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How a Meeting in Munich and Recent Lawsuit May Predict Synthetic-Bio Market Shake-Out

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This week the Industry Association of Synthetic Biology, a consortium of biotech firms with an interest in the nascent market for synthetic genes, will meet at the Analytica biotechnology trade show in Munich to discuss the future of the market, with a special emphasis on biosecurity.
 
The meeting coincides with the recent settlement of litigation between Codon Devices and Blue Heron Technology, two firms that are poised to be major competitors in the synthetic-biology market as it expands in coming years.
 
The consortium, which includes the German array firm Febit Biotech as well as MWG Biotech, Entelechon, Sloning Biotechnology, and ATG:Biosynthetics, will discuss current and future biosecurity policies, and will compare the state of policy making in the US and Europe, according to IASB’s website.
 
The consortium will also focus on technical solutions for selecting sequences for a synthetic biology-reference database, how to keep that database up-to-date, how to categorize risk-associated sequences, and quality control issues in general.
 
According to Febit Chief Scientific Officer Peer Stähler, the IASB meeting could act as a springboard for the company to enter the synthetic biology market sometime next year after the major ethical and technical questions surrounding the methods in which synthetic genes are created for sale are addressed.
 
“IASB wants to be involved and help develop measures for biosafety and biosecurity, especially in Germany and Europe,” Stähler told BioArray News this week. “The workshop is designed to talk about those tools that are needed and address these safety concerns,” he said. “I see this as a starting point, and the whole idea is to address these issues in a constructive manner. Synthetic biology is very promising but it needs to be safe.”
 
Febit Biotech could be the lone array company to play in the market, but all companies that manufacture synthetic genes impact the overall market for gene-expression profiling tools. Other companies competing in the space, such as MWG Biotech, use ligase-chain-reaction and PCR to synthesize their genes. Stähler said that Febit’s advantage could be its ability to synthesize genes at a higher throughput using its Geniom One array-synthesizing instrument.
 
“Our genes will be cheaper and easier to obtain, so more researchers will be able to obtain them,” Stähler said. “So far this field hasn’t exploded yet, but with the availability of much cheaper DNA and much cheaper genes, this field is set to expand in the next few years.”
 
Last year Febit founded a subsidiary called SynBio to commercialize its method for producing synthetic genes. Originally Stähler was bullish about a prospective launch date for the system, and he said SynBio would be open to orders sometime this year (see BAN 11/27/2007).
 
This week, however, Stähler said that it is more likely that Febit will focus on commercializing its new RT-Analyzer system and a suite of catalog arrays this year, while SynBio will be “the major commercial focus” for the company next year (see related story, this issue).
 
Litigation Update
 
While Febit looks to the future of synthetic biology, it has also sued a potential competitor for patent infringement to defend its turf in this developing market. Febit Biotech announced in July that it was seeking an injunction and unspecified monetary damages from Boston-based synthetic biology firm Codon Devices for allegedly infringing US Patent No. 6,586,211, which covers a method for making synthetic nucleic acids on microarrays (see BAN 7/17/2007).
 
Codon, which entered the market in 2005, uses a proprietary genetic-synthesis tool called BioFAB to construct its oligonucleotides. Court documents obtained by BioArray News this week show that in October, attorneys for Codon filed an answering brief in opposition. Last month, Magistrate Judge Leonard Stark was appointed to oversee the case.
 
This week Stähler said that the suit, proceeding in the US District Court for the District of Delaware, is “ongoing” and that Febit is “satisfied with the process.” He added that “it will take quite a few more months before the next step happens” in the case.
 
While Febit’s case against Codon has yet to heat up, Codon’s suit against rival Blue Heron just wound down. The two firms this week announced that they have settled a suit filed by Codon in March 2007 against Blue Heron for allegedly infringing five patents exclusively licensed to Codon by Duke University and the Massachusetts Institute of Technology.
 
The suit, filed in a US District Court in Delaware, claimed that Blue Heron infringed Duke patents used to map gene mutations, manipulate genes, and fractionate DNA molecules, and an MIT patent used to screen for genetic variation.
 
As part of the settlement, Codon granted Blue Heron a perpetual, fully paid sublicense to continue to use error correction technology employed in its gene synthesis activities. Cambridge, Mass.-based Codon also said that it would ask the court to dismiss its suit against Blue Heron.
 
Financial terms of the settlement were not disclosed. Codon declined to comment on the litigation with Febit.

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