`
`Nos. 2014-1469, 2014-1504
`
`
`IN THE UNITED STATES COURT OF APPEALS
`FOR THE FEDERAL CIRCUIT
`
`
`
`THE MEDICINES COMPANY,
`
`
`Plaintiff-Appellant,
`
`
`v.
`
`HOSPIRA, INC.,
`
`
`Defendant-Cross-Appellant,
`
`
`
`
`On Appeal from the United States District Court for the District of Delaware,
`Case No. 1:09-cv-00750-RGA (Judge Richard G. Andrews)
`
`
`
`EN BANC BRIEF FOR THE UNITED STATES AS AMICUS CURIAE
`IN SUPPORT OF APPELLANT
`
`
`
`BENJAMIN C. MIZER
`Principal Deputy Assistant Attorney General
`MARK R. FREEMAN
`MEGAN BARBERO
`Attorneys, Appellate Staff
`Civil Division, Room 7226
`U.S. Department of Justice
`950 Pennsylvania Avenue NW
`Washington, DC 20530
`(202) 532-4631
`
`Of Counsel:
`
`THOMAS W. KRAUSE
`Acting Solicitor
`
`KRISTI L. R. SAWERT
`JOSEPH G. PICCOLO
`ROBERT E. MCBRIDE
`Associate Solicitors
`United States Patent and
`Trademark Office
`
`Helsinn Healthcare Exhibit 2087
`Dr. Reddy's Laboratories, Ltd., et al. v. Helsinn Healthcare S.A.
`Trial PGR2016-00008
`
`Page 1 of 36
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`
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`Case: 14-1469 Document: 132 Page: 2 Filed: 03/02/2016
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`TABLE OF CONTENTS
`
`Page
`
`INTRODUCTION .................................................................................................................. 1
`
`INTEREST OF THE UNITED STATES .......................................................................... 3
`
`QUESTION PRESENTED ................................................................................................... 3
`
`ARGUMENT ............................................................................................................................ 4
`
`THE CIRCUMSTANCES OF THIS CASE DO NOT TRIGGER THE ON-SALE
`BAR ................................................................................................................................... 4
`
`A.
`
`The Statutory Term “On Sale” Means A Sale Or Offer For Sale
`Of The Invention To The Public .................................................................... 4
`
`1.
`
`2.
`
`3.
`
`4.
`
`The on-sale bar requires a sale or offer for sale of the
`invention .................................................................................................. 5
`
`The sale or offer for sale of the invention must be public .............. 9
`
`Congress’s 2011 amendments confirm that “on sale”
`means a sale that makes the invention available to the
`public ...................................................................................................... 15
`
`This Court should overrule its decisions interpreting the
`on-sale bar to reach non-public sales, including confidential
`supplier agreements ............................................................................. 17
`
`B.
`
`The Medicines Company’s Purchase Of Manufacturing Services
`Did Not Trigger The On-Sale Bar ................................................................ 20
`
`1.
`
`2.
`
`There was no sale or offer for sale of the patented drug
`product ................................................................................................... 20
`
`Even if there were a sale or offer for sale, it was not public ......... 23
`
`C.
`
`The Experimental Use Doctrine Does Not Apply ..................................... 24
`
`CONCLUSION ..................................................................................................................... 27
`
`
`
`Page 2 of 36
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`Case: 14-1469 Document: 132 Page: 3 Filed: 03/02/2016
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`CERTIFICATE OF COMPLIANCE
`
`CERTIFICATE OF SERVICE
`
`
`
`ii
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`Page 3 of 36
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`Case: 14-1469 Document: 132 Page: 4 Filed: 03/02/2016
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`TABLE OF AUTHORITIES
`
`Page(s):
`
`
`Cases:
`
`Andrews v. Hovey,
`123 U.S. 267 (1887) ............................................................................................................. 11
`
`
`Atlanta Attachment Co. v. Leggett & Platt, Inc.,
`516 F.3d 1361 (Fed. Cir. 2008) .......................................................................................... 26
`
`
`Bonito Boats, Inc. v. Thunder Craft Boats, Inc.,
`489 U.S. 141 (1989) ..................................................................................... 9, 10, 13, 14, 17
`
`
`Brasseler, U.S.A. I, L.P. v. Stryker Sales Corp.,
`182 F.3d 888 (Fed. Cir. 1999) ............................................................................................ 18
`
`
`Butler v. Thomson,
`92 U.S. 412 (1876) ................................................................................................................. 6
`
`
`Cannon v. University of Chi.,
`441 U.S. 677 (1979) ............................................................................................................. 10
`
`
`City of Elizabeth v. American Nicholson Pavement Co.,
`97 U.S. 126 (1878) ........................................................................................... 12, 14, 25, 26
`
`
`Coffin v. Ogden,
`85 U.S. (18 Wall.) 120 (1873) ............................................................................................. 14
`
`
`Consolidated Fruit-Jar Co. v. Wright,
`94 U.S. 92 (1877) ................................................................................................................. 13
`
`
`Delemater v. Heath,
`58 F. 414 (2d Cir. 1893) ...................................................................................................... 13
`
`
`Egbert v. Lippmann,
`104 U.S. 333 (1881) ............................................................................................................. 13
`
`
`Finisar Corp. v. DirecTV Grp., Inc.,
`523 F.3d 1323 (Fed. Cir. 2008) .......................................................................................... 17
`
`
`
`
`
`iii
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`Page 4 of 36
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`Case: 14-1469 Document: 132 Page: 5 Filed: 03/02/2016
`
`Gayler v. Wilder,
`51 U.S. (10 How.) 477 (1851) ............................................................................................ 14
`
`
`Graham v. John Deere Co.,
`383 U.S. 1 (1966) ................................................................................................................. 14
`
`
`Group One, Ltd. v. Hallmark Cards, Inc.,
`254 F.3d 1041 (Fed. Cir. 2001) ............................................................................................ 6
`
`
`Hobbs v. United States,
`451 F.2d 849 (5th Cir. 1971) .............................................................................................. 17
`
`
`In re Cygnus Telecomm. Tech., LLC Patent Litig.,
`536 F.3d 1343 (Fed. Cir. 2008) .......................................................................................... 25
`
`
`In re Hall,
`781 F.2d 897 (Fed. Cir. 1986) ............................................................................................ 15
`
`
`In re Kollar,
`286 F.3d 1326 (Fed. Cir. 2002) ..................................................................................... 7, 21
`
`
`International Tooth-Crown Co. v. Gaylord,
`140 U.S. 55 (1891) ............................................................................................................... 14
`
`
`Medicines Co. v. Hospira, Inc.,
`791 F.3d 1368 (Fed. Cir. 2015) ................................................................................... 21, 25
`
`
`Montclair v. Ramsdell,
`107 U.S. 147 (1883) ............................................................................................................. 16
`
`
`Muncie Gear Works v. Outboard, Marine & Mfg. Co.,
`315 U.S. 759 (1942) ............................................................................................................. 12
`
`
`NTP, Inc. v. Research In Motion, Ltd.,
`418 F.3d 1282 (Fed. Cir. 2005), abrogated in part on other grounds by
` Zoltek Corp. v. United States, 672 F.3d 1309 (Fed. Cir. 2012) ............................................ 6
`
`Pennock v. Dialogue,
`27 U.S. (2 Pet.) 1 (1829) ........................................................................................... 9, 10, 14
`
`
`
`
`
`iv
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`Page 5 of 36
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`Case: 14-1469 Document: 132 Page: 6 Filed: 03/02/2016
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`Pfaff v. Wells Elecs., Inc.,
`525 U.S. 55 (1998) .............................................................................. 4, 5, 9, 11, 13, 14, 24
`
`
`Procter & Gamble Co. v. Kraft Foods Glob., Inc.,
`549 F.3d 842 (Fed. Cir. 2008) ............................................................................................ 10
`
`
`Purdue Pharma L.P. v. Epic Pharma, LLC,
` __ F.3d __, 2016 WL 380174 (Fed. Cir. Feb. 1, 2016) .................................................. 21
`
`Scaltech, Inc. v. Retec/Tetra, LLC,
`269 F.3d 1321 (Fed. Cir. 2001) ............................................................................................ 6
`
`
`Smith & Griggs Mfg. Co. v. Sprague,
`123 U.S. 249 (1887) ............................................................................................................. 14
`
`
`Special Devices, Inc. v. OEA, Inc.,
`270 F.3d 1353 (Fed. Cir. 2001) ................................................................................... 18, 19
`
`
`Strom v. Goldman, Sachs & Co.,
`202 F.3d 138 (2d Cir. 1999) ............................................................................................... 16
`
`
`United States v. Eurodif S.A.,
`555 U.S. 305 (2009) .............................................................................................. 7, 8, 22, 23
`
`
`United States v. Menasche,
`348 U.S. 528 (1955) ............................................................................................................. 16
`
`
`Universal City Studios, Inc. v. Reimerdes,
`111 F. Supp. 2d 294 (S.D.N.Y. 2000) ............................................................................... 16
`
`
`Williamson v. Southern Reg’l Council, Inc.,
`154 S.E.2d 21 (Ga. 1967).................................................................................................... 16
`
`
`
`Statutes:
`
`Act of July 4, 1836, ch. 357, 5 Stat. 117 ................................................................................. 9
`
`Act of Mar. 3, 1839, ch. 88, 5 Stat. 353 ................................................................................ 11
`
`Act of July 8, 1870, ch. 230, 16 Stat. 198 ............................................................................. 11
`v
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`Page 6 of 36
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`Case: 14-1469 Document: 132 Page: 7 Filed: 03/02/2016
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`Act of Aug. 5, 1939, ch. 450, 53 Stat. 1212 ......................................................................... 11
`
`Leahy-Smith America Invents Act,
` Pub. L. No. 112-29, 125 Stat. 284 (2011) .......................................................................... 1
`
`UCC § 2-106(1) .......................................................................................................................... 6
`
`35 U.S.C. § 102(a) .................................................................................................................... 15
`
`35 U.S.C. § 102(a)(1) (2012) ..................................................................................................... 5
`
`35 U.S.C. § 102(b)........................................................................................................... 1, 3, 11
`
`35 U.S.C. § 154(a)(1) ................................................................................................................. 5
`
`35 U.S.C. § 271(a) ...................................................................................................................... 5
`
`
`
`Legislative Materials:
`
`157 Cong. Rec. S1368 (daily ed. Mar. 8, 2011) ................................................................... 16
`
`H.R. Rep. No. 112-98 (2011) ................................................................................................. 16
`
`S. Rep. No. 24-338 (1836) ...................................................................................................... 10
`
`
`
`Other Authorities:
`
`Black’s Law Dictionary (10th ed. 2014) ..................................................................................... 6
`
` 1
`
` Anthony William Deller, Walker on Patents (1937) ........................................................... 14
`
`
`Manual of Patent Examining Procedure (9th ed. Mar. 2014) ........................................... 17
`
` William C. Robinson, The Law of Patents for Useful Inventions (1890) .............................. 11
`
`
`vi
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` 1
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`Page 7 of 36
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`Case: 14-1469 Document: 132 Page: 8 Filed: 03/02/2016
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`INTRODUCTION
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`Section 102(b) of Title 35 prohibits patenting an “invention” that was “on sale”
`
`in this country more than one year before the date the patent application was filed. 35
`
`U.S.C. § 102(b).1 At issue here are confidential transactions between a patent owner,
`
`the Medicines Company, and a third-party manufacturer, Ben Venue Laboratories
`
`(Ben Venue), to produce drug products that the Medicines Company later patented.
`
`Under the correct interpretation of the statute, those transactions did not place the
`
`invention “on sale” before the critical date for two reasons.
`
` First, the statutory term “on sale” requires not merely commercial activity, but
`
`a commercial sale or offer for sale. Where, as here, the patented invention is a
`
`product (or product-by-process), the traditional hallmark of a sale is the transfer of
`
`title.2 In this case, the parties do not dispute that the Medicines Company retained
`
`title to the drug product at all times. Nor is there anything about the nature of the
`
`transaction or Ben Venue’s manufacturing services that would warrant disregarding
`
`the parties’ agreement that this was a sale of manufacturing services. Because the
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`patented drug product was never the subject of a commercial sale or offer for sale
`
`before the critical date, section 102(b) does not apply.
`
`
`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). All references to Section
`102 are to the pre-AIA version unless otherwise noted.
`2 As discussed below, the fact that some of the Medicines Company’s claims
`are product-by-process claims does not affect the analysis.
`
`
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`Page 8 of 36
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`Case: 14-1469 Document: 132 Page: 9 Filed: 03/02/2016
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`Second, section 102(b) requires not merely evidence that a sale or offer for sale
`
`occurred, but also proof that the invention was “on sale.” The Supreme Court has
`
`long construed that phrase to mean a sale or offer for sale that makes the invention
`
`available to the public. The on-sale bar, the Court has explained, reflects a
`
`fundamental policy of the patent laws: that an inventor should not be permitted to
`
`remove from the public an invention that was lawfully in the public’s hands.
`
`Congress has repeatedly ratified that interpretation of the on-sale bar, and in 2011 it
`
`expressly confirmed it in the AIA: by adding the phrase “or otherwise available to the
`
`public” without revising the long-standing term “on sale,” Congress made clear its
`
`understanding that “on sale” means sales or offers for sale that make the invention
`
`“available to the public.” Even if the transactions between the Medicines Company
`
`and Ben Venue involved a sale of the invention, therefore, section 102(b) would not
`
`apply because the invention was never made available for sale to the public. It
`
`appears to be undisputed that the transactions were confidential and exclusive, such
`
`that no member of the public could have purchased the drug product from Ben
`
`Venue.
`
`Adopting the correct statutory interpretation of the term “on sale” obviates any
`
`need for a “supplier exception” to the bar, as the facts of this case demonstrate.
`
`Many startup companies and small-scale inventors are unable to produce their
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`inventions in-house. But when an inventor contracts confidentially with a third party
`
`to manufacture the invention on its behalf, that transaction may not make the
`2
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`Page 9 of 36
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`Case: 14-1469 Document: 132 Page: 10 Filed: 03/02/2016
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`invention available to the public any more than a large company’s confidential in-
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`house manufacturing does. Even if (unlike here) such an arrangement involves a
`
`transfer of title, it does not place the invention “on sale” within the meaning of
`
`section 102(b).
`
`Finally, because the on-sale bar does not apply, this Court need not reach the
`
`question of whether the “experimental use” doctrine applies. If the Court addresses
`
`this question, however, it should take the opportunity to revisit its bright-line rule that
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`experimental use cannot occur after an invention is reduced to practice.
`
`INTEREST OF THE UNITED STATES
`
`The question presented here implicates the expertise and responsibilities of
`
`several federal agencies and components, including the Department of Commerce
`
`and the Patent and Trademark Office. On November 13, 2015, this Court invited the
`
`United States Department of Justice to file a brief expressing the views of the United
`
`States.
`
`QUESTION PRESENTED
`
`The on-sale bar provides that “[a] person shall be entitled to a patent unless …
`
`the invention was … 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(b)
`
`(emphasis added).
`
`
`
`3
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`Page 10 of 36
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`Case: 14-1469 Document: 132 Page: 11 Filed: 03/02/2016
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`The question presented is whether the on-sale bar applies where an inventor
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`confidentially contracts with a third-party manufacturer to produce the invention for
`
`later sale by the inventor to the public.
`
`ARGUMENT
`
`THE CIRCUMSTANCES OF THIS CASE DO NOT TRIGGER THE ON-SALE BAR
`A. The Statutory Term “On Sale” Means A Sale Or Offer For Sale
`Of The Invention To The Public
`
`Section 102(b) precludes patenting an “invention” that was “on sale” before
`
`the critical date. In Pfaff v. Wells Electronics, Inc., 525 U.S. 55, 67 (1998), the Supreme
`
`Court clarified that the bar applies when two conditions are met: (1) “the product
`
`must be the subject of a commercial offer for sale;” and (2) “the invention must be
`
`ready for patenting.”3 Pfaff thus made clear that there must be a commercial sale or
`
`offer for sale of the invention. And for more than 180 years, the Supreme Court has
`
`consistently held that an invalidating sale or offer is one that makes the invention
`
`available to interested members of the public before the critical date and thereby
`
`places the invention in the public domain.
`
`Congress repeatedly reenacted the on-sale bar against the backdrop of that
`
`settled understanding. In the AIA, Congress made that longstanding requirement
`
`explicit: an invention cannot be patented when it has been placed “on sale,” meaning
`
`
`3 The “ready for patenting” prong of Pfaff is not at issue in this en banc
`proceeding.
`
`
`
`4
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`Page 11 of 36
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`Case: 14-1469 Document: 132 Page: 12 Filed: 03/02/2016
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`that the invention has been made “available to the public” through a sale or offer for
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`sale. 35 U.S.C. § 102(a)(1) (2012) (“in public use, on sale, or otherwise available to the
`
`public”). By retaining the language “on sale,” Congress indicated its understanding
`
`that only sales or offers for sale that make the invention available to the public fall
`
`within the scope of the bar.
`
`1. The on-sale bar requires a sale or offer for sale of the
`invention
`
`The statutory text requires that the invention be “on sale,” meaning that “the
`
`product must be the subject of a commercial offer for sale.” Pfaff, 525 U.S. at 67.
`
`Hospira elides this basic statutory requirement in arguing that, where the two sides to
`
`a transaction were “commercially exploiting the invention prior to the critical date, it
`
`was necessarily ‘on sale’ within the meaning of § 102(b).” Hospira Br. 29-30. Under
`
`the plain language of the statute, what triggers the bar is not any form of commercial
`
`exploitation, but a specific one: selling or offering to sell the invention. In a case such
`
`as this, therefore, where the patented invention is a product or a product-by-process,
`
`section 102(b) requires evidence of a sale or offer for sale of goods embodying the
`
`invention.
`
`The term “sale” is used throughout the patent laws. See, e.g., 35 U.S.C.
`
`§ 154(a)(1) (exclusive rights conferred by a patent include “offering for sale, or selling
`
`the invention”); id. § 271(a) (acts constituting direct infringement include “offers to
`
`sell, or sell[ing]” the invention). The traditional hallmark of a sale of goods is the
`
`
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`5
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`Page 12 of 36
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`Case: 14-1469 Document: 132 Page: 13 Filed: 03/02/2016
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`transfer of title. Butler v. Thomson, 92 U.S. 412, 415 (1876) (“The essential idea of a sale
`
`is that of an agreement or meeting of minds by which a title passes from one, and
`
`vests in another.”); Black’s Law Dictionary (10th ed. 2014) (defining “sale” as “[t]he
`
`transfer of property or title for a price”); NTP, Inc. v. Research In Motion, Ltd., 418 F.3d
`
`1282, 1319 (Fed. Cir. 2005) (explaining, in context of direct infringement, that “the
`
`ordinary meaning of a sale includes the concept of a transfer of title or property”),
`
`abrogated in part on other grounds by Zoltek Corp. v. United States, 672 F.3d 1309, 1322 (Fed.
`
`Cir. 2012) (en banc).
`
`Indeed, the Uniform Commercial Code (UCC) specifically defines a “sale” as
`
`“the passing of title from the seller to the buyer for a price.” UCC § 2-106(1). As this
`
`Court has explained, the Supreme Court’s reference in Pfaff to a “‘a commercial offer for
`
`sale’” as part of the on-sale bar test “strongly suggests 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.” Group One, Ltd. v. Hallmark Cards, Inc., 254 F.3d 1041,
`
`1046 (Fed. Cir. 2001); see also id. at 1048 (observing that Pfaff “also supports
`
`consulting the UCC”). This Court has, therefore, appropriately “look[ed] to the
`
`Uniform Commercial Code … to define whether … a communication or series of
`
`communications rises to the level of a commercial offer for sale” under section
`
`102(b). Id. at 1047 (noting that the “UCC has been recognized as the general law
`
`governing the sale of goods”); Scaltech, Inc. v. Retec/Tetra, LLC, 269 F.3d 1321, 1328
`
`(Fed. Cir. 2001) (explaining that the UCC is “[a]n important relevant source of general
`6
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`Page 13 of 36
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`Case: 14-1469 Document: 132 Page: 14 Filed: 03/02/2016
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`contract law” for determining whether an offer for sale has occurred); In re Kollar, 286
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`F.3d 1326, 1332 (Fed. Cir. 2002) (citing the UCC and concluding that, “[w]hen money
`
`changes hands as a result of the transfer of title to the tangible item, a sale normally
`
`has occurred”).
`
`In some cases, it may be difficult to determine whether title has transferred and
`
`a sale of goods has occurred. As discussed below, this is not such a case, because no
`
`one disputes that the Medicines Company retained title to the drug product at all
`
`times. In United States v. Eurodif S.A., 555 U.S. 305 (2009), however, a case involving
`
`the “antidumping” provisions of the Tariff Act, the Supreme Court provided helpful
`
`guidance in distinguishing a sale of goods from a sale of services in those difficult
`
`cases. The issue in Eurodif was whether the transactions between domestic utilities
`
`and foreign uranium enrichers were sales of uranium enrichment services or of
`
`enriched uranium. Id. at 308. The Supreme Court upheld the Department of
`
`Commerce’s decision to treat the transactions “as sales of goods rather than services,”
`
`id., emphasizing that the proper inquiry focused not on “the legal fiction” created by
`
`the parties’ contracts but instead on the “substance” and “economic reality,” id. at
`
`317-18 (quotation marks omitted).
`
`The Supreme Court observed that “the exchange of cash combined with a
`
`commodity for a product that uses that very commodity as a constituent material is
`
`sometimes a sale of services and sometimes a sale of goods, the distinction being clear
`
`at the extremes.” Eurodif, 555 U.S. at 318. On one extreme, “[a] customer who
`7
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`Page 14 of 36
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`Case: 14-1469 Document: 132 Page: 15 Filed: 03/02/2016
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`comes to a laundry with cash and dirty shirts is clearly purchasing cleaning services,
`
`not clean shirts.” Id. On the other, “a customer who provides cash and sand to a
`
`manufacturer of generic silicon processors is clearly buying computer chips rather
`
`than sand enhancement services.” Id.
`
`In concluding that the Department of Commerce had permissibly characterized
`
`the uranium transactions in Eurodif as a sale of goods, the Court emphasized that the
`
`uranium that was supplied to the enrichers was “a fungible commodity that [was] not
`
`tracked after its delivery,” and was thus effectively treated as owned by the enrichers.
`
`555 U.S. at 319 & n.9. In other words, the utilities did not receive back at the end of
`
`the transaction the same uranium that they had originally sent to the enrichers, as
`
`might be expected in a sale of services. Rather, in exchange for their contributions,
`
`they received new, different uranium, suggesting that the transaction was in substance
`
`a sale of goods. The Court observed that, in the laundry example, “there are no good
`
`reasons to treat [the shirts] as owned for a time by the laundry, and no one does.” Id.
`
`“And without any transfer of ownership, the salient feature of the transaction is the
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`cleaning of the shirt, a service.” Id. By contrast, where the “constituent material is
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`untracked and fungible, ownership is usually seen as transferred, and the transaction is
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`less likely to be a sale of services.” Id.
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`8
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`Page 15 of 36
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`Case: 14-1469 Document: 132 Page: 16 Filed: 03/02/2016
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`2. The sale or offer for sale of the invention must be public
`
`Section 102(b) requires more, however, than a sale or offer for sale of the
`
`invention. The Supreme Court has long construed the on-sale bar to mean that the
`
`invention must be available for sale to the public.
`
`The Supreme Court has explained that “[f]rom 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.” Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 148-49 (1989)
`
`(emphasis added). The Court has stressed that the patent laws, including the on-sale
`
`bar, reflect Congress’s determination to “exclude from consideration for patent
`
`protection knowledge that is already available to the public” because “the creation of
`
`a monopoly in such information would not only serve no socially useful purpose, but
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`would in fact injure the public by removing existing knowledge from public use.” Id.
`
`at 148. Thus, it is Congress’s “reluctance to allow an inventor to remove existing
`
`knowledge from public use [that] undergirds the on-sale bar.” Pfaff, 525 U.S. at 64.
`
`Congress first codified the on-sale bar in 1836, prohibiting the patenting of any
`
`invention that, at the time the application was filed, was “in public use or on sale, with
`
`[the inventor’s] consent or allowance.” Act of July 4, 1836, ch. 357, § 6, 5 Stat. 117,
`
`119. Congress enacted that provision against the backdrop of the Supreme Court’s
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`decision only a few years earlier in Pennock v. Dialogue, 27 U.S. (2 Pet.) 1 (1829), which
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`held that an inventor loses his right to a patent “if he suffers the thing invented to go
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`into public use, or to be publicly sold for use, before he makes application for a patent.
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`His voluntary act or acquiescence in the public sale and use is an abandonment of his
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`right.” Id. at 23-24 (emphases added). The Court in Pennock noted “that under the
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`common law of England, letters patent were unavailable for the protection of articles
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`in public commerce at the time of the application, and that this same doctrine was
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`immediately embodied in the first patent laws passed in this country.” Bonito Boats,
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`Inc., 489 U.S. at 149 (citation omitted) (describing Pennock, 27 U.S. at 20-22).
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`The on-sale bar thus codified the principle announced in Pennock that an
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`invention already “in public commerce” cannot be made the subject of a patent. See
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`Cannon v. University of Chi., 441 U.S. 677, 698-99 (1979) (explaining that “evaluation of
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`congressional action … must take into account its contemporary legal context”);
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`Procter & Gamble Co. v. Kraft Foods Glob., Inc., 549 F.3d 842, 848 (Fed. Cir. 2008). The
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`legislative history of the 1836 statute indicates that Congress was motivated by a
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`concern that the then-existing patent laws accorded “no power to the Secretary to
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`refuse a patent for want of either novelty or usefulness.” S. Rep. No. 24-338, at 2
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`(1836). This enabled the “reprehensible” practice “of taking out patents for what has
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`been long in public use, and what every one has therefore a right to use.” Id. at 3-4.
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`The “on sale” bar was part of Congress’s answer to that problem. As a leading 19th
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`century commentator explained, the early public-use and on-sale statutory restrictions
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`were premised on the principle that “no invention, which has already passed from the
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`control of the inventor into the possession of the public is entitled to protection.” 1
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`William C. Robinson, The Law of Patents for Useful Inventions § 71, 109 (1890).
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`Congress retained the public-use and on-sale bars in subsequent amendments
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`to the patent laws, although it soon ameliorated the effect of those bars “by enacting a
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`2-year grace period” after the public use or sale “in which the inventor could file an
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`application.” Pfaff, 525 U.S. at 65; see Act of Mar. 3, 1839, ch. 88, 5 Stat. 353, 354
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`(1839 Act) (providing that a prior “purchase, sale, or use” would not invalidate a
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`patent “except on proof of abandonment of such invention to the public; or that such
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`purchase, sale or prior use has been for more than two years prior to such application
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`for a patent”).4 The Patent Act of 1870, for example, provided that a patent was not
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`available for an invention that was “in public use or on sale for more than two years
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`prior to [the] application, unless the same is proved to have been abandoned.” Act of
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`July 8, 1870, ch. 230, 16 Stat. 198, 201.5 And when Congress reenacted and recodified
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`the patent laws in the Patent Act of 1952, it again provided that no person would be
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`entitled to a patent on an invention that that was “in public use or on sale” prior to
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`the critical date. 35 U.S.C. § 102(b).
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`Over the nearly two centuries during which Congress has reenacted the on-sale
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`bar without changing the “on sale” language, the Supreme Court has repeatedly
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`4 Congress also eliminated the “consent or allowance requirement” in 1839. See
`1839 Act, 5 Stat. at 354; see also Andrews v. Hovey, 123 U.S. 267, 274 (1887).
`5 In 1939, Congress reduced the grace period from two years to one. Act of
`Aug. 5, 1939, ch. 450, 53 Stat. 1212.
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`described the statute as addressed to public sales, consistent with the Court’s original
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`articulation in Pennock of the policy underlying on-sale bar. In 1877, for example, the
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`Supreme Court considered whether a patented invention for the construction of
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`wooden pavement had been “in public use or on sale” within the meaning of the 1836
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`and 1839 statutes where the inventor had placed the pavement on a public road and
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`tested it for six years before filing his patent application. City of Elizabeth v. American
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`Nicholson Pavement Co., 97 U.S. 126, 133 (1878). The Supreme Court concluded that
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`the inventor had “intended this piece of pavement as an experiment, to test its
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`usefulness and durability,” which the Court concluded was not a “public use” within
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`the meaning of the law. Id. at 134-35. In reaching this conclusion, the Court
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`emphasized that, so long as the inventor “does not voluntarily allow others to make it
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`and use it, and so long as it is not on sale for general use, he keeps the invention under h