Innovare, Ltd. v. Sciteck Diagnostics, Inc.

2023 NCBC 5
North Carolina Business Court·Decided January 19, 2023·No. 21-CVS-2180·Published

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. SalivaQuick [sic]), PDA and smart phone software and Sciteck which has developed and manufactures a rapid diagnostic single use test device technology (“SALIVAQUIKTM”). The term “SalivaQuik” shall mean and include all rapid test strips produced by Sciteck designed for COVID-19, influenza or any other infectious disease which are part of Sciteck’s Chemtest® line of dry chemistry products which “IP/Content” belong to Sciteck.

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

2023 NCBC 5 (Innovare, Ltd. v. Sciteck Diagnostics, Inc.) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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