This article has been updated from a previous version to clarify CHG's reasons for discontinuing the tests.
Boston University’s Center for Human Genetics will stop offering 16 genetic tests for which Athena Diagnostics holds an exclusive license, citing tightened intellectual property restrictions by the firm.
BU said in a statement this week that the decision follows a “negotiated settlement agreement with Athena, which had brought the issue to the attention of the university and CHG.” The statement did not elaborate.
Aubrey Milunsky, director of the BU CHG, told BTW that Athena, which is a subsidiary of Thermo Fisher Scientific, has “bought exclusive licenses for all of [the] tests [and] has essentially moved to prevent anyone else from doing these tests, since they hold the exclusive licenses.”
Milunsky declined to discuss any further terms of the agreement, citing a strict confidentiality agreement between CHG and Athena. However, he said that the underlying issue is not unique to Athena, but starts at the level of the academic institutions that hold the IP rights to the tests and exclusively license them to companies such as Athena.
BU went on to say that much of the technology underlying the testing services performed by the center was discovered by academic scientists, patented by their respective universities, and licensed to Athena for commercial development. BU said in the statement that it “respects intellectual property rights.”
CHG offers almost 100 genetic tests for “a whole range of disorders for which the genes have been established, just like the ones we can no longer test for,” Milunsky said. “Typically they have been established by original work supported by taxpayers” through research grants, he added, and then ultimately sold, “usually by the discoverers, at mostly universities or similar institutions.”
Genetic testing centers like CHG are free to offer genetic tests discovered by universities or research institutions provided that there is not “strict enforceable patent protection” in place, Milunsky said. The problem has been not so much that these universities have restricted access to the tests by enforcing patents, but have licensed them exclusively to companies that have.
“That’s where the problem has begun,” Milunsky said. Despite best licensing recommendations for genetic tests laid out in recent years by the National Institutes of Health’s Department of Health and Human Services and others, “the universities have gone ahead and allowed patent licenses to be taken exclusively, and that has been a problem, unfortunately,” he added.
“Clinical Data also has excluded us, among others, from doing analysis of Long QT syndrome, which is a disorder … that might cause sudden death,” Milunsky said. “They also stopped us from doing this by holding the exclusive license.”
A spokesperson for Athena told BTW that the company acknowledges having reached an agreement with BU as started by the university, but declined to add anything further.
Athena … has “bought exclusive licenses for all of [the] tests [and] has essentially moved to prevent anyone else from doing these tests, since they hold the exclusive licenses.”
Other academic genetic testing centers have raised the issue of how university licensing practices can affect access to genetic tests. At the Association of University Technology Managers annual meeting in March, researchers from Duke University’s Institute for Genome Sciences and Policy presented preliminary research findings on the topic using as an example 93 patents that are the backbone of Athena’s DNA-based diagnostics.
Specifically, the researchers investigated whether university tech-transfer offices could greatly influence how a genetic test will be used in their licensing deals with companies; 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 (see BTW, 3/5/2008
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.
In addition, the researchers found that more than 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, while the remaining assignees included US or international corporations or individuals, including the seven assigned to Athena.
The patented tests that the BU CHG will discontinue include tests relating to CADASIL; hearing loss related to A1555G or Connexin 26 mutations; developmental disorders caused by mutation of the ARX gene; Duchenne's muscular dystrophy; myotonic dystrophy; Freidreich's ataxia; hereditary neuropathy with pressure palsies; polycystic kidney disease; spinal muscular atrophy; spinocerebellar ataxia (SCA1, 2, 3, 6, 7 and 8); and tuberous sclerosis (type 2).
Athena lists the patents underlying its genetic tests on its website. According to the US Patent and Trademark Office patent database, the assignees to the patents underlying the discontinued CHG tests include, but are not limited to, the Institut National de la Santé et de la Recherche Médicale (Inserm) and Institut Pasteur in France; the University of Wales College of Medicine and Medical Research Council in the UK; Children’s Hospital Boston; the Massachusetts Institute of Technology; Baylor University College of Medicine; University of Utah; Johns Hopkins University; Albert Einstein College of Medicine; University of Minnesota; Cedars Sinai Medical Center; and the Research Development Foundation of Carson City, Nev.
Biotech firm Genzyme and Athena are also the assignees on two patents that serve as the basis for the discontinued tests. It is unclear whether the Athena-owned tests discontinued by BU’s CHG are offered at any other academic genetic testing centers.
BU said in a statement that the CHG has advised its clients that it will now either forward future requests for an Athena-licensed testing service to Athena for processing, or notify the requesting client that it may procure the services directly from Athena.
BU also said that Athena has made no objection to, and that the settlement does not affect any non-commercial research activities at the university.