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Consumer Groups Appeal USPTO’s Ruling on WARF’s ‘913 Stem Cell Patent
 
Consumer groups Consumer Watchdog and the Public Patent Foundation last week filed an appeal in their challenge of a patent on primate embryonic stem cells held by the Wisconsin Alumni Research Foundation.
 
Consumer Watchdog, formerly the Foundation for Taxpayer and Consumer Rights, and the PPF appealed to the US Patent Office’s Board of Appeals and Interferences in regards to US Patent No. 7,029,913, entitled “Primate embryonic stem cells.”
 
The US Patent and Trademark Office examiner narrowed WARF’s patent after the groups requested a re-examination of the patent in July 2006. Initially all the patent claims were rejected, the consumer groups said, but this spring the PTO granted the narrowed claims.
 
Jeanne Loring, director of the Center for Regenerative Medicine at the Scripps Research Institute, initially joined the consumer groups in their challenge of the patent. Later in the case, Alan Trounson, then of Australia’s Monash University and now president of the California Institute for Regenerative Medicine, along with Harvard researchers Douglas Melton and Chad Cowan, filed affidavits supporting the challenge, the groups said.
 
The appeal intends to show that the creation of hESC lines was obvious in the light of work that had been done in other species.
 
Late last month, WARF said that the USPTO issued reexamination certificates for two other base embryonic stem cell patents (US Patent Nos. 5,843,780 and 6,200,806) held by WARF, officially concluding a reexamination process for the patents that began in October 2006 (see BTW, 3/5/2007) and was decided in WARF’s favor in March of this year (see BTW, 3/12/2008).

 

WARF said that those rulings are not appealable, meaning that the claims of the patents stand confirmed and enforceable. However, at the time WARF also said that the ‘913 patent followed a slightly different process, and was still subject to appeal.
 

 
Arizona State’s Tech-Transfer Arm to Market Techs for Mexican, Irish Universities
 
Arizona Technology Enterprises, the technology venturing arm of Arizona State University, has agreed to market technologies developed by ASU partner universities Dublin City University in Ireland and Tec de Monterrey in Mexico, the school said last week.

AzTE will collaborate with each university by protecting and commercializing in the US selected intellectual property developed by their researchers. The collaborations are intended to leverage the extensive US networks of corporate executives, investors, and entrepreneurs developed by AzTE's professional staff, ASU said.

 
In turn, technology transfer to US companies could benefit the US public with potential development of useful products and services, and could return discretionary income to the universities, including ASU through AzTE's share of licensing income, for reinvestment in their research and educational enterprises, the university said.
AzTE is located at SkySong, ASU’s Scottsdale-based innovation center, and is working in collaboration with Julia Rosen of ASU's Innovation and Entrepreneurship to bolster the relationships with Tec de Monterrey and Dublin City University.
 
AzTE is sending its life sciences team, led by Jack Geltosky, senior vice president of business development, to visit Tec de Monterrey to begin reviewing technologies developed at the university's biotechnology center.
 
Dublin City University has won several large research awards from the Irish government in the areas of sensors and adaptive information technologies, and it is expected that AzTE will work to commercialize technologies related to those areas.
 

 
ACT Licenses HPV Vaccine Tech from Louisville’s Brown Cancer Center
 
Advanced Cancer Therapeutics this week said that it has signed an agreement with the University of Louisville’s James Graham Brown Cancer Center for the exclusive worldwide development and commercialization rights to monovalent vaccines derived from the minor capsid protein of human papillomavirus.
 
The intellectual property, licensed to ACT through Louisville’s Office of Technology Transfer, is based on research conducted by Louisville faculty members Kenneth Palmer, Bennett Jenson, and others.
 
The licensing deal is expected to advance development of ACT’s novel HPV vaccine program, ACT said.
 
The company also announced that it has signed an agreement with Owensboro’s Kentucky BioProcessing for exclusive worldwide development and commercialization rights to KP’s Geneware plant-based gene expression system for developing an HPV vaccine.
 
Financial terms of the agreements were not disclosed.
 

 
Armed Forces to Use Calibrant's Gemini for Biomarker Research
 
The Armed Forces Institute of Pathology will use Calibrant Biosystems’ Gemini proteomics platform to validate biomarkers for brain cancer and to discover other predictive markers, Calibrant said last week.
 
Under a Cooperative Research and Development Agreement, AFIP, which is part of the US Department of Defense, will produce custom tissue microarrays in agreement with Calibrant’s specifications. The collaboration will focus initially on brain cancer with the ultimate goal of identifying predictive markers for personalized medicine, said Calibrant.
 
The Gemini platform is compatible with fresh and formalin-fixed archival tissues, allowing users to map protein networks between different cell types within one tissue section.
 
Michael Salgaller, COO of Gaithersburg, Md.-based Calibrant, said in a statement that the AFIP partnership is “an excellent way to conduct high-throughput validation on a large population set of carefully chosen samples.”
 
Financial terms of the agreement were not released.
 

 
Raptor Pharma to Conduct Clinical Trials for NASH Treatment at UCSD
 
Raptor Pharmaceuticals said last week that the University of California, San Diego’s General Clinical Research Center will conduct a Phase 2a trial to evaluate Raptor’s delayed-release cyseamine bitartrate in adolescents diagnosed with non-alcoholic steatohepatitis, or NASH.
 
Under the agreement, Raptor will provide funding and clinical supply of cysteamine to clinical researchers at UCSD’s GCRC.
 
In March, Raptor’s clinical development subsidiary Bennu Pharmaceuticals acquired an exclusive worldwide license to intellectual property from UCSD covering the use of cysteamine and delayed-release cysteamine for treating NASH (see BTW, 3/26/2008).
 
NASH is a progressive form of liver disease that accounts for approximately 10 percent of newly diagnosed cases of chronic liver disease, and is one of the leading causes of cirrhosis of the liver in the US.
 

 
Fishers, Ind., Long Performance Advisors Plan $12M Biotech Incubator
 
The Fishers (Ind.) Economic and Community Development Commission has joined with Mark Long of Long Performance Advisors to establish the Fishers Research and Technology Campus, a cluster of tech facilities to start with a $12 million building set to open within the next 18 months.
 
The building will be between 40,000 and 50,000 square feet, and be designed for startup biotechnology companies from Indiana universities and research institutes. According to the commission, the building will offer wet laboratories, flexible tenant spaces suitable for research and development, and production facilities.
 
In addition, the facility will provide shared conference space and a network of professional consultants, such as attorneys and accountants, who can mentor early-stage entrepreneurs.
 
The commission has hired Long, who served as president of Indiana University’s Research & Technology Corp. from 2002 until early this year, to head development of the Research and Technology Campus. Long — who also built the IU Emerging Technologies Center, the university’s flagship business incubator — will continue to teach entrepreneurship and life sciences courses at IU’s Kelley School of Business.
 
The commission is a partnership between the town of Fishers and the Fishers Chamber of Commerce.
 

 
Hadasit Portfolio Firm Verto Completes Human Trial for Lupus Treatment
 
Hadasit Bio-Holdings -- a subsidiary of Hadasit, the tech-transfer company of the Hadassah University Hospital -- said this week that portfolio company Verto has successfully completed a human clinical trial of a device for treating patients with systemic lupus erythematosus.
 
The goal of the trial at Haddasah Medical Center in Ein Kerem, Israel, in which ten lupus patients took part, was to demonstrate the safety and efficacy of Verto’s Lupusorb technology – a filter column that can be incorporated into the standard process of plasmapheresis for lupus patients.
 
Hadasit Bio-Holdings said that it owns a 75 percent stake in Verto.
 

 
ChromaDex Licenses Plant-Based Chemicals from SUNY Buffalo
 
ChromaDex said this week that it has entered into a worldwide licensing agreement with the Research Foundation of the State University of New York, on behalf of the University of Buffalo, covering the production and marketing of three classes of plant-based ingredients for a variety of applications.
 
Under the terms of the agreement, ChromaDex, based in Irvine, Calif., made an undisclosed up-front cash payment to SUNY Buffalo and will pay earned royalties on sales of covered technology products and services.
 
The technology licensed to ChromDex includes methods to selectively manufacture anthocyanins, leucoanthocyanidins, and anthocyanidins, which are naturally occurring pigments and antioxidants that can be used as natural colorants and may also aid in controlling blood glucose levels to assist with weight management and diabetes control, ChromDex said.
 
ChromDex’s deal with the SUNY Research Foundation allows it to market the chemicals for use in the nutraceutical, functional food, beverage, natural chemical, cosmetic, and pharmaceutical industries.
 

 
Metabolon, UT Health Science Center Collaborating on Diabetes Dx
 
Metabolon said this week that it is collaborating with researchers at the University of Texas Health Science Center at San Antonio on the development of Metabolon’s pre-diabetes diagnostic products.
 
Research Triangle Park, NC-based Metabolon will analyze samples from studies being conducted by Ralph DeFronzo and his colleagues at UTHSC in an effort to discover and validate biochemical biomarkers reflective of insulin resistance and beta cell dysfunction.
 
The markers will be used by Metabolon to develop diagnostic tests for insulin resistance and how this relates to the risk of developing metabolic diseases, such as diabetes.
 
Metabolon CEO John Ryals said in a statement that the company hopes to develop a test that can help physicians “identify asymptomatic, pre-diabetic patients years before they become diabetic.”
 
Further terms of the alliance were not disclosed.
 

 
TEDCO, USMRMC, and Frederick County Award $100K to Maryland Biotechs
 
The Maryland Technology Development Corporation, in collaboration with the US Army Medical Research and Materiel Command and the Frederick County Office of Economic Development, has awarded two companies a total of $100,000 in funding through the Ft. Detrick Technology Transfer Initiative.
 
The companies, Theradigm and APE-BridgePath Scientific, each received $50,000 through the initiative, and are the first companies to receive funding through TEDCO’s $750,000 extension of the FDTTI.
 
Theradigm, based in Baltimore, is a portfolio company of Toucan Capital Fund II, and is developing cell-based therapies for treating central nervous system disorders.
 
APE-BridgePath Scientific, located in Frederick, is assisting privately and publicly funded researchers and companies with preclinical development of pharmaceuticals, vaccines, and research tools.

The Scan

US Supports Patent Waivers

NPR reports that the Biden Administration has announced its support for waiving intellectual property protections for SARS-CoV-2 vaccines.

Vaccines Versus Variants

Two studies find the Pfizer-BioNTech SARS-CoV-2 vaccine to be effective against viral variants, and Moderna reports on booster shots to combat variants.

CRISPR for What Ails You

The Wall Street Journal writes that CRISPR-based therapies could someday be used to treat common conditions like heart attacks.

Nature Papers Review Integration of Single-Cell Assay Data, Present Approach to Detect Rare Variants

In Nature this week: review of ways to integrate data from single-cell assays, and more.