Court Opinion

ID: 3203303
Source: CourtListenerOpinion
Date Created: 2016-05-13 15:01:21.853777+00
Date Added: 2024-06-11T14:18:36.962250
License: Public Domain

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-cv-
01272-RGA, Judge Richard G. Andrews.
                 ______________________

                Decided: May 13, 2016
                ______________________

    JOHN SCOTT MCBRIDE, Bartlit Beck Herman Pa-
lenchar & Scott LLP, Chicago, IL, argued for plaintiffs-
appellees. 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.
                ______________________
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 Deci-
sion, 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).
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 Agree-
ment”). 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 advertis-
ing 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 Mar-
tin, 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 de-
   livered to your R&D center in the U.S. Payment
   terms are 60 days net. With Rick Blair and Rich-
   ard Bizzaro we discussed a purchase of 2 kg [of
   MTHF]. If you need more, we have no problem for
4                  MERCK & CIE   v. WATSON LABORATORIES INC.

    an immediate[] delivery. After receiving your or-
    der you will get the official confirmation of the or-
    der.
J.A. 1386.
     On September 16, 1998, Gary Jepson, Weider’s pur-
chasing 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 physi-
cal, 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 certif-
icate of insurance naming Weider as an additional in-
sured. 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 ob-
taining 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 “de-
termine [a] delivery date.” J.A. 1438. In December 1998,
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] immedi-
ately.” J.A. 1428. Zoller further stated that it was his
“understanding that there wouldn’t be any dire conse-
quences to cancelling [Weider’s purchase order] (if one
exists) until such time as a new [MTHF] product is actual-
ly 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 Phar-
maceuticals 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 Sep-
tember 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
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 Feder-
al 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 on-
sale bar is triggered when a claimed invention is: (1)
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 de-
termination, we “apply[] traditional contract law princi-
ples.” 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 consid-
eration), 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 kilo-
grams of MTHF on a stand-alone basis. J.A. 1419. In
response, on September 9, 1998, Martin, a Merck manag-
er, 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 ap-
plication for the patent is known as the critical date.”
Scaltech, Inc. v. Retec/Tetra, LLC, 269 F.3d 1321, 1327
(Fed. Cir. 2001).
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 kilo-
gram, 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, moreo-
ver, that if it needed more than two kilograms of MTHF,
Merck had “no problem . . . immediately” delivering add-
itional quantities. J.A. 1386.
    Martin’s September 9, 1998, fax was not an unsolicit-
ed 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) (explain-
ing 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 (con-
cluding 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.
MERCK & CIE   v. WATSON LABORATORIES INC.                 9

     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 addi-
tional 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 thereaf-
ter, on October 8, 1998, Merck sent Weider a letter con-
firming 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, re-
gardless 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,
10                MERCK & CIE   v. WATSON LABORATORIES INC.
476 F.3d at 1370 (“[E]vidence of an offer to sell is suffi-
cient 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 “dan-
gerous new drug.” J.A. 1035, 1089, 1540. To the contra-
ry, 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 Mar-
tin’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 testimo-
ny was insufficient, however, to demonstrate that it was
standard practice in the industry to include such provi-
sions in an offer to sell a particular product on a stand-
alone basis. The record is likewise devoid of any docu-
mentary evidence showing that it was standard practice
in the industry to include safety and liability apportion-
ment 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.
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 indus-
try. 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 testi-
fied 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 Car-
gill, 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 confir-
mation 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.
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 purpos-
es, 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 super-
sede the contemporaneous documentary evidence. See
Linear Tech., 275 F.3d at 1053 (explaining that under
“general principle[s] of contract law . . . the parties’ objec-
tive, expressed intent—not their secret, subjective in-
tent—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
MERCK & CIE   v. WATSON LABORATORIES INC.                 13

Merck executed in February 1998, required any “defini-
tive agreement” to be “signed by both parties.” J.A. 1371.
This argument is unavailing. As a preliminary matter,
Merck and Weider executed the Confidentiality Agree-
ment 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 Confi-
dentiality Agreement can be stretched to cover a stand-
alone 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, nei-
ther 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 agree-
ment” 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 re-
quires 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 ‘defini-
tive 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
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 Wei-
der with MTHF for experimental purposes. See Pfaff, 525
U.S. at 64 (“[A]n inventor who seeks to perfect his discov-
ery 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 manufac-
ture the inventor’s product is sufficient to trigger the on-
sale bar, see The Medicines Co. v. Hospira, Inc., 805 F.3d
1357, 1358 (Fed. Cir. 2015) (order granting en banc re-
view), 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 com-
plete 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
MERCK & CIE   v. WATSON LABORATORIES INC.            15

                        CONCLUSION
     Accordingly, the judgment of the United States Dis-
trict Court for the District of Delaware is reversed.
                       REVERSED

placed into the public domain through commercializa-
tion.”).