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IT-IS Lawsuits Versus Roche Focus on LightCycler qPCR Instrument

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IT-IS International, a privately owned product development company specializing in the life sciences, has filed a pair of lawsuits in Germany against Roche for allegedly infringing intellectual property belonging to IT-IS and breaching a confidentiality disclosure agreement related to quantitative PCR technology.

Specifically, London-based IT-IS disclosed this week that in August it filed the infringement action against Roche in an intellectual property court based in Düsseldorf and the CDA action in a court in Mannheim. In its suits, IT-IS alleges that in 2008 it shared a prototype for a qPCR instrument with Roche under a CDA as part of a tender process. The company said that it also filed for a European patent for the technology.

IT-IS also alleges that in 2010 it was told the tender process and project had been cancelled, and in 2012 Roche launched its own branded product to the market. The company believes that the Roche product — the LightCycler 96 qPCR instrument — is "clearly based on unique intellectual property and technology developed by IT-IS and shared with Roche under [the] CDA," the company said in statement.

Further elaborating on the lawsuits, James Howell, co-founder and managing director of IT-IS, and IT-IS CEO Roderic Fuerst explained to PCR Insider this week that the lawsuits directly relate to a specific fiber optic technology developed by IT-IS, disclosed to Roche under the CDA, and later used by Roche in the LightCycler 96.

"We developed technology from 2005 to 2008, and then in 2008 we shared that technology with Roche for assessment purposes under a CDA" that Roche authored, Howell said.

"We believe that Roche used this information that was shared with them in their product," Howell added. "Not only that, we protected the idea with intellectual property. We're a small company and basically our lifeblood is our ideas and the IP that we have, and we've got to protect it. We don't really feel that large multinationals should be able to profit from ideas and innovations from smaller companies without compensation, just taking them without permission."

Fuerst added that in the case of the particular fiber optic technology applied to the LC96, "Roche said they were interested in the technology for developing a 96-well-plate instrument, and actually … started a [feasibility] project with us … to start work on the system based on that IP. Then they cancelled the project; at least that's what they told us — that they'd decided not to bring this product to market."

"And much to our surprise, a few years later, the LightCycler 96 was launched incorporating technology that we had disclosed to them under [the] CDA and in fact were protecting with patents," he added.

Howell referenced specific marketing materials from Roche that promote how the fiber optic technology, which performs both excitation and collection of fluorescence data above each well, is responsible for the superior performance of the instrument.

"There is a presentation [from Roche] that notes these optics that give wonderful data, developed by [Roche] engineers — that's a real kick in the teeth for us," Howell said. "We have a disclosure of the exact layout of fibers, in our opinion, even down to the same fiber optics being used and mounted in the same way, reading the plate from above with excitation and emission fibers. That's something [that had] not been done before."

Roche commercially launched the LightCycler 96 in November 2012, with company officials telling PCR Insider that the instrument closed "a very important gap" in Roche's qPCR instrumentation portfolio because of its mid-range throughput and price. At that point in time Roche was already selling the LightCycler 480, which allows users to switch between a 96- and 384-well plate format, and can be integrated with laboratory automation systems; the LightCycler 1536, its highest throughput and most expensive system; and the LightCycler Nano, a 32-well format instrument that Roche launched in 2011.

Notably, IT-IS is an OEM manufacturer of the LightCycler Nano. In addition, its subsidiary IT-IS Life Sciences has previously licensed its Thermaxis thermal stability technology to Roche for use in the LightCycler 1536 system.

"This is a fairly long-term relationship which has had a number of wins along the way," Fuerst said. "We are … outraged that despite us being very open … and trusting Roche with a lot of information, in our opinion they breached a contract, and have, beyond that, betrayed our confidence in them."

In an email to GWDN, a Roche spokesperson noted that the company does not comment on pending legal cases as policy. However, the spokesperson confirmed that there is an ongoing legal case between Roche Diagnostics GmbH in Mannheim and IT-IS International. The spokesperson also confirmed that "IT-IS International and Roche had several collaborations … and some of them are still ongoing," and that "IT-IS International is currently manufacturing LightCycler Nano for Roche."

The cases are due to be heard in the Mannheim court in February and in the Düsseldorf court in March, IT-IS said.

IT-IS is asking the courts to issue an injunction on further sales of the LightCycler 96 instrument; an order that Roche implement a global product recall; and damages, IT-IS officials said. Should these judgments be granted, IT-IS is also seeking judgment that Roche sign a license agreement with the company to resume selling the product.

IT-IS said that it currently manufactures more than 90 percent of the real-time PCR instruments made in the UK, 95 percent of which are exported for use in DNA analysis. A market research report issued by BCC Research in August 2011 estimates that the global market for PCR instrumentation is valued at $2 billion, and as such, IT-IS said that it believes its business has been significantly damaged by Roche's alleged actions.

Fuerst and Howell also noted that IT-IS attempted to resolve its dispute "amicably" with Roche through both written and verbal communications, but that Roche responded that it had no liability and did not breach the CDA.

"I can assure that resorting to the courts is not something we do lightly, and is not our preferred option," Fuerst said. "But we've been offered little choice by Roche."

Fuerst added that Roche's alleged actions are ironic considering its well-documented attempts to protect its own qPCR intellectual property estate over the years. "Strangely, a company like Roche that normally is suing other people for infringing IP related to qPCR, now seems to not be respecting the intellectual property rights of others," he said.

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