction 

under 28 U.S.C. § 1295(a)(1).

DISCUSSION

A. Standard of Review

Invalidity under the on-sale bar is a question of law 

based on underlying questions of fact. Robotic Vision 

Sys., Inc. v. View Eng’g, Inc., 249 F.3d 1307, 1310 (Fed. 

Cir. 2001). “[T]he question of whether an invention is the 

subject of a commercial offer for sale is a matter of Federal Circuit law, to be analyzed under the law of contracts 

as generally understood.” Grp. One, Ltd. v. Hallmark 

Cards, Inc., 254 F.3d 1041, 1047 (Fed. Cir. 2001).

B. The On-Sale Bar

“Our patent laws deny a patent to an inventor who 

applies for a patent more than one year after making an 

attempt to profit from his invention by putting it on sale.” 

Atlanta Attachment Co. v. Leggett & Platt, Inc., 516 F.3d 

1361, 1365 (Fed. Cir. 2008); see City of Elizabeth v. Am. 

Nicholson Pavement Co., 97 U.S. 126, 137 (1877) (“[A]n 

inventor acquires an undue advantage over the public by 

delaying to take out a patent, inasmuch as he thereby 

preserves the monopoly to himself for a longer period than 

is allowed by the policy of the law.”). Section 102(b)’s onsale bar is triggered when a claimed invention is: (1) 

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MERCK & CIE v. WATSON LABORATORIES INC. 7

ready for patenting; and (2) the subject of a commercial 

offer for sale prior to the critical date.2 Pfaff v. Wells 

Elecs., Inc., 525 U.S. 55, 67–68 (1998); see Lacks Indus., 

Inc. v. McKechnie Vehicle Components USA, Inc., 322 F.3d 

1335, 1347 (Fed. Cir. 2003).

Here, because Merck does not challenge the district 

court’s determination that “MTHF was . . . ready for 

patenting by September 1998,” District Court Decision, 

125 F. Supp. 3d at 508, our focus is on whether there was 

an invalidating commercial offer to sell the product prior 

to the critical date—April 17, 1999. In making this determination, we “apply[] traditional contract law principles.” Allen Eng’g Corp. v. Bartell Indus., Inc., 299 F.3d 

1336, 1352 (Fed. Cir. 2002); see also Grp. One, 254 F.3d at 

1047 (explaining that “the offer must meet the level of an 

offer for sale in the contract sense, one that would be 

understood as such in the commercial community”). 

“Only an offer which rises to the level of a commercial 

offer for sale, one which the other party could make into a 

binding contract by simple acceptance (assuming consideration), constitutes an offer for sale under § 102(b).” 

Grp. One, 254 F.3d at 1048.

By August 1998, Weider had decided that it did not 

wish to enter into a partnership with Merck to market 

MTHF in the United States. J.A. 1419. Weider informed 

Merck, however, that it wanted to purchase two kilograms of MTHF on a stand-alone basis. J.A. 1419. In 

response, on September 9, 1998, Martin, a Merck manager, sent Weider a signed fax directing it to send its order 

for the purchase of MTHF to him directly, explaining that 

 

2 “The date exactly one year prior to the date of application for the patent is known as the critical date.” 

Scaltech, Inc. v. Retec/Tetra, LLC, 269 F.3d 1321, 1327 

(Fed. Cir. 2001). 

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8 MERCK & CIE v. WATSON LABORATORIES INC. 

he would “arrange everything.” J.A. 1386. Martin stated 

that the price for the MTHF would be $25,000 per kilogram, that payment terms were “60 days net,” and that 

the product would be delivered, free of charge, to Weider’s 

U.S. facility. J.A. 1386. Martin assured Weider, moreover, that if it needed more than two kilograms of MTHF, 

Merck had “no problem . . . immediately” delivering additional quantities. J.A. 1386.

Martin’s September 9, 1998, fax was not an unsolicited price quote sent to numerous potential customers. See 

Restatement (Second) of Contracts § 26, cmt. c (1981) 

(explaining that a “relevant factor[]” in determining 

whether an offer has been made is “the number of persons 

to whom a communication is addressed”); see also Grp. 

One, 254 F.3d at 1048 (noting that “mere advertising” 

may not rise to the level of a commercial offer). To the 

contrary, that fax was sent in direct response to Weider’s 

request to purchase two kilograms of MTHF. J.A. 1419. 

Martin’s detailed fax—providing essential price, delivery,

and payment terms—contained all the required elements 

to qualify as a commercial offer for sale. See Cargill, Inc. 

v. Canbra Foods, Ltd., 476 F.3d 1359, 1369 (Fed. Cir. 

2007) (concluding that a letter which specified the price 

per unit of a product and the terms for delivery qualified 

as an invalidating offer for sale); Linear Tech. Corp. v. 

Micrel, Inc., 275 F.3d 1040, 1052 (Fed. Cir. 2001) (explaining that purchase orders were “offers to buy” because 

“they included quantity terms and clearly identified the 

requested product,” notwithstanding the fact that they 

did not specify a price); Scaltech, 269 F.3d at 1329 (concluding that proposals to process refinery waste were 

commercial offers because they contained “sufficiently 

definite offer language”). Notably, Martin did not qualify 

his offer to sell MTHF. To the contrary, he expressly 

invited Weider to send its purchase order to his attention 

and assured it that he would “arrange everything.” J.A. 

1386.

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Merck argues that Martin’s September 9, 1998, fax 

was not an invalidating commercial offer because “neither 

Weider nor Merck ever acted as if Merck had made . . . a 

binding offer to sell [MTHF].” Br. of Plaintiffs-Appellees 

at 10. This contention is belied by the record, which 

shows that in the weeks following Martin’s fax both 

Merck and Weider proceeded on the understanding that 

Merck had made an unequivocal offer to sell MTHF. A 

week after receiving Martin’s fax, Weider sent Merck an 

email confirming that it would “order 2 KG of [MTHF]” 

for delivery to its Utah facility. J.A. 1352. It also asked 

for the “[MTHF] safety data sheets” and the “certificate of 

analysis” it needed to complete its purchase order, as well 

as a certificate of insurance naming Weider as an additional insured. J.A. 1352. On September 25, 1998, Merck 

provided Weider with technical and safety information on 

the MTHF product. J.A. 1353–57; see also J.A. 1465. 

Merck further stated that it would provide a certificate of 

insurance naming Weider as an additional insured after 

the MTHF was “dispatch[ed].” J.A. 1354. Soon thereafter, on October 8, 1998, Merck sent Weider a letter confirming that Weider had placed a “first order” for two 

kilograms of MTHF. J.A. 1455. Regardless of whether 

the communications between Merck and Weider in the 

fall of 1998 were sufficient to establish a binding contract 

for the sale of MTHF, they confirm that, at a minimum, 

both parties understood that Martin’s September 9, 1998, 

fax was an offer to sell the product. Although Merck 

ultimately failed to deliver any MTHF to Weider—

possibly because it subsequently decided to pursue a more 

lucrative exclusive licensing arrangement with one of 

Weider’s competitors, J.A. 1462—this is not dispositive. 

An offer to sell is sufficient to raise the on-sale bar, regardless of whether that sale is ever consummated. See 

Hamilton Beach Brands, Inc. v. Sunbeam Prods., Inc., 726 

F.3d 1370, 1374–76 (Fed. Cir. 2013) (explaining that the 

on-sale bar applies to a commercial offer regardless of 

whether the parties execute a binding contract); Cargill, 

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10 MERCK & CIE v. WATSON LABORATORIES INC. 

476 F.3d at 1370 (“[E]vidence of an offer to sell is sufficient to trigger the on-sale bar under 35 U.S.C. § 102(b). 

There is no requirement that the sale be completed.”).

C. The District Court’s Analysis

The district court concluded that Merck’s September 

9, 1998, fax did not qualify as an invalidating commercial 

offer because MTHF was “a potentially dangerous new 

drug,” and “important safety and liability terms, which 

Dr. Buchholz testified were standard in the industry, 

were missing.” District Court Decision, 125 F. Supp. 3d at 

510. We do not find this reasoning persuasive. First, the 

record provides no credible support for the conclusion that 

MTHF—which is simply a crystalline form of the natural 

isomer of folate produced by the human body—is a “dangerous new drug.” J.A. 1035, 1089, 1540. To the contrary, as Merck represented to the district court, MTHF “is 

sold as a folate supplement, similar to folic acid in most 

people’s common understanding.” J.A. 1035.

Second, Buchholz’s testimony failed to establish that 

any “industry standard” terms were missing from Martin’s September 9, 1998, fax. Buchholz asserted that 

certain safety and apportionment of liability provisions 

would likely be included in a standard industry contract 

or supply agreement. J.A. 1291–95. Buchholz’s testimony was insufficient, however, to demonstrate that it was 

standard practice in the industry to include such provisions in an offer to sell a particular product on a standalone basis. The record is likewise devoid of any documentary evidence showing that it was standard practice 

in the industry to include safety and liability apportionment provisions in a product sales offer. See Lacks, 322 

F.3d at 1348 (concluding that the issue of whether there 

had been an invaliding offer could not be resolved based 

on conclusory testimony as to “how business [was] done in 

the automotive industry” (internal quotation marks 

omitted)); see also H & W Indus., Inc. v. Occidental Chem. 

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MERCK & CIE v. WATSON LABORATORIES INC. 11

Corp., 911 F.2d 1118, 1122 (5th Cir. 1990) (“To establish 

‘regularity of observance,’ the proffering party must 

demonstrate a dominant pattern of use within the industry. The testimony of one officer as to that company’s 

practices is generally insufficient to establish such a 

pattern.”). 

Finally, and most importantly, Buchholz’s conclusory 

testimony cannot trump the unambiguous documentary 

record. See Cucuras v. Sec’y of Dep’t of Health & Human 

Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993) (“[O]ral 

testimony in conflict with contemporaneous documentary 

evidence deserves little weight.”). While Buchholz testified that Merck would not have sold MTHF to Weider 

without first resolving safety and liability issues, J.A. 

1291–99; see also J.A. 1057, his testimony was squarely 

contradicted by Martin’s September 9, 1998, fax in which 

he agreed to “arrange everything” and “immediately” 

supply Weider with two or more kilograms of MTHF, J.A. 

1386.3

The situation here parallels that presented in Cargill. 

There, Procter & Gamble Co. (“P&G”) made a verbal 

request to purchase a particular type of canola oil from 

DNA Plant Technology Corporation (“DNAP”). See Cargill, 476 F.3d at 1369. In response, DNAP sent a letter to 

P&G which contained the price, quantity, and shipping 

 

3 Significantly, moreover, the record shows that 

Merck had, in fact, addressed certain safety and liability 

apportionment issues related to MTHF prior to the time 

Martin sent his September 9, 1998, fax. In an internal 

Merck memorandum, dated September 4, 1998, Martin 

stated that Merck had no supply agreement in place with 

Weider and that a note should be attached to the confirmation of Weider’s MTHF purchase order stating that 

“with respect to patent infringement and toxicology the 

[MTHF] will be used at Weider’s risk.” J.A. 1421. 

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12 MERCK & CIE v. WATSON LABORATORIES INC. 

terms for the oil. Id. Subsequently, however, DNAP’s 

successor-in-interest attempted to establish that DNAP’s 

letter was not an invalidating commercial offer by relying 

on a declaration from a DNAP employee who stated that 

DNAP “did not view the . . . letter as an offer for a sale.” 

Id. at 1370. We rejected this attempt to evade the on-sale 

bar, concluding that the testimony of the DNAP employee 

was insufficient to override “what [was] abundantly plain 

from the price, quantity, and delivery terms on the face of 

[DNAP’s] letter.” Id. We explained that because the 

language of DNAP’s letter was “unambiguous . . . the 

subsequent testimony of [the DNAP employee] about the 

intended purpose of the letter [was], for practical purposes, irrelevant.” Id.

A similar analysis applies here. Although Buchholz 

testified that Merck would not have sold MTHF to Weider 

without first resolving certain safety and liability issues, 

J.A. 1291–95, his post hoc testimony cannot override what 

was “abundantly plain from the price, quantity, and 

delivery terms,” Cargill, 476 F.3d at 1370, on the face of 

Martin’s September 9, 1998, fax. Simply put, Buchholz’s 

testimony—which he gave in May 2015 about events 

occurring nearly seventeen years before—does not supersede the contemporaneous documentary evidence. See 

Linear Tech., 275 F.3d at 1053 (explaining that under 

“general principle[s] of contract law . . . the parties’ objective, expressed intent—not their secret, subjective intent—controls whether a bargain has been struck”); 

Sinskey v. Pharmacia Ophthalmics, Inc., 982 F.2d 496, 

498–99 (Fed. Cir. 1992) (concluding that an inventor’s 

affidavit regarding events occurring many years before 

was entitled to little weight in the on-sale bar analysis).

D. The Confidentiality Agreement

Merck further contends that Martin’s September 9, 

1998, fax was not an invalidating offer to sell MTHF 

because the Confidentiality Agreement, which Weider and 

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Merck executed in February 1998, required any “definitive agreement” to be “signed by both parties.” J.A. 1371. 

This argument is unavailing. As a preliminary matter, 

Merck and Weider executed the Confidentiality Agreement during a period when they were contemplating 

entering into a broad-ranging joint venture relationship. 

Merck points to nothing in that agreement indicating that 

it was intended to have any applicability to a stand-alone 

product purchase.

Even assuming arguendo, however, that the Confidentiality Agreement can be stretched to cover a standalone purchase of MTHF, it does not help Merck. Section 

5.2 of that agreement states: “Unless and until such 

definitive agreement regarding a transaction between 

Weider and Merck has been signed by both parties, neither party will be under any legal obligation of any kind 

with respect to such a transaction.” J.A. 1371. By its 

plain terms, section 5.2 requires any “definitive agreement” to be reduced to writing and signed by both Weider 

and Merck. J.A. 1371. Nothing in the Confidentiality 

Agreement suggests that an offer is valid only if it is 

signed by both parties.

Merck contends, however, that because section 5.2 requires any agreement to be signed by both parties, “no fax 

or other communication could be a legally binding offer to 

sell unless it invited the other party to counter-sign it and 

such counter-signature would create the required ‘definitive agreement.’” Br. of Plaintiffs-Appellees at 17. Thus, 

in Merck’s view, Martin’s September 9, 1998, fax was not 

a valid offer to sell MTHF because it did not contain a 

signature line or otherwise “invite” Weider’s signature. 

We disagree. Nothing in the Confidentiality Agreement 

suggests that an offer for sale and a completed sales 

agreement must be contained in the same document. 

Thus, Martin’s September 9, 1998, fax qualifies as a 

commercial offer to sell MTHF notwithstanding the fact 

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14 MERCK & CIE v. WATSON LABORATORIES INC. 

that it did not invite Weider to accept that offer by signing 

the fax and returning it to Merck.

Merck does not contend that it offered to supply Weider with MTHF for experimental purposes. See Pfaff, 525 

U.S. at 64 (“[A]n inventor who seeks to perfect his discovery may conduct extensive testing without losing his right 

to obtain a patent for his invention . . . . The law has long 

recognized the distinction between inventions put to 

experimental use and products sold commercially.”). 

Indeed, Merck acknowledges that two kilograms of MTHF 

“was an enormous amount of material, representing 

62,500,000 doses.” Br. of Plaintiffs-Appellees at 7; see

also J.A. 1075; Atlanta Attachment, 516 F.3d at 1366 

(concluding that the on-sale bar applied where a patent 

holder “presented a commercial offer for sale of [its] 

invention en masse”). Because Merck’s September 9, 

1998, offer to sell MTHF was a premature commercial 

exploitation of its invention, claim 4 of the ’168 patent is 

invalid under the on-sale bar.4

 

4 While this court is currently considering whether 

an inventor’s agreement with another party to manufacture the inventor’s product is sufficient to trigger the onsale bar, see The Medicines Co. v. Hospira, Inc., 805 F.3d 

1357, 1358 (Fed. Cir. 2015) (order granting en banc review), there is no dispute that the bar arises when a 

product is marketed to the public prior to the critical date. 

See Pfaff, 525 U.S. at 67; see also Bonito Boats, Inc. v. 

Thunder Craft Boats, Inc., 489 U.S. 141, 148–49 (1989)

(“From the Patent Act of 1790 to the present day, the 

public sale of an unpatented article has acted as a complete bar to federal protection of the idea embodied in the 

article thus placed in public commerce.”); Abbott Labs. v. 

Geneva Pharm., Inc., 182 F.3d 1315, 1319 (Fed. Cir. 1999) 

(“One of the primary purposes of the on-sale bar is to 

prohibit the withdrawal of inventions that have been 

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MERCK & CIE v. WATSON LABORATORIES INC. 15

CONCLUSION

Accordingly, the judgment of the United States District Court for the District of Delaware is reversed. 

REVERSED 

 

placed into the public domain through commercialization.”). 

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