JB: How do you keep abreast of new developments in science?
MC: For the most part, it’s simply reading. I do visit occasionally laboratories, but not very often, and there are sort of two reasons for it: one is that when one goes to an individual laboratory, one spends time with someone who has a particularly strong interested in a very narrow area, which is usually not my area of interest, and the other thing is that to read is the equivalent of talking to people on the telephone—it’s just simply much faster, it’s a much quicker way, and the journals stack up in my office and I go through them as best I can.
JB: Your first goal as a writer I’m sure is to entertain, and you’ve done that brilliantly in this book, but in terms of asking readers to think about the issues that you’re exploring, what do you want the reader to take away fromNext after they’ve finished it?
MC: What my experience was in working on this was a kind of combination of anxiety and excitement—the possibility of really wonderful things that might happen—the possibility that for example, certain genetic diseases might actually be cured, and people who might previously either were certain to die or could only be treated in fairly unsatisfactory ways—there now is the likelihood that you will be able to inject the gene and that person is cured—that’squite extraordinary, and there are many other examples of new cancer treatments and other things that are just amazing. And then on the other side, there is this connection of law and business and academia which is very distressing in the directions that it’s going, and it involves a tremendous amount of secrecy and involves a tremendous direction which I think is against the public interest and which I think really ought to distress and frighten people.
JB: If you were in a position to create legislation, how would you being to reign in the “bad science”—the combination of science, business, and academics moving in the wrong direction as you see it?
MC: I think there are actually three or four things that would really transform the field. The first thing that I would do is I would make the testing of genes for medical diagnoses completely legal, irrespective of patents. I think that would do a great public service and also oblige scientists to start to look at the patenting business in a different way. The second thing I would do is I would require universities to follow federal guidelines for use of tissues in research. Federal guidelines are excellent—they give people a tremendous amount of control over the tissues that they donate—many universities, institutions of higher learning, are trying to break these rules, trying to go in another direction—they ought not to be allowed to, and I would change that. The third thing I would do is I would make sure people got the information that they needed to make informed decisions. There are some situations now where patients have died from gene therapy, and the institutions involved have said that they don’t want the deaths reported because they’re a trade secret. This is so insane that the mind boggles—this, whatever legislation is needed to stop that we ought to do. And the final thing is that in 1980 there was a law passed that was called BiDole—bipartisan law that enabled universities to sell their products to industry, and it was well-intentioned, but it has had the effect of creating this gigantic commercial consulation within universities that is very damaging, and so I would reverse that law.
JB: In spite of the serious message of the book and the profound issues you’re tackling, there is a lot of fun in this book. There are many jokes, there are many very amusing passages and stories, and there are a number of ideas—concepts—that perhaps are true or perhaps are fictional. Is there anything in the book that you would like to be real, that perhaps isn’t real—that would improve your life?
MC: Interesting question…I don’t know how to answer that…I guess what I feel is that whatever I might imagine is probably right around the corner anyway.
JB: Absolutely.
Thank you so much for this interview, and we are sure that this book is going to be a huge success.
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. Acorporation 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 may patent it and sell it for as much as you can, if that’s your goal. Companies can certainly own a test they have invented. But they 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 gra
nt 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.
The New York Times
OP-ED Section
Sunday, March 19, 2006
Author’s Note
At the end ofmy research for this book, I arrived at the following conclusions:
1. Stop patenting genes.Gene patents might have looked reasonable twenty years ago, but the field has changed in ways nobody could have predicted. Today we have plenty of evidence that gene patents are unnecessary, unwise, and harmful.
There is great confusion about gene patents. Many observers conflate a call to end gene patents with anticapitalist and anti-private property sentiments. It is nothing of the sort. It is perfectly reasonable for industry to seek a mechanism that will ensure a profit on productive investment. Such a mechanism implies a restriction on competition involving a created product. However, such protection doesnot imply that genes themselves should be patented. On the contrary, gene patents contradict long-established traditions of intellectual property protection.
First, genes are facts of nature. Like gravity, sunlight, and leaves on trees, genes exist in the natural world. Facts of nature can’t be owned. You can own a test for a gene, or a drug that affects a gene, but not the gene itself. You can own a treatment for a disease, but not the disease itself. Gene patents break that fundamental rule. Of course one can argue about what’s a fact of nature, and there are people paid to do that. But here’s a simple test. If something exists for millions of years before the arrival of Homo sapiens on earth, it’s a fact of nature. To argue that a gene is in any way a human invention is absurd. To grant a gene patent is like granting a patent on iron or carbon.
Because it’s a patent on a fact of nature, a gene patent becomes an undeserved monopoly. Ordinarily, patent protection enables me to protect my invention but encourages others to make their own versions. My iPod doesn’t prevent you from making a digital audio player. My patented mousetrap is wood, but your titanium mousetrap is allowed.
This is not what happens with gene patents. The patent consists of pure information already existing in nature. Because there has been no invention, no one can innovate any other use of the patent without violating the patent itself, so further innovation is closed. It’s like allowing somebody to patent noses. You couldn’t make eyeglasses, Kleenex, nasal sprays, masks, makeup, or perfume because they all rely on some aspect of noses. You could put suntan lotion on your body, but not on your nose, because any modification of your nose would violate the patent on noses. Chefs could be sued for making fragrant dishes unless they paid the nose royalty. And so on. Of course, we would all agree that a patent on noses is absurd. If everyone has one, how can anyone own it? Gene patents are absurd for the same reason.
It takes little imagination to see that monopolistic patenting inhibits creation and productivity. If the creator of Auguste Dupin could own all fictional detectives, we would never have had Sherlock Holmes, Sam Spade, Philip Marlowe, Miss Marple, Inspector Maigret, Peter Wimsey, Hercule Poirot, Mike Hammer, or J. J. Gittes, to name just a few. This rich heritage of invention would be denied us by a patenting error. Yet that is exactly the error in patenting genes.
Gene patents are bad public policy. We have ample evidence that they hurt patient care and suppress research. When Myriad patented two breast cancer genes, they charged nearly three thousand dollars for the test, even though the cost to create a gene test is nothing like the cost to develop a drug. Not surprisingly, the European patent office revoked that patent on a technicality. The Canadian government announced that it would conduct gene tests without paying for the patent. Some years ago, the owner of the gene for Canavan disease refused to make the test widely available, even though families who had suffered with the disease had contributed time, money, and tissues to get the gene identified. Now those same families could not afford the test.
That is an outrage, but it is far from the most dangerous consequence of gene patents. In its heyday, research on SARS (Severe Acute Respiratory Syndrome) was inhibited because scientists were unsure who owned the genome—three simultaneous patent claims had been filed. As a result, research on SARS wasn’t as vigorous as it might have been. That should scare every sensible person. Here was a contagious disease with a 10 percent death rate that had spread to two dozen countries around the world. Yet scientific research to combat the disease was inhibited—because of patent fears.
At the moment, hepatitis C, HIV, hemophilus influenza, and various diabetes genes are all owned by some entity. They shouldn’t be. Nobody should own a disease.
If gene patents are ended, we can expect screams of outrage and threats that business will abandon research, that companies will go bankrupt, that health care will suffer and the public will die. But it is more likely that an end to gene patents will be phenomenally liberating to everyone, and will result in a burst of new products for the public.
2. Establish clear guidelines for the use of human tissues.Human tissue collections are increasingly important to medical research, and increasingly valuable. Appropriate federal regulations to manage tissue banks already exist, but courts have ignored federal rules. Historically, the courts have decided questions about human tissues based on existing property law. In general, they have ruled that once your tissue leaves your body, you no longer maintain any rights to it. They analogize tissues to, say, the donation of a book to a library. But people have a strong feeling of ownership about their bodies, and that feeling will never be abrogated by a mere legal technicality. Therefore we need new, clear, emphatic legislation.
Why do we need legislation? Consider a recent court ruling on the case of Dr. William Catalona. This eminent prostate cancer physician assembled a collection of tissue samples from his patients so he could work on the disease. When Dr. Catalona moved to another university, he tried to take the tissues with him. Washington University refused, saying that it owned the tissues; the judge upheld the university, citing such trivial facts as some o
f the releases’ being printed on Washington University stationery. Patients are now understandably outraged. They believed they were giving their tissues to a beloved doctor, not a shadowy university lurking in the background; they thought they were giving tissues specifically for prostate cancer research, not for any use, which the university now claims the right to do.
The notion that once you part with your tissue you no longer have any rights is absurd. Consider this: Under present law, if somebody takes my picture, I have rights forever in the use of that photo. Twenty years later, if somebody publishes it or puts it in an advertisement, I still have rights. But if somebody takes my tissue—part of my physical body—I have no rights. This means I have more rights over my image than I have over the actual tissues of my body.