An enlightened decision by the National Institutes of Health has freed up crucial transgenic strains of mice whose use for research was being threatened by a patent troll.
Alzheimer’s disease is one of the major scourges of old age, causing progressive deterioration of brain tissue. The result is symptoms including irritability, confusion, mood swings, difficulties with language, short- and long-term memory loss, and death. On average, once a patient is diagnosed with Alzheimer’s, their life expectancy is about seven years.
The overall prevalence of Alzheimer’s in the US population is about 1.5%, whereas the worldwide prevalence is about 4 times smaller. The apparent discrepancy between US and worldwide numbers is likely due in part to underreporting in less developed countries and longer life expectancy in the US, but there may be environmental issues as well. Regardless, roughly half of all people living beyond an age of 85 years have Alzheimer’s.
There is at present no confirmed method of preventing Alzheimer’s and a lack of effective methods for delaying the progress of symptoms. The vast majority of Alzheimer’s treatment is supportive, involving drugs that help patients perform better with their damaged brains, and simple caregiving and therapy. The US cost of such treatment is roughly $300 billion/year. The quest for effective pharmaceutical intervention is very active, driven by the NIH and an enormous market to be gained.
An important step in finding treatments for a disease is to develop a suitable animal model for the illness. Mice are easy to maintain in a laboratory environment and their short life span is often of use in their role as animal models. One result has been a number of transgenic mouse strains, whose development was based on patents issued in 1995, now being assigned to the Alzheimer’s Institute of America (AIA).
A lawsuit for infringement was filed in February 2010 by the AIA against various parties, including the Jackson Laboratory, for distributing a type of transgenic mouse to the research community on which AIA held the patents. The Jackson Laboratory is a non-profit organization to whom the NIH contracted the job of distributing transgenic mouse strains to the research community.
The suit alleged that such distribution infringed AIA’s patent covering a DNA mutation linked to Alzheimer’s disease. AIA was apparently asking as part of the suit for the various companies to identify each researcher to whom the mouse strains at issue were delivered – presumably as a prelude to bringing suit against individual researchers – an action which might put Alzheimer’s research back by as much as a decade.
To prevent this prospect, Dr. Francis Collins, Director of the NIH, on June 17, 2011 invoked 35 USC 203, by which the US Government has the right to require licenses to be granted on any invention developed with government funding. He issued a letter assigning to Jackson Laboratories retroactive ‘authorization and consent’ of the United States Government to use any inventions covered by United States patents’ when making mice available for Alzheimer’s research projects. The validity of this assignment might be brought against the US Government, but the odds of successful challenge appear small.
Dr. Collins later said, "At NIH, we believe that science advances most rapidly when new technologies and research tools resulting from federal funding are made available to others."
Royalties associated with the march-in rights will be paid retroactively and for the remaining term of the patent by Jackson Laboratories to the AIA. This is a wise decision, respecting the rights of all parties to the lawsuit while ensuring that research on this devastating disease will go forward.