This article in Nature discusses a pre-trial hearing for UNIVERSITY OF SOUTH FLORIDA v THE JACKSON LABORATORY scheduled for March 21, 2017. The case of interest relates to US Patent 5,898,094 for “Transgenic Mice Expressing APPK670N,M671L and a Mutant Presenilin Transgenes.” This patent’s assignee is the University of South Florida. In the case (originally filed in late 2015), USF asserts that Jackson has infringed on its intellectual property as claimed in the ‘094 patent and demands a jury trial for the determination of injunctive and monetary relief per 35 USC 271 and 284. Although no specific claims are mentioned in the complaint document (which includes a full text of the ‘094 patent), the complaint basically asserts that a government-funded laboratory in Maine (the Jackson lab) willfully infringed on the ‘094 patent by selling genetically-engineered mice from 2009 to the time of the complaint’s filing.
The patent, which was issued in 1999, protects an animal model with "accelerated pathology for Alzheimer's Disease” consisting of selectively breeding mice from parents with differing mutations; when both mutations are inherited in this second generation, the mice are especially disposed to the amyloid aggregation indicative of Alzheimer’s disease. (The mutations are a mutant presenilin M146L gene in one parent and the mutant APPK670N,M671L gene in the other parent. Both of these mutations relate to and accelerate the generation of amyloid β from amyloid precursor protein so that mice with combined mutations reach a suitable disease state for research in less than half the time of non-mutated alternatives.) Jackson sells a variety of genetically engineered mice lines, many of which are produced by the two-mutation breeding strategy utilized by the ‘094 patent; however, it does not appear that any of Jackson’s lines specifically contain the M146L and APPK670N,M671L genes in combination.
Jackson’s website still lists several mice lines for sale that contain the transgenes mentioned in USF’s patent in combination with transgenes that are not listed in the patent. I anticipate that Jackson will be found not to have infringed on USF’s intellectual property on the basis that the changes to the patent resulting in Jackson’s products may not have been anticipatable by the patent authors at the time of its authorship: genetic research relating to Alzheimer's is a growing field and the Court would set a dangerous precedent by allowing USF dominion over any combination of the two transgenes in their ‘094 patent with other (newly discovered) genes; such a ruling would discourage innovations in the field and run contrary to the intent of the patent system.
Additionally, it seems that Nature mistakenly stated that USF was suing the NIH. Although USF’s complaint does include the statement "USF is therefore pursuing appropriate relief from the United States for such conduct under §1498 in the U.S. Court of Federal Claims, and such conduct is excluded from this complaint,” no such case seems to exist. As the article notes, it is unlikely USF would pursue a suit against the NIH as they are a "more costly and formidable defendant to take on in court.”
As a sidenote, I found the journal article The mouse that trolled: the long and tortuous history of a gene mutation patent that became an expensive impediment to Alzheimer’s research to be very interesting as supplementary reading.