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Legal Probe PCR Goes Back to Court

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Thought PCR lawsuits were over? Think again. This time, Applera charges that Roche breached a licensing agreement and damaged Applera’s standing in the field

No matter what your specialty, chances are, your job at least occasionally involves using PCR. Kary Mullis’ invention has become a ubiquitous laboratory technique — and that’s probably the single biggest reason it’s always a hot topic for litigation.

Exhibit A: Last year, Promega won a critical lawsuit against PCR patent holder Roche, and judges declared the original Taq patent invalid. Promega is still going after Roche for its follow-on enzyme patents in what promises to be a years-long, multi-court event.

Last October, the PCR scene heated up again when Applera filed a lawsuit against Roche for violating the companies’ patent-licensing agreement. The relationship between the two companies is tricky, to say the least. According to the complaint Applera submitted to California’s Superior Court, the original patent rights were owned by Applera and Cetus, where Mullis worked at the time of his invention. Roche later bought out Cetus and took over its part of the joint venture. In 1991, Applera and Roche signed the first of several agreements governing how they would split up rights to the lucrative PCR patent estate.

Because of that joint positioning, to this day PCR users have to figure out which company controls the rights to the patent that pertains to their work, and pay any licensing fees accordingly. Not surprisingly, that relationship has made for tough navigation over the years.

As most people understand it, Roche controls rights pertaining to PCR for diagnostics, and Applera has rights to research-based PCR. But Roche attorney Steve Zovickian of Bingham McCutchen assures me that it’s far more complicated than that. Indeed, I have yet to find someone who can sum up the real boundaries of each company’s IP holdings.

The current lawsuit will likely have little or no effect on scientists in the near future. At press time, Zovickian was preparing to argue the first motions in court in mid-February, and top on his agenda was Roche’s push for the suit to be sent to arbitration. If that happened, Zovickian says, the lawsuit would probably be handled by a three-member arbitration committee. (Unfortunately, I can’t say what Applera is pushing for, or whether it has filed any motions. The company declined to give its lawyers permission to explain their lawsuit to me.)

Applera’s lawsuit alleges that Roche violated the bounds of the companies’ licensing agreement, and charges that Roche has damaged Applera’s standing in the PCR arena by not filing for patent continuations and other protections that would have strengthened Applera’s side of the territory. If that’s actually true, it could mean that a few years have been shaved off Applera’s command of the market.

Applera also brings up an order from the European Union Commission, which according to the complaint rejected Roche’s bid to merge with Boehringer Mannheim on antitrust grounds — and as a safeguard, threw in an order forcing Roche to give access to PCR technology for diagnostics to all interested parties. Applera argues that Roche discriminated against it by making the company jump through unfair hoops for its diagnostic license, including a requirement that Applera buy all its PCR enzymes from Roche.

No matter what happens with the lawsuit, another factor lurks in the background: the expiration of the original PCR patent next year. That alone could mean most scientists using generic enzymes and license-free equipment would finally be free of PCR royalty payments.

As for the Applera-Roche case, it’s anybody’s guess what will come of it — and even if it will make it to trial. If it does, says Zovickian, “It would take no less than a year.” One thing he can say for sure: For scientists worried that the conflict might have an impact on their work, “It’s business as usual right now.”

 

Meredith Salisbury, editor of Genome Technology, can be reached at msalisbury @genomeweb.com. Her Legal Probe column on legal and IP issues affecting the genomics industry appears bimonthly.