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.
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