Are patents the protectors of innovation or repressors of research? - Why the academic community can’t make up its mind
In February 2010, the Alzheimer's Institute of America (AIA) filed lawsuits against several research institutes, one of which was the Jackson Laboratory, for alleged infringement of their patented Alzheimer’s mouse. These unfortunate rodents are engineered to carry a mutant form of the gene for human amyloid precursor protein in their genetic code, a characteristic that guarantees the mice will develop Alzheimer’s disease symptoms. This makes them particularly useful models for studying the development and prevention of the disease in humans. The Jackson Laboratory is a non-profit institute that is funded by the National Institute for Health (NIH) to produce these mice and distribute them to the research community. Herein lies the problem – by distributing the mice (and allegedly making a profit from them, according to AIA), the Jackson Laboratory is infringing AIA’s exclusive right to make and sell their patented invention (35 U.S.C. 271).
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| Photo: Rama |
Both sides accept that these mice are vital to Alzheimer’s research. According to judge Elizabeth Laporte for the US District Court of Northern California, AIA has not disputed Jackson's claim that "prolonging the litigation in this case would harm Jackson and the public by extending the chilling effect of the litigation on mice research on Alzheimer's disease".
An interesting facet to this whole case is how reflective it is of academic science’s love-hate relationship with patents.
In April, we (or maybe just those of us who follow patent news) heard the outrage from the academic community at the European Court of Justice’s Advocate General’s opinion regarding the patentability of human embryonic stem cells (hESC). As explained in an earlier post, the AG found that inventions that used hESC were contrary to ordré public and morality, and as such, unpatentable under European Law. This was unacceptable to much of the academic community. Thirteen prominent academics implored the ECJ to rule against the AG’s opinion in a letter to Nature. If stem cell inventions were ruled unpatentable, the academics argued, stem cell research in Europe would be severely disadvantaged. Selling and licensing patented technology to large pharmaceutical companies gives university and small and medium enterprises an indispensable funding source. Without such funding, the future of stem cell research and potential cures for the millions suffering diseases such as Parkinson’s, would be severely threatened. Being able to patent research is essential.
Yet in the states, a very similar rhetoric is being used to support a completely incompatible point. Researchers are arguing that by enforcing their patent, the AIA is threatening research and essential funding for the development of therapies for a devastating disease. The Jackson Lab has the advantage that Alzheimer’s is an incredibly emotive issue – blocking Alzheimer’s therapies arguably has a lot more sympathy than blocking stem cell research. So much so, that the NIH has come to the rescue, granting the Jackson lab government sanction to use the patent (the US government has the power to commandeer any US patent for it’s own use - within reason). Not being too keen on attempting to sue the US federal government, the AIA dropped their case against the Jackson Laboratory. But not, however, against the other defendants.
To the outside observer, there does seem to be some inconsistency in the academic communities’ approach to patents. Rudolf Tanzi, a researcher studying Alzheimer's disease at the Massachusetts General Hospital in Charlestown, taking to Nature News remarked “I think you need to respect people's intellectual property, but the impact on field if the mice were not freely available would be devastating.” However this same argument could equally be applied to any patented stem-cell inventions. For example, the stem-cell patent in dispute in Europe refers to neural precursor cells produced from hESC – surely if these were not freely available it would be devastating on any field researching potential therapies for neurodegenerative diseases, for example Parkinson's, and indeed, Alzheimer’s.
(Interestingly, the application to patent the original transgenic mouse, Harvard University’s “Oncomouse”, provoked similar ethical opposition as has arisen to the patenting of stem cells. If “Oncomouse”, genetically programmed to get cancer, had been ruled unpatentable due to ethical considerations, AIA’s “Alzheimer’s mouse” would be freely available to use.)
The problem is that the arguments on both sides are convincing. (Note that I am referring to the value of the patenting tools of scientific research per se, not any morality issues relating the use of transgenic mice or stem cells.) Arguably, these patents do the job they are intended for – that is to promote scientific advancement by encouraging investment in research. The potential loss of this investment is driving the scientific outrage at the Advocate General’s opinion on stem cells in Europe. However, any exclusive rights to a technology are bound also to produce some blocking effects, especially if the owner of those rights sets a high price to use the technology, as AIA has presumably done.* Personally, I have my own opinion on whether the current patent system is a Good or a Bad thing with regards to medical research, but this would be a much longer (and much rantier) post. However, which side of the fence you are on as a scientist, seems to depend on where you are with your research – i.e. at a patenting stage or an exploiting stage. I just wonder if the laboratories that purchased Jackson Lab’s mice are planning on patenting any of the cures they develop. I would bet that they probably are.
*Outside of medicine, the case may be more clear-cut. For example, in engineering, patents are probably a good thing. In other fields, such as computer programming, the blocking effect seems to dominate (as discussed in This American Life’s brilliant episode “When Patents Attack!”).
