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German Court Sets Conditions for Removal of Injunction on MJ s RT-PCR Thermal Cyclers

Biozym Diagnostik, which has been barred from selling MJ Research’s real-time PCR thermal cyclers in Germany since June, has the option of getting back into the business, BioCommerce Week has learned.

One week after the European Patent Office revoked Applera’s real-time PCR instrumentation patent, the Appellate Court of D sseldorf decided on conditions for lifting the injunction against Biozym, co-CEO Winfried Duven told BioCommerce Week. Biozym, based in Hessisch Oldendorf in Lower Saxony, is MJ Research’s exclusive distributor for thermal cyclers in Germany and Austria.

The court, the Oberlandesgericht, decided that the injunction may be lifted if Biozym makes an escrow deposit of €1 million with the court, according to Duven. “We are thinking about doing that, but we have not yet made a decision,” he said.

The market for real-time PCR instruments, which is currently dominated by Applied Biosystems, is growing. The technology, invented in the early 1990s, allows researchers to quantify DNA by measuring PCR products online during the amplification. The outcome of this and other patent disputes will determine the role of the market players in the future. According to Frost and Sullivan, ABI holds a 50-percent share in the market for real-time thermal cyclers, while Bio-Rad’s share is 12 percent, followed by Roche (9 percent), and MJ Research, which was acquired by Bio-Rad in August, with 6 percent.

Applied Biosystems obtained injunctions against Bio-Rad Laboratories, MJ Research, and Biozym in June, prohibiting these companies from manufacturing and selling thermal cyclers for real-time PCR in Germany.

At the time, the court found that the defendants infringed on a German patent corresponding to Applera’s European patent, EP 0872562 B1. But the EPO revoked that patent two weeks ago, accepting as prior art a research report that was available to a number of scientists before the patent application was filed (see BioCommerce Week 12/15/04).

In April 2003, ABI obtained a similar injunction against Bio-Rad in Japan based on Applera’s Japanese patent.

The injunctions in Germany have seriously impacted Biozym’s business, which focuses exclusively on the distribution of MJ Research thermal cyclers, said Duven. “We have lost a tremendous amount of customers, a tremendous amount of money,” he said.

The amount of revenues lost this year “comes close to” €1 million, he said.

The final outcome of the dispute in Germany hinges on the decision of the EPO’s Board of Appeal on Applera’s patent, which is not expected before the end of 2006. If the board upholds the revocation of the patent, Biozym may consider seeking damages from Applera, Duven said.

But even if ABI can no longer prevent other companies from selling RT-PCR instrumentation in Europe, its patent estate remains untouched in the US and in Japan. Last month, Applera was granted a US patent, No. 6,814,934, entitled “Instrument for monitoring nucleic acid amplification” and immediately sued Bio-Rad, its MJ Research subsidiary, and Stratagene for infringement, seeking a permanent injunction against all three parties.

The US patent is unlikely to be revoked, according to industry experts, because in the US, it is not the priority date of the patent application but the date on which the invention was made that is relevant in terms of earning patent protection.

The best solution, in Duven’s opinion, would be if Bio-Rad and MJ Research negotiated a licensing agreement with Applera.

A spokesperson for Applera said the company had no comment on the German court’s decision, or on whether it would consider granting a license for its US and Japanese RT-PCR patents to Bio-Rad and MJ Research.

Bio-Rad’s CFO, Christine Tsingos, said that the company does not comment on ongoing litigation.

— Julia Karow ([email protected])

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