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Osmetech, Epidauros, Affymetrix, Illumina, Children's Hospital of Eastern Ontario, Epigenomics, J&J, Affy, Roche, Agilent, Affymetrix

Osmetech and Epidauros to Co-Develop Companion Dx Products; HIV, Cancer to Be Focus
Osmetech and Epidauros plan to jointly develop companion diagnostics for pharmaceuticals and pharmacogenomic biomarkers, the companies said this week.

Under the terms of the agreement, Osmetech will use Epidauros’ biomarkers to develop and market assays for its eSensor array system, the companies said.

Osmetech CEO James White said the agreement gives the company “access to a very strong pipeline” of companion diagnostics for biomarkers and pharmaceutical development. He said the company will use these in its efforts to expand its market position by “linking the drug to the diagnostic.”

Epidauros CEO Michael Lutz said the deal will spur advances not only in the company’s biomarker pipeline, “but also any personalized medicine-related marker our pharma partners may want to develop into molecular diagnostic tests, in particular in the fields of HIV and oncology.”


Trial Date in Affymetrix vs. Illumina Moved to March
The trial date in Affymetrix’s patent infringement lawsuit against Illumina has been moved to March. In a Dec. 11, 2006, court order Judge Joseph Farnan of the US District Court for the District of Delaware set a pre-trial conference date of Feb. 8 and a trial date of March 5.
The trial date was originally set for October 2006 but was moved to January 2007 in August giving the legal teams for both firms more time to prepare after receiving the results from a mid-August Markman hearing (see BAN 9/5/2006).
Affymetrix sued Illumina on July 26, 2004, for allegedly infringing six patents in the DNA microarray field. Affy dropped one of the patents from the suit in March 2006. The Markman hearing in the case was held in April.
Illumina has said it does not infringe Affymetrix' patents and that these patents are, in any event, invalid and unenforceable. Affymetrix is seeking remedies including lost profits, a royalty, trebled damages for willfulness, and a permanent injunction.

Illumina and Canadian Children's Hospital Partner for Newborn Screening
Illumina this week said that it will work with the Children's Hospital of Eastern Ontario to develop molecular tests that would screen infants for spinal muscular atrophy and blood diseases.
Under the terms of the agreement, Illumina will hold the commercial rights for any assays it develops with the CHEO, which is located in Ottawa.
The research collaboration calls for Illumina to use its VeraCode technology on its BeadXpress reader initially to screen for hemaglobinopathies, which are genetic conditions causing blood disorders such as sickle-cell anemia and thalassemia. 
Illumina said that spinal muscular atrophy is the number-one genetic killer of infants and toddlers, but added that there is hope that it may be treatable if the mutation causing it is detected early enough.
The company said CHEO screens roughly 135,000 newborns for 27 different diseases every year.

Epigenomics, J&J Unit Ink Cancer Biomarker Discovery Pact
Epigenomics last week said it will help Johnson & Johnson unit Centocor identify and analyze cancer-related biomarkers.
Under the agreement, Epigenomics will use its Differential Methylation Hybridization microarray to profile samples with the aim of selecting patients who are more likely to benefit from one of Centocor’s candidate drugs.
Financial terms of the agreement were not disclosed.

Affy, Roche Amend GeneChip Deal; Roche Trades License Payments for Milestones
Affymetrix and Roche have amended an ongoing licensing agreement that gives Roche access to Affy’s GeneChip microarray technology, Affymetrix said in an SEC filing last month.
The amendment, disclosed on Dec. 22, 2006, releases Roche from upcoming license payments and instead offers Affy payments based on commercial milestones. Roche had previously agreed to begin paying installments in 2008.
Additionally, the original agreement was to last as long as 18 years but the new version will enable Roche to terminate it at the end of 2010 or at the end of 2015.
The companies originally penned their agreement in 2003 under which Roche agreed to pay Affy $70 million in up-front plus license payments for access to the GeneChip technology (see BAN 2/7/2003).
Roche uses the Affy technology in genotyping, gene expression, and resequencing research to develop molecular diagnostics. 
Affymetrix would not disclose the specific sums involved in the new deal, and filed a secure SEC copy containing that information.

Agilent, Affymetrix Agree to Mediation in Patent-Interference Dispute
Agilent Technologies and Affymetrix have agreed to mediate a dispute regarding a patent interference decision by the US Patent and Trademark Office, according to court documents filed last month.
In a filing with the US District Court for the Northern District of Northern California, attorneys from Affymetrix and Agilent agreed to hold an alternative dispute resolution session by Oct. 1.
The mediation will address a dispute that began in October, when Agilent requested the court to review a USPTO decision that found that an Affymetrix patent application does not interfere with an existing Agilent patent (see BAN 10/10/2006).
Agilent claimed that the inventors of Affy’s US Patent Application No. 10/619,224 filed claims "literally copying" the language of Agilent’s US Patent No. 6,513,968, entitled "Apparatus and method for mixing a film of fluid," which was assigned in February 2003.
After Affy filed its application with the USPTO, Agilent contested its claims, but the USPTO found that Affy's claims are indeed patentable, and proceeded to cancel several of Agilent’s claims from its '968 patent.
In its October motion, Agilent asked the court to reverse the USPTO’s decision that certain claims in Affy's patent application are patentable and also sought "other and further relief as the court sees just and proper.”
In a response, Affymetrix argued that Patent Application 10/619,224 was a continuation of a series of applications it had filed prior to Agilent’s patent and noted that the USPTO “determined that the earliest application to which Affymetrix was accorded benefit was filed more than three years before the earliest application to which Agilent was accorded benefit.”

Affy requested that Agilent’s case be dismissed with prejudice, that the USPTO uphold its cancellation of the claims in question, that the inventors on its application be declared the “first and true” inventors of the subject matter corresponding to the interference, as well as attorneys’ fees and other costs.

The Scan

Wolf Howl Responses Offer Look at Vocal Behavior-Related Selection in Dogs

In dozens of domestic dogs listening to wolf vocalizations, researchers in Communication Biology see responses varying with age, sex, reproductive status, and a breed's evolutionary distance from wolves.

Facial Imaging-Based Genetic Diagnoses Appears to Get Boost With Three-Dimensional Approach

With data for more than 1,900 individuals affected by a range of genetic conditions, researchers compared facial phenotype-based diagnoses informed by 2D or 3D images in the European Journal of Human Genetics.

Survey Suggests Multigene Cancer Panel VUS Reporting May Vary Across Genetic Counselors

Investigators surveyed dozens of genetic counselors working in clinical or laboratory settings, uncovering attitudes around VUS reporting after multigene cancer panel testing in the Journal of Genetic Counseling.

Study Points to Tuberculosis Protection by Gaucher Disease Mutation

A mutation linked to Gaucher disease in the Ashkenazi Jewish population appears to boost Mycobacterium tuberculosis resistance in a zebrafish model of the lysosomal storage condition, a new PNAS study finds.