LTC BULLETIN BOARD
LTC Bulletin Board - July 2011: Page 5 of 5
Patent Dispute Detracts from Alzheimer’s Research
Transgenic mouse models are at the center of a lawsuit that is threatening a community of Alzheimer’s disease researchers. According to a report by Nature News, the Alzheimer’s Institute of America (AIA) is involved in litigation against Jackson Laboratory, a Maine-based source of laboratory mice funded by the National Institutes of Health (NIH).
In 2010, AIA filed a lawsuit claiming Jackson infringed upon its Swedish mutation patent when it sold and distributed 22 strains of mice with the mutation to researchers. The AIA holds a patent on a human DNA sequence used in mice to trigger early onset of Alzheimer’s, and the NIH requires scientists to share transgenic mouse strains developed using NIH funds. The AIA claims its mouse model patents may not be used for profit; they may only be used for academic purposes.
“Jackson Laboratory is not giving away the mice for academic research. On the contrary, these mice are being sold, and Jackson Laboratory is making quite a lot of money in the process,” the AIA wrote in a statement. Jackson has denied selling the mice to companies.
Nature reported that the AIA would drop the lawsuit if Jackson turns over names of the scientists who received the mice, but doing so could put the researchers at risk for litigation. Jackson officials say that Jackson only allows academics, and not companies, to use the models. But litigation to disprove AIA’s claims could cost Jackson years and a wealth of resources. The laboratory has asked NIH to assume the cost of its defense.
“We haven’t been able to settle this case because we’re trying to do the right thing by trying to support the NIH policy and protect researchers out there in the community,” said David Einhorn, Jackson house counsel, in Nature.
Read the entire report online at www.nature.com/news/2011/110405/full/472020a.html.
New Alzheimer’s Research Suggests Presymptomatic Detection Possible
New criteria and guidelines for diagnosing Alzheimer’s disease have been published for the first time in nearly 30 years. Led by the Alzheimer’s Association and the National Institute on Aging of the National Institutes of Health, a team of researchers has published several articles that expand the definition of Alzheimer’s to include a preclinical stage. The new guidelines also refine the existing guidelines for diagnosing mild cognitive impairment (MCI) and establish a framework for monitoring certain biomarkers to diagnose Alzheimer’s at every stage.
Reflecting an emerging consensus, the authors propose that Alzheimer’s begins with a long, asymptomatic period, during which measurable changes in the brain can be detected years and even decades before symptoms of memory and thinking lapses are noticeable. Researchers are hopeful that biomarkers detected with brain imaging studies and cerebrospinal fluid assays will move the field toward earlier diagnosis and more precise, effective treatment. However, the use of biomarkers in Alzheimer’s dementia and MCI was proposed as a research agenda only and is not intended for application in a clinical setting until additional research has been conducted. The guidelines do not yet specify which biomarkers should be considered as signature indications of preclinical Alzheimer’s.
“Currently, Alzheimer’s therapies are in development that may be able to slow or stop the progression of the disease. By improving early detection and risk evaluation, we will better be able to test potential therapies and eventually prescribe them for people at increased risk,” said William Thies, PhD, chief medical and scientific officer, Alzheimer’s Association, in a press statement.
The articles also formalize the distinction that everyone who develops Alzheimer’s experiences a preceding MCI stage, but not everyone with MCI will receive an Alzheimer’s diagnosis because MCI may occur for other reasons. The new guidelines define the condition of “MCI due to Alzheimer’s disease” and outline four levels of certainty for diagnosis. One of the workgroups was charged with examining postmortem, pathological criteria for Alzheimer’s. The results of its research are expected to appear later this year.
The new guidelines can be downloaded at www.alz.org/research/diagnostic_criteria.