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As UK Patent Office Upholds Enigma's PCR Patents, Biogene Exec Says Dispute 'Far from Closed'

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This article has been updated from a previous version to clarify the identities of the parties in the original lawsuit.

By Ben Butkus

The UK Intellectual Property Office has recently rejected a revocation action brought by an executive from molecular biology firm Biogene against three PCR patents owned by the UK's Defence Science and Technology Laboratory and exclusively licensed to Enigma Diagnostics, according to recently filed court documents.

In a statement issued this week, Oxford, UK-based Enigma said that in its decision, the IPO "issued summary judgment" against Biogene and awarded undisclosed costs to DSTL, part of the UK Ministry of Defence. Enigma also said that the decision means that the patents in question are no longer open to challenge by any entity, barring a subsequent appeal to the UK's High Court.

However, in an interview this week with PCR Insider, Nelson Nazareth, a managing director at Biogene who initiated the patent challenge, refuted Enigma's claims, pointing out that the IPO's ruling was against him personally, and that it doesn't preclude other entities such as Biogene from re-challenging the patents in question.

"The case was taken over by me as an individual," a fact that Nazareth noted is made clear in the court documents, available here. "At no point is Biogene mentioned, nor is judgment made against Biogene," Nazareth said.

"Also, it is an assumption on [Enigma's] part that, absent of any subsequent appeal to the high court by me, the patents are now free from any challenge," Nazareth added. "If Biogene decided to pursue it, it could. But I cannot."

Further, Nazareth said that this point may come into play as he and Biogene contemplate additional patent challenges or even legal action against DSTL, Engima, or both.

"We would not rule it out," Nazareth said. "All we can say is that the matter is far from closed."

The patents in question, EP 0942781, GB 2333250, and EP 1080178, were issued to DSTL in the 1990s and early 2000s. They relate to electrically conducting polymer, or ECP, technology, which Enigma is using in its Enigma ML automated real-time PCR-based molecular testing system, currently under development.

The ECP technology, which in theory enables rapid, inexpensive thermal cycling, was developed at DSTL in the 1990s, and Biogene "started working exclusively as a potential licensee" on the project in 1998, Nazareth told PCR Insider.

However, as of 2006, "no product had been realized," Nazareth said, at which time Biogene realized that there was a "fundamental flaw" with the ECP technology that would prevent it from working in a rapid thermal cycler for PCR.

"Very simply, it's a resistor in a carbon polymer tube," Nazareth said. "You apply a voltage across it, and that produces heat … and by generating heat within the tube, you're heating up the contents of the vessel. But what happens is you get … an electrical current of varying magnitude … within the contents of the biological reaction. And because you have a polarized DNA molecule, you sometimes kill it, and sometimes you don't, and it's a variable result."

As such, Biogene secured its own patents covering technology — such as an insulating layer to the carbon polymer tube — designed to improve upon the original technology and correct for this "fundamental flaw," Nazareth said.

A year later, in 2007, Nazareth initiated the patent challenge against DSTL, which had exclusively licensed several patents to Enigma so it could develop its PCR-based diagnostic testing platform. Enigma has not licensed the Biogene patents.

"The reason we tried to revoke [the DSTL patents] is that … we had had a long discussion with the Ministry of Defence … and being a government organization they were refusing to allow us access to what should have been ours — information about how the technology wasn't working," Nazareth said.

"We wanted to prove their patents don't work; and … take them to court, on the basis that they misrepresented the technology and caused us financial issues to take on the technology. And we felt there were a lot of issues where they may have misled us based on inside information that they knew it didn't work. There's a lot of stuff there that hasn't come out, but may at some point in the very near future."

Nazareth also said that he believes he lost the patent challenge due to "quasi-legal grounds — we didn't provide enough paperwork, or didn't do it the right way." But, he added, the technical argument about the flawed technology "has never been addressed by the patent court."

Nazareth declined to say definitively whether Biogene would be pursuing legal action against either DSTL or Enigma. He told PCR Insider that his company doesn't yet have a quarrel with Enigma, since it only licensed technology from DSTL that Biogene abandoned. Indeed, an Enigma spokesperson confirmed in an e-mail to PCR Insider that the patent challenge was initiated against DSTL, and not Enigma, but that Enigma "has had the continued support of DSTL throughout the case, which was regarded as without foundation."

However, should Enigma's PCR testing platform successfully be commercialized, Biogene may have a reason to claim patent infringement, since "fundamentally ECP doesn't work … without the additions that we've made," Nazareth said.

"It doesn’t work for the 96-well [format]," he said. "It may work with a lot of cost, and if they take some of our patented ideas and use it for one or two wells, which is what I think they're doing."

However, Nazareth added that Enigma has been "very coy" about whether or how it's using the ECP technology in its instrumentation. "They have still not tackled the technical hurdle," he said. "And until they release an instrument, and their information, we are not in a position to say they are infringing our patents. But we believe they are from what we saw in 2006 and 2007."

Enigma said definitively in its statement this week that the ECP technology "is used in Enigma's fully automated real-time PCR system, the Enigma ML, to enable rapid molecular testing at the point of care."

In addition, in February, following an announcement by Enigma that it had inked a global manufacturing and supply agreement with Tecan to manufacture the Enigma ML, Enigma Chairman and CEO John McKinley told PCR Insider that the company was using ECP as part of "our own unique thermal cycling [technology], which is exceedingly fast, very robust, and very small."

McKinley was unable to be reached for comment this week due to travel. However, an Enigma spokesperson wrote in an e-mail that the recent IPO decision "does not affect Enigma’s core technologies used in its current and or anticipated portfolio of products. Enigma’s IP strategy, and that of the supporting DSTL, is to protect Enigma’s entire IP portfolio against any third parties ensuring maximum coverage and protection across the extensive patent portfolio and application across others’ products and technology usage."

Enigma said that its IP portfolio covers molecular diagnostics and sample preparation technologies, and comprises 220 granted patents and more than 350 patent filings.

When Enigma announced the Tecan alliance in February, it said that it had hoped to launch its testing platform by the fourth quarter of this year for POC influenza diagnostics in Europe in partnership with GlaxoSmithKline. The status of that project is unclear.

Enigma already markets the Enigma FL, or Field Laboratory platform, which it designed in collaboration with DSTL and launched in November 2008 for the defense and veterinary markets.

As for Biogene, it is currently developing its own compact PCR platform for POC diagnostic use, Nazareth said. "Our own technology is not relying on ECP. It's for rapid PCR diagnostics [at the] point of care, but with a totally different facet."

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