Case 2:20-cv-00337-JRG Document 261 Filed 01/14/22 Page 1 of 38 PageID #: 9521
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
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`SEAGEN INC.,
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`Plaintiff,
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`v.
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`DAIICHI SANKYO CO., LTD.,
`Defendant, and
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`ASTRAZENECA PHARMACEUTICALS
`LP AND ASTRAZENECA UK LTD.,
`Intervenor-Defendants
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`CASE NO. 2:20-cv-00337-JRG
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`DEFENDANT DAIICHI SANKYO COMPANY, LIMITED AND INTERVENOR-
`DEFENDANTS’ ASTRAZENECA PHARMACEUTICALS LP
`AND ASTRAZENECA UK LTD.’S
`MOTION FOR SUMMARY JUDGMENT OF ANTICIPATION
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`
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`1
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`

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`Case 2:20-cv-00337-JRG Document 261 Filed 01/14/22 Page 2 of 38 PageID #: 9522
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`TABLE OF CONTENTS
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`I.
`
`II.
`
`INTRODUCTION ...............................................................................................................1
`
`STATEMENT OF ISSUES TO BE DECIDED BY THE COURT ....................................3
`
`III.
`
`BACKGROUND AND STATEMENT OF UNDISPUTED MATERIAL FACTS............4
`
`A.
`
`The ’039 Patent ........................................................................................................4
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`1.
`
`2.
`
`3.
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`4.
`
`The Asserted Claims ....................................................................................4
`
`The ’039 Patent and Priority Applications Disclose 47 Million
`Linkers in the Tetrapeptide Category Alone ................................................5
`
`Seagen’s Inventors Admit That They Were Not In Possession Of
`the Claimed Invention in 2003-2004. ..........................................................7
`
`Seagen Identifies “Blaze Marks” to the Wrong Subgenera .........................8
`
`B.
`
`DS-8201 Was Published Before Seagen’s Patent Claims Were Filed and
`Therefore it Anticipates if, as Seagen Alleges, It Infringes ...................................10
`
`IV.
`
`LEGAL STANDARDS .....................................................................................................10
`
`A.
`
`Summary Judgment ...............................................................................................11
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`B. Written Description ................................................................................................11
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`C.
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`Anticipation............................................................................................................13
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`V.
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`ARGUMENT .....................................................................................................................14
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`A.
`
`The Asserted Claims are Invalid as Anticipated Unless Seagen Can
`Establish Priority to Earlier-Filed Applications. ....................................................14
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`B.
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`The ’039 Patent Cannot Claim Priority to a Date Before 2019 .............................15
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`1.
`
`2.
`
`3.
`
`The ’340 Application’s Disclosure of 47 Million Tetrapeptides
`Does Not Describe the Claimed Subgenus of G/F-Only
`Tetrapeptides ..............................................................................................16
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`The Priority Applications Provide No Blaze Marks Leading to the
`Claimed Subgenus of Gly/Phe-Only tetrapeptides ....................................20
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`Seagen’s Named Inventors Admit That They Did Not Have
`Possession of Nor Provide Blazemarks to the Claimed Subgenus ............27
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`VI.
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`CONCLUSION ..................................................................................................................30
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`i
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`Case 2:20-cv-00337-JRG Document 261 Filed 01/14/22 Page 3 of 38 PageID #: 9523
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`CASES
`
`AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc.,
`759 F.3d 1285 (Fed. Cir. 2014)................................................................................................10
`
`Agilent Techs., Inc. v. Affymetrix, Inc.,
`567 F.3d 1366 (Fed. Cir. 2009)..................................................................................................1
`
`Application of Ruschig,
`379 F.2d 990 (C.C.P.A. 1967) .....................................................................................12, 19, 24
`
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) (en banc)........................................................................ passim
`
`Biogen Int’l GMBH v. Mylan Pharms. Inc.,
`18 F.4th 1333 (Fed. Cir. 2021) ................................................................................................25
`
`Bos. Sci. Corp. v. Johnson & Johnson,
`647 F.3d 1353 (Fed. Cir. 2011)........................................................................................ passim
`
`Burns v. Board of County Comm. of Jackson County,
`330 F.3d 1275 (10th Cir. 2003) ...............................................................................................28
`
`Centocor Ortho Biotech, Inc. v. Abbott Labs.,
`636 F.3d 1341 (Fed. Cir. 2011)................................................................................................12
`
`D Three Enters., LLC v. SunModo Corp.,
`890 F.3d 1042 (Fed. Cir. 2018)..........................................................................................11, 24
`
`Devon Energy Corp. v. Westacott, 2
`011 WL 1157334 (S.D. Tex. Mar. 24, 2011) ...........................................................................28
`
`Falko-Gunter Falkner v. Inglis,
`448 F.3d 1357 (Fed. Cir. 2006)......................................................................................2, 26, 30
`
`Fujikawa v. Wattanasin,
`93 F.3d 1559 (Fed. Cir. 1996).......................................................................................... passim
`
`FWP IP ApS v. Biogen MA, Inc.,
`749 F. App’x 969 (Fed. Cir. 2018) ................................................................................2, 13, 20
`
`Gonzalez v. Fresenius Med. Care N. Am.,
`689 F.3d 470 (5th Cir. 2012) ...................................................................................................27
`
`Idenix Pharms., LLC v. Gilead Scis. Inc.,
`941 F.3d 1149 (Fed. Cir. 2019)................................................................................................13
`
`In re Chu, 66 F.3d 292
`(Fed. Cir. 1995) ........................................................................................................................11
`
`-ii-
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`

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`Case 2:20-cv-00337-JRG Document 261 Filed 01/14/22 Page 4 of 38 PageID #: 9524
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`In re Driscoll, 562 F.2d 1245
`(C.C.P.A. 1977) .......................................................................................................................19
`
`In re Schoenwald,
`964 F.2d 1122 (Fed. Cir. 1992)................................................................................................13
`
`In re Wako Pure Chem. Indus., Ltd.,
`4 F. App’x 853 (Fed. Cir. 2001) ........................................................................................19, 20
`
`L. A. Biomedical Rsch. Inst. v. Eli Lilly & Co.,
`849 F.3d 1049 (Fed. Cir. 2017)................................................................................9, 13, 24, 25
`
`Novartis Pharms. Corp. v. Accord Healthcare, Inc.,
`2022 WL 16759, *5 (Fed. Cir. 2022).......................................................................................20
`
`Novozymes A/S v. DuPont Nutrition Bioscis. APS.,
`723 F.3d 1336 (Fed. Cir. 2013)....................................................................................13, 22, 24
`
`Peters v. Active Mfg. Co.,
`129 U.S. 530 (1889) ...................................................................................................................3
`
`Purdue Pharma L.P. v. Faulding Inc.,
`230 F.3d 1320 (Fed. Cir. 2000)..........................................................................................12, 23
`
`Seal-Flex, Inc. v. Athletic Track & Court Constr.,
`172 F.3d 836 (Fed. Cir. 1999)....................................................................................................3
`
`SRAM Corp. v. AD-II Eng’g, Inc.,
`367 F. App’x 150 (Fed. Cir. 2010) ..........................................................................................13
`
`Univ. of Rochester v. G.D. Searle & Co.,
`358 F.3d 916 (Fed. Cir. 2004)..................................................................................................29
`
`Upsher-Smith Labs v. Pamlab,
`412 F.3d 1319 (Fed. Cir. 2005)..........................................................................................13, 15
`
`STATUTES
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`35 U.S.C. § 112 ....................................................................................................................1, 11, 24
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`35 U.S.C. § 112(a) .........................................................................................................................11
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`35 U.S.C. § 119 ..............................................................................................................................11
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`Fed. R. Civ. P. 56(a) ......................................................................................................................11
`
`RULES
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`-iii-
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`Case 2:20-cv-00337-JRG Document 261 Filed 01/14/22 Page 5 of 38 PageID #: 9525
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`Michael Risch, A Brief Defense of the Written Description Requirement, 119 YALE L. J.
`127, 130 (2010) ........................................................................................................................10
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`OTHER
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`-iv-
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`Case 2:20-cv-00337-JRG Document 261 Filed 01/14/22 Page 6 of 38 PageID #: 9526
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`
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`I.
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`INTRODUCTION
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`Claim 1 recites a group, or “genus,” of antibody-drug conjugates. One critical feature of
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`the claim concerns the “linker” that connects the drug to the antibody. Claim 1 requires that the
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`linker comprise a “tetrapeptide” (a chain of four amino acids) that consists only of two particular
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`amino acids: glycine and phenylalanine.
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`But the claimed “Gly/Phe-only” tetrapeptide linkers are nowhere disclosed in the asserted
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`patent or the applications to which it claims priority. None of the patent’s ADC examples contain
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`a Gly/Phe-only tetrapeptide. The concept is mentioned nowhere in the patent’s disclosure or in
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`the 2003 or 2004 priority applications (collectively the “Priority Applications”).1 In 2019, years
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`after filing those applications, and years after first learning of an ADC with a Gly/Phe-only
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`tetrapeptide by attending a Daiichi Sankyo Company (“DSC”) presentation regarding DS-8201,
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`Seagen filed a new, continuation application that claimed ADCs comprising what its own scientists
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`called “Daiichi-Sankyo’s drug-linker”—a Gly/Phe-only tetrapeptide. SGIEDTX00164812 (Ex. 1)
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`at 815. That application became asserted U.S. Patent No. 10,808,039 (the “’039 patent”).
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`Patent law does not countenance claiming the inventions of others. The written description
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`requirement of § 112 prevents an inventor “from later asserting that he invented that which he did
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`not.” Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009). A patentee
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`may claim priority to the filing date of an earlier-filed application only if it describes the later-
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`claimed invention in a way that demonstrates the inventors were in possession of that invention at
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`the earlier time. This “written description requirement is particularly important when, as here,
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`1 The “2003 Application” refers to U.S. Provisional Patent Application No. 60/518,534, and the
`“2004 Application” refers to U.S. Patent Application No. 10/983,340.
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`1
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`

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`
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`claims are added later during prosecution in response to development by others.” FWP IP ApS v.
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`Biogen MA, Inc., 749 F. App’x 969, 974 (Fed. Cir. 2018).
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`The ’039 patent’s utter lack disclosure of ADCs with a Gly/Phe-only tetrapeptide is plain.
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`Indeed, Seagen does not even try to identify any support within its own patent or “Priority
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`Applications” for this particular subgenus of tetrapeptides. There is no dispute that the applications
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`provide no examples of an ADC with a Gly/Phe-only tetrapeptide. Nor is there any dispute that,
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`at the time they filed either of the Priority Applications, the inventors had not made or even thought
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`of an ADC with a Gly/Phe-only tetrapeptide—a proposition that forecloses a claim to priority as a
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`matter of logic and controlling law, because “[o]ne cannot describe what one has not conceived.”
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`Falko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1367 n.13 (Fed. Cir. 2006) (quoting Fiers v. Revel,
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`984 F.2d 1164, 1171 (Fed. Cir. 1993)).
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`Despite the admitted lack of actual possession of the claimed tetrapeptide or any specific
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`disclosure of it in the Priority Applications, Seagen nonetheless contends that it is entitled to claim
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`priority because its earlier applications broadly disclosed using linkers having between two and
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`twelve amino acids, with any of 83 amino acids at each of the two to twelve positions. Thus,
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`according to Seagen, the Priority Applications described each of the unfathomably large number
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`of sequences that fall within that disclosure. But this runs headlong into a clear and consistent line
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`of Federal Circuit authority rejecting conclusively the possibility that such a “‘laundry list’
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`disclosure of every possibly moiety for every possible position would constitute a written
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`description of every species in the genus.” Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir.
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`1996). Where, as here, the earlier-filed “priority” application broadly discloses a genus, and the
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`later-filed patent claims only a partial “subgenus” of that disclosure, the priority application must
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`include “blaze marks” directing the person of ordinary skill (“POSA”) to the narrower, later-
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`2
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`Case 2:20-cv-00337-JRG Document 261 Filed 01/14/22 Page 8 of 38 PageID #: 9528
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`
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`claimed subgenus. Seagen has not identified any such “blaze marks” in its Priority Applications.
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`Rather, Seagen resorts to identifying blaze marks that, Seagen does not dispute, point to at least
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`three subgenera other than the one it claimed in the ’039 patent.
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`The consequence of Seagen’s inability to claim priority is undisputed. Seagen agrees that,
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`without a successful claim to a Priority Application, the Asserted Claims (1-5, 9-10) are anticipated
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`by Daiichi Sankyo Japan’s 2016 publication of DS-8201 by Ogitani2—and thus invalid. To
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`succeed on its infringement claims, it must demonstrate that DS-8201 meets every limitation of
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`the Asserted Claims. See Seal-Flex, Inc. v. Athletic Track & Court Constr., 172 F.3d 836, 842
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`(Fed. Cir. 1999). But “[t]hat which infringes, if later, would anticipate, if earlier.” Peters v. Active
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`Mfg. Co., 129 U.S. 530, 537 (1889). Accordingly, if the Asserted Claims cannot claim priority
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`back to the early 2003-2004, then they are anticipated by disclosures of DS-8201 if, as Seagen
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`alleges, it infringes. Seagen cannot—and does not— argue otherwise, lest it plead itself out of an
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`infringement case.
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`This motion for summary judgment of anticipation thus does not require a comparison of
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`the prior art to the Asserted Claims. Instead, it turns on a different question: whether Seagen’s
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`broad 2003/2004 disclosure of using any of 83 amino acids in peptide linkers of any length can
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`support its far narrower claims to ADCs with a Gly/Phe-only tetrapeptide. Controlling authority
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`says “no” as a matter of law. The claims are therefore anticipated if Seagen’s infringement theory
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`is correct.
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`II.
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`STATEMENT OF ISSUES TO BE DECIDED BY THE COURT
`
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`2 Ogitani, Yusuke et al., DS-8201a, A Novel HER2-Targeting ADC with a Novel DNA
`Topoisomerase I Inhibitor, Demonstrates a Promising Antitumor Efficacy with Differentiation
`from T-DM1, 22 CLIN. CANCER RES. 5097 (2016), DSC_ENHERTU_00025303-315 (“Ogitani”)
`(Ex. 2). Other anticipatory publications will be addressed if this case proceeds to trial, but are
`unnecessary for purposes of this motion since Seagen concedes Ogitani disclosed every limitation
`of the Asserted Claim.
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`
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`3
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`

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`Case 2:20-cv-00337-JRG Document 261 Filed 01/14/22 Page 9 of 38 PageID #: 9529
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`Defendants’ motion respectfully requests the Court decide the following issue:
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`• The ’039 patent is not entitled to a priority date before July 2019 and therefore is
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`anticipated by Ogitani if Seagen’s infringement theory is correct.
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`III. BACKGROUND AND STATEMENT OF UNDISPUTED MATERIAL FACTS
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`A.
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`The ’039 Patent
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`1.
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`The Asserted Claims
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`The Asserted Claims claim antibody-drug conjugates (“ADCs”) with particular structural
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`features and function.3 ADCs are complicated molecules designed to deliver potent chemotherapy
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`to cancerous cells while sparing healthy ones. Bertozzi4 Opening Rep. (Ex. 3) at ¶ 43; Lambert5
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`Opening Rep. (Ex. 4) at ¶ 42. In particular, ADCs are composed of three principal components:
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`(1) an antibody connected to (2) a drug moiety via (3) a linker. Bertozzi Opening Rep. at ¶ 42;
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`Lambert Opening Rep. at ¶¶ 42-43.
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`
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`The antibody targets cancer cells, bringing along with it the drug moiety that can kill the cancer
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`cells after it is released from the antibody by cleavage of the connecting linker. Bertozzi Opening
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`3 The Asserted Claims do not limit the drug that can be used in the ADC, pursuant to this Court’s
`Markman order. Dkt. 155, at 15. Defendants dispute that the patent provides written description
`support for the use of any/all drugs in an ADC but that dispute is not the subject of this motion.
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`4 Dr. Bertozzi submitted expert reports on behalf of Seagen.
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`5 Dr. Lambert submitted expert reports on behalf of Defendants and Intervenor-Defendants.
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`4
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`Case 2:20-cv-00337-JRG Document 261 Filed 01/14/22 Page 10 of 38 PageID #: 9530
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`
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`Rep. at ¶ 43, 56; Lambert Opening Rep. at ¶ 52. Linkers in ADCs can include “peptides”—i.e.,
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`chains of amino acids of various lengths; these are called “peptide linkers.” Bertozzi Opening
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`Rep. at ¶ 56, 58; Lambert Opening Rep. at ¶ 52.
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`The claimed ADCs have a small subset of one category of peptide linkers. Specifically,
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`the Asserted Claims require tetrapeptide linkers (i.e., the category with four amino acids in the
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`chain) in which the only amino acids used are glycine or phenylalanine. Bertozzi Opening Rep.
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`at ¶ 58; Lambert Opening Rep. at ¶ 120. This Motion refers to them as “G/F-only tetrapeptides.”
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`Phenylalanine (abbreviated “Phe” or “F”) is an amino acid that can occur in one of two
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`configurations, called “isomers”—D-Phenylalanine or L-Phenylalanine. Glycine (abbreviated
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`“Gly” or “G”) can occur in only one isomer. The Asserted Claims do not require use of any
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`particular isomer, and the parties therefore agree that there are 81 possible Gly/Phe-only
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`tetrapeptides within the scope of the claims (three possible isomers at each of four positions, or
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`three to the fourth power). Senter Dep. Tr.6 (Ex. 5) 440:15-25; Lambert Opening Rep. ¶ 351.
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`2.
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`The ’039 Patent and Priority Applications Disclose 47 Million Linkers
`in the Tetrapeptide Category Alone
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`The ’039 patent and the Priority Applications contain a general disclosure of eleven
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`categories of peptide linkers, ranging from two amino acids long (dipeptides) to twelve amino
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`acids long (dodecapeptides), and containing at each position any of 39 different amino acids. ’039
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`patent (Ex. 6), 65:46-66:43; Bertozzi Rebuttal Rep. (Ex. 7) at ¶ 144; Lambert Opening Rep. at
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`¶ 347-49. Because all but one of those 39 amino acids can exist in two or three different
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`configurations or “isomers,” the parties agree that the ’039 patent (and the identical disclosure in
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`the 2004 application) discloses 83 options for each position in the amino acid linker chain.
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`6 Dr. Senter, Seagen’s Vice President of Chemistry, is a named inventor and Seagen’s 30(b)(6)
`designee on conception of the claimed subject matter. Exs. 19-20.
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`5
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`Bertozzi Tr. (Ex. 8) 156:15-157:20; Lambert Opening Rep. at ¶ 350. Glycine and the two
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`phenylalanine isomers are three among the 83 amino acids the patent discloses. They are not
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`singled out. ’039 patent, 65:55-66:43.
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`The result is an enormous number of possible peptide linkers. In the tetrapeptide category
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`alone (setting aside the categories of 2-3 or 5-12 amino acid linkers), the parties agree the 2004
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`Application discloses over 47 million linkers, and that is only one of many categories of peptide
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`linkers disclosed. Senter Tr. 437:9-25 (30(b)(6) witness) (“Can you provide for me what the
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`number of options that are disclosed just for the tetrapeptide category is in your patent? . . . A:
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`You’ll be so happy. It’s over 47 million. . . . It’s 47,458,321.”); Bertozzi Tr. 156:15-157:20.
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`Nothing in this broad disclosure points to the narrow subgenus of 81 Gly/Phe-only tetrapeptides.
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`Infra Section V.B.
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`Seagen makes priority claims to two earlier applications filed in 2003 and 2004. The 2003
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`Application and 2004 Application differ only modestly in relevant part,7 and there are no relevant
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`differences between the 2004 Application and the ’039 patent specification. Bertozzi Rebuttal
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`Rep. ¶ 62-66, 293. All three applications disclose exemplary dipeptides, tripeptides and
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`tetrapeptides.
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`’039 patent
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`(Ex. 6) at 66:47-68:12; 2003 Application
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`(Ex. 9) at
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`SGIEDTX000000857-59; 2004 Application (Ex. 10) at 86-87;
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`From among the 47 million sequences covered by the tetrapeptide category alone, the 2004
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`application and the ’039 patent disclose three examples of tetrapeptide linkers: glycine-
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`phenylalanine-leucine-glycine;
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`alanine-leucine-alanine-leucine;
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`and glycine-serine-valine-
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`7 See, e.g.,
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`8 Svetlana Doronina is a Seagen employee and the first named inventor of the ’039 patent.
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`6
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`Case 2:20-cv-00337-JRG Document 261 Filed 01/14/22 Page 12 of 38 PageID #: 9532
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`
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`glutamine.9 ’039 patent, 67:45-50; 68:5-9. None of these is a Gly/Phe-only tetrapeptide, and none
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`falls within the scope of the Asserted Claims.
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` Indeed, the applications do not recite or exemplify
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`Gly/Phe-only peptides of any length.
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`3.
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`Seagen’s Inventors Admit That They Were Not In Possession Of the
`Claimed Invention in 2003-2004.
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`The reason Seagen’s inventors did not describe an ADC with a Gly/Phe-only tetrapeptide
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`linker in their 2004 application is that
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` Seagen’s inventors and its expert, Dr. Carolyn Bertozzi, admit that
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` Indeed, several of Seagen’s named inventors testified that
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`9 The 2003 Application discloses only the first two examples; it does not include glycine-serine-
`valine-glutamine. SGIEDTX000000831 (Ex. 9) at 858-59.
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`10 Dr. Scott Jeffrey is Seagen’s Senior Director of Chemistry. Jeffrey Tr. 13:16-20.
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`11 Dr. Stephen Alley is an Executive Director at Seagen and 30(b)(6) designee on topics including
`Seagen’s knowledge of DS-8201 and the basis for its priority claim.
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`12 Dr. Brian Toki is a Seagen employee and a named inventor on the ’039 patent.
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`7
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`Case 2:20-cv-00337-JRG Document 261 Filed 01/14/22 Page 13 of 38 PageID #: 9533
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`was asked whether
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` Indeed, when Dr. Doronina
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`It was not until seven years later, on the eve of DS-8201’s launch as Enhertu® in 2019,
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`and well after Seagen had seen DS-8201’s structure, that Seagen introduced the concept of
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`Gly/Phe-only tetrapeptide linkers into its patent family for the very first time. It did so via the
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`claims of the ’839 Application, filed on July 10, 2019, and which issued as the ’039 patent on
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`October 20, 2020. Ex. 16 (’839 Application) at SGIEDTX00000404, 827-30; ’039 patent, 331:50-
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`63.
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`4.
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`Seagen Identifies “Blaze Marks” to the Wrong Subgenera
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`
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`Seagen suggests the Priority Applications contain blaze marks to the claimed invention
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`because, Seagen alleges, the POSA would have been motivated to modify the examples disclosed
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`in the Priority Applications, or synthesize wholly new peptide sequences, based on certain prior
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`8
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`Case 2:20-cv-00337-JRG Document 261 Filed 01/14/22 Page 14 of 38 PageID #: 9534
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`art references.13
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`Bertozzi Rebuttal Rep. at ¶¶ 174-177, 182.
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`Seagen identifies assorted information that it asserts would motivate the POSA who wished
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`to modify the examples of the ’039 patent.
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` Seagen asserts that this prior art—found nowhere in the Priority
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`Applications—would have motivated the POSA to prepare additional sequences undisclosed in
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`the Priority Applications but allegedly disclosed or suggested by the prior art, and thereby arrive
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`at three new subgenera of peptide sequences. See
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`
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`; Bertozzi Rebuttal Rep. at ¶¶ 174-77, 182. None of those three
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`subgenera are recited in the Priority Applications.
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`Most importantly for purposes of this motion, Seagen agrees that none of those three
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`subgenera is the Gly/Phe-only tetrapeptide subgenus claimed in the Asserted Claims.
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`acids other than Glycine and Phenylalanine, and none of the subgenera contains all, most, or even
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`. Each of these subgenera contains tetrapeptides using amino
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`many of the 81 claimed Gly/Phe-only tetrapeptides.
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`
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`13 This approach is improper. Written description requires more than disclosure that “merely
`renders the invention obvious,” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed.
`Cir. 2010) (en banc), and “proof of priority requires written description disclosure in the parent
`application, not simply information and inferences drawn from uncited references.” L. A.
`Biomedical Rsch. Inst. v. Eli Lilly & Co., 849 F.3d 1049, 1058 (Fed. Cir. 2017); infra Section
`V.B.2.b.1.
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`
`
`9
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`Case 2:20-cv-00337-JRG Document 261 Filed 01/14/22 Page 15 of 38 PageID #: 9535
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`
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`B.
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`DS-8201 Was Published Before Seagen’s Patent Claims Were Filed and
`Therefore it Anticipates if, as Seagen Alleges, It Infringes
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`In March 2019, AstraZeneca and DSC announced a collaboration worth billions of dollars
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`regarding the development and commercialization of DS-8201. Only months later, Seagen filed
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`an application seeking to claim DS-8201, which matured into the asserted ’039 patent. See ’039
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`Patent (Ex. 6); Complaint ¶ 17 (Ex. 17); Bertozzi Opening Rep. at ¶ 55. Those patent claims were
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`filed years after DS-8201 had been disclosed to the public as a promising new compound. See
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`Ogitani (Ex. 2) (disclosing DS-8201’s structure in 2016).
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`It is undisputed that unless the ’039 patent is entitled to the early 2003-04 priority date
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`Seagen claims, DS-8201 is prior art to the ’039 patent. Bertozzi Rebuttal Rep. at ¶¶ 8, 321. To
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`prove its infringement case, Seagen contends that DS-8201 meets every limitation of the Asserted
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`Claims. Id. Thus, if the Asserted Claims lack priority to 2003-04, they are anticipated by DS-
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`8201 if it infringes. Seagen does not argue otherwise.
`
`
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`; Bertozzi Rebuttal Rep. ¶ 321.
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`IV.
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`LEGAL STANDARDS
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`Patents reflect a bargain: An inventor reaps the rewards of a temporary monopoly on her
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`invention in exchange for disclosing that invention to the public. The public receives the benefit
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`of this bargain only if the inventor actually disclosed the claimed invention. The various doctrines
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`of patent validity—in particular, written description—exist to police this principle, preventing
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`patentees from “looking at later developments and then claiming to have invented them when the
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`initial application makes no mention of the subject matter.” Michael Risch, A Brief Defense of the
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`Written Description Requirement, 119 YALE L. J. 127, 130 (2010); see also AbbVie Deutschland
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`GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1298 (Fed. Cir. 2014). Seagen’s predatory
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`behavior seeks to flout this tenet of patent law by mining an extremely broad, general disclosure
`
`
`
`10
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`Case 2:20-cv-00337-JRG Document 261 Filed 01/14/22 Page 16 of 38 PageID #: 9536
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`
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`of peptide linkers filed in 2003-2004 to claim an ADC using a very specific kind of peptide linker
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`that the public did not receive until 2015 (and even then the public received it from DSC, not
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`Seagen). The written description requirement was designed to prevent precisely this result.
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`Seagen’s Priority Applications do not disclose Gly/Phe-only tetrapeptide linkers, so the ’039 patent
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`cannot benefit from their filing date. DS-8201 is therefore prior art to the ’039 patent and
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`anticipates every asserted claim.
`
`A.
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`Summary Judgment
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`Summary judgment is appropriate when “there is no genuine dispute as to any material
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`fact.” Fed. R. Civ. P. 56(a). “At summary judgment, the evidence of the non-movant is to be
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`believed, and all justifiable inferences are to be drawn in his favor.” D Three Enters., LLC v.
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`SunModo Corp., 890 F.3d 1042, 1046 (Fed. Cir. 2018) (internal quotes omitted). Although
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`compliance with the written description requirement is a “question of fact . . .[it] is amenable to
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`summary judgment in cases where no reasonable fact finder could return a verdict for the non-
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`moving party.” Bos. Sci. Corp. v. Johnson & Johnson, 647 F.3d 1353, 1361 (Fed. Cir. 2011).
`
`B. Written Description
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`“It is elementary patent law that a patent application is entitled to the benefit of the filing
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`date of an earlier filed application only if the disclosure of the earlier application provides support
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`for the claims of the later application, as required by 35 U.S.C. § 112.” In re Chu, 66 F.3d 292,
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`297 (Fed. Cir. 1995); 35 U.S.C. § 119. Section 112 provides in relevant part that “[t]he
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`specification shall contain a written description of the invention.” 35 U.S.C. § 112(a). To satisfy
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`the written description requirement for purposes of priority, the earlier-filed application must
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`“must clearly allow persons of ordinary skill in the art to recognize that the inventor invented what
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`is claimed” in the later-filed application, in order to “convey[] to those skilled in the art that the
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`inventor had possession of the claimed subject matter as of the [earlier] filing date.” Ariad, 598
`
`
`
`11
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`Case 2:20-cv-00337-JRG Document 261 Filed 01/14/22 Page 17 of 38 PageID #: 9537
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`
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`F. 3d at 1351. Adequate written description “requires a precise definition,” id. at 1350; “[a] mere
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`wish or plan to obtain the claimed invention is not sufficient.” Centocor Ortho Biotech, Inc. v.
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`Abbott Labs., 636 F.3d 1341, 1348 (Fed. Cir. 2011).
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`When an earlier-filed application discloses a broad genus but the later-filed application
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`claims a species or narrower subgenus from within that disclosure, courts apply a “blaze marks”
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`analysis. Bos. Sci. Corp, 647 F.3d at 1367. “[S]imply describing a large genus of compounds is
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`not sufficient to satisfy the written description requirement as to particular species or sub-genuses.”
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`Fujikawa, 93 F.3d at 1571 (emphasis added). Otherwise, “a ‘laundry list’ disclosure of every
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`possible moiety for every possible position would constitute a written description of every species
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`in the genus,” and “[t]his cannot be” the case. Id. Instead, the specification must contain “blaze
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`marks” directing the POSA through the “forest” of the broad disclosure to the “particular trees”
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`that constitute the claimed subgenus. Application of Ruschig, 379 F.2d 990, 995 (C.C.P.A. 1967);
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`Fujikawa, 93 F.3d at 1571. In the words of the Federal Circuit’s predecessor:
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`It is no help in finding a trail or in finding one’s way through the
`woods where the trails have disappeared— or have not yet been
`made, which is more like the case here— to be confronted simply
`by a large number of unmarked trees.…We are looking for blaze
`marks which single out particular trees. We see none.
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`Ruschig, 379 F.2d at 995. Blaze marks must indicate “what compounds, other than those disclosed
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`as preferred, might of special interest.” Fujikawa, 93 F.3d at 1571. Examples—a type of blaze
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`mark—that are “close by” a later-claimed tree or set of trees are therefore legally insufficient, as
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`they must “direct one to the proposed tree in particular.” Id. (emphasis added).
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`For a claim to priority, “the blaze marks directing the skilled artisan to that tree must be in
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`the originally filed disclosure.” Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1326-27
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`(Fed. Cir. 2000). Where, as here, a patentee adds claims in response to development by others,
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`the written description requirement is particularly vital to enforce strictly, as it serves a