Case 1:22-cv-00458-UNA Document 1 Filed 04/06/22 Page 1 of 14 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`QIAGEN HAMBURG GMBH and QIAGEN,
`LLC,
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`Plaintiffs,
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`v.
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`Civil Action No. __________________
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`JURY TRIAL DEMANDED
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`BIO-RAD LABORATORIES, INC.,
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`Defendant.
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`COMPLAINT FOR DECLARATORY JUDGMENT
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`Plaintiffs QIAGEN Hamburg GmbH and QIAGEN, LLC, by and through their
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`undersigned counsel, file this Complaint for Declaratory Judgment against Bio-Rad Laboratories,
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`Inc., and allege as follows:
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`NATURE OF THE ACTION
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`1.
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`This is an action for declaratory judgment of non-infringement arising under the
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`patent laws of the United States, Title 35 of the United States Code. Plaintiffs QIAGEN Hamburg
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`GmbH and QIAGEN, LLC (collectively “QIAGEN”) request this relief because Defendant Bio-
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`Rad Laboratories, Inc. (“Bio-Rad”) has threatened QIAGEN1 and claimed that QIAGEN infringes
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`United States Patent Nos. RE41780 (the “’780 patent”) (Exhibit A), 10,782,226 (the “’226 patent”)
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`(Exhibit B), 10,921,237 (the “’237 patent”) (Exhibit C), 11,073,468 (the “’468 patent”) (Exhibit
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`1 The threat was to QIAGEN Hamburg GmbH; however, it concerned products sold by QIAGEN,
`LLC, therefore QIAGEN, LLC joins this lawsuit as a co-plaintiff.
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`1
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`D), 11,231,355 (the “’355 patent”) (Exhibit E) and 11,237,096 (the “’096 patent) (Exhibit F)
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`(collectively, the “Bio-Rad patents”).
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`2.
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`QIAGEN provides sampling and assay products for a variety of molecular biology
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`applications.
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`3.
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`One of these products is QIAGEN’s QIAcuity® Digital Polymerase Chain Reaction
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`(“PCR”) system. PCR is a biochemical method of amplifying a particular strand of target DNA
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`and tagging it with a fluorescent marker. Amplification of the target DNA and its subsequent
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`tagging then allows the detection and measurement of very small initial concentrations of DNA.
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`PCR has medical and research applications. The QIAcuity system in particular delivers precise,
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`comprehensive, and rapid results. Among other uses, it has recently found a use in 48 out of 50
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`states in testing municipal wastewater for signs of COVID-19. Testing municipal wastewater
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`assists public health officials in tracking, tracing, and treating COVID-19 infections.
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`4.
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`Bio-Rad is a company that also manufactures a variety of biochemical and
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`biomedical research and diagnostic tools.
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`5.
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`On May 27, 2021, Bio-Rad sent QIAGEN a letter accusing QIAGEN’s QIAcuity
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`system of practicing “at least” the ’780, ’226, and ’237 patents. See May 27, 2021 Letter, Exhibit
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`G at 1. The letter stated that Bio-Rad believed that “Qiagen’s QIAcuity® Digital PCR System
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`utilizes Bio-Rad’s patented technology without authorization.” Id. at 3.
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`6.
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`On February 10, 2022, Bio-Rad sent QIAGEN another letter escalating the dispute.
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`In that letter, Bio-Rad reasserted the patents identified in the first letter, and further accused
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`QIAGEN of practicing the newly issued ’468, ’355, and ’096 patents.
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`7.
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`QIAGEN has denied that it infringes any claims of the Bio-Rad patents.
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`2
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`8.
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`Since Bio-Rad sent its initial letter to QIAGEN, the parties have attempted to
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`negotiate and settle the issues outside of court. However, it has become clear that the parties
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`cannot resolve this issue without court assistance, and QIAGEN believes further discussions would
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`be futile in their current form. Due to the imminent threat of a lawsuit being brought against it,
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`QIAGEN files suit in Delaware, the state in which Bio-Rad is incorporated.
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`THE PARTIES
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`9.
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`QIAGEN Hamburg GmbH is a Gesellschaft mit beschränkter Haftung (“GmbH”)
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`(a company with limited liability) headquartered in Monheim am Rhein, North Rhine-Westphalia
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`in the Federal Republic of Germany.
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`10.
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`QIAGEN, LLC is a California limited liability company with an office at 1700
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`Seaport Blvd Ste 300, Redwood City, CA 94063.
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`11.
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`On information and belief, Defendant Bio-Rad is a Delaware corporation with its
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`principal place of business at 800 Alfred Nobel Dr., Hercules, California. Upon information and
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`belief, Bio-Rad has consented to and agreed that the courts of Delaware have jurisdiction to resolve
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`disputes between itself and other parties.
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`JURISDICTION AND VENUE
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`12.
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`This action arises under the Declaratory Judgment Act, 28 U.S.C. § 2201, and under
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`the patent laws of the United States, 35 U.S.C. § 1 et seq.
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`13.
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`This Court has subject matter jurisdiction over this action under 28 U.S.C. §§ 1331,
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`1332, 1338, 2201, and 2202 because this Court has exclusive jurisdiction over declaratory
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`judgment claims arising under the patent laws of the United States pursuant to 28 U.S.C. §§ 1332,
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`1338, 2201, and 2202.
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`3
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`14.
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`Bio-Rad is subject to general jurisdiction in Delaware because it is a Delaware
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`Corporation. It is subject to specific personal jurisdiction in this judicial district based upon its
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`purposeful, systematic, and continuous contacts with Delaware.
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`15.
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`This Court can provide the declaratory relief brought in this Declaratory Judgment
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`Complaint because an actual case and controversy exists between the parties within the scope of
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`this Court’s jurisdiction pursuant to 28 U.S.C. § 2201. An actual case and controversy exists at
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`least because QIAGEN does not infringe and has not infringed any of the claims of the Bio-Rad
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`patents, and Bio-Rad has accused QIAGEN of infringing the Bio-Rad patents. Bio-Rad’s actions
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`have created a real, live, immediate, and justiciable case or controversy between Bio-Rad and
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`QIAGEN. Bio-Rad has taken the affirmative act to enforce its purported patent rights by explicitly
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`alleging that QIAGEN is infringing its patents. QIAGEN alleges, upon information and belief,
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`that Bio-Rad is attempting to assert or license the Bio-Rad patents against others as well.
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`16.
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`Venue is proper in this judicial district pursuant to 28 U.S.C. §§ 1391 and 1400,
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`including because venue in declaratory judgment actions for non-infringement of patents is
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`determined under the general venue statute, 28 U.S.C. § 1391.
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`17.
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`Under 28 U.S.C. § 1391(b)(1), venue is proper in any judicial district where a
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`defendant resides. Because Bio-Rad is incorporated in this District, Bio-Rad resides in the District
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`of Delaware and venue is proper under 28 U.S.C. § 1391.
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`THE ASSERTED PATENTS
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`18.
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`On September 28, 2010, the United States Patent and Trademark Office (the “Patent
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`Office”) issued the ’780 patent, entitled “Chemical Amplification Based on Fluid Partitioning in
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`an Immiscible Liquid” to Brian L. Anderson, Bill W. Colston, and Christopher J. Elkin. A true
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`and correct copy of the ’780 patent is attached as Exhibit A. On information and belief, Bio-Rad
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`purports to be the owner by assignment or the exclusive licensee of the ’780 patent.
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`4
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`19.
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`The ’780 patent is a reissue of United States Patent No. 7,041,481, which issued on
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`May 9, 2006 from U.S. Patent Application No. 10/389,130 filed on March 14, 2003.
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`20.
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`On September 22, 2020, the Patent Office issued the ’226 patent, entitled “Cell
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`Capture System and Method of Use” to Kalyan Handique. A true and correct copy of the ’226
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`patent is attached as Exhibit B. On information and belief, Bio-Rad purports to own by assignment
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`the ’226 patent.
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`21.
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`The ’226 patent issued from U.S. Patent Application No. 16/929,427 filed on July
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`15, 2020.
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`22.
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` On February 16, 2021, the Patent Office issued the ’237 patent, entitled “Cell
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`Capture System and Method of Use” to Kalyan Handique. A true and correct copy of the ’237
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`patent is attached as Exhibit C. On information and belief, Bio-Rad purports to own by assignment
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`the ’237 patent.
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`23.
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`The ’237 patent issued from U.S. Patent Application No. 17/005,611 filed on
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`August 28, 2020.
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`24.
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`On July 27, 2021, the Patent Office issued the ’468 patent, entitled “Cell Capture
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`System and Method of Use” to Kalyan Handique. A true and correct copy of the ’468 patent is
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`attached as Exhibit D. On information and belief, Bio-Rad purports to own by assignment the
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`’468 patent.
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`25.
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`The ’468 patent issued from U.S. Patent Application No. 17/005,159 filed on
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`August 27, 2020.
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`26.
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`On January 25, 2022, the Patent Office issued the ’355 patent, entitled “Cell
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`Capture System and Method of Use” to Kalyan Handique. A true and correct copy of the ’355
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`5
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`patent is attached as Exhibit E. On information and belief, Bio-Rad purports to own by assignment
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`the ’355 patent.
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`27.
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`The ’355 patent issued from U.S. Patent Application No. 17/241,897 filed on April
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`27, 2021.
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`28.
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`On February 1, 2022, the Patent Office issued the ’096 patent, entitled “Cell
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`Capture System and Method of Use” to Kalyan Handique. A true and correct copy of the ’096
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`patent is attached as Exhibit F. On information and belief, Bio-Rad purports to own by assignment
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`the ’096 patent.
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`29.
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`The ’096 patent issued from U.S. Patent Application No. 17/387,716 filed on July
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`28, 2021.
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`FIRST CLAIM FOR RELIEF
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`(Declaratory Judgment that QIAGEN Does Not Infringe the ’780 Patent)
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`30.
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`QIAGEN repeats and realleges each and every allegation contained in paragraphs
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`1 through 29 of this Complaint as if fully set forth herein.
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`31.
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`In view of the facts and allegations set forth above, there is an actual, justiciable,
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`substantial, and immediate controversy between QIAGEN and Bio-Rad regarding whether
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`QIAGEN infringes any claim of the ’780 patent.
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`32.
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`Bio-Rad has alleged and continues to allege that products made, used, or sold by
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`QIAGEN, or QIAGEN products that utilize certain methods of use, are covered by the claims of
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`the ’780 patent, and has threatened to commence litigation against QIAGEN regarding this matter.
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`33.
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`QIAGEN contends that it has not infringed and does not infringe, induce
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`infringement, or contribute to the infringement of any valid or enforceable claim of the ’780 patent.
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`QIAGEN has not made, used, sold, offered for sale, or imported any products that literally infringe,
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`directly or indirectly, each and every claim of the ’780 patent.
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`6
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`34.
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`For example, and without limitation, QIAGEN’s accused product does not practice
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`the limitation “means for partitioning said sample into partitioned sections, wherein said means
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`for partitioning said sample into partitioned sections comprises an injection orifice,” of claim 1.
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`35.
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`Therefore, a substantial controversy exists between QIAGEN and Bio-Rad, parties
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`having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a
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`declaratory judgment that QIAGEN has not infringed and does not infringe any valid or
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`enforceable claim of the ’780 patent.
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`36.
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`An actual and justiciable controversy exists between QIAGEN and Bio-Rad as to
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`whether QIAGEN’s products infringe the ’780 patent. QIAGEN accordingly requests a judicial
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`determination of its rights, duties, and obligations regarding the ’780 patent.
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`37.
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`A judicial declaration is necessary and appropriate so that QIAGEN may ascertain
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`its rights regarding the ’780 patent.
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`SECOND CLAIM FOR RELIEF
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`(Declaratory Judgment that QIAGEN Does Not Infringe the ’226 Patent)
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`38.
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`QIAGEN repeats and realleges each and every allegation contained in paragraphs
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`1 through 29 of this Complaint as if fully set forth herein.
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`39.
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`In view of the facts and allegations set forth above, there is an actual, justiciable,
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`substantial, and immediate controversy between QIAGEN and Bio-Rad regarding whether
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`QIAGEN infringes any claim of the ’226 patent.
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`40.
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`Bio-Rad has alleged and continues to allege that products made, used, or sold by
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`QIAGEN, or QIAGEN products that utilize certain methods of use, are covered by the claims of
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`the ’226 patent, and has threatened to commence litigation against QIAGEN regarding this matter.
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`41.
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`QIAGEN contends that it has not infringed and does not infringe, induce
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`infringement, or contribute to the infringement of any valid or enforceable claim of the ’226 patent.
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`7
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`QIAGEN has not made, used, sold, offered for sale, or imported any products that literally infringe,
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`directly or indirectly, each and every claim of the ’226 patent.
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`42.
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`For example, and without limitation, QIAGEN’s accused product does not practice
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`the limitation “an outlet channel positioned downstream of the set of chambers and fluidly coupled
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`to the set of chambers, wherein fluid from the inlet channel reaches the outlet channel only by way
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`of the set of chambers” of claim 1.
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`43.
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`Therefore, a substantial controversy exists between QIAGEN and Bio-Rad, parties
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`having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a
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`declaratory judgment that QIAGEN has not infringed and does not infringe any valid or
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`enforceable claim of the ’226 patent.
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`44.
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`An actual and justiciable controversy exists between QIAGEN and Bio-Rad as to
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`whether QIAGEN’s products infringe the ’226 patent. QIAGEN accordingly requests a judicial
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`determination of its rights, duties, and obligations regarding the ’226 patent.
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`45.
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`A judicial declaration is necessary and appropriate so that QIAGEN may ascertain
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`its rights regarding the ’226 patent.
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`THIRD CLAIM FOR RELIEF
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`(Declaratory Judgment that QIAGEN Does Not Infringe the ’237 Patent)
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`46.
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`QIAGEN repeats and realleges each and every allegation contained in paragraphs
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`1 through 29 of this Complaint as if fully set forth herein.
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`47.
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`In view of the facts and allegations set forth above, there is an actual, justiciable,
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`substantial, and immediate controversy between QIAGEN and Bio-Rad regarding whether
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`QIAGEN infringes any claim of the ’237 patent.
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`8
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`48.
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`Bio-Rad has alleged and continues to allege that products made, used, or sold by
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`QIAGEN, or QIAGEN products that utilize certain methods of use, are covered by the claims of
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`the ’237 patent, and has threatened to commence litigation against QIAGEN regarding this matter.
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`49.
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`QIAGEN contends that it has not infringed and does not infringe, induce
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`infringement, or contribute to the infringement of any valid or enforceable claim of the ’237 patent.
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`QIAGEN has not made, used, sold, offered for sale, or imported any products that literally infringe,
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`directly or indirectly, each and every claim of the ’237 patent.
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`50.
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`For example, and without limitation, QIAGEN’s accused product does not practice
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`the limitation “an outlet channel positioned downstream of the set of chambers and fluidly coupled
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`to the set of chambers, wherein fluid from the inlet channel reaches the outlet channel only by way
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`of the set of chambers” of claim 1.
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`51.
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`Therefore, a substantial controversy exists between QIAGEN and Bio-Rad, parties
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`having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a
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`declaratory judgment that QIAGEN has not infringed and does not infringe any valid or
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`enforceable claim of the ’237 patent.
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`52.
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`An actual and justiciable controversy exists between QIAGEN and Bio-Rad as to
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`whether QIAGEN’s products infringe the ’237 patent. QIAGEN accordingly requests a judicial
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`determination of its rights, duties, and obligations regarding the ’237 patent.
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`53.
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`A judicial declaration is necessary and appropriate so that QIAGEN may ascertain
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`its rights regarding the ’237 patent.
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`FOURTH CLAIM FOR RELIEF
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`(Declaratory Judgment that QIAGEN Does Not Infringe the ’468 Patent)
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`54.
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`QIAGEN repeats and realleges each and every allegation contained in paragraphs
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`1 through 29 of this Complaint as if fully set forth herein.
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`9
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`55.
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`In view of the facts and allegations set forth above, there is an actual, justiciable,
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`substantial, and immediate controversy between QIAGEN and Bio-Rad regarding whether
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`QIAGEN infringes any claim of the ’468 patent.
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`56.
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`Bio-Rad has alleged and continues to allege that products made, used, or sold by
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`QIAGEN, or QIAGEN products that utilize certain methods of use, are covered by the claims of
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`the ’468 patent, and has threatened to commence litigation against QIAGEN regarding this matter.
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`57.
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`QIAGEN contends that it has not infringed and does not infringe, induce
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`infringement, or contribute to the infringement of any valid or enforceable claim of the ’468 patent.
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`QIAGEN has not made, used, sold, offered for sale, or imported any products that literally infringe,
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`directly or indirectly, each and every claim of the ’468 patent.
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`58.
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`For example, and without limitation, QIAGEN’s accused product does not practice
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`the limitation “an outlet channel positioned downstream of the set of chambers and fluidly coupled
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`to the set of chambers, wherein fluid from the inlet channel reaches the outlet channel only by way
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`of the set of chambers” of claim 1.
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`59.
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`Therefore, a substantial controversy exists between QIAGEN and Bio-Rad, parties
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`having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a
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`declaratory judgment that QIAGEN has not infringed and does not infringe any valid or
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`enforceable claim of the ’468 patent.
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`60.
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`An actual and justiciable controversy exists between QIAGEN and Bio-Rad as to
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`whether QIAGEN’s products infringe the ’468 patent. QIAGEN accordingly requests a judicial
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`determination of its rights, duties, and obligations regarding the ’468 patent.
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`61.
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`A judicial declaration is necessary and appropriate so that QIAGEN may ascertain
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`its rights regarding the ’468 patent.
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`10
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`FIFTH CLAIM FOR RELIEF
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`(Declaratory Judgment that QIAGEN Does Not Infringe the ’355 Patent)
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`62.
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`QIAGEN repeats and realleges each and every allegation contained in paragraphs
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`1 through 29 of this Complaint as if fully set forth herein.
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`63.
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`In view of the facts and allegations set forth above, there is an actual, justiciable,
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`substantial, and immediate controversy between QIAGEN and Bio-Rad regarding whether
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`QIAGEN infringes any claim of the ’355 patent.
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`64.
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`Bio-Rad has alleged and continues to allege that products made, used, or sold by
`
`QIAGEN, or QIAGEN products that utilize certain methods of use, are covered by the claims of
`
`the ’355 patent, and has threatened to commence litigation against QIAGEN regarding this matter.
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`65.
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`QIAGEN contends that it has not infringed and does not infringe, induce
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`infringement, or contribute to the infringement of any valid or enforceable claim of the ’355 patent.
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`QIAGEN has not made, used, sold, offered for sale, or imported any products that literally infringe,
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`directly or indirectly, each and every claim of the ’355 patent.
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`66.
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`For example, and without limitation, QIAGEN’s accused product does not practice
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`the limitation “wherein flow from the inlet channel is configured to reach the outlet channel only
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`upon passing into the set of compartments” of claim 1.
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`67.
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`Therefore, a substantial controversy exists between QIAGEN and Bio-Rad, parties
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`having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a
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`declaratory judgment that QIAGEN has not infringed and does not infringe any valid or
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`enforceable claim of the ’355 patent.
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`68.
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`An actual and justiciable controversy exists between QIAGEN and Bio-Rad as to
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`whether QIAGEN’s products infringe the ’355 patent. QIAGEN accordingly requests a judicial
`
`determination of its rights, duties, and obligations regarding the ’355 patent.
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`11
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`69.
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`A judicial declaration is necessary and appropriate so that QIAGEN may ascertain
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`its rights regarding the ’355 patent.
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`SIXTH CLAIM FOR RELIEF
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`(Declaratory Judgment that QIAGEN Does Not Infringe the ’096 Patent)
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`70.
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`QIAGEN repeats and realleges each and every allegation contained in paragraphs
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`1 through 29 of this Complaint as if fully set forth herein.
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`71.
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`In view of the facts and allegations set forth above, there is an actual, justiciable,
`
`substantial, and immediate controversy between QIAGEN and Bio-Rad regarding whether
`
`QIAGEN infringes any claim of the ’096 patent.
`
`72.
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`Bio-Rad has alleged and continues to allege that products made, used, or sold by
`
`QIAGEN, or QIAGEN products that utilize certain methods of use, are covered by the claims of
`
`the ’096 patent, and has threatened to commence litigation against QIAGEN regarding this matter.
`
`73.
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`QIAGEN contends that it has not infringed and does not infringe, induce
`
`infringement, or contribute to the infringement of any valid or enforceable claim of the ’096 patent.
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`QIAGEN has not made, used, sold, offered for sale, or imported any products that literally infringe,
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`directly or indirectly, each and every claim of the ’096 patent.
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`74.
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`For example, and without limitation, QIAGEN’s accused product does not practice
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`the limitation “an outlet channel positioned downstream of the set of chambers and fluidly coupled
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`to the set of chambers, wherein fluid from the inlet channel reaches the outlet channel only by way
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`of the set of chambers” of claim 1.
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`75.
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`Therefore, a substantial controversy exists between QIAGEN and Bio-Rad, parties
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`having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a
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`declaratory judgment that QIAGEN has not infringed and does not infringe any valid or
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`enforceable claim of the ’096 patent.
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`76.
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`An actual and justiciable controversy exists between QIAGEN and Bio-Rad as to
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`whether QIAGEN’s products infringe the ’096 patent. QIAGEN accordingly requests a judicial
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`determination of its rights, duties, and obligations regarding the ’096 patent.
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`77.
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`A judicial declaration is necessary and appropriate so that QIAGEN may ascertain
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`its rights regarding the ’096 patent.
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`JURY DEMAND
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`78.
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`Pursuant to Federal Rule of Civil Procedure 38(b), QIAGEN demands a trial by
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`jury on all issues so triable.
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`PRAYER FOR RELIEF
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`QIAGEN respectfully requests the following relief:
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`a) That the Court enter a judgment declaring that QIAGEN has not infringed and does not
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`infringe any valid or enforceable claim of U.S. Patent No. RE41780;
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`b) That the Court enter a judgment declaring that QIAGEN has not infringed and does not
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`infringe any valid or enforceable claim of U.S. Patent No. 10,782,226;
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`c) That the Court enter a judgment declaring that QIAGEN has not infringed and does not
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`infringe any valid or enforceable claim of U.S. Patent No. 10,921,237;
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`d) That the Court enter a judgment declaring that QIAGEN has not infringed and does not
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`infringe any valid or enforceable claim of U.S. Patent No. 11,073,468;
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`e) That the Court enter a judgment declaring that QIAGEN has not infringed and does not
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`infringe any valid or enforceable claim of U.S. Patent No. 11,231,355;
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`f) That the Court enter a judgment declaring that QIAGEN has not infringed and does not
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`infringe any valid or enforceable claim of U.S. Patent No. 11,237,096;
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`g) That the Court declare that this case is exceptional under 35 U.S.C. § 285 and award
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`QIAGEN its attorneys’ fees, costs, and expenses incurred in this action;
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`Case 1:22-cv-00458-UNA Document 1 Filed 04/06/22 Page 14 of 14 PageID #: 14
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`h) That the Court award QIAGEN any and all other relief to which QIAGEN may show
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`itself to be entitled; and
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`i) That the Court award QIAGEN any other relief as the Court may deem just, equitable,
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`and proper.
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`Dated: April 6, 2022
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`Respectfully submitted,
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`/s/ John C. Phillips, Jr.
`John C. Phillips, Jr. (#110)
`David A. Bilson (#4986)
`PHILLIPS, MCLAUGHLIN & HALL, P.A.
`1200 North Broom Street
`Wilmington, Delaware 19806
`(302) 655-4200
`jcp@pmhdelaw.com
`dab@pmhdelaw.com
`
`Of Counsel:
`Thomas M. Melsheimer (pro hac vice
`pending)
`Rex A. Mann (pro hac vice pending)
`WINSTON & STRAWN LLP
`2121 North Pearl Street, Suite 900
`Dallas, TX 75201
`(214) 453-6500
`TMelsheimer@winston.com
`rmann@winston.com
`
`Evan D. Lewis (pro hac vice pending)
`WINSTON & STRAWN LLP
`800 Capitol Street, Suite 2400
`Houston, TX 77002
`(713) 651-2600
`EDLewis@winston.com
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`Attorneys for Plaintiffs QIAGEN Hamburg
`GmbH and QIAGEN, LLC
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`14
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