When genes meet the law. Last week, the Supreme Court of the United States of America (SCOTUS) ruled that genes are not patentable, a decision that will be known as the “Myriad Decision”, named after Myriad Genetics, a commercial laboratory that is the single provider for BRCA1/2 testing in breast cancer and ovarian cancer in the United States. For more than a decade, Myriad has had virtually exclusive rights to the genetic analysis of both genes, given a large number of patents surrounding BRCA1/2 analysis.
Genes are not, but cDNA is. I am not a lawyer, but I will try to summarize how I understand the Myriad decision. The SCOTUS decision was generally perceived as a “mixed bag”. Genes occurring in nature are not considered patentable, but cDNA may be patentable. It is generally believed that other laboratories may now offer BRCA1/2 testing based on this decision. However, Myriad Genetics is also believed to have a gigantic head start. As a result of the SCOTUS decision, the stock price for Myriad paradoxically went up by 10%. With the SCOTUS decision, the situation regarding gene patents is finally clarified. However, how is the situation in Europe?
Patenting genes in Europe. As far as I understand the story in Europe, it goes as follows: the European regulations for gene patenting are issued by the European Patenting Office (EPO). The so-called Biotech Directive allows for the patenting of natural biological products, including gene sequences, as long as they are “isolated from [their] natural environment or produced by means of a technical process”. I am not a patent lawyer, but I can imagine that this phrase is subject to interpretation, resulting in lengthy legal proceedings.
Patenting BRCA1/2 in Europe. Regarding BRCA1/2, my understanding of the situation is this: Myriad Genetics applied for a patent for BRCA1/2, which was granted in 2001. After protests, it was revoked in 2004, but was finally upheld in 2008. I understand that Myriad Genetics may collect royalties for BRCA1/2 testing in many European countries, even though the testing is cheaper in Europe compared to the US. In addition, some smaller European countries such as Belgium are not covered by the patent.
An alternative history of SCN1A. As I am not familiar with the history of the BRCA1/2 gene discovery in detail, let’s do a thought experiment. Imagine that after the discovery of SCN1A in epilepsy, one of the participating groups would have managed to obtain both the patent for the gene and for “a method to assess the risk for epilepsy based on the sequence of the SCN1A gene”. In our parallel world, this company (“Company X”) would have aggressively defended their right to exclusively work with this gene, repeatedly extend their patent with minor modifications to the test (alternative exons, copy numbers, promotor regions, splice sites) and issue “cease and desist” letters to any other group or laboratory working with this gene. Even though some claims of Company X might have been exaggerated and not verified in court, the fact that working with SCN1A might cause legal issues would have deterred many groups or laboratories. We might have less knowledge about SCN1A in the public domain today and much would be owned by Company X that used the decades of patent protection to create a unique database, which –in turn- might be part of yet another patent. Not much would change with the SCOTUS decision in June 2013 declaring genes non-patentable, as clinicians might still prefer Company X to other, emerging companies with less experience with this gene. Now the big question is whether this scenario would be a dystopia or maybe even a blessing?
A shifting perception. During my career in neuroscience, the general perception on the biotech industry has changed virtually by 180 degrees. During the early years of my thesis, there was the general, slightly arrogant perception that working for a company was only something for scientists who have failed in academia. Then came along Celera, deCODE and the rise of the next-gen sequencing giants. In 2013, biotech industry is a sought-after partner on large-scale grants (the magic SME – small and medium enterprise factor on EU grants). Some high-profile publications in the field now actually rely on data generated in commercial laboratories and companies offering commercial genetic tests publish their own research papers. With the likely decline of public support in the near future, biotech companies, commercial laboratories and the sequencing industry will be more involved in research than ever – if this research is supposed to happen at all.
Good or bad? Coming back to my initial question whether the “Company X” scenario would be positive or negative – intuitively, I would assume that most of you would prefer the actual situation to the hypothetical “big bad company” scenario. However, significant amounts of public funding would have been saved. Also, comparing the present situation, the price for clinical SCN1A testing is not much different to BRCA1/2 (~2000 Euros), indicating that decades of public funding do not necessarily guarantee a lower price. This comparison might not be fair, given that the number of patients undergoing BRCA1/2 testing is larger than the group of patients tested for SCN1A, but I am not convinced that sequence analysis of a gene can be obtained at a much cheaper rate. One thing missing would be the multi-facetted research on SCN1A.