Tuesday, April 16, 2013

Supremely Irritating

This blog has been pretty dull lately, but as I’ve said before, I try to keep my mouth shut if I have nothing to say. This one has me pretty riled up.

The Supreme Court heard arguments yesterday on the patentability of genes.  There is a sense of jubilation coming from the academic camp, as evidenced by Eric Lander’s and Bob Cook-Deegan’s high five following the hearing. I’m not convinced that their jubilation is justified. If you’re having trouble sleeping, you can read the whole transcript, but from my reading, the Court didn’t sound like it’s ready to clamp down on gene patents.

What got me really riled up was, in the aftermath of the events at the Boston Marathon, on the advice of a tweet, I turned to PBS to watch what was promised to be unvarnished coverage. I happened on a piece about the SCOTUS hearings on gene patents. On the “academic” side of the argument was Ellen Matloff, a genetic counselor at Yale. She, characteristically of many academics, completely confused the issue, bringing arguments about the reduced cost of whole genome sequencing, insurance companies denying reimbursement, etc. None of which have anything to do with what’s at issue.

She claims that “Myriad invented nothing.” Really? Through linkage analysis, the BRCA1 gene was localized to one arm of one chromosome by the team led by Mary-Claire King, announced at an ASHG meeting in 1990. Four years later, the gene’s sequence was identified by, in part, Myriad scientists. Turning it into a commercially reliable clinical diagnostic test was done by one company: Myriad.

She also claims that Yale had been conducting diagnostic testing, which was subsequently shut down by Myriad. Correct. That’s how patents work. But it’s independent of whether or not the gene itself can be patented. What she’s really complaining about is that she can’t perform the testing in her lab (read: can’t make money from offering the test). That’s what gets under the skin of most academics. I’m not aware that Myriad, or any other patent holder, prevents others from doing true, basic, academic research. It’s not in their interest to do so. Think of it this way: a company discovers a bunch of mutations responsible for a disease. An unrelated researcher identifies a new mutation. Would they propose not licensing that mutation to the dominant provider and offering testing for that single mutation? How does that benefit anyone – the company, the researcher, or most importantly, patients?

I’m not a lawyer, and certainly not qualified to argue before the Supreme Court, but it all seems pretty simple to me. If you identify a method to diagnose a patient with a disease, assuming that it’s scientifically and clinically justified, it is novel, non-obvious, and reduced to practice, and therefore, should be patentable. Why does it matter if the method uses DNA as the substrate as opposed to, say, serum?

Nobody is patenting a person’s DNA. Never have; never will. Nobody with any knowledge of the matter believes that such a thing would be patentable. However, utilizing the chemical nature of something found in nature to identify a person with a disease meets the criteria of patent eligibility. What’s so difficult about that?

1 comment:

back of back of beyond said...

Great blog, as usual. I have been following this case with considerably less technical expertise and background than you have. Seems to me that people are getting wound up around their ideas about what a patent protects. Instead, if you consider Myriad's "intellectual property" that is the result of considerable investment and intellectual creativity, the rights of the company become easier to accept as are the fees for borrowing borrowing that property for one's own research or services.