Bioethics, healthcare policy, and related issues.
Michael Crichton (yes, that Michael Crichton) had a good Op-Ed in The New York Times last weekend, on the patenting of simple biological facts. He notes that patent law on genetic discoveries and other biological non-inventions have reached such an absurd point that it is now literally illegal not merely to make use of genetic sequences someone else discovered, but in fact to discuss or even think about such facts! Even in these days of unrepentant corporate feudalism, that’s a staggering length to go to.
The Earth revolves around the Sun.
- The speed of light is a constant.
- Apples fall to earth because of gravity.
- Elevated blood sugar is linked to diabetes.
- Elevated uric acid is linked to gout.
- Elevated homocysteine is linked to heart disease.
- Elevated homocysteine is linked to B-12 deficiency, so doctors should test homocysteine levels to see whether the patient needs vitamins.
ACTUALLY, I can’t make that last statement. A corporation has patented that fact, and demands a royalty for its use. Anyone who makes the fact public and encourages doctors to test for the condition and treat it can be sued for royalty fees. Any doctor who reads a patient’s test results and even thinks of vitamin deficiency infringes the patent. A federal circuit court held that mere thinking violates the patent.
All this may sound absurd, but it is the heart of a case that will be argued before the Supreme Court on Tuesday. In 1986 researchers filed a patent application for a method of testing the levels of homocysteine, an amino acid, in the blood. They went one step further and asked for a patent on the basic biological relationship between homocysteine and vitamin deficiency. A patent was granted that covered both the test and the scientific fact. Eventually, a company called Metabolite took over the license for the patent.
Although Metabolite does not have a monopoly on test methods — other companies make homocysteine tests, too — they assert licensing rights on the correlation of elevated homocysteine with vitamin deficiency. A company called LabCorp used a different test but published an article mentioning the patented fact. Metabolite sued on a number of grounds, and has won in court so far.
The unbelievable asininity of this situation should be obvious. I have always been skeptical of patents for genetic sequences and other discoveries of basic scientific facts that are ubiquitous in nature; I would prefer to see patents restricted only to newly-created devices and to some extent methods or processes (all traditionally patentable) - not to knowledge itself, and not to the extent that it implies literal ownership of natural parts of other people’s bodies. But the idea that you can patent not only naturally-existing structures but mere facts about them seems a bizarre perversion of the whole point to “intellectual property” in the first place.
Crichton does a good job on the issue (to his credit - I am not usually a fan of either his fiction or his scientific politics). The essay is worth reading (it may disappear from the Times’s open site soon, though).
The more general question is how exclusive property rights have served patients. Crichton notes that royalty licensing costs affect not only the price of treatments but even the ability to do research on particular diseases, and claims that “such barriers to medical testing and research are not in the public interest”. Most people would agree, but they would certainly be met with a flurry of denunciation by the same voices that defend high drug prices (necessary to pay for research) and for-profit health insurance (necessary to guarantee “choice” in the marketplace). Without saying so, the normally slightly conservative Crichton is endorsing a non-marketplace view of healthcare - the idea that health is a unique kind of good that should not be subject to an open market.
Many people would agree, but defenders of the present US system would reject that position. Yet what we see in the absurdity of patent laws that amount to thoughtcrime regulations is nothing more than capitalist healthcare taken to the next level. (And it affects not only healthcare: there is no reason the same court rulings that prohibit thinking about your own body would not also prohibit thinking about, say, plant growth, oil deposit distribution, or the weather - all natural facts that could have significant commercial potential if you could extort money out of people simply for knowing them.
What mixture of economic incentive and public service should we expect in the healthcare industry? What kinds of advances in knowledge should be patentable? Should the exclusive-patent scheme be different for clinically-applicable discoveries, as opposed to other kinds of knowledge? It seems to me obvious that capitalist incentives in clinical practice are an almost-unmitigated disaster, but that they are a necessity for pharmaceutical research. Is this correct in either respect?
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