Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336 (2010)
`94 U.S.P.Q.2d 1161
`
`
`
`KeyCite Yellow Flag - Negative Treatment
` Distinguished by GlaxoSmithKline LLC v. Banner Pharmacaps, Inc.,
`Fed.Cir.(Del.), February 24, 2014
`598 F.3d 1336
`United States Court of Appeals,
`Federal Circuit.
`
`ARIAD PHARMACEUTICALS, INC., Massachusetts
`Institute of Technology, The Whitehead Institute
`for Biomedical Research, and the President and
`Fellows of Harvard College, Plaintiffs–Appellees,
`v.
`ELI LILLY AND COMPANY, Defendant–Appellant.
`
`No. 2008–1248.
`|
`March 22, 2010.
`
`Synopsis
`Background: Owners of patent claiming methods
`comprising the single step of reducing Nuclear Factor
`Kappa B (NF-kB) activity in eukaryotic cells brought
`infringement action against competitor. After a jury found
`infringement, and concluded that the asserted claims were
`not invalid for anticipation, lack of enablement, or lack
`of written description, the United States District Court
`for the District of Massachusetts, Rya W. Zobel, J., 529
`F.Supp.2d 106, denied competitor's motion for judgment
`as a matter of law (JMOL), and a final judgment was
`entered, 2007 WL 2712087. Competitor appealed. The
`United States Court of Appeals for the Federal Circuit,
`560 F.3d 1366,affirmed in part and reversed in part, and
`patentees petitioned for rehearing en banc.
`
`Holdings: The Court of Appeals, en banc, Lourie, Circuit
`Judge, held that:
`
`[1] statute requiring that patent specification contain a
`written description of the invention contained a written
`description requirement separate from enablement, and
`
`[2] patent was invalid for failure to provide adequate
`written description.
`
`Reversed in part and affirmed in part.
`
`Newman, Circuit Judge, wrote separately, expressing
`additional views.
`
`Gajarsa, Circuit Judge, filed concurring opinion.
`
`Rader, Circuit Judge, filed opinion dissenting-in-part and
`concurring-in-part in which Linn, Circuit Judge, joined.
`
`Linn, Circuit Judge, filed opinion dissenting-in-part and
`concurring-in-part in which Rader, Circuit Judge, joined.
`
`Attorneys and Law Firms
`
`*1337 John M. Whealan, of Silver Spring, MD, argued
`for plaintiffs-appellees. With him on the brief were James
`W. Dabney, Stephen S. Rabinowitz, and Randy C.
`Eisensmith, Fried Frank Harris Shriver & Jacobson LLP,
`of New York, NY, and John F. Duffy, of Washington,
`DC. Of counsel were Leora Ben–Ami, Patricia A. Carson,
`Christopher T, Jagoe, Sr., Matthew McFarlane, and
`Howard S. Suh, Kaye Scholer LLP, of New York, NY.
`
`Charles E. Lipsey, Finnegan, Henderson, Farabow,
`Garrett & Dunner, L.L.P., of Reston, VA, argued for
`defendant-appellant. With him on the brief were Robert
`D. Bajefsky, David S. Forman, Howard W. Levine,
`Laura P. Masurovsky, and Jennifer A. Johnson, of
`Washington, DC, and Jennifer S. Swan, of Palo Alto,
`CA. Of counsel on the brief were Paul R. Cantrell,
`Gilbert T. Voy, and Alexander Wilson, Eli Lilly and
`Company, of Indianapolis, IN. Of counsel was Sanya
`Sukduang, Finnegan, Henderson, Farabow, Garrett &
`Dunner, L.L.P., of Washington, DC.
`
`*1338 Mark R. Freeman, Attorney, Appellate Staff,
`Civil Division, United States Department of Justice, of
`Washington, DC, argued for amicus curiae United States.
`With him on the brief were Ann Ravel, Acting Assistant
`Attorney General, and Scott R. McIntosh, Attorney. Of
`counsel on the brief were James A. Toupin, General
`Counsel, and Raymond T. Chen, Solicitor, United States
`Patent and Trademark Office, of Arlington, VA.
`
`Roberta J. Morris, of Menlo Park, CA, for amicus curiae
`Roberta J. Morris, Esq., Ph.D.
`
`Kenneth J. Burchfiel, Sughrue Mion, PLLC, of
`Washington, DC, for amicus curiae Novozymes A/S. With
`him on the brief was John T. Callahan.
`
` © 2017 Thomson Reuters. No claim to original U.S. Government Works.
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`

`Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336 (2010)
`94 U.S.P.Q.2d 1161
`
`Christopher M. Holman, University of Missouri–Kansas
`City School of Law, of Kansas City, MO, for amicus
`curiae Law Professor Christopher M. Holman.
`
`Mark D. Janis, Indiana University Maurer School of Law,
`of Bloomington, IN, for amici curiae Mark D. Janis and
`Timothy R. Holbrook.
`
`Charles A. Weiss, Kenyon & Kenyon LLP, of New York,
`NY, for amicus curiae New York Intellectual Property
`Law Association. With him on the brief was Dale L.
`Carlson, Wiggin and Dana LLP, of New Haven, CT.
`
`Lynn H. Pasahow, Fenwick & West LLP, of Mountain
`View, CA, for amici curiae The Regents of the University
`of California, et al. With him on the brief were Heather
`N. Mewes and Carolyn C. Chang. Of counsel on the brief
`was P. Martin Simpson, Jr., The Regents of the University
`of California, of Oakland, CA.
`
`Charles Lee Thomason, Spalding & Thomason, of
`Bardstown, KY, for amici curiae The University of
`Kentucky Intellectual Property Law Society, et al.
`
`Christopher A. Cotropia, Intellectual Property Institute,
`University of Richmond Law School, of Richmond, VA,
`for Professor Christopher A. Cotropia.
`
`Herbert C. Wamsley, Intellectual Property Owners
`Association, of Washington, DC, for amicus curiae
`Intellectual Property Owners Association. On the brief
`were Peter G. Pappas, William F. Long, and Elizabeth
`A. Lester, Sutherland Asbill & Brennan LLP, of Atlanta,
`GA, and Steven W. Miller and Richard F. Phillips,
`Intellectual Property Owners Association, of Washington,
`DC.
`
`William P. Atkins, Pillsbury Winthrop Shaw Pittman
`LLP, of McLean, VA, for amicus curiae Medtronic, Inc.
`With him on the brief was Jack S. Barufka.
`
`Oskar Liivak, Cornell Law School, of Ithaca, NY, for
`amicus curiae Oskar Liivak.
`
`Robert F. Kramer, Howrey LLP, of San Francisco, CA,
`for amicus curiae RealNetworks, Inc. With him on the
`brief were David R. Stewart and Irene I. Yang.
`
`James E. Brookshire, Federal Circuit Bar Association, of
`Washington, DC, for amicus curiae Federal Circuit Bar
`Association. With him on the brief were Edward R. Reines
`
`and Sonal N. Mehta, Weil, Gotshal & Manges LLP, of
`Redwood Shores, CA.
`
`Walter Dellinger, O'Melveny & Myers LLP, of
`Washington, DC, for amicus curiae Hynix Semiconductor
`Inc. With him on the brief were Sri Srinivasan, Mark S.
`Davies, and Kathryn E. Tarbert; and Kenneth L. Nissly
`and Susan Roeder, of Menlo Park, CA. Of counsel on
`the brief were Theodore G. Brown, III and Julie J. Han,
`Townsend and Townsend and Crew LLP, of Palo Alto,
`CA. On the brief for amicus curiae Samsung Electronics
`Co., Ltd. was Matthew D. Powers, Weil Gotshal &
`Manges LLP, of Redwood Shores, CA. With him on the
`brief were Steven S. Cherensky; Robert S. Berezin, of New
`*1339 York, NY; and Carmen E. Bremer, of Dallas, TX.
`
`R. Carl Moy, William Mitchell College of Law, of St.
`Paul, MN, for amicus curiae William Mitchell College of
`Law, Intellectual Property Institute. With him on the brief
`was Jay A. Erstling.
`
`William F. Lee, Wilmer Cutler Pickering Hale and
`Dorr LLP, of Boston, MA, for amicus curiae Abbott
`Laboratories. With him on the brief were William G.
`McElwain, Randolph D. Moss, Amy K. Wigmore, and
`Thomas G. Saunders of Washington, DC. Of counsel on
`the brief were Eric P. Martin and Peter N. Witty, Abbott
`Laboratories, of Abbott Park, IL.
`
`Nancy J. Linck, Rothwell, Figg, Ernst & Manbeck,
`P.C., of Washington, DC, for amicus curiae Monsanto
`Company. With her on the brief were Minaksi Bhatt and
`Martha Cassidy. Of counsel on the brief was Dennis R.
`Hoerner, Monsanto Company, of St. Louis, MO.
`
`Sherry M. Knowles, GlaxoSmithKline, of King of
`Prussia, PA, for amicus curiae GlaxoSmithKline.
`
`Constantine L. Trela, Jr., Sidley Austin LLP, of Chicago,
`IL, for amicus curiae Microsoft Corporation. With him
`on the brief were Richard A. Cederoth and Tacy F. Flint;
`and Jeffrey P. Kushan, of Washington, DC. Of counsel
`on the brief was Thomas Andrew Culbert, Microsoft
`Corporation, of Redmond, WA.
`
`Richard A. Samp, Washington Legal Foundation, of
`Washington, DC, for amicus curiae Washington Legal
`Foundation. With him on the brief was Daniel J. Popeo.
`
`Lloyd R. Day, Jr., Howrey LLP, of East Palo Alto, CA,
`for amicus curiae Amgen Inc. With him on the brief
`
` © 2017 Thomson Reuters. No claim to original U.S. Government Works.
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`

`Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336 (2010)
`94 U.S.P.Q.2d 1161
`
`was Linda A. Sasaki–Baxley. Of counsel on the brief
`were Stuart L. Watt, Wendy A. Whiteford, Monique L.
`Cordray, and Gail A. Katz, Amgen Inc., of Thousand
`Oaks, CA.
`
`Teresa Stanek Rea, Crowell & Moring LLP, of
`Washington, DC, for amicus curiae American Intellectual
`Property Law Association. Of counsel on the brief was
`Alan J. Kaspar, American Intellectual Property Law
`Association, of Arlington, VA.
`
`Paul D. Clement, King & Spalding LLP, of Washington,
`DC, for amici curiae Google Inc., and Verizon
`Communications, Inc. With him on the brief were Erin E.
`Morrow and Scott T. Weingaertner, of New York, NY.
`Of counsel for Verizon Communications, Inc. was John
`Thorne, Verizon Communications, Inc., of Arlington,
`VA. Of counsel for Google Inc. was Michelle K. Lee,
`Google Inc., of Mountain View, CA. On the brief for
`amicus curiae Cisco Systems, Inc. was Louis Norwood
`Jameson, Duane Morris LLP, of Atlanta, GA.
`
`Joshua D. Sarnoff, Glushko–Samuelson Intellectual
`Property Law Clinic, Washington College of Law,
`American University, of Washington, DC, for amicus
`curiae Public Patent Foundation.
`
`Before MICHEL, Chief Judge, NEWMAN, MAYER,
`LOURIE, RADER, BRYSON, GAJARSA, LINN,
`DYK, PROST, and MOORE, Circuit Judges.
`
`Opinion
`
`Opinion for the court filed by Circuit Judge LOURIE,
`in which Chief Judge MICHEL and Circuit Judges
`NEWMAN, MAYER, BRYSON, GAJARSA, DYK,
`PROST, and MOORE join. Additional views filed by
`Circuit Judge NEWMAN. Concurring opinion filed by
`Circuit Judge GAJARSA. Dissenting-in-part, concurring-
`in-part opinion filed by Circuit Judge RADER, in which
`Circuit Judge LINN joins. Dissenting-in-part, concurring-
`in-part opinion filed by Circuit Judge LINN, in which
`Circuit Judge RADER joins.
`
`*1340 LOURIE, Circuit Judge.
`
`Ariad Pharmaceuticals, Inc., Massachusetts Institute of
`Technology, the Whitehead Institute for Biomedical
`Research, and the President and Fellows of Harvard
`College (collectively, “Ariad”) brought suit against
`Eli Lilly & Company (“Lilly”) in the United States
`
`District Court for the District of Massachusetts, alleging
`infringement of U.S. Patent 6,410,516 (“the ′516
`patent”). After trial, at which a jury found infringement,
`but found none of the asserted claims invalid, a panel
`of this court reversed the district court's denial of Lilly's
`motion for judgment as a matter of law (“JMOL”)
`and held the asserted claims invalid for lack of written
`description. Ariad Pharms., Inc. v. Eli Lilly & Co., 560 F.3d
`1366 (Fed.Cir.2009).
`
`Ariad petitioned for rehearing en banc, challenging this
`court's interpretation of 35 U.S.C. § 112, first paragraph,
`as containing a separate written description requirement.
`Because of the importance of the issue, we granted Ariad's
`petition and directed the parties to address whether
`§ 112, first paragraph, contains a written description
`requirement separate from the enablement requirement
`and, if so, the scope and purpose of that requirement. We
`now reaffirm that § 112, first paragraph, contains a written
`description requirement separate from enablement, and
`we again reverse the district court's denial of JMOL
`and hold the asserted claims of the ′516 patent invalid
`for failure to meet the statutory written description
`requirement.
`
`BACKGROUND
`
`The ′516 patent relates to the regulation of gene
`expression by the transcription factor NF-êB. The
`inventors of the ′516 patent were the first to identify
`NF-êB and to uncover the mechanism by which NF-êB
`activates gene expression underlying the body's immune
`responses to infection. The inventors discovered that NF-
`êB normally exists in cells as an inactive complex with
`a protein inhibitor, named “IêB” (“Inhibitor of kappa
`B”), and is activated by extracellular stimuli, such as
`bacterial-produced lipopolysaccha rides, through a series
`of biochemical reactions that release it from IêB. Once
`free of its inhibitor, NF-êB travels into the cell nucleus
`where it binds to and activates the transcription of
`genes containing a NF-êB recognition site. The activated
`genes (e.g., certain cytokines), in turn help the body to
`counteract the extracellular assault. The production of
`cytokines can, however, be harmful in excess. Thus the
`inventors recognized that artificially interfering with NF-
`êB activity could reduce the harmful symptoms of certain
`diseases, and they filed a patent application on April 21,
`1989, disclosing their discoveries and claiming methods
`
` © 2017 Thomson Reuters. No claim to original U.S. Government Works.
`
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`Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336 (2010)
`94 U.S.P.Q.2d 1161
`
`for regulating cellular responses to external stimuli by
`reducing NF-êB activity in a cell.
`
`Ariad brought suit against Lilly on June 25, 2002, the
`day the ′516 patent issued. Ariad alleged infringement of
`claims 80, 95, 144, and 145 by Lilly's Evista® and Xigris®
`pharmaceutical products. The asserted claims, rewritten
`to include the claims from which they depend, are as
`follows:
`
`80. [A method for modifying effects of external
`influences on a eukaryotic cell, which external
`influences
`induce NF-êB-mediated
`intracellular
`signaling, the method comprising altering NF-êB
`activity in the cells such that NF-êB-mediated effects
`of external influences are modified, wherein NF-êB
`activity in the cell is reduced] wherein reducing NF-êB
`activity comprises reducing binding of NF-êB to NF-
`êB recognition sites on genes which are transcriptionally
`regulated by NF-êB.
`
`*1341 95. [A method for reducing, in eukaryotic cells,
`the level of expression of genes which are activated by
`extracellular influences which induce NF-êBmediated
`intracellular signaling, the method comprising reducing
`NF-êB activity in the cells such that expression of said
`genes is reduced], carried out on human cells.
`
`bacterial
`reducing
`for
`[A method
`144.
`lipopolysaccharide-induced expression of cytokines in
`mammalian cells, which method comprises reducing
`NF-êB activity
`in
`the cells so as
`to reduce
`bacterial lipopolysaccharide-induced expression of said
`cytokines in the cells] wherein reducing NF-êB activity
`comprises reducing binding of NF-êB to NF-êB
`recognition sites on genes which are transcriptionally
`regulated by NF-êB.
`
`bacterial
`reducing
`for
`[A method
`145.
`lipopolysaccharide-induced expression of cytokines in
`mammalian cells, which method comprises reducing
`NF-êB activity
`in
`the cells so as
`to reduce
`bacterial lipopolysaccharide-induced expression of said
`cytokines in the cells], carried out on human cells.
`
`The claims are thus genus claims, encompassing the
`use of all substances that achieve the desired result of
`reducing the binding of NF-êB to NF-êB recognition
`sites. Furthermore, the claims, although amended during
`prosecution, use language that corresponds to language
`present in the priority application. Specifically, the
`
`asserted claims recite methods of reducing NF-êB
`activity, and more specifically reducing binding of NF-
`êB to NF-êB recognition sites, in cells in response to
`external influences like bacterial lipopolysaccha rides. The
`specification filed on April 21, 1989, similarly recites
`the desired goal of reducing NF-êB activity and binding
`to NF-êB recognition sites in cells in response to such
`external influences. See ′ 516 patent col.3 l.59–col.4 l.19;
`col.31 l.65–col.32 l.11; see also id. at col.2 ll.54–59. The
`specification also hypothesizes three types of molecules
`with the potential to reduce NF-êB activity in cells: decoy,
`dominantly interfering, and specific inhibitor molecules.
`Id. at col.37 l.43–col.38 l.22.
`
`In April 2006, the district court held a fourteen-day jury
`trial on the issues of infringement and validity. The jury
`rendered a special verdict finding infringement of claims
`80 and 95 with respect to Evista® and claims 144 and
`145 with respect to Xigris®. The jury also found that
`the asserted claims were not invalid for anticipation, lack
`of enablement, or lack of written description. The court
`denied without opinion Lilly's motions for JMOL and,
`in the alternative, a new trial. In August 2006, the court
`conducted a four-day bench trial on Lilly's additional
`defenses of unpatentable subject matter, inequitable
`conduct, and prosecution laches, ruling in favor of Ariad
`on all three issues. Ariad Pharms., Inc. v. Eli Lilly & Co.,
`529 F.Supp.2d 106 (D.Mass.2007).
`
`Lilly timely appealed to this court, and on April 3, 2009,
`a panel affirmed in part and reversed in part. Ariad, 560
`F.3d at 1369. The panel upheld the district court's finding
`of no inequitable conduct, id. at 1380, but reversed the
`jury's verdict on written description, holding the asserted
`claims invalid for lack of an adequate written description
`as required by 35 U.S.C. § 112, first paragraph, id. at 1376.
`Ariad petitioned for rehearing en banc, challenging the
`existence of a written description requirement in § 112, first
`paragraph, separate from the enablement requirement.
`Although not a new question, see In re Barker, 559 F.2d
`588, 591–93 (CCPA 1977), its prominence has increased
`in recent years, see Lizardtech, Inc. v. Earth Res. Mapping,
`Inc., 433 F.3d 1373 (Fed.Cir.2005) (denying rehearing
`en banc on the question whether a separate written
`description requirement exists in § 112, first paragraph);
`Univ. of Rochester v. *1342 G.D. Searle & Co., Inc., 375
`F.3d 1303 (Fed.Cir.2004) (same); Enzo Biochem, Inc. v.
`Gen–Probe Inc., 323 F.3d 956, 970 (Fed.Cir.2002) (same).
`In light of the controversy concerning the distinctness and
`
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`Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336 (2010)
`94 U.S.P.Q.2d 1161
`
`proper role of the written description requirement, we
`granted Ariad's petition, vacating the prior panel opinion
`and directing the parties to brief two questions:
`
`(1) Whether 35 U.S.C. § 112, paragraph 1, contains
`a written description requirement separate from an
`enablement requirement?
`
`(2) If a separate written description requirement is set
`forth in the statute, what is the scope and purpose of that
`requirement?
`
`In addition to the parties' briefs, the court received
`twenty-five amicus briefs. Of those, seventeen were filed
`in support of Lilly, one was filed in support of Ariad,
`and seven were filed in support of neither party. The
`majority, including a brief filed by the United States, were
`filed in support of this court's current written description
`doctrine. The court heard oral arguments on December 7,
`2009.
`
`DISCUSSION
`
`I.
`
`Although the parties differ in their answers to the
`court's questions, their positions converge more than
`they first appear. Ariad, in answering the court's first
`question, argues that § 112, first paragraph, does not
`contain a written description requirement separate from
`enablement. Yet, in response to this court's second
`question on the scope and purpose of a written description
`requirement, Ariad argues that the statute contains
`two description requirements: “Properly interpreted, the
`statute requires the specification to describe (i) what the
`invention is, and (ii) how to make and use it.” Appellee Br.
`1; see also id. at 43 (“[T]he written description requirement
`of § 112, ¶ 1 requires, first, that the specification describe
`(identify) what the invention is and, second, that the
`specification teach how to make and use the invention.”).
`Ariad reconciles this apparent contradiction by arguing
`that the legal sufficiency of its two-prong description
`requirement is judged by whether it enables one of skill
`in the art to make and use the claimed invention. Thus,
`according to Ariad, in order to enable the invention, the
`specification must first identify “what the invention is,
`for otherwise it fails to inform a person of skill in the
`art what to make and use.” Id. at 30. Yet Ariad argues
`
`that this first step of “identifying” the invention applies
`only in the context of priority (i.e., claims amended during
`prosecution; priority under 35 U.S.C. §§ 119, 120; and
`interferences) because original claims “constitute their
`own description.” Id. at 44.
`
`Lilly, in contrast, answers the court's first question in the
`affirmative, arguing that two hundred years of precedent
`support the existence of a statutory written description
`requirement separate from enablement. Thus, Lilly argues
`that the statute requires, first, a written description of
`the invention and, second, a written description of how
`to make and use the invention so as to enable one of
`skill in the art to make and use it. Finally, Lilly asserts
`that this separate written description requirement applies
`to all claims—both original and amended—to ensure
`that inventors have actually invented the subject matter
`claimed.
`
`Thus, although the parties take diametrically opposed
`positions on the existence of a written description
`requirement separate from enablement, both agree that
`the specification must contain a written description of
`the invention to establish what the invention is. The
`dispute, therefore, centers on the standard to be applied
`and whether it applies to original claim language.
`
`*1343 A.
`
`As in any case involving statutory interpretation, we begin
`with the language of the statute itself. Consumer Prod.
`Safety Comm'n v. GTE Sylvania, Inc., 447 U.S. 102, 108,
`100 S.Ct. 2051, 64 L.Ed.2d 766 (1980). Section 112, first
`paragraph, reads as follows:
`
`The specification shall contain a
`written description of the invention,
`and of the manner and process of
`making and using it, in such full,
`clear, concise, and exact terms as
`to enable any person skilled in the
`art to which it pertains, or with
`which it is most nearly connected, to
`make and use the same, and shall set
`forth the best mode contemplated
`by the inventor of carrying out his
`invention.
`
` © 2017 Thomson Reuters. No claim to original U.S. Government Works.
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`Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336 (2010)
`94 U.S.P.Q.2d 1161
`
`According to Ariad, a plain reading of the statute reveals
`two components: a written description (i) of the invention,
`and (ii) of the manner and process of making and using it.
`Yet those two components, goes Ariad's argument, must
`be judged by the final prepositional phrase; both written
`descriptions must be “in such full, clear, concise, and exact
`terms as to enable any person skilled in the art ... to make
`and use the same.” Specifically, Ariad parses the statute
`as follows:
`
`2
`
`The specification shall contain
`
`[A] a written description
`
`[i] of the invention, and
`
`[ii] of the manner and process of making and using it,
`
`[B] in such full, clear, concise, and exact terms as to
`enable any person skilled in the art to which it pertains,
`or with which it is most nearly connected, to make and
`use the same ...
`
`Ariad argues that its interpretation best follows the rule
`of English grammar that prepositional phrases (here, “of
`the invention,” “of the manner and process of making
`and using it,” and “in such full, clear, concise, and
`exact terms”) modify another word in the sentence (here,
`“written description”), and that it does not inexplicably
`ignore the comma after “making and using it” or sever the
`“description of the invention” from the requirement that
`it be in “full, clear, concise, and exact terms,” leaving the
`description without a legal standard.
`
`Ariad also argues that earlier versions of the Patent Act
`support its interpretation. Specifically, Ariad contends
`that the first Patent Act, adopted in 1790, and its
`immediate successor, adopted in 1793, required a written
`description of the invention that accomplished two
`purposes: (i) to distinguish the invention from the prior
`art, and (ii) to enable a person skilled in the art to make
`and use the invention. 1 Ariad then asserts that when
`Congress assigned the function of defining the invention
`to the claims in 1836, Congress amended the written
`description requirement so that it served a single purpose:
`enablement. 2
`
`1
`
`Section 3 of the 1793 Patent Act provided, in relevant
`part: “[E]very inventor, before he can receive a
`patent shall ... deliver a written description of his
`
`invention, and of the manner of using, or process of
`compounding the same, in such full, clear and exact
`terms, as to distinguish the same from all other things
`before known, and to enable any person skilled in the
`art or science, of which it is a branch, or with which
`it is most nearly connected, to make, compound, and
`use the same.”
`
`Section 6 of the 1836 Patent Act provided, in relevant
`part: “[B]efore any inventor shall receive a patent for
`any such new invention or discovery, he shall deliver a
`written description of his invention or discovery, and
`of the manner and process of making, constructing,
`using, and compounding the same, in such full, clear,
`and exact terms, avoiding unnecessary prolixity, as
`to enable any person skilled in the art or science to
`which it appertains, or with which it is most nearly
`connected, to make, construct, compound, and use
`the same.”
`
`*1344 Lilly disagrees, arguing that § 112, first paragraph,
`contains three separate requirements. Specifically, Lilly
`parses the statute as follows:
`
`(1) “The specification shall contain a written description
`of the invention, and ”
`
`(2) “The specification shall contain a written
`description ... of the manner and process of making
`and using it, in such full, clear, concise, and exact
`terms as to enable any person skilled in the art to
`which it pertains, or with which it is most nearly
`connected, to make and use the same, and ”
`
`(3) “The specification ... shall set forth the best mode
`contemplated by the inventor of carrying out the
`invention.”
`
`Lilly argues that Ariad's construction ignores a long line
`of judicial precedent interpreting the statute's predecessors
`to contain a separate written description requirement, an
`interpretation Congress adopted by reenacting the current
`language of § 112, first paragraph, without significant
`amendment.
`
`[1]
` We agree with Lilly and read the statute to give
`effect to its language that the specification “shall contain
`a written description of the invention” and hold that §
`112, first paragraph, contains two separate description
`requirements: a “written description [i] of the invention,
`and [ii] of the manner and process of making and using
`[the invention”]. 35 U.S.C. § 112, ¶ 1 (emphasis added).
`On this point, we do not read Ariad's position to be in
`
` © 2017 Thomson Reuters. No claim to original U.S. Government Works.
`
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`Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336 (2010)
`94 U.S.P.Q.2d 1161
`
`disagreement as Ariad concedes the existence of a written
`description requirement. See Appellee Br. 2 (“Under a
`plain reading of the statute, a patent specification ... must
`contain a description (i) of the invention, and (ii) of the
`manner and process of making and using it.”). Instead
`Ariad contends that the written description requirement
`exists, not for its own sake as an independent statutory
`requirement, but only to identify the invention that must
`comply with the enablement requirement.
`
`But, unlike Ariad, we see nothing in the statute's
`language or grammar that unambiguously dictates that
`the adequacy of the “written description of the invention”
`must be determined solely by whether that description
`identifies the invention so as to enable one of skill in
`the art to make and use it. The prepositional phrase “in
`such full, clear, concise, and exact terms as to enable any
`person skilled in the art ... to make and use the same”
`modifies only “the written description ... of the manner
`and process of making and using [the invention],” as Lilly
`argues, without violating the rules of grammar. That the
`adequacy of the description of the manner and process of
`making and using the invention is judged by whether that
`description enables one skilled in the art to make and use
`the same follows from the parallelism of the language.
`
`While Ariad agrees there is a requirement to describe
`the invention, a few amici appear to suggest that
`the only description requirement
`is a requirement
`to describe enablement. If Congress had
`intended
`enablement to be the sole description requirement of §
`112, first paragraph, the statute would have been written
`differently. Specifically, Congress could have written the
`statute to read, “The specification shall contain a written
`description of the invention, in such full, clear, concise,
`and exact terms as to enable any person skilled in the art ...
`to make and use the same,” or “The specification shall
`contain a written description of the manner and process
`of making and using the invention, in such full, clear,
`concise, and exact terms as to enable any person skilled in
`the art ... to make and use the same.” Under the amicis'
`construction a portion of the statute *1345 —either
`“and of the manner and process of making and using
`it” or “[a written description] of the invention”—becomes
`surplusage, violating the rule of statutory construction
`that Congress does not use unnecessary words. See United
`States v. Menasche, 348 U.S. 528, 538–39, 75 S.Ct. 513,
`99 L.Ed. 615 (1955) (“It is our duty ‘to give effect, if
`possible, to every clause and word of a statute.’ ”) (quoting
`
`Montclair v. Ramsdell, 107 U.S. 147, 152, 2 S.Ct. 391, 27
`L.Ed. 431 (1883)).
`
`Furthermore, since 1793, the Patent Act has expressly
`stated that an applicant must provide a written description
`of the invention, and after the 1836 Act added the
`requirement for claims, the Supreme Court applied this
`description requirement separate from enablement. See
`infra Section I.B. Congress recodified this language in the
`1952 Act, and nothing in the legislative history indicates
`that Congress intended to rid the Act of this requirement.
`On the contrary, “Congress is presumed to be aware of
`a[ ] ... judicial interpretation of a statute and to adopt that
`interpretation when it reenacts a statute without change.”
`Forest Grove Sch. Dist. v. T.A., 557 U.S. 230, 129 S.Ct.
`2484, 2492, 174 L.Ed.2d 168 (2009) (quoting Lorillard
`v. Pons, 434 U.S. 575, 580, 98 S.Ct. 866, 55 L.Ed.2d 40
`(1978)).
`
`Finally, a separate requirement to describe one's invention
`is basic to patent law. Every patent must describe an
`invention. It is part of the quid pro quo of a patent; one
`describes an invention, and, if the law's other requirements
`are met, one obtains a patent. The specification must then,
`of course, describe how to make and use the invention
`(i.e., enable it), but that is a different task. A description
`of the claimed invention allows the United States Patent
`and Trademark Office (“PTO”) to examine applications
`effectively; courts to understand the invention, determine
`compliance with the statute, and to construe the claims;
`and the public to understand and improve upon the
`invention and to avoid the claimed boundaries of the
`patentee's exclusive rights.
`
`B.
`
`Ariad argues that Supreme Court precedent comports
`with its reading of the statute and provides no support
`for a written description requirement separate from
`enablement. Specifically, Ariad asserts that in Evans v.
`Eaton, 20 U.S. (7 Wheat.) 356, 433–34, 5 L.Ed. 472 (1822),
`the Supreme Court recognized just two requirements
`under § 3 of the 1793 Act, the requirements “to enable”
`the invention and “to distinguish” it from all things
`previously known. And, goes Ariad's argument, since the
`1836 Act, which removed the latter language and added
`the requirement for claims, the Court has consistently
`held that a patent applicant need fulfill but a single
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`Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336 (2010)
`94 U.S.P.Q.2d 1161
`
`“written description” requirement, the measure of which
`is enablement.
`
`Lilly disagrees and reads Evans as acknowledging
`a written description
`requirement
`separate
`from
`enablement. Lilly further contends that the Court has
`continually confirmed the existence of a separate written
`description requirement, including in O'Reilly v. Morse,
`56 U.S. (15 How.) 62, 14 L.Ed. 601 (1853) under the 1836
`Act; Schriber–Schroth Co. v. Cleveland Trust Co., 305 U.S.
`47, 59 S.Ct. 8, 83 L.Ed. 34 (1938), under the 1870 Act; and
`more recently in Festo Corp. v. Shoketsu Kinzoku Kogyo
`Kabushiki Co., 535 U.S. 722, 736, 122 S.Ct. 1831, 152
`L.Ed.2d 944 (2002).
`
`4
`
`Like Lilly, we also read Supreme Court precedent as
`recognizing a written description requirement separate
`from an enablement requirement even after