The US patent office has made it very clear that purified DNA is not the same, in their view, as the DNA in each of our cells. Myriad Genetics used this ruling to put a choke hold on medical tests for BRCA1, which was first identified not as a gene, but as a region of Chromosome 7 associated with susceptibility to breast and ovarian cancer (review, 1993). The gene was later cloned, a patent issued, and the patent rights ended up licensed from, near as I can tell without going into it deeply, the University of Utah to Myriad Genetics. Knowing whether a patient has BRCA1 has strong implications in deciding the right course of patient care for breast cancer, both in treatment of the disease and in screening. It’s one small example of the potential for personalized medicine, and it was in the hands of one company.
The 10th anniversary of the first completed sequencing of a human genome coincided with a “jaw dropping” decision to strike down Myriad’s patents (see genomicslawyreport.com‘s excellent analysis. The US case was brought by none other than the ACLU. BNET has one of the better quick summaries, explaining how the ACLU has used free speech rights to attack both the patenting both of a DNA sequence and of a method for analysis. From my understanding, Myriad both denied anyone the right to compare DNA sequences with the one under patent (in some cases even for research purposes), and patented a method for testing for a mutated sequence that amounted to a patent on a thought process.
At the end of March, Nature magazine ran a special on the 10th anniversary of the sequencing of the human genome. The structure of DNA, as we all know, was originally suggested by Watson and Crick in 1953, and in the original paper they note, “It has not escaped our notice that the specific pairing we have postulated immediately suggests a possible copying mechanism for the genetic material.” In one way of looking at it, this seemingly off-hand comment should invalidate most patents having to do with DNA—the ideas are obvious to any reasonable biochemist familiar with the chemical structure of the molecule. The thought processes behind Myriad’s patented method are very like ones that I myself could conceivably have had when I was in the lab mucking about with DNA. I was doing something quite different from trying to identify whether someone carried a gene mutation making them susceptible cancer, but as the ACLU lawyers have said of Myriad’s method, “It’s a standard, garden-variety lab methodology.” (Law360.com article)
The US patent office laid out in 2001 why DNA molecules can be patented (Federal Register, search for DNA). It was fascinating reading for a molecular biologist who is not a lawyer, because I found myself disagreeing with the patent office’s conclusions, but understanding why they came to them, based on their reference to statute. Essentially, you could patent a piece of DNA as long as you could describe one “useful” benefit. You didn’t have to demonstrate that your idea for a benefit would work, just that you could imagine a reasonable benefit. An analysis by Philip Ball in Nature magazine’s recent celebratory issue compares the interest in sequencing the genome to economic bubbles, concluding that the results do not necessarily justify the exuberant interest. However, in Francis Collin’s article Has the Revolution Arrived?, he lists six predictions he made a decade ago, which have all borne out. He notes that while there has been acceleration in discovery thanks to the Human Genome Project, there has not yet been a strong clinical impact of the information in true personalized medicine. In genome pioneer Craig Venter’s essay, he can list the current, direct clinical benefits of all the genomics work to date in one single paragraph, and he probably did it off the top of his head. In a lot of cases, the claimed benefits on patents are either not going to materialize, or it may not be possible to develop the idea for use in patients – people – until after the patent expires, given current technology.
But that’s not why the judge’s ruling undercuts the USTPO’s interpretation of the statute. There have long been arguments about patenting DNA. As noted above, the USTPO interpreted the statutes in a specific way, but Judge Robert W. Sweet of the United States District Court for the Southern District of New York completely invalidated the patent office’s long-standing policies that isolated DNA was “substantially different” from the DNA found in nature. This constitutes a major shift, and to borrow from Watson and Crick, it immediately suggests implications for the world of biotechnology. The ruling doesn’t invalidate every patent involving DNA, but it has far-reaching potential consequences. However, my favorite quote from Judge Sweet’s opinion has to do with the invalidation of the patent on the method for analyzing BRCA1: “The claimed ‘process’ is, in fact, the scientific method itself…”
The human genome project was worth doing for many of the same reasons it was worth going to the moon. The technology spin-offs have accelerated biomedical research by just the sheer speed at which data can be gathered. Computational biology and bioinformatics advances help researchers interpret the data and form new hypotheses. We don’t have extensive personalized medicine yet, and one hurdle has been the network of individual gene patents that prevented assaying for many genes at the same time. Thanks to the recent district court summary judgment, and to the Human Genome Project, we’re a step closer.