The New York Times

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 so far.

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 research?"

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!


The New York Times

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."





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Copyrights and Computers

When programming, how many times can you write differently the code to print a file, to copy, or cut and paste? How many different ways can a person write a story about something without running afoul of some copyright law or an inventor step on someone's patent? How many modern stories are based on stories written in ancient times or are inspired by other modern writers? How many great painters copied each other as they learned their craft? How far does 'creative coincidence' go? Individual ownership is important but the US court seems to agree that only certain individuals have absolute rights about ownership, such as developers that come into a community and seize property through the court under the pretense of eminent domain. Obviously the court will side with whoever has the most postential for bringing into a community the most dollars or whoever happens to have the most money at the time the case goes to court. Patents and copyrights should be for the creator of the product, however this returns to the argument, how much should be enforceable? I believe that blatant disregard for ownership could be enforceable--where one person steals the product through distribution as if that person were the actual creator, a fraud. To disamantle financially and incarcerate someone who develops something from someone else's idea or is inspired by written works eliminates and destroys creativity.