Case 5:21-cv-00871 Document 1 Filed 05/19/21 Page 1 of 23 Page ID #:1
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`
`
`Ashe Puri (SBN 297814)
`Joshua Hartman (VA Bar No. 77894;
`MAYNARD COOPER & GALE, LLP
`D.C. Bar No. 992165)
`1925 Century Park East, Suite 1700
`(Pro Hac Vice Application to be filed)
`Los Angeles, CA 90067
`Hartman@adduci.com
`Telephone: (310) 596-4344
`Hayley Ostrin (TX Bar No. 24116862;
`apuri@maynardcooper.com
`D.C. Bar No. 1720043)
`
`(Pro Hac Vice Application to be filed)
`Brandon Stroy (SBN 289090)
`Ostrin@adduci.com
`MAYNARD COOPER & GALE, LLP
`ADDUCI MASTRIANI &
`600 Montgomery Street, Suite 2600
`SCHAUMBERG LLP
`San Francisco, CA 94111
`1133 Connecticut Avenue NW
`Telephone: (415) 646-4703
`Washington, DC 20036
`bstroy@maynardcooper.com
`Telephone: (202) 467-6300
`
`
` Attorneys for Plaintiff ARK Diagnostics, Inc.
`
`
`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA
`
`EASTERN DIVISION
`
`
`Case No. 5:21-cv-00871
`
`COMPLAINT FOR INFRINGEMENT
`OF U.S. PATENT NO. 10,203,345
`
`JURY TRIAL DEMANDED
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`
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`ARK DIAGNOSTICS, INC., a
`California Corporation
`
`
`Plaintiff,
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`v.
`
`
`ACRO BIOTECH, INC., a California
`Corporation, HANGZHOU ALLTEST
`BIOTECH CO., LTD., and DOES 1-
`10, inclusive
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`Defendants.
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`Case 5:21-cv-00871 Document 1 Filed 05/19/21 Page 2 of 23 Page ID #:2
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`Plaintiff ARK Diagnostics, Inc. (“ARK” or “Plaintiff”) states and alleges as
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`follows:
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`SUMMARY OF THE DISPUTE
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`1.
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`This is an action for patent infringement arising under the patent laws of
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`the United States of America, including specifically 35 U.S.C. § 271(a)-(c), based on
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`Defendants Hangzhou AllTest Biotech Co., Lt. (“AllTest”) and Acro Biotech, Inc.’s
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`(“Acro”) (collectively, “Defendants”) willful infringement of United States Patent
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`No. 10,203,345 (the “’345 Patent) by the unauthorized use, offer for sale, sale, and/or
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`importation of Defendants’ infringing gabapentin immunoassay rapid drug tests
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`accused below (“the Accused Product”), and by their inducement of and contribution
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`to infringement of the ’345 Patent.
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`2.
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`ARK is a pioneer in the therapeutic drug monitoring (“TDM”) and urine
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`drug testing (“UDT”) markets, which include assays and tests to detect and monitor
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`the presence of therapeutic and illicit drugs and other small molecules. Since its
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`incorporation in 2003, ARK’s mission has been to improve healthcare through the
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`design, research and development, manufacture, and distribution of in vitro diagnostic
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`(“IVD”) immunoassays for TDM and UDT. ARK’s innovations include its
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`homogeneous enzyme immunoassay technology, which it introduced for the next
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`generation of clinical laboratory testing. This technology includes the ARK
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`Gabapentin Assay, an immunoassay capable of rapidly detecting the presence of
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`gabapentin, an entirely new field in the TDM and UDT markets. The ’345 Patent
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`protects the ARK Gabapentin Assay.
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`3.
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`The products and processes covered by the ’345 Patent relate to
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`immunoassays for detecting the presence of gabapentin in a biological sample.
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`Gabapentin (trade name Neurontin) is a chemical compound used as an anti-seizure
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`and anti-convulsant medication that has the following chemical structure:
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`Case 5:21-cv-00871 Document 1 Filed 05/19/21 Page 3 of 23 Page ID #:3
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`Figure 1 – Chemical Structure of Gabapentin
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`4.
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`Patients can metabolize gabapentin at different rates. As a result, two
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`patients who receive the same dose of gabapentin may experience different levels of
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`serum drug concentration, which will result in inconsistent therapeutic effects. Thus,
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`monitoring a patient’s concentration level of gabapentin is essential to determining the
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`correct dosage to prescribe.
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`5.
`Apart from its therapeutic uses, gabapentin has become popular as a drug
`of abuse, which users take in tandem with opioids to increase their potency.1 When
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`abused with opioids, gabapentin increases the risk of respiratory problems and fatal
`overdose.2 The growing abuse of gabapentin has led to demand for quick, accurate,
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`and inexpensive methods for testing the presence of gabapentin in a test subject’s
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`biological sample.
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`6.
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`ARK researched, developed, and invented novel methods and compounds
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`for assaying gabapentin that can be used to test for the presence of gabapentin quickly,
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`accurately, and inexpensively. ARK’s gabapentin immunoassay products use
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`antibodies, enzymes, and a substrate to test for the presence of gabapentin and
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`gabapentin conjugates in a biological sample. When gabapentin is absent from a
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`1 See Alyssa M. Peckham et. al., Gabapentin use, abuse, and the US opioid
`epidemic: the case for reclassification as a controlled substance and the need for
`pharmacovigilance, 11 RISK MANAG. HEALTHCARE 11, 109, 110 (2018),
`www.ncbi.nlm.nih.gov/pmc/articles/PMC6103607/pdf/rmhp-11-109.pdf.
`2 Id. at 109; FDA warns about serious breathing problems with seizure and nerve
`pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica,
`Lyrica CR), FDA (last updated Jan. 30, 2020), www.fda.gov/drugs/drug-safety-and-
`availability/fda-warns-about-serious-breathing-problems-seizure-and-nerve-pain-
`medicines-gabapentin-neurontin.
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`Case 5:21-cv-00871 Document 1 Filed 05/19/21 Page 4 of 23 Page ID #:4
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`sample, the gabapentin-specific antibody binds to the enzyme, preventing the enzyme
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`from producing NADH. Conversely, when gabapentin is present, the antibody binds
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`to the gabapentin, allowing the enzyme to bind to the substrate and produce NADH.
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`NADH levels can then be measured and used to determine the presence and
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`concentration of gabapentin.
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`Figure 2 - ARK Gabapentin Assay, which includes
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`Reagent R1 – Antibody/Substrate; and Reagent R2 – Enzyme.
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`7.
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`ARK’s Gabapentin Assay can be used with clinical analyzers to test for
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`the presence and concentration levels of gabapentin and gabapentin conjugates in a
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`patient’s biological sample. To do so, a known quantity of Reagent R1 is mixed with
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`the biological sample. Reagent R1 contains rabbit polyclonal antibodies that
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`specifically bind to gabapentin as well as nicotinamide adenine dinucleotide (“NAD”).
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`If the sample contains gabapentin, Reagent R1’s antibodies will bind to the free
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`gabapentin. When Reagent R2 is introduced, these bound antibodies will not be free to
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`bind to the enzyme-tagged gabapentin. Reagent R2 contains gabapentin conjugated at
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`the carboxyl group to bacterial glucose-6-phosphate dehydrogenase (“G6PDH”).
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`When G6PDH is active, it converts NAD to NADH, which changes the way the
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`solution absorbs light. Conversely, if the sample does not contain gabapentin, Reagent
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`R1’s antibodies will bind to Reagent R2’s enzyme-tagged gabapentin, in turn
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`inhibiting production of NADH. A spectrometer can measure this change in
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`Case 5:21-cv-00871 Document 1 Filed 05/19/21 Page 5 of 23 Page ID #:5
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`absorbance with enough specificity to allow users to determine appropriate dosage
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`rates.
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`Figure 3 - Diagram of ARK Gabapentin Assay’s Response to Different Samples
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`8.
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`In addition to use with a clinical chemistry analyzer, ARK’s gabapentin-
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`specific antibodies can be and are used in competitive lateral flow test strips in cups,
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`dip-cards, and other test formats for performing rapid drug tests without using
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`specialized equipment. Lateral flow tests include gabapentin antibodies deposited on
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`the test’s “dip zone” that are designed to bind with gabapentin and specific gabapentin
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`conjugates. In these lateral flow tests, the gabapentin antibodies are labeled with a
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`marker, such as a gold microparticle, that becomes visible to the naked eye when
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`antibodies concentrate in a small enough area. Gabapentin lateral flow tests also
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`include a “test line” that includes unbound gabapentin molecules and a “control line”
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`that includes gabapentin antibodies that bind with excess labeled antibody.
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`Figure 4 - Diagram of Gabapentin Lateral Flow Test
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`9. When a biological sample, such as a blood or urine sample, is added to
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`the dip zone, the sample diffuses along the strip, carrying the gabapentin antibodies. A
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`properly functioning strip will carry the sample, including the gabapentin antibodies
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`Case 5:21-cv-00871 Document 1 Filed 05/19/21 Page 6 of 23 Page ID #:6
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`dispersed within it, all the way to the control line. The antibodies bind to free
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`gabapentin and specific gabapentin conjugates on a first-come, first-serve basis.
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`Because the tagged antibodies are located at the test strip’s dip zone, they interact with
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`the biological sample before reaching the gabapentin on the test line. If the biological
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`sample contains gabapentin, the tagged antibodies will bind to the sample’s gabapentin
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`and not to the gabapentin on the test line. All the tagged antibodies then flow to the
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`control line, resulting in a single-line, positive test. If the sample contains little or no
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`gabapentin, the tagged antibodies are free to bind to the gabapentin on the test line, at
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`a concentration significant enough to make the test line visible. Excess tagged
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`antibodies will flow to the control line, resulting in a double-line, negative test.
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`Figure 5 - Diagram of Positive and Negative Gabapentin Lateral Flow Tests
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`10. ARK has entered into a Licensing and Supply Agreement with Advin
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`Biotech Inc (“Advin”). Advin uses components of ARK’s Gabapentin Immunoassay
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`to create rapid drug tests that practice the ’345 Patent.
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`11. On December 1, 2020, Plaintiff filed a complaint at the International
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`Trade Commission, alleging that Defendants’ infringement of the ’345 Patent resulted
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`in a violation of 19 U.S.C. § 1337. Plaintiff amended its complaint on December 23,
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`2020, and the International Trade Commission instituted Certain Gabapentin
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`Immunoassay Kits and Test Strips, Components Thereof, and Methods Therefor, Inv.
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`No. 337-TA-1239, on January 19, 2021.
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`THE PARTIES
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`12. Plaintiff ARK Diagnostics, Inc. is a California corporation founded in
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`2003. ARK’s principal place of business is located at 48089 Fremont Boulevard,
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`Case 5:21-cv-00871 Document 1 Filed 05/19/21 Page 7 of 23 Page ID #:7
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`Fremont, California 94538.
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`13. Defendant Acro Biotech, Inc. is a California corporation. Acro maintains
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`its principal place of business at 9500 7th Street, Unit M, Rancho Cucamonga, CA
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`91730.
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`14. Defendant Hangzhou AllTest Biotech Co., Ltd. is a company organized
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`under the laws of the Peoples Republic of China maintaining its principal place of
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`business at No. 550, Yinhai Street, Hangzhou Economy and Technology Development
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`Area, Hangzhou, China, 310018.
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`15. ARK does not know the true names and capacities of the Defendants sued
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`herein as Does 1 through 10, inclusive, and therefore sues these Defendants by their
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`fictitious names. Pursuant to Federal Rules of Civil Procedure 15(a)(2) and 21, ARK
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`will seek leave to amend this Complaint to allege the true names and capacities of Does
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`1 through 10, inclusive, when ascertained.
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`JURISDICTION
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`16. This court has jurisdiction over this action pursuant to 28 U.S.C. §§ 1331
`and 1338.
`17. Defendant Acro is subject to personal jurisdiction in the State of
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`California, including within this judicial district, because it is a California corporation
`and because it has its principal place of business within this judicial district.
`18. On information and belief, Defendant AllTest is subject to personal
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`jurisdiction in the State of California, including within this judicial district, because
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`AllTest carries on continuous and systematic business in the State of California.
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`Among other things, AllTest’s U.S. agent registered with the U.S. Food and Drug
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`Administration resides in California within this district. Further, as noted above,
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`AllTest’s wholly owned subsidiary Acro is located in California within this district,
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`and on information and belief, AllTest regularly imports, sells, and distributes
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`products, including accused products, for marketing, distribution, and resale to
`California and in particular to this district.
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`Case 5:21-cv-00871 Document 1 Filed 05/19/21 Page 8 of 23 Page ID #:8
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`19.
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`In addition, AllTest has committed acts of infringement in California
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`within this district that give rise to this action by purposefully and voluntarily placing
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`the accused products into the stream of commerce with the intention and expectation
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`that they will be resold and distributed within California. On information and belief,
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`AllTest has sold and distributed accused products to its wholly owned subsidiary Acro,
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`which resides within this district, with the understanding that Acro would resell and
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`distribute those products within this district. Therefore, AllTest has sufficient
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`minimum contacts with California, such that exercising jurisdiction over AllTest is
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`appropriate under the applicable jurisdictional statutes and would not offend traditional
`notions of fair play and substantial justice.
`VENUE
`20. Venue is proper in this district under 28 U.S.C. §§ 1391(c)(3) and 1400(b)
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`because Defendant AllTest resides outside the United States in Hangzhou, China and
`Defendant Acro resides within this judicial district, as alleged above.
`THE PATENTS IN SUIT
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`21. The ’345 Patent generally discloses and claims a method of detecting
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`gabapentin by combining a target sample, an anti-gabapentin antibody, and a
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`gabapentin conjugate in which a detectable label is bound to a gabapentin molecule
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`via one of three specific chemical structures—GAB-II, GAB-V, or GAB-VII. In
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`general, the target samples are biological samples (such as urine samples) suspected of
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`containing gabapentin. The anti-gabapentin antibody is capable of binding with
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`gabapentin or gabapentin conjugates. Any free gabapentin in the sample will form
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`complexes with the anti-gabapentin antibodies, making the antibodies unavailable to
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`bind with the gabapentin conjugate when it is introduced into the sample. The output
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`of the conjugated label is affected by the presence or absence of the antibody-
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`gabapentin conjugate complex. This method detects the presence and concentration of
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`gabapentin in the sample based on the label’s output.
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`22. The ’345 Patent also generally discloses and claims a gabapentin
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`Case 5:21-cv-00871 Document 1 Filed 05/19/21 Page 9 of 23 Page ID #:9
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`immunoassay kit including an anti-gabapentin antibody and a gabapentin conjugate
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`comprising a detectable label bound to a gabapentin molecule via one of the GAB-II,
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`GAB-V, and GAB-VII structures. The claimed kit can be used for performing
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`identifying the presence or absence of gabapentin in a sample.
`Defendants’ Infringing Activities
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`23.
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`On information and belief, Defendants make, use, sell, offer for sale,
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`and/or import gabapentin immunoassay products that infringe the ’345 Patent.
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`24.
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`Defendants infringe the ’345 Patent at least by importing, selling, and
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`offering for sale gabapentin immunoassay kits, gabapentin-specific test strips, and
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`multi-drug test kits and strips that test for gabapentin among other drugs that practice
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`one or more claims of the ’345 Patent. On information and belief, Defendant AllTest
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`manufactures accused products in China. AllTest imports these accused products into
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`the U.S. by shipping them to its wholly owned subsidiary, Defendant Acro, which
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`markets, sells, and offers for sale accused products on its own and through independent
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`distributors. These accused products include a “GAB Rapid Test Panel,” which
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`Defendant AllTest and Acro advertise on their websites (see, e.g., Exs. 2, 3) and their
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`distributors advertise as an “AllTest/Acro Biotech” product. (See Ex. 4.)
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`25.
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`Defendants’ actions have irreparably harmed ARK and will continue to
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`do so unless they permanently cease. Continued sales of Defendants’ accused products
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`will further damage ARK’s market position and good reputation in the marketplace. In
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`addition, Defendants’ continued knowing acts of infringement will frustrate ARK’s
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`ongoing and potential business relationships and contracts, with resulting lost sales and
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`profits, and are otherwise causing or will cause substantial irreparable harm to ARK’s
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`business.
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`26.
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`As a result of Defendants’ actions, ARK was forced to file this lawsuit
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`to protect its patented invention and its reputation as a leader in the IVD industry.
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`27.
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`Defendants’ accused products, including their Gabapentin Rapid Test
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`Panel, practice one or more claims of the ’345 Patent. Defendants’ Gabapentin Rapid
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`Case 5:21-cv-00871 Document 1 Filed 05/19/21 Page 10 of 23 Page ID #:10
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`Test Panel meets each and every limitation of independent claims 1 and 28. To the
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`extent that the accused products do not literally meet a claim limitation, they meet them
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`under the doctrine of equivalents.
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`28.
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`As shown below, during ordinary use, the accused products practice
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`every step of the method of independent claim 1:
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`Claim 1
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`Defendants’ Gabapentin Rapid Test Panel
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`A method for detecting the
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`Defendants’ accused products, including its
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`presence or absence of
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`Gabapentin (GAB) Rapid Test Panel are one-step,
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`gabapentin in a sample, the
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`competitive lateral flow immunoassay tests for
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`method comprising:
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`detecting the presence or absence of gabapentin in a
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`biological sample.
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`(Excerpt of Defendants’ Product Insert)
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`Case 5:21-cv-00871 Document 1 Filed 05/19/21 Page 11 of 23 Page ID #:11
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`Claim 1
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`Defendants’ Gabapentin Rapid Test Panel
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`(a) combining in a reaction
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`Defendants’ accused products combine certain
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`mixture:
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`recited substances in a reaction mixture. When used
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`as intended, a biological sample is introduced to the
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`dip card’s test strip. The sample and anti-gabapentin
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`antibodies placed on the test strip diffuse to the
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`strip’s test zone, where they react with the gabapentin
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`conjugate deposited on the strip.
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`(Excerpt of Defendants’ Product Insert)
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`(i) a sample suspected
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`During ordinary use, samples suspected of
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`of containing
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`containing gabapentin are introduced into a reaction
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`gabapentin;
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`mixture on the test strip of the accused products.
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`. . .
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`(Excerpts of Defendants’ Product Insert)
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`(ii) an anti-gabapentin
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`The accused products contain anti-gabapentin
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`antibody capable of
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`antibodies that are capable of forming a complex
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`forming of a
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`with gabapentin present in the sample. The
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`Case 5:21-cv-00871 Document 1 Filed 05/19/21 Page 12 of 23 Page ID #:12
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`Claim 1
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`Defendants’ Gabapentin Rapid Test Panel
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`complex with
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`antibodies specifically bind gabapentin epitopes
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`gabapentin that
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`present in free gabapentin, whether contained in a
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`may be present in
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`test subject’s urine sample or pre-placed at the
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`the sample; and
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`accused products’ test line (denoted “T”).
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`(Excerpt of Defendants’ Product Insert)
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`When the accused products are used on a urine
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`sample containing gabapentin molecules, the
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`molecules bind to antibodies contained on the dip
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`zone, preventing them from binding to fixed
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`gabapentin-conjugates preplaced at the test line, such
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`that the test line will not display a visual marker.
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`Alternatively, when the accused products are used for
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`a urine sample that does not contain gabapentin
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`molecules, unbound antibodies bind to the preplaced
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`gabapentin conjugates at the test line, such that the
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`test line will display a visual marker.
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`12
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`Case 5:21-cv-00871 Document 1 Filed 05/19/21 Page 13 of 23 Page ID #:13
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`
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`
`
`Claim 1
`
`Defendants’ Gabapentin Rapid Test Panel
`
`(Diagram of Competitive Lateral Flow Assay)
`
`
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`. . .
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`(Excerpt of Defendants’ Product Insert)
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`(Excerpt of Defendants’ Product Insert, describing
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`product limitations)
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`13
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`10
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`Case 5:21-cv-00871 Document 1 Filed 05/19/21 Page 14 of 23 Page ID #:14
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`
`
`
`
`
`
`Claim 1
`
`Defendants’ Gabapentin Rapid Test Panel
`
`(iii) a gabapentin
`
`The accused products include a gabapentin
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`conjugate capable
`
`conjugate capable of binding to the afore-mentioned
`
`of binding to the
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`anti-gabapentin antibodies. On information and
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`anti-gabapentin
`
`belief, this gabapentin conjugate has the recited R1
`
`antibody, wherein
`
`structure of ⸺X⸺W-L-Z, in which X is NH, W is a
`
`the gabapentin
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`lower alkyl group or carbonyl group, L is a linker or
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`conjugate has the
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`at least one bond between W and Z, and Z is a
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`structure:
`
`“detectable label.”
`
`Per the product’s package insert, the accused dip
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`card includes a “Gabapentin-protein conjugate”—i.e.,
`
`a gabapentin-protein conjugate—deposited in the test
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`region. During use of the dip card as intended with a
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`sample containing gabapentin levels below the cut-
`
`off concentration for a positive result, the dip card’s
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`anti-gabapentin will “[t]he antibody coated particles
`
`
`
`will then be captured by immobilized Gabapentin-
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`protein conjugate and a visible colored line will show
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`up in the test line region” indicating a negative result.
`
`
`
`(Excerpt of Defendants’ Product Insert)
`
`The appearance of a colored line in the accused
`
`Wherein:
`
`R1, R2, or R3 is
`
`⸺X⸺W-L-Z;
`
`when R1 is ⸺X⸺W-L-
`
`Z, X is NH, R2 is ⸺OH,
`
`and R3 is ⸺H;
`
`when R2 is ⸺X⸺W-L-
`
`Z, X is NH, R1 is
`
`⸺NH2, and R3 is ⸺H;
`
`and
`
`when R3 is ⸺X⸺W-L-
`
`Z, X is a heteroatom or
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`1 2 3 4 5 6 7 8 9
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`10
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`14
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`

`

`Case 5:21-cv-00871 Document 1 Filed 05/19/21 Page 15 of 23 Page ID #:15
`
`
`
`
`
`
`
`Claim 1
`
`Defendants’ Gabapentin Rapid Test Panel
`
`lower alkyl group, R1 is
`
`products’ test zone when the card’s anti-gabapentin
`
`⸺NH2, and R2 is
`
`antibodies bind with its Gabapentin-protein conjugate
`
`⸺OH;
`
`is a detectable signal, such that the protein is a
`
`W is a lower alkyl group
`
`detectable label as recited in claim 1.
`
`or carbonyl group;
`
`Further, testing of the accused products shows that
`
`L is a linker or at least
`
`the anti-gabapentin antibodies included with the dip
`
`one bond between W
`
`card specifically bind to gabapentin conjugates
`
`and Z; and Z is a
`
`having a GAB-II structure, which in turn indicates
`
`detectable label;
`
`that the gabapentin conjugates included with the
`
`accused dip card also have a GAB-II structure—just
`
`like the R1 structure recited in claim 1. Specifically,
`
`when testing the accused dip card with samples
`
`containing gabapentin conjugates having GAB-II,
`
`GAB-V, and GAB-VII structures respectively, the
`
`accused product indicated a positive result only with
`
`the GAB-II sample and not with the GAB-V or
`
`GAB-VII samples. As shown below, the accused dip
`
`card’s test line indicated a positive result for the
`
`GAB-II sample (no visual marker at the “T” line) and
`
`negative results with the GAB-V and GAB-VII
`
`conjugates and for a control sample that did not
`
`include gabapentin.
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`15
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`

`

`Case 5:21-cv-00871 Document 1 Filed 05/19/21 Page 16 of 23 Page ID #:16
`
`
`
`
`
`
`
`
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`(Photograph of gabapentin conjugate test results
`
`chart with the accused dip card)
`
`Based on this testing, the accused products’ anti-
`
`gabapentin antibodies form complexes with GAB-II
`
`conjugates and not with other gabapentin conjugates.
`
`Consequently, the gabapentin conjugates included on
`
`the accused dip card during manufacture must also
`
`have a GAB-II structure, as recited in claim 1, or else
`
`these conjugates would not form complexes with the
`
`dip card’s anti-gabapentin antibodies.
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`In addition, by its nature, the dip card’s
`
`Gabapentin-protein conjugate must include “at least
`
`one bond” between the conjugate’s protein and its
`
`gabapentin molecule, as required by claim 1.
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`Finally, on information and belief, the remaining
`
`portions of claim 1’s R1 structure—NH and either a
`
`
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`

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`Case 5:21-cv-00871 Document 1 Filed 05/19/21 Page 17 of 23 Page ID #:17
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`
`
`
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`
`
`Claim 1
`
`Defendants’ Gabapentin Rapid Test Panel
`
`“lower alkyl group or a carbonyl group”—are present
`
`based on the GAB-II structure of the conjugate and
`
`the methods and chemicals typically used for
`
`conjugation.
`
`(b) detecting the
`
`The accused products perform the step of
`
`presence or absence of
`
`detecting the presence or absence of the antibody-
`
`the complex, wherein
`
`gabapentin complex, which is indicative of the
`
`the presence or
`
`absence of the
`
`presence or absence of gabapentin in the sample.
`
`When the dip card is used as directed, its test strip is
`
`complex is indicative
`
`inserted into a biological sample, causing diffusion to
`
`of the presence or
`
`occur along the test strip, creating the recited reaction
`
`absence of gabapentin
`
`mixture. If gabapentin is present in the sample, the
`
`in said sample.
`
`anti-gabapentin antibodies deposited on the test strip
`
`form complexes with the free gabapentin present in
`
`the sample. Because the anti-gabapentin antibodies
`
`have formed complexes with the free gabapentin,
`
`they are not available to bind with the gabapentin
`
`conjugates deposited on the test strip’s test line. As
`
`such, the test line does not display a marker, which
`
`indicates that gabapentin is present in the sample.
`
`If gabapentin is absent from the sample, the anti-
`
`gabapentin antibodies deposited on the test strip do
`
`not form complexes with anything in the sample and
`
`thus are free to bind with the deposited gabapentin
`
`conjugates as the mixture diffuses along the test strip.
`
`The binding of the antibodies with the gabapentin
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`

`

`Case 5:21-cv-00871 Document 1 Filed 05/19/21 Page 18 of 23 Page ID #:18
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`
`
`
`
`
`
`Claim 1
`
`Defendants’ Gabapentin Rapid Test Panel
`
`conjugates causes a visual marker to display at the
`
`strip’s test line, indicating that gabapentin is absent
`
`from the sample.
`
`. . .
`
`
`
`
`
`(Excerpt of Defendants’ Product Insert)
`
`29.
`
`In addition, the accused products meet each and every limitation of
`
`independent claim 28, which is directed to “[a] kit” comprising “an anti-gabapentin
`
`antibody, capable of specifically binding to gabapentin” and “a gabapentin conjugate
`
`capable of binding to the anti-gabapentin antibody” and having one of the same three
`
`structures required by claim 1. For the same reasons provided regarding the “anti-
`
`
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`18
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`28
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`Case 5:21-cv-00871 Document 1 Filed 05/19/21 Page 19 of 23 Page ID #:19
`
`
`
`
`
`
`gabapentin antibody” and “gabapentin conjugate” limitations of claim 1, the accused
`
`products meet these limitations of claim 28.
`
`FIRST CAUSE OF ACTION
`
`Infringement of U.S. Patent No. 10,203,345
`
`30. Plaintiff incorporates and realleges the allegations in the preceding
`
`paragraphs as if fully set forth here.
`
`31. On February 2, 2019, the United States Patent and Trademark Office duly
`
`and legally issued the ’345 Patent, titled “Compounds and Methods for Use in
`
`Detecting Gabapentin.” A true and correct copy of the ’345 patent is attached as
`
`Exhibit 1.
`
`32. ARK is the owner, by assignment, of all rights, title, and interest in the
`
`’345 Patent, including the right to recover damages for past infringement.
`
`33. Defendants have infringed and continue to infringe the ’345 Patent, both
`
`literally and by equivalents, under 35 U.S.C. § 271(a) in this district and elsewhere in
`
`the United States by using, importing, offering for sale, and/or selling the accused
`
`products, which practice one or more of the claims of the ’345 Patent. The accused
`
`products satisfy each limitation of at least independent claims 1 and 28. (See supra ¶¶
`
`28–29.)
`
`34. On information and belief, Defendants have actively induced and
`
`contributed to infringement of one or more claims of the ’345 Patent under 35 U.S.C.
`
`§ 271(b) and (c). Defendants have had knowledge of the ’345 Patent at least since
`
`December 1, 2020, when ARK filed a complaint with the U.S. International Trade
`
`Commission under Section 337 of the Tariff Act of 1930 asserting the ’345 Patent
`
`against Defendants.
`
`35. Defendants have induced infringement of one or more claims of the ’345
`
`Patent, both literally and by equivalents, under 35 U.S.C. § 271(b). On information and
`
`belief, Defendants have actively, knowingly, and intentionally induced infringement
`
`of the ’345 Patent by selling, offering to sell, advertising, marketing, and distributing
`
`
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`Case 5:21-cv-00871 Document 1 Filed 05/19/21 Page 20 of 23 Page ID #:20
`
`
`
`
`
`
`accused products with the knowledge and specific intent that third parties will use them
`
`to infringe the ’345 Patent during ordinary and customary use of those products.
`
`Defendants have actively encouraged third parties, including customers and end users,
`
`to use the accused products in an infringing manner, including: (1) by marketing those
`
`products for use in gabapentin UDT, including through websites (see, e.g., 2-4); (2) by
`
`selling, offering for sale, and distributing the accused products to third parties and end
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`users; and (3) by providing instructions, including package inserts supplied with the
`
`accused products, that direct third parties to use those products in an infringing manner
`
`(see, e.g., Ex. 5).
`
`36. On information and belief, Defendants have contributorily infringed one
`
`or more claims of the ’345 Patent, both literally and by equivalents, under 35 U.S.C. §
`
`271(c). Within the United States, Defendants have sold, offered to sell, and/or imported
`
`the accused products with the knowledge that they are especially made or adapted for
`
`use in infringing the ’345 Patent. (See supra ¶¶ 28-29.) Further, the accused products
`
`are not staple articles or commodities of commerce suitable for substantial
`
`noninfringing use. For example, they are not intended and cannot be used substantially
`
`for testing for drugs of abuse other than gabapentin.
`
`37. As a result of Defendants’ infringement of the ’345 Patent, ARK has
`
`suffered and will continue to suffer damages. ARK is entitled to recover from
`
`Defendants damages adequate to compensate for such infringement, in an amount to
`
`be determined at trial.
`
`38. Defendants have committed acts of infringement of the ’345 Patent
`
`discussed above with full knowledge of ARK’s rights in the patent. On information
`
`and belief, and as discussed above, Defendants received notice of their infringing
`
`activities at least by ARK’s December 1, 2021 complaint filed with the U.S.
`
`International Trade Commission. On information and belief, Defendants continued
`
`infringing acts after that date, including by continuing to market the accused products
`
`and to offer them for sale, such as through their websites, despite an objectively high
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