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Biosearch Countersues Life Tech, Denies Infringement Allegations in PCR Probe Patent Battle


By Ben Butkus

Biosearch has denied all allegations set forth by Life Technologies in a previously filed patent-infringement lawsuit revolving around the use of fluorescence-quenched oligonucleotide probes in PCR, diagnostics, and other DNA analysis applications, according to a recently filed court document.

In addition, Biosearch has filed its own counterclaims against Life Tech, alleging breach of contract, unfair advertising and competition, and patent infringement, among other misdeeds.

This most current legal spat between the companies began in January when Life Tech filed a suit in the US District Court for the Southern District of California alleging that Biosearch infringes upon US Patent No. 7,160,997, which pertains to methods of using fluorescent energy transfer-labeled oligonucleotides that include a 3'-to-5' exonuclease-resistant quencher domain (PCR Insider, 1/6/2011).

Specifically, the suit claims that Biosearch is infringing one or more claims of the '997 patent through the manufacture, sale, and use of its BHQplus probes for quantitative PCR applications.

In a document filed last month with the same court, Biosearch said that it "denies each and every allegation contained in Life Tech's complaint;" and presented several defenses including assertions that Life Tech failed to state a claim; that Biosearch has not infringed the '997 patent; and that the patent is invalid.

Further, Biosearch asserts, among other defenses, that Life Tech has a lack of standing to sue, acted unethically in its filing, and failed to pursue its infringement claims in a timely manner. Biosearch has asked the court to dismiss any and all claims made against it by Life Tech; to judge the '997 patent and its claims invalid; and to award Biosearch costs of suit and attorney's fees.

In addition to denying Life Tech's original allegations, Biosearch has made several of its own counterclaims. First, Biosearch alleges that Life Tech has engaged in breach of contract, claiming that its predecessor, Invitrogen, entered into an end-user license agreement with Biosearch in 2001 that allowed Invitrogen to use Biosearch's BHQ probes for research and development applications only but prohibited their use in commercial, clinical, or diagnostic applications.

Biosearch notes in the court documents that in 2009, a year after Invitrogen acquired Applied Biosystems to form Life Tech, the US Centers for Disease Control selected its BHQ technology for use in H1N1 probes, and arranged to purchase the probes from a third-party supplier, Glen Research.

However, according to Biosearch, Life Tech knowingly purchased the same BHQ probes from Glen Research under the terms of the end-user agreement, purportedly for use in research applications, but subsequently "sold, and continues to sell probes labeled with Biosearch's BHQs at least as part of or in connection with the Influenza A (H1N1) primer and probe set marketed and sold under the Invitrogen brand, which may be used to clinically diagnose swine flu," the complaint states.

This H1N1 kit is still sold by Life Tech, for commercial, clinical, and/or diagnostic purposes, Biosearch claims. As such, Biosearch has countersued Life Tech for breach of contract for not adhering to the end-user license agreement; for unfair advertising and competition, intentional interference with prospective economic advantage, and common law unfair competition.

As part of those allegations, Biosearch specifically noted that Life Tech "developed a scheme to exploit the fact that it was using the CDC-approved BHQs" and used its "worldwide sales organization to market the H1N1 probes with BHQs."

Biosearch also claims that, for example, in 2009 it was approached by Gene Logic, an Ocimum Biosolutions subsidiary, to manufacture and supply approximately $10 million to $15 million worth of Biosearch H1N1 kits for the Indian market; but that Life Tech purchased the same probes from Glen Research for a reduced RUO price and "advertised to Gene Logic and other potential suppliers to the Indian market that it had the right to sell commercially Biosearch's BHQs or products incorporating the BHQs."

Lastly, Biosearch claims that Life Tech is infringing upon three US patents issued to Biosearch — Nos. 7,019,129; 7,109,312; and 7,582,432, all entitled "Dark Quenchers for Donor-Acceptor Energy Transfer" — by "making, using, selling, and/or offering for sale oligonucleotide probes incorporating BHQs that infringe" the claims of the patents.

Biosearch has asked the court to rule that Life Tech has breached the end-user license agreement; that it has engaged in unlawful and unfair competition and unfair advertising; and that it has intentionally interfered with Biosearch's prospective economic advantage.

Further, Biosearch has requested that the court enjoin and restrain Life Tech from using BHQs in violation of the end-user license agreement or from advertising in connection with at least the H1N1 kit; and that it award Biosearch damages, the value of any profits Life Tech has made related to the allegations, royalties, and court and attorney's fees.

Biosearch and Life Tech are also currently embroiled in another legal battle surrounding similar technologies: In September 2009 Life Tech sued Biosearch Technologies in the US District Court for the Eastern District of Texas Marshall Division for allegedly infringing five patents not covered in the aforementioned suit in the US District Court for the Southern District of California.

The patents in that suit — Nos. 5,538,848; 5,723,591; 5,876,930; 6,030,787; and 6,258,569 — cover various aspects of "dual-labeled probes incorporating a quencher and fluorophore reporter covalently linked to the 3' or 5' ends of an oligonucleotide [and] used to monitor DNA amplification in real-time."

The most recent filing in that lawsuit was an order by the court to grant a motion for extension of time to file, one of several such similar motions granted thus far.

Have topics you'd like to see covered in PCR Insider? Contact the editor at bbutkus [at] genomeweb [.] com.

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