Next Phase of Affymetrix vs. Illumina Trial to Occur in ‘08, According to Court Documents
Scheduling conflicts between the attorneys representing Illumina and Affymetrix, as well as the US District Court where the ongoing patent litigation between the array companies is being heard, have led the parties in the case to agree to move the next phase of the trial to January or February of next year, according to court documents.
In an Aug. 9 letter to Judge Joseph Farnan of the US District Court for the District of Delaware, Affy attorney Maryellen Noreika wrote that “counsel for Affymetrix and Illumina have met and conferred to discuss additional possible dates and have agreed that both parties are presently available for a trial commencing on any of the following weeks, January 14, February 4, 11, and 18, 2008.”
In the first phase of the litigation, which was initiated by Affy against Illumina in July 2004, a jury found in March that Illumina’s products infringe on five Affymetrix patents (see BAN 3/20/2007).
However, before the case can be settled, the court must hear Illumina’s charges of invalidity and inequitable conduct on enforcing the patents in the case. Illumina has also alleged in its response to the lawsuit that Affy is guilty of unfair competition and anti-trust claims, charges that could extend into a third phase of the case.
Attorneys for the two parties attempted to schedule a second phase of the trial for late October or early November, but scheduling conflicts with the court forced them to push the possible trial start date into next year. According to Noreika’s letter, the “parties have also agreed that a status conference with the court is needed” to determine the “issues to be included in the next phase of trial, the order in which the issues will be tried, and the length of the next phase of trial.”
Illumina and Affy have requested that a status conference should occur by the end of September.
NHGRI Sets Aside $27.5M for Population-Based GWA Studies for 'Complex Diseases'
The National Human Genome Research Institute plans to hand out a total of $27.5 million in grants for large-scale genome-wide association studies aimed at identifying genetic variants that relate to undisclosed ”complex diseases.”
The allocation will support between three and five studies over four years that aim to create population-based data to speed the process of understanding how certain genes are related to certain complex diseases.
According to an NHGRI RFA, the research will use information from population-based cohort studies or clinical trials with “detailed existing information on demographics, health characteristics, environmental exposures, and disease risk factors and traits.”
The NHGRI said it expects the studies to attempt to “determine the population-based profile, or ‘epidemiologic architecture,’” of variants such as those in racial and ethnic subgroups in the US.
The studies also would identify modifiers of gene-trait associations, such as lifestyle or medicinal factors, and would identify clues that link causal variants to phenotypes.
Letters of intent for the grants are due on Oct. 19, and applications must be received by Nov. 19.
Additional information can be found here.
NIH Offers $1.8M for GWA Studies Linking Environment and Disease
The National Human Genome Research Institute has allocated $1.8 million to fund between two and four projects to conduct genome-wide association and replication studies that explore environmental and genetic influences on human disease.
The two-year grants, which will be disbursed from fiscal 2008 funds, will be administered under the National Institutes of Health’s Genes, Environment, and Health Initiative, a program the NIH announced in November.
According to an NIH RFA, the studies will use data and specimens from human subjects about whom there is information concerning environmental exposures and “traits of public health importance.”
Specifically, the grants will support investigators planning to add genome-wide association studies to existing studies of diseases and traits of “substantial public health impact.”
Although the focus of the RFA is on initial genome-wide scanning and replication studies, follow-up genotyping studies “may be proposed,” according to the NIH.
Study designs may include case-control, population, cohort, clinical, or family studies or clinical trials, and investigators may seek to identify associations of genetic variants with the presence of a particular disease or discrete trait or with levels of a quantitative trait, and may examine interactions among genetic and environmental factors, susceptibility to multiple conditions, or associations of genes with disease risk factors, disease incidence, or therapeutic responsiveness.
Letters of intent for the funding are due Sept. 18, and applications are due Oct. 18. More information about the RFA can be found here.
Applera Mulls Spinning Out ABI and Celera into Two Independent Firms
Applera said last week that it has hired investment bank Morgan Stanley to advise the company as it considers restructuring its Applied Biosystems and Celera groups, which are currently traded as tracking stocks under the parent firm.
Applera said it will explore alternatives to its current structure, and will look into “creating two independent publicly traded companies in place of the two tracking stocks.”
ABI markets instruments, consumables, software, and services for the research and applied markets. Celera, originally formed to sequence the human genome, has evolved into a molecular diagnostics firm.
"We regularly review Applera's corporate structure, and in view of Celera's continued strong financial progress, we believe the time is now right to explore alternatives to our tracking stock structure, including the possibility of creating two independent publicly traded companies in place of the two tracking stocks," said Applera CEO, president, and chairman Tony White.
"While the tracking stock structure has facilitated the interests of both Celera and Applied Biosystems,” White added, “the evolution of our businesses makes it timely to explore the potential benefits of these businesses going their separate ways."
Applera’s board of directors also has nearly doubled its share repurchase authorization for ABI’s stock to $1.2 billion, which represents around 20 percent of the company’s outstanding common stock.
Through that repurchase, Applera expects to buy $600 million shares either through a tender offer or an accelerated share repurchase, the company said.
The balance of that deal will come “from open market purchases or privately negotiated transactions” over the next year to year and a half, the company said.
"The substantial increase and acceleration of the Applied Biosystems share repurchase program reflects our confidence in its business outlook and our belief that its shares continue to be undervalued in the market,” added White.
White also said ABI’s “strong cash position” makes the share repurchase program “an effective way to return value to shareholders.”