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University of Iowa, Amgen, Carnegie Mellon University, Hoffmann-La Roche, Ligand Pharmaceuticals, Salk Institute for Biological Studies, Southeast TechInventures, UNC-Charlotte, Altor Bioscience, Massachusetts General Hospital, Molecular Sensing, CDC, Van

U of Iowa Sues Amgen for Alleged Patent Infringement
The University of Iowa and the UI Research Foundation have sued Amgen for allegedly infringing two patents owned by UIRF related to the use of a genetic promoter sequence for enhancing the manufacture of vaccines and therapeutics.
The lawsuit, filed this week in the US District Court for the Southern District of Iowa, alleges that Amgen has infringed US Patent Nos. 5,168,062 and 5,385,839, both of which are based on inventions by Mark Stinski, a professor of microbial virology at IU’s Carver College of Medicine.
Specifically, the patents are directed to a human cytomegalovirus promoter-regulatory sequence that was obtained from purified HCMV DNA, the patents’ abstracts state.
According to court documents, Amgen infringes the patents when, for example, “[Amgen] and its affiliates use the inventions to manufacture drugs such as its multi-billion-dollar blockbuster drug Enbrel.” UI also contends that Amgen has infringed the ‘062 and ‘839 patents through by manufacturing its human therapeutic Vectibix.
Enbrel is a tumor necrosis factor blocker used to treat rheumatoid arthritis, psoriasis, ankylosing spondylitis, psoriatic arthritis, and juvenile rheumatoid arthritis; while Vectibix is a human monoclonal antibody used to treat metastatic colorectal carcinoma following chemotherapy.
In addition, UI alleges that “despite diligent efforts by the plaintiffs to persuade Amgen to respect the Iowa patents, Amgen has refused to do so,” adding that Amgen and its affiliates have “for many years infringed the patents with full knowledge of them.”
In the suit, UI said that it has granted 113 active licenses, including 13 royalty-bearing products, to the patents allowing research institutions and commercial ventures to use the inventions.
Immunex, a biopharmaceutical company and subsidiary of Amgen, is named as a co-defendant in the suit.
UI is seeking monetary damages and compensation for attorney’s fees in the lawsuit.

Federal Court Upholds Non-Infringement Verdict in Carnegie Mellon-Roche Case
The US Court of Appeals for the Federal Circuit this week upheld a summary judgment by a US district court that Hoffmann-La Roche and a number of co-defendants did not infringe patents assigned to Carnegie Mellon University related to recombinant plasmids for the enhanced expression of DNA polymerase I.
The Federal Circuit also upheld a decision, handed down by the District Court for the Northern District of California, that certain claims of the CMU patents are invalid “for lack of written description.”
Co-plaintiffs CMU and Three Rivers Biologicals originally sued Roche in 1994 for infringing US Patent Nos. 4,767,708 and 5,126,270. In response, Roche filed motions for summary judgment of invalidity and noninfringement of the patents, which the district court granted.
In 2001, Carnegie Mellon sued Roche again for infringement of US Patent No. 6,017,745. Roche again filed motions for judgment of invalidity and the district court again granted the motion.
According to court documents, the district court entered final judgment in favor of Roche in 2007, which CMU appealed claiming that the court had erred in its decision.
All of the patents relate to recombinant plasmids for enhancing expression of DNA polymerase, bacterial strains containing such plasmids, and methods for conditionally controlling the expression of DNA polymerase I using such bacterial strains.
Co-defendants named in one or both of the original suits included Roche Molecular Systems, Roche Diagnostic Systems, Roche Biomedical Laboratories, PerkinElmer, Laboratory Corporation of America, and Applera.

Ligand to Pay Salk Institute $13M as Part of Arbitration Settlement
Ligand Pharmaceuticals has agreed to pay the Salk Institute for Biological Studies around $13 million to settle an ongoing legal dispute over royalties Salk claimed it was owed after Ligand sold its Targretin product to Eisai.
The deal also calls for the parties to jointly seek dismissal with prejudice of all claims and counterclaims of the row, Ligand said.
The terms of the settlement call for Salk to drop a claim for at least $25.3 million, and for Ligand to pay Salk $9.5 million immediately upon settlement and $3.5 million six months from the date of settlement.
According to documents filed last year by Ligand to the US Securities and Exchange Comission, Salk alleged in 2007 that Ligand owed the institute royalties on prior product sales of Targretin as well as a percentage of the money that Eisai paid Ligand in 2006 for its oncology product line.
Salk alleged that it was owed at least 25 percent of the consideration paid by Eisai for the Targretin portion of the sale, according to the SEC filing. In a subsequent request for mediation, Salk repeated its claims and asserted additional claims allegedly increasing the amount of royalty buy-out payments.
After unsuccessful mediation, Salk filed a demand for arbitration in July 2007, seeking at least $22 million for alleged breach of contract based on its theory that it is entitled to a portion of the money from the Eisai sale, according to the documents.
This week, Ligand said that a settlement was reached, and that it largely ends the relationship between the entities that dates back to 1988 when Ligand initially licensed from Salk certain intracellular receptor technology.
Ligand and Salk also agreed to terminate a 1997 license agreement relating to certain technologies, as well as a 2002 amended and restated agreement. The end of these alliances does not affect any previously granted sublicense or any sublicenses granted to third parties, Ligand said.
Ligand also said that it does not believe it requires a license from Salk for its ongoing business activities, but Salk has granted the company and its sublicensees a covenant not to sue under any patents or know-how that were the subject of these terminated agreements.
Ligand said it has used the Salk technology to achieve early recognition of the drug-discovery opportunities inherent in IR research as well as build substantial expertise in intracellular receptors applicable to drug discovery and development for potential therapeutic benefit.

Southest TechInventures to Help UNC-Charlotte ‘Streamline’ Tech Transfer
Southeast TechInventures this week said it has signed a master licensing agreement with the University of North Carolina-Charlotte to speed the commercialization of technologies developed at the school.
The goal of the agreement is to “streamline negotiations and accelerate the acquisition of intellectual property,” STI said in a statement.
STI, based in Research Triangle Park, NC, uses Small Business Innovation Research grants and other government and corporate funds to develop technologies culled primarily from university research labs.
STI said it is also currently working with several UNC-Charlotte early-stage technologies and is interested in identifying other promising research from the school that might benefit from its approach.
The company also said that it has similar licensing agreements with several other undisclosed North Carolina-based institutions.

Altor Bioscience Licenses HIV, HCV Rx Tech from MGH
Altor Bioscience said this week that it has obtained from Massachusetts General Hospital exclusive, worldwide rights to develop and commercialize T-cell receptors specific for cells infected by HIV and hepatitis C.
Altor has already converted the licensed TCRs into targeted therapeutic reagents using its Soluble T-cell Antigen Receptor technology, it said.
Financial terms of the agreement were not disclosed.
The license follows on the heels of a research collaboration established in 2004 between Altor, the Howard Hughes Medical Institute, and the Partners AIDS Research Center at MGH, Altor said.

Molecular Sensing Signs CRADA with Vanderbilt, CDC for STD Dx Platform
Molecular Sensing this week announced that it has signed a Cooperative Research and Development Agreement with Vanderbilt University and the Center for Disease Control’s National Center to develop a diagnostic platform based on back scattering interferometry for detecting HIV/AIDS and other sexually transmitted diseases, viral hepatitis, and tuberculosis.
The BSI technology, invented by Vanderbilt chemistry professor Darryl Bornhop, enables researchers to perform free-solution, label-free, and tether-free molecular interaction, kinetic, and end-point assays at zeptomole levels of sensitivity.
Molecular Sensing has exclusively licensed from Vanderbilt IP allowing it to further develop and commercialize BSI technology in the areas of life-sciences research, in vitro diagnostics, biodefense, environmental testing, and food safety.
MSI said it has shipped a pre-production assay system to the CDC to be used in the program.

ASU and Spinout Heliae Development Enter $3M Biofuel-Development Pact
Arizona State University has entered into a $3 million research and commercialization agreement with Heliae Development and Science Foundation Arizona to develop and market kerosene-based aviation fuel derived from algae.
Heliae Development was spun out of ASU to develop the algal strains and techniques for producing fuel with them, which were developed by professors Qiang Hu and Milton Sommerfeld at the ASU Laboratory for Algae Research and Biotechnology.
Under a licensing agreement between Heliae and ASU, Arizona Technology Enterprise, the venture arm of ASU, will receive an equity stake in the company and other standard dilutions including licensing fees and a share of commercialization income.
In addition, Heliae will provide $1.5 million in research funding to ASU to support the development of the algal strains. This funding will be matched by a Strategic Research Group award from Science Foundation Arizona.

Opexa Thera Inks Research Partnership with Mylein Repair Foundation
Opexa Therapeutics last week announced that it has established a multiple sclerosis research partnership with the Myelin Repair Foundation.
As part of the collaboration, the partners will look for therapeutically relevant biomarkers in MS in order to help Opexa continue develop Tovaxin, its T-cell vaccine currently in Phase IIb clinical testing in MS patients.
Biomarkers identified during the program may also help the drug maker discover and develop other MS drugs and diagnostics, Opexa said.
The collaboration will be jointly managed by research and development officials from Opexa and the MRF. Both partners will own the intellectual property that its representatives conceive during the program. IP that is conceived collaboratively will be jointly owned by Opexa and the MRF, with Opexa retaining the option to negotiate an exclusive license to such IP, or that which is solely owned by the MRF.
The MRF is a non-profit medical research foundation formed to accelerate basic medical research into myelin repair treatments, the principle target for MS drugs.
The group's Accelerated Research Collaboration model establishes collaborations with a variety of MS researchers who agree to work jointly to develop and conduct experiments that may lead to targeted myelin repair discoveries (see BTW, 6/4/2008).
To date, the MRF has partnered with researchers at Stanford University, Northwestern University, University of Chicago, and Case Western Reserve University.

LANL, ARCH Venture, Verge Fund Partner to Create Startups
Los Alamos National Laboratory and its operating contractor, Los Alamos National Security, plan to partner with ARCH Venture Partners and Verge Fund to spin out technology-based companies from research conducted at the laboratory.
The initiative, called the Los Alamos Venture Acceleration Initiative, will emphasize establishing new businesses in Northern New Mexico, where Los Alamos is based. The partners will negotiate an agreement with a financial contribution by LANL valued at up to $1 million over three years, and a contribution of time and effort from the combined ARCH-Verge team of 20 investment professionals, including eight located in New Mexico.

ARCH Venture Partners is a venture capital firm with more than $1.5 billion in total capital under management. Verge Fund is an Albuquerque-based venture capital fund that invests in seed-stage, high-growth ventures in New Mexico.

The Scan

Study Tracks Responses in Patients Pursuing Polygenic Risk Score Profiling

Using interviews, researchers in the European Journal of Human Genetics qualitatively assess individuals' motivations for, and experiences with, direct-to-consumer polygenic risk score testing.

EHR Quality Improvement Study Detects Demographic-Related Deficiencies in Cancer Family History Data

In a retrospective analysis in JAMA Network Open, researchers find that sex, ethnicity, language, and other features coincide with the quality of cancer family history information in a patient's record.

Inflammatory Bowel Disease Linked to Gut Microbiome Community Structure Gradient in Meta-Analysis

Bringing together data from prior studies, researchers in Genome Biology track down microbial taxa and a population structure gradient with ties to ulcerative colitis or Crohn's disease.

Ancient Greek Army Ancestry Highlights Mercenary Role in Historical Migrations

By profiling genomic patterns in 5th century samples from in and around Himera, researchers saw diverse ancestry in Greek army representatives in the region, as they report in PNAS.