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Study: Academic Tech-Transfer IP-Licensing Policies Can Affect Access to Genetic Dxs

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SAN DIEGO – 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 here 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.
 
It is unclear how many of the gene-related patents licensed by Athena from universities are exclusive. Calls to the company were not returned in time for this publication.
 
“What is clear is that there has been a lot of discussion about what has happened with genetic testing covered by … patents owned by universities or non-profit research institutes,” Chandrasekharan told BTW. “So we are saying that academic university practices can make a very big difference in thinking about how a genetic test will be used.”
 
According to Chandrasekharan, 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.
 
Examples of these best licensing practices include Best Practices for the Licensing of Genomic Inventions guidelines released in 2004 by the NIH’s Department of Health and Human Services; guidelines for the licensing of genetic inventions published in 2006 by member countries of the Organization for Economic Cooperation and Development; and recommendations for licensing of gene-based patents included in a white paper published last year describing nine points of university licensing, authored by AUTM member universities (see BTW, 3/19/2007).
 
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.
 

“The group that you licensed to, if a clinician thinks they haven’t got the answer right, is there a provision enabling verification testing? As far as I know, that is not a standard licensing provision, but it sure could be.”

Another well-publicized example of a company accused in the past of hoarding patents related to gene-based tests is Myriad Genetics and its patents for the BRCA 1 and BRCA 2 genes, which are linked to breast and ovarian cancer, and which the company developed in collaboration with the University of Utah, Canada’s Centre de Recherche du Chul, and the Cancer Institute of Japan, among others.
 
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 BTW. “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.
 
Chandrasekharan and Cook-Deegan said that universities should consider incorporating into their tech-transfer policies some of the existing best practice guidelines.
 
“In the few cases where there has been a concern about access to genetic testing, some [thinking on] the use of these genetic tests in the licensing provisions could have made a difference,” Chandrasekharan said.
 
For example, Cook-Deegan said that schools could incorporate march-in rights in licensing provisions that would ensure sublicensing. Another idea is to ensure that the underlying patents could be exclusively used for research purposes by entities other than the original licensee.
 
Yet another issue surrounding genetic testing is making sure that companies that license genetic test patents allow researchers to use the tests in clinical trials, Cook-Deegan said.
 
“That would be a logical provision,” he said. “And verification testing — the group that you licensed to, if a clinician thinks they haven’t got the answer right, is there a provision enabling verification testing? As far as I know, that is not a standard licensing provision, but it sure could be.”
 
Staking Claims
 
In their preliminary study, the Duke researchers also found that about 82 percent of the patents underlying Athena’s diagnostic tests actually claimed a diagnostic application, while about 40 percent of the patents claimed a specific gene sequence.
 
According to Chandrasekharan, this data is significant because many of these claims might be constructed in such a way that could allow other entities to use the pertinent genes in order to conduct their own genetic tests.
 
She said that this is part of a larger ongoing effort by the Duke researchers to “identify ways to develop tools that researchers and business-development people could use to identify patents that might cover diagnostic uses of certain genes or genetic sequences,” Chandrasekharan said.
 
“It is difficult to do that right now, because it takes a lot of digging through lots of patents,” she added. “Looking at the claims gives you a sense of what you can exclude someone from doing or not doing.”
 
For instance, she said that the group plans to examine some of the sequence-only patents for which no use of that sequence for diagnosing a disease has been claimed.
 
“We are then going to compare whether those patents have been granted in the US and Europe to see what the different standards of utility are,” she said. “Would the same patent be granted by the EPO, for instance, if it claims only a sequence and that patent is being used to offer a genetic test in the US?”
 
Lastly, the researchers found that almost half of all the patents licensed to Athena were funded at least in part by the US government. The group argues that as such, the US government also has a role to play in ensuring widespread access to genetic testing.
 
“The US government could influence how the norms of practice for diagnostic patents are established by attaching appropriate IP reporting and management requirements to grant funding,” the poster’s authors wrote.
 
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.
 
Moving forward, Chandrasekharan said that her group will attempt to flesh out the Athena data with information about patents underlying other popular genetic tests – a task that is proving very difficult to do because not many corporations publicly disclose all their underlying IP as Athena does.
 
“Since we only have one example, it doesn’t make such a strong case,” Chandrasekharan said. “If we could look at all the most commonly offered genetic tests … we can see what patents are associated with those. But awareness and discussion about these best practices among tech-transfer professionals is certainly a good thing, as is thinking about the future of genetic testing and how this might impact it.
 
“Some of the traditional ways of thinking about how to license something out in order to commercialize it might not be the best option,” she added.
 
University tech-transfer offices are often just as shy about disclosing specific licensing terms, typically citing confidentiality agreements with their licensees.
 
“There are things that universities can do, and I don’t know if they are doing them or not,” Cook-Deegan said. “Part of the problem with our doing this research is that most of the licensing information is proprietary, and licensing offices do not share it with us, except in exceptional circumstances. Stanford and Berkeley have been very open. But most licensing offices are not, so we don’t know if they’re incorporating terms into licenses or not.”
 
Cook-Deegan said that he has never been informed of any specific licensing terms even at Duke’s tech-transfer office, which originally licensed the portfolio of Alzheimer’s genetic testing patents to Athena.
 
“I’ve never seen any of the Duke licenses, because I’ve been told they are covered by non-disclosure agreements, and if I look at them I can’t write about them, and if I can’t write about them there is no point in my looking at them,” Cook-Deegan said. Calls to the Duke Office of Licensing and Ventures were not returned in time for this publication.
 
Still, Cook-Deegan said that university tech-transfer offices are learning.
 
“I think tech licensing officers have a domain of expertise, and this is it,” he said. “They need to incorporate the best practices of their field as they learn. All of us screw up all the time, and if the system is working, you have to learn from the mistakes that others have made, or you learn from the models that people have provided for you.”
 
Added Cook-Deegan, “the message to the AUTM community is to formulate these best practices and follow them.”

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