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Court Dismisses False-Marking Suit Against Firms Marketing Nucleic Acid Analysis Tools

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A US district court has dismissed a lawsuit filed earlier this year against more than a dozen life science companies alleging that they falsely marked certain nucleic acid detection, amplification, and cloning technologies as being patented after the relevant patents expired.

However, the court also granted the plaintiff, intellectual property watchdog firm Troll Busters, 30 days' leave to amend certain deficiencies in its complaint — namely, the citation of specific instances of false patent marking by the defendants.

The original lawsuit, filed in January in the US District Court for the Southern District of California, accused 13 life science tool vendors, including Roche and Life Technologies, of falsely marking products or services based on a number of expired patents, include those pertaining to nucleic acid polymerase detection, nucleic acid sequence amplification, methods for generating DNA through PCR, cloning of nucleic acids, and other related technologies.

The qui tam suit alleged that each of the defendants "has and continues … to mark upon, affix to, and/or use expired patents in advertising, sales, and promotion through online sales channels and in providing their products through the Internet."

In addition, the suit had claimed that the defendants, "with the purpose of deceiving the public, make, sell, advertise or have made, sold, advertised or at least have required either suppliers and/or consumers to obtain licenses in one or more of the 15 expired patents," a number that was later amended to 22.

Besides Life Tech and three Roche divisions — Roche Diagnostics, Roche Molecular Systems, Roche Applied Sciences — the defendants are Qiagen, Thermo Fisher Scientific, Cepheid, Clontech Laboratories, Eurogentec North America, Integrated DNA Technologies, Quanta Biosciences, Trilink Biotechnologies, GeneScript, and EMD Chemicals.

In a decision handed down on Aug. 31, the court granted the defendants' motions to dismiss the case for failure to state a claim. The defendants argued that Troll Busters' complaint failed to plead with sufficient particularity either the conduct constituting false marking in violation of 35 USC Section 292; or that the defendants acted with intent to deceive.

In its decision, the court determined that Troll Busters sufficiently alleged the "who," but did not sufficiently allege "when" false marking occurred.

"Plaintiff alleges defendants' false marking is ongoing [and] plaintiff identifies each of the patents and their expiration dates," the court wrote in its decision. "However, the [complaint] gives defendants no notice of when, within that time period" they engaged in false marking in violation of 35 USC Section 292.

Instead, the court wrote, Troll Busters "pleads much of its complaint 'on information and belief' and based upon its 'knowledge through searching the Internet web sites" of the defendants. In addition, it said that Troll Busters' complaint does not sufficiently identify "where" the false marking occurred.

"Most troubling, however, is plaintiff's failure to allege with particularity 'what' statements by defendants constitute false marking and 'how,'" the court wrote. Plaintiff argues the offending conduct is the use of the expired patents 'in advertising in connection with any unpatented article,' [but] it is ordinarily insufficient to allege claims sounding in fraud 'on information and belief.'"

Similarly, the court decided that "even assuming the [complaint] alleges sufficient facts regarding defendants' conduct, plaintiff has not pleaded facts with sufficient particularity to support the allegation that defendants engaged in false marking with an intent to deceive."

However, the court also granted Troll Busters a leave to further amend its complaint, stating that if Troll Busters "could identify the website (or online publication) it reviewed, the date on which it was reviewed, and identify one or more of the statements it contends constitutes false marking," that pleading with such a level of specificity "would provide factual basis for alleging 'on information and belief'" that the defendants engaged in false marking.

The court granted Troll Busters 30 days from the date of its decision to file an amended complaint. It is unclear whether the firm will do so. A phone call and e-mail to Troll Busters were not immediately returned.

Troll Busters is also pursuing a separate patent reexamination of a patent owned by Roche and related to nucleic acid amplification and detection methods in clinical research and diagnostics, and has said that it plans to file additional similar reexaminations to challenge what it perceives as a "PCR patents duopoly" enjoyed by Roche and Life Tech, Troll Busters representative Jeff Oster told PCR Insider in June (PCR Insider, 6/23/11).

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