Tuesday, September 3, 2013

Gene Patenting: What Did the Supreme Court Rule in Myriad?

I forget what I was doing back in the late spring when the US Supreme Court issued a couple of major rulings on issues of interest to this blog. I did not have time just then to post about these rulings but made a mental note to get back to them as soon as possible. Right…Anyway, last week’s New England Journal of Medicine has forced my hand (main article for subscribers only).

In Association for Molecular Pathology v. Myriad Genetics, Myriad’s claim to have patented the gene sequence for the BRCA1 and BRCA2 cancer-causing locations, and hence their exclusive right to offer a genetic test for those conditions, was at issue. The article mentions one major downside of one company having this exclusive right to a genetic test—its price. Myriad charges about $4000 and one competitor firm is promising to market a test for $1200. The article omitted to mention an issue that is even more serious regarding medical science and practice. Myriad has been able to sequester data on the effectiveness of its genetic tests as proprietary information. That means any physician counseling a patient on whether or not to be tested, and what a test means, is dependent on the company profiting from the test to say how well its own test works, and that is rather obviously a bad situation.

Lower courts had thrown out first all, then only some of the Myriad patents. The Supreme Court basically split the difference. Some patents involved the actual DNA that makes up the genes. The court said that exists in nature and you cannot patent that. But some patents involve complementary DNA which the company manufactures off messenger RNA that is taken from those genes. That cDNA does not exist in nature, so the court said the company could patent that. (Plaintiffs had alleged that cDNA is really the same as native DNA because what matters is the information in it, not its physical form, and that is the same as the native DNA; the court did not buy that argument.)

Patient advocates such as the ACLU trumpeted the decision as a big win because it does now open the door to competing gene tests. Let’s take a step back, akin to the discussion of patents in HOOKED, and see what basic issues are involved.

First let’s do Patent Law for Dummies. The noise made these days by corporate apologists about “intellectual property rights” obscures the basic fact that a patent is a monopoly. The government is supposed to break up monopolies, not create them. So the whole idea behind patents is that it’s a tradeoff. The government grants temporary monopoly rights. In exchange it’s supposed to get useful innovation that’s in the public good. No patents, no firms willing to invest their cash in bringing new inventions to market, no innovation to benefit the public. Too many or too burdensome patents, prices go way up, public interest is harmed, and in extreme cases (like arguably today’s biotech sector), innovation is actually squelched.

The law says that patents should be granted only if some basic conditions are met. The Supreme Court in Myriad issued a very narrow ruling. It decided one issue only—whether naturally occurring things can be subject to patents—and decided “no,” in keeping with many earlier rulings. The Court refused to review the Myriad patents on other grounds, such as whether they met the conditions of being novel, useful, and non-obvious. Those other grounds are important to most patents relating to Pharma. The argument against the present patent system for drugs is that firms are allowed to patent all different aspects of a drug, even those that are non-useful and obvious. This simply puts barriers in the way of generic competition, and does nothing to spur innovation.

(As I argued in HOOKED, following Marcia Angell, the Patent Office could squelch these nuisance patents without any need for a court ruling, simply by enforcing its own rules. Alternatively, the FDA could refuse to list any such nuisance patents in its reference book that states the conditions for drug approval and generic equivalence. But both Federal bodies are more interested in cozying up to industry, apparently.)

The authors of the NEJM paper provided a bit of good news in that regard—they report that in recent years the Patent Office had issued many fewer patents for naturally occurring gene sequences because they had tightened up their criteria and insisted that biotech companies could not simply patent genes wholesale, they had to make a plausible case that they knew how to do something useful with the discovery. (Presumably the Myriad decision will raise the bar still higher by ruling out all such patents anyway.)

As a bonus, the New England Journal threw in two historical essays:

These address events leading up to the passage of the Bayh-Dole Act of 1980, that opened the floodgates to universities patenting all manner of scientific discoveries, including those paid for with federal research dollars. They make a case for not regarding Bayh-Dole as carved in stone, but as needing review and updating as conditions have changed so much since its creation.

Kesselheim AS, Cook-Degan RM, Winickoff DE, Mello MM. Gene patenting—the Supreme Court finally speaks. New England Journal of Medicine 369:869-874, Aug. 29, 2013.

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