Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

MorphoSys AG v. Janssen Biotech, Inc.

United States District Court, D. Delaware

January 28, 2019

MORPHOSYS AG, Plaintiff,
v.
JANSSEN BIOTECH, INC., GENMAB US, INC. and GENMAB A/S, Defendants.

          Kelly E. Farnan, Christine D. Haynes, RICHARDS, LAYTON & FINGER, PA., Wilmington, DE.

          James F. Hurst, KIRKLAND & ELLIS LLP, Chicago, IL Patricia A. Carson, Christopher T. Jagoe, and Aaron D. Resetarits, KIRKLAND & ELLIS LLP, New York, NY Attorneys for Plaintiff.

          Jack B. Blumenfeld and Brian P. Egan, MORRIS, NICHOLAS, ARSHT & TUNNELL LLP, Wilmington, DE.

          Michael A. Morin, David P. Frazier, and Emily K. Sauter, LATHAM & WATKINS LLP, Washington, DC Roger J. Chin, LATHAM & WATKFNS LLP, San Francisco, CA Brenda L. Danek and Ann Marie Wahls, LATHAM & WATKINS LLP, Chicago, IL 60661 Michael R. Seringhaus, LATHAM & WATKFNS LLP, Menlo Park, CA Attorneys for Defendants.

          MEMORANDUM OPINION

          STARK, U.S DISTRICT JUDGE.

         MorphoSys, Inc. (“MorphoSys” or “Plaintiff”) sued Janssen Biotech, Inc., Genmab US, Inc., and Genmab A/S (together, “Janssen” or “Defendants”) for infringement of three patents on antibodies that bind to the CD38 protein. (D.I. 205) Pending before the Court are summary judgment motions filed by both sides. Janssen moves for summary judgment of (1) non-infringement of the “human” antibody claims (D.I. 384) and (2) invalidity for lack of written description, lack of enablement, and indefiniteness (D.I. 382). MorphoSys moves for summary judgment of no invalidity for lack of enablement. (D.I. 390) The Court heard argument on November 27, 2018.[1] (D.I. 461) (“Tr.”)

         For the reasons stated below, the Court will grant summary judgment as to non-infringement of the human antibody claims; grant-in-part and deny-in-part summary judgment of invalidity for lack of written description; deny summary judgment of invalidity for indefiniteness; and grant summary judgment of invalidity for lack of enablement.

         I. BACKGROUND

         MorphoSys alleges infringement of U.S. Patent Nos. 8, 263, 746 (“the ‘746 patent”), 9, 200, 061 (“the ‘061 patent”), and 9, 758, 590 (“the ‘590 patent”).[2] The asserted patents describe antibodies that can be used to treat blood cancer. (‘746 patent, Abstract) Specifically, in certain kinds of blood cancer, a protein called CD38 appears on the surface of cancerous cells. (Id. at 1:14-19) The patents describe antibodies that bind to CD38, thus causing the destruction of the cancerous cells. (Id. at 1:49-63, 2:33-42) More specifically, the antibodies disclosed by the patents are “human or humanized” - they appear human to the human immune system, and therefore they do not trigger a deleterious immune response. (Id. at 6:55-60) Janssen produces an antibody drug, Darzalex (chemical name “daratumumab”), that MorphoSys contends infringes the asserted patents. (D.I. 205)

         II. LEGAL STANDARDS

         Pursuant to Rule 56(a) of the Federal Rules of Civil Procedure, “[t]he court shall grant summary judgment if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” The moving party bears the burden of demonstrating the absence of a genuine issue of material fact. See Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 585-86 (1986). An assertion that a fact cannot be - or, alternatively, is - genuinely disputed must be supported either by citing to “particular parts of materials in the record, including depositions, documents, electronically stored information, affidavits or declarations, stipulations (including those made for purposes of the motion only), admissions, interrogatory answers, or other materials, ” or by “showing that the materials cited do not establish the absence or presence of a genuine dispute, or that an adverse party cannot produce admissible evidence to support the fact.” Fed.R.Civ.P. 56(c)(1)(A) & (B). If the moving party has carried its burden, the nonmovant must then “come forward with specific facts showing that there is a genuine issue for trial.” Matsushita, 475 U.S. at 587 (internal quotation marks omitted). The Court will “draw all reasonable inferences in favor of the nonmoving party, and it may not make credibility determinations or weigh the evidence.” Reeves v. Sanderson Plumbing Prods., Inc., 530 U.S. 133, 150 (2000).

         To defeat a motion for summary judgment, the nonmoving party must “do more than simply show that there is some metaphysical doubt as to the material facts.” Matsushita, 475 U.S. at 586; see also Podobnik v. U.S. Postal Serv., 409 F.3d 584, 594 (3d Cir. 2005) (stating party opposing summary judgment “must present more than just bare assertions, conclusory allegations or suspicions to show the existence of a genuine issue”) (internal quotation marks omitted). The “mere existence of some alleged factual dispute between the parties will not defeat an otherwise properly supported motion for summary judgment;” a factual dispute is genuine only where “the evidence is such that a reasonable jury could return a verdict for the nonmoving party.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48 (1986). “If the evidence is merely colorable, or is not significantly probative, summary judgment may be granted.” Id. at 249-50 (internal citations omitted); see also Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986) (stating entry of summary judgment is mandated “against a party who fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial”). Thus, the “mere existence of a scintilla of evidence” in support of the nonmoving party's position is insufficient to defeat a motion for summary judgment; there must be “evidence on which the jury could reasonably find” for the nonmoving party. Anderson, 477 U.S. at 252.

         III. NON-INFRINGEMENT OF THE “HUMAN” ANTIBODY CLAIMS

         Some of the asserted claims are directed to solely “human” antibodies (e.g., claim 1 of the ‘746 patent, which claims “[a]n isolated human antibody”) while other asserted claims are directed to “human or humanized” antibodies (e.g., claim 14 of the ‘746 patent, which claims “[a]n isolated human or humanized antibody or antibody fragment thereof”). The terms “human” and “humanized” are defined in the specifications (‘746 patent, 6:61-7:22), and these definitions were adopted by the Court in its claim construction order (D.I. 102):

Human

Humanized

one that is not chimeric (e.g., not “humanized”) and not from (either in whole or in part) a nonhuman species

one that is (i) derived from a non-human source (e.g., a transgenic mouse which bears a heterologous immune system), which antibody is based on a human germline sequence; or (ii) chimeric, wherein the variable domain is derived from a non-human origin and the constant domain is derived from a human origin or (iii) CDR-grafted, wherein the CDRs of the variable domain are from a nonhuman origin, while one or more frameworks of the variable domain are of human origin and the constant domain (if any) is of human origin

         Based on these constructions, in order for an antibody to be “human, ” it must not be any of the following: (i) chimeric, (ii) humanized, and (iii) derived even in part from a nonhuman species. In other words, if an antibody is chimeric, humanized, or derived even in part from a nonhuman species, then it is not human. Additionally, if an antibody satisfies one or more of the three sets of conditions for being characterized as “humanized” then that antibody is not human. This is because in order to be “human” an antibody must be “not humanized” and, as a matter of logic, the same antibody cannot be both “humanized” and “not humanized.”[3]

         Janssen moves for summary judgment of non-infringement of the “human” antibody claims, [4] contending that daratumumab is not a “human” antibody either (1) literally (D.I. 385 at 4-7); or (2) under the doctrine of equivalents (id. at 7-10).

         For the reasons below, the Court concludes that no reasonable factfinder could find infringement of the “human” antibody claims either literally or under the doctrine of equivalents.

         1. Literal Infringement

         Janssen contends that the “human” antibody claims are not literally infringed because, under the Court's claim construction, daratumumab is “humanized” and not “human.” (Id. at 4-7) Specifically, Janssen argues that (1) “human” and “humanized” are mutually exclusive (id. at 4-6); and (2) undisputed facts establish that daratumumab is humanized (id. at 6-7). Thus, to Janssen, non-infringement of the “human” claims can be determined as a matter of law. (Id.)

         In its briefing, MorphoSys countered that: (1) an antibody can be both “human” and “humanized” (D.I. 425 at 4-6); and (2) even if “human” and “humanized” are mutually exclusive, a reasonable factfinder could conclude that daratumumab is “human” (id. at 2-4). MorphoSys contends that substantial evidence exists for finding that the accused antibodies are “human” because: (a) daratumumab is derived from human genes (albeit in mice); (b) Janssen has characterized the accused product as “human” in representations to regulators and other parties; and (c) the antibodies are not chimeric, and therefore, not “humanized” under the Court's constructions. (Id. at 2-4)

         However, during the hearing, MorphoSys dropped its argument that an antibody can be both “human” and “humanized.” Instead, MorphoSys acknowledged that “human” and “humanized” are mutually exclusive terms, though still contended that daratumumab is a “human” antibody:

THE COURT: [Y]our view [is] that the accused compound is both human and humanized; correct?
COUNSEL: That is not our position . . . under the law we have from the Court now, that is not our position.
THE COURT: So what is your position?
COUNSEL: Our position is that [daratumumab] meets every, every part of the definition of “human, ” and it does not meet the definition of “humanized antibody.” Specifically, that little Roman numeral (i) which says “derived from a nonhuman source.” It doesn't meet that because that means that the source contributed to the sequence.
THE COURT: So you do agree then that a compound is either human or humanized in the context of this patent, these patents?
COUNSEL: Under the claim constructions that the Court has given as they exist now, our understanding, yes.
THE COURT: So they're mutually exclusive; correct?
COUNSEL: If the claim construction is as we see it, yes.
THE COURT: Under my claim construction as you understand it, “human” and “humanized” are mutually exclusive; correct?
COUNSEL: Yes.

(Tr. 21-22) (emphases added)

         The Court agrees with Janssen that no reasonable juror could conclude that daratumumab is a human antibody. This conclusion follows from the Court's claim construction and undisputed facts.

         First, any reasonable juror would conclude that daratumumab is a humanized antibody. The relevant facts are not in dispute: MorphoSys agrees that daratumumab was made using a transgenic mouse bearing a heterologous immune system and is based on a human germline sequence. (See D.I. 389 Ex. 17, Davis Dep.[5] 115-16, 133; Tr. 19-20) Thus, daratumumab is a humanized antibody as defined under romanette (i) of the Court's construction of “humanized.” Since daratumumab is “humanized, ” it is not “not humanized, ” and, therefore, is not “human.”

         MorphoSys contends, nonetheless, that there is sufficient evidence to find that daratumumab is not “derived from a non-human source” because the antibody is derived entirely from human genes. (D.I. 425 at 3) But MorphoSys' argument is premised on a flawed interpretation of “derived from a non-human source.” MorphoSys' interpretation excludes the specification's sole example of an antibody “derived from a non-human source”: “a transgenic mouse which bears a heterologous immune system.” (See ‘746 patent, 6:61-7:22) Thus, MorphoSys' argument fails as a matter of law. See Markman v. Westview Instruments, Inc., 517 U.S. 370, 388-91 (1996).

         The conclusion that daratumumab is not a human antibody follows from the Court's conclusion that daratumumab is a humanized antibody and MorphoSys' admission that “human” and “humanized” are mutually exclusive. Even without MorphoSys' admission, the Court concludes that an antibody produced using a transgenic mouse is a humanized antibody because it is, as any reasonable factfinder would conclude, “from (either in whole or in part) a nonhuman species.” Further, it is not a human antibody because it is not “not from . . . a nonhuman species.”

         MorphoSys notes that Janssen has characterized daratumumab as “human” to regulators. (D.I. 425 at 1) In those contexts, however, Janssen was not using the term “human” as it appears in the patents or, crucially, as construed by the Court. At best, Janssen's usage of “human” might be considered extrinsic evidence as to the ordinary meaning of the claim term, but such extrinsic evidence may not be used to modify the meaning clearly directed by the intrinsic evidence. See Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005).

         2. Doctrine of Equivalents

         MorphoSys contends that even if the “human” antibody claims are not literally infringed, they are infringed under the doctrine of equivalents. (D.I. 425 at 6-10) Janssen argues that the doctrine of equivalents does not apply for three reasons: (1) the disclosure-dedication rule; (2) the specific exclusion principle; and (3) prosecution history estoppel. (D.I. 385 at 7-10)

         The Court finds that both disclosure-dedication and specific exclusion apply and will not reach the issue of prosecution history estoppel.

         a. Disclosure-Dedication

         Under the “disclosure-dedication” rule, the doctrine of equivalents is unavailable for subject matter disclosed in a patent but not included in the claims at issue. Johnson & Johnston Assocs. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1054-55 (Fed. Cir. 2002) (en banc). “[T]he relevant test is whether one of ordinary skill in the art reading the patent could identify a specific, unclaimed alternative and understand that it could be used as a substitute for the claimed matter.” Cent. Inst. for Experimental Animals v. Jackson Lab., 726 F.Supp.2d 1045, 1048 (N.D. Cal. 2010); see also Toro Co. v. White Consol. Indus., Inc., 383 F.3d 1326, 1334 (Fed. Cir. 2004). Disclosure-dedication is a question of law. See Toro, 383 at 1331.

         In the view of Janssen, the patents note that humanized antibodies could be made from transgenic mice but do not claim (in the relevant claims) such antibodies. (D.I. 385 at 7-8) MorphoSys counters that the disclosure-dedication rule does not apply because the patents do not describe “humanized” antibodies as an alternative to “human” antibodies. (D.I. 425 at 9-10)

         The Court concludes that the disclosure-dedication doctrine applies here. A person of ordinary skill reading the patent would identify humanized antibodies as an alternative to human antibodies. See, e.g., ‘746 patent, 6:57-60 (“The antibodies of the invention . . . may be human or humanized”); id. 6:61-7:22 (defining “human” antibody as “not humanized, ” and defining “humanized” antibody as having “non-human” source or origin); id., cl. 1 (claiming “human or humanized” antibodies). Therefore, having claimed only human antibodies in some claims, MorphoSys cannot now argue that those claims should also cover humanized antibodies under the doctrine of equivalents.

         b. Specific Exclusion

         Under the “specific exclusion” principle, the doctrine of equivalents cannot broaden a claim to cover a feature that is “the opposite of, or inconsistent with, the recited limitation.” Augme Techs., Inc. v. Yahoo! Inc., 755 F.3d 1326, 1335 (Fed. Cir. 2014). Whether a purported equivalent is specifically excluded is a question of law. See Lockheed Martin Corp. v. Space Sys./Loral, Inc., 324 F.3d 1308, 1318 (Fed. Cir. 2003).

         Janssen contends that daratumumab is specifically excluded because it is a humanized antibody, which is the “opposite[]” of a human antibody. (D.I. 385 at 8-9) In its briefing, MorphoSys contended that specific exclusion does not apply because “human” and “humanized” are not mutually exclusive. (D.I. 425 at 10) However, as noted above, MorphoSys admitted during oral argument that “human” and “humanized” are mutually exclusive terms, as construed by the Court. (Tr. 21-22)

         The Court concludes that humanized antibodies are specifically excluded from the claims directed solely to human antibodies. This conclusion follows logically from MorphoSys' admission; given that a human antibody cannot also be a humanized antibody (and vice versa), the terms are “inconsistent with each other.” Augme, 755 F.3d at 1335. Moreover, a holding that humanized antibodies were equivalent to human antibodies would render the claim term “human or humanized” redundant. Cf. Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 29 (1997) (“It is important to ensure that the application of the doctrine [of equivalents], even as to an individual element, ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.