No. 22-671
`
`IN THE
`Supreme Court of the United States
`————
`
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Petitioner,
`
`v.
`
`HEC PHARM CO., LTD., HEC PHARM USA INC.,
`Respondents.
`
`————
`
`On Petition for a Writ of Certiorari to the
`United States Court of Appeals
`for the Federal Circuit
`
`————
`
`BRIEF OF AMICI CURIAE
`INTELLECTUAL PROPERTY PROFESSORS
`IN SUPPORT OF PETITIONER
`
`————
`
`DOMINICK A. CONDE
`Counsel of Record
`CHRISTOPHER E. LOH
`VENABLE LLP
`1290 Avenue of the Americas
`New York, NY 10104
`(212) 218-2204
`dconde@venable.com
`Counsel for Amici Curiae
`
`February 21, 2023
`WILSON-EPES PRINTING CO., INC. – (202) 789-0096 – WASHINGTON, D.C. 20002
`
`

`

`TABLE OF CONTENTS
`
`TABLE OF AUTHORITIES ................................
`
`INTEREST OF AMICI CURIAE ........................
`
`INTRODUCTION AND SUMMARY OF
`ARGUMENT ....................................................
`
`ARGUMENT ........................................................
`
`I. The New Written Description Standard
`Conflicts with Supreme Court and
`Federal Circuit Precedent ........................
`
`II. The New Written Description Standard
`Deprives Patentees of the Ability to Limit
`Claims to Avoid the Prior Art ..................
`
`III. The Second Federal Circuit Panel
`Engaged in Improper Fact-Finding .........
`
`Page
`
`ii
`
`1
`
`1
`
`2
`
`2
`
`6
`
`9
`
`CONCLUSION ....................................................
`
`13
`
`APPENDIX:
`
`LIST OF SIGNATORIES .............................
`
`1a
`
`(i)
`
`

`

`ii
`TABLE OF AUTHORITIES
`
`CASES
`
`Page(s)
`
`10
`
`12
`
`10
`
`Allergan, Inc. v. Sandoz Inc.,
`796 F.3d 1293 (Fed. Cir. 2015) .................
`Apotex Inc. v. Novartis AG,
`IPR2017-00854, 2018 WL 3414289
`(P.T.A.B. July 11, 2018) ............................
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) ............. 4, 10, 11
`Bell & Howell Document Mgmt. Prods. Co.
`v. Altek Sys.,
`132 F.3d 701 (Fed. Cir. 1997) ...................
`Capon v. Eshhar,
`418 F.3d 1349 (Fed. Cir. 2005) ................. 10-12
`Falkner v. Inglis,
`448 F.3d 1357 (Fed. Cir. 2006) .................
`Gentry Gallery, Inc. v. Berkline Corp.,
`134 F.3d 1473 (Fed. Cir. 1998) .................
`Halo Elecs., Inc. v. Pulse Elecs., Inc.,
`579 U.S. 93 (2016) .....................................
`Hybritech, Inc. v. Monoclonal Antibodies, Inc.,
`802 F.2d 1367 (Fed. Cir. 1986) .................
`In re Johnson,
`558 F.2d 1008 (C.C.P.A. 1977) .................
`In re Saunders,
`444 F.2d 599 (C.C.P.A. 1971) ...................
`In re Wertheim,
`541 F.2d 257 (C.C.P.A. 1976) ................... 6, 7
`
`12
`
`12
`
`5
`
`11
`
`7
`
`7
`
`
`
`
`
`

`

`iii
`TABLE OF AUTHORITIES—Continued
`Page(s)
`
`
`
`4
`
`5
`
`3-4
`
`Inphi Corp. v. Netlist, Inc.,
`805 F.3d 1350 (Fed. Cir. 2015) .................
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ...................................
`Microsoft Corp. v. I4I Ltd. Partnership,
`564 U.S. 91 (2011) .....................................
`Octane Fitness, LLC v. ICON Health &
`Fitness, Inc.,
`572 U.S. 545 (2014) ...................................
`Pozen Inc. v. Par Pharm., Inc.,
`696 F.3d 1151 (Fed. Cir. 2012) .................
`Pozen Inc. v. Par Pharm., Inc.,
`800 F. Supp. 2d 789 (E.D. Tex. 2011) .......
`Smith v. Snow,
`294 U.S. 1 (1935) .......................................
`Streck, Inc. v. Research & Diagnostic Sys., Inc.,
`665 F.3d 1269 (Fed. Cir. 2012) .................
`Tech. Licensing Corp. v. Videotek, Inc.,
`545 F.3d 1316 (Fed. Cir. 2008) .................
`Teva Pharms. USA, Inc. v. Sandoz, Inc.,
`574 U.S. 318 (2015) ...................................
`Tronzo v. Biomet, Inc.,
`156 F.3d 1154 (Fed. Cir. 1998) .................
`Union Oil Co. of Cal. v. Atl. Richfield Co.,
`208 F.3d 989 (Fed. Cir. 2000) ................... 7, 12
`
`5
`
`5
`
`5
`
`4
`
`12
`
`4
`
`9
`
`4
`
`STATUTES
`
`35 U.S.C. § 103 .............................................
`
`5
`
`
`
`

`

`
`
`iv
`TABLE OF AUTHORITIES—Continued
`Page(s)
`35 U.S.C. § 284 .............................................
`5
`35 U.S.C. § 285 .............................................
`5
`
`RULES
`
`
`
`Fed. R. Civ. P. 52(a)(6) ................................. 2, 9
`
`OTHER AUTHORITIES
`
`Andrew Karpan, Fed. Circ. Reverses Initial
`Panel To Find Gilenya IP Invalid, Law
`360, June 21, 2022 ....................................
`D. Karshtedt et al., The Death of the Genus
`Claim, 35 Harv. J.L. & Tech. 1 (2021) .....
`J.A. DiMasi et al., Innovation in the
`Pharmaceutical Industry: New Estimates
`of R&D Costs, 47 J. Health Econ. 20
`(2016) .........................................................
`John Carroll, One Drug, Many Uses, 2
`Biotechnol. Healthc. 56 (2005) .................
`Jorge Mestre-Ferrandiz et al., The R&D
`Cost of a New Medicine, Off. Health Econ.
`(2012) .........................................................
`Kaitlin Farrell and Austin Keith, Federal
`Circuit Rehearing Panel Vacates its
`January Decision and Reverses District
`Court Finding of Sufficient Written
`Description
`for Negative
`Claim
`Limitation, J.D. Supra, July 6, 2022 ........
`
`11
`
`8
`
`8-9
`
`8
`
`9
`
`11
`
`
`
`
`
`
`

`

`
`
`v
`TABLE OF AUTHORITIES—Continued
`Page(s)
`Luke T. Shannon and Andrew M. Solomon,
`Silence is Not Golden - Federal Circuit
`Invalidates Method of Treatment Patent
`for Lack of Written Description, The
`National Law Review, June 24, 2022 ......
`
`11
`
`
`
`

`

`INTEREST OF AMICI CURIAE1
`Amici curiae are intellectual property law professors
`who have considerable experience with patent practice
`and patent doctrine. They have no personal interest in
`the outcome of this case. They submit this brief to
`apprise the Court of conflicts between the Federal
`Circuit’s June 21, 2022 decision and Supreme Court
`and Federal Circuit precedent on the law of written
`description. Amici respectfully urge the Court to grant
`Novartis’s petition to address those conflicts.
`
`INTRODUCTION AND
`SUMMARY OF ARGUMENT
`On January 3, 2022, the first Federal Circuit panel
`in this case affirmed the district court’s judgment of
`patent validity over a written description challenge.
`The January 2022 decision adhered to Supreme Court
`and Federal Circuit written description precedent,
`eschewing the application of wooden rules—specifically,
`the need for in haec verba recitation of patent claim
`limitations in a patent specification—and emphasiz-
`ing the fact-based nature of the written description
`inquiry. Pet. App. 39a, 48a. In accordance with that
`precedent, the decision affirmed the district court’s
`finding, based on the unrebutted testimony of four
`experts, that the written description requirement had
`been met. Id. at 49a–52a.
`
`
`1 Pursuant to Supreme Court Rule 37.6, counsel for amici
`represent that no counsel for a party authored the brief in whole
`or in part, and that none of the parties or their counsel, nor any
`other person or entity, made a monetary contribution intended to
`fund the preparation or submission of this brief. Pursuant to
`Supreme Court Rule 37.2, counsel for amici provided counsel of
`record for all parties with notice of amici’s intention to file this
`brief at least 10 days prior to the due date.
`
`

`

`2
`On June 21, 2022, the second Federal Circuit panel
`in this case reversed. That June 2022 decision ignored
`Supreme Court and Federal Circuit precedent to
`announce a new written description standard: a patent
`owner now must show that any claim limitation not
`recited in haec verba in the specification must be
`understood by a skilled artisan to be “always” or
`“necessarily” present. Pet. App. 8a. That rigid rule
`conflicts with the Supreme Court’s and Federal Circuit’s
`flexible approach to written description. It also upsets
`settled expectations and discourages incentives to
`invent by depriving patentees the ability to limit their
`claims to avoid the prior art.
`In addition, the Federal Circuit’s June 2022 decision
`engaged in appellate fact-finding in violation of
`Fed. R. Civ. P. 52(a)(6) and this Court’s precedent. By
`failing to defer to the unrebutted fact-finding of the
`district court and four experts, the Federal Circuit
`added further unpredictability to the written descrip-
`tion inquiry and undermined the independent authority
`of district courts to resolve questions of fact. The
`Federal Circuit should not be permitted to engage in
`de novo fact-finding on written description contrary to
`the record below.
`
`ARGUMENT
`I. The New Written Description Standard
`Conflicts with Supreme Court and Federal
`Circuit Precedent
`While the June 2022 decision purports to create no
`new written description standard, that is incorrect.
`The June 2022 decision states that written description
`exists only if there is express support or if “a particular
`limitation would always be understood by skilled
`artisans as being necessarily” present. Pet. App. 8a
`
`

`

`3
`(emphasis added). The decision explains that, “[w]hen
`the specification is itself silent regarding a negative
`limitation, testimony from a skilled artisan as to possi-
`bilities or probabilities that the recited element would
`be excluded would not suffice, lest such testimony
`could effectively eliminate the written description
`requirement.” Id. That rule forecloses reliance on
`testimony about how a person having ordinary skill in
`the art (“PHOSITA”) would understand not only the
`text and structure, but also the technological context,
`of the specification. And although a negative claim
`limitation here is at issue, the decision suggests that
`the new “always/necessarily” standard should apply
`equally to positive and negative limitations. Pet. App.
`14a (emphasizing that the same standard applies “for
`positive limitations” as “for negative limitations”).
`The new “always/necessarily” standard for written
`description is contrary to Supreme Court and Federal
`Circuit precedent.
`As a procedural matter, the new written description
`standard erroneously places the burden of proving
`validity upon the owner of an issued patent. The June
`2022 decision states that “[i]f . . . a patent owner
`could establish that a particular limitation would
`always be understood by skilled artisans as being
`necessarily excluded from a particular claimed method
`or apparatus if that limitation is not mentioned, the
`written description requirement would be satisfied
`despite the specification’s silence.” Pet. App. 8a
`(emphasis added). That articulation of the written
`description standard is at odds with Supreme Court
`and Federal Circuit precedent holding that the burden
`of proving the invalidity of an issued patent rests with
`the patent challenger, not with the patent owner.
`Microsoft Corp. v. I4I Ltd. Partnership, 564 U.S. 91,
`
`

`

`4
`100 (2011); Tech. Licensing Corp. v. Videotek, Inc., 545
`F.3d 1316, 1329 (Fed. Cir. 2008).
`As a substantive matter, the new written descrip-
`tion standard conflicts with the flexible approach to
`written description advocated by this Court and by the
`en banc Federal Circuit. In Smith v. Snow, 294 U.S. 1,
`11 (1935), the Court asserted that the statutory
`written description standard did not require the
`recitation in a specification of “all possible forms in
`which the claimed principle may be reduced to
`practice.” In Ariad Pharms., Inc. v. Eli Lilly & Co., 598
`F.3d 1336, 1351–52 (Fed. Cir. 2010) (en banc), the en
`banc Federal Circuit affirmed that written description
`does not require any “particular form of disclosure.”
`And on the specific issue of negative claim limitations,
`the Federal Circuit in Inphi Corp. v. Netlist, Inc., 805
`F.3d 1350, 1356 (Fed. Cir. 2015) clarified that there is
`no “reason to [] articulate a new and heightened
`standard for negative claim limitations.”
`Decisions like Smith, Ariad and Inphi establish that
`a patent specification’s written description must be
`evaluated in its proper technological context, without
`wooden rules. To be clear, although the Federal
`Circuit has held that written description can also be
`shown based upon inherent disclosure, in which a
`claim limitation not expressly disclosed in the speci-
`fication would be understood by the PHOSITA to be
`necessarily present, e.g., Tronzo v. Biomet, Inc., 156
`F.3d 1154, 1159 (Fed. Cir. 1998), the Federal Circuit
`until now has never suggested that, absent an express
`disclosure, the written description requirement can
`only be met through inherent disclosure, wherein
`the specification “always” or “necessarily” includes a
`positive limitation or excludes a negative one.
`
`

`

`5
`An apt illustration of the Federal Circuit’s flexible
`approach to written description is provided by Pozen
`Inc. v. Par Pharm., Inc., 696 F.3d 1151 (Fed. Cir.
`2012). There, patent claims to a drug’s packaging
`and container were challenged for lack of written
`description because those ideas were nowhere in the
`specification. Id. at 1166. The district court never-
`theless found that a PHOSITA “would know that
`medications are not simply handed out to patients.
`Rather, pharmaceutical products, like the claimed
`tablets, are routinely administered in containers or
`packages.” Pozen Inc. v. Par Pharm., Inc., 800 F. Supp.
`2d 789, 821–22 (E.D. Tex. 2011). The Federal Circuit
`affirmed for lack of clear error. 696 F.3d at 1167.
`The same flexible approach adopted by the Federal
`Circuit in Pozen should have yielded the same result
`here. But it did not. Instead, the June 2022 decision
`applied the sort of rigid rule the Supreme Court has
`repeatedly admonished against in patent law. E.g.,
`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 407, 419,
`428 (2007) (rejecting rigid Federal Circuit require-
`ments for obviousness inquiry under 35 U.S.C. § 103);
`Octane Fitness, LLC v. ICON Health & Fitness, Inc.,
`572 U.S. 545, 553 (2014) (reversing “unduly rigid”
`Federal Circuit fee-shifting rule under 35 U.S.C.
`§ 285); Halo Elecs., Inc. v. Pulse Elecs., Inc., 579 U.S.
`93, 104 (2016) (rejecting “unduly rigid” Federal Circuit
`test for enhanced damages under 35 U.S.C. § 284). In
`so doing, the June 2022 decision jeopardizes the
`validity of thousands of issued patent claims and
`upsets settled expectations over how the written
`description requirement should apply to future claims.
`
`
`

`

`6
`II. The New Written Description Standard
`Deprives Patentees of the Ability to Limit
`Claims to Avoid the Prior Art
`In addition to the June 2022 decision’s broader
`implications, its new “always/necessarily” written
`description standard will deprive patentees of the
`ability to limit claims to avoid the prior art through
`negative limitations. Doing so will have widely felt
`adverse policy consequences.
`Negative claim limitations often are introduced
`during patent prosecution for the purpose of narrow-
`ing claims to avoid prior art. Negative limitations
`readily understood by PHOSITAs thus are an important
`tool in ensuring that claims are of appropriate scope.
`If allowed to stand, however, the new “always/
`necessarily” written description standard will in many
`situations deprive patent applicants of that option.
`Consider the situation described by the Federal
`Circuit’s predecessor court, the Court of Customs and
`Patent Appeals: a patent applicant discovers, while
`prosecuting its patent application at the United States
`Patent and Trademark Office, that the prior art covers
`part of its invention as originally claimed and
`described. In re Wertheim, 541 F.2d 257, 263 (C.C.P.A.
`1976). The applicant in that circumstance should be
`able to narrow its original claims with a negative
`limitation to carve out that aspect of the invention.
`Doing so would serve the public interest by allowing
`the applicant to limit its patent claims to a scope
`commensurate with the invention, without impairing
`the rights of others to practice subject matter covered
`by the prior art. Indeed, prior decisions have encour-
`aged patentees to include negative limitations in
`their claims—even if not specified in their written
`descriptions—so long as a PHOSITA reasonably would
`
`

`

`7
`understand that the patentee possessed the narrowed
`invention. E.g., Union Oil Co. of Cal. v. Atl. Richfield
`Co., 208 F.3d 989, 1000 (Fed. Cir. 2000); In re Johnson,
`558 F.2d 1008, 1018–19 (C.C.P.A. 1977).
`As the Federal Circuit’s predecessor court observed
`in Wertheim:
`That what appellants claim as patentable to
`them is less than what they describe as their
`invention is not conclusive if their specifica-
`tion also reasonably describes that which
`they do claim . . . “To rule otherwise would let
`form triumph over substance, substantially
`eliminating the right of an applicant to
`retreat to an otherwise patentable species
`merely because he erroneously thought he
`was first with the genus when he filed.”
`541 F.2d at 263 (quoting In re Saunders, 444 F.2d 599,
`607 (C.C.P.A. 1971)).
`Under the new “always/necessarily” standard, by
`contrast, patent claims amended during prosecution to
`include negative limitations would often be invalid for
`lack of written description. Indeed, it is difficult to
`imagine a scenario in which the amended claims,
`coupled with the original specification, will satisfy the
`new standard. After all, if the original specification
`were drafted to support the original claims—which did
`not include the negative limitation—then the original
`specification is unlikely to have “necessarily” excluded
`that limitation.
`In depriving patent applicants of the option to rely
`on negative limitations, the new standard imperils
`meaningful patent protection for all inventions. This
`burden, however, likely will fall heaviest upon phar-
`maceutical and biotechnology inventions, which often
`
`

`

`8
`are capable of addressing an array of diseases through
`the same mechanism of action. John Carroll, One Drug,
`Many Uses, 2 Biotechnol. Healthc. 56, 58–61 (2005).
`For example, fingolimod—the drug at issue in this
`case—not only can be used to treat relapsing remitting
`multiple sclerosis (“RRMS”), but also has utility in
`treating transplant rejection, viral myocarditis, and
`autoimmune disorders other than RRMS. U.S. Patent
`No. 8,324,283 at col. 12, ll. 19–37. To meet the new
`“always/necessarily” standard any time treatment-
`related prior art is cited during prosecution, specifica-
`tions for drug patents would have to include every
`detail of every treatment protocol for every disease for
`which the drugs have been found useful, even if those
`details were already well-known in the art. Such a
`standard would be prohibitive and would endanger a
`significant percentage of drug patents.
`Likewise, pharmaceutical and biotechnology patent
`applicants often must file broad genus claims at the
`start of each drug development cycle to cover all
`potential drug candidates that may later enter clinical
`trials. D. Karshtedt et al., The Death of the Genus
`Claim, 35 Harv. J.L. & Tech. 1, 63–65 (2021). The law
`should not limit the ability of these applicants to pare
`back the scope of their original genus claims, including
`through the use of negative limitations, in order to
`avoid the prior art and to align patent scope with the
`subset of drug candidates ultimately selected for
`development.
`The new standard thus would undermine the value
`of pharmaceutical and biotechnology patents and in
`turn undermine incentives to develop innovative new
`medicines. Patents are pivotal to protecting the multi-
`year and multi-billion dollar investments necessary
`to develop new products. E.g.¸ J.A. DiMasi et al.,
`
`

`

`9
`Innovation in the Pharmaceutical Industry: New
`Estimates of R&D Costs, 47 J. Health Econ. 20, 24–25,
`31 (2016) (estimating costs exceeding $1.395 billion for
`development of a pharmaceutical, and a synthesis-to-
`market approval timeline totaling more than 10
`years); Jorge Mestre-Ferrandiz et al., The R&D Cost of
`a New Medicine, Off. Health Econ. (2012), (https://
`www.ohe.org/wp-content/uploads/2014/07/380-RD-Cost-
`NME-Mestre-Ferrandiz-2012.pdf) (similar). Absent
`the prospect of obtaining appropriate patent protec-
`tion, most pharmaceutical and biotechnology companies
`would not be able to bear the time and cost associated
`with developing new medicines.
`
`III. The Second Federal Circuit Panel
`Engaged in Improper Fact-Finding
`Fed. R. Civ. P. 52(a)(6) states that a court of appeals
`“must not . . . set aside” a district court’s “[f]indings
`of fact” unless they are “clearly erroneous.” In Teva
`Pharms. USA, Inc. v. Sandoz, Inc., 574 U.S. 318
`(2015), this Court characterized that rule as a “clear
`command,” id. at 318, and criticized the Federal
`Circuit there for engaging in improper appellate fact-
`finding to overturn the district court’s conclusion that
`a patent was valid based upon the testimony of the
`patentee’s expert. Id. at 335–36.
`This case presents an even more egregious case than
`Teva of improper appellate fact-finding. Here, the
`June 2022 decision by the second Federal Circuit
`panel overturned both the district court’s finding of
`patent validity and the January 2022 affirmance by
`the first Federal Circuit panel of the district court’s
`finding—all of which were consistent with fact find-
`ings by four prior judges (three Administrative Law
`Judges in a parallel inter partes review proceeding
`on the ’405 patent-in-suit, and then-District Judge
`
`

`

`10
`Leonard P. Stark on a motion for a preliminary
`injunction). The second panel did so by treating the
`“plain text” of the specification as negating, as a
`matter of law, the unrebutted testimony of four
`experts. Pet. App. 9a. The sole decision the second
`panel cites to support its disregard of lower-court fact-
`finding is not about written description, but instead is
`about claim construction and de novo review. Id. at
`9a–10a (citing Bell & Howell Document Mgmt. Prods.
`Co. v. Altek Sys., 132 F.3d 701, 706 (Fed. Cir. 1997)).
`The second panel engaged in improper fact-finding,
`notwithstanding that the written description require-
`ment is a pure issue of fact addressed from the
`perspective of the PHOSITA. Allergan, Inc. v. Sandoz
`Inc., 796 F.3d 1293, 1308 (Fed. Cir. 2015); Ariad, 598
`F.3d at 1351. See also Capon v. Eshhar, 418 F.3d 1349,
`1357 (Fed. Cir. 2005) (written description “varies with
`the nature and scope of the invention at issue, and
`with the scientific and technologic knowledge already
`in existence”). And the second panel did so with respect
`to a quintessentially factual question not amenable to
`“plain text” analysis: whether a PHOSITA, based upon
`the state of the art, reasonably would have understood
`the specification of the ’405 patent-in-suit to have
`excluded administration of a “loading dose” of fingolimod
`to treat RRMS patients.
`By failing to defer to the unrebutted fact-finding of
`four experts and the district court on that question,
`the June 2022 decision by the second Federal Circuit
`panel added a further layer of unpredictability to an
`already intractable written description requirement.
`Decisions like these create uncertainty over the value
`of existing patents and discourage incentives to seek
`future ones; fuel the perception of the Federal Circuit
`
`

`

`11
`as an overactive and unpredictable court;2 diminish
`the importance of expert testimony in patent litiga-
`tion; and undermine the independent authority of
`district courts to resolve questions of fact.
`Last, the June 2022 decision contradicts the Federal
`Circuit’s long-standing assurance that, to satisfy the
`written description requirement, a patent specifica-
`tion need not teach, and “preferably omits,” that which
`is already known in the art. E.g., Hybritech, Inc. v.
`Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384 (Fed.
`Cir. 1986). The June 2022 decision ignores that written
`description—like enablement—requires consideration
`of the PHOSITA’s knowledge of the art at the time the
`invention was made. Ariad, 598 F.3d at 1351; Capon,
`418 F.3d at 1358. As the three Administrative Law
`Judges found in the above-mentioned parallel IPR
`proceeding, “the use of loading doses [according to both
`expert testimony and supporting evidence], ‘are not
`today, and were not in June 2006, part of the accepted
`
`2 E.g., Andrew Karpan, Fed. Circ. Reverses Initial Panel
`To Find Gilenya IP Invalid, LAW 360, June 21, 2022 (https://
`www.law360.com/articles/1504555?scroll=1&related=1) (describing
`how the second panel’s “sudden about-face startled” patent
`practitioners); Kaitlin Farrell and Austin Keith, Federal Circuit
`Rehearing Panel Vacates its January Decision and Reverses
`District Court Finding of Sufficient Written Description for
`Negative Claim Limitation, J.D. SUPRA, July 6, 2022 (https://
`www.jdsupra.com/legalnews/federal-circuit-rehearing-panel-vac
`ates-7497636) (describing how the panel decisions here “expose
`discord among Federal Circuit Judges” and create uncertainty);
`Luke T. Shannon and Andrew M. Solomon, Silence is Not Golden -
`Federal Circuit Invalidates Method of Treatment Patent for Lack
`of Written Description, THE NATIONAL LAW REVIEW, June 24,
`2022 (https://www.natlawreview.com/article/silence-not-golden-
`federal-circuit-invalidates-method-treatment-patent-lack-written)
`(noting how the second panel decision can be used to create
`uncertainty).
`
`

`

`12
`MS or RR-MS treatment protocols.’” Apotex Inc. v.
`Novartis AG, IPR2017-00854, 2018 WL 3414289
`(P.T.A.B. July 11, 2018), at *10. A PHOSITA therefore
`clearly would have known that a loading dose was
`not part of what was the standard regimen in the art,
`and thus not part of the ’405 patent’s claimed RRMS
`treatment method as of its 2006 invention date.
`Contrary to the rigid approach of the June 2022
`decision, the Federal Circuit previously has allowed
`patentees to rely on prior art to demonstrate that a
`PHOSITA would have understood that the inventor
`had invented what was claimed. E.g., Falkner v.
`Inglis, 448 F.3d 1357, 1366–68 (Fed. Cir. 2006); Streck,
`Inc. v. Research & Diagnostic Sys., Inc., 665 F.3d 1269,
`1285–87 (Fed. Cir. 2012); Union Oil Co. of Cal., 208
`F.3d at 999–1001. And because avoidance of loading
`doses was known in the art, the exclusion of a loading
`dose could not have been a novel or “essential element”
`of the invention for which written description support
`was particularly important. Cf. Gentry Gallery, Inc.
`v. Berkline Corp., 134 F.3d 1473, 1479–80 (Fed. Cir.
`1998) (invalidating claims for lack of written de-
`scription of “essential element”); Capon, 418 F.3d at
`1358 (finding error in Board of Patent Appeals and
`Interferences’ requirement that written description
`specify prior art element unrelated to novelty of
`claimed invention). The written description inquiry
`here thus did not warrant any contrary, “plain text”
`fact-finding by the second Federal Circuit panel.
`
`
`
`
`
`
`
`
`

`

`13
`CONCLUSION
`The Court should reverse the Federal Circuit’s June
`2022 decision because it is contrary to Supreme Court
`and Federal Circuit precedent.
`
`Respectfully submitted,
`
`DOMINICK A. CONDE
`Counsel of Record
`CHRISTOPHER E. LOH
`VENABLE LLP
`1290 Avenue of the Americas
`New York, NY 10104
`(212) 218-2204
`dconde@venable.com
`Counsel for Amici Curiae
`
`February 21, 2023
`
`

`

`
`
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`
`
`APPENDIX
`APPENDIX
`
`

`

`APPENDIX TABLE OF CONTENTS
`
`Page
`
`APPENDIX:
`
`LIST OF SIGNATORIES .............................
`
`1a
`
`

`

`1a
`APPENDIX
`LIST OF SIGNATORIES1
`
`Professor Martin J. Adelman
`George Washington University Law School
`
`Professor Emily Michiko Morris
`University of Akron School of Law
`
`Professor Adam Mossoff
`George Mason University, Antonin Scalia Law School
`
`Professor Kristen Osenga
`University of Richmond School of Law
`
`Professor Mark F. Schultz
`University of Akron School of Law
`
`Professor Ted Sichelman
`University of San Diego
`
`Joshua Kresh
`Managing Director, Center for Intellectual Property
`x Innovation Policy (C-IP2)
`George Mason University, Antonin Scalia Law School
`
`
`1 All signatories are participating in their individual capacity,
`not on behalf of their institutions. Institutions are listed for
`identification purposes only.
`
`