By Ben Butkus
Idaho Technology said last week that it has licensed reagents and methods using SYBR Green I and post-PCR melting curve analysis to DuPont's Qualicon business.
In addition, Idaho Tech has completed similar agreements with two additional undisclosed companies in the life science research sector, though it has not yet formally announced the deals, Jill Powlick, legal counsel for Idaho Tech, told PCR Insider this week.
Under its agreement with Idaho Tech, the financial details of which have not been disclosed, DuPont Qualicon will use the IP to enable and enhance real-time PCR assay development on its BAX System, an automated, benchtop PCR-based detection system for pathogen and food-quality testing (see related story, this issue).
Several of the microbial detection assays that DuPont offers on its platform are SYBR Green-based and, in general, post-PCR melting curve technology goes hand-in-hand with SYBR Green because it is used as a tool to verify results from SYBR Green-based real-time PCR, according to Powlick.
The DuPont licensing agreement and two undisclosed agreements are the latest in a spate of similar deals completed in the last several years that take advantage of Idaho Tech's "broad and valuable intellectual property portfolio" in cooperation with Roche Diagnostics, the company said.
"We're in a unique position where we sometimes find ourselves between Roche and ABI or some of the other big players" in the PCR space," Powlick said. "It puts us in a much different position than most companies with 200 employees."
Idaho Tech's PCR IP position is primarily the result of two arrangements: an exclusive licensing agreement the company has with the University of Utah Research Foundation for patents surrounding the use of SYBR Green in PCR applications; and an arrangement to package those patents together with key patents related to post-PCR melting curve analysis owned by Evotec and licensed to Roche, Powlick said.
"Because almost everyone selling SYBR Green kits need the Evotec patents and the melting afterwards, we have set up this joint arrangement where either Idaho or Roche can offer the package, and it's the same terms," she said.
Powlick estimated that Idaho Technology and Roche have together executed some 15 licenses to the packaged technologies, although probably fewer than 15 individual companies have active licenses because of continued consolidation within the life science research tool space.
For example, Idaho Tech has reached similar licensing deals with Qiagen, Thermo Fisher Scientific, and Finnzymes, now part of Thermo Fisher; as well as with Cepheid to settle a patent-infringement Idaho Tech brought against Cepheid in 2007. Meantime, Roche has also licensed the combined SYBR Green and melting curve package to companies such as Takara Bio and Kapa Biosystems.
Perhaps most notably, in January Idaho Tech completed a cross-licensing pact with Life Technologies' Applied Biosystems business in which Idaho obtained the right to use the TaqMan 5' nuclease process, and ABI obtained the right to use SYBR Green in PCR. This deal helped navigate the fact that Life Tech predecessors Invitrogen and Molecular Probes own patents surrounding the actual SYBR Green dye; and gave all interested parties the freedom to operate in the PCR space (PCR Insider, 1/28/10).
And, in April, the company further bolstered its PCR IP position when it was awarded US Patent No. 7,670,832, "System for fluorescence monitoring," the claims of which Idaho said apply "to most of the real-time PCR instruments on the market." Specifically, the patent broadly covers devices for performing PCR followed by melt curve analysis using dsDNA-binding dyes such as SYBR Green or probes labeled with a fluorescent dye.
"We have a few key patents," Powlick said. "We also have some up-and-coming patents. Our high-resolution melting portfolio is growing rapidly. That's a tech that is being embraced by bigger companies and starting to filter down through smaller companies."
Idaho Tech's solid IP position has also allowed it to develop its own PCR products primarily in the biodefense space and, although the privately held company does not disclose its revenues, its ability to outlicense its IP and generate revenue may help it better weather any setbacks in its own product-development efforts.
For instance, Powlick told PCR Insider this week that the company's FilmArray respiratory panel — a multiplex PCR platform that detects 21 common respiratory viruses and bacteria and that has undergone clinical trials at three US hospital labs (PCR Insider, 1/28/10) — will not be launched this fall as the company had hoped.
"The [US Food and Drug Administration] told us we had to do more testing, so it looks like we've got to go through another flu season before that's ready," Powlick said.