Case 2:20-cv-00337-JRG Document 317 Filed 02/15/22 Page 1 of 17 PageID #: 11163
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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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`DEFENDANTS’ REPLY IN SUPPORT OF THEIR
`MOTION FOR SUMMARY JUDGMENT OF ANTICIPATION
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`Case 2:20-cv-00337-JRG Document 317 Filed 02/15/22 Page 2 of 17 PageID #: 11164
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`Table of Contents
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`SEAGEN’S PRIORITY CLAIM FAILS AS A MATTER OF LAW .................................1
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`A.
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`Seagen’s “Precise Formula” Is Irrelevant ................................................................1
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`1.
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`2.
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`The “Precise Formula” Fails to Disclose Gly/Phe-Only
`Tetrapeptides ................................................................................................1
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`The Remaining “Laundry List” of Linkers is Legally Insufficient..............2
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`B.
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`No Blazemarks in the Priority Applications Point to the Alleged Invention ...........5
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`1.
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`2.
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`3.
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`The Applications Must Describe the Invention, Not Render It
`Obvious ........................................................................................................5
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`Seagen Argues the Asserted Claims are Obvious, not Described ...............5
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`Seagen’s Blazemarks Point to the Wrong Subgenus ...................................9
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`THE INVENTORS ADMIT LACK OF CONCEPTION AND DESCRIPTION .............10
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`CONCLUSION ..................................................................................................................10
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`I.
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`II.
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`III.
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`Case 2:20-cv-00337-JRG Document 317 Filed 02/15/22 Page 3 of 17 PageID #: 11165
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`TABLE OF AUTHORITIES
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`All Dental Prodx, LLC v. Advantage Dental Prods., Inc.,
`309 F.3d 774 (Fed. Cir. 2002)....................................................................................................8
`
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010)........................................................................................ passim
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`Bos. Sci. Corp. v. Johnson & Johnson,
`647 F.3d 1353 (Fed. Cir. 2011)........................................................................................8, 9, 10
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`Falko-Gunter Falkner v. Inglis,
`448 F.3d 1357 (Fed. Cir. 2006)............................................................................................8, 10
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`Fujikawa v. Wattanasin,
`93 F.3d 1559 (Fed. Cir. 1996).......................................................................................... passim
`
`FWP IP ApS v. Biogen MA,
`749 F. App’x 969 (Fed. Cir. 2018) ............................................................................................4
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`Immunex Corp. v. Sandoz Inc.,
`964 F.3d 1049 (Fed. Cir. 2020)..................................................................................................8
`
`In re Driscoll,
`562 F.2d 1245 (C.C.P.A. 1977) .............................................................................................3, 4
`
`In re Wako Pure Chem. Indus. Ltd.,
`4 F. App’x 853 (Fed. Cir. 2001) ............................................................................................3, 4
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`Lockwood v. Am. Airlines, Inc.,
`107 F.3d 1565 (Fed. Cir. 1997)........................................................................................ passim
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`Novozymes A/s v. DuPont Nutrition Biosciences APS,
`723 F.3d 1336 (Fed. Cir. 2013)............................................................................................9, 10
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`Otsuka Pharm. v. Sandoz,
`678 F.3d 1280 (Fed. Cir. 2012)..................................................................................................6
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`PowerOasis v. T-Mobile USA,
`522 F.3d 1299 (Fed. Cir. 2008)..................................................................................................6
`
`Purdue Pharma L.P. v. Faulding Inc.,
`230 F.3d 1320 (Fed. Cir. 2000)..................................................................................................3
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`Purdue Pharma L.P. v. Iancu,
`767 F. App’x 918 (Fed. Cir. 2019) ............................................................................................4
`
`Rivera v. Int’l Trade Comm.,
`857 F.3d 1315 (Fed. Cir. 2017)..............................................................................................7, 8
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`

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`Case 2:20-cv-00337-JRG Document 317 Filed 02/15/22 Page 4 of 17 PageID #: 11166
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`TurboCare Div. of Demag Delaval Turbomachinery v. Gen. Elec., 264 F.3d 1111 (Fed.
`Cir. 2001) ...................................................................................................................................6
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`Novartis Pharms. Corp. v. Plexxikon Inc., PGR2018-00069, Paper 16 (P.T.A.B. Jan. 16,
`2019) ............................................................................................................................3, 4, 8, 10
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`Case 2:20-cv-00337-JRG Document 317 Filed 02/15/22 Page 5 of 17 PageID #: 11167
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`I.
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`SEAGEN’S PRIORITY CLAIM FAILS AS A MATTER OF LAW
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`Seagen concedes that “the textual disclosure of the priority applications is not in dispute.”
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`Opp. 9. The Parties agree that: (1) the Priority Applications disclose eleven categories of peptide
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`linkers, Def. Br. 5; (2) the Priority Applications disclose more than 47 million options within the
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`single “tetrapeptide” category, id. at 6; (3) the Asserted Claims are limited to ADCs with only 81
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`of those 47 million tetrapeptides (those using only glycine (“Gly”) and phenylalanine (“Phe”)), id.
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`at 16; (4) none of the tetrapeptide examples fall within claimed subset, id. at 7; and (5) to the extent
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`DS-8201 infringes, the Asserted Claims are anticipated absent a valid priority claim, id. at 4, 10;
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`see Opp. §§ IV-V (nowhere disputing anticipation based on Seagen’s infringement theory). Those
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`agreed-upon facts legally foreclose Seagen’s priority claim and mandate summary judgment of
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`anticipation. Def. Br. 16-20; Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996).
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`A.
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`Seagen’s “Precise Formula” Is Irrelevant
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`1.
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`The “Precise Formula” Fails to Disclose Gly/Phe-Only Tetrapeptides
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`Seagen first argues that Defendants “ignore a crucial aspect of the claims: the recitation of
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`a precise formula depicting the structure of the claimed compound.” Opp. 9 (“an ADC having a
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`linker unit defined by a formula ‘-Aa-Ww-Yy-’”). That formula (“-Aa-Ww-Yy-”) appears in both
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`the Priority Applications and Asserted Claims, id., but it is not all the claims require. The disputed
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`limitation—restricting the linker (“Ww”) to a tetrapeptide consisting only of Gly and Phe—is not
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`present in this “precise” formula and is absent from the Priority Applications. They therefore
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`cannot support the ’039 patent’s claim to an earlier priority date.
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`The Asserted Claims require that the “—Ww—unit is a tetrapeptide”—a unit of 4 amino
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`acids, one of the many categories of amino acid units disclosed in the Priority Applications. They
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`further require that “each —W—unit is independently an Amino Acid unit” defined as follows:
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`1
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`Case 2:20-cv-00337-JRG Document 317 Filed 02/15/22 Page 6 of 17 PageID #: 11168
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`’039 Patent (D.I. 255-01), claim 1. The Parties agree that the term “wherein R19 is hydrogen or
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`benzyl” requires all four amino acids in the tetrapeptide to be Gly or Phe, Opp. 6, 10, rather than
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`one of the many other amino acids disclosed in the Priority Applications, Def. Br. 5-6. This greatly
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`restricts the possible linker units—where the formula “-Aa-Ww-Yy-” in the Priority Applications
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`would cover infinite sequences, the Asserted Claims cover a mere 81—and it is entirely absent
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`from the Priority Applications. Seagen’s “precise formula” does not support its priority claim.
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`It is thus correct and irrelevant that the Asserted Claims and Priority Applications both
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`disclose the same ADC formula and “structure for each amino acid within the peptide unit”:
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`Opp. 10 (citing ’340 application ¶¶ 0684, 0715). Neither of these images address the key limitation
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`that Ww must be four amino acids with R19 as hydrogen or benzyl at each of the four positions.
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`That requirement comes from the words of the Asserted Claims, not a picture. And fatally for
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`Seagen, those words are absent from the Priority Applications. Def. Br. 1-2, 15-20.
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`2.
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`The Remaining “Laundry List” of Linkers is Legally Insufficient
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`Because its “precise formula” is silent as to the limitation at issue, Seagen relies on the
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`broad generic disclosure of the 2004 Application (App. No. 10/983,340). Seagen argues that
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`“Application discloses detailed information about the amino acid unit” including that “it is a
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`dipeptide, tripeptide, tetrapeptide, pentapeptide . . . or dodecapeptide unit,” and “states that each
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`R19 side chain is selected from a group of 39 side chains.” Opp. 11. That list of 39 side chains
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`2
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`Case 2:20-cv-00337-JRG Document 317 Filed 02/15/22 Page 7 of 17 PageID #: 11169
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`“include[s]” hydrogen and benzyl—the side chains corresponding to Gly and Phe. Id.
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`In the tetrapeptide category alone, Seagen agrees this “laundry list” of amino acid side
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`chains covers 47 million sequences. Id. at 9; Def. Br. 16-20. The Federal Circuit consistently has
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`held as a matter of law that such an undifferentiated “laundry list” does not provide written
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`description support for all possible combinations of listed items. Def. Br. at 17-20; Fujikawa, 93
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`F.3d at 1571; Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1326 (Fed. Cir. 2000).
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`Seagen’s only response turns the law on its head. Seagen notes that the claims are “limited
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`to only ‘a minute subgenus’ of those linkers: only 81 tetrapeptides, not millions.” Opp. 12. This
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`discrepancy is a problem for Seagen, not an asset. To satisfy the written description requirement,
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`the Priority Applications must show the POSA that Seagen invented ADCs with the claimed set
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`of 81 Gly/Phe-only linkers, from among the forest of 47 million tetrapeptide linkers they disclose.
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`Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1571-72 (Fed. Cir. 1997). The narrowness of the
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`claimed set of linkers compared to the breadth of the Priority Applications’ disclosure makes
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`Seagen’s conclusion less likely—not more likely, as Seagen wrongly suggests. Opp. 12.
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`The Federal Circuit in Fujikawa provided the rubric to evaluate the written description of
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`claims that recite a chemical formula with substituents selected from a list of options in the
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`specification. See Def. Br. 18. Seagen’s cases—In re Driscoll, 562 F.2d 1245 (C.C.P.A. 1977),
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`and Novartis Pharms. Corp. v. Plexxikon Inc., PGR2018-00069, Paper 16 (P.T.A.B. Jan. 16, 2019)
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`(“Plexxikon”)—neither conflict with Fujikawa nor suggest a different result here.
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`The Federal Circuit clearly addressed the key distinction between Driscoll and Fujikawa,
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`rejecting the very argument Seagen advances here: while claiming a category disclosed in the
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`specification is permitted, claiming “only a narrow subset” of that category that requires multiple
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`selections not disclosed in the specification violates the written description requirement. In re
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`3
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`Case 2:20-cv-00337-JRG Document 317 Filed 02/15/22 Page 8 of 17 PageID #: 11170
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`Wako Pure Chem. Indus. Ltd., 4 F. App’x 853, 855-57 (Fed. Cir. 2001). The Driscoll application
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`disclosed “fourteen distinct classes of compounds, each class” defined by a different option at a
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`single variable. Driscoll, 562 F.2d at 1249. The claim in Driscoll recited “one of the fourteen
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`classes of compounds.” Id. The Federal Circuit deemed this the crucial distinction between
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`Driscoll and Fujikawa: Driscoll simply required selection of a single category disclosed in the
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`priority application in its entirety—without further subdividing it—rather than a “subset” of a
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`category. Wako, 4 F. App’x at 857. Had Seagen claimed ADCs using “tetrapeptides” (the
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`disclosed category) rather than “Gly/Phe-only tetrapeptides” (only part of it), Driscoll might be
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`instructive. But Seagen agrees it did not do so. Def. Br. 5-6. Unlike Driscoll, Seagen’s claims
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`require first selecting 1 of 11 disclosed peptide categories (tetrapeptides), then selecting “only a
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`narrow subset” of that category by picking and choosing among 83 options at each of four different
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`positions to arrive at the claimed tetrapeptides. Wako, 4 F. App’x at 855. That further refinement,
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`absent from Driscoll, is dispositive here. Id.; Fujikawa, 93 F.3d at 1371; Purdue Pharma L.P. v.
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`Iancu, 767 F. App’x 918, 924 (Fed. Cir. 2019) (“laundry list” of “undifferentiated compounds”
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`suitable for use in combination did not support claim to a specific combination); FWP IP ApS v.
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`Biogen MA, 749 F. App’x 969, 977-78 (Fed. Cir. 2018) (no support where POSA “would need to
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`pick and choose from” a “laundry list of diseases” and “numerous possible dosing schedules”).
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`Nor does Plexxikon, a PTAB decision, support the indiscriminate picking and choosing
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`Seagen urges. The Board found sufficient blazemarks leading to the claimed choices for variable
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`“R1” because “3 compounds disclosed in the specification . . . [fell] within the scope of the claims”
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`and exemplified the precise combination of substituents claimed. Plexxikon, at *17. It was those
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`examples (wholly absent here) that “adequately support[ed] . . . the sub-genus now claimed,” id.—
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`not, as Seagen contends, the mere recitation of “a Markush group of 23 substituents,” Opp. 13.
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`4
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`Case 2:20-cv-00337-JRG Document 317 Filed 02/15/22 Page 9 of 17 PageID #: 11171
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`B.
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`No Blazemarks in the Priority Applications Point to the Alleged Invention
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`Seagen also seeks to conjure a factual dispute as to whether the Priority Applications’
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`examples provide blazemarks to the claimed 81 ADCs with Gly/Phe-only tetrapeptides. Opp. 16-
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`22. Seagen’s arguments cannot succeed for two reasons, each of which independently mandates
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`summary judgment. Def Br. 20-27. First, Seagen supplants the written description inquiry with
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`an improper obviousness analysis, relying on material wholly outside the Priority Applications to
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`identify other peptides the POSA would make based on their disclosure, rather than to interpret
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`what the applications themselves disclose. Opp. 19-22; Def Br. 24-25. Second, even Seagen’s
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`spurious “blazemarks” admittedly identify sets of sequences that are not the claimed invention.
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`Opp. 28-29; Def. Br. 25-27. Either legal flaw is sufficient to foreclose Seagen’s priority claim.
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`1.
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`The Applications Must Describe the Invention, Not Render It Obvious
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`The Priority Applications must describe the claimed invention, not render it obvious. Per
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`the en banc Federal Circuit: “[A] description that merely renders the invention obvious does not
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`satisfy the requirement.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1352 (Fed. Cir.
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`2010). “Entitlement to a filing date does not extend to subject matter which is not disclosed, but
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`would be obvious over what is expressly disclosed. It extends only to that which is disclosed.”
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`Lockwood, 107 F.3d at 1571-72. “It is not sufficient for purposes of . . . written description . . .
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`that the disclosure, when combined with the knowledge in the art, would lead one to speculate as
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`to modifications that the inventor might have envisioned, but failed to disclose.” Id. at 1572.
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`2.
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`Seagen Argues the Asserted Claims are Obvious, not Described
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`Crucially, Seagen concedes that none of the Priority Applications’ examples show
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`Gly/Phe-only tetrapeptides. Opp. 17 (citing 2004 App. at ¶¶ 0690-91) (examples are Gly-Phe-
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`Leu-Gly, Ala-Leu-Ala-Leu, and Gly-Ser-Val-Gln). Thus, Seagen cannot argue that the examples
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`standing alone direct the POSA to the claimed invention—to the contrary, the examples point to
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`5
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`Case 2:20-cv-00337-JRG Document 317 Filed 02/15/22 Page 10 of 17 PageID #: 11172
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`tetrapeptides that fall outside the Asserted Claims. Def. Br. 21 (collecting testimony).
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`Accordingly, Seagen can offer only obviousness arguments. First, Seagen argues that the
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`POSA would have been motivated to modify the examples to make sequences undisclosed in the
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`Priority Applications that fall within the claims. Opp. § V.B.1. Per Seagen, “[t]hese examples,
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`along with other exemplary amino acid sequences, would have guided a person of ordinary skill
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`to gly/phe tetrapeptides.” Id. at 17. Critically, Seagen does not argue that the Priority Applications
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`(beyond the unavailing broad formula discussed above) actually disclose Gly/Phe-only
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`tetrapeptides (let alone the set of 81 claimed). Rather, Seagen argues the POSA would have
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`selected one of the three tetrapeptide examples in the 2004 Application, and then been “drawn to
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`consider several modifications” to that example “based on the disclosure of the Priority
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`Applications and the literature on substrates for lysosomal proteases.” Id. That is a classic “lead
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`compound” obviousness theory, see Otsuka Pharm. v. Sandoz, 678 F.3d 1280, 1291-92 (Fed. Cir.
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`2012)—i.e., the POSA “would have started their analysis” with the lead compound Gly-Phe-Leu-
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`Gly, and been motivated to modify it (“considered substituting a [Phe]”) to make Gly/Phe-only
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`tetrapeptides, Opp. 18-19. But “[t]he question is not whether a claimed invention [ADCs with
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`Gly/Phe-only tetrapeptides] is an obvious variant of that which is disclosed in the specification
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`[ADCs using Gly-Phe-Leu-Gly].” Lockwood, 107 F.3d at 1572. “Rather, a prior application itself
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`must describe an invention, and do so in sufficient detail that one skilled in the art can clearly
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`conclude that the inventor invented the claimed invention as of the filing date sought.” Id.
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`(affirming summary judgment of anticipation for improper priority claim); TurboCare Div. of
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`Demag Delaval Turbomachinery v. Gen. Elec., 264 F.3d 1111, 1120 (Fed. Cir. 2001) (affirming
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`summary judgment of no written description); PowerOasis v. T-Mobile USA, 522 F.3d 1299, 1310
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`(Fed. Cir. 2008) (rejecting “expert declaration” suggesting obviousness and affirming summary
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`6
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`Case 2:20-cv-00337-JRG Document 317 Filed 02/15/22 Page 11 of 17 PageID #: 11173
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`
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`judgment of anticipation for improper priority claim). Seagen’s theory fails as a matter of law.
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`Second, Seagen argues, Opp. § V.B.2, that prior art outside the Priority Applications and
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`“not about ADCs” nonetheless “would have informed persons of ordinary skill how to design an
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`ADC when read in the context of the disclosures of the [Priority Applications],” id. at 19. That is
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`another obviousness theory—that the Priority Applications’ disclosures, in combination with prior
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`art, would have led the POSA to “design” the undisclosed claimed invention. Seagen asserts that
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`the POSA would have ignored the ADC prior art discouraging tetrapeptides, and “reevaluate[d]”
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`certain “non-ADC literature” that happens to disclose (in the context of different molecules) what
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`the Priority Applications do not: a few Gly/Phe-only tetrapeptides. Id. 20-21.
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`Setting aside the implausibility of Seagen’s convoluted assertion (which contradicts its
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`argument, made to secure allowance, that the POSA would have eschewed non-ADC prior art, Ex.
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`23 at 7-9), this theory fails because it is an obviousness one as well, and also because it improperly
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`relies on prior art outside the Priority Applications to supply the disclosure of the critical limitation.
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`The written description “test requires an objective inquiry into the four corners of the specification
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`from the perspective” of a POSA. Ariad, 598 F. 3d at 1351. The law is clear that, while “the
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`meaning of terms, phrases, or diagrams in a disclosure is to be explained or interpreted from the
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`vantage point of one skilled in the art, all the limitations must appear in the specification.”
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`Lockwood, 107 F.3d at 1571 (“It is the disclosures of the applications that count.”). In other words,
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`“[t]he knowledge of ordinary artisans may be used to inform what is actually in the
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`specification . . . but not to teach limitations that are not in the specification.” Rivera v. Int’l Trade
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`Comm., 857 F.3d 1315, 1322 (Fed. Cir. 2017) (emphasis added).
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`Had the Priority Applications disclosed a Gly/Phe-only tetrapeptide limitation, but merely
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`used different words to do so, the law would permit reliance on prior art to interpret that disclosure.
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`7
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`Case 2:20-cv-00337-JRG Document 317 Filed 02/15/22 Page 12 of 17 PageID #: 11174
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`Id. at 1322-23; Lockwood, 107 F.3d at 1571. But the Priority Applications do not disclose Gly/Phe-
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`only tetrapeptides, Def. Br. 16-20, and longstanding, controlling precedent precludes the prior art
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`from “gap-filling” that missing disclosure. Rivera, 857 F.3d at 1322; Lockwood, 107 F.3d at 1571-
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`72; Falko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1367 n.13 (Fed. Cir. 2006).
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`Seagen cites no case to the contrary. Contra Opp. § B.3. The Priority Applications “must
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`be read from the perspective of a person of skill in the art.” Novartis Pharms. Corp. v. Accord
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`Healthcare, Inc., 2022 U.S. App. LEXIS 58, at *22 (Fed. Cir. Jan. 3, 2022). But no law, including
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`Novartis, permits the prior art to provide description for limitations wholly absent from the Priority
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`Applications. Indeed, the Federal Circuit expressly rejects such an approach. Rivera, 857 F.3d at
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`1322-23; Lockwood, 107 F.3d at 1571-72. In Falkner, the priority “application disclosed the use
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`of essential genes . . . and simply did not include the well-known sequence” of that gene. Rivera,
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`857 F.3d at 1315 (citing 448 F.3d at 1366-68); see also All Dental Prodx, LLC v. Advantage Dental
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`Prods., Inc., 309 F.3d 774, 779 (Fed. Cir. 2002) (claim using different words nonetheless “reflects
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`what the specification shows has been invented”); Immunex Corp. v. Sandoz Inc., 964 F.3d 1049,
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`1064 (Fed. Cir. 2020) (claim reciting well-known full-length DNA sequence supported where
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`specification cited identification numbers for that sequence and prior art disclosing it). By
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`contrast, the Priority Applications here fail to disclose ADCs with the 81 claimed tetrapeptides
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`(from among the category of 47 million) using any words or examples, and Seagen does not allege
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`that Gly/Phe-only tetrapeptides were “well-known” ADC linkers. To the contrary, Seagen
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`acknowledges they appear in uncited, non-ADC art the POSA would have needed to “reevaluate.”
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`Opp. 19. They are not described as a matter of law. Ariad, 598 F.3d at 1351; Rivera, 857 F.3d at
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`1322-23; Lockwood, 107 F.3d at 1571-72; Bos. Sci. Corp. v. Johnson & Johnson, 647 F.3d 1353,
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`1365-66 (Fed. Cir. 2011) (rejecting reliance on prior art to supply a critical limitation, and
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`8
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`Case 2:20-cv-00337-JRG Document 317 Filed 02/15/22 Page 13 of 17 PageID #: 11175
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`affirming summary judgment given the absence of disclosure or examples meeting the limitation).
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`3.
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`Seagen’s Blazemarks Point to the Wrong Subgenus
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`Seagen’s theory of written description contains an independent legal flaw: the blazemarks
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`Seagen conjures from its obviousness theories point to a subgenus that is not the claimed invention.
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`Opp. 18-19 (obviousness theory including tetrapeptides with serine, leucine, valine, and alanine),
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`20-21 (reciting six of 81 Gly/Phe-only tetrapeptides and one tetrapeptide with leucine).
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`Seagen concedes that its alleged blazemarks do not point to the 81-member genus it
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`claimed. Id. That ends this case. Seagen relies solely on a desperate legal argument: that
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`Defendants’ legal standard requiring that the blazemarks point to the “exact claimed subgenus” is
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`“made-up.” Id. at 2. It is Seagen, not Defendants, who misapprehend the law, ignoring the
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`blackletter requirement for written description of “the invention claimed.” Ariad, 598 F.3d at 1351
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`(disclosure must “show that the inventor actually invented the invention claimed”); Bos. Sci., 647
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`F.3d at 1369 (“Given the paucity of disclosure regarding the claimed sub-genus, no reasonable
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`juror could conclude that … the inventors were in possession of the claimed invention.”).
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`In this context, that longstanding precedent requires, in the forest of the priority disclosure,
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`blazemarks identifying the “invention claimed,” whether it be a tree (if a single species is claimed)
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`or trees (if a subgenus of multiple species is claimed). Fujikawa, 93 F.3d at 1571 (“one of ordinary
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`skill would not be led to Fujikawa’s sub-genus in particular” (emphasis added)); Bos. Sci., 647
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`F.3d at 1367 (“[T]he lack of such blaze marks . . . prevents any conclusion that the patent contains
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`sufficient written description of the claimed [subgenus]. No reasonable juror could determine that
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`the specification ‘reasonably convey[s] to persons skilled in the art that the inventor had
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`possession’ of the claimed sub-genus.” (emphases added)).
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`The cases Seagen cites do not—and cannot—suggest that blazemarks to a single species
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`within a claimed subgenus would be sufficient. Contra Opp. 29. Novozymes explains the
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`Case 2:20-cv-00337-JRG Document 317 Filed 02/15/22 Page 14 of 17 PageID #: 11176
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`unremarkable proposition that (as here) the absence of examples within the scope of the claims
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`tends to show lack of written description, not that, contrary to controlling law, blazemarks to a
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`single species describe an entire subgenus. Novozymes A/s v. DuPont Nutrition Biosciences APS,
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`723 F.3d 1336, 1349 (Fed. Cir. 2013); Ariad, 598 F.3d at 1350; Bos. Sci., 647 F.3d at 1367. And
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`Novartis explained that, “where the specification describes a broad genus and the claims are
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`directed to a single species or a narrow subgenus, . . . the specification must contain ‘blaze marks’
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`that would lead an ordinarily skilled investigator toward such a species among a slew of competing
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`possibilities.” Novartis Pharms., 2022 U.S. App. LEXIS 58, at *5 (emphasis added). Contrary to
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`Seagen’s strained reading, the reference to “such a species” plainly refers to the antecedent “single
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`species”—not a single species within a claimed subgenus.
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`There is no dispute that Seagen’s proposed blazemarks lead to subgenuses that exclude
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`most of the 81 claimed tetrapeptides and add other unclaimed tetrapeptides. Whatever this motley
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`assortment reflects, it is not the claimed “sub-genus in particular.” Fujikawa, 93 F.3d at 1571.
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`II.
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`THE INVENTORS ADMIT LACK OF CONCEPTION AND DESCRIPTION
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`“[O]ne cannot describe what one has not conceived.” Falkner, 448 F.3d at 1367 n.13.
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`Seagen nevertheless urges the court to ignore the inventors’ myriad admissions regarding lack of
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`conception by 2004 because written description “is not based on actual reduction to practice of the
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`claimed invention by the inventors.” Opp. 23. Defendants never asserted that actual reduction to
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`practice is required. Rather, the inventors’ repeated sworn admissions that they did not conceive
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`or describe ADCs with Gly/Phe-only tetrapeptides before 2017, Def. Br. § V.B.3—most of which
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`Seagen does not seek to explain or erase by errata—show that they were not in possession of such
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`ADCs in 2004 and, as a matter of law and common sense, did not then describe them either.
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`III. CONCLUSION
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`For the foregoing reasons, Defendants are entitled to summary judgment of anticipation.
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`Case 2:20-cv-00337-JRG Document 317 Filed 02/15/22 Page 15 of 17 PageID #: 11177
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`Dated: January 28, 2022
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`Respectfully submitted,
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`/s/ Deron R. Dacus
`(with permission by Jennifer P. Ainsworth)
`Deron R. Dacus
`Texas State Bar No. 00790553
`ddacus@dacusfirm.com
`THE DACUS FIRM, P.C.
`821 ESE Loop 323, Suite 430
`Tyler, Texas 75701
`Telephone: 903.705.1117
`Facsimile: 903.581.2543
`
`J. Mark Mann
`Texas State Bar No. 12926150
`mark@themannfirm.com
`G. Blake Thompson
`Texas State Bar No. 240420033
`blake@themannfirm.com
`MANN | TINDEL | THOMPSON
`201 E. Howard Street
`Henderson, Texas
`Telephone: 903.357.8540
`Facsimile: 903.657.6003
`
`Preston K. Ratliff II
`Joseph M. O’Malley, Jr.
`Ashley N. Mays-Williams
`PAUL HASTINGS LLP
`200 Park Avenue
`New York, New York 10166
`Telephone: 212.318.6000
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`Jeffrey A. Pade
`PAUL HASTINGS LLP
`2050 M Street NW
`Washington, DC 20036
`Telephone: 202.551.1700
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`Attorneys for Defendant Daiichi Sankyo
`Company, Limited
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`Case 2:20-cv-00337-JRG Document 317 Filed 02/15/22 Page 16 of 17 PageID #: 11178
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`/s/ David I. Berl
`(with permission by Jennifer P. Ainsworth)
`David I. Berl
`dberl@wc.com
`Thomas S. Fletcher
`tfletcher@wc.com
`Jessica L. Pahl
`jpahl@wc.com
`Kathryn S. Kayali
`kkayali@wc.com
`Kevin Hoagland-Hanson
`khoagland-hanson@wc.com
`Andrew L. Hoffman
`ahoffman@wc.com
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`Phone: (202) 434-5000
`Facsimile: (202) 434-5029
`
`Jennifer Parker Ainsworth
`Texas State Bar No. 00784720
`jainsworth@wilsonlawfirm.com
`Wilson, Robertson & Cornelius, P.C.
`909 ESE Loop 323, Suite 400
`Tyler, Texas 75701
`Phone: (903) 509-5000
`Facsimile: (903) 509-5092
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`Attorneys for AstraZeneca Pharmaceuticals
`LP and AstraZeneca UK Ltd.
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a true and correct copy of the above and foregoing
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`document was filed electronically UNDER SEAL and served by e-mail on January 28, 2022, to
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`all counsel of record.
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`/s/ Jennifer P. Ainsworth
`Jennifer P. Ainsworth
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`Case 2:20-cv-00337-JRG Document 317 Filed 02/15/22 Page 17 of 17 PageID #: 11179
`Case 2:20-cv-00337-JRG Document 317 Filed 02/15/22 Page 17 of 17 PagelD #: 11179
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