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GTG Targets PGx Firms with Aggressive Licensing Strategy In Wake of Applera Non-Coding DNA Patent Settlement

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In an agreement that will result in a more aggressive licensing program for its non-coding DNA patents — some of which pertain to genomic regions important to pharmacogenomics research — Australian firm Genetic Technologies last week settled its ongoing patent-infringement suit with Applera.

The settlement includes a license agreement, a supply agreement, and a requirement that the Foster City, Calif.-based biotech firm pay Genetic Technologies an undisclosed amount.

Both companies agreed to seek the dismissal of all claims and counterclaims in the case. Neither company would disclose further terms of the deal.

"Now that [the dispute with Applera] has been resolved, it allows us to embark on our licensing strategy with a bit more expediency than we have in the past," Geoff Newing, Genetic Technologies' group general manager of business development, told Pharmacogenomics Reporter this week. In the wake of the Applera deal, "I am now setting my sights on hundreds of targets who, in our view, already owe substantial amounts for past activities, and will owe us more for future activities," Genetic Technologies CEO Mervyn Jacobson said last week in an interview with Australian Biotechnology News, a web-based news service.

While the biological functions of so-called junk DNA were largely unknown in the 1980s, when Genetic Technologies originally filed its patents, research has gradually revealed some of these functions, many of them related to gene-expression regulation. The patents concerning the junk DNA are "very relevant to pharmacogenomics, because we would argue that a substantial amount of activity that's undertaken in the pharmacogenomics field requires a license to our patent," Newing said.


"We would argue that a substantial amount of activity that's undertaken in the pharmacogenomics field requires a license to our patent."

Although he declined to spell out his company's licensing strategy, Newing said, "There will be resources engaged in major jurisdictions like the United States to undertake licensing activity on our behalf or for us — between those parties and ourselves." Genetic Technologies will also be looking for collaboration agreements and cross licenses with potentially infringing companies, such as the arrangement the company worked out with Myriad Genetics, under which Genetic Technologies licensed intellectual property in exchange for exclusive rights to market some of Myriad's genetic tests in the Asia-Pacific region, he said.

Genetic Technologies originally sued Applera and two other US companies in March 2003 for not purchasing licenses or paying royalties related to US patent 5,612,179, entitled "Intron Sequence Analysis Method for Detection of Adjacent and Remote Locus Alleles as Haplotypes." Genetic Technologies later added to the complaint US patent 5,851,762, entitled "Genomic Mapping Method by Direct Haplotyping Using Intron Sequence Analysis." Applera responded by challenging the patents' validity in a countersuit.

The two other companies, Covance and Nuvelo, who settled separately in November 2004, agreed to take a license and pay royalties on the patents. Applera agreed to pursue further negotiations on Oct. 13 and both sides agreed to a settlement on Dec. 9.

A considerable number of Applera's products were under dispute. Genetic Technologies alleged that Applera infringed its patents through the sale of its cystic fibrosis reagent kits, TaqMan genotyping and gene-expression assays and assay services for non-coding regions, AmpFLSTR kits, its SNPlex genotyping system, the SNPbrowser tool, the Discovery System employed by Applera subsidiary Celera, and Celera's haplotype-analysis business.

Other pharmacogenomics- and molecular diagnostics-related companies that have taken a junk-DNA license from Genetic Technologies include: Sequenom; Nanogen; Perlegen; Myriad Genetics; Pyrosequencing; Orchid Biosciences; Quest Diagnostics; Tm Biosciences; Laboratory Corporation of America; Genzyme; and Bionomics. A number of academic institutions have taken licenses as well — see this link for a complete list of the 25 licensees and basic terms of the agreements. Four licenses were signed by the New Zealand Crown Research Institutes and Livestock Improvement Corporation.

Because of the long time that elapsed between Genetic Technologies' junk-DNA patent filings and their issue, "it's only been in the last four years that we've been able to embark on a licensing program," said Newing. While details of the 18-hour mediation session that resulted in the Applera settlement remain confidential, the companies executed several binding agreements, including a final settlement agreement, according to an announcement made to Gene Technologies shareholders this week. All claims and counterclaims will be dismissed, the firm said.

The technologies on which the case was built represents the only US patents on the use of non-coding DNA markers for gene testing, according to Genetic Technologies.

— Chris Womack ([email protected])

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