Alere Can’t Get Second Review of Rembrandt Test Kit Patent

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By Dana A. Elfin

Diagnostic test company Alere Inc. can’t get a second bite at the same apple ( Alere, Inc. v. Rembrandt Diagnostics LP , P.T.A.B., No. IPR 2017-01130, petition denied 9/28/17 ).

The Patent Trial and Appeal Board rejected Alere’s request to review the validity of certain claims in Rembrandt Inc.'s drug test kit patent, finding it didn’t show why it couldn’t have raised the challenges in an earlier challenge it filed on the same patent.

The PTAB declined Alere’s invitation to review for a second time U.S. Patent No. 6,548,019, which claims a kit, including test cups and test strips, that can be used to collect and quickly screen urine samples for illicit drugs or other substances. The Sept. 28 decision to deny a second review of the Rembrandt patent reflects the board’s concern about the high potential for abuse of the patent review process posed by multiple petition filings by the same petitioner against the same patent.

Seven-Factor Test

In this case, Alere and its subsidiary and co-petitioner Innovacon had already brought a challenge to the ’019 patent before the PTAB in 2016. The board instituted review of some of the patent claims in February but not on the claims Alere pressed in its second request. Determining it shouldn’t institute a second review of the patent, the board applied a seven-factor test it set out Sept. 6 in Gen. Plastic Indus Co. v. Canon Kabushiki Kaisha.

Some of these factors include:

  •  whether the same petitioner filed an earlier challenge at the PTAB directed to the same claims of the same patent;
  •  whether the petitioner knew or should have been aware of the prior art asserted in the second petition when the petitioner filed the first petition; and
  •  whether the petitioner provided sufficient explanation of the time elapsed between filing the multiple petitions.
A majority opinion filed by Administrative Patent Judge (APJ) Jon Tornquist said all of the General Plastic factors weighed against instituting a second review of the Rembrandt patent.

The board also noted a Nov. 7 final hearing was already scheduled on the first petition and, even if it had agreed to hear the second petition, it would have been too late to join the two cases.

Concurring Opinion

But the board didn’t need to go through an exhaustive analysis to deny the request, APJ Christopher L. Crumbley said in a separate concurring opinion.

“The instant Petition contains no justification for Petitioner’s subsequent challenge, or explanation why the grounds presented were not brought at the time of the first Petition,” Crumbley said. This alone, he said, was enough for the board to deny review.

Bloomberg BNA contacted the parties for comment on the board’s decision but no one was available to respond.

Abbott-Alere Deal

Alere, based in Waltham, Mass., is set to be acquired by Abbott Laboratories if the companies receive final Federal Trade Commission approval. The FTC tentatively approved the deal Sept. 28 on the condition Abbott sell two point-of-care medical testing businesses it owns: a blood gas testing system and a cardiac marker system.

Meanwhile, the Justice Department closed an investigation into the company’s sales, sales practices, and dealings with certain third parties—primarily occurring at previously acquired foreign subsidiaries, without taking any action against Alere, the company said in a Sept. 29 statement.

Rembrandt is suing Alere and Innovacon in California district court, alleging Alere’s sales of competing test cups infringes the ’019 patent and an additional patent covering dip testing devices.

APJ Brian P. Murphy also joined the majority opinion.

Goodwin Procter LLP represented Alere and Innovacon. Innovacon, based in San Diego, is a wholly owned subsidiary of Alere.

Knobbe Martens Olson & Bear LLP represented Rembrandt, based in Bala Cynwyd, Pa.

To contact the reporter on this story: Dana A. Elfin in Washington at

To contact the editor responsible for this story: Brian Broderick at

For More Information

The PTAB's decision is at

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