`
`No. 21-1566
`================================================================================================================
`
`In The
`Supreme Court of the United States
`--------------------------------- ♦ ---------------------------------
`
`JUNO THERAPEUTICS, INC.; SLOAN KETTERING
`INSTITUTE FOR CANCER RESEARCH,
`
`Petitioners,
`
`Respondent.
`
`v.
`
`KITE PHARMA, INC.,
`
`--------------------------------- ♦ ---------------------------------
`
`On Petition For A Writ Of Certiorari
`To The United States Court Of Appeals
`For The Federal Circuit
`
`--------------------------------- ♦ ---------------------------------
`
`BRIEF OF AMICI CURIAE
`MARK D. JANIS AND TIMOTHY R. HOLBROOK
`IN SUPPORT OF PETITIONERS
`
`--------------------------------- ♦ ---------------------------------
`
`MARK D. JANIS
`INDIANA UNIVERSITY
`MAURER SCHOOL OF LAW
`211 South Indiana Avenue
`Bloomington, IN 47405
`(812) 855-1205
`mdjanis@indiana.edu
`
`TIMOTHY R. HOLBROOK
`Counsel of Record
`EMORY UNIVERSITY
`SCHOOL OF LAW
`1301 Clifton Rd., NE
`Atlanta, GA 30322
`(404) 712-0353
`tholbrook@emory.edu
`
`================================================================================================================
`COCKLE LEGAL BRIEFS (800) 225-6964
`WWW.COCKLELEGALBRIEFS.COM
`
`
`
`
`
`i
`
`TABLE OF CONTENTS
`
`2
`
`Page
`Table of Contents .................................................
`i
`Table of Authorities .............................................
`iii
`Interests of Amici Curiae ....................................
`1
`Summary of the Argument ..................................
`1
`2
`Argument .............................................................
`I. This Court Has Underscored the Patent
`
`System’s Delicate Balance of Interests,
`and the Federal Circuit’s Adoption of a
`Written Description Requirement Puts
`that Balance at Risk ..................................
`A. Patent Statutes Must Balance the Pub-
`lic Benefits of Thorough Disclosure
`Against the Private Costs of Provid-
`ing It ....................................................
`B. The U.S. Patent Statute Includes Sev-
`eral Provisions that Together Set the
`Cost/Benefit Balance Regarding Dis-
`closure ..................................................
` II. Neither the Text of the Patent Statute nor
`this Court’s Jurisprudence Supports the
`Federal Circuit’s Independent Written De-
`scription Requirement ...............................
`A. The Text of Section 112 Establishes an
`Enablement Requirement but not a
`Written Description Requirement .......
`B. This Court Has Not Adopted an Inde-
`pendent Written Description Require-
`ment ..................................................... 10
`
`8
`
`8
`
`4
`
`6
`
`
`
`ii
`
`TABLE OF CONTENTS—Continued
`
`Page
` III. This Court’s Intervention Is Critical to Re-
`store the Appropriate Balance within the
`Patent System............................................ 13
`A. The Federal Circuit Is Applying Its
`Written Description Requirement Ag-
`gressively to Strike Down Patents ...... 13
`1. The Federal Circuit Has Extended
`the Reach of the Written Descrip-
`tion Requirement ............................ 14
`2. The Federal Circuit Has Aggran-
`dized the Power to Invalidate Pa-
`tents at the Appellate Level through
`the Written Description Require-
`ment ................................................ 16
`B. The Federal Circuit Has Never Ade-
`quately Distinguished Its Written De-
`scription Requirement from the Statutory
`Enablement Requirement ................... 18
`C. This Case Is an Appropriate Vehicle
`for Review ............................................ 23
`Conclusion ............................................................ 24
`
`
`
`
`iii
`
`TABLE OF AUTHORITIES
`
`Page
`
`CASES
`AK Steel Corp. v. Sollac,
`344 F.3d 1234 (Fed. Cir. 2003) ................................ 21
`Amgen Inc. v. Sanofi,
`No. 21-757 ................................................................ 23
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) ........................ passim
`Biogen Int’l GmbH v. Mylan Pharms., Inc.,
`18 F.4th 1333 (Fed. Cir. 2021) ........................... 13, 16
`Biogen Int’l GmbH v. Mylan Pharms., Inc.,
`28 F.4th 1194 (Fed. Cir. 2022) ................................. 17
`Biogen Int’l GmbH v. Mylan Pharms., Inc.,
`No. 21-1567 .............................................................. 23
`Bonito Boats, Inc. v. Thunder Craft Boats, Inc.,
`489 U.S. 141 (1989) ................................................... 3
`Brenner v. Manson,
`383 U.S. 519 (1966) ................................................... 7
`Capon v. Eshhar,
`418 F.3d 1349 (Fed. Cir. 2005) ................................ 20
`Enzo Biochem, Inc. v. Gen-Probe Inc.,
`323 F.3d 956 (Fed. Cir. 2002) .................................. 21
`Evans v. Eaton,
`20 U.S. 356 (1822) ............................................. 11, 12
`Festo Corp. v. Shoketsu Kinzoku
`Kogyo Kabushiki Co.,
`535 U.S. 722 (2002) ........................................... 10, 11
`
`
`
`iv
`
`TABLE OF AUTHORITIES—Continued
`
`Page
`
`Gentry Gallery, Inc. v. Berkline Corp.,
`134 F.3d 1473 (Fed. Cir. 1998) ................................ 14
`In re Barker,
`559 F.2d 588 (C.C.P.A. 1977) ............................. 10, 19
`In re DiLeone,
`436 F.2d 1404 (C.C.P.A. 1971) ................................. 21
`In re Rasmussen,
`650 F.2d 1212 (C.C.P.A. 1981) ............................. 7, 15
`In re Ruschig,
`379 F.2d 990 (C.C.P.A. 1967) ................................... 14
`In re Wands,
`858 F.2d 731 (Fed. Cir. 1988) .................................. 20
`Juno Therapeutics, Inc. v. Kite Pharma, Inc.,
`10 F.4th 1330 (Fed. Cir. 2021) ................. 3, 16, 17, 20
`Kennecott Corp. v. Kyocera Int’l, Inc.,
`835 F.2d 1419 (Fed. Cir. 1987) ................................ 19
`Kewanee Oil Co. v. Bicron Corp.,
`416 U.S. 470 (1974) ............................................... 4, 5
`LizardTech, Inc. v. Earth Res. Mapping, Inc.,
`424 F.3d 1336 (Fed. Cir. 2005) ................................ 19
`Markman v. Westview Inst., Inc.,
`517 U.S. 370 (1996) ................................................. 12
`McRO, Inc. v. Bandai Namco Games Am., Inc.,
`959 F.3d 1091 (Fed. Cir. 2020) ................................ 21
`Nautilus, Inc. v. Biosig Instr., Inc.,
`572 U.S. 898 (2014) ............................................. 7, 12
`
`
`
`v
`
`TABLE OF AUTHORITIES—Continued
`
`Page
`
`Novartis Pharms. Corp. v. Accord Healthcare, Inc.,
`2022 WL 2204163 (Fed. Cir. Jun. 21, 2022) ............ 17
`Pacific Biosciences of Cal., Inc. v.
`Oxford Nanopore Techs., Inc.,
`996 F.3d 1342 (Fed. Cir. 2021) ................................ 21
`Pfaff v. Wells Elecs., Inc.,
`525 U.S. 55 (1998) ................................................. 2, 3
`Regents of the Univ. of Cal. v. Eli Lilly & Co.,
`119 F.3d 1559 (Fed. Cir. 1997) ................................ 15
`Schriber-Schroth Co. v. Cleveland Tr. Co.,
`305 U.S. 47 (1938) ................................................... 11
`Teva Pharms. USA, Inc. v. Sandoz, Inc.,
`574 U.S. 318 (2015) ................................................. 18
`TurboCare Div. of Demag Delaval Tur-
`bomachinery Corp. v. General Elec. Co.,
`264 F.3d 1111 (Fed. Cir. 2001) ................................ 15
`United States v. Dubilier Condenser Corp.,
`289 U.S. 178 (1933) ................................................... 5
`Universal Oil Prods. Co. v. Globe Oil & Ref. Co.,
`322 U.S. 471 (1944) ................................................... 6
`Univ. of Rochester v. G.D. Searle & Co.,
`358 F.3d 916 (Fed. Cir. 2004) ............................ 20, 21
`Vas-Cath, Inc. v. Mahurkar,
`935 F.2d 1555 (Fed. Cir. 1991) .................... 13, 14, 19
`
`
`
`
`
`
`vi
`
`TABLE OF AUTHORITIES—Continued
`
`Page
`
`STATUTES
`35 U.S.C. § 101 .............................................................. 7
`35 U.S.C. § 112 .................................................... passim
`35 U.S.C. § 132 ............................................ 7, 11, 14, 15
`Leahy-Smith America Invents Act of 2011, Pub.
`L. 112-29, 125 Stat. 284 (2011) ................................. 3
`Patent Act of 1793, Ch. 11, 1 Stat. 318-23 (Feb.
`21, 1793) .................................................................. 12
`
`
`OTHER MATERIALS
`GATT-WTO Agreement on the Trade Related
`Aspects of Intellectual Property TRIPS art.
`29(1) ........................................................................... 7
`Timothy R. Holbrook, Patents, Presumptions,
`and Public Notice, 86 Ind. L.J. 779 (2011) ............. 18
`Timothy R. Holbrook, Possession in Patent Law,
`59 SMU L. Rev. 123 (2006) ...................................... 22
`Mark D. Janis, On Courts Herding Cats: Con-
`tending with the “Written Description” Require-
`ment (and Other Unruly Patent Disclosure
`Doctrines), 2 Wash. U. J.L. & Pol’y 55 (2000) ........ 6, 7
`Dmitry Karshtedt, Mark A. Lemley, and Sean B.
`Seymore, The Death of the Genus Claim, 35
`Harv. J.L. & Tech. 1 (2021) ...................................... 16
`
`
`
`
`
`
`vii
`
`TABLE OF AUTHORITIES—Continued
`
`Page
`
`Janice M. Mueller, The Evolving Application of
`the Written Description Requirement to Bio-
`technological Inventions, 13 Berkeley Tech.
`L.J. 615 (1998) ......................................................... 22
`Katherine J. Strandburg, What Does the Public
`Get? Experimental Use and the Patent Bar-
`gain, 2004 Wis. L. Rev. 81 ......................................... 5
`
`
`
`1
`
`INTERESTS OF AMICI CURIAE1
`Amici curiae are professors who teach and write
`
`about patent law and policy. Amici have no personal
`interest in the outcome of this case. Our interest in this
`case is to contribute to the development of patent law
`and policy.
`
`--------------------------------- ♦ ---------------------------------
`
`SUMMARY OF THE ARGUMENT
`
`
`This case presents the Court with the opportunity
`to speak for the first time to the Federal Circuit’s “writ-
`ten description” requirement for patentability. In
`adopting that requirement, the Federal Circuit and its
`predecessor court have thrown the patent system out
`of balance, especially for inventions in the life sciences.
`In particular, the Federal Circuit’s requirement im-
`poses prohibitive costs on innovators without a corre-
`sponding public benefit. It threatens to impede the
`very innovation that the patent system is designed to
`induce.
`
`The Federal Circuit’s written description require-
`
`ment is not supported by the text of the patent statute,
`
`
`1 Pursuant to Sup. Ct. R. 37.6, amici curiae affirm that no
`
`part of this brief was authored by counsel for any party, person,
`or organization besides amici, and that no person or entity, other
`than amici curiae, their members, or their counsel, has made a
`monetary contribution to the preparation or submission of this
`brief. Pursuant to Supreme Court Rule 37.2, amici provided no-
`tice to both parties of the intent to file this brief more than ten
`days prior to the due date for filing this brief. Both parties con-
`sented to the filing of this brief.
`
`
`
`2
`
`nor found in this Court’s precedent. Nevertheless, the
`Federal Circuit is deploying its requirement aggres-
`sively to strike down patents. The requirement’s scope
`is expanding, and the Federal Circuit often applies it
`without discernible deference to district court fact-
`finding and without a clearly articulated standard.
`Moreover, the Federal Circuit has never been able to
`explain the relationship between its extra-statutory
`written description requirement and other related re-
`quirements that the patent statute does explicitly im-
`pose, such as the requirement to provide a disclosure
`that enables a person in the field to make and use the
`invention. The Federal Circuit’s approach has thus cre-
`ated costly uncertainty about what content a patent
`applicant must include in a patent document, and, for
`some types of inventions in the life sciences, may make
`it nearly impossible to secure meaningful patent pro-
`tection. This Court’s intervention is critical.
`--------------------------------- ♦ ---------------------------------
`
`ARGUMENT
`I. This Court Has Underscored the Patent
`System’s Delicate Balance of Interests, and
`the Federal Circuit’s Adoption of a Written
`Description Requirement Puts that Bal-
`ance at Risk.
`
`This Court has emphasized that “the patent sys-
`
`tem represents a carefully crafted bargain that encour-
`ages both the creation and the public disclosure of new
`and useful advances in technology, in return for an ex-
`clusive monopoly for a limited period of time.” Pfaff v.
`
`
`
`3
`
`Wells Elecs., Inc., 525 U.S. 55, 63 (1998). At the heart of
`this balance is the quid-pro-quo of the patent system:
`in exchange for the patent, an inventor must suffi-
`ciently disclose the invention within the patent docu-
`ment itself. See Bonito Boats, Inc. v. Thunder Craft
`Boats, Inc., 489 U.S. 141, 150-51 (1989) (“The federal
`patent system thus embodies a carefully crafted bar-
`gain for encouraging the creation and disclosure of
`new, useful, and nonobvious advances in technology
`and design in return for the exclusive right to practice
`the invention for a period of years.” (emphasis added)).
`This disclosure obligation is codified in 35 U.S.C.
`§ 112(a).2
`
`As demonstrated in this case, however, the Federal
`
`Circuit has disrupted this carefully tailored balance by
`embracing a disclosure obligation unsupported by the
`text of the statute. Here, the Federal Circuit declared
`a patent invalid on the basis that the patent did not
`comply with the “written description” requirement,
`overturning a contrary jury verdict. Juno Therapeutics,
`Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337-38 (Fed.
`Cir. 2021). The en banc Federal Circuit adopted the
`in 2010, Ariad
`written description requirement
`Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir.
`2010) (en banc), building on its prior cases. The Federal
`Circuit ruled that the test for compliance with this
`
`
`2 Prior to the adoption of the Leahy-Smith America Invents
`
`Act of 2011, Pub. L. 112-29, 125 Stat. 284 (2011) (AIA), convention
`was to refer to the paragraphs of § 112, such as § 112, ¶ 1. For
`convenience, this brief uses the current format of § 112. The AIA
`did not alter the substance of 35 U.S.C. § 112(a).
`
`
`
`4
`
`so-called written description requirement is whether
`the patent’s disclosure “reasonably conveys to those
`skilled in the art that the inventor had possession of
`the claimed subject matter as of the filing date,” while
`at the same time admitting that the possession test
`“has never been very enlightening.” Ariad, 598 F.3d at
`1351. The court invoked § 112(a) as the statutory basis
`for its requirement.
`
`This Court has never reviewed the Federal Cir-
`
`cuit’s questionable approach to the text of Section
`112(a), its possession test, or its aggressive, seemingly
`standardless application of that test in a variety of
`cases involving innovation in pharmaceuticals and the
`life sciences. Given the serious consequences for inno-
`vation incentives, the Court should do so now.
`
`
`
`A. Patent Statutes Must Balance the Pub-
`lic Benefits of Thorough Disclosure
`Against the Private Costs of Providing
`It.
`
`The patent laws grant exclusive rights to inven-
`
`tors, but also “impose upon the inventor a requirement
`of disclosure” of the patented invention. Kewanee Oil
`Co. v. Bicron Corp., 416 U.S. 470, 480 (1974). This Court
`has explained how patent disclosures benefit the pub-
`lic: “When a patent is granted and the information con-
`tained in it is circulated to the general public and those
`especially skilled in the trade, such additions to the
`general store of knowledge are of such importance to
`the public weal that the Federal Government is willing
`
`
`
`5
`
`to pay the high price of [exclusive use during the pa-
`tent term] for its disclosure, which disclosure, it is
`assumed, will stimulate ideas and the eventual devel-
`opment of further significant advances in the art.” Id.
`at 481. Without an incentive to disclose, an inventor
`might “keep [the] invention secret and reap its fruits
`indefinitely.” United States v. Dubilier Condenser Corp.,
`289 U.S. 178, 186-87 (1933). Katherine J. Strandburg,
`What Does the Public Get? Experimental Use and the
`Patent Bargain, 2004 Wis. L. Rev. 81, 105-06.
`
`The patent statute includes several provisions de-
`
`signed to balance the public benefits of patent disclo-
`sures against the costs of providing those disclosures.
`See infra I.B. On the one hand, these provisions must
`induce inventors to provide high-quality, rigorous, de-
`tailed disclosures to serve the patent system’s public
`interest goals. On the other hand, they must recognize
`that providing such disclosures entails significant
`costs—not merely drafting costs, but potentially the
`costs of extensive testing, clinical evaluations, and the
`like. Left unchecked, such costs could rise to a level at
`which they impede the very innovation that the patent
`system seeks to encourage. These costs can be exacer-
`bated if there is no clear standard for what is a suffi-
`cient disclosure.
`
`The Federal Circuit’s written description require-
`
`ment, relied upon in the present case, adds profoundly
`to the cost of complying with the system’s disclosure
`obligations without concomitant benefits to the public.
`Accordingly, the requirement warrants this Court’s
`attention.
`
`
`
`6
`
`B. The U.S. Patent Statute Includes Several
`Provisions that Together Set the Cost/
`Benefit Balance Regarding Disclosure.
`
`Recognizing the public benefit of disclosure and its
`
`attendant costs, the modern statutory scheme includes
`several provisions intended to strike an optimal bal-
`ance. The most prominent of these is the enablement
`requirement. 35 U.S.C. § 112(a) (requiring that the pa-
`tent document “contain a written description of the in-
`vention, 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 per-
`tains, or with which it is most nearly connected, to
`make and use the same . . . ”). This Court has noted
`that the requirement that the inventor supply an ena-
`bling description of the invention, and receive time-
`limited patent rights in exchange, is central to the
`quid-pro-quo that animates the patent bargain. Uni-
`versal Oil Prods. Co. v. Globe Oil & Ref. Co., 322 U.S.
`471, 484 (1944) (“[T]he 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 pe-
`riod of the monopoly has expired. . . .”). A patent that
`is shown to fail the enablement requirement will be
`ruled invalid.
`
`The enablement requirement has been the subject
`
`of scores of cases, including many cases from this
`Court, tracing back to the earliest days of the US pa-
`tent system. See Mark D. Janis, On Courts Herding
`Cats: Contending with the “Written Description” Require-
`ment (and Other Unruly Patent Disclosure Doctrines),
`
`
`
`7
`
`2 Wash. U. J.L. & Pol’y 55, 55 n. 3-4 (2000). It remains
`today the international benchmark for correlating
`claim scope with the scope of the inventor’s contribu-
`tion. See GATT-WTO Agreement on the Trade Related
`Aspects of Intellectual Property TRIPS art. 29(1) (des-
`ignating enablement as a minimum standard for
`TRIPS-compliant patent systems but not mandating a
`written description requirement). It is explicit in mod-
`ern Section 112(a), and its existence has never been
`disputed.
`
`In the modern statutory scheme, the enablement
`
`requirement does not operate alone to ensure adequate
`disclosure. The invention disclosed in a patent also
`must have utility. 35 U.S.C. § 101; Brenner v. Manson,
`383 U.S. 519 (1966) (ruling that utility must be specific
`and substantial). After the application is filed, it may
`not be amended in any way that introduces “new mat-
`ter.” 35 U.S.C. § 132(a). But cf. In re Rasmussen, 650
`F.2d 1212, 1214-15 (C.C.P.A. 1981) (interpreting Sec-
`tion 132 to prohibit only additions to the disclosure
`portion of the patent document, not additions to the
`claims); Ariad, 598 F.3d at 1348 (dismissing Section
`132 as a mere “examiner’s instruction”). Proscribing
`new matter is important to prevent inventors from
`continually updating their disclosures to reflect post-
`filing advances in the technology, to the detriment of
`competitors. The statute includes still other require-
`ments that complement the foregoing, such as the def-
`initeness requirement of Section 112(b). Nautilus, Inc.
`v. Biosig Instr., Inc., 572 U.S. 898 (2014).
`
`
`
`8
`
`To this mix of explicit statutory safeguards, the
`
`Federal Circuit (and its predecessor tribunal) added a
`“written description” requirement, purporting to find it
`in the text of 35 U.S.C. § 112(a). In doing so, the court
`fundamentally altered the balance that the statute
`established. This Court should review the Federal Cir-
`cuit’s decision to create a written description require-
`ment separate from enablement, and should scrutinize
`the methodology by which the court arrived at such a
`requirement.
`
`
`II. Neither the Text of the Patent Statute nor
`this Court’s Jurisprudence Supports the
`Federal Circuit’s Independent Written De-
`scription Requirement.
`
`To arrive at its conclusion that Section 112(a)
`
`imposes an independent written description require-
`ment, the Federal Circuit in Ariad rejected a straight-
`forward reading of the plain text of the statute. It also
`asserted that scattered cases from this Court implicitly
`recognized such a requirement or remarked on it in
`dicta. Neither the statutory text nor this Court’s cases
`establish an independent written description require-
`ment.
`
`
`
`A. The Text of Section 112 Establishes an
`Enablement Requirement but not a
`Written Description Requirement.
`
`The relevant language from Section 112 bears re-
`
`iterating: the patent document “shall contain a written
`
`
`
`9
`
`description of the invention, and of the manner and
`process of making and using it, in such full, clear, con-
`cise, 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(a). The text is plain and its structure
`straightforward. The first two clauses, ending with the
`term “it,” specify what the patent document must con-
`tain: a written description (1) “of the invention” and (2)
`“of the manner and process of making and using it.”
`The remaining clauses, which follow a comma after the
`term “it,” specify how those contents are to be evalu-
`ated: they must be rendered “in such full, clear, concise,
`and exact terms as to enable. . . .” By its plain terms,
`Section 112(a) declares that the patent document must
`comply with an enablement requirement.
`
`To conjure up an additional written description re-
`
`quirement, the Federal Circuit has ignored the struc-
`ture of Section 112(a). Ariad, 598 F.3d at 1343-45
`(court’s textual analysis). The Federal Circuit’s con-
`struction requires the reader to erase the comma after
`“it” but retain the one after “invention,” setting off the
`phrase “written description of the invention” as if it
`might be a requirement independent from enablement.
`But even that does not plainly yield an independent
`written description requirement. Instead, it yields an
`ungrammatical mishmash, such as “the specification
`shall contain (1) a written description of the invention,
`and (2) of the manner and process of making and using
`it[ ] in such full, clear, concise, and exact terms as to
`
`
`
`10
`
`enable. . . .” (numerals and emphasis added; comma
`omitted).
`
`Not surprisingly, this convoluted approach to the
`
`text has long had its detractors. See Ariad, 598 F.3d at
`1363-64 (Rader, J., concurring in part); id. at 1367-68
`(Linn, J., concurring in part); In re Barker, 559 F.2d
`588, 594-95 (C.C.P.A. 1977) (Markey, J., dissenting). Cf.
`Ariad, 598 F.3d at 1360 (Gajarsa, J., concurring) (as-
`serting that Section 112 is a “model of legislative am-
`biguity”; joining the majority but doubting whether an
`independent written description requirement should
`be viewed as a “necessity of patent law”). Nonetheless,
`the Federal Circuit has shown no willingness to recon-
`sider its approach to the text. This Court should inter-
`vene for purposes of reviewing the Circuit’s suspect
`statutory interpretation.
`
`
`
`B. This Court Has Not Adopted an Inde-
`pendent Written Description Require-
`ment.
`
`In addition to its textual analysis, the Federal Cir-
`
`cuit has attempted to justify its creation of an inde-
`pendent written description requirement by gesturing
`towards scattered statements in this Court’s jurispru-
`dence. But this Court has never announced the adop-
`tion of a separate written description requirement
`resembling what the Federal Circuit has applied in
`this and several prior cases.
`In Ariad, the Federal Circuit invoked this Court’s
`
`remarks in Festo Corp. v. Shoketsu Kinzoku Kogyo
`
`
`
`11
`
`Kabushiki Co., 535 U.S. 722, 736 (2002), that the patent
`document “must describe, enable, and set forth the best
`mode of carrying out the invention.” But Festo was ad-
`dressing a patent infringement doctrine. The quoted
`remarks are dicta, notwithstanding the Federal Cir-
`cuit’s profession of subservience to them. See Ariad,
`598 F.3d at 1347 (“As a subordinate federal court, we
`may not so easily dismiss such statements as dicta but
`are bound to follow them.”).
`The Federal Circuit in Ariad also rested on a few
`
`other cases from this Court decided before 1952, the
`year when Congress enacted the patent statute in its
`modern form. These cases are of dubious relevance to
`the proposition that the post-1952 statutory scheme
`allows for a separate written description require-
`ment, and none of them announce the adoption of a
`separate written description requirement. For exam-
`ple, in Schriber-Schroth Co. v. Cleveland Tr. Co., 305
`U.S. 47, 57 (1938), this Court asserted that a patent
`application “cannot be broadened by amendment so as
`to embrace an invention not described in the appli-
`cation as filed”—an enunciation of the new matter
`prohibition. At that time, however, the new matter pro-
`hibition was not separately codified, as it is today in 35
`U.S.C. § 132. See also Ariad, 598 F.3d at 1363 (Rader,
`J., dissenting in part) (agreeing that Schriber-Schroth
`stands only for “the unremarkable proposition that an
`applicant cannot add new matter to an original disclo-
`sure.”).
`In addition, in Evans v. Eaton, 20 U.S. 356, 433-
`
`34 (1822), this Court referred to “two objects” of the
`
`
`
`12
`
`patent’s disclosure: first, “to make known the manner
`of constructing the machine . . . so as to enable artizans
`to make and use it,” and, second, “to put the public in
`possession of what the party claims as his own inven-
`tion” so as to distinguish the invention from what was
`known and to put others on notice as to what would
`constitute infringement. However, the Court was con-
`struing the 1793 Patent Act, Patent Act of 1793, Ch. 11,
`1 Stat. 318-23 (Feb. 21, 1793), which included no sepa-
`rate requirement for including patent claims in the pa-
`tent document. In the modern statute, the claims
`perform this second “object,” Markman v. Westview
`Inst., Inc., 517 U.S. 370, 372 (1996). This Court has con-
`firmed as much, noting that “the focus of patent con-
`struction has shifted” to the claims. Nautilus, Inc., 572
`U.S. at 902. It is a fallacy, therefore, to suggest that this
`Court’s 1822 Evans decision implies that the modern
`statutory scheme includes a separate written descrip-
`tion requirement.
`
`The most that these cases can demonstrate is that
`
`this Court has not addressed the Federal Circuit’s
`written description requirement in the post-1952 stat-
`utory scheme. Indeed, the Federal Circuit’s imagina-
`tive reconstruction of this Court’s cases belies the
`Circuit’s assertion that a separate written description
`requirement is “basic to patent law.” Ariad, 598 F.3d at
`1345. It is not basic; it is a recent creation supported
`by neither the modern statutory text nor this Court’s
`cases.
`
`
`
`
`
`13
`
`III. This Court’s Intervention Is Critical to Re-
`store the Appropriate Balance within the
`Patent System.
`
`The written description requirement has now os-
`
`sified at the Federal Circuit. See, e.g., Ariad, 598 F.3d
`at 1347 (invoking stare decisis to justify its separate
`written description requirement); Biogen Int’l GmbH
`v. Mylan Pharms., Inc., 18 F.4th 1333, 1341 (Fed. Cir.
`2021) (insisting that “[t]he statutory mandate for a
`written description as a prerequisite for patenting an
`invention has been a fixture of our laws for more than
`two centuries”); Vas-Cath, Inc. v. Mahurkar, 935 F.2d
`1555, 1560 (Fed. Cir. 1991) (suggesting that only the
`“uninitiated” would question the existence of a sepa-
`rate written description requirement). No further pro-
`ductive percolation at the circuit can be expected.
`
`But the story of the written description require-
`
`ment is more than just a remarkable instance of Fed-
`eral Circuit intransigence. In recent years, the Federal
`Circuit has allowed the doctrine to expand without
`discernible limits and has largely abandoned any pre-
`tense of explaining how the doctrine fits into the
`modern statutory scheme.
`
`
`
`A. The Federal Circuit Is Applying Its
`Written Description Requirement Ag-
`gressively to Strike Down Patents.
`
`The written description requirement now plays a
`
`substantial role in modern patent cases involving
`pharmaceuticals and the life sciences. In part this is
`
`
`
`14
`
`because the Federal Circuit has expanded the doc-
`trine’s reach, often reviewing supposedly factual writ-
`ten description determinations without meaningful
`deference.
`
`
`
`1. The Federal Circuit Has Extended
`the Reach of the Written Descrip-
`tion Requirement.
`
`The Federal Circuit has steadily extended the
`
`reach of its written description requirement far beyond
`even what its predecessor court had done. This case
`well illustrates the trend.
`
` When the Court of Customs and Patent Appeals
`(C.C.P.A.) first devised the written description re-
`quirement, the court confined it to cases where a pa-
`tent applicant had amended an application during
`prosecution to claim subject matter that had not been
`contained in the disclosure of the patent application
`as filed. See, e.g., In re Ruschig, 379 F.2d 990, 995-96
`(C.C.P.A. 1967). The Federal Circuit continued this
`practice in its early cases. See, e.g., Gentry Gallery, Inc.
`v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998); Vas-
`Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1560 (Fed. Cir.
`1991). The court could have used existing statutory
`tools—the Section 112 enablement requirement or the
`Section 132 new matter prohibition—to handle these
`cases, but it embraced the written description require-
`ment instead. Regarding the new matter prohibition,
`which prohibits amendments that add new matter
`into the “disclosure of the invention,” the C.C.P.A. had
`
`
`
`15
`
`already hamstrung itself by interpreting the term “dis-
`closure” strictly to exclude amendments to the claims,
`in sharp contrast to its freewheeling interpretation of
`Section 112. In re Rasmussen, 650 F.2d 1212, 1214-15
`(C.C.P.A. 1981); see also TurboCare Div. of Demag Dela-
`val Turbomachinery Corp. v. General Elec. Co., 264 F.3d
`1111, 1118 (Fed. Cir. 2001) (treating Section 132 as
`subsumed within the written description require-
`ment).
`
`In time, the Federal Circuit expanded the reach of
`
`the written description requirement considerably, ap-
`plying it to claims that were included in the original
`patent application, but which recited therapeutic
`outcomes or functional attributes. Ariad, 598 F.3d at
`1349-51; Regents of the Univ. of Cal. v. Eli Lilly & Co.,
`119 F.3d 1559, 1566 (Fed. Cir. 1997). As a result, even
`though the disclosure in the patent document may
`have fully taught a person of ordinary skill in the art
`how to make and use the invention, the Federal Circuit
`empowered judges to second-guess whether the inven-
`tor had full “possession” of the chemical or biological
`entities that would generate those therapeutic out-
`comes or functional benefits.
`
`In recent years, culminating in the present case,
`
`the written description requirement has crept even
`further outward. Under the Federal Circuit’s current
`caselaw, where a claim is directed to a “genus” (a label
`that could describe most claims), the written descrip-
`tion requirement is satisfied only if the patent docu
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