Case 1:18-cv-12029-ADB Document 571 Filed 11/02/22 Page 1 of 11
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MASSACHUSETTS
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`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBH and
`TEVA PHARMACEUTICALS
`USA, INC.,
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`Plaintiffs,
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`v.
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`ELI LILLY AND COMPANY,
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`
`
`
`Civil Action No.
`1:18-cv-12029-ADB
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`
`
`Defendant.
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`
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`TEVA’S BENCH BRIEF CONCERNING THE FINAL JURY INSTRUCTION ON
`THE 35 U.S.C. § 112 WRITTEN DESCRIPTION REQUIREMENT
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`Case 1:18-cv-12029-ADB Document 571 Filed 11/02/22 Page 2 of 11
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`TABLE OF AUTHORITIES
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`Page(s)
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`Cases
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`AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc.,
`759 F.3d 1285 (Fed. Cir. 2014)..............................................................................................1, 3
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`Ajinomoto v. ITC,
`932 F.3d 1342 (Fed. Cir. 2019)..........................................................................................2, 3, 4
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`In re Alonso,
`545 F.3d 1015 (Fed. Cir. 2008)..................................................................................................4
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`Amgen Inc. v. Sanofi,
`2019 WL 4058927 (D. Del. Aug. 28, 2019), aff’d sub nom. Amgen Inc. v.
`Sanofi, Aventisub LLC, 987 F.3d 1080 (Fed. Cir. 2021) ...........................................................1
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`Amgen v. Sanofi,
`872 F.3d 1367 (Fed. Cir. 2017)..................................................................................................3
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`BASF Plant Science, LP v. CSIRO,
`28 F.4th 1247 (Fed. Cir. 2022) ..............................................................................................2, 4
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`Hybritech Inc. v. Monoclonal Antibodies, Inc.,
`802 F.2d 1367 (Fed. Cir. 1986)..................................................................................................5
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`Idenix Pharma. LLC v. Gilead Sciences Inc.,
`941 F.3d 1149 (Fed. Cir. 2019)..................................................................................................3
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`Invitrogen Corp. v. Clontech Labs., Inc.,
`429 F.3d 1052 (Fed. Cir. 2005)..................................................................................................4
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`Juno Therapeutics, Inc. v. Kite Pharma, Inc.,
`10 F.4th 1330 (Fed. Cir. 2021) ..............................................................................................1, 4
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`Juno Therapeutics, Inc. v. Kite Pharma, Inc.,
`2:17-cv-07639 SJO-KS, 2020 WL 10460622, (C.D. Cal. Mar. 24, 2020) ................................1
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`Statutes
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`35 U.S.C. §112 ....................................................................................................................... passim
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`i
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`Case 1:18-cv-12029-ADB Document 571 Filed 11/02/22 Page 3 of 11
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`Lilly has proposed including in the final jury instructions concerning the § 112 written
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`description requirement the following language: “[A] patent specification must disclose at least
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`some species (i.e., antibodies) that are structurally similar to the accused infringing product (e.g.,
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`Lilly’s Emgality).” Lilly’s Jury Tr. Br., ECF No. 523-3 at 15. The Court had included similar
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`language in its draft preliminary jury instructions, before removing it for further consideration.
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`For the reasons given in this bench brief, the inclusion of such language in a case (1)
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`involving method of treatment claims, not composition claims, and (2) limited to the use of
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`humanized antibodies, would be error.
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`As an initial matter, Lilly’s sole support for the proposed instruction (see ECF No. 523-3
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`at 15 n.26.) is AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285,
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`1301 (Fed. Cir. 2014), which actually says something somewhat different: “[P]atents must at least
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`describe some species representative of antibodies that are structurally similar to” the accused
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`product. “[S]pecies representative of antibodies that are structurally similar” is a step removed
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`from, and broader than, “species” that themselves “are structurally similar” to the accused product.
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`Moreover, that sentence in AbbVie is not well-settled law. In the eight years since AbbVie, the
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`Federal Circuit has never repeated that specific formulation, or even something resembling it. The
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`Federal Circuit has only ever described the relevant portion in AbbVie in passing, and the only
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`district court cases to quote this language have done so in the context of recounting a party’s
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`arguments, not as an affirmative statement of the law. See Juno Therapeutics, Inc. v. Kite Pharma,
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`Inc., 2020 WL 10460622, at *3 (C.D. Cal. Mar. 24, 2020), rev’d, 10 F.4th 1330 (Fed. Cir. 2021);
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`Amgen Inc. v. Sanofi, 2019 WL 4058927, at *4 (D. Del. Aug. 28, 2019), aff’d sub nom. Amgen
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`Inc. v. Sanofi, Aventisub LLC, 987 F.3d 1080 (Fed. Cir. 2021).
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`Case 1:18-cv-12029-ADB Document 571 Filed 11/02/22 Page 4 of 11
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`As discussed at summary judgment, Judge Bryson’s decisions in the “UroPep” case are
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`instructive here. In that case, Judge Bryson delivered the following instruction, which is similar
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`to Teva’s proposed written description language and does not include the rigid “structurally
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`similar” instruction Lilly asks this Court to include:
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`The written description requirement can be satisfied by any
`combination of the words, structures, figures, diagrams, formulas,
`etc., contained in the patent, as understood by a person of skill in the
`art. It is not necessary to describe every compound used in the
`claimed method by name or structure in order to satisfy the written
`description requirement as applied to a group of compounds, as long
`as the patent includes a sufficient number of representative
`compounds or a common structural feature, such that a person of
`ordinary skill in the art would understand, from reading the patent,
`that the inventor invented the full scope of the claimed method.
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`Erfindergemeinschaft Uropep GbR v. Eli Lilly & Co., No. 2:15-CV-1202-WCB, ECF No. 333
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`(E.D. Tex. Apr. 21, 2017) (attached as Exhibit 1).
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`The less-rigid approach seen in UroPep and Teva’s proposed instruction is consistent with
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`the Federal Circuit’s flexible approach to written description. That Court repeatedly has stated
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`that “the critical inquiry” under § 112’s written description requirement “is whether the relevant
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`artisan reading the specification would understand that the inventor was in possession of the
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`claimed invention at the time of filing.” BASF Plant Science, LP v. CSIRO, 28 F.4th 1247, 1265
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`(Fed. Cir. 2022) (cleaned up). An “actual reduction to practice is not a requirement,” and “a
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`patentee may rely on information that is well-known in the art to the extent it informs how a
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`relevant artisan would reasonably understand what is actually described in the specification.” Id.
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`(cleaned up). “The amount of disclosure necessary to satisfy the written-description requirement
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`will necessarily vary depending on the context, considering such facts as the existing knowledge
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`in the particular field, the extent and content of the prior art, the maturity of the science or
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`technology, and the predictability of the aspect at issue.” Ajinomoto v. ITC, 932 F.3d 1342, 1359
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`(Fed. Cir. 2019) (cleaned up).
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`Under that context-specific approach to written description, the instruction Lilly seeks
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`would be improper for at least two reasons.
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`First, AbbVie was a case involving composition claims, and most Federal Circuit decisions
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`discussing structure in the context of written description likewise involve composition claims,
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`usually to chemical compounds. There are numerous Federal Circuit written description cases
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`involving method of treatment claims and written description, of which only one uses the phrase
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`“structurally similar” in a relevant context—which is unsurprising, because the invention in a
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`method of treatment claim is the method, not necessarily the composition being used to perform
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`that method. Tellingly, that single case involved novel chemical compounds, meaning the inventor
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`selectively assembled a compound using handpicked elements in a particular, novel structure in
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`order to treat a particular condition. See Idenix Pharma. LLC v. Gilead Sciences Inc., 941 F.3d
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`1149, 1165 (Fed. Cir. 2019) (method of treating hepatitis C with a chemical compound); cf.
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`Ajinomoto, 932 F.3d at 1359 (merely recounting the holding in AbbVie). With respect to method
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`of treatment claims where the method involves use of a novel chemical compound, it could make
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`sense to require some degree of structural similarity between the patented invention and the
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`accused compound. Even so, Idenix did not recite the “structurally similar” language from AbbVie
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`that Lilly wants imported into the jury instructions here; instead, it stated that “written description
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`does not require a nucleotide-by-nucleotide recitation of the entire genus. The purpose of that rule
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`is to allow relatively few representative examples or formulas to support a claim on a structurally
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`similar genus.” 945 F.3d at 1165.
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`Method of treatment claims are very different from composition claims, in that one can
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`have a novel method even if the underlying composition is not novel at all. This case illustrates
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`the point. The PTAB found, in a decision affirmed by the Federal Circuit, that the composition
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`claims in the Zeller patents—covering the humanized antibodies themselves—were unpatentable
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`because they were obvious. At the same time, the PTAB found, in a decision affirmed by the
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`Federal Circuit, that the method of treatment claims in the patents-in-suit—covering the use of that
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`same class of humanized antibodies to treat migraine and other headaches—were patentable
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`because the method of treatment was not obvious. Reading those decisions together, the invention
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`in this case consists of taking a class of otherwise obvious antibodies and using them to perform a
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`novel method. In that situation, where the antibody was determined to be obvious but the method
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`of treatment was determined to be novel, § 112 simply does not require applicants to describe the
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`breadth of the antibodies in the same detail that might be necessary to practice the method: “[A]
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`patent need not teach, and preferably omits, what is well known in the art.” Hybritech Inc. v.
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`Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384 (Fed. Cir. 1986). So long as least some
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`representative example(s) of the pertinent antibodies are provided to illustrate the invention, the
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`focus properly then turns to the novel method of treatment itself.
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`Second, the Federal Circuit’s cases discussing § 112’s written description requirement in
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`the context of antibodies all involve composition claims to novel antibodies that—like chemical
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`compounds—were assembled or had their proteins selectively altered to achieve the desired effect.
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`See AbbVie, 759 F.3d at 1301 (composition claims to human antibodies that were genetically
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`engineered through site-directed mutagenesis and a “trial and error” approach); see also Amgen v.
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`Sanofi, 872 F.3d 1367 (Fed. Cir. 2017) (composition claims for antibodies made through “amino
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`acid substitutions” requiring a “trial and error process”); Juno, 10 F.4th at 1333 (composition claim
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`to reprogrammed T-cells with a binding element, where the binding element consisted of an
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`antibody that itself had been assembled); Ajinomoto, 429 F.3d at 1347 (antibodies altered through
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`chemical mutagenesis); cf. BASF, 28 F.4th at 1255–56 (composition claim to genetically modified
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`plants); Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052, 1070 (Fed. Cir. 2005)
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`(composition claims to genetically engineered enzyme through deletion mutation); cf. also In re
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`Alonso, 545 F.3d 1015, 1020 (Fed. Cir. 2008) (finding no written description where specification,
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`inter alia, “does not characterize the antigens to which the monoclonal antibodies must bind” and
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`“teaches nothing about the structure, epitope characterization, binding affinity, specificity, or
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`pharmacological properties common to the large family of antibodies implicated by the method”).
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`Humanized antibodies are not the same, with consequences for the application of § 112.
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`As recited above, “[t]he amount of disclosure necessary to satisfy the written-description
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`requirement will necessarily vary depending on … the existing knowledge in the particular field,
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`… the maturity of the science or technology, and the predictability of the aspect at issue,” among
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`other factors. Ajinomoto, 932 F.3d at 1359. There can be no dispute that generating humanized
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`antibodies is routine, even if methods of using them can be novel. The Federal Circuit recognized
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`this a decade ago, in Centocor v. Abbott Lab’ys, 636 F.3d 1341, 1351 n.4 (Fed. Cir. 2011),
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`observing that “[i]t is routine to raise a spectrum of antibodies to a known protein simply by
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`injecting that protein into a host animal that is a different species. The host generates antibodies to
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`the foreign protein.” And of course Lilly admitted as much in the IPR over the Zeller patents.
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`E.g., IPR No. 2018-01710, Eli Lilly & Co. Petition for Inter Partes Review, Paper No. 1 (Sept.
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`28, 2018) (“[A] POSA would have reasonably expected to succeed in making a murine anti-CGRP
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`antagonist antibody that bound human CGRP. . . . A POSA also would have had a reasonable
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`expectation of success in humanizing that antibody.”) (challenging ’045 patent, attached as Exhibit
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`2). At the same time, as the evidence in this case and Lilly’s stipulation to direct infringement
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`shows, humanized antibodies capable of performing the same patented method of treatment might
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`be generated with different protein sequences. Those variances, however, are the result not of
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`inventive choices by scientists—as in cases involving novel chemical compounds or novel
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`selectively-mutated antibodies—but instead the happenstance of the particular animal’s immune
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`system during routine humanization.
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`There is no Federal Circuit case applying the § 112 written description requirement in the
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`specific context of claims limited to humanized antibodies since humanization itself became
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`routine. Consequently, no precedent holds that a claim limited to a method of using humanized
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`antibodies is invalid under § 112 unless it discloses an antibody that is “structurally similar” to the
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`accused antibody, as Lilly’s proposed instruction would tell the jury. Where, as here, what is novel
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`and inventive is the method of treatment, not a class of obvious antibodies created through routine
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`humanization processes, it makes no sense to require applicants to describe the humanized
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`antibodies with the same degree of breadth required for composition claims or claims employing
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`novel compositions. Because humanization is routine, the Zeller team did not need to engage in
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`the repetitive work of immunizing thousands more mice in order to satisfy § 112. A POSA would
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`understand that the Zeller team possessed the invention of using all anti-CGRP antagonist
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`antibodies that might be generated through routine humanization to perform the novel claimed
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`method, not just the specific antibodies disclosed.
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`For these reasons, the Court should not adopt Lilly’s proposed language. No Federal
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`Circuit precedent requires such an instruction in a case involving either (1) a method of treatment
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`claim or (2) a claim limited to humanized antibodies, and such an instruction would be
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`Case 1:18-cv-12029-ADB Document 571 Filed 11/02/22 Page 9 of 11
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`inappropriate in those situations. The Court should instead adopt Teva’s proposed instruction on
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`this issue, which provides, in most relevant part, that:
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`[A] patent can have adequate written description support as long as
`it describes a sufficient number of representative antibodies or a
`common structural feature that would be shared by the antibodies
`used in the claimed method, such that a person of ordinary skill in
`the art would understand from reading the patent that the inventor
`invented the full scope of claimed.
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`Teva’s Tr. Br., ECF No. 525 at 29.
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`Case 1:18-cv-12029-ADB Document 571 Filed 11/02/22 Page 10 of 11
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`Respectfully Submitted,
`
`/s/ Elaine Herrmann Blais
`Douglas J. Kline (BBO# 556680)
`Elaine Herrmann Blais (BBO# 656142)
`Robert Frederickson III (BBO# 670111)
`Molly Grammel (BBO# 688439)
`Kevin P. Martin (BBO# 655222)
`Joshua S. Weinger (BBO# 690814)
`Alexandra Lu (BBO# 691114)
`Eric T. Romeo (BBO# 691591)
`Kathleen A. McGuinness (BBO# 693760)
`Tara R. Thigpen (BBO# 707508)
`GOODWIN PROCTER LLP
`100 Northern Avenue
`Boston, MA 02210
`Tel.: (617) 570-1000
`Fax: (617) 523-1231
`dkline@goodwinlaw.com
`kmartin@goodwinlaw.com
`eblais@goodwinlaw.com
`rfrederickson@goodwinlaw.com
`mgrammel@goodwinlaw.com
`jweinger@goodwinlaw.com
`alu@goodwinlaw.com
`eromeo@goodwinlaw.com
`kmcguinness@goodwinlaw.com
`tthigpen@goodwinlaw.com
`
`
`Attorneys for Plaintiffs
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`
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`Dated: November 2, 2022
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`Natasha E. Daughtrey (pro hac vice)
`Sean M. Anderson (pro hac vice)
`GOODWIN PROCTER LLP
`601 S. Figueroa St.
`Los Angeles, CA 90017
`Tel.: (213) 426-2500
`Fax: (213) 623-1673
`ndaughtrey@goodwinlaw.com
`sanderson@goodwinlaw.com
`
`Madeline R. DiLascia (pro hac vice)
`GOODWIN PROCTER LLP
`1900 N Street N.W.
`Washington, D.C. 20036
`Tel.: (202) 346-4000
`Fax: (202) 204-7250
`mdilascia@goodwinlaw.com
`
`Audie Soucy (pro hac vice)
`Grace P. Truong (pro hac vice)
`Gabriel B. Ferrante (pro hac vice)
`GOODWIN PROCTER LLP
`The New York Times Building
`620 8th Ave
`New York, NY 10018
`Tel.: (212) 813-8800
`Fax: (212) 355-3333
`asoucy@goodwinlaw.com
`gtruong@goodwinlaw.com
`gferrante@goodwinlaw.com
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`Case 1:18-cv-12029-ADB Document 571 Filed 11/02/22 Page 11 of 11
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`CERTIFICATE OF SERVICE
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`I, Elaine Herrmann Blais, hereby certify that this document filed through the ECF system
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`will be sent electronically to the registered participants as identified on the Notice of Electronic
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`Filing (“NEF”) and paper copies will be sent to those indicated as non-registered participants on
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`November 2, 2022.
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`/s/ Elaine Herrmann Blais
`Elaine Herrmann Blais (BBO# 656142)
`GOODWIN PROCTER LLP
`100 Northern Avenue
`Boston, MA 02210
`Tel.: (617) 570-1000
`Fax: (617) 523-1231
`eblais@goodwinlaw.com
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`9
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