Sophion Bioscience, Inc. v. United States

CourtUnited States Court of Federal Claims
DecidedJuly 12, 2021
Docket21-1065
StatusPublished

This text of Sophion Bioscience, Inc. v. United States (Sophion Bioscience, Inc. v. United States) is published on Counsel Stack Legal Research, covering United States Court of Federal Claims primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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Sophion Bioscience, Inc. v. United States, (uscfc 2021).

Opinion

In the United States Court of Federal Claims No. 21-1065 (Filed Under Seal: June 25, 2021) Reissued: July 12, 20211

) SOPHION BIOSCIENCE, INC., ) ) Plaintiff, ) ) v. ) ) THE UNITED STATES, ) ) Defendant. ) )

Jonathan Perrone, Whitcomb, Selinsky, PC, Denver, CO, for plaintiff.

Daniel B. Volk, U.S. Department of Justice, Civil Division, Washington, DC, for defendant.

OPINION AND ORDER

SMITH, Senior Judge

This post-award bid protest is before the Court on the parties’ Cross-Motions for Judgment on the Administrative Record. Plaintiff, Sophion Bioscience, Inc. (“Sophion”), challenges the evaluation of offerors and the award decision issued by the U.S. Department of Health and Human Services, Food and Drug Administration (“FDA” or “Agency”) for a device called an automated high throughput patch clamp system (“APC” or “device” or “system”) used to analyze heart ion channel pharmacology under Request for Quotation No. FDA-20-RFQ- 1224178B, Amendment 3 (“RFQ” or “Solicitation”). Administrative Record 271–94 [hereinafter AR]. Specifically, plaintiff challenges the Agency’s award to 3T Federal Solutions (“3T” or “awardee”)2, based on the following: (1) the RFQ contained a latent ambiguity; (2) construing that ambiguity against the Agency, the FDA conducted a flawed technical evaluation; (3) the FDA conducted evaluations based on unstated criteria; and (4) the FDA treated offerors unequally. See generally Plaintiff’s Motion for Judgment on the Administrative Record, ECF No. 19 [hereinafter Pl.’s MJAR]. In response, defendant contends the following: (1) the RFQ is unambiguous; and (2) in the alternative, plaintiff’s arguments serve as a challenge to the terms of the solicitation and, as such, are waived pursuant to Blue & Gold Fleet, L.P. v. United States, 492

1 An unredacted version of this opinion was issued under seal on June 25, 2021. The parties were given an opportunity to propose redactions, but no such proposals were made . 2 3T Federal Solutions (“3T” or “awardee”) of Austin Texas is a distributor for manufacturer Nanion Technologies, GmbH of Munich Germany. Plaintiff’s Motion for Judgment on the Administrative Record at 1, ECF No. 19 [hereinafter Pl.’s MJAR]. F.3d 1308 (Fed. Cir. 2007) (“Blue & Gold”). See generally Defendant’s Response in Opposition to Plaintiff’s Motion for Judgment upon the Administrative Record, and Cross-Motion for Judgment upon the Administrative Record, ECF No. 21[hereinafter Def.’s CMJAR]. For the reasons set forth below, the Court denies plaintiff’s Motion for Judgment on the Administrative Record and grants defendant’s Cross-Motion for Judgment on the Administrative Record.

I. Background

A. Solicitation

On April 22, 2020, the FDA issued its initial RFQ, No. FDA-20-RFQ-1224178A, for the procurement of an APC device. AR 1. The Solicitation indicated that the device would be utilized by the FDA’s Division of Applied Regulatory Science “to protect and advance public health by ensuring drugs are safe and effective.” AR 7–8. Specifically, the Solicitation provided that the device would “characterize drug effects on heart ion channels[,]” as APC systems automate a technique called manual patch clamping, a critical part of electrophysiology – the study of the electrical properties of cells and tissues in the body. AR 7. In simpler terms, to utilize the device, a researcher places a drug into the APC system, and the device simulates what effect it would have on the ion channels of a person’s heart. Id.

After the receipt and evaluation of quotations, on June 9, 2020, the FDA published notice of its original contract award to 3T for a total contract value of $831,166.89. Complaint at 4, ECF No. 1 [hereinafter Compl.]. Subsequently, plaintiff and another competitor protested the award before the Government Accountability Office (“GAO”). See id. at 5; see also AR 196; AR 202. After reviewing the post-award protests, the FDA determined that the solicitation needed to be revised and took corrective action. AR 198, 218. On August 17, 2020, the FDA issued a revised RFQ, No. FDA-20-1224178B, to recompete the procurement. AR 227. On August 27, 2020, plaintiff filed a pre-award protest at the GAO, arguing that the revised solicitation was still not clear enough in various respects. AR 262–68. Upon review of that protest, the FDA decided to take corrective action once more to provide further clarifications. AR 269.

On September 11, 2020, the FDA amended the RFQ to its final iteration, FDA-20-RFQ- 1224178B, Amendment 3. AR 271–94. This amendment contains the language at issue in this case. The RFQ anticipated awarding a firm-fixed price contract for a one-year base period of service/maintenance with four one-year option periods. AR 271, 75. Further, the RFQ provided for a best-value evaluation, prioritizing technical capability over price, based on two sets of evaluation factors. AR 292.

First, there were nine “Minimum Technical Capabilit[ies],” to be assessed on a pass/fail basis. AR 292–93. One of the requirements, pertinent to this case, required the APC device to “[r]ecord from at least 48 individual cells in single hole experiments per each run” – meaning that the device must contain at least 48 wells. AR 292 (emphasis added). Another required the APC device to have a minimum success rate of 20% – meaning that for a given test run, the system had to successfully measure at least 20% of the cells it had the capacity to measure. AR

-2- 293 (“Achieve seal resistance greater than or equal to 1 gigaohm and a 20% success rate[.]”) (emphasis added)). For quotations that met the minimum requirements, the Solicitation stated that offerors would next be evaluated for “Performance Capability” on an adjectival basis. Id. The RFQ indicated that “[a] system will be given a higher technical consideration if it is capable of the following,” listed in descending order of importance:

1. Can achieve higher successful throughput in single hole experiments per each run at 37±1ºC on more than one of the 4 ionic currents that the FDA intends on studying (see link on these currents). Successful throughput is defined as the total number of cells achieving ≥ 1 gigaohm seal without using seal enhancer or elevation of divalent cations to facilitate seal formation per each chip/plate, and that the ionic current elicited in that cell exhibits signs of adequate voltage control.

2. Can achieve higher successful throughput in single hole experiments per each run at 37±1ºC on at least one of the 4 ionic currents that the FDA intends on studying (see link on these currents). Successful throughput is defined as the total number of cells achieving ≥ 1 gigaohm seal without using seal enhancer or elevation of divalent cations to facilitate seal formation per each chip/plate, and that the ionic current elicited in that cell exhibits signs of adequate voltage control.

3. Can achieve higher successful throughput in single hole experiments per each run at 23±1ºC on at least one of the 4 ionic currents that the FDA intends on studying. (see link on these currents). Successful throughput is defined as the total number of cells achieving ≥ 1 gigaohm seal without using seal enhancer or elevation of divalent cations to facilitate seal formation per each chip/plate, and that the ionic current elicited in that cell exhibits signs of adequate voltage control.

AR 293–94 (emphasis in original). Central to this case is the meaning of the term “throughput,” defined above. Finally, the RFQ stated that price would be evaluated on a “fair and reasonable” basis. AR 294.

After the issuance of the final RFQ, the FDA received questions, which it posted with answers on September 15, 2020. AR 299–301.

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