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Banned in the EU: Eppendorf Takes Steps to Block European Sales of Nanosphere Products

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This article was originally published on Dec. 18.

By Justin Petrone

In the latest twist of an ongoing IP dispute, Eppendorf announced last week that it has taken steps to ensure that products sold by Nanosphere will be confiscated upon shipment to European Union member states, including Eppendorf's home country of Germany, because they allegedly infringe Eppendorf patents that relate to microarray-based products.

The company said last week that it has initiated an import ban that would cover any and all imports of Northbrook, Ill.-based Nanosphere's Verigene and Verigene SP systems.

"It is approved and in effect," said Sven Bülow, managing director of Eppendorf Biochip Systems.

In its filing for the ban, Hamburg-based Eppendorf argued that the Verigene products infringe European patent EP1179180 B2, entitled "Method for the identification and/or quantification of a target compound," as well as German utility model DE 20023342U1, both of which cover Eppendorf's Silverquant array-based colorimetric technology.

The Verigene System is a benchtop molecular diagnostics workstation that uses patented gold nanoparticle technology to detect nucleic acid and protein targets of interest for a variety of applications, according to Nanosphere. The Verigene SP is a benchtop, free-standing instrument with a single, independent sample processing module.

Nanosphere has announced that it had received a CE Mark for Verigene and is seeking European distributors to market and sell the system. That prompted Eppendorf to take action to block the sales of Nanosphere's products in the EU.

"Nanosphere has announced that they are looking for distributors in Europe and other countries and that they have received a CE Mark," Bülow told BioArray News last week. "Since in our very clear opinion their Verigene system violates our intellectual property, this was a relatively fast action we could take."

Eppendorf's import ban is based on a European regulation designed to prevent imports of products violating trademarks, copyrights, utility models, and patent rights. The company's specific action is based on Article 5, Section 2 of Council Regulation (EC) No 1383/2003, "Concerning customs action against goods suspected of infringing certain intellectual property rights and the measures to be taken against goods found to have infringed such rights."

To implement the ban, Eppendorf filed an application with German federal customs authorities. Once granted, the ban became effective in all 27 EU member states.

"This type of import ban is frequently used to keep pirated and trademark-imitating products out of the EU, things like fake Gucci bags or fake Nike t-shirts or, in the case of the pharmaceutical industry, fake Viagra," Bülow said. He added that he was unaware if such a ban had been implemented by a biotech company before.

In a statement, Nanosphere said that no IP litigation had been filed against it in Europe, "nor have we been notified of any ban on the sale of our products." But Bülow said it was unlikely Nanosphere would be notified of the ban. "As far as I know, the approval process does not include any notification other than the notification of the customs authorities of the respective EU countries," he said. "The [customs] authorities, if they find the products, would simply confiscate them."

The move comes five months after Eppendorf filed a suit in the US District Court for the District of Delaware against Nanosphere, claiming that it has willfully infringed on a patent covering its Silverquant microarray technology. The patent at the center of that case is US patent No. 7,321,829, and is titled, "Method for the identification and/or the quantification of a target compound obtained from a biological sample upon chips." Eppendorf is seeking "treble damages of substantial magnitude" and legal fees.

In September, Nanosphere denied infringing the patent, and filed a counterclaim seeking judgment that the claims of the '829 patent are invalid and unenforceable. A trial date has been set for Nov. 1, 2010.

Bülow said that Eppendorf is willing to license its IP, and has done so with several other companies. For instance, Madison, Wis.-based Gentel Biosciences took a license to Silverquant last year (see BAN 6/3/2008)."We have offered Nanosphere a license at very reasonable terms within the framework of our industry prior to taking any legal action," Bülow said. "Now it is up to them to approach us. We are not willing to give anyone a free ride on our issued IP."

Eppendorf’s Silverquant system is based on its colorimetric Silverquant staining technology, which allows the detection of any biotinylated biomolecule, providing light grey-to-black spots that can be visualized first by the naked eye and then subsequently scanned with Eppendorf’s Silverquant scanner. The company believes its system offers technical and cost advantages over fluorescence-based detection methods.

Eppendorf currently sells DualChip arrays for gene expression, transcription-factor profiling, and the monitoring of genetically modified organisms, all of which run on the Silverquant system. Bülow said that Eppendorf is "still in the early stages" of developing its Silverquant microarray business, and that future kits are likely to be made available in the GMO and TF profiling areas, where the company feels it has a strong IP position. Eppendorf is also developing a molecular diagnostic platform, called real-time PCR or RAP, which "promises to become the future focus of their microarray business," Bülow added.

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