With the US patent now in hand for its TMT1 isobaric mass-labeling technology, Proteome Sciences said it now expects to be paid by those companies that have been using the technology commercially.
Last week, the US Patent and Trademark Organization issued Cobham, UK-based Proteome Sciences patent No. 7,294,456, a development that could become a major revenue source for the company, which has not recorded a profit since it was founded in 1994.
Proteome Sciences officials declined to discuss plans to pursue fees retroactively or whether it is in contact with other companies that have commercialized the technology. But they stressed that as official holders of the patent on the technology they would protect it.
“And it would mean that anybody who has products out there, who’s either manufacturing or basically using isobaric tandem mass tagging, would need to go out and [sublicense] the right to use those products,” Christopher Pearce, CEO of Proteome Sciences, told ProteoMonitor this week. “Clearly, if people have had products out there on the market before, it may well be that those positions will have to be regularized to catch up on any past sales that have taken place.
“TMT will transform the business,” he added.
Proteome Sciences is discussing licensing opportunities with several companies, Pearce said, but declined to identify them.
The patent issued last week covers the company’s TMT1 technology. A patent for its TMT2 technology, built on the TMT1 work but with applications for peptides, is pending.
The TMT technology pertains to a method for labeling analytes in multiplex fashion in a mass spectrometer. The sample kit that Proteome Sciences has developed, and which is currently being distributed to customers, can analyze up to six samples simultaneously.
In addition, the method “crushes ... the technical or analytical variability in your system” from about 30 to 40 percent in typical 2D gel experiments and non-tagged LC-MS experiments down to about 10 to 15 percent, said Ian Pike, chief business officer of Proteome Sciences. On some mass-spectrometry systems, the variability can be driven down even further to about 5 percent, he said.
According to Pearce, with the patent Proteome Sciences became the first company to “reduce to practice” the whole field of isobaric mass tagging, which it began exploring about 10 years ago.
“Clearly, if people have had products out there on the market before, it may well be that those positions will have to be regularized to catch up on any past sales that have taken place.”
“As a consequence, this provides the backcloth, the umbrella, in terms of this IP to the whole of the field of isobaric mass tagging,” he said.
In addition to using the technology in-house for biomarker discovery and validation work it does for pharmaceutical firms, Proteome Sciences plans to license the technology to other firms that would bring the technology to market.
Some companies, such as Applied Biosystems, with its iTRAQ reagent, and PerkinElmer, with its ExacTag mass tags, already are selling products using isobaric mass-tag technology. It is unclear how those companies could be impacted by last week’s patent issuance.
Renaldo Juanso, a spokesman for ABI said that it is aware of Proteome Science’s IP and that “We have extensive IP covering iTRAQ.” He declined to comment whether ABI has been in contact with Proteome Sciences over its IP.
PerkinElmer did not respond to messages seekingcomment.
Proteome Sciences declined to comment on what companies it believes is using the TMT technology and thus could owe it back payments.
“We do not want to take on the established players in the life-science reagents area, but what we do see is that isobaric mass tagging is probably the most important technology to come out of proteomics for a long time,” said Pike.
The company also owns the patent rights to the technology in parts of Europe, Australia, New Zealand, and Canada, and has pending applications in parts of Asia, including China and Japan, and elsewhere.
However, the company has regarded a US patent as the linchpin to its commercialization plans because the US market represents such an enormous opportunity, company officials said.
“If you look at all of the recent reports about the growth in biomarkers, biomarker validation, proteomics, they all still point to the US as the engine of growth,” he said.
According to Pearce, industry estimates last year had the mass tagging market at between $600 million and $1.4 billion. In addition, Proteome Sciences has been identifying new applications for the TMT technology, including the isobaric labeling of reference materials for quantitative analysis.
The company also plans to use the TMT technology for the service part of its business, using its ProteoShop platform for protein and peptide biomarker discovery and validation. The company conducts research for pharmaceutical companies.
Officials could not put a figure on the effect the TMT technology will have on its services business, but Pike said that it would open up early biomarker discovery opportunities it otherwise would not have. As regulators like the US Food and Drug Administration place greater emphasis on data for biomarker-related research, application of the TMT technology will add value to the ProteoShop platform, Pearce said.
“It will very much [speak] to the requirements of the end users, and clearly this is really addressing a very much unmet and unfulfilled need in this point in time,” Pearce said.