Case: 16-1284 CASE PARTICIPANTS ONLY Document: 89 Page: 1 Filed: 05/02/2016
`
`Nos. 2016-1284, -1787
`
`UNITED STATES COURT OF APPEALS
`FOR THE FEDERAL CIRCUIT
`
`HELSINN HEALTHCARE S.A., ROCHE PALO ALTO LLC,
`Plaintiffs-Appellees,
`
`v.
`
`TEVA PHARMACEUTICALS USA, INC., TEVA PHARMACEUTICAL INDUSTRIES, LTD.,
`Defendants-Appellants.
`
`
`On Appeal from the United States District Court for the District of New Jersey,
`Nos. 3:11-cv-03962, 3:11-cv-05579, 3:13-cv-05815, Judge Mary L. Cooper
`
`
`BRIEF FOR AMICI CURIAE PHARMACEUTICAL RESEARCH AND
`MANUFACTURERS OF AMERICA AND BIOTECHNOLOGY
`INNOVATION ORGANIZATION IN SUPPORT OF PLAINTIFFS-
`APPELLEES
`
`
`JAMIE T. WISZ
`THOMAS G. SAUNDERS
`ROBBIE MANHAS
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`1875 Pennsylvania Ave., NW
`Washington, DC 20006
`(202) 663-6000
`
`Attorneys for Amici Curiae
`Pharmaceutical Research and
`Manufacturers of America and
`Biotechnology Innovation
`Organization
`
`
`
`
`
`May 2, 2016
`
`Helsinn Healthcare Exhibit 2089
`Dr. Reddy's Laboratories, Ltd., et al. v. Helsinn Healthcare S.A.
`Trial PGR2016-00008
`
`Page 1 of 35
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`

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`Case: 16-1284 CASE PARTICIPANTS ONLY Document: 89 Page: 2 Filed: 05/02/2016
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`
`CERTIFICATE OF INTEREST
`
`Counsel for amici curiae Pharmaceutical Research and Manufacturers of
`America and Biotechnology Innovation Organization certify the following:
`
`1.
`
`The full name of every party or amicus represented by us is:
`
`Pharmaceutical Research and Manufacturers of America (PhRMA)
`
`Biotechnology Innovation Organization (BIO)
`
`2.
`
`The names of the real party in interest represented by us is:
`
`Not applicable
`
`All parent corporations and any publicly held companies that own 10
`3.
`percent or more of the stock of the party or amicus curiae represented by me are:
`
`PhRMA has no parent corporation and no publicly traded company owns
`10% of more of its stock. However, its membership includes companies that
`have issued stock or debt securities to the public. A list of PhRMA’s
`members is available at http://www.phrma.org/about/member-companies.
`
`BIO has no parent corporation and no publicly traded company owns 10% of
`more of its stock. However, its membership includes companies that have
`issued stock or debt securities to the public. A list of BIO’s members is
`available at https://www.bio.org/articles/bio-members-web-site-links.
`
`The names of all law firms and the partners or associates that
`4.
`appeared for the party or amicus now represented by me in the trial court or agency
`or are expected to appear in this court are:
`
`WILMER CUTLER PICKERING HALE AND DORR LLP: Robbie Manhas, Thomas
`G. Saunders, Jamie T. Wisz
`
`Dated: May 2, 2016
`
`
`
`- i -
`
`
`
`
`
`
`
`/s/ Jamie T. Wisz
`JAMIE T. WISZ
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`1875 Pennsylvania Ave., NW
`Washington, DC 20006
`(202) 663-6000
`
`Page 2 of 35
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`Case: 16-1284 CASE PARTICIPANTS ONLY Document: 89 Page: 3 Filed: 05/02/2016
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`
`TABLE OF CONTENTS
`
`
`
` C.
`
`II.
`
`Page
`CERTIFICATE OF INTEREST ................................................................................. i
`TABLE OF AUTHORITIES ................................................................................... iii
`INTEREST OF AMICI CURIAE .............................................................................. 1
`SUMMARY OF THE ARGUMENT ........................................................................ 2
`ARGUMENT ............................................................................................................. 5
`I.
`THE AIA REQUIRES THAT “ON SALE” PRIOR ART BE
`“AVAILABLE TO THE PUBLIC” .......................................................................... 5
`
`The Text Of AIA Section 102(a)(1) Requires Public
` A.
`Availability ............................................................................................ 5
`
` A Public Availability Reading Of AIA Section 102(a)(1) B.
`Is Most Consistent With The Statutory Scheme ................................. 10
`The Legislative History Confirms A Public Availability
`Reading Of AIA Section 102(a)(1) ..................................................... 15
`SOUND PATENT POLICY REQUIRES THAT “ON SALE” PRIOR ART
`BE PUBLICLY AVAILABLE ............................................................................... 19
`
`Eliminating Secret Prior Art Ensures A Simpler, More
` A.
`Predictable, And Fully Transparent Patent System ............................ 19
`Eliminating Secret Prior Art Allows Inventive
`Companies Greater Flexibility, Fostering Competition
`And Innovation .................................................................................... 22
`The AIA’s First-To-File Regime Undercuts The
`Rationale That Originally Motivated An Unnatural,
`Secret-Prior-Art Reading Of Pre-AIA Section 102(b)—A
`Reading The Supreme Court Has Never Endorsed ............................. 24
`CONCLUSION ........................................................................................................ 27
`CERTIFICATE OF SERVICE
`CERTIFICATE OF COMPLIANCE
`
`
`
` B.
`
`
`
` C.
`
`- ii -
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`Page 3 of 35
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`Case: 16-1284 CASE PARTICIPANTS ONLY Document: 89 Page: 4 Filed: 05/02/2016
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`
`TABLE OF AUTHORITIES
`
`Page(s)
`Barnhart v. Thomas, 540 U.S. 20 (2003) ................................................................... 8
`
`CASES
`
`Bates v. Coe, 98 U.S. 31 (1878) ............................................................................... 26
`
`Beachcombers International, Inc.v. Wildewood Creative Products
`Inc., 31 F.3d 1154 (Fed. Cir. 1994) ............................................................... 22
`
`Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141 (1989).................... 26
`
`Dey, L.P. v. Sunovion Pharmaceutivcals, Inc., 715 F.3d 1351
`(Fed. Cir. 2013) .............................................................................................. 18
`
`Egbert v. Lippmann, 104 U.S. 333 (1881) ............................................................... 25
`
`Electric Storage Battery Co. v. Shimadzu, 307 U.S. 5 (1939) ................................. 25
`
`Federal Maritime Commission v. Seatrain Lines, Inc., 411 U.S. 726
`(1973) ............................................................................................................... 7
`
`Garcia v. United States, 469 U.S. 70 (1984) ........................................................... 15
`
`Hall v. Macneale, 107 U.S. 90 (1883) ..................................................................... 25
`
`In re Eltgroth, 419 F.2d 918 (C.C.P.A. 1970) ......................................................... 14
`
`In re Theis, 610 F.2d 786 (C.C.P.A. 1979) ................................................................ 9
`
`Jama v. Immigration & Customs Enforcement, 543 U.S. 335 (2005) ....................... 8
`
`JumpSport, Inc. v. Jumpking, Inc., 191 F. App’x 926 (Fed. Cir. 2006) .................. 22
`
`Metallizing Engineering Co. v. Kenyon Bearing & Auto Parts Co.,
`153 F.2d 516 (2d Cir. 1946) .............................................................. 10, 19, 24
`
`Montgomery v. United States, 65 Ct. Cl. 526 (1928) .............................................. 14
`
`Nobelman v. American Savings Bank, 508 U.S. 324 (1993) ..................................... 8
`
`PAR Pharmacetical, Inc. v. TWI Pharmaceuticals, Inc., 773 F.3d 1186
`(Fed. Cir. 2014) .............................................................................................. 14
`
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`Page 4 of 35
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`

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`Case: 16-1284 CASE PARTICIPANTS ONLY Document: 89 Page: 5 Filed: 05/02/2016
`
`
`Parks v. Booth, 102 U.S. 96 (1880) ......................................................................... 26
`
`Paroline v. United States, 134 S. Ct. 1710 (2014) ................................................ 6, 7
`
`Paulik v. Rizkalla, 760 F.2d 1270 (Fed. Cir. 1985) ................................................. 22
`
`Peeler v. Miller, 535 F.2d 647 (C.C.P.A. 1976) ...................................................... 14
`
`Pennock v. Dialogue, 27 U.S. (2 Pet.) 1 (1829) ...................................................... 25
`
`Porto Rico Railway, Light & Power Co. v. Mor, 253 U.S. 345 (1920)..................... 7
`
`Sanitary Refrigerator Co. v. Winters, 280 U.S. 30 (1929) ...................................... 14
`
`Woodland Trust v. Flowertree Nursery, Inc., 148 F.3d 1368 (Fed. Cir.
`1998) .............................................................................................................. 18
`
`STATUTES, RULES, AND REGULATIONS
`
`18 U.S.C. § 2259 .................................................................................................... 6, 7
`
`35 U.S.C. § 102 .................................................................................................... 5, 12
`
`Examination Guidelines for Implementing the First Inventor To File
`Provisions of the Leahy-Smith America Invents Act, 78 Fed.
`Reg. 11,059 (Feb. 14, 2013) .......................................................................... 20
`
`Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284
`(2011) ............................................................................................................... 2
`
`LEGISLATIVE MATERIALS
`
`H.R. 2795, 109th Cong. (2005) ................................................................................ 18
`
`H.R. Rep. No. 112-98 (2011) ....................................................................... 11, 12, 16
`
`S. Rep. No. 110-259 (2008) ..................................................................................... 16
`
`157 Cong. Rec. H4420 (daily ed. June 22, 2011) .............................................. 15, 17
`
`157 Cong. Rec. S1175 (daily ed. Mar. 3, 2011) ................................................ 14, 17
`
`157 Cong. Rec. S1360 (daily ed. Mar. 8, 2011) ................................ 8, 13, 17, 21, 22
`
`157 Cong. Rec. S1496 (daily ed. Mar. 9, 2011) ................................................ 16, 17
`
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`Case: 16-1284 CASE PARTICIPANTS ONLY Document: 89 Page: 6 Filed: 05/02/2016
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`
`OTHER AUTHORITIES
`Barner, Sharon R. & Harold C. Wegner, TACPI, Second Generation
`Chinese Patent Sophistication (Nov. 6, 2007) .............................................. 11
`
`Black’s Law Dictionary (10th ed. 2014) .................................................................... 5
`
`Cotropia, Christopher A., The Folly of Early Filing in Patent Law, 61
`Hastings L.J. 65 (2009) .................................................................................. 23
`
`Cotropia, Christopher A., Modernizing Patent Law’s Inequitable
`Conduct Doctrine, 24 Berkeley Tech. L.J. 723 (2009) ................................. 21
`
`http://www.phrma.org/about/member-companies ..................................................... 1
`
`https://www.bio.org/articles/bio-members-web-site-links ........................................ 1
`
`Intellectual Property Owners Association, Comments on Proposed
`Rules and Examination Guidelines (Oct. 5, 2012) ........................................ 10
`
`Karshtedt, Dmitry, The Riddle of Secret Public Use: A Response to
`Professor Lemley, 93 Tex. L. Rev. See Also 159 (2015) .............................. 23
`
`Manual of Patent Examining Procedure § 2151 (2015) .......................................... 12
`
`Matal, Joe, A Guide to the Legislative History of the America Invents
`Act: Part I of II, 21 Fed. Cir. B.J. 435 (2012) ................................................. 9
`
`PhRMA, 2015 Profile: Biopharmaceutical Research Industry vi
`(2015), available at http://www.phrma.org/sites/default/files/
`pdf/2015_phrma_profile.pdf ............................................................................ 2
`
`Scalia, Antonin & Bryan A. Garner, Reading Law: The Interpretation
`of Legal Texts (2012) ................................................................................... 5, 8
`
`White House Office of the Press Secretary, Press Release, President
`Obama Signs America Invents Act, Overhauling the Patent
`System to Stimulate Economic Growth, and Announces New
`Steps to Help Entrepreneurs Create Jobs (Sept. 16, 2011)........................... 20
`
`
`
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`Case: 16-1284 CASE PARTICIPANTS ONLY Document: 89 Page: 7 Filed: 05/02/2016
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`
`INTEREST OF AMICI CURIAE1
`
`Pharmaceutical Research and Manufacturers of America (PhRMA) is a
`
`voluntary, nonprofit association of leading research-based pharmaceutical and
`
`biotechnology companies. PhRMA’s members are the primary source of the many
`
`new drugs and biologics introduced each year. These new medicines have played
`
`a key role in extending longevity and improving the quality of human life.
`
`Biotechnology Innovation Organization (BIO) is the world’s largest trade
`
`association, representing over 1100 biotechnology companies, academic
`
`institutions, state biotechnology centers, and related organizations across the
`
`United States and in more than 30 other nations. BIO members research and
`
`develop biotechnological healthcare, agricultural, environmental, and industrial
`
`products. BIO members range from startup entities and university spinoffs to
`
`Fortune 500 multinational corporations, though the majority of BIO members are
`
`small companies that have yet to bring products to market or attain profitability,
`
`and thus depend on venture capital and other private investment for their growth.
`
`Medical advances such as those made by PhRMA’s and BIO’s members
`
`require enormous investments in research and development. For example,
`
`1
`No counsel for a party authored this brief in whole or part, and no person
`other than amici, their members, or their counsel made a monetary contribution to
`fund its preparation or submission. Both appellants and appellees have consented
`to the filing of this brief. A complete list of PhRMA members is available at
`http://www.phrma.org/about/member-companies. A complete list of BIO
`members is available at https://www.bio.org/articles/bio-members-web-site-links.
`
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`PhRMA member companies invested $51.2 billion in research and development of
`
`new medicines in 2014 and over half a trillion dollars since 2000. PhRMA, 2015
`
`Profile: Biopharmaceutical Research Industry vi (2015), available at http://www.
`
`phrma.org/sites/default/files/pdf/2015_phrma_profile.pdf.
`
`The protections of patent law provide incentives for companies to take on the
`
`huge risks of drug development. For those incentives to work effectively,
`
`biopharmaceutical innovation requires stability and predictability in patent law.
`
`“Secret” prior art creates uncertainty that clouds investment decisions. PhRMA and
`
`BIO accordingly have an interest in ensuring that the America Invents Act is not
`
`misconstrued to revive the categories of secret prior art that Congress eliminated.
`
`SUMMARY OF THE ARGUMENT
`
`Secret prior art has long been recognized as a drag on the patent system. It
`
`creates uncertainty about the validity of issued patents, increases the burdens of
`
`litigation and administrative proceedings, and restrains corporate dealings in a way
`
`that stifles competition and innovation. The Leahy-Smith America Invents Act
`
`(AIA), Pub. L. No. 112-29, 125 Stat. 284 (2011), addressed these problems by
`
`eliminating most forms of secret prior art, including secret uses and sales that
`
`existed under pre-AIA Section 102(b). Such prior-art references no longer qualify
`
`under the plain text of AIA Section 102(a)(1), which added the modifier “or
`
`otherwise available to the public” at the end of a series of parallel terms to make
`
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`clear that all of the categories of prior art listed in AIA Section 102(a)(1) must be
`
`“available to the public.”
`
`The meaning of this plain text is reinforced by the statutory context. In an
`
`effort to push the patent system toward international harmonization and overall
`
`efficiency, the AIA expanded the scope of prior art in certain respects by
`
`simplifying the categories of prior art now available. It eliminated geographic
`
`restrictions, meaning that references from anywhere in the world now qualify as
`
`prior art. It also eliminated temporal restrictions previously tied to the date of
`
`invention. In light of these changes, allowing secret prior art to qualify under AIA
`
`Section 102(a)(1) would have vastly increased the scope of secret art that could
`
`operate to invalidate a patent, transforming a carefully circumscribed category
`
`under pre-AIA versions of the statute into a sprawling and unpredictable form of
`
`new art. To prevent this unprecedented expansion, Congress modified AIA
`
`Section 102(a)(1) to eliminate most forms of secret prior art and to make clear that
`
`prior art under that section must be available to the public.
`
`Disregarding Congress’s considered judgment to eliminate secret prior art
`
`would undermine the purposes of the AIA. Far from advancing international
`
`harmonization, expanding secret prior art would put the United States out of step
`
`with the rest of the world, which does not recognize secret prior art. Similarly,
`
`expanding the scope of secret prior art conflicts with novel AIA efficiency
`
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`measures, such as post-grant review, which are not equipped to handle the
`
`discovery-intensive burdens that secret prior art entails. The elimination of secret
`
`prior art therefore achieves intra-statutory harmony. And it is not inconsistent with
`
`the varying usage of “disclosure” and “publicly disclose” in AIA Section
`
`102(b)(1), which merely reflects the fact that certain disclosures can be non-public,
`
`not that the prior-art categories under AIA Section 102(a)(1) can be.
`
`The legislative history confirms the elimination of secret prior art under AIA
`
`Section 102(a)(1). It contains a number of explicit and powerful statements of
`
`such intent, including in the final Committee Report and in the statements of key
`
`sponsors. No such evidence of intent exists in favor of retaining secret prior art.
`
`The district court’s recognition of Congress’s clear intent should therefore
`
`be affirmed. Not only does sound patent policy support eliminating secret prior
`
`art, but the rationale that motivated the pre-AIA rule that an applicant’s secret uses
`
`and sales should constitute prior art has little applicability in the AIA’s first-to-file
`
`regime. And the reading that rationale supports is made only weaker by the fact
`
`that the Supreme Court has never squarely endorsed it—indeed, the Court has
`
`made statements to the effect that secret uses and sales do not qualify as prior art.
`
`Because secret prior art is unsound as a matter of both general patent policy and
`
`the specific concerns the Court has said animate the public use and on-sale bars,
`
`secret activities should not be treated as prior art under AIA Section 102(a)(1).
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`ARGUMENT
`
`I.
`
`THE AIA REQUIRES THAT “ON SALE” PRIOR ART BE “AVAILABLE TO
`THE PUBLIC”
`
`Congress fundamentally altered patent law in multiple ways through passage
`
`of the AIA. One important change—signaled uniformly across the AIA’s text,
`
`structure, and legislative history—was the elimination of most forms of secret prior
`
`art, including secret prior-art sales that existed under pre-AIA Section 102(b). This
`
`Court should affirm the district court’s recognition of Congress’s clear intent with
`
`respect to this important reform.
`
`
`
` The Text Of AIA Section 102(a)(1) Requires Public Availability A.
`
`AIA Section 102(a)(1) provides that “[a] person shall be entitled to a patent
`
`unless … the claimed invention was patented, described in a printed publication, or
`
`in public use, on sale, or otherwise available to the public before the effective
`
`filing date of the claimed invention.” 35 U.S.C. § 102(a)(1) (emphasis added).
`
`The plain text of this provision indicates that sales and offers to sell do not qualify
`
`as prior art unless they make the invention “available to the public.”
`
`The bolded phrase is a series qualifier: a modifier at the end of list that
`
`applies to every item in the list. Scalia & Garner, Reading Law: The Interpretation
`
`of Legal Texts 147 (2012) (“When there is a straightforward, parallel construction
`
`that involves all nouns or verbs in a series, a prepositive or postpositive modifier
`
`normally applies to the entire series.”); see also Black’s Law Dictionary 1574 (10th
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`ed. 2014) (explaining the “series-qualifier canon”). The preceding clauses,
`
`including “on sale,” run parallel to the clause “otherwise available to the public.”
`
`Therefore, the most natural reading of the text is that “on sale” prior art must be
`
`“available to the public.”
`
`The Supreme Court has repeatedly and recently applied the series-qualifier
`
`canon to provisions similar to AIA Section 102(a)(1). For example, in Paroline v.
`
`United States, 134 S. Ct. 1710 (2014), the Court interpreted 18 U.S.C. § 2259, a
`
`statute that provides restitution to victims of offenses involving sexual exploitation
`
`of children. At issue was the effect of the final clause of a list that defined the
`
`phrase “full amount of the victim’s losses”:
`
`Definition.--For purposes of this subsection, the term “full amount of
`the victim’s losses” includes any costs incurred by the victim for—
`
`(A) medical services relating to physical, psychiatric, or psychological
`care;
`
`(B) physical and occupational therapy or rehabilitation;
`
`(C) necessary transportation, temporary housing, and child care
`expenses;
`
`(D) lost income;
`
`(E) attorneys’ fees, as well as other costs incurred; and
`
`(F) any other losses suffered by the victim as a proximate result of
`the offense.
`
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`18 U.S.C. § 2259(b)(3) (emphasis added). The Court determined that the final
`
`clause was a series qualifier—that every preceding loss in the list also had to be “a
`
`proximate result of the offense.” Paroline, 134 S. Ct. at 1720-1722.
`
`In reaching this conclusion, the Court relied on commonsense grammatical
`
`principles. It noted that “‘[w]hen several words are followed by a clause which is
`
`applicable as much to the first and other words as to the last, the natural
`
`construction of the language demands that the clause be read as applicable to all.”
`
`Paroline, 134 S. Ct. at 1721 (quoting Porto Rico Railway, Light & Power Co. v.
`
`Mor, 253 U.S. 345, 348 (1920)). It also noted that “‘[catch-all] clauses are to be
`
`read as bringing within a statute categories similar in type to those specifically
`
`enumerated.’” Id. (quoting Federal Maritime Comm’n v. Seatrain Lines, Inc., 411
`
`U.S. 726, 734 (1973)) (alteration in original).
`
`Because AIA Section 102(a)(1)’s “otherwise available to the public”—like
`
`Paroline’s “any other losses”—“defines a broad, final category” of the same
`
`substantive character and syntactic structure as the items in the list preceding it, the
`
`phrase too should be read to restrict the meaning of every item in the list.2
`
`Paroline, 134 S. Ct. at 1721. Indeed, Congress was well aware of the series-
`
`qualifier canon and expressly invoked it in connection with AIA Section 102(a)(1).
`
`
`2
`At a minimum, under the series-qualifier cannon, the catch-all clause would
`apply to the “in public use” and “on sale” categories of prior art, which are not
`affected by the “or” that immediately follows “described in a printed publication.”
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`See 157 Cong. Rec. S1360, S1370 (daily ed. Mar. 8, 2011) (statement of Senator
`
`Jon Kyl) (“Courts have consistently found that when the words ‘or otherwise’ or
`
`‘or other’ are used to add a modifier at the end of a string of clauses, the modifier
`
`thus added restricts the meaning of the preceding clauses.” (citing case law from
`
`various jurisdictions)).
`
`The so-called “rule of the last antecedent” is not to the contrary. That rule,
`
`which holds that “a limiting clause or phrase … should ordinarily be read as
`
`modifying only the noun or phrase that it immediately follows,” applies only in
`
`limited circumstances not present here. Barnhart v. Thomas, 540 U.S. 20, 26
`
`(2003) (last-antecedent rule “can assuredly be overcome by other indicia of
`
`meaning”); see also, e.g., Nobelman v. American Savings Bank, 508 U.S. 324, 330-
`
`331 (1993) (refusing to apply last-antecedent rule when a contrary interpretation
`
`was “the more reasonable one”). In particular, the last-antecedent rule applies
`
`where—unlike here—“the syntax involves something other than a parallel series of
`
`nouns or verbs,” Scalia & Garner, Reading Law: The Interpretation of Legal Texts
`
`152 (2012), or lacks a linking word, such as “otherwise,” indicating commonality.
`
`The relevant clause at issue in AIA Section 102(a)(1) is not “a structurally discrete
`
`statutory provision” but “the end of a single, integrated list”—a context in which
`
`the last-antecedent rule holds no purchase. Jama v. Immigration & Customs
`
`Enforcement, 543 U.S. 335, 344 n.4 (2005).
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`Even if the last-antecedent rule were applied, the most logical modifier
`
`would be “otherwise available to the public” and the last antecedent would be “on
`
`sale.” To contend that “available to the public” is the modifier and “otherwise” is
`
`the last antecedent makes little sense: “otherwise” has no independent meaning in
`
`the series, which could not simply end “in public use, on sale, or otherwise” and be
`
`coherent. The only way to give “otherwise” meaning is to read it as part of the
`
`modifying phrase “otherwise available to the public”; in this capacity, the term acts
`
`as a bridge across different types of prior art, all of which share the characteristic
`
`of being publicly available.
`
`Whatever canon is applied, interpreting “on sale” prior art to be “available to
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`the public” accords with the AIA’s change to the title of Section 102. Pre-AIA
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`Section 102 was entitled “Conditions for patentability; novelty and loss of right to
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`patent.” AIA Section 102 is entitled “Conditions for patentability; novelty.” The
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`removal of the phrase “and loss of right to patent” reflects that AIA Section
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`102(a)(1)’s “otherwise available to the public” language eliminates the pre-AIA
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`loss-of-right rule of counting an inventor’s secret activities as prior art. Matal, A
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`Guide to the Legislative History of the America Invents Act: Part I of II, 21 Fed.
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`Cir. B.J. 435, 450 (2012) (“In light of the AIA’s repeal of all ‘loss of right to
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`patent’ provisions based on secret activities from § 102, those words have been
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`removed from the title of § 102.”); see also In re Theis, 610 F.2d 786, 792
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`(C.C.P.A. 1979) (citing Metallizing Eng’g Co. v. Kenyon Bearing & Auto Parts
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`Co., 153 F.2d 516, 520 (2d Cir. 1946)), and noting that an “inventor’s loss of right
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`to patent flows from the attempt to profit from the invention by commercial
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`exploitation beyond the grace period” (emphasis added)).
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` A Public Availability Reading Of AIA Section 102(a)(1) Is Most B.
`Consistent With The Statutory Scheme
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`Statutory context reinforces the fact that “on sale” prior art must be publicly
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`available. The AIA expanded the scope of prior art in several respects. For
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`example, it eliminated geographic restrictions that had limited the on-sale and
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`public use bars to activities in the United States. It also relaxed temporal
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`restrictions as part of the move to a first-to-file system. At the same time,
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`Congress added the qualifier “otherwise available to the public” to ensure that
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`these expansions—intended to harmonize U.S. patent law with the law of other
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`countries and to simplify patent litigation—would not have perverse consequences.
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`In the pre-AIA regime, secret prior art was a small, carefully circumscribed
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`universe of potentially invalidating references. Even then it created tremendous
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`uncertainty. See Intellectual Property Owners Association, Comments on
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`Proposed Rules and Examination Guidelines 3 (Oct. 5, 2012) (“[P]atent litigation
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`… [is] burdened with extensive discovery into whether or not a patentee secretly
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`sought to sell or offer to sell his invention.”). The last thing Congress wanted was
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`to give that uncertainty global reach, exposing inventors to secret prior art from
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`around the world. Doing so would have vastly increased the scope of secret prior-
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`art references, multiplying the burden and cost of patent-related litigation and
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`administrative proceedings. See infra Part II.A; see also, e.g., H.R. Rep. No. 112-
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`98, at 42 (“[T]he America Invents Act … simplifies how prior art is determined,
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`provides more certainty, and reduces the cost associated with filing and litigating
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`patents.”).
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`The amicus brief submitted by intellectual property professors ignores this
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`critical context when it argues that Congress would not have abandoned prior
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`interpretations of the terms “on sale” and “in public use.” See IP Professors’ Br.
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`11. The question before Congress was not whether to maintain the status quo with
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`respect to those categories of prior art, but how far they would be allowed to
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`expand. Congress drew the line at secret prior art, which was already problematic
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`even when limited to the United States, by inserting the requirement that all AIA
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`Section 102(a)(1) prior art be “available to the public.”
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`Indeed, creating a system of global secret prior art would have run against
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`the AIA’s goal of international harmonization. See, e.g., H.R. Rep. No. 112-98, at
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`42 (2011). Other countries do not follow any rule comparable to the pre-AIA’s
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`“unique bar against patenting an applicant’s secret invention.” Barner & Wegner,
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`TACPI, Second Generation Chinese Patent Sophistication 5 n.8 (Nov. 6, 2007)
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`(“No other country has followed the lead of Learned Hand in Metallizing
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`Engineering.”). Expanding the scope of secret prior art would have made the
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`United States even more of an outlier. The only place Congress did allow a type of
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`secret prior art was in AIA Section 102(a)(2), which treats as prior art originally
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`confidential patent applications later published under AIA Section 122(b). But
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`unlike the proposed expansion of Section 102(a)(1), that provision was limited to
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`art easily accessible to the PTO. Elsewhere, the AIA eliminated pre-AIA
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`categories of secret prior art, such as derivation under pre-AIA Section 102(f) and
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`prior invention under pre-AIA Section 102(g). See 35 U.S.C. § 102(f) (pre-AIA)
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`(person not entitled to a patent if “he did not himself invent the subject matter
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`sought to be patented”); id. § 102(g) (person not entitled to a patent if, “before such
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`person’s invention[,] … the invention was made” by another inventor meeting
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`certain requirements); see also MPEP § 2151 (overview discussing the AIA’s
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`elimination of pre-AIA Section 102(g) and (f) art).
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`Moreover, allowing secret prior art under AIA Section 102(a)(1) would
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`undermine other provisions of the AIA. Particularly relevant are the provisions
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`establishing post-grant review, which are meant to “make the patent system more
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`efficient[,] … improve the quality of patents and the patent system[,] … and
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`restore confidence in the presumption of validity that comes with issued patents in
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`court.” H.R. Rep. No. 112-98, at 48. These goals would be thwarted by the
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`inclusion of secret prior art.