Genetic Veterinary Sciences v. Laboklin Gmbh & Co. Kg , 933 F.3d 1302 ( 2019 )


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  •   United States Court of Appeals
    for the Federal Circuit
    ______________________
    GENETIC VETERINARY SCIENCES, INC., DBA
    PAW PRINTS GENETICS,
    Plaintiff-Appellee
    v.
    LABOKLIN GMBH & CO. KG, THE UNIVERSITY OF
    BERN,
    Defendants-Appellants
    ______________________
    2018-2056
    ______________________
    Appeal from the United States District Court for the
    Eastern District of Virginia in No. 2:17-cv-00108-HCM-
    DEM, Senior Judge Henry C. Morgan, Jr.
    ______________________
    SEALED OPINION ISSUED: July 29, 2019
    PUBLIC OPINION ISSUED: August 9, 2019 *
    ______________________
    MARK P. WALTERS, Lowe Graham Jones PLLC, Seattle,
    WA, argued for plaintiff-appellee.
    *    This opinion was originally filed under seal and has
    been unsealed in part with the remaining sealed portions
    modified to omit confidential information from the public
    opinion.
    2    GENETIC VETERINARY SCIENCES v. LABOKLIN GMBH & CO. KG
    JOHANNA WILBERT, Quarles & Brady, LLP, Milwaukee,
    WI, argued for defendants-appellants. Also represented by
    MICHAEL PIERY; NIKIA L. GRAY, Washington, DC.
    ______________________
    Before WALLACH, HUGHES, and STOLL, Circuit Judges.
    WALLACH, Circuit Judge.
    Appellee Genetic Veterinary Sciences, Inc., d/b/a Paw
    Prints Genetics (“PPG”) sued Appellants LABOKLIN
    GmbH & Co. KG (“LABOKLIN”) and the University of
    Bern (“the University”) (together, “Appellants”) in the U.S.
    District Court for the Eastern District of Virginia (“District
    Court”), seeking a declaratory judgment that claims 1−3
    (“Asserted Claims”) of the University’s U.S. Patent No.
    9,157,114 (“the ’114 patent”) are patent-ineligible under 35
    U.S.C. § 101 (2012). 1 J.A. 50−57 (Complaint). Appellants
    filed a motion to dismiss the Complaint for, inter alia, lack
    of subject-matter jurisdiction and lack of personal jurisdic-
    tion, see J.A. 58−60, which the District Court denied, see
    J.A. 302−16 (Order). Following the close of the parties’ ev-
    idence during a jury trial but before submitting the case to
    the jury, the District Court granted PPG’s motion for judg-
    ment as a matter of law (“JMOL”) and held the Asserted
    Claims patent-ineligible under § 101. See Genetic Veteri-
    nary Scis., Inc. v. LABOKLIN GmbH & Co., KG, 314 F.
    Supp. 3d 727, 728 (E.D. Va. 2018), appeal dismissed, No.
    18-1625, 
    2018 WL 6334978
    (4th Cir. June 5, 2018); see also
    J.A. 1 (Final Judgment).
    1 Congress did not amend § 101 when it passed the
    Leahy-Smith America Invents Act (“AIA”). See generally
    Pub L. No. 112-29, 125 Stat. 284 (2011).
    GENETIC VETERINARY SCIENCES v. LABOKLIN GMBH & CO. KG        3
    Appellants appeal the District Court’s conclusions as to
    jurisdiction and patent-ineligibility. We have jurisdiction
    pursuant to 28 U.S.C. § 1295(a)(1) (2012). We affirm.
    BACKGROUND
    The University is the owner of the ’114 patent and an
    agent or instrumentality of the Swiss Confederation, “hav-
    ing a place of business in Bern, Switzerland.” J.A. 1090.
    In 2013, the University granted an exclusive license of its
    ’114 patent to the German company LABOKLIN, J.A.
    1091, whose “principal place of business is in Bad Kis-
    singen, Germany,” J.A. 1090; see J.A. 173−218 (Confiden-
    tial License Agreement). Among many conditions of the
    License Agreement, LABOKLIN was required to commer-
    cialize the invention in North America “within [a specific
    time period] of the Effective date.” J.A. 214−15. Subse-
    quently, and at the time of the filing of Appellants’ Motion
    to Dismiss, LABOKLIN had entered into two sublicenses
    in the United States. See J.A. 309, 349−51 (referencing
    California and Michigan sublicensees). The License Agree-
    ment required both LABOKLIN and the University to ob-
    tain the other’s consent prior to sending any cease-and-
    desist letter to a potential infringer. J.A. 217. The License
    Agreement further stated that if the infringing activity
    “d[oes] not abate within [a specific time period]” and the
    University gives LABOKLIN written notice of its election
    not to bring suit, LABOKLIN has a right to sue for infringe-
    ment. J.A. 218.
    PPG is a corporation headquartered in the State of
    Washington. J.A. 302. It offers laboratory services for test-
    ing for genetic variations and mutations known to cause
    certain diseases in dogs, including a test for “detect[ing] the
    presence of a mutation in the SUV39H2 gene.” J.A. 302.
    Relevant to the facts of this case, PPG would accept a cus-
    tomer’s request to test sample DNA received “from all over
    the world” and once the DNA test was concluded, would
    send the results back to the customer. See J.A. 101−02, 68.
    4   GENETIC VETERINARY SCIENCES v. LABOKLIN GMBH & CO. KG
    In January 2017, after obtaining the University’s consent
    to send PPG a cease-and-desist letter, see J.A. 312, 349,
    353, counsel for LABOKLIN sent a cease-and-desist letter
    to PPG at its business location in Spokane, Washington, see
    J.A. 99−104. The cease-and-desist letter explained that
    “[LABOKLIN] is the exclusive license holder of [the ’114
    patent],” J.A. 100, as well as the exclusive licensee of the
    related European and German patents, see J.A. 99, all of
    which were attached as enclosures, and the letter stated
    that given “[PPG] make[s] use of the patent as defined in
    above-mentioned patent claim 1[,] . . . you [PPG] have com-
    mitted an act of patent infringement,” J.A. 102. After re-
    ceiving the cease-and-desist letter, PPG brought suit
    against both LABOKLIN and the University, requesting
    declaratory judgment that the Asserted Claims of the ’114
    patent are ineligible under § 101 for failing to claim patent-
    eligible subject matter, and ultimately asserting that PPG
    therefore cannot be liable for infringing the Asserted
    Claims. See J.A. 50−57. 2
    LABOKLIN and the University moved to dismiss the
    Complaint under, inter alia, Federal Rules of Civil Proce-
    dure 12(b)(1) for lack of subject-matter jurisdiction and
    12(b)(2) for lack of personal jurisdiction. J.A. 35. Following
    an evidentiary hearing, the District Court issued its Order
    finding jurisdiction established over both LABOKLIN and
    the University. See J.A. 302−16. First, applying Federal
    Rule of Civil Procedure 4(k)(2), and considering the cease-
    and-desist letter and LABOKLIN’s licensing activities in
    the United States, the District Court held that it may ex-
    ercise personal jurisdiction over LABOKLIN because
    LABOKLIN had sufficient minimum contacts with the
    United States to comport with due process. J.A. 310; see
    2   Counsel for PPG also responded to counsel for Ap-
    pellants in a letter dated after the filing of the declaratory
    judgment. See J.A. 68.
    GENETIC VETERINARY SCIENCES v. LABOKLIN GMBH & CO. KG      5
    Fed. R. Civ. P. 4(k)(2) (explaining how personal jurisdiction
    is established for a federal claim outside state-court juris-
    diction). Second, the District Court held that jurisdiction
    was established over the University as a foreign sovereign
    in the United States because, inter alia, the University had
    engaged in “commercial activity” sufficient to trigger an ex-
    ception to jurisdictional immunity under 28 U.S.C.
    § 1605(a)(2) by “obtain[ing] a patent and then
    threaten[ing] PPG by proxy with litigation.” J.A. 314.
    Appellants subsequently asserted counterclaims for in-
    fringement of the ’114 patent, J.A. 317−28; however, PPG
    stipulated to infringement of the Asserted Claims, and the
    only issue that proceeded to trial was PPG’s invalidity de-
    fense, J.A. 1088, 1089−116 (containing, in a draft final pre-
    trial order, the stipulated facts of both parties). Following
    the close of both parties’ evidence at trial but before sub-
    mitting the case to the jury, the District Court granted
    PPG’s Motion for JMOL and held the Asserted Claims pa-
    tent-ineligible under § 101. See Genetic Veterinary, 314 F.
    Supp. 3d at 728. This appeal followed.
    JURISDICTION
    Appellants aver that the District Court: (1) “lacks per-
    sonal jurisdiction over LABOKLIN” because LABOKLIN
    lacks sufficient contacts with the forum; and (2) “lacks per-
    sonal and subject[-]matter jurisdiction over the University
    because the University enjoys sovereign immunity.” Ap-
    pellants’ Br. 16. We address each issue in turn.
    I. Personal Jurisdiction Over LABOKLIN
    A. Standard of Review and Legal Standards
    “Personal jurisdiction is a question of law that we re-
    view de novo.” Autogenomics, Inc. v. Oxford Gene Tech.
    Ltd., 
    566 F.3d 1012
    , 1016 (Fed. Cir. 2009) (citation omit-
    ted). We apply Federal Circuit law to questions of personal
    jurisdiction because the issue “is intimately involved with
    the substance of the patent laws.” Grober v. Mako Prods.,
    6   GENETIC VETERINARY SCIENCES v. LABOKLIN GMBH & CO. KG
    Inc., 
    686 F.3d 1335
    , 1345 (Fed. Cir. 2012) (internal quota-
    tion marks and citation omitted); see Hildebrand v. Steck
    Mfg. Co., 
    279 F.3d 1351
    , 1354 (Fed. Cir. 2002) (applying
    Federal Circuit law to determinations of personal jurisdic-
    tion over out-of-state defendant-patentees in patent in-
    fringement cases and declaratory judgment cases). Where
    the district court’s disposition as to personal jurisdiction is
    based on affidavits and other written materials in the ab-
    sence of an evidentiary hearing, a plaintiff need only make
    a prima facie showing that defendants are subject to per-
    sonal jurisdiction. See Elecs. For Imaging, Inc. v. Coyle,
    
    340 F.3d 1344
    , 1349 (Fed. Cir. 2003). Where discovery is
    conducted, however, the plaintiff bears the burden of prov-
    ing by a preponderance of the evidence the facts necessary
    to establish personal jurisdiction over the defendant. Piec-
    zenik v. Dyax Corp., 
    265 F.3d 1329
    , 1334 (Fed. Cir. 2001).
    We review any underlying factual findings for clear error.
    
    Grober, 686 F.3d at 1345
    . A factual finding is “clearly er-
    roneous” only when the entire record leaves the reviewing
    court “with the definite and firm conviction that a mistake
    has been committed.” Anderson v. City of Bessemer City,
    
    470 U.S. 564
    , 573–74 (1985).
    Federal Rule of Civil Procedure 4(k)(2) states, in rele-
    vant part: “For a claim that arises under federal law, serv-
    ing a summons . . . establishes personal jurisdiction over a
    defendant if: (A) the defendant is not subject to jurisdiction
    in any state’s courts of general jurisdiction; and (B) exer-
    cising jurisdiction is consistent with the United States Con-
    stitution and laws.” Fed. R. Civ. P. 4(k)(2). In applying
    and interpreting Rule 4(k)(2), we therefore allow a court to
    exercise personal jurisdiction over a nonresident if: “(1) the
    plaintiff’s claim arises under federal law, (2) the defendant
    is not subject to jurisdiction in any state’s courts of general
    jurisdiction, and (3) the exercise of jurisdiction comports
    with due process.” Synthes (U.S.A.) v. G.M. Dos Reis Jr.
    Ind. Com de Equip. Medico, 
    563 F.3d 1285
    , 1293−94 (Fed.
    Cir. 2009).
    GENETIC VETERINARY SCIENCES v. LABOKLIN GMBH & CO. KG         7
    For the assertion of jurisdiction to comport with due
    process, a nonresident defendant must have “certain mini-
    mum contacts with [the forum] such that the maintenance
    of the suit does not offend traditional notions of fair play
    and substantial justice.” Int’l Shoe Co. v. Washington, 
    326 U.S. 310
    , 316 (1945) (internal quotation marks and citation
    omitted). Relevant here, “if Rule 4(k)(2) supplies the due
    process analysis, then the forum is the United States,” “as
    opposed to the state in which the district court sits [i.e. Vir-
    ginia].” Synthes 
    (U.S.A.), 563 F.3d at 1291
    , 1295.
    We have summarized the Supreme Court’s due process
    jurisprudence for specific personal jurisdiction 3 as a three-
    part test: “(1) whether the defendant purposefully directed
    its activities at residents of the forum; (2) whether the
    claim arises out of or relates to the defendant’s activities
    with the forum; and (3) whether assertion of personal ju-
    risdiction is reasonable and fair.” Inamed Corp. v. Kuz-
    mak, 
    249 F.3d 1356
    , 1360 (Fed. Cir. 2001) (internal
    quotation marks and citation omitted). “The first two fac-
    tors correspond with the ‘minimum contacts’ prong of the
    [International Shoe] analysis, and the third factor corre-
    sponds with the ‘fair play and substantial justice’ prong of
    the analysis.” 
    Id. “We have
    consistently rejected attempts
    to satisfy the defendant-focused ‘minimum contacts’ in-
    quiry by demonstrating contacts between the plaintiff (or
    third parties) and the forum State.” 
    Walden, 571 U.S. at 284
    .
    3    “Specific” jurisdiction “depends on an ‘affiliatio[n]
    between the forum and the underlying controversy,’ (i.e.,
    an activity or an occurrence that takes place in the forum
    State and is therefore subject to the State’s regulation).”
    Walden v. Fiore, 
    571 U.S. 277
    , 283 n.6 (2014). This case
    concerns the “minimum contacts” necessary to create spe-
    cific jurisdiction because PPG relies on specific jurisdiction
    only. See Appellee’s Br. 13−16, 18.
    8    GENETIC VETERINARY SCIENCES v. LABOKLIN GMBH & CO. KG
    Related to the third factor regarding whether assertion
    of personal jurisdiction is “reasonable and fair,” “[w]here a
    defendant who purposefully has directed his activities at
    forum residents seeks to defeat jurisdiction, he must pre-
    sent a compelling case that the presence of some other con-
    siderations would render jurisdiction unreasonable.”
    Burger King Corp. v. Rudzewicz, 
    471 U.S. 462
    , 476 (1985)
    (emphasis added). In Burger King, the Supreme Court
    identified five considerations relevant to the reasonable-
    ness inquiry:
    [C]ourts in “appropriate case[s]” may evaluate
    [1] “the burden on the defendant,” [2] “the forum
    State’s interest in adjudicating the dispute,”
    [3] “the plaintiff’s interest in obtaining convenient
    and effective relief,” [4] “the interstate judicial sys-
    tem’s interest in obtaining the most efficient reso-
    lution of controversies,” and [5] the “shared
    interest of the several States in furthering funda-
    mental substantive social policies.”
    
    Id. at 477
    (second alteration in original) (quoting World-
    Wide Volkswagen Corp. v. Woodson, 
    444 U.S. 286
    , 292
    (1980)).
    B. The District Court Had Personal Jurisdiction over
    LABOKLIN
    The District Court determined that “in addition to
    [sending] the cease-and-desist letter to PPG,” LABOKLIN
    conducted business in the United States by entering into
    sublicenses in California and Michigan in accordance with
    an exclusive license granted to it on the disputed ’114 pa-
    tent. J.A. 309; see J.A. 307−09. Taken together, the Dis-
    trict Court held that these contacts establish fair and
    reasonable     “specific    personal     jurisdiction  over
    LABO[KLIN].” J.A. 310. Appellants argue that the Dis-
    trict Court lacks personal jurisdiction over LABOKLIN be-
    cause “LABOKLIN does not have sufficient contacts to
    satisfy due process” and a cease-and-desist letter along
    GENETIC VETERINARY SCIENCES v. LABOKLIN GMBH & CO. KG      9
    with licensing activity in the forum is not “enough to confer
    jurisdiction.” Appellants’ Br. 17, 18. We disagree with Ap-
    pellants.
    The District Court’s exercise of personal jurisdiction
    over LABOKLIN comports with due process. As it relates
    to the application of the first and second requirements of
    Rule 4(k)(2)(A), the parties do not dispute the District
    Court’s findings “that [PPG’s] claim arises under federal
    law and that LABO[KLIN agreed it was] not subject to ju-
    risdiction in any state’s courts of general jurisdiction.”
    J.A. 307. Thus, the dispositive inquiry is whether the ex-
    ercise of personal jurisdiction here comports with a due
    process analysis under the third requirement of Rule
    4(k)(2)(B), and, more specifically, LABOKLIN’s conduct
    and contacts within the entire United States as the forum.
    See 
    Synthes, 563 F.3d at 1295
    . We therefore turn to the
    three-pronged due process inquiry. See 
    Inamed, 249 F.3d at 1360
    .
    As it relates to the first two factors of the due process
    inquiry for specific personal jurisdiction—i.e. the “mini-
    mum contacts” prong—these factors are met based upon
    LABOKLIN’s sending of the cease-and-desist letter to-
    gether with its commercial sublicenses.                 Here,
    LABOKLIN’s cease-and-desist letter was clearly directed
    to PPG at its United States address, and the cease-and-de-
    sist letter threatened PPG’s domestic testing business by
    accusing PPG of “commit[ting] an act of patent infringe-
    ment” when it identified its patent portfolio including the
    ’114 patent. J.A. 102. As counsel for LABOKLIN testified,
    LABOKLIN sent the letter “[b]ecause it was aware that
    PPG was and is still infringing the [’114] patent and
    wanted to inform PPG that it was infringing.” J.A. 347−48
    (emphasis added). Counsel for LABOKLIN also “[sought]
    for PPG to either cease its conduct or enter into a licensing
    agreement whereby it was a sublicensee of [LABOKLIN].”
    J.A. 348. PPG’s claim for declaratory judgement arises out
    of or relates to LABOKLIN’s patent sublicensing and its
    10 GENETIC VETERINARY SCIENCES v. LABOKLIN GMBH & CO. KG
    enforcement activities in the United States pursued in a
    cease-and-desist letter from LABOKLIN’s counsel. See
    Jack Henry & Assocs., Inc. v. Plano Encryption Techs. LLC,
    
    910 F.3d 1199
    , 1205 (Fed. Cir. 2018) (applying due process
    considerations and reversing a district court’s determina-
    tion that it did not have jurisdiction where, inter alia, “[ap-
    pellee had] undertaken a licensing program, with threats
    of litigation, directed to the [appellants] conducting bank-
    ing activity in the Northern District” of Texas); cf. Genetic
    Implant Sys. v. Core-Vent Corp., 
    123 F.3d 1455
    , 1458−59
    (Fed. Cir. 1997) (holding that the licensee of a patent as-
    signee not being incorporated in the forum state did not
    preclude a finding that the assignee “had sufficient mini-
    mum contacts” with a state to support personal jurisdiction
    over the assignee because it nonetheless conducted busi-
    ness there based on its agreement with the licensee that
    had promoted and sold patented “dental implants” in-
    state). Thus, the cease-and-desist letter taken together
    with both of LABOKLIN’s successful efforts to commercial-
    ize by sublicensing the ’114 patent within the United
    States satisfy the “minimum contacts” element of the due
    process inquiry for specific personal jurisdiction.
    As it relates to the third factor of the due process in-
    quiry for specific personal jurisdiction, exercising jurisdic-
    tion over LABOKLIN is “reasonable and fair” because
    LABOKLIN has purposefully availed itself of the benefits
    and protections of U.S. laws through its commercial subli-
    censing as well as its enforcement of a U.S. patent.
    J.A. 348. In assessing such relevant factors as “the forum
    State’s interest in adjudicating the dispute” and “the plain-
    tiff’s interest in obtaining convenient and effective relief,”
    Burger 
    King, 471 U.S. at 477
    , LABOKLIN’s enforcement of
    a U.S. patent, as well as the interest of PPG in determining
    whether it could be potentially liable for infringement,
    weigh in favor of finding jurisdiction reasonable, see Syn-
    
    thes, 563 F.3d at 1299
    (“[T]he United States has a ‘substan-
    tial interest’ in enforcing the federal patent laws.”). This is
    GENETIC VETERINARY SCIENCES v. LABOKLIN GMBH & CO. KG      11
    further supported by the fact that “no other . . . forum is
    available to [PPG] for its . . . claim.” 
    Id. at 1300.
        Moreover, where a defendant’s “activities are shielded
    by the benefits and protections of the forum’s laws it is pre-
    sumptively not unreasonable to require him to submit to
    the burdens of litigation in that forum as well.” Burger
    
    King, 471 U.S. at 476
    (emphasis added) (internal quotation
    marks omitted). Such is the case here. As the District
    Court aptly pointed out, here, “LABO[KLIN] is not merely
    a remote patentee assisting a U.S. company with enforce-
    ment, but instead, it is the U.S. enforcer.” J.A. 310. For
    this reason, the burden placed on LABOKLIN by litigating
    in the United States is outweighed by the other fairness
    factors. See World-Wide 
    Volkswagen, 444 U.S. at 294
    (“[P]rogress in communications and transportation has
    made the defense of a suit in a foreign tribunal less bur-
    densome.” (quoting Hanson v. Denckla, 
    357 U.S. 235
    , 250–
    51 (1958))).
    Appellants argue that “[m]erely sending a [cease-and-
    desist] letter does not create specific personal jurisdiction
    over LABOKLIN,” while relying on Red Wing Shoe Com-
    pany v. Hockerson-Halberstadt and Avocent Huntsville
    Corporation v. Aten International Company for the propo-
    sition that patent enforcement letters cannot provide the
    basis for jurisdiction without “some ‘other activity’ related
    to PPG’s claim [] connect[ing] LABOKLIN to the forum be-
    yond the letter” in a declaratory judgment action. Appel-
    lants’ Br. 18 (first citing Red Wing Shoe, 
    148 F.3d 1355
    ,
    1360 (Fed. Cir. 1998); then citing Avocent, 
    552 F.3d 1324
    ,
    1334 (Fed. Cir. 2008)). This argument fails. As we have
    expressly stated, “Red Wing Shoe and Avocent did not cre-
    ate such a [bright-line] rule, and doing so would contradict
    the Court’s directive to ‘consider a variety of interests’ in
    assessing whether jurisdiction would be fair.” Jack 
    Henry, 910 F.3d at 1206
    (citing Bristol-Myers Squibb Co. v. Supe-
    rior Court of Cal., 
    137 S. Ct. 1773
    , 1780 (2017)). Here, Ap-
    pellants have failed to sufficiently rebut the presumption
    12 GENETIC VETERINARY SCIENCES v. LABOKLIN GMBH & CO. KG
    that personal jurisdiction would be reasonable and fair. As
    we have found above, the factors outlined in Burger King
    favor the establishment of jurisdiction over LABOKLIN.
    Cf. Deprenyl Animal Health, Inc. v. Univ. of Toronto Inno-
    vations Found., 
    297 F.3d 1343
    , 1356 (Fed. Cir. 2002) (“Just
    as a state has a substantial interest in preventing patent
    infringement within its borders, it also has a substantial
    interest in protecting its residents from claims of patent in-
    fringement that may be unwarranted[.]”). Therefore, the
    facts of this case establish that LABOKLIN’s activities sat-
    isfy the minimum contacts requirement without offense to
    due process; thus, personal jurisdiction over LABOKLIN in
    the District Court is reasonable and fair.
    II. Personal and Subject-Matter Jurisdiction Over The
    University
    A. Standard of Review and Legal Standard
    The Foreign Sovereign Immunities Act (“FSIA”) “pro-
    vides the sole basis for obtaining jurisdiction” over a for-
    eign sovereign in the United States. Saudi Arabia v.
    Nelson, 
    507 U.S. 349
    , 355 (1993); see 28 U.S.C. §§ 1330 et.
    seq. In reviewing a district court order regarding subject-
    matter jurisdiction, we apply the standard of review of the
    regional circuit—here the Fourth Circuit—unless the issue
    pertains to or is unique to patent law. Intel Corp. v. Com-
    monwealth Sci. & Indus. Research Org., 
    455 F.3d 1364
    ,
    1369 (Fed. Cir. 2006). The Fourth Circuit reviews the ex-
    istence of sovereign immunity and subject-matter jurisdic-
    tion de novo. In re Tamimi, 
    176 F.3d 274
    , 277 (4th Cir.
    1999). Pursuant to the FSIA, “a foreign state is presump-
    tively immune from the jurisdiction of United States
    courts; unless a specified exception applies, a federal court
    lacks subject-matter jurisdiction over a claim against a for-
    eign state.” 
    Saudi, 507 U.S. at 355
    . Relevant to this ap-
    peal, if a foreign state engages in “commercial
    activity . . . in the United States,” an exception to sovereign
    GENETIC VETERINARY SCIENCES v. LABOKLIN GMBH & CO. KG      13
    immunity applies. 28 U.S.C. § 1605(a)(2). 4 We have stated
    that a defendant’s “acts of (1) obtaining a United States pa-
    tent and then (2) enforcing its patent so it could reap the
    profits thereof—whether by threatening litigation or by
    proffering licenses to putative infringers—certainly” are
    commercial activity. 5 Intel 
    Corp., 455 F.3d at 1370
    . Deter-
    mining whether subject-matter jurisdiction exists “entails
    an application of the substantive terms of the [FSIA] to de-
    termine whether one of the specified exceptions to immun-
    ity applies.” Verlinden B.V. v. Central Bank of Nigeria, 
    461 U.S. 480
    , 498 (1983).
    B. The District Court Had Personal and Subject-Matter
    Jurisdiction over the University
    The District Court held that jurisdiction exists over the
    University because the University is an agent or
    4   Specifically, 28 U.S.C. § 1605(a) provides that:
    A foreign state shall not be immune from the juris-
    diction of courts of the United States or of the
    States in any case . . . (2) in which the action is
    based upon a commercial activity carried on in the
    United States by the foreign state; or upon an act
    performed in the United States in connection with
    a commercial activity of the foreign state else-
    where; or upon an act outside the territory of the
    United States in connection with a commercial ac-
    tivity of the foreign state elsewhere and that act
    causes a direct effect in the United States[.]
    5    “Commercial activity” is “either a regular course of
    commercial conduct or a particular commercial transaction
    or act.” 28 U.S.C. § 1603(d). The FSIA further indicates
    that “[t]he commercial character of an activity shall be de-
    termined by reference to the nature of the course of conduct
    or particular transaction or act, rather than by reference to
    its purpose.” 
    Id. 14 GENETIC
    VETERINARY SCIENCES v. LABOKLIN GMBH & CO. KG
    instrumentality of a foreign state that engaged in commer-
    cial activity sufficient to trigger an exception to immunity
    under § 1605(a)(2) as it had “obtained a [U.S.] patent and
    then threatened PPG by proxy with litigation.” J.A. 314.
    Appellants argue that the University is “presumptively im-
    mune from the jurisdiction of U.S. courts” under the FSIA
    because “the District Court erred in finding that “[the com-
    mercial activity] exception [under the FSIA] applies to the
    University’s immunity.” Appellants’ Br. 23 (capitalizations
    modified). We disagree with Appellants.
    The University cannot claim immunity in the District
    Court because it obtained a U.S. patent and then partici-
    pated in licensing and enforcing the ’114 patent, which con-
    stitutes “commercial activity” under the FSIA. See 28
    U.S.C §§ 1603(d), 1605(a)(2). As an initial matter, the pre-
    sumption of sovereign immunity applies to the University
    because it is undisputedly an “agency or instrumentality of
    a foreign state” here, the Swiss Confederation. J.A. 303;
    see Appellants’ Br. 23. The commercial activity exception
    of § 1605(a)(2), however, provides a basis for jurisdiction
    over the University within U.S. district courts. Here, the
    University obtained a U.S. patent and consented to
    LABOKLIN sending the cease-and-desist letter relating to
    that patent in accordance with the terms of the Licensing
    Agreement. See J.A. 353−54. These actions constitute
    “commercial activity” having a direct effect in the United
    States. See 28 U.S.C §§ 1603(d), 1605(a)(2). By consenting
    to the cease-and-desist letter, the University directly par-
    ticipated in the act of threatening infringement-related lit-
    igation, and did so in order to benefit from this commercial
    activity. The University’s involvement is further under-
    scored by the fact that it had the first option in deciding
    whether to proceed with litigation in the United States,
    and was required to notify LABOKLIN within ninety days
    of the sending of the cease-and-desist letter of its decision
    in that regard.
    GENETIC VETERINARY SCIENCES v. LABOKLIN GMBH & CO. KG       15
    We have found similar conduct to fall under the “com-
    mercial activity” exception to the FSIA jurisdictional im-
    munity. In Intel, we determined that the actions of
    Australia’s national science agency constituted a commer-
    cial exception to jurisdictional immunity because it had ob-
    tained a U.S. patent and sought to enforce it against U.S.
    entities—“whether by threatening litigation or by proffer-
    ing licenses to putative infringers”—so that it “could reap
    the profits 
    thereof.” 455 F.3d at 1370
    . We further recog-
    nized that we had previously held “that ‘a patentee’s at-
    tempt to conduct license negotiations is a commercial
    activity.’” 
    Id. (quoting Phillips
    Plastics Corp. v. Hatsujou
    Kabushiki Kaisha, 
    57 F.3d 1051
    , 1054 (Fed. Cir. 1995), ab-
    rogated on other grounds by MedImmune, Inc. v. Genen-
    tech, Inc., 
    549 U.S. 118
    (2007)). Here, LABOKLIN, on
    behalf of the University, admitted that it “[sought] for PPG
    to either cease its conduct or enter into a licensing agree-
    ment whereby it was a sublicensee of [LABOKLIN].”
    J.A. 348. Contrary to the University’s assertion on appeal,
    it matters not to this analysis that it was LABOKLIN that
    physically wrote and sent the cease-and-desist letter to
    PPG, because the University conceded that it still retained
    substantial rights in the patent, such that the University,
    as the sole “patentee,” ultimately controlled enforcement of
    the ’114 patent. See J.A. 359−61; see also J.A. 360 (“[T]he
    [U]niversity did not transfer all substantial rights.”).
    Moreover, the Supreme Court has held, in the context
    of § 1605(a)(2), that “based on” means that a foreign state’s
    commercial activity forms “those elements of a claim that,
    if proven, would entitle a plaintiff to relief under his theory
    of the case.” Saudi 
    Arabia, 507 U.S. at 357
    . PPG’s lawsuit
    for a declaratory judgment on the ’114 patent is based upon
    the University’s steps to commercialize the ’114 patent’s
    claimed technology by engaging LABOKLIN as an exclu-
    sive licensee and then affirmatively consenting to
    LABOKLIN’s threat of infringement against PPG. See
    J.A. 214−15, 348−49. The University’s conduct can, and
    16 GENETIC VETERINARY SCIENCES v. LABOKLIN GMBH & CO. KG
    here does, qualify under § 1605(a)(2)’s exceptions for “com-
    mercial activity carried on in the United States by the for-
    eign state” or “an act performed in the United States in
    connection with a commercial activity of the foreign state
    elsewhere.” 28 U.S.C. § 1605(a)(2); Republic of Arg. v. Wel-
    tover, Inc., 
    504 U.S. 607
    , 614 (1992) (determining that a
    district court properly asserted jurisdiction under the FSIA
    and stating that actions are determined to be commercial
    if they “are the type of actions by which a private party en-
    gages in trade and traffic or commerce” (internal quotation
    marks omitted)). Accordingly, the commercial activity ex-
    ception to sovereign immunity applies such that the Dis-
    trict Court properly exercised subject-matter jurisdiction
    over the University pursuant to § 1605(a). 6
    DISCUSSION
    Patent Eligibility Under § 101
    I. Standards of Review and Legal Standard
    We apply regional circuit law when “reviewing the
    grant or denial of JMOL,” ABT Sys., LLC v. Emerson Elec.
    Co., 
    797 F.3d 1350
    , 1354 (Fed. Cir. 2015), here, the Fourth
    Circuit. The Fourth Circuit reviews JMOL rulings de novo.
    In re Wildewood Litig., 
    52 F.3d 499
    , 502 (4th Cir. 1995).
    Pursuant to Federal Rule of Civil Procedure 50, before sub-
    mitting the case to a jury during a jury trial and after a
    party is fully heard on an issue, the district court may
    6    Moreover, the University having waived service,
    J.A. 33–34 (evidencing, as part of the District Court’s
    docket report, the issuance and waiver of service of sum-
    mons to and by the University), the District Court’s exer-
    cise of personal jurisdiction over the University was also
    proper, see 28 U.S.C. § 1330(b) (providing that “[p]ersonal
    jurisdiction over a foreign state shall exist as to every claim
    for relief over which the district courts have jurisdiction
    under [§ 1605(a)] where service has been made”).
    GENETIC VETERINARY SCIENCES v. LABOKLIN GMBH & CO. KG      17
    grant JMOL if the court finds “there is no legally sufficient
    evidentiary basis for a reasonable jury to have found for
    that party with respect to that issue.” Fed. R. Civ. P. 50(a).
    “In deciding a JMOL motion, all reasonable inferences [are
    to be drawn] in favor of the nonmoving party without mak-
    ing credibility assessments or weighing the evidence.”
    ABT 
    Sys., 797 F.3d at 1350
    (internal quotation marks and
    citations omitted) (applying the Fourth Circuit standards
    of review when reviewing a §101 challenge).
    “We review issues unique to patent law, including pa-
    tent eligibility under § 101, consistent with our circuit’s
    precedent.” Smart Sys. Innovations, LLC v. Chi. Transit
    Auth., 
    873 F.3d 1364
    , 1367 (Fed. Cir. 2017) (internal quo-
    tation marks and citation omitted). Although a district
    court’s determination of patent eligibility under § 101 is
    typically an issue of law, which we review de novo, see In-
    tellectual Ventures I LLC v. Erie Indem. Co., 
    850 F.3d 1315
    ,
    1325 (Fed. Cir. 2017), “[t]he patent eligibility inquiry may
    contain underlying issues of fact,” Berkheimer v. HP Inc.,
    
    881 F.3d 1360
    , 1365 (Fed. Cir. 2018).
    “Whoever invents or discovers any new and useful pro-
    cess, machine, manufacture, or composition of matter, or
    any new and useful improvement thereof, may obtain a pa-
    tent therefor, subject to the conditions and requirements
    of” Title 35 of the United States Code. 35 U.S.C. § 101.
    “The Supreme Court, however, has long interpreted § 101
    and its statutory predecessors to contain an implicit excep-
    tion: ‘laws of nature, natural phenomena, and abstract
    ideas’ are not patentable.” Content Extraction & Transmis-
    sion LLC v. Wells Fargo Bank, Nat’l Ass’n, 
    776 F.3d 1343
    ,
    1346 (Fed. Cir. 2014) (quoting Alice Corp. Pty. Ltd. v. CLS
    Bank Int’l, 
    573 U.S. 208
    , 217 (2014)).
    The Supreme Court’s Alice and Mayo Collaborative
    Services v. Prometheus Laboratories, Inc. decisions provide
    the two-stage framework by which we assess patent
    18 GENETIC VETERINARY SCIENCES v. LABOKLIN GMBH & CO. KG
    eligibility under § 101. 
    See 573 U.S. at 216
    −18; 
    566 U.S. 66
    , 70−80 (2012). A patent
    claim falls outside § 101 where (1) it is “directed to”
    a patent-ineligible concept, i.e., a law of nature,
    natural phenomenon, or abstract idea, and (2), if
    so, the particular elements of the claim, considered
    “both individually and ‘as an ordered combina-
    tion,’” do not add enough to “‘transform the nature
    of the claim’ into a patent-eligible application.”
    Elec. Power Grp., LLC v. Alstom S.A., 
    830 F.3d 1350
    , 1353
    (Fed. Cir. 2016) (quoting 
    Alice, 573 U.S. at 217
    ). It is
    against this framework that we analyze the Asserted
    Claims.
    II. The Asserted Claims
    Entitled “Method of Determining the Genotype Relat-
    ing to Hereditary Nasal Parakeratosis [(‘HNPK’)] and Nu-
    cleic Acids Usable in Said Method,” the ’114 patent
    generally relates to in vitro methods for genotyping Labra-
    dor Retrievers, in order to discover whether the dog might
    be a genetic carrier of the disease HNPK. See ’114 patent
    col. 1 ll. 15−20. HNPK is a disease that causes “crusts and
    fissur[es]” to appear on the nose of dogs “at a young age,”
    but the dogs are otherwise considered healthy. 
    Id. col. 1
    ll.
    27−28. HNPK is a “recessive” condition that only passes to
    a puppy when both of the dog’s parents are “carriers” of the
    gene that causes HNPK. 
    Id. col. 1
    ll. 34, 38−39. Therefore,
    “a genetic test method that can discriminate the three gen-
    otypes” of “free,” “carrier,” and “affected” is “highly valua-
    ble for dog breeding as well as for veterinary medicine to
    confirm the diagnosis of suspicious cases.” 
    Id. col. 1
    ll.
    46−50; see 
    id. Abstract (“The
    invention also concerns poly-
    peptide[-]based methods for determining said disorder.
    Further, nucleic acids, polypeptides and antibodies usable
    in said method are disclosed.”). The ’114 patent describes
    how the University’s professor discovered that the presence
    GENETIC VETERINARY SCIENCES v. LABOKLIN GMBH & CO. KG     19
    of HNPK in Labrador Retrievers resulted from a point mu-
    tation in gene SUV39H2. See 
    id. col. 7
    ll. 8−21.
    Claims 1−3 of the ’114 patent recite:
    1. An in vitro method for genotyping a Labrador
    Retriever comprising:
    a) obtaining a biological sample from the
    Labrador Retriever;
    b) genotyping a SUV39H2 gene encoding
    the polypeptide of SEQ ID NO: 1[;] and
    c) detecting the presence of a replacement
    of a nucleotide T with a nucleotide G at po-
    sition 972 of SEQ ID NO: 2.
    2. The method according to claim 1, wherein the
    genotyping is achieved by [polymerase chain reac-
    tion (“PCR”)], real-time PCR, melting point analy-
    sis of double-stranded DNA, mass spectroscopy,
    direct DNA sequencing, restriction fragment
    length polymorphism (RFLP), single strand confor-
    mation polymorphism (SSCP), high performance
    liquid chromatography (HPLC), or single base pri-
    mer extension.
    3. The method of claim 1, wherein the genotyping
    utilizes a primer pair compris[ed] of a first primer
    and a second primer, each compromising a contig-
    uous span of at least 14 nucleotides of the sequence
    SEQ ID NO: 2 or a sequence complementary
    thereto, wherein:
    a) said first primer hybridizes to a first
    DNA strand of the SUV39H2 gene;
    b) said second primer hybridizes to the
    strand complementary to said first DNA
    strand of the SUV39H2 gene; and
    20 GENETIC VETERINARY SCIENCES v. LABOKLIN GMBH & CO. KG
    c) the 3’ ends of said first and second pri-
    mers are located on regions flanking the po-
    sition 972 of SEQ ID NO: 2, or of nucleotide
    positions complementary thereto.
    
    Id. col. 1
    5 l. 11−col. 16 l. 14.
    III. The District Court Did Not Err in Granting JMOL Be-
    cause It Correctly Determined that the Asserted Claims
    Are Patent-Ineligible Under § 101
    A. The Asserted Claims Are Directed to a Natural Phe-
    nomenon
    The District Court held that the Asserted Claims, both
    individually and in combination, are “directed to patent in-
    eligible subject matter, namely the discovery of the genetic
    mutation that is linked to HNPK.” Genetic 
    Veterinary, 314 F. Supp. 3d at 730
    . Appellants argue that the Asserted
    Claims “are directed to a patent-eligible application” of the
    discovery of the “underlying natural phenomenon” because
    the Asserted Claims “claim a man-made laboratory proce-
    dure.” Appellants’ Br. 37−38. They further contend that
    “[n]o one in the industry was even studying the SUV39H2
    gene, let alone developing genotyping methods for Labra-
    dor Retrievers.” 
    Id. at 45.
    We disagree with Appellants.
    We begin our analysis by examining previous eligibility
    determinations. See, e.g., 
    Mayo, 566 U.S. at 72
    , 74−77
    (evaluating eligibility by comparing the challenged claims
    “in light of the Court’s precedents” and holding that the
    claims were directed to the relationship between the con-
    centration of metabolites in the blood and the likelihood
    that a drug dose will be ineffective, which it referred to as
    a law of nature). We have applied the Supreme Court’s
    guidance in Alice and Mayo to find claims “directed to a
    patent-ineligible concept when they amounted to nothing
    more than observing or identifying the ineligible concept
    itself.” Rapid Litig. Mgmt. v. CellzDirect, Inc., 
    827 F.3d 1042
    , 1048 (Fed. Cir. 2016) (internal quotation marks
    GENETIC VETERINARY SCIENCES v. LABOKLIN GMBH & CO. KG        21
    omitted). For example, in Ariosa Diagnostics, Inc. v. Se-
    quenom, Inc., we held that claims reciting methods for de-
    tecting paternally inherited cell-free fetal DNA (“cffDNA”)
    mutations were directed to a patent-ineligible law of na-
    ture because they were “generally directed to detecting the
    presence of a naturally occurring thing or a natural phe-
    nomenon, cffDNA in maternal plasma or serum.” 
    788 F.3d 1371
    , 1376 (Fed. Cir. 2015). Similarly, in In re BRCA1- &
    BRCA2-Based Hereditary Cancer Test Patent Litigation,
    we concluded that the claims were directed to a patent-in-
    eligible law of nature because the claims’ “methods, di-
    rected to identification of alterations of the gene, require[d]
    merely comparing the patient’s gene with the wild-type
    gene and identifying any differences that ar[o]se.” 
    774 F.3d 755
    , 763 (Fed. Cir. 2014). In each of these cases, “the
    end result of the process, the essence of the whole, was a
    patent-ineligible concept.” 
    CellzDirect, 827 F.3d at 1048
    .
    In contrast, we held that the claims in CellzDirect were
    not directed to “an observation or detection of the ability of
    [liver cells] to survive multiple freeze thaw cycles” but, in-
    stead, were directed to a “new and improved technique[] for
    producing a tangible and useful result,” i.e., preserving
    those cells for later use. 
    Id. at 1048,
    1050. Therefore, we
    recognized that the claims fell “squarely outside those cat-
    egories of inventions that are directed to patent-ineligible
    concepts.” 
    Id. at 1050
    (internal quotation marks omitted).
    Similarly, in Vanda Pharmaceuticals, Inc. v. West-Ward
    Pharmaceuticals International Ltd., we held that a claimed
    method of treating schizophrenia with the drug iloperidone
    was directed to patent-eligible subject matter because it
    taught “a specific method of treatment for specific patients
    using a specific compound at specific doses to achieve a spe-
    cific outcome.” 
    887 F.3d 1117
    , 1136 (Fed. Cir. 2018) (em-
    phases added). There, the representative claim taught “‘a
    new way of using an existing drug’ that is safer for pa-
    tients,” 
    id. at 1135,
    specifically involving the steps of deter-
    mining a particular genotype in a patient and then
    22 GENETIC VETERINARY SCIENCES v. LABOKLIN GMBH & CO. KG
    “administering specific dose ranges” of the drug based on
    that genotype, 
    id. at 1134.
    Finally, in Natural Alternatives
    International, Inc. v. Creative Compounds, LLC, we held
    that a patent claiming methods for use of dietary supple-
    ments, dietary supplements, and uses of beta-alanine in
    manufacturing a human dietary supplement to increase
    the anaerobic working capacity of muscle and other tissue
    was directed to patent-eligible subject matter. 
    918 F.3d 1338
    , 1346–47 (Fed. Cir. 2019). We explained that the
    claims were not directed to a law of nature or a natural
    product because the claims “require[d that] specific
    [claimed] steps be taken in order to bring about a change
    in a subject, altering the subject’s natural state.” 
    Id. at 1345.
        Here, the Asserted Claims are not directed to a new
    and useful method for discovery because they begin and
    end with the point discovery of the HNPK mutation in the
    SUV39H2 gene. See, e.g., 
    Ariosa, 788 F.3d at 1380
    (“We do
    not disagree that detecting cffDNA in maternal plasma or
    serum that before was discarded as waste material is a pos-
    itive and valuable contribution to science. But even such
    valuable contributions can fall short of statutory patenta-
    ble subject matter[.]”). The parties do not dispute that the
    mutation itself is a naturally occurring phenomenon. See
    Appellants’ Br. 39; Appellee’s Br. 37.
    Looking to the claim language, claim 1 breaks down,
    into three parts, the “in vitro method for genotyping a Lab-
    rador Retriever” 7 for detection of this mutation. ’114 pa-
    tent col. 15 l. 11. As explained by the parties’ experts, first,
    7   The scientific term “in vitro means outside of the
    main organism . . . in a petri dish or in a test tube,”
    J.A. 1365 (deposition testimony of PPG’s expert), and “gen-
    otyping . . . refers to determining the order or the composi-
    tion of the nucleotides or bases in DNA,” J.A. 1493
    (deposition testimony of LABOKLIN’s expert).
    GENETIC VETERINARY SCIENCES v. LABOKLIN GMBH & CO. KG       23
    step (a) “obtaining a biological sample” requires a sample
    of DNA from a dog, which both parties’ experts testified
    usually requires obtaining a blood sample or cheek swab
    from the dog, see J.A. 1366, 1493; second, step (b) “genotyp-
    ing a SUV39H2 gene encoding the polypeptide of SEQ ID
    NO: 1,” identifies the location of the genetic mutation, see
    J.A. 1496; and third, step (c) “detect[ing] the presence of a
    replacement of a nucleotide” at a specific base pair position
    identifies the location of the equivalent normal gene, see
    J.A. 1496, 1598; see also ’114 patent col. 15 ll. 14−19. In
    other words, claim 1 simply states that the search for the
    mutation involves the laboratory examination of Labrador
    Retriever DNA, which resulted in the revelation of the mu-
    tation. See 
    id. col. 15
    ll. 11−19. The mutation location itself
    and the fact that it is inherited through male and female
    dog carriers mating are both natural phenomena. See
    Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 
    569 U.S. 576
    , 590 (2013) (“Myriad did not create or alter any of
    the genetic information encoded in the BRCA1 and BRCA2
    genes. The location and order of the nucleotides existed in
    nature before Myriad found them.”). Taken together, the
    plain language of claim 1 demonstrates that it is directed
    to nothing more than “observing or identifying” the natural
    phenomenon of a mutation in the SUV39H2 gene. See
    
    CellzDirect, 827 F.3d at 1048
    . Claims 2 and 3 depend from
    independent claim 1 and add only generic methods of de-
    tecting the natural phenomenon. Thus, the Asserted
    Claims are directed to natural phenomenon at Alice step
    one.
    B. The Asserted Claims Do Not Recite an Inventive Con-
    cept
    Because the Asserted Claims are directed to a natural
    phenomenon, the second step of the Alice § 101 analysis re-
    quires us to determine whether the subject patent’s
    claims—when viewed individually and as an ordered com-
    bination of elements—contain “an inventive concept suffi-
    cient to transform the claimed [natural law] into a patent-
    24 GENETIC VETERINARY SCIENCES v. LABOKLIN GMBH & CO. KG
    eligible application.” 
    Alice, 573 U.S. at 221
    (internal quo-
    tation marks omitted). A claim contains an inventive con-
    cept if it “include[s] additional features,” 
    id., that are
    more
    than “well-understood, routine, [or] conventional activi-
    ties,” 
    id. at 225
    (internal quotation marks, brackets, and
    citations omitted).
    The District Court determined “the additional steps
    and claims [of the ’114 patent]” lack “any inventive concept
    to transform it from patent ineligible subject matter to pa-
    tent eligible subject matter.” Genetic Veterinary, 314 F.
    Supp. 3d at 733. Appellants argue that “the claimed meth-
    ods . . . apply a new discovery” of the SUV39H2 gene and
    develop novel “genotyping methods for Labrador Retriev-
    ers.” Appellants’ Br. 45. We disagree with Appellants.
    The Asserted Claims do not recite an inventive concept
    that transforms the observation of a natural phenomenon
    into a patentable invention. Nothing in claim 1’s language
    suggests the invention of a new method for genotyping. See
    ’114 patent col. 15 l. 16 (claiming “genotyping” but not ex-
    plaining specific steps of how to genotype). Rather, instruc-
    tive to our analysis is that LABOKLIN’s expert agreed that
    the genotyping method in claim 1 uses conventional or
    known laboratory techniques to observe the newly discov-
    ered mutation in the SUV39H2 at position 972. See, e.g.,
    J.A. 1520 (agreeing with counsel that claim 1 is “not talk-
    ing about a particular way to genotype the [SUV39H2]
    gene encoding”). Conducting conventional detection in a
    laboratory does not transform the discovery of a natural
    phenomenon into patent eligible subject matter. Rather,
    similar to the claims at issue in Mayo, a natural phenome-
    non, together with well-understood, conventional activity,
    is not patent-eligible under § 101. See 
    Mayo, 566 U.S. at 73
    , 79–80.
    Claims 2 and 3 also do not move the natural phenome-
    non into eligible § 101 territory. For example, claim 2 lim-
    its the method of claim 1 to specific techniques, including
    GENETIC VETERINARY SCIENCES v. LABOKLIN GMBH & CO. KG      25
    “genotyping achieved by PCR, [and] real-time PCR,” see
    ’114 patent col. 15 l. 21; however, we have recognized that
    laboratory techniques, such as using “[PCRs] to amplify
    and detect cffDNA,” are well-understood, routine, conven-
    tional activities in the life sciences when they are claimed
    in a merely generic manner (e.g., at a high level of general-
    ity) or as insignificant extra-solution activity, Genetic
    Techs. v. Merial LLC, 
    818 F.3d 1369
    , 1377–78 (Fed. Cir.
    2016); see 
    id. at 1379–80
    (finding claims patent-ineligible
    and stating that the physical steps of “detecting a coding
    region of a person’s genome by amplifying and analyzing a
    linked non-coding region of that person’s genome” did not
    provide an inventive concept necessary to render the claim
    patent-eligible). Additionally, LABOKLIN’s expert con-
    firmed that claim 2 contained techniques that “have been
    around for years,” J.A. 1521, and had no specific order or
    requirement to use these techniques a particular way, see
    J.A. 1526−27; see also J.A. 1368–75, 1429, 1490–91, 1498.
    As for claim 3, which recites “utiliz[ing] a primer pair” as
    the means for locating the mutation, ’114 patent col. 15
    l. 28, LABOKLIN’s expert testified that while he had never
    used primer pairs to genotype base pair position 972 in the
    SUV39H2 gene, primer pairs is a “decades old” technique
    “just like boiling or baking,” J.A. 1528−29. As the Supreme
    Court explained in Mayo, “simply appending conventional
    steps, specified at a high level of generality, to laws of na-
    ture, natural phenomena, and abstract ideas cannot make
    those laws, phenomena, and ideas patentable.” 
    Mayo, 566 U.S. at 82
    . Therefore, the Asserted Claims are patent-
    ineligible at Alice step two.
    We are unpersuaded by Appellants’ primary counter-
    argument that the District Court erred because the As-
    serted Claims “do not merely recite the underlying natural
    phenomenon, the causative mutation of HNPK, but instead
    recite a particular application of that discovery.” Appel-
    lants’ Br. 39. Appellants argue further that the “claimed
    steps of obtaining a biological sample, genotyping a
    26 GENETIC VETERINARY SCIENCES v. LABOKLIN GMBH & CO. KG
    SUV39H2 gene, and detecting the presence of the replace-
    ment nucleotide do not recite or even mention the correla-
    tion between the point mutation and HNPK.”                  
    Id. Appellants rely
    heavily upon our precedent in CellzDirect,
    to argue that “[s]imilar to the inventors in CellzDirect, [the
    ’114 patentee] discovered that the existence of the replace-
    ment nucleotide at position 972 of a specific gene indicates
    [that] the Labrador Retriever is a carrier of HNPK.” 
    Id. at 40
    (citing 827 F.3d at 1052
    ). However, any reliance on
    CellzDirect is misguided. As we stated above, the claims at
    issue in CellzDirect were directed to a “new and improved
    technique[] for producing a tangible and useful result,” i.e.,
    preserving those cells for later use. 
    CellzDirect, 827 F.3d at 1048
    . Here, the Asserted Claims provide no tangible re-
    sult save the observation and detection of a mutation in a
    dog’s DNA. While a positive and valuable contribution,
    these claims fall short of statutory patentable subject mat-
    ter.
    CONCLUSION
    We have considered the parties’ remaining arguments
    and find them unpersuasive. Accordingly, the Final Judg-
    ment of the U.S. District Court for the Eastern District of
    Virginia is
    AFFIRMED
    

Document Info

Docket Number: 2018-2056

Citation Numbers: 933 F.3d 1302

Judges: Wallach, Hughes, Stoll

Filed Date: 7/29/2019

Precedential Status: Precedential

Modified Date: 10/19/2024

Authorities (19)

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Deprenyl Animal Health, Inc. v. The University of Toronto ... , 297 F.3d 1343 ( 2002 )

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George Pieczenik and I C Technologies America, Inc. v. Dyax ... , 265 F.3d 1329 ( 2001 )

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