Myriad Genetics Can't Patent a Human Gene
The wise judicial ruling in a lawsuit over a test for breast cancer.
Andrews' example gets to the heart of the concern about gene patents. We want to encourage research and testing because they can improve patient care. By some estimates, many drugs benefit as few as a third of their users. Those aren't great odds. Genetic research and testing has the potential to "personalize" medicine by helping consumers find out which drugs will work best for them. The problem for pharma companies is that tailoring drugs to subsets of the population shrinks the market for drugs that have already been developed. As a result, the companies have an incentive to limit research on diagnostic tests that would identify the patients who are less likely to benefit from their products. Patents on human genes are the perfect mechanism for such blocking. According to the Wall Street Journal, GlaxoSmithKline, for instance, took out patents on genetic tests that could evaluate the effectiveness of its drug Flovent, but intentionally left them undeveloped. (The company disputed these allegations and last year released some of its "neglected disease" patents into a patent pool for researchers; you can read their stated policy on human gene patents here [PDF].)
It may sound paradoxical, but obstacles to genetic testing could get worse as our ability to sequence genes gets better. The $1,000 genome (subscription required) is a milestone of affordability that would give many people access to their entire genetic profile and spawn new research and clinical advancements. But as Dan Vorhaus and John Conley explain in the Genomics Law Report, cheap access to the entire genome isn't compatible with the licensing fees charged by gene patent holders. Why pay $3,000 for Myriad's BRCA test when you could get your entire genome sequenced for less? Nobody would. And so in order to avoid losing business, holders of individual gene patents could try to exert control over companies offering to sequence entire genomes. This is the GlaxoSmithKline example writ large.
Judge Sweet's ruling, by contrast, moves the law a step in the opposite direction. A long list of plaintiffs—including breast cancer survivors, the ACLU, and a panoply of scientific and medical organizations—argued that human genes can't be patented because they are "products of nature," a category not covered by patent law. Significantly, Judge Sweet's ruling applied the product of nature doctrine to "isolated" DNA, genetic material that has been purified via human intervention and is therefore different than what naturally occurs in the body. Judge Sweet reasoned that isolated DNA derives its value from the information contained within it, which is naturally encoded in the genome. According to this view, removing the irrelevant parts of a DNA sequence doesn't make you the inventor of a gene any more than removing advertising inserts from a magazine makes you a writer.
Biotech companies have defended themselves against the controversy this case has generated by arguing that Myriad is an outlier. Licenses on human gene patents, they say, are generally reasonable and promote the public interest. If they're right, then maybe we don't need to worry about whether Judge Sweet's decision survives Myriad's inevitable appeal. But as the era of personalized medicine approaches, it will only become more important to fend off aggressive patent holders. We may need the help of another body known for its "lawyer's tricks"—Congress.