IVD Market Update

Beckman Coulter Sues Quidel for Right to Sell BNP Assay

THERE IS AN INTERESTING COURT FIGHT UNFOLDING between Beckman Coulter Corporation and Quidel over the rights to sell a B-type natriuretic peptide (BNP) assay. The lawsuit is a consequence of Abbott Laboratories’ acquisition of Alere, Inc., last fall.

With that acquisition, Abbott Laboratories became the world’s largest manufacturer of point-of-care (POCT) lab tests. But federal anti-trust regulators required Abbott to divest and sell certain Alere assets as a condition for government approval of the merger. (See TDR, Oct. 30, 2017.)

That is how the BNP test then became the subject of litigation between Beckman Coulter and Quidel. It is a court fight that should be of particular interest for those clinical labs that currently use Beckman analyzers to run BNP tests.

On November 27, 2017, Beckman Coulter issued a press release in which, among other things, it said it had “requested that the San Diego courts in California clarify and enforce Beckman Coulter’s rights to sell a natriuretic peptide assay directly to its customers.”

In the lawsuit, filed on Nov. 27, Beckman Coulter said it seeks a court ruling to allow it to sell its own BNP test, using proprietary technology that it had originally developed.

In 1997, Biosite Diagnostics Inc., licensed rights to the BNP marker from Scios, Inc. In 2003, in an arrangement with Biosite Diagnostics Inc., Beckman had helped Biosite develop a BNP assay.

The history of this BNP test and technology—and the rights to them—is complex. A timeline on page 18 helps to understand the developments.

Beckman’s Plans For BNP

“Beckman Coulter plans in the future to sell directly to its customers a natriuretic peptide assay for its Access Family of Immunoassay Systems,” said the company in its November 27 press release. “Currently, Beckman Coulter customers have access to a BNP assay which, although developed and manufactured by Beckman Coulter, is sold exclusively by Quidel and its designated distributors.”

Quidel responded in a follow-up press release the same day, stating, “Quidel views Beckman’s claims as meritless, and in opposition to Beckman’s long-standing strategy of honoring the Supply Agreement with its previous partners— Alere and Biosite—over the last 14 years, and merely a tool in an effort to purchase the BNP assay business from Quidel.”

Beckman Coulter is seeking rights to sell B-type natriuretic peptide (BNP) assays directly. Currently, the TRIAGE BNP Assay is sold exclusively by Quidel due to rights obtained in the $680-million October purchase of Alere assay assets.

In the current arrangement, Quidel provides proprietary antibodies to Beckman Coulter under a license from Scios. Beckman Coulter then manufactures the assays for sale by Quidel. Quidel then sells these assays for use in its POC instrument. It also sells the assay to labs that perform the BNP test on Beckman Coulter analyzers.

Quidel claims that as long as the Scios license is in effect, the supply agreement previously in place—including a non-compete clause—remains in effect as well.

The agreement initially came from Biosite during its 2007 acquisition by Inverness Medical Innovations—who changed its name to Alere in 2010. A potential merger between Biosite and Beckman Coulter was planned. However, Inverness Medical Innovations entered a higher bid.

Alere’s recent acquisition by Abbot required divesting of certain assets—one of which is the TRIAGE BNP Assay. Quidel bought the rights to the assay on October 6, 2017, thereby transferring the terms of the supply agreement from Alere to Quidel.

Quidel Rejected Offers

Quidel claims that “in recent weeks,” Danaher—parent firm of Beckman Coulter—submitted multiple offers to acquire the BNP assay business. The board of directors rejected these offers, citing the potential of their latest acquisition to “create substantial long-term value for Quidel’s shareholders.”

Analysts at The Motley Fool speculate that the recent court filing from Beckman Coulter might be used to increase leverage on the board of directors at Quidel and encourage the sale of the BNP assay assets instead of entering a lengthy—and potentially costly—litigation and defense of their existing rights.

Until an outcome is reached—either in negotiations or a win by Beckman in court—Quidel continues to maintain the exclusive right to sell TRIAGE BNP assays to customers for use on Beckman Coulter analyzers.

Timeline Shows BNP Test Development, Licensing

IT WAS ON DEC. 30, 1996, when Biosite Diagnostics Inc.—then a public company based in San Diego—signed an agreement with Scios, Inc., whereby Scios granted Biosite “a semi-exclusive license under the Patent Rights and Know-how to make, have made, use, offer for sale, sell, and import” a diagnostic product using Scios’ patents relating to B-type natriuretic peptide (BNP).

In November 2000, Biosite received FDA clearance for the Triage BNP assay of which sales rights are now in question.

In 2003, Beckman entered into a BNP Assay Agreement with Biosite. Beckman developed the BNP assay as part of this agreement. Several years later, Biosite obtained FDA clearance to perform the assay using capillary whole blood. In 2006, the BNP assay received a CLIA waiver.

Beckman Coulter announced its intention to buy Biosite in March 2007. At this time, Biosite had the sales rights to the BNP assay for use with Beckman analyzers. However, Inverness Medical Innovations entered a competing offer. It outbid Beckman Coulter. Inverness paid $1.68 billion to acquire Biosite in mid-2007.

As the new owner of Biosite, Inverness Medical Innovations also acquired the BNP licensing agreement with Scios.

In 2010, Inverness Medical Innovations announced it had changed its name to Alere, Inc. Six years later, Abbott Laboratories initiated talks to buy Alere. To meet antitrust approvals, Alere had to divest its Triage MeterPro and Triage BNP businesses. Abbott also holds a semi-exclusive license with Scios from May 29, 1997.

In October 2017, Quidel acquired these businesses from Alere so as to improve its POCT offerings. This again transferred the Scios BNP license—now to Quidel.

Less than two months later, Beckman Coulter filed its lawsuit against Quidel in a San Diego court. At the time of writing, a hearing is scheduled for February 16, 2018.

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