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Stratagene and Focus Pen Dx Alliance; Third Wave s IP Not Likely Infringed

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In a wide-ranging deal that signals Stratagene's intent to advance its molecular diagnostics goals in light of a recently lost patent battle, the company has licensed its FullVelocity technology to Focus Diagnostics and will supply materials related to the SNP-detection method, the company said this week.

Stratagene will also manufacture diagnostics developed by Focus as part of the deal and supply the privately held company with reagents for homebrew tests that Focus will sell in its reference labs.

The move is the first diagnostics-related deal Stratagene has made involving its FullVelocity technology, some of whose patents were judged invalid in a September patent-infringement lawsuit filed by Third Wave Technologies.

"The embodiment of FullVelocity that will be used in relationship with Focus does not infringe with Third Wave patents," Steve DiMattia, a Stratagene spokesperson, told Pharmacogenomics Reporter this week.


"Stratagene's FullVelocity technology benefits from the sensitivity advantages of PCR amplification, something not found in Third Wave's Invader methods."

Stratagene said in September that it would appeal the verdict, along with a $5.29-million damage award, and company officers pledged to push the QPCR and QRT-PCR technology into the molecular diagnostics space.

Nevertheless, Joe Sorge, Stratagene CEO, told attendees of the September UBS Global Life Sciences conference in New York that the firm planned to capitalize on its non-infringing FullVelocity technology to develop molecular diagnostic products, according to Pharmacogenomics Reporter sister publication, BioCommerce Week. The agreement with Focus appears to validate this story.

Charlie Harwood, Focus' CEO, declined to comment on the patent-infringement issue, and wouldn't say whether the company had evaluated Third Wave's Invader before choosing FullVelocity. But the company's decision to use FullVelocity in its own diagnostics can be viewed as a vote of confidence in the technology's longevity.

Harwood would say that his company had evaluated real-time PCR platforms "as well as probably most of the molecular technologies that are out there, and were very pleased with the Stratagene chemistry." Harwood cited the technology's speed and the ease of test development as important characteristics guiding his firm's choice.

Focus plans to develop infectious disease assays in-house, which Stratagene will manufacture for Focus to commercialize and offer as a reference laboratory service. Focus will also launch testing services in its reference laboratory using homebrew tests based on FullVelocity, and Stratagene will sell the firm the necessary reagents and other materials. "Primarily we are going to develop, for the US market, FDA-[cleared] kits and sell to Europe CE-marked products or obtain whatever other regulatory approvals we might need to sell outside the United States," said Harwood.

Focus, which operates a national reference lab that offers more than 1,200 infectious disease tests, is not planning on producing strain-typing or other pharmacogenomic-type products, but the company is "periodically approached by pharmaceutical companies to evaluate certain companion diagnostics," Harwood said. Any companion diagnostic the company may create is not necessarily linked to FullVelocity, he added.

Steve Martin, Stratagene CFO, said in an e-mail exchange with Pharmacogenomics Reporter sister publication BioCommerce Week that the company regards as confidential information whether a second diagnostic partner would be allowed to create a FullVelocity-based assay competing with a test made by Focus.

What, Third Wave Worry?

In infectious disease, Third Wave manufactures a hepatitis C virus strain-typing diagnostic based on its Invader technology, and the company has human papillomavirus screening and strain-typing tests in its pipeline.

Third Wave spokesperson Rod Hise said he was unable to comment on how the company will view the new tests involving Stratagene's FullVelocity.

In the past, Third Wave has aggressively defended its areas of diagnostic specialty. "Third Wave wants to clear any remaining ambiguities about the company's freedom to operate in valuable markets like those for [hepatitis C virus] and [human papilloma virus]," said John Puisis, Third Wave president and CEO, in an October statement.

Stratagene holds five FullVelocity-related US patents, with additional patents pending, while Third Wave's Invader technology is covered by more than 30 US patents, with more than 60 patents pending, Stratagene's Sorge told BioCommerce Week in July, "Stratagene does not include overlapping DNA molecules in its kits [as Third Wave's Invader does]. Stratagene's FullVelocity technology benefits from the sensitivity advantages of PCR amplification, something not found in Third Wave's Invader methods," Sorge said.

Sorge told BioCommerce Week that Stratagene was in discussions with "four or five" large diagnostic companies about the possibility of using FullVelocity-based technology in their molecular diagnostic product lines.

During the September UBS conference in New York, Sorge also mentioned that the firm was discussing with undisclosed reference laboratories the possibility of using FullVelocity reagents as molecular diagnostics. This week, Martin, the company's CFO, confirmed that one of those reference labs was indeed Focus Diagnostics. Martin declined to specify how many such partners Stratagene expects to have by the end of 2006.

— Chris Womack ([email protected])

 

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