Earlier this month the U.S. Senate Judiciary Subcommittee on Intellectual Property held hearings regarding a bipartisan draft proposal that would eliminate the current restrictions on the eligibility of patents including those on “abstract ideas,” “laws of nature,” or “natural phenomena."
As of the 2013 Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, human genes are not patentable because they are a “product of nature,” but synthetically created DNA, also known as complementary DNA (cDNA), can be patented. At the time, the ACLU argued that that because Myriad had patented the BRCA1 and BRCA2 genes, the company had created a monopoly on genetic testing for breast cancer risk screening.
But, six years is a long time in the world of genomic science. With the current explosion in direct-to-consumer DNA testing kits offering all kinds of new risk prediction scores for different diseases, biotech companies and their patent attorneys seem to be more interested in patenting specific combinations of DNA variants associated with disease and the algorithms for arriving at such scores. How different is that really from what Myriad was doing six years ago?
Experts also say that given all the information already known about the human genome, single genes probably would not meet the novelty criteria required for patents. But as most researchers writing grants are aware of, novelty is a squishy concept, and as This American Life reported back in 2011 and 2013, the language in patents can be vague—so vague that some companies exist for the sole purpose of buying patents and suing, or threatening to sue, for millions of dollars for patent violation. How does broadening the eligibility for patents help define novelty?
This debate is ongoing, but major scientific organizations and the ACLU want to keep the ban on gene patenting in place for the good of medical patients as well as research. You can read the ACLU's letter (signed by over 100 other groups) here.