NNo. 21-757
`============================================================================================
`In The
`Supreme Court of the United States
`
`AMGEN INC., AMGEN MANUFACTURING,
`LIMITED, AND AMGEN USA, INC.,
`
`
`
` Petitioners,
`v.
`SANOFI, AVENTISUB LLC, FKA AVENTIS
`PHARMACEUTICALS INC., REGENERON
`PHARMACEUTICALS, INC., AND
`SANOFI-AVENTIS U.S., LLC,
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`
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`Respondents.
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`
`On Writ of Certiorari to the
`United States Court of Appeals
`for the Federal Circuit
`
`
`BRIEF OF CHEMISTRY AND THE LAW DIVISION
`OF THE AMERICAN CHEMICAL SOCIETY AS
`AMICUS CURIAE IN SUPPORT OF PETITIONERS
`
`
`JUSTIN J. HASFORD
` Counsel of Record
`
`MATTHEW J. HLINKA
`FINNEGAN, HENDERSON,
` FARABOW, GARRETT
` & DUNNER, LLP
`901 New York Avenue, NW
`Washington, DC 20001
`(202) 408-4000
`justin.hasford@finnegan.com
`Additional Counsel Listed on Inside Cover
`
`JAMES C. CARVER
`THE CARVER LAW FIRM
`201 St. Charles Street
`Baton Rouge, LA 70802
`(225) 636-2642
`jim@thecarverlawfirm.com
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`============================================================================================
`In The
`Supreme Court of the United States
`
`AMGEN INC., AMGEN MANUFACTURING,
`LIMITED, AND AMGEN USA, INC.,
`
`
`
` Petitioners,
`v.
`SANOFI, AVENTISUB LLC, FKA AVENTIS
`PHARMACEUTICALS INC., REGENERON
`PHARMACEUTICALS, INC., AND
`SANOFI-AVENTIS U.S., LLC,
`
`
`
`Respondents.
`
`
`
`
`
`
`
`
`On Writ of Certiorari to the
`United States Court of Appeals
`for the Federal Circuit
`
`
`BRIEF OF CHEMISTRY AND THE LAW DIVISION
`OF THE AMERICAN CHEMICAL SOCIETY AS
`AMICUS CURIAE IN SUPPORT OF PETITIONERS
`
`
`JUSTIN J. HASFORD
` Counsel of Record
`
`MATTHEW J. HLINKA
`FINNEGAN, HENDERSON,
` FARABOW, GARRETT
` & DUNNER, LLP
`901 New York Avenue, NW
`Washington, DC 20001
`(202) 408-4000
`justin.hasford@finnegan.com
`Additional Counsel Listed on Inside Cover
`
`JAMES C. CARVER
`THE CARVER LAW FIRM
`201 St. Charles Street
`Baton Rouge, LA 70802
`(225) 636-2642
`jim@thecarverlawfirm.com
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`
`
`
`
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`KENDREW H. COLTON
`FITCH, EVEN, TABIN
` & FLANNERY LLP
`700 12th Street, NW
`Suite 700
`Washington D.C. 20005
`(202) 419-7000
`kcolton@fitcheven.com
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`TTABLE OF CONTENTS
`INTEREST OF AMICUS CURIAE............................. 1
`SUMMARY OF ARGUMENT ..................................... 3
`I. TTHE FEDERAL CIRCUIT’S NEW “FULL SCOPE”
`TEST IS A HIGHER BAR THAN WHAT
`CONGRESS CONTEMPLATED IN 35 U.S.C. §
`112(A). .......................................................................... 5
`A. CONGRESS—NOT THE COURTS—HAS THE
`AUTHORITY TO SET THE REQUIREMENTS FOR
`PATENTABILITY. ......................................................... 5
`B. 35 U.S.C. § 112(A) REQUIRES A DISCLOSURE
`SUFFICIENT “TO ENABLE ANY PERSON SKILLED IN THE
`ART” TO “MAKE AND USE” THE “INVENTION.” .............. 6
`C. THE FEDERAL CIRCUIT’S NEW “FULL SCOPE”
`GENUS CLAIM TEST IS NOT SUPPORTED BY THE
`PRECEDENT CONGRESS ENDORSED IN THE AMERICA
`INVENTS ACT. ............................................................ 8
`D. THE PLAIN LANGUAGE OF 35 U.S.C. § 112 DOES
`NOT SUPPORT THE FEDERAL CIRCUIT’S HEIGHTENED
`“FULL SCOPE” TEST. .................................................. 11
`E. THE FEDERAL CIRCUIT’S NEW “FULL SCOPE” TEST
`DEPARTS FROM EARLIER FEDERAL CIRCUIT, COURT OF
`CUSTOMS AND PATENT APPEALS, USPTO, AND EVEN
`SUPREME COURT INTERPRETATIONS. ....................... 13
`F. THIS COURT HAS CAUTIONED THE FEDERAL
`CIRCUIT TO NOT ADD REQUIREMENTS TO
`PATENTABILITY. ....................................................... 16
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`III. TTHE FEDERAL CIRCUIT’S NEW “FULL SCOPE”
`TEST FRUSTRATES INNOVATION. ..................... 17
`A. THE PATENT SYSTEM IS DESIGNED TO BALANCE
`THE INTERESTS OF INNOVATORS AND THE PUBLIC. ... 17
`B. DRUG DISCOVERY IS EXPENSIVE AND TIME
`CONSUMING. ............................................................ 19
`C. AFFIRMING THE FEDERAL CIRCUIT WILL CREATE
`AN IMPRACTICAL AND UNWORKABLE STANDARD. ...... 21
`CONCLUSION .......................................................... 26
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`iii
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`TTABLE OF AUTHORITIES
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`CASES
`Amgen Inc. v. Sanofi,
` 987 F.3d 1080 (Fed. Cir. 2021) ................................ 9
`Atlas Powder Co. v. E.I. du Pont de Nemours & Co.,
`750 F.2d 1569 (Fed. Cir. 1984) .............................. 14
`Bilski v. Kappos,
` 561 U.S. 593 (2010) ................................................ 16
`Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki
`Co., 535 U.S. 722 (2002) ........................................... 6
`Halo Elecs., Inc. v. Pulse Elecs., Inc.,
` 579 U.S. 93 (2016) .................................................. 17
`Hybritech Inc. v. Monoclonal Antibodies, Inc.,
` 802 F.2d 1367 (Fed. Cir. 1986) .......................... 9, 12
`Idenix Pharms. LLC v. Gilead Scis. Inc.,
` 941 F.3d 1149 (Fed. Cir. 2019) ........................ 10, 15
`In re Angstadt,
` 537 F.2d 498 (C.C.P.A. 1976) ..................... 12, 14, 22
`In re Grimme,
` 274 F.2d 949 (C.C.P.A. 1960) ................................. 14
`In re Kalm,
` 378 F.2d 959 (C.C.P.A. 1967) ................................... 8
`In re Sarett,
` 327 F.2d 1005 (C.C.P.A. 1964) ............................... 15
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`In re Wands,
` 858 F.2d 731 (Fed. Cir. 1988) ............ 7, 8, 10, 12, 14
`Johns Hopkins Univ. v. CellPro, Inc.,
` 152 F.3d 1342 (Fed. Cir. 1998) .............................. 13
`KSR Int’l Co. v. Teleflex Inc.,
` 550 U.S. 398 (2007) ................................................ 16
`LizardTech, Inc. v. Earth Res. Mapping, Inc.,
` 424 F.3d 1336 (Fed. Cir. 2005) .............................. 13
`Lorillard v. Pons,
` 434 U.S. 575 (1978) .................................................. 7
`Minerals Separation, Ltd. v. Hyde,
` 242 U.S. 261 (1916) ............................................ 7, 15
`Nautilus, Inc. v. Biosig Instruments, Inc.,
` 572 U.S. 898 (2014) .................................................. 7
`Octane Fitness, LLC v. ICON Health & Fitness, Inc.,
`572 U.S. 545 (2014) ................................................ 17
`Universal Oil Prod. Co. v. Globe Oil & Ref. Co.,
` 322 U.S. 471 (1944) ................................................ 17
`Webster Loom Co. v. Higgins,
` 105 U.S. 580 (1881) .................................................. 9
`Wyeth & Cordis Corp. v. Abbott Labs.,
` 720 F.3d 1380, 1384 (Fed. Cir. 2013) .............. 13, 15
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`STATUTES
`35 U.S.C. § 112 ............................................ 6, 7, 11, 22
`Patent Act of 1952 § 112, 35 U.S.C. § 112 ¶ 1,
` (July 19, 1952) .......................................................... 7
`U.S. Const. art. I, § 8, cl. 8 .......................................... 5
`
`OTHER AUTHORITIES
`Brian Buntz, 50 of 2021’s Best-Selling
`Pharmaceuticals, Drug Development
` & Discovery (Mar. 29, 2022),
`https://www.drugdiscoverytrends.com/
` 50-of-2021s-best-selling-pharmaceuticals/. ........... 20
`Giles S. Rich, The Principles of Patentability,
` 28 Geo. Wash. L. Rev. 393 (1960) .......................... 18
`Maria Sofia Castelli et al., The Pharmacology and
`Therapeutic Applications of Monoclonal
`Antibodies, 7 Pharmacology Res. & Persp., 2019
`https://www.ncbi.nlm.nih.gov/pmc/articles/
` PMC6923804/pdf/PRP2-7-e00535.pdf ................... 19
`PhRMA, Biopharmaceuticals in Perspective
` 27 (Fall 2020), https://phrma.org/-
`/media/Project/PhRMA/PhRMA-Org/PhRMA-
`Org/PDF/A-C/ChartPack_Biopharmaceuticals_
`in_Perspective_Fall2020.pdf .................................. 20
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`IINTEREST OF AMICUS CURIAE
`The Chemistry and the Law Division (“CHAL”)
`
`of the American Chemical Society (“ACS”) comprises
`ACS members who profess an interest in and a
`professional practice that includes both chemistry and
`law.1 Founded in 1876 and chartered by the U.S.
`Congress, ACS is one of the world’s largest scientific
`organizations with membership of over 151,000 in 140
`countries. Most of the members of CHAL are
`attorneys, and a majority of the attorney members of
`CHAL are patent attorneys. CHAL’s purpose is to
`advance the understanding and application of the
`interrelationship of the science of chemistry and the
`relevant
`legal
`statutory,
`regulatory,
`and
`jurisprudential decisions. CHAL has no direct interest
`in the outcome of this appeal.
`
`Nevertheless, this case addresses an issue of
`great importance to CHAL’s members, who rely on a
`robust system of patent rights in their practice as
`patent attorneys. CHAL has over 2,000 members, and
`a significant number of those are patent attorneys
`who represent clients and/or their employers on
`pharmaceutical
`inventions.
`Clarifying
`the
`precedential effect of decisions from the United States
`Court of Appeals for the Federal Circuit, as well as
`
`
`1 CHAL certifies that no party or party’s counsel or person other
`than CHAL’s members and counsel authored in whole or in part
`or contributed money that was intended to fund the preparation
`or submission of this brief. Counsel for all parties have filed
`blanket consents to the filing of any amicus curiae brief.
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`what is required under 35 U.S.C. § 112, is critically
`important to those who are members of CHAL and the
`Patent Bar to see that the patent laws are applied in
`such a way as to provide adequate incentives for
`innovation.
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`SSUMMARY OF ARGUMENT
`The costs of research and development in the
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`pharmaceutical and biotechnology
`fields are
`enormous, and the potential benefits—both to the
`innovators and those in need of that innovation—are
`at least equally large if not larger. Those working in
`these fields often utilize genus claims, an important
`feature of patent law that allows patentees to protect
`their inventions where competitors could otherwise
`evade infringement liability by making minor changes
`that otherwise do not depart from the heart of the
`claimed invention.
`
`The substantial investment that research and
`development in the pharmaceutical and biotechnology
`fields demands must be encouraged through a robust
`and predictable patent system wherein innovators are
`properly
`compensated
`for
`their efforts. Only
`Congress—not the courts—has the authority to
`establish and modify patentability requirements. The
`enablement requirement described in 35 U.S.C. §
`112(a) was carefully crafted to achieve the delicate
`balance of promoting innovation while maintaining
`the public’s access to those inventions.
`
`For decades, the Federal Circuit, the Court of
`Customs and Patent Appeals, and the United State
`Patent and Trademark Office have applied a flexible,
`case-specific enablement test focused on whether the
`patent disclosure required “undue experimentation.”
`But the Federal Circuit’s “full scope” test represents a
`significant departure from this established standard
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`that fundamentally alters the balance of incentives by
`creating an impractical and inefficient enablement
`requirement that cuts against the reliability of the
`patent system in a way that stifles innovation and
`forces an inefficient allocation of resources that harms
`potential inventors and the public at large. This Court
`should restore that balance, applying the enablement
`standard as Congress enacted.
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`AARGUMENT
`I. The Federal Circuit’s New “Full Scope” Test Is a
`Higher Bar Than What Congress Contemplated
`in 35 U.S.C. § 112(a).
`
`A. Congress—not the courts—has the
`authority to set the requirements for
`patentability.
`Section 8 of the United States Constitution
`
`provides, as relevant here, “The Congress shall have
`Power . . . To promote the Progress of Science and
`useful Arts, by securing for limited Times to Authors
`and Inventors the exclusive Right to their respective
`Writings and Discoveries.” U.S. Const. art. I, § 8, cl. 8.
`One of the core tenants of our country is that Congress
`shall have the power to promote innovation and
`creativity through the patent system. Our founding
`fathers were clear that this power rests with
`Congress, not the courts. Congress has exercised this
`power through codification of Title 35, the Patent Act.
`In doing so, Congress has carefully crafted legislation
`explicitly defining the boundaries of patentability to
`achieve a delicate balance of promoting incentives
`while maintaining access to innovation. This Court
`should restore that balance, applying the enablement
`standard as Congress enacted.
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`BB. 35 U.S.C. § 112(a) requires a disclosure
`sufficient “to enable any person skilled in
`the art” to “make and use” the “invention.”
`The only appropriate
`requirements
`for
`
`patentability are those Congress enumerates. One of
`those is defined in 35 U.S.C. § 112(a). This statutory
`section provides that a patent 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 or joint inventor of
`carrying out the invention.
`
`This Court has enunciated the plain meaning of
`§ 112: a patent specification must provide a sufficient
`description of the invention “to enable any person
`skilled in the art to which it pertains” to “make and
`use” the invention. 35 U.S.C. § 112(a); see, e.g., Festo
`Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535
`U.S. 722, 731 (2002) (“[T]he patent laws require
`inventors to describe their work in ‘full, clear, concise,
`and exact terms,’ 35 U.S.C. § 112, as part of the
`delicate balance the law attempts to maintain
`between inventors, who rely on the promise of the law
`to bring the invention forth, and the public, which
`should be encouraged
`to pursue
`innovations,
`creations, and new ideas beyond the inventor’s
`exclusive rights.”); Minerals Separation, Ltd. v. Hyde,
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`242 U.S. 261, 271 (1916); Nautilus, Inc. v. Biosig
`Instruments, Inc., 572 U.S. 898, 908 (2014). But
`nowhere in the text of 35 U.S.C. § 112(a) or this
`Court’s precedent is there a requirement that the
`specification equip a person of ordinary skill in the art
`(“POSA”) to be capable of readily making and using
`every conceivable embodiment of a patent claim.
`
`Congress even revisited 35 U.S.C. § 112 in the
`America Invents Act of 2011 and recodified the statute
`to keep the substance of § 112(a) unchanged from
`earlier versions. In reconsidering § 112, Congress
`chose to keep the text of the statute from the Patent
`Act of 1952, adding only paragraph enumerations.
`Compare Patent Act of 1952 § 112, 35 U.S.C. § 112 ¶
`1, (July 19, 1952) with 35 U.S.C. § 112(a). And
`implicitly, Congress endorsed the Federal Circuit’s
`interpretation of the statute up through that
`recodification in 2011. See Lorillard v. Pons, 434 U.S.
`575, 580 (1978) (“Congress is presumed to be aware of
`an administrative or judicial interpretation of a
`statute and to adopt that interpretation when it re-
`enacts a statute without change.”); see also In re
`Wands, 858 F.2d 731, 736–37 (Fed. Cir. 1988) (a claim
`is invalid for lack of enablement, if a person of
`ordinary skill in the art would not be able to practice
`the
`claimed
`invention
`without
`“undue
`experimentation,” assessed by the multifactor factual
`test considering “(1) the quantity of experimentation
`necessary, (2) the amount of direction or guidance
`presented, (3) the presence or absence of working
`examples, (4) the nature of the invention, (5) the state
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`of the prior art, (6) the relative skill of those in the art,
`(7) the predictability or unpredictability of the art,
`and (8) the breadth of the claims.”). But any different
`standard asserted after the passage of the AIA has not
`been endorsed by Congress and is not supported by
`the statute as Congress intended.
`
`CC. The Federal Circuit’s new “full scope”
`genus claim test is not supported by the
`precedent Congress endorsed in the
`America Invents Act.
`from
`The Federal Circuit has departed
`
`Congress’s intended meaning of the America Invents
`Act by adopting a heightened standard for genus
`claims under 35 U.S.C. § 112(a) that violates the
`canons of statutory construction and contradicts
`established judicial precedent. Genus claims—those
`that claim an invention covering multiple related
`species, typically with broad functionality—have long
`been accepted as an important part of the patent
`system. See In re Kalm, 378 F.2d 959, 963 (C.C.P.A.
`1967) (“When one speaks of a ‘genus’ in the chemical
`arts, one ordinarily speaks of a group of compounds
`closely related both in structure and properties.”). For
`genus claims, the Federal Circuit no longer asks
`whether a POSA can “make and use” the invention, as
`§ 112(a) and this Court’s precedents require.
`
`Historically, the inquiry was whether a POSA
`could “make and use” the invention “without undue
`experimentation.” Wands, 858 F.2d at 736
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`(“Enablement is not precluded by the necessity for
`some experimentation such as routine screening.”). In
`Wands, the Federal Circuit examined a genus claim
`covering an immunoassay method employing highly
`sensitive monoclonal antibodies capable of detecting a
`hepatitis B antigen. While the Federal Circuit
`concluded a POSA would engage in an extensive
`amount of experimentation to determine which would
`bind to the hepatitis B antigen, and further screening
`to select those with the claimed sensitivity, the
`Federal Circuit noted “there was a high level of skill
`in the art at the time when the application was filed,
`and all of the methods needed to practice the
`invention were well known.” Id. at 740. Even though
`experimentation was required, it was spelled out in
`the specification or known in the art, and thus the
`claims were enabled. Id.; see also Webster Loom Co. v.
`Higgins, 105 U.S. 580, 586 (1881) (“That which is
`common and well known is as if it were written out in
`the patent and delineated
`in the drawings.”);
`Hybritech Inc. v. Monoclonal Antibodies, Inc., 802
`F.2d 1367, 1384 (Fed. Cir. 1986) (“[A] patent need not
`teach, and preferably omits, what is well known in the
`art.”) (citation omitted).
`
`But recently, the Federal Circuit has imposed a
`heightened “full scope” test, “pos[ing] high hurdles in
`fulfilling the enablement requirement for claims with
`broad functional language” evaluating if “‘substantial
`time and effort’ would be required to reach the full
`scope of claimed embodiments.” Amgen Inc. v. Sanofi,
`987 F.3d 1080, 1087–88 (Fed. Cir. 2021) (emphasis
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`added) (explaining “no reasonable jury could conclude
`under these facts that anything but ‘substantial time
`and effort’ would be required to reach the full scope of
`claimed embodiments” where a jury made the factual
`finding that a POSA would not require undue
`experimentation to make and use the claimed
`invention). This departs from the Wands precedent
`endorsed by Congress in the America Invents Act,
`which asks whether undue experimentation would be
`needed to make and use the invention. Instead, the
`Federal Circuit has substituted an inquiry into how
`long it would take a POSA to make and use every
`possible
`species and
`“know, without undue
`experimentation, which [embodiments] would be
`effective” within the claimed genus, regardless of
`whether that testing is described with specificity in
`the specification or even routine and conventional in
`the art. Idenix Pharms. LLC v. Gilead Scis. Inc., 941
`F.3d 1149, 1156 (Fed. Cir. 2019).
`
`The decision below confirms the Federal Circuit
`has adopted a new “full scope” test departing from the
`text of 35 U.S.C. § 112(a). Virtually every genus claim
`would require “substantial time and effort” to practice
`the full scope of the claims. By imposing a sliding scale
`that is not supported by the Act’s text, a genus may
`lack enablement regardless of the number of working
`examples identified or how well-understood the
`processes of identifying the working embodiments are
`to a POSA. If the genus claims by function, there will
`be many embodiments. Thus, under this new test,
`even if the specification describes to a POSA how to
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`make and use the invention using even routine and
`conventional screening, because
`it would take
`“substantial
`time”
`to
`screen
`every possible
`embodiment, the claim would be invalid. The Federal
`Circuit’s departure should be reversed, so that the
`enablement inquiry recited in This Court’s precedent
`and endorsed in the America Invents Act is restored
`to its proper, intended standard.
`
`DD. The plain language of 35 U.S.C. § 112 does
`not support the Federal Circuit’s
`heightened “full scope” test.
`There is one standard for enablement: a patent
`
`specification must describe the invention “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.”
`35 U.S.C. § 112 (emphasis added). Nowhere in the text
`of 35 U.S.C. § 112 did Congress enact a special
`enablement standard for genus claims. And nowhere
`did Congress use the language “full scope” or prohibit
`“substantial time and effort” to conduct routine or
`conventional testing. Thus, the text of § 112
`contemplates but one standard for enablement. From
`the perspective of a POSA, the specification must
`include a concise specification sufficient to “enable
`any [POSA] . . . to make and use” the claimed
`invention.
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`In accordance with the statutory requirement
`that the specification be concise, courts have long
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`instructed that “a patent need not teach, and
`preferably omits, what is well known in the art.”
`Hybritech, 802 F.2d at 1384 (citation omitted).
`Likewise, “enablement is not precluded by the
`necessity for some experimentation such as routine
`screening . . . However, experimentation needed to
`practice
`the
`invention must not be undue
`experimentation. The key word
`is undue, not
`experimentation.” Wands, 858 F.2d at 736 (internal
`quotations omitted). But under the heightened “full
`scope” enablement standard prohibiting genus claims
`where “substantial time and effort is required,” even
`if testing is routine, “then all ‘experimentation’ is
`‘undue,’ since the term ‘experimentation’ implies that
`the success of the particular activity is uncertain.” In
`re Angstadt, 537 F.2d 498, 503 (C.C.P.A. 1976).
`
`The Federal Circuit’s new
`“full scope”
`enablement test requirement that a patent drafter
`make, test, and disclose every embodiment of an
`invention is impractical and contravenes the intent of
`the Patent Act. Such a specification would not be
`concise and would be much more than what is
`necessary to enable a POSA to “make and use” the
`claimed
`invention.
`If Congress wanted
`this
`heightened standard, Congress could have crafted a
`special enablement standard for genus claims or
`changed the text of the statute in the overhaul of Title
`35 in the America Invents Act. But Congress did not
`do so.
`
`
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`13
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`
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`EE. The Federal Circuit’s new “full scope” test
`departs from earlier Federal Circuit, Court
`of Customs and Patent Appeals, USPTO,
`and even Supreme Court interpretations.
`Only recently has the Federal Circuit departed
`
`from the plain meaning of the Patent Act. Compare
`LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d
`1336, 1345 (Fed. Cir. 2005) (“A claim will not be
`invalidated on section 112 grounds simply because the
`embodiments of the specification do not contain
`examples explicitly covering the full scope of the claim
`language. That is because the patent specification is
`written for a person of skill in the art, and such a
`person comes to the patent with the knowledge of
`what has come before. Placed in that context, it is
`unnecessary to spell out every detail of the invention
`in the specification; only enough must be included to
`convince a person of skill in the art that the inventor
`possessed the invention and to enable such a person
`to make and use the invention without undue
`experimentation”) (internal citations omitted) and
`Johns Hopkins Univ. v. CellPro, Inc., 152 F.3d 1342,
`1360-61 (Fed. Cir. 1998) (“[A] considerable amount of
`experimentation is permissible,” as long as it is
`“merely routine” or the specification “provides a
`reasonable amount of guidance” regarding the
`direction of experimentation) with Wyeth & Cordis
`Corp. v. Abbott Labs., 720 F.3d 1380 (Fed. Cir. 2013)
`(adding a temporal element to the enablement
`inquiry, shifting the analysis to “whether practicing
`
`
`
`
`
`
`
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`
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`14
`
`
`the full scope of the claims requires excessive—and
`thus undue—experimentation” even where “one of
`ordinary skill could routinely use the assays disclosed
`in the specification”).
`
`Prior to this departure, the Federal Circuit and
`Court of Customs and Patent Appeals applied a
`flexible, case-specific enablement test for any patent
`claim: The specification must teach those skilled in
`the art to make and use the invention without “undue
`experimentation.” Wands, 858 F.2d at 737. Undue
`experimentation
`is a case-specific, multi-factor
`inquiry. Id. (applying an 8-factor test that “is not
`precluded by the necessity for some experimentation
`such as routine screening”). Consistent with the plain
`meaning of the Patent Act, that test is built on the
`foundation of a POSA’s level of skill and background
`knowledge.
`
`The Federal Circuit has historically held that
`routine experimentation for genus claims is expected
`and “does not preclude enablement.” Atlas Powder Co.
`v. E.I. du Pont de Nemours & Co., 750 F.2d 1569,
`1576–77 (Fed. Cir. 1984) (noting that the disclosed
`40% failure rate enabled a user to likely only have to
`try two or maybe three compounds to find one that
`would work). “The key word
`is
`‘undue,’ not
`‘experimentation.’” Id.
`
`Likewise, the Court of Customs and Patent
`Appeals consistently upheld genus claims. See, e.g.,
`Angstadt, 537 F.2d at 503-04; In re Grimme, 274 F.2d
`949, 952
`(C.C.P.A. 1960)
`(“It
`is manifestly
`impracticable for an applicant who discloses a generic
`
`
`
`
`
`
`
`
`
`
`
`15
`
`
`invention to give an example of every species falling
`within it, or even to name every such species. It is
`sufficient if the disclosure teaches those skilled in the
`art what the invention is and how to practice it.”). It
`recognized that requiring the patentee to identify and
`test every possible species in a genus would be
`unworkable as “the research to do this would quite
`evidently be endless.” In re Sarett, 327 F.2d 1005,
`1019 (C.C.P.A. 1964).
`
`This Court also has acknowledged that an
`enabled patent claim may “deal[] with a large class of
`substances” and “leav[e] something to the skill of
`persons applying the invention.” Minerals Separation,
`242 U.S. at 270-71 (upholding process with “infinite[]”
`embodiments as “clearly sufficiently definite to guide
`those skilled in the art”).
`
`Over the last decade, the Federal Circuit began
`crafting a stricter, “full scope” test for genus claims,
`particularly in the chemical and biological arts. The
`Federal Circuit consistently focused on the number of
`species a genus claim could encompass instead of
`focusing on the species a POSA would be motivated to
`pursue, framing the question as “whether practicing
`the full scope of the claims requires excessive—and
`thus undue—experimentation.” Wyeth & Cordis, 720
`F.3d at 1384; see also Idenix, 941 F.3d at 1163
`(“[P]racticing the full scope of the claims would
`require synthesizing and screening tens of thousands
`of candidate compounds for the claimed efficacy.”). For
`example, in the case of antibody genus claims, the
`Federal Circuit held that “practicing the full scope of
`
`
`
`
`
`
`
`
`
`
`
`16
`
`
`the claims would require synthesizing and screening
`each of at least tens of thousands of compounds.”
`Wyeth & Cordis, 720 F.3d at 1384. But the Patent Act
`says
`nothing
`about
`elevating
`patentability
`requirements for genus claims.
`
`FF. This Court has cautioned the Federal
`Circuit to not add requirements to
`patentability.
`The Federal Circuit’s new “full scope” test is
`
`inconsistent with its obligation to adhere to the text of
`the Patent Act. This Court has consistently
`intervened where the Federal Circuit applies a test
`that “is inconsistent with the text and the statute’s
`purpose and design,” Bilski v. Kappos, 561 U.S. 593,
`603 (2010), explaining courts may not add “additional
`rigid and mandatory formulas” that are “inconsistent
`with [the text of the Patent Act].” KSR Int’l Co. v.
`Teleflex Inc., 550 U.S. 398, 407, 419, 428 (2007)
`(rejecting the “‘teaching, suggestion, or motivation’
`test (TSM test), under which a patent claim is only
`proved obvious if ‘some motivation or suggestion to
`combine the prior art teaching’ can be found in the
`prior art” because it “transforms the general principle
`[of the Patent Act into a rigid rule”) (emphasis added).
`This is such a case. The Federal Circuit’s heightened
`“full scope” test raises the bar for the validity of genus
`claims and departs from the text of the Patent Act,
`disturbing the delicate balance Congress crafted. The
`Federal Circuit’s application of such rigid tests is not
`
`
`
`
`
`
`
`
`
`
`
`17
`
`
`supported by the Patent Act and should be reversed.
`Cf. Octane Fitness, LLC v. ICON Health & Fitness,
`Inc., 572 U.S. 545, 553 (2014) (reversing the Federal
`Circuit’s test for attorney fees as “unduly rigid”); Halo
`Elecs., Inc. v. Pulse Elecs., Inc., 579 U.S. 93, 104
`(2016) (rejecting Federal Circuit’s test for enhanced
`damages as “unduly rigid”).
`
`III. The Federal Circuit’s New “Full Scope” Test
`Frustrates Innovation.
`
`A. The patent system is designed to balance
`the interests of innovators and the public.
`Patent law is rooted in the quid pro quo bargain
`
`that an inventor may obtain temporary exclusivity in
`exchange for disclosing an invention to the public.
`Universal Oil Prod. Co. v. Globe Oil & Ref. Co., 322
`U.S. 471, 484 (1944). (“As a reward for inventions and
`to encourage their disclosure, the United States offers
`a [] monopoly to an inventor who refrains from
`keeping his invention a trade secret. But the quid pro
`quo is disclosure of a process or device in sufficient
`detail to enable one skilled in the art to practice the
`invention once the period of the monopoly has expired;
`and the same precision of disclosure is likewise
`essential to warn the industry concerned of the precise
`scope of the monopoly asserted.”). The filing of patent
`applications must be encouraged, because a patent
`application progresses the art and enriches society.
`Giles S. Rich, The Principles of Patentability, 28 Geo.
`Wash. L. Rev. 393, 400 (1960) (“Whenever novel
`
`
`
`
`
`
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`
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`
`
`18
`
`
`subject matter, unobvious to the workers of ordinary
`skill in the art, is published, progress in the art is
`promoted. The literature of the art is enriched,
`another way of doing something is made known, and
`even if it be inferior to the means already known,
`there is no telling when it may give another inventor
`an idea or when someone will improve on it in such a
`way as to surpass all that is known.”). As Issac
`Newton explained, innovation is derived by “standing
`on the shoulders of giants” and building on the work
`of those that came before.
`
`Perhaps no other fields depend on patent
`protection more than do the pharmaceutical and
`biotechnology industries. As discussed below, the
`costs of research in these fields are enormous, and the
`potential benefits—both to the innovators and the
`patients in need of that innovation—are equally large.
`Those working in these industries are also among the
`most likely to take advantage of genus claims. By
`filing a patent application, the applicant is providing
`a roadmap to the public, thereby progressing the art
`and enriching the public, but simultaneously enabling
`competitors who are now aware of the benefits of the
`genus and can quickly capitalize off the innovator’s
`discovery.
`inventors to be
`
`It is only equitable for
`compensated for this disclosure and the enormous
`amounts invested in developing it. The significant
`resources
`and
`substantial
`investment
`that
`pharmaceutical research demands require
`the
`reasonable means with which to recoup those
`
`
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`19
`
`
`expenditures. This is only feasible through a rational
`and dependable patent system
`that protects
`pioneering inventions and the investments that make
`them possible, thereby encouraging the innovation
`the public demands. After all, no company will spend
`its money to develop a product that will be copied
`without impunity by its rivals after the breakthrough
`has been made. Thus, to maintain the incentives to
`innovate while maintaining access to inventions
`Congress balanced, there must be predictable,
`workable patent law standards.
`
`BB. Drug discovery is expensive and time
`consuming.
`The demand for innovative healthcare solutions
`and the groundbreaking research necessary to achieve
`those solutions has never been higher. Monoclonal
`antibodies, like the ones covered by the patent claims
`at issue here, have emerged as a major class of
`therapeu
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