Quidel Corporation v. Super. Ct.

CourtCalifornia Court of Appeal
DecidedAugust 29, 2019
DocketD075217
StatusPublished

This text of Quidel Corporation v. Super. Ct. (Quidel Corporation v. Super. Ct.) is published on Counsel Stack Legal Research, covering California Court of Appeal primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Quidel Corporation v. Super. Ct., (Cal. Ct. App. 2019).

Opinion

Filed 8/29/19 CERTIFIED FOR PUBLICATION

COURT OF APPEAL, FOURTH APPELLATE DISTRICT

DIVISION ONE

STATE OF CALIFORNIA

QUIDEL CORPORATION, D075217

Petitioner,

v. (Super. Ct. No. 37-2017-00044865-CU- THE SUPERIOR COURT OF SAN AT-CTL) DIEGO COUNTY,

Respondent;

BECKMAN COULTER, INC.,

Real Party in Interest.

ORIGINAL PROCEEDING in mandate challenging an order of the Superior

Court of San Diego County, Gregory W. Pollack, Judge. Petition granted.

Horvitz & Levy, Jeremy B. Rosen, Robert H. Wright, Stanley H. Chen; Charis

Lex, Sean P. Gates, Eugene Illovsky, Douglas J. Beteta; Kesselman Brantly Stockinger,

Amy T. Brantly and Trevor V. Stockinger, for Petitioner.

No appearance for Respondent. California Appellate Law Group, Anna-Rose Mathieson, Susan Horst; Behmer &

Blackford, Timothy S. Blackford; Williams & Connolly, John E. Schmidtlein and Carl R.

Metz, for Real Party in Interest.

Quidel Corporation (Quidel) has petitioned for a writ of mandate and/or

prohibition directing the trial court to vacate its order granting summary adjudication.

Quidel contends the trial court incorrectly concluded a provision in its contract with

Beckman Coulter, Inc. (Beckman) was an invalid restraint on trade in violation of

Business and Professions Code,1 section 16600. Quidel argues the trial court improperly

extended the holding from Edwards v. Arthur Andersen LLP (2008) 44 Cal.4th 937

(Edwards) beyond the employment context to a provision in the parties' 2003 BNP Assay

Agreement (the Agreement). We are called upon to determine whether the trial court's

per se application of section 16600 to section 5.2.3 of the Agreement between Quidel and

Beckman was correct. We conclude it was not, and we grant the petition and issue a writ

instructing the trial court to vacate the December 7, 2018 order granting summary

adjudication on the first cause of action.

FACTUAL BACKGROUND

In 1996, Biosite Inc. (Biosite)2 licensed patent rights and know-how related to a

B-type natriuretic peptide (BNP), which can be measured in a person's blood. The semi-

1 Future section references are to the Business and Professions Code unless otherwise specified.

2 As a result of acquisitions, Quidel is the successor in interest to Biosite, and Quidel is the current counter-party to Beckman under the BNP Assay Agreement. 2 exclusive licensing agreement allowed Biosite to develop an immunoassay to determine

the level of BNP in a person's blood sample, to help diagnose congestive heart failure.

After acquiring the intellectual property rights and know-how, Biosite developed and

created a BNP assay for use with its point-of-care analyzer device, and it obtained

regulatory approval. BNP assays only work on the analyzer for which they are designed.

By 2003, Beckman had developed a laboratory analyzer, but it did not have a

license for a BNP assay compatible with its analyzer. Around this same time, other

companies were also pursuing BNP assays for use with their larger analyzers, which

could run multiple, different immunoassays at higher volumes than the point-of-care

analyzer Biosite had. One company was also developing an assay to detect NT-proBNP,

a closely-related assay that is a potential direct substitute for the BNP assay and is also

based on B-protein.

If Biosite were to correlate a new BNP assay for use with the Beckman lab

analyzer to its Federal Drug Administration-approved BNP assay, it could avoid the need

to establish the new assay's efficacy through extensive clinical trials. Collaborating

would mean Biosite could expand its customer base to those who wanted to use the larger

capacity laboratory analyzers and Beckman could include the BNP assay in its menu of

immunoassay offerings.

Biosite and Beckman, each represented by legal counsel, negotiated the

Agreement over several months, and they exchanged numerous drafts before executing it

on June 24, 2003. Under the terms of the Agreement, Beckman manufactured the BNP

assay for Biosite using proprietary materials that Biosite provided, including the

3 antibodies Biosite had developed. In exchange, Biosite purchased its requirements of the

BNP assay from Beckman. The Agreement prohibited Biosite from engaging other

manufacturers to provide the BNP assay for their competing lab analyzers. The term of

the Agreement was negotiated to coincide with the term of a related licensing agreement

Biosite had with Scios.

Section 5.2.1 of the Agreement requires Beckman to offer for sale and to sell the

BNP assay exclusively to Biosite. Section 5.2.2 prohibits Biosite from engaging third

parties other than Beckman to manufacture for Biosite a diagnostic BNP assay for use.

Section 5.2.3 of the Agreement prohibits Beckman from researching or developing an

assay that detects the presence or absence of the BNP or NT-proBNP proteins or markers

for use in diagnosing cardiac disease until two years before the Agreement's expiration.

It does not prohibit the research or development of assays that detect the presence or

absence of other proteins or markers, including the biomarkers ST2 or Galectin 3.

Although Beckman did not dispute that BNP and NT-proBNP assays were seen as

and have become potential substitutes for purposes of the motion for summary

adjudication, the parties' characterization of the BNP assays and NT-proBNP assays are

slightly different. Quidel characterizes the two as closely-related, with the NT-proBNP

assay serving as a potential direct substitute for the BNP assay because it detects a

peptide that is secreted alongside the BNP. Beckman has alleged the NT-proBNP assay

measures a different protein and uses different antibodies and proteins than the BNP

assay, suggesting they are distinctly different.

4 PROCEDURAL HISTORY

On November 27, 2017, Beckman sued Quidel for declaratory relief for violation

of section 16600 and violation of the Cartwright Act (§ 16720 et seq.). Beckman asked

the court to issue a declaratory judgment that section 5.2.3 of the Agreement was void

and unenforceable as a violation of Business and Professions Code section 16600 and to

issue a permanent injunction preventing the enforcement of section 5.2.3 of the

Agreement.

In August 2018, Beckman filed a motion for partial summary adjudication on the

declaratory judgment cause of action. In its papers, Beckman stated it was developing

and planning to launch a new laboratory analyzer platform and wanted to develop a

competing assay product for the new platform. It argued section 5.2.3 of the Agreement

was a non-compete clause that was void under Business and Professions Code

section 16600.

On November 7, 2018, Quidel moved ex parte for a continuance of the motion. In

the hearing, Quidel argued additional discovery was necessary to determine if there were

material issues of fact in dispute. Beckman contended there was no need for additional

discovery to determine the impact of section 16600 on the parties' Agreement. The court

denied the ex parte request.

The trial court ultimately granted Beckman's motion for summary adjudication. It

noted none of the statutory exceptions to the restraint on trade outlined in section 16600

apply and explained it was unpersuaded by the legal authority cited by Quidel because it

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