NEW YORK (GenomeWeb News) – How a university tech-transfer office handles its IP-licensing deals “can make a very big difference” in how a genetic test will be used, according to the authors of an ongoing study by researchers at Duke University.
The study is also investigating whether federal agencies that help underwrite the research behind genetic tests can influence their dissemination, and whether claim constructs in many existing gene patents are sufficient to protect the tests.
The scientists, from Duke’s Institute for Genome Sciences and Policy, presented preliminary findings of their research in a poster presentation at the Association of University Technology Managers annual meeting held in San Diego last week.
The team comprises Subhashini Chandrasekharan, a postdoctoral research fellow in the Center for Public Genomics within IGSP’s Center for Genome Ethics, Law, and Policy; Carla Rydholm, a student at the Duke School of Law, and principal investigator Robert Cook-Deegan, director of the CGELP.
As part of their study, the researchers analyzed 93 patents that are the basis for a suite of DNA-based diagnostics offered by reference laboratory Athena Diagnostics.
The researchers chose to analyze Athena’s patents because they were easily obtainable from the company’s website. The patents cover part of the more than 240 individual genetic tests the lab performs for a wide variety of specific conditions across approximately 30 diseases categories.
The Duke researchers analyzed each of the patents to assess what the specific claims were; who the original assignees of the patents were (i.e., whether Athena in-licensed the patents from non-profit research institutes or other companies); and whether the patents disclosed federal support for the research leading to the patented invention.
They found that of the 93 patents granted to a total of 101 different assignees, Athena Diagnostics was the sole assignee of just seven, meaning that most of the IP covering the lab’s genetic tests has been in-licensed from other entities.
Further analysis revealed that over 75 percent of the licensed patents were originally assigned to non-profit entities worldwide. About half of the 101 patent assignees are US-based non-profits, including 41 US-based universities and 14 US-based non-profit research institutes. The remaining assignees included US or international corporations or individuals, including the seven assigned to Athena.
Chandrasekharan said that the preliminary data is only a taste of a larger scale study that the group is now conducting to investigate whether patents licensed to genetic test providers like Athena have or can be licensed according to best practices recommended in recent years by various agencies and groups seeking to ensure that the tests are made widely available when appropriate.
According to the study’s authors, one concern is that widespread access to gene-based diagnostics might be limited due to one company aggregating all of the IP surrounding the test.
Athena, for one, has been criticized in the past for enforcing its patents against infringers at other companies, universities, and hospitals. One well-publicized case in the late 1990s involved an Alzheimer’s gene test that Athena non-exclusively licensed from Duke and, according to critics, prevented others from using on even a research level.
Athena, a specialty brand of Thermo Fisher Scientific, has recently begun to expand access to the Alzheimer’s patents. For instance, last month it sublicensed rights to the Alzheimer’s test to startup genetic testing shop Smart Genetics, which is using it as part of a new Alzheimer’s risk-assessment service.
According to the Duke researchers, even when companies keep a tight grip on university-developed patents for genetic tests, it does not always have a negative impact.
“Every test that is on that list that Athena Diagnostics has licensed from a university has not necessarily created a situation where they are the sole providers of the test. We do want to make that clear,” Chandrasekharan told GenomeWeb Daily News sister publication Biotech Transfer Week. “In some cases, they may have negotiated licenses to other providers.”
According to Cook-Deegan, problems typically arise when one company assembles and controls all of the IP for a particular line of genetic tests.
“For the most part, we’re not hearing that people can’t get their tests at all,” Cook-Deegan told BTW. “We are sometimes hearing complaints that you have to go to a single provider.”
In fact, Cook-Deegan said that when one company aggregates IP around a particular genetic test, “that doesn’t always generate complaints of access, because in fact, sometimes by doing that, you can accumulate what you need to do all the genetic tests for a clinical syndrome, with the patents all held by different universities.
“The testing service can assemble all of that IP and actually come together with a coherent business plan that none of [the individual universities] … could do because they aren’t in the business of doing genetic testing or licensing key patents to do that genetic testing,” he added.
The Duke study was funded primarily by the National Human Genome Research Institute and is being performed in part to contribute to the National Institutes of Health Secretary’s Advisory Committee on Genetics, Health, and Society, which has recently assembled a task force to investigate specific issues of access to genetic testing in the US, the authors said.
A comprehensive version of this article appears in this week's issue of Biotech Transfer Week.