`
`In the
`Supreme Court of the United States
`
`JUNO THERAPEUTICS, INC., et al.,
`
`v.
`
`KITE PHARMA, INC.,
`
`Petitioners,
`
`Respondent.
`
`On PetitiOn fOr a Writ Of CertiOrari tO the United
`StateS COUrt Of aPPealS fOr the federal CirCUit
`
`BRIEF OF REGENXBIO INC. AS AMICUS
`CURIAE IN SUPPORT OF PETITIONER
`
`lauRa a. coRuzzI
`ReGenXbIo Inc.
`9600 Blackwell Road,
`Suite 210
`Rockville, Maryland 20850
`(240) 552-8181
`
`Matthew J. DowD
`Counsel of Record
`RobeRt J. Scheffel
`DowD Scheffel Pllc
`1717 Pennsylvania Ave. NW,
`Suite 1025
`Washington, D.C. 20006
`(202) 559-9175
`mdowd@dowdscheffel.com
`
`Counsel for Amicus Curiae
`
`July 15, 2022
`
`314317
`
`A
`
`(800) 274-3321 • (800) 359-6859
`
`
`
`i
`
`TABLE OF CITED AUTHORITIES . . . . . . . . . . . . . . iii
`
`INTEREST OF AMICUS CURIAE . . . . . . . . . . . . . . . .1
`
`SUMMARY OF ARGUMENT . . . . . . . . . . . . . . . . . . . . .2
`
`ARGUMENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
`
`I. The Federal Circuit’s “Possession” Analysis
`Does Not Comport with the Text and
`Purpose of 35 U.S.C. § 112. . . . . . . . . . . . . . . . . . .3
`
`
`
`A. The Text of § 112 Does Not Contemplate
`
`a “Possession” Analysis . . . . . . . . . . . . . . . . .3
`
`B. “Full, Clear, Concise, and Exact
`
`Terms” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
`
`C. This Court’s Precedent Does Not
`
`Require “Possession” . . . . . . . . . . . . . . . . . . .6
`
`II. The Federal Circuit’s Atextual “Possession”
`Analysis Has Been Imported from Priority
`and Timing Disputes to Incorrectly
`Invalidate Original Claim Scope. . . . . . . . . . . . . .7
`
`
`
`A. The Purpose of a Written Description
`Requirement and Its Accepted Role in
`Disputes about Priority and Timing. . . . . . .7
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`
`
`ii
`
`B. The Federal Circuit Has Imported
`Its “Possession” Analysis from Cases
`about Priority and Invention Timing . . . . .12
`
`
`
`III. The Federal Circuit’s Rule is Extremely
`Detrimental to Pioneering Biomedical
`Innovation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
`
`
`
`A. Pioneering Biomedical Inventions
`Deserve and Need Broad Patent
`Protection. . . . . . . . . . . . . . . . . . . . . . . . . . . .22
`
`
`
`B. Broad Patent Protection Furthers the
`Constitutional Objective of Promoting
`Innovation. . . . . . . . . . . . . . . . . . . . . . . . . . . .23
`
`
`
`CONCLUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
`
`Table of Contents
`
`Page
`
`
`
`iii
`
`CASES
`
`AbbVie Deutschland GmbH & Co. v.
`Janssen Biotech, Inc.,
`759 F.3d 1285 (Fed. Cir. 2014). . . . . . . . . . . . . . . . . . .19
`
`
`
`Amgen Inc. v. Hoechst Marion Roussel Inc.,
`
`314 F.3d 1313 (Fed. Cir. 2003). . . . . . . . . . . . . . . . . . . .9
`
`Amgen, Inc. v. Chugai Pharmaceutical Co.,
`
`927 F.2d 1200 (Fed. Cir. 1991) . . . . . . . . . . . . . . .13, 14
`
`Ariad Pharmaceuticals, Inc. v.
`Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) (en banc) . . . .18, 19, 21
`
`
`
`Biogen International GmbH v.
`Mylan Pharmaceuticals Inc.,
`28 F.4th 1194 (Fed. Cir. 2022). . . . . . . . . . . . . . . . . . .21
`
`
`
`Boston Scientific Corp. v. Johnson & Johnson,
`
`647 F.3d 1353 (Fed. Cir. 2011). . . . . . . . . . . . . . . . . . .20
`
`Carnegie Mellon University v.
`Hoffman-La Roche Inc.,
`541 F.3d 1115 (Fed. Cir. 2008) . . . . . . . . . . . . . . . . . .20
`
`
`
`Diamond v. Chakrabarty,
`
`447 U.S. 303 (1980). . . . . . . . . . . . . . . . . . . . . .12, 13, 23
`
`TABLE OF CITED AUTHORITIES
`
`Page
`
`
`
`iv
`
`Enzo Biochem, Inc. v. Gen-Probe Inc.,
`
`285 F.3d 1013 (Fed. Cir. 2002) . . . . . . . . . . . . . . . . . .17
`
`Falkner v. Inglis,
`
`448 F.3d 1357 (Fed. Cir. 2006) . . . . . . . . . . . . . . . . . .11
`
`Fiers v. Revel,
`
`984 F.2d 1164 (Fed. Cir. 1993) . . . . . . . . . . . . 14, 15, 16
`
`Idenix Pharmaceuticals LLC v.
`Gilead Sciences Inc.,
`941 F.3d 1149 (Fed. Cir. 2019). . . . . . . . . . . . . . . . . . .20
`
`
`
`In re Lukach,
`
`442 F.2d 967 (C.C.P.A. 1971) . . . . . . . . . . . . . . . . . . . . .8
`
`In re Smythe,
`
`480 F.2d 1376 (C.C.P.A. 1973) . . . . . . . . . . . . . . . . .5, 23
`
`In re Wertheim,
`
`541 F.2d 257 (C.C.P.A. 1976) . . . . . . . . . . . . . . . . . . . . .9
`
`In re Wright,
`
`866 F.2d 422 (Fed. Cir. 1989) . . . . . . . . . . . . . . . . . . . .9
`
`Moba, B.V. v. Diamond Automation, Inc.,
`
`325 F.3d 1306 (Fed. Cir. 2003) . . . . . . . . . . . . . . . . . .10
`
`Oka v. Youssefyeh,
`
`849 F.2d 581 (Fed. Cir. 1988) . . . . . . . . . . . . . . . . . . .11
`
`Cited Authorities
`
`Page
`
`
`
`v
`
`Paperless Accounting v.
`Bay Area Rapid Transit,
`804 F.2d 659 (Fed. Cir. 1986) . . . . . . . . . . . . . . . . . . . .5
`
`
`
`Regents of the University of California v.
`Eli Lilly & Co.,
`119 F.3d 1559 (Fed. Cir. 1997) . . . . . . . . . 12, 15, 16, 17
`
`
`
`Schriber-Schroth Co. v. Cleveland Trust Co.,
`
`305 U.S. 47 (1938) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
`
`The Telephone Cases,
`
`126 U.S. 1 (1887). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
`
`Tronzo v. Biomet, Inc.,
`
`156 F.3d 1154 (Fed. Cir. 1998). . . . . . . . . . . . . . . . . . . .9
`
`United States v. Dubilier Condenser Corp.,
`
`289 U.S. 178 (1933) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
`
`Vas-Cath Inc. v. Mahurkar,
`
`935 F.2d 1555 (Fed. Cir. 1991) . . . . . . . . . . . . . . . . . . .9
`
`CONSTITUTIONAL PROVISIONS
`
`U.S. Const., Art. I, § 8, cl. 8 . . . . . . . . . . . . . . . . . . . . . . .13
`
`U.S. STATUTES
`
`Leahy-Smith America Invents Act of 2011
` Pub. L. No. 112–29. . . . . . . . . . . . . . . . . . . . . . . . . . . .10
`
`Cited Authorities
`
`Page
`
`
`
`vi
`
`35 U.S.C § 101 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
`
`35 U.S.C. § 102(g) (2006). . . . . . . . . . . . . . . . . . . . .8, 10, 13
`
`35 U.S.C § 102(g)(2) (2006) . . . . . . . . . . . . . . . . . . . . .10, 11
`
`35 U.S.C. § 112 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . passim
`
`35 U.S.C. § 132 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8, 9
`
`35 U.S.C. § 135 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
`
`OTHER AUTHORITIES
`
`U.S. Patent No. 4,259,444. . . . . . . . . . . . . . . . . . . . . . . . .24
`
`A rti Rai, Intellectual Property Rights in
`Biotechnology: Addressing New Technology,
`34 Wake Forest L. Rev. 827 (1999). . . . . . . . . . . . 16, 17
`
`
`
`Christopher M. Holman, Enablement Invoked as
`a ‘Super-Written Description Requirement’
`to Overturn $2.5 Billion Jury Verdict, 37
` Biotech. L. Rep. 63 (Nov. 2, 2018) . . . . . . . . . . . . . . .17
`
`Janice M. Mueller, The Evolving Application
`of the Written Description Requirement to
`Biotechnological Inventions, 13 Berkeley
` Tech. L.J. 615 (1998) . . . . . . . . . . . . . . . . . . . . . . . 16, 17
`
`Cited Authorities
`
`Page
`
`
`
`vii
`
`Timothy R. Holbrook, Possession in Patent Law,
`
`59 SMU L. Rev. 123 (2006) . . . . . . . . . . . . . . . . . . . . .16
`
`Cited Authorities
`
`Page
`
`
`
`1
`
`INTEREST OF AMICUS CURIAE1
`
`REGENXBIO Inc. is a clinical-stage biotechnology
`company seeking to improve lives through the curative
`potential of gene therapy. Amicus has no interest in the
`present matter, other than ensuring that the U.S. patent
`system appropriately incentivizes and protects ground-
`breaking and life-saving innovations.
`
`Millions of people are affected by genetic changes—
`mutations or deletions in their DNA—or other metabolic
`dysfunctions that adversely impact their health. They
`face chronic disease and require expensive medications
`to control their symptoms. Gene therapy offers a
`revolutionary alternative: a chance to treat the underlying
`cause of the disease—by introducing a therapeutic gene
`that corrects the course of disease—and potentially
`provide lasting results from a single therapeutic dose.
`
`Gene therapy uses a “vector” to transport therapeutic
`DNA into the body’s cells. REGENXBIO has exclusive
`rights to innovative viral vectors developed at the
`University of Pennsylvania, known as NAV® Vectors, to
`treat genetic defects or supply therapeutic factors such
`as antibodies to treat other serious conditions. Upon
`administration to a patient, the vectors deliver functional
`genes to the nucleus of affected cells. Once there, they
`serve as a genetic blueprint, supplying the function needed
`to treat or cure the disease.
`
`1. Pursuant to Supreme Court Rule 37.2, counsel of record for
`all parties received timely notice of Amicus’s intention to file this
`brief and all parties consented to filing. No counsel for any party
`authored this brief, in whole or in part. No person or entity other
`than Amicus contributed monetarily to its preparation or submission.
`
`
`
`2
`
`REGENXBIO focuses on diseases with significant
`u n met needs, such a s ret i na l, met abol ic, a nd
`neurodegenerative diseases. As a key aspect of its
`business, REGENXBIO also licenses the patented NAV®
`Vector technology to other companies developing their
`own gene therapies. Like many other biotechnology
`companies, REGENXBIO relies on the patent system to
`protect its inventions. Patents are critical to its business
`and its ability to fund future research.
`
`SUMMARY OF ARGUMENT
`
`The Federal Circuit’s “possession”-based written
`description test is the erroneous product of a 1997
`Federal Circuit decision that does not comport with the
`text and purpose of 35 U.S.C. § 112. The “possession”
`analysis, as it is, was imported from disputes about the
`timing of inventions. It now creates damaging obstacles
`to obtaining patent protection for pioneering biomedical
`inventions. This misapplication lessens inventors’
`likelihood of recouping the costly investments necessary
`for groundbreaking biotechnology and biomedical
`innovation, and it impedes the objective of the patent
`system to promote the progress of the useful arts. The
`Court should grant the petition to restore the correct
`interpretation of the written description requirement of
`35 U.S.C. § 112.
`
`
`
`3
`
`ARGUMENT
`
`I. The Federal Circuit’s “Possession” Analysis Does
`Not Comport with the Text and Purpose of 35 U.S.C.
`§ 112
`
`The Federal Circuit currently applies a possession-
`based written description analysis that finds no support
`in the statute. This possession standard is an incorrect
`product of a 1997 Federal Circuit decision that strays from
`the statute’s text. Rather than stay true to the statute, the
`appeals court imposed, for the first time, a “possession”-
`based written description standard to original claims.
`
`A. The Text of § 112 Does Not Contemplate a
`“Possession” Analysis
`
`The statute’s language is plain. A patent must contain
`a written description of the invention and the manner and
`process of making and using the invention. The description
`must be “in such full, clear, concise, and exact terms as to
`enable any person skilled in the art to which it pertains .
`. . to make and use” the invention.
`
`The “written description of the invention” and of “the
`manner and process of making and using the invention”
`is not a mere abstract mandate read in isolation. The
`structure and syntax of § 112 command that this written
`description requirement is not separate and apart from
`the enablement requirement. Rather, the statute’s
`“enablement” element establishes the requirement that
`the written description must satisfy.
`
`Reading the “written description of the invention”
`element of § 112 divorced from the enabling requirement
`
`
`
`4
`
`leads to the conceptual problem as to what qualifies as
`a satisfactory “written description of the invention.”
`In other words, reading the phrase in isolation—as the
`Federal Circuit does—provides no textual context of what
`constitutes a “written description of the invention.”
`
`For these reasons, Amicus agrees with the Petition’s
`analysis. The plain-text requirement of an enabling
`“written description”—and not any “inventor possession”
`standard—is what Congress prescribed by § 112. It should
`be the one applied, especially when the unduly demanding
`“possession” standard invalidates patents disclosing
`pioneering, lifesaving inventions.
`
`B. “Full, Clear, Concise, and Exact Terms”
`
`The statute specifies that the written description
`invention must be in “full, clear, concise, and exact terms.”
`The terms used must be be full, clear, concise, and exact
`enough “to enable any person skilled in the art . . . to make
`and use the same.” These words cannot be ignored when
`interpreting the statute.
`
`Notably, the statutory directive that the written
`description be “concise” is equally important, but it is too
`often overlooked. At its base, the conciseness requirement
`is a congressional recognition that it is impractical and,
`in fact, counterproductive to force an inventor to include
`all potentially relevant information in a patent’s “written
`description.” Almost every invention builds on another,
`and there is no basis for a patent specification to ignore
`the “conciseness” requirement by including information
`that is known or to explicate every single possible example
`of the invention within a given genus.
`
`
`
`5
`
`Historically, courts have recognized the conciseness
`requirement, though less so in current Federal Circuit
`decisions. For instance, it is well settled that the patent
`need not include a “written description” of what one
`of ordinary skill in the art already knows. Paperless
`Accounting v. Bay Area Rapid Transit, 804 F.2d 659,
`664 (Fed. Cir. 1986) (“A patent applicant need not include
`in the specification that which is already known to and
`available to the public.”).
`
`Without the conciseness requirement, patent
`applications would balloon to thousands of pages. Almost
`fifty years ago, the Court of Customs and Patent Appeals
`(“CCPA”) recognized this very problem with an alternative
`interpretation of the written description requirement that
`would mandate the inclusion of all possible embodiments
`of a genus. Writing for the CCPA, Judge Rich (one of the
`architects of the 1952 Patent Act) explained why this
`“alternative” interpretation of § 112 was not feasible and
`not correct:
`
`The alternative places upon patent applicants,
`the Patent Office, and the public the undue
`burden of listing, in the case of applicants,
`reading and examining, in the case of the Patent
`Office, and printing and storing, in the case
`of the public, descriptions of the very many
`structural or functional equivalents of disclosed
`elements or steps which are already stored in
`the minds of those skilled in the arts, ready for
`instant recall upon reading the descriptions of
`specific elements or steps.
`
`In re Smythe, 480 F.2d 1376, 1384 (C.C.P.A. 1973). Thus,
`under accepted practice, an applicant need not include
`
`
`
`6
`
`every example within a genus to satisfactorily describe
`the genus.
`
`C. This Court’s Precedent Does Not Require
`“Possession”
`
`The Federal Circuit’s focus on “possession” also
`does not conform to this Court’s precedent. Adequacy
`of a patent’s written description should be assessed in
`conjunction with whether that patent enabled a skilled
`artisan to make and use the invention.
`
`The Court applied its view of § 112 (and its earlier
`equivalents) through several notable cases. See, e.g., The
`Telephone Cases, 126 U.S. 1, 536 (1887) (“It is enough
`if [the inventor] describes his method with sufficient
`clearness and precision to enable those skilled in the
`matter to understand what the process is, and if he points
`out some practicable way of putting it into operation.”);
`United States v. Dubilier Condenser Corp., 289 U.S.
`178, 187 (1933) (explaining that “the law requires such
`disclosure to be made in the application for patent that
`others skilled in the art may understand the invention and
`how to put it to use”).
`
`Notably, in the twenty-five years that the Federal
`Circuit has applied its possession requirement for the
`written description standard, it has not once found support
`in this Court’s precedents. This Court has never applied
`the written description requirement—under its current
`form in § 112 or the predecessor statutes, going back to
`the Patent Act of 1790—to require a distinct possession-
`based written description requirement. The imposition of
`the “possession” standard for assessing original written
`
`
`
`7
`
`description of a patent is entirely a product of the Federal
`Circuit.
`
`II. The Federal Circuit’s Atextual “Possession”
`Analysis Has Been Imported from Priority and
`Timing Disputes to Incorrectly Invalidate Original
`Claim Scope
`
`With the concept of “possession” entirely absent from
`the text of § 112, a pertinent question is how this undefined
`concept was imported into the “written description”
`requirement. A careful reading of Federal Circuit
`precedents reveals that the “possession” analysis is largely
`a product of certain unique inquiries necessary in patent
`disputes, namely disputes about priority of inventorship
`and “new matter” issues for amendments to claims. The
`“possession” inquiry is relevant in priority contests (unlike
`in the present case), where vast amounts of information
`beyond the patent specification is considered in order
`to ascertain the first inventor to have conceived of the
`invention. Before 1997, the Federal Circuit did not apply
`the “possession” standard to original claims or original
`description. The Federal Circuit’s recent importation of
`its modern “possession” test overlooks the purpose of the
`court’s earlier precedent.
`
`A. The Purpose of a Written Description
`Requirement and Its Accepted Role in Disputes
`about Priority and Timing
`
`The written description requirement traces its roots
`to the early years of the U.S. patent system. For the
`vast majority of years, the requirement for a “written
`description of the invention” was never applied to original
`
`
`
`8
`
`claims, which themselves served as a description of the
`invention, and instead was used in two instances: (1) To
`confirm that a later-filed claim had “written description
`support” in the original or earlier-filed application; and
`(2) to resolve timing-of-invention disputes, such as in
`interferences or in validity challenges, such as under 35
`U.S.C. § 102(g).
`
`The first category is a natural consequence of the
`patent application process. Under current practice, a
`patent application’s claims can be and are frequently
`amended during the examination process. A patent
`applicant can amend claims for any number of reasons,
`for example, to avoid prior art identified during the patent
`examination or to add additional claims to protect various
`aspects of the disclosed invention.
`
`During the process of amending claims, an applicant
`need not use the same exact words in the original
`specification. This premise has long been accepted in
`patent law. In re Lukach, 442 F.2d 967, 969 (C.C.P.A. 1971)
`(“[T]he invention claimed does not have to be described in
`ipsis verbis in order to satisfy the description requirement
`of § 112.”).
`
`But later-added claims must still be supported by
`the earlier-filed specification, and an applicant cannot
`add “new matter” that was not part of the originally
`disclosed invention. 35 U.S.C. § 132; Schriber-Schroth Co.
`v. Cleveland Tr. Co., 305 U.S. 47, 57 (1938) (holding that a
`patent application “cannot be broadened by amendment so
`as to embrace an invention not described in the application
`as filed”). When assessing if later claim amendments were
`compliant with §§ 112 and 132, the Federal Circuit and its
`
`
`
`9
`
`predecessor court have asked whether the inventor had
`“possession” of the claimed invention at an earlier time.
`E.g., Tronzo v. Biomet, Inc., 156 F.3d 1154, 1158 (Fed.
`Cir. 1998) (“To meet this requirement, the disclosure
`of the earlier application, the parent, must reasonably
`convey to one of skill in the art that the inventor possessed
`the later-claimed subject matter at the time the parent
`application was filed.”); accord In re Wertheim, 541 F.2d
`257, 262 (C.C.P.A. 1976).
`
`In other words, “[t]he purpose of the written
`description requirement is to prevent an applicant from
`later asserting that he invented that which he did not; the
`applicant for a patent is therefore required ‘to recount
`his invention in such detail that his future claims can
`be determined to be encompassed within his original
`creation.’” Amgen Inc. v. Hoechst Marion Roussel Inc.,
`314 F.3d 1313, 1330 (Fed. Cir. 2003) (quoting Vas-Cath
`Inc. v. Mahurkar, 935 F.2d 1555, 1561 (Fed. Cir. 1991)).
`
`When the scope of a claim has been changed
`by amendment in such a way as to justify
`an assertion that it is directed to a different
`invention than was the original claim, it is
`proper to inquire whether the newly claimed
`subject matter was described in the patent
`application when filed as the invention of
`the applicant. That is the essence of the so-
`called ‘description requirement’ of § 112, first
`paragraph.
`
`In re Wright, 866 F.2d 422, 424 (Fed. Cir. 1989). Thus,
`“until 1997, the new matter doctrine, cloaked either in the
`specific language of § 132 or the innovative new reading
`
`
`
`10
`
`of § 112, operated only to determine whether new claim
`language deserved priority back to the patent’s original
`filing date.” Moba, B.V. v. Diamond Automation, Inc., 325
`F.3d 1306, 1324 (Fed. Cir. 2003) (Rader, J., concurring).
`
`In the second context, courts used the written
`description requirement to determine issues of priority
`of invention, whether it concerned identifying the first
`true inventor of the claimed invention or whether earlier
`activity by a third-party invalidated a patent claim. Such
`disputes could arise in the context of an “interference”
`proceeding. See 35 U.S.C. § 135 (2006).2 In an interference,
`two or more separate inventors would have claims directed
`to similar subject matter, and a court or the USPTO would
`determine which inventor was the first to have “invented”
`the claimed subject matter.
`
`In other contexts, the patentability or validity of a
`claim would be assessed under 35 U.S.C. § 102(g) (prior
`to enactment of the America Invents Act). Section 102(g)
`defined certain prior art that could bar the patentability of
`a patent claim, including that “the invention was made in
`this country by another inventor who had not abandoned,
`suppressed, or concealed it.” Id. § 102(g)(2) (2006). If
`another party had made the same invention before the
`patent applicant, then the patent applicant could not get
`a patent on the invention.
`
`Whether in the context of an interference or a validity
`challenge under § 102(g), the inquiry considered “the
`respective dates of conception and reduction to practice of
`
`2. The America Invents Act (“AIA”) amended the Patent Act
`to eliminate interference proceedings. Pub. L. No. 112–29, § 3, 125
`Stat. 284, 290 (2011). In its place, the AIA authorized derivation
`proceedings, 35 U.S.C. § 135 (2012), which can involve priority issues.
`
`
`
`11
`
`the invention.” Id. § 102(g)(2) (2006). In other words, the
`inquiry was not focused on what was necessarily disclosed
`in the patent specification, but instead on activities
`beyond the specification, to determine who was the first
`to “possess” the claimed invention. See, e.g., Falkner v.
`Inglis, 448 F.3d 1357, 1365 (Fed. Cir. 2006) (applying the
`“possession” standard in an interference appeal).
`
`This distinction yielded a line of cases concentrating
`on evidentiary issues about whether an application could
`prove “possession” of a claimed invention at some point
`prior to the patent application being filed. The possession
`analysis involved detailed inquiries into laboratory
`notebooks, diary entries, grant proposals, manuscripts,
`letters of correspondence, and the like—all intended
`to determine whether there had been a conception and
`thus possession of the claimed invention at a time early
`enough to establish priority of invention. See, e.g., Oka v.
`Youssefyeh, 849 F.2d 581, 583 (Fed. Cir. 1988) (“Conception
`requires both the idea of the invention’s structure and
`possession of an operative method of making it.”).
`
`The priority disputes in the context of inventorship
`focused on the concept of possession because it was
`axiomatic that evidentiary support beyond what was in
`the patent application itself could be used to support
`an earlier date of invention. And because that other
`evidence—whether lab notebooks, witness testimony, or
`the like—had to be considered, the courts necessarily
`had to assess whether the inventor “possessed” a full
`conception of the invention, at a specific earlier time—
`before the full written description was set forth in the
`application. But despite the “possession” analysis having
`an accepted role in priority determinations, it had no
`
`
`
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`
`role in assessing the sufficiency of original claims to the
`invention, when the claimed invention was fully described
`in the claims themselves and in the application as filed.
`That is to say, the possession analysis did not have a role
`until 1997, when the Federal Circuit changed the law in
`Regents of the University of California v. Eli Lilly & Co.,
`119 F.3d 1559 (Fed. Cir. 1997).
`
`B. The Federal Circuit Has Imported Its
`“Possession” Analysis from Cases about
`Priority and Invention Timing
`
`The Federal Circuit’s importation of the possession
`analysis to apply to original claims was largely fueled by
`priority contests involving DNA patents. These priority
`disputes, by themselves, were not necessarily an improper
`application of the “possession” requirement, as they
`focused on ensuring that later-filed claims found support
`in an earlier application or were supported by evidence
`that the inventor was in fact the first to invent. But the
`problem arose when the possession/conception analysis
`was applied outside the context of priority/timing issues.
`
`In hindsight, the legal disputes about the correct role
`of the written description can trace to this Court’s decision
`in Diamond v. Chakrabarty, 447 U.S. 303 (1980)—a
`decision before the Federal Circuit existed that correctly
`laid the legal foundation for the biotech revolution. In
`that case, the Court affirmed that biotech inventors could
`obtain broad patent protection on pioneering DNA-based
`inventions. While Chakrabarty decided patent-eligibility
`under 35 U.S.C. § 101, the breadth of the later-issued
`claims ensured that innovators in the early years of the
`biotech revolution could obtain sufficient patent protection
`
`
`
`13
`
`for their ground-breaking inventions. In essence,
`Chakrabarty reaffirmed the constitutional quid pro quo.
`Inventors would disclose their ground-breaking inventions
`as early as possible, and, in exchange, they would be
`granted the exclusive right. See U.S. Const. art I, § 8, cl. 8.
`
`The quid pro quo worked. Chakrabarty promoted
`one of the greatest technological revolutions in human
`history—the biotechnology industry. The broad patent
`protection granted in Chakrabarty also enabled the
`United States to become the global biotechnology leader.
`
`Chakrabarty incentivized inventors to disclose
`their inventions in patent applications, and this led
`to races between competing biotechnology inventors.
`These competitions encouraged the early disclosure of
`pioneering biotechnology developments, but they also
`led to disputes about who invented first (under the U.S.
`first-to-invent patent system). And as noted above,
`the “possession” standard was used to ensure that the
`inventor claiming to be first had the evidentiary proof (i.e.,
`written description plus other extrinsic evidence, such as
`laboratory notebooks, grant proposals, and reports) to
`show first “possession” of the invention. These priority
`disputes were particularly prevalent in the biotechnology
`field.
`
`One early example is Amgen, Inc. v. Chugai
`Pharmaceutical Co., 927 F.2d 1200 (Fed. Cir. 1991).
`A mgen’s patent claimed DNA encoding human
`erythropoietin (“EPO”). The defendant challenged the
`claims as anticipated under § 102(g), i.e., that someone
`else had made the invention before Amgen’s inventors.
`The defendants alleged that Fritsch, not Amgen, was
`
`
`
`14
`
`first to conceive of the cloning strategy to obtain the EPO
`gene. Fritsch’s cloning strategy and experiments were
`not enough to establish a prior conception. What was
`required was the DNA sequence itself. The court opined
`that, in the case of genes, conception does not occur until
`the inventor reduced the invention to practice through a
`successful experiment.
`
`We hold that when an inventor is unable to
`envision the detailed constitution of a gene so
`as to distinguish it from other materials, as well
`as a method for obtaining it, conception has not
`been achieved until reduction to practice has
`occurred, i.e., until after the gene has been
`isolated.
`
`927 F.2d at 1206.
`
`The next case on point, Fiers v. Revel, 984 F.2d 1164
`(Fed. Cir. 1983), involved a three-way interference over
`claims directed to the cDNA for fibroblast interferon-
`beta. The interference was unusual as it involved three
`foreign inventive entities who could not rely on their acts of
`invention outside the United States. They were therefore
`constrained to rely only on their patent filings. Sugano,
`the party first to disclose the DNA sequence (not just
`the method for cloning the gene), won. Citing Amgen, the
`Fiers court noted:
`
`An adequate written description of a DNA
`requires more than a mere statement that it is
`part of the invention and reference to a potential
`method for isolating it; what is required is a
`description of the DNA itself.
`
`
`
`15
`
`***
`
`If a conception of a DNA requires a precise
`definition, such as by structure, formula,
`chemical name, or physical properties, as we
`have held, then a description also requires that
`degree of specificity. To paraphrase the Board,
`one cannot describe what one has not conceived.
`
`Id. at 1170-71. Again, the appeals court invoked the
`“possession” concept when trying to assess which party
`was the first to have conceived of the claimed invention.
`
`As noted above, in 1997, the Federal Circuit’s written-
`description jurisprudence drastically changed. For the
`first time, the court applied the “possession” standard to
`original claims, and in the absence of any priority issues,
`in Regents of the University of California v. Eli Lilly
`& Co., 119 F.3d 1559 (Fed. Cir. 1997). This sea-change
`required the patent specification to do all the work of
`extrinsic evidence that was routinely relied on to establish
`“possession,” such as laboratory notebooks and the like.
`This new standard was later applied by the Federal
`Circuit to each aspect of the disclosure, whether novel or
`routine. See infra.
`
`In Lilly, the University of California’s patent claimed
`rat, human, vertebrate, and mammalian insulin cDNAs.
`Id. at 1563. The specification as originally filed disclosed
`the sequence of rat cDNA and the human protein; a
`process for obtaining the human cDNA; and a definition of
`the claimed genus of DNAs, i.e., vertebrate, mammalian,
`and human insulin. Id. Lilly attacked the claims as invalid
`for lack of an adequate written description under 35 U.S.C.
`§ 112.
`
`
`
`16
`
`Even though there was no issue of priority in Lilly,
`the Federal Circuit imported the possession standard
`from the interference context in Fiers. Relying on Fiers,
`the Lilly court stated: “An adequate written description
`of a DNA, such as the cDNA of the recombinant plasmids
`and microorganisms of the ’525 patent, ‘requires a precise
`definition, such as by structure, formula, chemical name,
`or physical properties,’ not a mere wish or plan for
`obtaining the claimed chemical invention.” Id. at 1566
`(quoting Fiers, 984 F.2d at 1171). Invoking the Fiers
`analysis, the Lilly court applied the written description
`analysis to original claims as requiring “a description of
`the DNA itself.” Id. at 1567. The Federal Circuit majority
`thus held that, as a matter of law, the patent’s original
`description was adequate for the rat cDNA but not for
`the genus of vertebrate and mammalian DNAs or for the
`claimed human DNA. Id.
`
`The dramatic shift caused by Lilly was quickly noticed.
`See, e.g., Janice M. Mueller, The Evolving Application of
`the Written Description Requirement to Biotechnological
`Inventions, 13 Berkeley Tech. L.J. 615, 617 (1998) (“The
`Lilly decision establishes uniquely rigorous rules for
`the description of biotechnological subject matter that
`significantly contort written description doctrine away
`from its historic origins and policy grounding.”); see also
`Arti Rai, Intellectual Property Rights in Biotechnology:
`Addressing New Technology, 34 Wake Forest L. Rev.
`827, 834-35 (1999) (explaining that, in Lilly, the Federal
`Ci