Innovare, Ltd. v. Sciteck Diagnostics, Inc.

2023 NCBC 5
CourtNorth Carolina Business Court
DecidedJanuary 19, 2023
Docket21-CVS-2180
StatusPublished

This text of 2023 NCBC 5 (Innovare, Ltd. v. Sciteck Diagnostics, Inc.) is published on Counsel Stack Legal Research, covering North Carolina Business Court primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Innovare, Ltd. v. Sciteck Diagnostics, Inc., 2023 NCBC 5 (N.C. Super. Ct. 2023).

Opinion

Innovare, Ltd. v. SciTeck Diagnostics, Inc., 2023 NCBC 5.

STATE OF NORTH CAROLINA IN THE GENERAL COURT OF JUSTICE SUPERIOR COURT DIVISION HENDERSON COUNTY 21 CVS 2180

INNOVARE, LTD., A Nevada Limited Liability Company, ORDER AND OPINION ON Plaintiff, PLAINTIFF’S MOTION TO DISMISS COUNTERCLAIMS AND MOTION TO v. STRIKE AFFIRMATIVE DEFENSES AND DEFENDANT’S MOTION FOR SCITECK® DIAGNOSTICS, INC., A LEAVE TO AMEND Delaware Corporation,

Defendant.

THIS MATTER comes before the Court on Plaintiff’s Motion to Dismiss

Counterclaims and Motion to Strike Affirmative Defenses (“Motion to Dismiss,” ECF

No. 17) and Defendant’s Motion for Leave to Amend Sciteck Diagnostics, Inc.’s

Answer to Innovare Ltd.’s Complaint and Counterclaims (“Motion to Amend, ECF

No. 44) (collectively, “Motions”). THE COURT concludes that the Motions should be

GRANTED, in part, and DENIED, in part.

Kilpatrick Townsend & Stockton LLP by Joseph S. Dowdy and Elizabeth L. Winters for Plaintiff Innovare, Ltd., A Nevada Limited Liability Company.

King Law Offices PLLC by J. Patrick A. Twisdale for Defendant Sciteck® Diagnostics, Inc., A Delaware Corporation.

Davis, Judge.

INTRODUCTION

1. The parties to this action agree that they entered into a distributorship

agreement relating to a product manufactured by Defendant Sciteck Diagnostics, Inc.

(“Sciteck”) consisting of strips designed for COVID-19 testing. However, that is

practically all that they agree upon. Indeed, the parties are the proverbial ships passing in the night in terms of their respective pleadings in which they offer

competing narratives regarding the nature, extent, and cessation of their business

relationship. The issues currently before the Court concern the legal validity of the

counterclaims and affirmative defenses asserted by Sciteck and whether Sciteck

should be permitted to amend them.

FACTUAL AND PROCEDURAL BACKGROUND

2. “The Court does not make findings of fact on a motion to dismiss

[counterclaims] pursuant to Rule 12(b)(6)” and instead recites those factual

allegations from the counterclaims that are “relevant and necessary to a

determination of the [m]otion.” Chi v. N. Riverfront Marina & Hotel LLLP, 2022

NCBC LEXIS 98, at **2 (N.C. Super. Ct. Aug. 24, 2022).1

3. “Sciteck is a corporation organized under the laws of Delaware[.]” (Am.

Countercls. ¶ 1, ECF No. 44.1.) “Sciteck is a pioneer and innovator in the biological

testing industry, including antigen testing for SARS-CoV-2” (“COVID-19”). (Am.

Counterclaims ¶ 5.) Sciteck has created a COVID-19 test called SALIVAQUIK, a

viral testing strip that requires “only a small saliva sample to quickly test for the

virus.” (Am. Countercls. ¶ 8.)

4. As background information, Sciteck’s counterclaims explain how a

medical product that has not yet received full regulatory approval may nonetheless

1 As noted below, the Court is electing—in furtherance of judicial economy—to consider Plaintiff’s arguments in support of its Motion to Dismiss as applied to Sciteck’s proposed amended counterclaims. Accordingly, this opinion cites to the factual allegations and claims contained in the amended counterclaims rather than those set out in Sciteck’s original counterclaims. be used to “diagnose, treat or prevent serious or life-threatening diseases” under

Emergency Use Authorization (“EUA”) authority. (Am. Countercls. ¶ 13.) However,

certain criteria must be met in order to obtain EUA approval, “including that there

are no adequate, approved, and available alternatives.” (Am. Countercls. ¶ 13.) The

formal process for obtaining EUA approval involves “an application, relevant data

and evidence, and a formal request that the FDA [Food and Drug Administration]

issue an EUA for the device.” (Am. Countercls. ¶ 15.) “[T]he FDA has the authority

to require additional data and information on a case-by-case basis to ensure

compliance with the statutory criteria for EUA approval of a specific device[,]” and

the amount of required data can vary from device to device. (Am. Countercls. ¶ 17.)

5. Generally, a device’s sponsor “engage[s] in studies and testing that are

compliant with and sufficient for the FDA’s EUA approval conditions.” (Am.

Countercls. ¶ 19.) This necessary testing is called Research Use Only (“RUO”)

activity, which the FDA strictly regulates, including requiring labeling of all subject

devices “for research use only.” (Am. Countercls. ¶ 21.) The FDA provides pre-EUA

guidelines, “which include[] limiting testing ‘to laboratories certified to perform high

complexity testing, and at the point-of care when covered by the laboratory’s . . .

certificate for high complexity testing.’ ” (Am. Countercls. ¶ 26.)

6. In response to the growing need for COVID-19 testing devices as a result

of the coronavirus pandemic, Sciteck began developing the SALIVAQUIK device.

(Am. Countercls. ¶ 23.) 7. Sciteck’s counterclaims allege the existence of the SALIVAQUIK

trademark, which is not federally registered “but holds all relevant rights of an

unregistered trademark under both federal and state law, including common law.”

(Am. Countercls. ¶ 11.)

8. Defendant Innovare Ltd. (“Innovare”) “provides consulting, IT, and data

management services.” (Am. Countercls. ¶ 32.) In 2020, “Innovare was in need of an

oral fluid testing laboratory to assist Innovare in performing reverse transcriptase

polymerase chain reaction (‘RT-PCR’) testing.” (Am. Countercls. ¶ 33.) Innovare

engaged Sciteck to provide “oral fluid testing.” (Am. Countercls. ¶ 34.) “Sciteck also

became aware of Innovare’s software utilized in connection with RT-PCR testing.”

(Am. Countercls. ¶ 34.)

9. The parties subsequently entered into discussions “as to whether

Innovare would be capable of providing software for purposes of allowing a user to

interpret and validate the results of a SALIVAQUIKTM test device using a

smartphone.” (Am. Countercls. ¶ 35.) Innovare touted its experience in software

development in compliance with federal regulatory schemes, including those of the

FDA. (Amended Counterclaim ¶ 36.) Although the parties initially only drafted an

agreement concerning the licensing of Sciteck’s intellectual property, the parties

ultimately agreed that Innovare would serve as a “non-exclusive distributor of the

SALIVAQUIKTM device following EUA approval of the device.” (Am. Countercls. ¶¶

38–39.) Along with distribution, “Innovare was to provide [s]oftware for purposes of

allowing a user to interpret the result of the SALIVAQUIKTM test device using a smartphone.” (Am. Countercls. ¶ 41.) The parties formalized this relationship in a

document titled Licensing and Master Distributor Agreement (“Distributor

Agreement”) that was executed by the parties on 18 February 2021. (Distributor

Agreement, ECF No. 2, Ex. A.)

10. Because the Distributor Agreement—which is neither a model of

specificity nor clarity2— is relatively short and its terms are highly relevant to the

parties’ dispute, the Court deems it helpful to quote the terms of the document largely

verbatim:

This Agreement . . . is made and entered into on February 18, 2021 (the “Effective Date”) by and between Innovare, Ltd. a Nevada limited liability company (“Innovare”) and Sciteck® Diagnostics, Inc., a Delaware corporation (“Sciteck”).

WHEREAS, Innovare has developed and owns intellectual property and proprietary information (the “IP/Content”) to include but not limited to software, websites (e.g.

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2023 NCBC 5, Counsel Stack Legal Research, https://law.counselstack.com/opinion/innovare-ltd-v-sciteck-diagnostics-inc-ncbizct-2023.