March 19, 2006
This Essay Breaks the Law
By MICHAEL CRICHTON
* 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
But what the Supreme Court will focus on is the nature of the claimed
correlation. On the one hand, courts have repeatedly held that basic bodily
processes and "products of nature" are not patentable. That's why no one
owns gravity, or the speed of light. But at the same time, courts have
granted so-called correlation patents for many years. Powerful forces are
arrayed on both sides of the issue.
In addition, there is the rather bizarre question of whether simply thinking
about a patented fact infringes the patent. The idea smacks of thought
control, to say nothing of unenforceability. It seems like something out of
a novel by Philip K. Dick - or Kafka. But it highlights the uncomfortable
truth that the Patent Office and the courts have in recent decades ruled
themselves into a corner from which they must somehow extricate themselves.
For example, the human genome exists in every one of us, and is therefore
our shared heritage and an undoubted fact of nature. Nevertheless 20
percent of the genome is now privately owned. The gene for diabetes is
owned, and its owner has something to say about any research you do, and
what it will cost you. The entire genome of the hepatitis C virus is owned
by a biotech company. Royalty costs now influence the direction of research
in basic diseases, and often even the testing for diseases. Such barriers
to medical testing and research are not in the public interest. Do you want
to be told by your doctor, "Oh, nobody studies your disease any more because
the owner of the gene/enzyme/correlation has made it too expensive to do
The question of whether basic truths of nature can be owned ought not to be
confused with concerns about how we pay for biotech development, whether we
will have drugs in the future, and so on. If you invent a new test, you can still
patent it and sell it for as much as you can get, if that's your goal. [Even if companies
should] own a test they have invented, they [certainly] should not own the
disease itself, or the gene that causes the disease, or essential underlying
facts about the disease. The distinction is not difficult, even though
patent lawyers attempt to blur it. And even if correlation patents have
been granted, the overwhelming majority of medical correlations, including
those listed above, are not owned. And shouldn't be.
Unfortunately for the public, the Metabolite case is only one example of a
much broader patent problem in this country. We grant patents at a level of
abstraction that is unwise, and it's gotten us into trouble in the past.
Some years back, doctors were allowed to patent surgical procedures and sue
other doctors who used their methods without paying a fee. A blizzard of
lawsuits followed. This unhealthy circumstance was halted in 1996 by the
American Medical Association and Congress, which decided that doctors
couldn't sue other doctors for using patented surgical procedures. But the
beat goes on.
Companies have patented their method of hiring, and real estate agents have
patented the way they sell houses. Lawyers now advise athletes to patent
their sports moves, and screenwriters to patent their movie plots. (My
screenplay for "Jurassic Park" was cited as a good candidate.)
Where does all this lead? It means that if a real estate agent lists a
house for sale, he can be sued because an existing patent for selling houses
includes item No. 7, "List the house." It means that Kobe Bryant may serve
as an inspiration but not a model, because nobody can imitate him without
fines. It means nobody can write a dinosaur story because my patent
includes 257 items covering all aspects of behavior, like item No. 13,
"Dinosaurs attack humans and other dinosaurs."
Such a situation is idiotic, of course. Yet elements of it already exist.
And unless we begin to turn this around, there will be worse to come.
I wanted to end this essay by telling a story about how current rulings hurt
us, but the patent for "ending an essay with an anecdote" is owned. So I
thought to end with a quotation from a famous person, but that strategy is
patented, too. I then decided to end abruptly, but "abrupt ending for
dramatic effect" is also patented. Finally, I decided to pay the "end with
summary" patent fee, since it was the least expensive.
The Supreme Court should rule against Metabolite, and the Patent Office
should begin to reverse its strategy of patenting strategies. Basic truths
of nature can't be owned.
Oh, and by the way: I own the patent for "essay or letter criticizing a
previous publication." So anyone who criticizes what I have said here had
better pay a royalty first, or I'll see you in court.
Amazingly, the Supreme Court backed down, did
not review the case, and let the patent stand!
June 23, 2006
Justices Drop Consideration of Boundaries for Patents
By ANDREW POLLACK
The Supreme Court backed away yesterday from ruling on a closely watched case that could have set the boundaries on what kinds of discoveries and inventions can be patented.
The court, saying it had "improvidently" agreed to hear the case in the first place, instead dismissed it. That action effectively upheld the medical diagnostic testing patent at issue in the case. And it averted a decision that some patent lawyers said could have undermined thousands of patents on medical tests or genes.
Three justices dissented, saying the court should have decided the case. They strongly suggested that they were concerned that patents in areas like biotechnology and financial services were being granted too liberally and should be rolled back.
The failure to decide the case "threatens to leave the medical profession subject to the restrictions imposed by this individual patent and others of its kind," Justice Stephen G. Breyer wrote in the dissent, which was joined by Justices John Paul Stevens and David H. Souter. Justice Breyer said such restrictions "may raise the cost of health care while inhibiting its effective delivery."
The case, LabCorp v. Metabolite Laboratories, involved a patent that said that deficiencies of some B vitamins could be detected by finding high levels of the amino acid homocysteine in a person's blood.
The question for the Supreme Court was whether that part of the patent was merely the statement of a natural relationship between chemicals in the body. Natural phenomena, like gravity, are not patentable.
Some people in the biotechnology industry argue that such patents are fundamental, that many diagnostic tests are based on finding a relationship between a body chemical or gene and a disease.
Others, including groups representing doctors, argue that such patents would impede medicine. Doctors, for instance, might be guilty of infringement merely by thinking that a patient with high homocysteine levels had a vitamin deficiency.
A federal jury in Denver and a federal appeals court both upheld the patent, which is controlled by Metabolite Laboratories, a tiny testing company based at the University of Colorado, and Competitive Technologies, a patent management company in Fairfield, Conn. LabCorp, a giant clinical testing company, was found to have infringed and was ordered to pay $7.8 million in damages and lawyers' fees, according to LabCorp.
The Supreme Court agreed to hear LabCorp's appeal even though the United States solicitor general advised against it. The solicitor general argued that LabCorp had not formally made the argument about natural phenomena in the lower courts.
But after hearing arguments in March and reading about 20 briefs from interested parties, the court said yesterday that it would not consider the case after all. It did not offer a reason other than that its earlier decision had been improvident. Such decisions to drop cases are made occasionally.
A spokeswoman for LabCorp, formally known as Laboratory Corporation of America Holdings, said the company was "very disappointed that the court decided not to hear the case based on a technicality."
Competitive Technologies called yesterday's outcome "a big win." Millions of homocysteine tests are performed each year, though many companies offering such tests already pay royalties to the company, one of its lawyers said.
In their dissent, the three justices said the court had enough information to decide the case and said they would have invalidated the patent. They also questioned a 1998 appellate court decision that opened the door for patents on methods of doing business, like ways to order merchandise on the Internet or to calculate executive compensation.
The dismissal will be a relief to companies holding broad patents on diagnostic tests or genes, said Dennis Crouch, a patent lawyer who co-wrote a brief on behalf of a group of corporate patent holders, arguing against hearing the case.
"There are billions of dollars tied up" in such patents, said Mr. Crouch, who also runs the Patently-O patent law blog. "There was a potential that a decision would come out that would put all those rights into question."
But he and other experts said the dissent would encourage more challenges of broad patents.
"It says that some justices have a problem, at least with some patents that are extreme," said John Dragseth, a patent lawyer at Fish & Richardson in Minneapolis, who was not involved in the case. "So people are going to want to test that."
Yesterday's outcome, he added, "might mark the end of an expansion in terms of what you can patent, but it doesn't mark a contraction, at least not yet."