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European Patent Office Reinstates ABI's Thermal Cycler Patent; Financial Impact Remains Unclear

The European Patent Office has reinstated a patent covering Applied Biosystems' real-time PCR thermal cycler technology, a year and a half after it was revoked for alleged lack of novelty by the office's Opposition Division.

It is unclear, however, how significant the financial impact of the reinstated patent will be to ABI, since the firm has not disclosed how many parties have taken a European license rather than a global license. But the reinstatement could affect ABI's ongoing settlement talks with Stratagene regarding the technology.

"Every license is different," said an ABI spokesperson. "Some take US, some take worldwide, some take instrument, some take reagents. So, it's really hard to generalize," she said.

The patent, EP0872562, has been fully reinstated, according to the spokesperson, though the original case that challenged its validity has been returned to the Opposition Division for "review of other issues." She declined to comment on what those other issues entail.

"This makes the position of [ABI's] estate stronger," said Harry Glorikian, a partner in the life sciences advisory firm TSG Partners. Since the patent covers real-time PCR, rather than just PCR technology, "this is going to be more significant for them," he told BioCommerce Week.

ABI's "whole patent estate is migrating to, and they're getting all their revenue from, the real-time estate. Having holes in that strategy is undesirable."

"Their whole patent estate is migrating to, and they're getting all their revenue from, the real-time estate. Having holes in that strategy is undesirable," said Glorikian.

The '562 patent is entitled "Instrument for monitoring nucleic acid amplification reactions" and was granted in late 2002. The sole inventor is Russell Higuchi of San Francisco. Roche, the original applicant, transferred the patent to Applera in early 2003 — though Roche and Applera remain partners in the PCR patent estate.

The oppositions to the patent were filed between 2003 and 2005 by Bio-Rad; MJ Research, before its was acquired by Bio-Rad in August 2004; Cepheid; Eppendorf; Stratagene; Bibby Sterilin of Stone, UK; and the Intellectual Property Rights Group of the UK's Secretary of State for Defence.

Cepheid, Bio-Rad, and MJ withdrew their opposition as part of their settlements with Applera.

The EPO had revoked Applera's patent because of a single report containing prior art that it determined was distributed to a number of scientists at an international workshop in Germany about two weeks before the patent application was filed. Also, the scientists were not asked to keep the contents of the report confidential.

Applera has been aggressive in protecting the real-time PCR patents, and along with Roche has sued and settled litigation with several rivals. Many of these erstwhile defendants are global companies, and as such hold global licenses or have licensed the PCR-related patents for multiple regions, including the US, Europe, and Japan.

Most recently, Beckman Coulter settled a suit with Applera regarding the patents, and earlier this week licensed Roche's PCR-related patents for diagnostic applications (see related article).

Bio-Rad Laboratories settled a PCR patent dispute with Applera and Roche in February, enabling its MJ Research unit to resume selling thermal cyclers (see BioCommerce Week 2/15/2006).

Eppendorf licensed worldwide rights to Applera's real-time thermal cycler patents in November 2005, and Cepheid settled with both Applera and Roche in June 2004, taking licenses to the PCR patents.

Stratagene, which remains the sole defendant in a suit brought by Applera and Roche in November 2004, is currently in settlement talks with Applera (see BioCommerce Week 7/12/2006). The reinstatement of the European patent could affect the firms' negotiations and possibly give Applera greater leverage, depending on Stratagene's plans for the European market.

— Edward Winnick ([email protected])

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