`
`No. 21-
`
`IN THE
`Supreme Court of the United States
`
`
`BIOGEN INTERNATIONAL GMBH AND BIOGEN MA INC.,
`Petitioners,
`
`v.
`
`MYLAN PHARMACEUTICALS INC.,
`Respondent.
`
`
`ON PETITION FOR A WRIT OF CERTIORARI TO THE
`UNITED STATES COURT OF APPEALS
`FOR THE FEDERAL CIRCUIT
`
`PETITION FOR A WRIT OF CERTIORARI
`
`
`SETH P. WAXMAN
` Counsel of Record
`THOMAS G. SAUNDERS
`SPENCER L. TODD
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`1875 Pennsylvania Ave., NW
`Washington, DC 20006
`(202) 663-6000
`seth.waxman@wilmerhale.com
`
`WILLIAM F. LEE
`LISA J. PIROZZOLO
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`60 State Street
`Boston, MA 02109
`(617) 526-6000
`
`SCOTT G. GREENE
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`7 World Trade Center
`250 Greenwich St.
`New York, NY 10007
`(212) 230-8800
`
`ADDITIONAL COUNSEL LISTED ON INSIDE COVER
`
`
`
`

`

`
`
`J. MICHAEL JAKES
`JAMES B. MONROE
`PAUL W. BROWNING
`JASON L. ROMRELL
`FINNEGAN HENDERSON
` FARABOW GARRETT
` & DUNNER LLP
`901 New York Ave., NW
`Washington, DC 20001
`(202) 408-4000
`
`
`
`

`

`
`
`QUESTION PRESENTED
`
`Biogen’s asserted patent, which claims methods of
`treating multiple sclerosis by orally administering 480
`mg/day of dimethyl fumarate (DMF), expressly states
`that “an effective dose of DMF … to be administered to
`a subject orally can be from … about 480 mg to about
`720 mg per day.” Over a dissent from the panel deci-
`sion and the dissent of three additional judges from the
`denial of rehearing en banc, the Federal Circuit none-
`theless held that Biogen’s patent did not satisfy 35
`U.S.C. § 112’s requirement to provide a “written de-
`scription of the invention” because the patent’s descrip-
`tion of the claimed dose did not include data proving
`the 480 mg/day dose’s efficacy, the claimed effective
`dose was “listed only once” in the specification, and the
`patent disclosed other inventions as well.
`The question presented is:
`Is 35 U.S.C. § 112’s requirement that a patent spec-
`ification “contain a written description of the invention”
`met when the specification describes the invention, or
`must the specification also disclose data that demon-
`strates the claimed invention is “effective” and empha-
`size the claimed invention by singling it out and de-
`scribing it more than once?
`
`
`(i)
`
`

`

`
`
`CORPORATE DISCLOSURE STATEMENT
`
`Petitioners Biogen International GmbH and Biogen
`MA Inc. (collectively “Biogen”) are owned directly, or
`indirectly, by Biogen Inc. No other publicly held com-
`pany owns 10% or more of Petitioners’ stock.
`
`(ii)
`
`

`

`
`
`TABLE OF CONTENTS
`
`Page
`QUESTION PRESENTED ............................................... i
`CORPORATE DISCLOSURE STATEMENT ............. ii
`TABLE OF AUTHORITIES ........................................... v
`OPINIONS BELOW ........................................................... 1
`JURISDICTION .................................................................. 1
`STATUTORY PROVISION INVOLVED ....................... 1
`INTRODUCTION ............................................................... 1
`STATEMENT ...................................................................... 4
`A. Patents And Patent Prosecution ........................ 4
`B. Section 112’s Written Description
`Requirement .......................................................... 6
`C. Biogen’s Development Of Tecfidera® ............... 10
`D. The Patent ............................................................ 11
`E. Trial Court Proceedings ..................................... 13
`F. Appellate Proceedings ....................................... 15
`REASONS FOR GRANTING THE PETITION ........... 19
`I. The Federal Circuit’s Decision Conflicts
`With The Text And Purpose Of Section 112
`And Longstanding Precedent .................................. 19
`II. The Federal Circuit’s Decision Threatens
`Innovation And Warrants Review By This
`Court ............................................................................ 29
`
`(iii)
`
`

`

`iv
`
`TABLE OF CONTENTS—Continued
`
`Page
`
`III. The Federal Circuit Is Internally Divided
`On A Frequently Recurring Question,
`Creating A
`Substantial Risk Of
`Inconsistent
`And
`Panel-Dependent
`Decisions ...................................................................... 32
`IV. This Case Is An Ideal Vehicle For
`Addressing This Important Legal Question .......... 34
`CONCLUSION .................................................................. 35
`
`APPENDIX A: Opinion of the United States
`Court of Appeals for the Federal Circuit,
`dated November 30, 2021 .......................................... 1a
`APPENDIX B: Order of the United States
`Court of Appeals for the Federal Circuit
`denying petition for panel rehearing and
`rehearing en banc, dated March 16, 2022 .............. 37a
`APPENDIX C: Memorandum opinion and or-
`der of the United States District Court for
`the Northern District of West Virginia,
`dated June 18, 2020 .................................................. 55a
`APPENDIX D: Judgment of the United States
`District Court for the Northern District of
`West Virginia, dated June 22, 2020 ....................... 95a
`
`
`
`

`

`v
`
`TABLE OF AUTHORITIES
`
`CASES
`
`Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) .................. 9, 10, 21, 22
`Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d
`956 (Fed. Cir. 2002) ...................................................... 8
`Evans v. Eaton, 20 U.S. (7 Wheat.) 356 (1822) ............... 7
`Gill v. Wells, 89 U.S. (22 Wall.) 1 (1874) ......................... 27
`Halo Electronics, Inc. v. Pulse Electronics,
`Inc., 579 U.S. 93 (2016) .............................................. 28
`In re Brana, 51 F.3d 1560 (Fed. Cir. 1995) .............. 23, 31
`In re Wands, 858 F.2d 731 (Fed. Cir. 1988) ..................... 6
`Landgraf v. USI Film Products, 511 U.S. 244
`(1994) ............................................................................ 33
`LizardTech, Inc. v. Earth Resource Mapping,
`Inc., 433 F.3d 1373 (Fed. Cir. 2006) ........................... 9
`Markman v. Westview Instruments, Inc., 517
`U.S. 370 (1996) ...................................................... 31, 34
`Moba, B.V. v. Diamond Automation, Inc., 325
`F.3d 1306 (Fed. Cir. 2003) ....................................... 8, 9
`Mylan Pharmaceuticals Inc. v. Biogen MA
`Inc.,
`IPR2018-01403, Paper No.
`98
`(P.T.A.B. Feb. 5, 2020) ............................................... 14
`Nautilus, Inc. v. Biosig Instruments, Inc., 572
`U.S. 898 (2014) ............................................................ 28
`Novozymes A/S v. DuPont Nutrition Biosci-
`ences APS, 723 F.3d 1336 (Fed. Cir. 2013) ............... 9
`
`
`
`

`

`vi
`
`TABLE OF AUTHORITIES—Continued
`
`Page(s)
`
`Nuvo Pharmaceuticals (Ireland) Designated
`Activity Co. v. Dr. Reddy’s Laboratories
`Inc., 923 F.3d 1368 (Fed. Cir. 2019) ........................... 9
`Octane Fitness, LLC v. ICON Health & Fit-
`ness, Inc., 572 U.S. 545 (2014) ................................... 28
`Permutit Co. v. Graver Corp., 284 U.S. 52
`(1931) .............................................................................. 8
`Pfaff v. Wells Electronics, Inc., 525 U.S. 55
`(1998) .................................................................... passim
`Schriber-Schroth Co. v. Cleveland Trust Co.,
`305 U.S. 47 (1938) ..................................................... 7, 8
`Snitzer v. Etzel, 465 F.2d 899 (C.C.P.A. 1972). ............. 27
`The Telephone Cases, 126 U.S. 1 (1888) ............... 3, 24, 25
`University of Rochester v. G.D. Searle & Co.,
`375 F.3d 1303 (Fed. Cir. 2004) .................................... 9
`Vanda Pharmaceuticals Inc. v. West-Ward
`Pharmaceuticals International Ltd., 887
`F.3d 1117 (Fed. Cir. 2018) ......................................... 26
`
`STATUTES, REGULATIONS, AND LEGISLATIVE
`MATERIALS
`28 U.S.C. § 1254 ................................................................... 1
`35 U.S.C.
`§ 102 .............................................................................. 29
`§ 103 .............................................................................. 29
`§ 112 ...................................................................... passim
`§ 154 ................................................................................ 5
`§ 282 ........................................................................ 15, 27
`
`
`
`

`

`vii
`
`TABLE OF AUTHORITIES—Continued
`
`Page(s)
`42 U.S.C. § 282 ................................................................... 30
`Patent Act of 1790, 1 Stat. 109 ........................................... 6
`Patent Act of 1793, 1 Stat. 318 ........................................... 6
`Patent Act of 1836, 5 Stat. 117 ........................................... 7
`42 C.F.R. § 11 ..................................................................... 30
`H.R. Rep. No. 97-312 (1981) ............................................. 31
`S. Rep. No. 97-275 (1982) ............................................ 33, 34
`
`OTHER AUTHORITIES
`American Heritage College Dictionary (4th ed.
`2004) ............................................................................. 21
`Black’s Law Dictionary (11th ed. 2019) ......................... 21
`4A Chisum, Donald S., Chisum on Patents
`(2022) .............................................................................. 5
`DiMasi, Joseph A., et al., Innovation in the
`Pharmaceutical Industry: New Estimates
`of R&D Costs, 47 J. Health Econ. 20 (2016) ........... 30
`Grabowski, Henry G., et al., The Roles of Pa-
`tents and Research and Development In-
`centives in Biopharmaceutical Innovation,
`34 Health Affairs 302 (2015) ..................................... 30
`Manual of Patent Examining Procedure (9th
`ed. rev. 10, June 2020), https://www.uspto.
`gov/web/offices/pac/mpep/index.html ....................... 5
`Merriam-Webster Dictionary, https://www.
`merriam-webster.com/dictionary/
`description (visited June 14, 2022) ........................... 21
`
`
`
`

`

`viii
`
`TABLE OF AUTHORITIES—Continued
`
`Page(s)
`
`Rabinowitz, Aaron B., Ending the Invalidity
`Shell Game: Stabilizing the Application of
`the Written Description Requirement in
`Patent Litigation, 12 Minn. J.L. Sci. &
`Tech. 127 (2011) .......................................................... 33
`Thomas, David, et al., Clinical Development
`Success Rates and Contributing Factors
`2011-2020, BIO (2001), https://go.bio.org/rs/
`490-EHZ-999/images/ClinicalDevelopment
`SuccessRates2011_2020.pdf ................................ 30, 31
`Webster’s Third New International Dictionary
`(1976) ............................................................................ 21
`Yu, Allen K., The En Banc Federal Circuit’s
`Written Description Requirement: Time
`for the Supreme Court to Reverse Again?,
`33 Cardozo L. Rev. 895 (2012) .................................. 22
`
`
`
`
`
`
`

`

`
`
`OPINIONS BELOW
`The opinion of the Federal Circuit (App.1a-35a) is
`reported at 18 F.4th 1333. The Federal Circuit’s order
`denying rehearing en banc, along with the dissenting
`opinion (App.37a-54a), is reported at 28 F.4th 1194.
`The district court’s memorandum containing its find-
`ings of facts and conclusions of law (App.55a-93a) is un-
`reported.
`
`JURISDICTION
`The Federal Circuit entered judgment on Novem-
`ber 30, 2021. The court denied Biogen’s timely petition
`for rehearing en banc on March 16, 2022. This Court
`has jurisdiction under 28 U.S.C. § 1254(1).
`
`STATUTORY PROVISION INVOLVED
`Section 112 of Title 35 of the U.S. Code provides in
`part:
`The [patent] specification shall contain a writ-
`ten 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 con-
`nected, to make and use the same, and shall set
`forth the best mode contemplated by the inven-
`tor of carrying out his invention.
`
`INTRODUCTION
`This case presents a fundamental question of law
`that has fractured the Federal Circuit, and generated
`considerable confusion: What is required to satisfy 35
`U.S.C. § 112’s requirement that a patent provide a
`
`
`
`

`

`2
`
`“written description of the invention”? Rather than
`apply the statute’s plain text, the Federal Circuit has
`created additional, atextual requirements that distort
`the statute’s simple command to provide “written de-
`scription of the invention” and conflict with this Court’s
`precedent. This is an important and recurring issue,
`and the Court should grant review to restore the prop-
`er understanding of the statute as written and previ-
`ously interpreted.
`Biogen obtained a patent for a groundbreaking
`multiple sclerosis (“MS”) treatment comprising orally
`administering a therapeutically effective amount of di-
`methyl fumarate (“DMF”), wherein a therapeutically
`effective amount is about 480 mg/day (“DMF480”). The
`patent’s specification disclosed and linked together all
`elements of the claimed invention and expressly stated
`that “an effective dose of DMF … to be administered to
`a subject orally can be from … about 480 mg to about
`720 mg per day.” Nonetheless, a divided panel of the
`Federal Circuit held that Biogen’s patent was invalid
`because it did not satisfy Section 112’s written descrip-
`tion requirement. The Federal Circuit reasoned that
`the patent specification did not include data proving the
`efficacy of the claimed dose, the claimed dose was
`“listed only once” in the specification, and the claimed
`dose was not singled out from the other inventions de-
`scribed in the patent.
`The Federal Circuit’s decision ignores Section 112’s
`plain text, which requires only “a written description of
`the invention.” That straightforward statutory lan-
`guage does not require proof of efficacy. Nor does it
`require that the patent applicant repeatedly describe or
`single out the claimed invention from other unclaimed
`disclosures. “Written description” means written de-
`scription, no more and no less.
`
`
`
`

`

`3
`
`The flaws in the Federal Circuit’s ruling were laid
`bare by Judge O’Malley’s dissent from the panel deci-
`sion and the opinion of the three additional judges who
`dissented from the denial of rehearing en banc. Judge
`Lourie, writing for the en banc dissenters, explained
`that “this case, in which every claim limitation is ex-
`pressly described in the disclosure of the patent specifi-
`cation, is at the farthest end of the spectrum of cases
`where written description has not been found.”
`App.41a. The panel majority’s decision, they noted,
`“imports extraneous considerations into the written
`description analysis and blurs the boundaries between
`the written description requirement and the other
`statutory requirements for patentability.” Id. These
`are not simply “errors in one case” but rather an “erro-
`neous broadening of the written description inquiry”
`that will affect future litigants. App.54a. Judge Lourie
`warned that this decision “creates confusion for future
`patent applicants and litigants regarding what is re-
`quired to meet the written description requirement of
`35 U.S.C. § 112.” App.51a-52a.
`Indeed, the atextual requirements imposed by the
`Federal Circuit are flatly inconsistent with this Court’s
`precedent. For example, more than 130 years ago, this
`Court upheld Alexander Graham Bell’s patent for the
`telephone, even though he had not yet constructed a
`working model. His patent was valid, this Court ex-
`plained, because it “describe[d] accurately” the process
`of creating a telephone. The Telephone Cases, 126 U.S.
`1, 535 (1888). More than a century later, this Court, cit-
`ing that decision, reaffirmed the “well settled” rule
`“that an invention may be patented before it is reduced
`to practice.” Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 61
`(1998). The Federal Circuit’s demand for proof of effi-
`cacy upends this long-standing principle.
`
`
`
`

`

`4
`
`The consequences of the Federal Circuit’s errone-
`ous decision will be dramatic, and will chill investment
`in innovative technologies, including life-altering medi-
`cal treatments. And because every patent must comply
`with Section 112’s written description requirement, the
`Federal Circuit’s error will be felt well beyond the
`pharmaceutical industry.
`The internal divisions within the Federal Circuit
`also promise to generate yet more confusion about
`what is necessary to comply with the written descrip-
`tion requirement. The disagreement below reflects
`deep divisions over a fundamental feature of patent
`law. Those divisions create an unacceptable risk of in-
`consistent, panel-dependent decisions that will under-
`mine the stability and certainty on which the patent
`system depends.
`Because of the Federal Circuit’s stark departure
`from the text of the statute and this Court’s precedent,
`this case is an ideal vehicle to address an important
`question of law. This Court should act promptly to cor-
`rect the Federal Circuit’s serious errors and restore
`clarity to an issue integral to patent law. This Court
`should therefore grant the petition for certiorari and
`reverse.
`
`STATEMENT
`A. Patents And Patent Prosecution
`A patent is divided into two main parts, the specifi-
`cation and the claims. The specification begins by
`providing relevant background and teaching the public
`about the improvements conceived by the inventors.
`The claims, which appear at the end of the patent, de-
`fine the scope of the invention that the patent owner
`
`
`
`

`

`5
`
`has the exclusive right to make, use, sell, offer to sell,
`and import.
`The claims of a patent often do not take their final
`form until long after a patent application has been filed.
`Applicants can amend their claims in response to the
`Patent and Trademark Office’s rejections during the
`process known as patent “prosecution.” In addition, a
`single “parent” patent application may disclose multiple
`improvements that are ultimately claimed in separate
`patents. For example, an applicant can file continua-
`tion or continuation-in-part applications that rely on the
`original disclosure contained in an earlier “priority” ap-
`plication but that issue as separate “child” or “grand-
`child” patents with different claims.1 A patent’s term is
`measured from its earliest claimed priority date, so alt-
`hough a series of patents linked to the same priority
`application may issue over time, the patents will ordi-
`narily expire at the same time.
` See 35 U.S.C.
`§ 154(a)(2).
`
`
`1 A continuation application “must not include any subject
`matter” that was not disclosed in the original parent application.
`Manual of Patent Examining Procedure 201.07 (9th ed. rev. 10,
`June 2020). A continuation-in-part application retains a portion of
`the original disclosure but adds new matter. Id. at 201.08. Wheth-
`er a continuation or continuation-in-part is filed, the named inven-
`tors as well as the title of a patent application often change as mul-
`tiple patents each claiming different improvements are prosecuted
`from a single “parent” application. See 4A Chisum, Chisum on
`Patents § 13.07 (2022) (“The 1984 amendment [to 35 U.S.C. § 120]
`directly allows continuation, divisional, and continuation-in-part
`applications to be filed even though there is not a complete identi-
`ty of inventorship between the parent and subsequent applica-
`tions.”); Manual of Patent Examining Procedure 606.01 (“Where
`the title is not descriptive of the invention claimed, the examiner
`should require the substitution of a new title that is clearly indica-
`tive of the invention to which the claims are directed.”).
`
`
`
`

`

`6
`B. Section 112’s Written Description Require-
`ment
`Section 112 of the Patent Act, as interpreted by
`courts, imposes three distinct requirements on patent
`applicants, only the first of which is at issue in this case.
`First, applicants must include a “written description of
`the invention.” 35 U.S.C. § 112(a). Second, they must
`satisfy the “enablement” requirement by disclosing
`“the manner and process of making and using [the in-
`vention], 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.” Id. The enablement require-
`ment tests whether the claimed invention can be prac-
`ticed without “undue experimentation.” In re Wands,
`858 F.2d 731, 736-737 (Fed. Cir. 1988). Third, appli-
`cants must “set forth the best mode contemplated by
`the inventor or joint inventor of carrying out the inven-
`tion.” 35 U.S.C. § 112(a). The challenge to Biogen’s pa-
`tent in this case was based solely on the written de-
`scription requirement.2
`The requirement to provide a “description” of the
`invention originated in the Patent Act of 1790. Patent
`Act of 1790, § 2, 1 Stat. 109, 110. The phrase “written
`description” was first used in 1793. Patent Act of 1793,
`§ 3, 1 Stat. 318, 321. At the time, patents were not re-
`quired to have claims, so the written description served
`to inform the public of the scope of the invention. Thus,
`
`
`2 Respondent did not argue at trial that the patent was inva-
`lid for lack of enablement because undue experimentation would
`be required. App.56a-57a n.2. Nor did it argue that Biogen had
`failed to disclose the best mode. Respondent’s sole challenge un-
`der Section 112 alleged that Biogen’s specification did not “contain
`a written description of the invention.”
`
`
`
`

`

`7
`
`alongside an enablement requirement, the Patent Act
`of 1793 stated that the written description should “dis-
`tinguish” the invention “from all other things before
`known.” Id. This Court explained that the “object”
`was to inform the public of “what the party claims as
`his own invention, so as to ascertain if he claim[s] any-
`thing that is in common use, or is already known, and to
`guard against prejudice or injury from the use of an in-
`vention which the party may otherwise innocently sup-
`pose not to be patented.” Evans v. Eaton, 20 U.S. (7
`Wheat.) 356, 434 (1822).
`In 1836, Congress overhauled the patent system by
`creating the Patent Office and introducing a system of
`administrative examination of patent applications. Pa-
`tent Act of 1836, §§ 1, 7, 5 Stat. 117, 117, 119. The Pa-
`tent Act of 1836 first introduced the requirement that a
`patent contain claims “specifying what the patentee
`claims as his invention or discovery.” Id. § 5, 5 Stat. at
`119. At the same time, Congress amended the precur-
`sor to Section 112(a) to state that an applicant “shall
`deliver a written description of his invention or discov-
`ery, and of the manner and process of making, con-
`structing, using, and compounding the same, in such
`full, clear, and exact terms, avoiding unnecessary pro-
`lixity, as to enable any person skilled in the art or sci-
`ence to which it appertains, or with which it is most
`nearly connected, to make, construct, compound, and
`use the same.” Id. § 6, 5 Stat. at 119. This language
`remains in the statute with only limited modification.
`See 35 U.S.C. § 112(a).
`The written description requirement, consistent
`with its origin, has traditionally been understood to
`serve a public notice function. This Court explained
`that a patent must “‘inform the public during the life of
`the patent of the limits of the monopoly asserted, so
`
`
`
`

`

`8
`
`that it may be known which features may be safely
`used or manufactured without a license and which may
`not.’” Schriber-Schroth Co. v. Cleveland Tr. Co., 305
`U.S. 47, 57 (1938) (quoting Permutit Co. v. Graver
`Corp., 284 U.S. 52, 60 (1931)). Patent claims thus “can-
`not be broadened by amendment so as to embrace an
`invention not described in the application.” Id. For ex-
`ample, in Schriber-Schroth, the original patent applica-
`tion described the webs that had been invented as “‘ex-
`tremely rigid,’” id. at 55, but the patentee later amend-
`ed his claims to cover webs that were “‘laterally flexi-
`ble,’” id. at 53. This Court held that the patent could
`not claim webs with “antithetical properties” to what
`had been described. Id. at 58.
`This Court’s long-standing focus on whether the
`specification provides a “description” of the invention
`has never required that the specification also prove the
`invention’s efficacy. For example, this Court “upheld a
`patent issued to Alexander Graham Bell even though
`he had filed his application before constructing a work-
`ing telephone.” Pfaff, 525 U.S. at 61. Likewise, this
`Court has never required that an invention be de-
`scribed more than once or singled out from other un-
`claimed disclosures.
`The Federal Circuit has struggled in recent years
`to interpret and apply the written description require-
`ment. Several judges on the Federal Circuit ques-
`tioned whether there even is separate a written de-
`scription requirement given the focus of the statutory
`language on enablement.3 The Federal Circuit resolved
`
`
`3 See, e.g., Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d
`956, 976 (Fed. Cir. 2002) (Rader, J., dissenting from denial of re-
`hearing en banc); id. at 987 (Linn, J., dissenting from denial of re-
`hearing en banc); Moba, B.V. v. Diamond Automation, Inc., 325
`
`
`
`

`

`9
`
`this internal debate in 2010 by recognizing a separate
`written description requirement. Ariad Pharm., Inc.
`v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010)
`(en banc). New debates, however, have followed in the
`wake of the Ariad en banc majority’s announcement
`that “the test for sufficiency” of a patent’s written de-
`scription is whether the patent “reasonably conveys to
`those skilled in the art that the inventor had possession
`of the claimed subject matter as of the filing date.” Id.
`Since Ariad, courts have struggled to consistently
`apply the “possession” test. Some decisions have
`turned to an array of additional, atextual sub-tests ap-
`plied by the Federal Circuit. See, e.g., Novozymes A/S
`v. DuPont Nutrition Bioscis. APS, 723 F.3d 1336, 1346-
`1347 (Fed. Cir. 2013) (applying “blaze marks” test).
`Other recent decisions have invented new require-
`ments out of whole cloth. See, e.g., Nuvo Pharm. (Ire.)
`Designated Activity Co. v. Dr. Reddy’s Labs. Inc., 923
`F.3d 1368, 1384 (Fed. Cir. 2019) (requiring proof that
`disclosed compound and formulation “would be effica-
`cious”). And tests that might have made sense in one
`context have been applied where they do not belong.
`See, e.g., App.32a-35a (O’Malley, J., dissenting) (criticiz-
`ing extension of “blaze marks” test); App.46a (Lourie,
`J., dissenting) (same).
`The result has been a pronounced expansion of the
`written description requirement beyond its original
`
`
`F.3d 1306, 1322 (Fed. Cir. 2003) (Rader, J., concurring); University
`of Rochester v. G.D. Searle & Co., 375 F.3d 1303, 1307 (Fed. Cir.
`2004) (Rader, J., dissenting from denial of rehearing en banc); id.
`at 1325 (Linn, J., dissenting from denial of rehearing en banc); Liz-
`ardTech, Inc. v. Earth Res. Mapping, Inc., 433 F.3d 1373, 1376
`(Fed. Cir. 2006) (Rader, J., dissenting from denial of rehearing en
`banc).
`
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`10
`
`purpose and substantial disagreement over how to ap-
`ply the requirement. This trend reached its apogee in
`this case, resulting in a dissent from the panel opinion
`by Judge O’Malley and splitting the Federal Circuit 6-3
`on whether to grant rehearing en banc. Indeed, the
`panel decision in this case prompted the author of the
`Ariad en banc decision—joined by the Chief Judge of
`the Federal Circuit and the Federal Circuit’s longest-
`serving member—to criticize “the muddying of the
`written description requirement.” App.41a.
`
`C. Biogen’s Development Of Tecfidera®
`Biogen’s Tecfidera® (DMF) is a widely prescribed,
`oral treatment for MS that was approved by the FDA
`in 2013. Biogen began developing what would become
`Tecfidera® ten years earlier in 2003. At that time, the
`only FDA-approved drugs for the treatment of MS
`were administered by injection. C.A.J.A.2127.
`In 2003, based on confidential data and considera-
`tion of DMF’s pharmacology, Biogen scientist Gilmore
`O’Neill conceived of treating MS with an oral dose of
`480 mg/day of DMF based on his insight that peak lev-
`els of medication in the blood stream were driving the
`efficacy of DMF in the treatment of MS. App.9a, 59a.
`Biogen did not immediately put Dr. O’Neill’s invention
`into clinical trials. Instead, Biogen’s Phase II study,
`which took place between 2004 and 2006, tested the
`clinical efficacy of the lower and higher DMF doses of
`120, 360, and 720 mg/day. App.8a-9a, 60a; C.A.J.A.2184,
`2188. The results of the Phase II trial showed that 720
`mg/day (“DMF720”) effectively treated MS based on
`certain measurements collected via magnetic resonance
`imaging (“MRI”), such as the number of brain lesions,
`but the 120 and 360 mg/day doses did not have a statis-
`
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`11
`
`tically significant effect. App.60a; C.A.J.A.2188-91,
`1708, 2052-2059.
`In 2007, Biogen began two Phase III clinical trials
`of DMF in MS patients, which both included the
`480 mg/day dose (“DMF480”) that Dr. O’Neill had con-
`ceived, as well as the DMF720 dose tested in the Phase
`II trial. In the Phase III trials, DMF480 not only met
`all MRI endpoints and clinical endpoints, but it unex-
`pectedly performed similarly on each clinical endpoint
`to the higher DMF720 dose, which had itself outper-
`formed its own Phase II results. C.A.J.A.2059-2069.4
`
`D. The Patent
`In February 2007, after receiving the Phase II
`study results and shortly before starting one of the
`Phase III trials that included the 480 mg/day dose, Bio-
`gen filed the provisional patent application that estab-
`lished the priority date for Biogen’s U.S. Patent
`No. 8,399,514 (“the Patent”). App. 9a, 62a; C.A.J.A.52,
`3290-3291. That priority application disclosed methods
`of screening chemical compounds for the treatment of
`neurological diseases and methods for treating the
`same. C.A.J.A.3295.
`The application was originally titled “NRF2
`Screening Assays and Related Methods and Composi-
`tions,” and Dr. Matvey Lukashev was named as the in-
`ventor on the application based on his contributions to
`work relating to a specific biologic pathway (the Nrf2
`pathway). C.A.J.A.3290-3291, 3337. In June 2011, Bio-
`
`
`4 The clinical endpoints in Biogen’s Phase III clinical trials
`were: (1) proportion of relapsing MS patients at two years; (2) an-
`nual relapse rate; and (3) sustained 12-week disability progression.
`C.A.J.A.2059-2060.
`
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`12
`
`gen amended the application’s title to “Treatment for
`Multiple Sclerosis” and added Dr. O’Neill as a named
`inventor to reflect the prosecution of claims to specific
`methods of treatment that were disclosed in the appli-
`cation and that were based on Dr. O’Neill’s inventive
`contribution. C.A.J.A.3437-3439. The Patent was is-
`sued by the USPTO on March 19, 2013. C.A.J.A.52.
`MS is discussed throughout the specification of the
`Patent and is the only disease for which the Patent de-
`scribes disease pathology, epidemiology, and the goals
`of treatment. Indeed, the first substantive sentence of
`the Patent states that “Provided are certain compounds
`for treating neurological diseases, including demye-
`linating neurological diseases, such as, e.g., multiple
`sclerosis.” C.A.J.A.66(1:12-14); see also C.A.J.A.52
`(Abstract) (“[P]rovided are certain methods of utilizing
`such compounds in therapy for neurological disease,
`particularly for slowing or reducing demyelination, ax-
`onal loss, or neuronal and oligodendrocyte death.”).
`The first column of the specification provides a de-
`tailed discussion of MS and explains that MS is “an au-
`toimmune disease” that “is characterized by inflamma-
`tion in parts of the” central nervous system, “leading to
`the loss of the myelin sheathing around axonal neurons
`(demyelination), loss of axons, and the eventual death
`of neurons,
`oligodendrocytes
`and glial
`cells.”
`C.A.J.A.66(1:15-52).
` The focus on MS continues
`throughout the Patent. MS is often the only example of
`a demylineating disease that is given, C.A.J.A.67(3:10-
`14), and is the only disease for which multiple subtypes
`are described, C.A.J.A.73(16:23-26).
`Method 4 of the Patent discloses the administration
`of a “therapeutically effective” amount of DMF,
`C.A.J.A.67(4:29-32), and describes administering the
`
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`13
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`compound in an amount “sufficient to slow or prevent
`demyelination, axonal loss, and/or neuronal death,”
`C.A.J.A.67(4:33-38). The Patent’s definition of “thera-
`peutically effective amount”