By Kevin Noonan
Michael Crichton has always hated - or feared -
technology. In his novels The Andromeda
Strain, The Terminal Man, and Jurassic Park, he has been a technology Cassandra, a
modern-day Luddite warning that technology would get us if we weren't very
careful. And while space viruses,
inhuman cyborgs, and thunder lizards are entertaining as fiction, they shouldn't
inform national policy.
That is what Dr. Crichton has been trying to do recently,
neatly dovetailing these efforts with promoting his latest book, Next. The bogeyman this time is DNA patenting,
which he assails in an OpEd piece in The New York Times today. Unfortunately, the misstatements and
exaggerations in the piece make it closer to fiction than it has any right to
be, appearing in the pages of the "paper of record."
The problems begin with the title, "Patenting
Life." Patenting life isn't what he
is concerned with - it is patenting DNA. DNA is not life, any more than patenting Vitamin B12, proteins, or
hormones isolated from animal (or human) material. Writers like Dr. Crichton (particularly
academics, who should know better) have created a "new vitalism;" in
this philosophy DNA is "different" and patenting DNA should be
prohibited. One problem with their
position is its intellectual dishonesty: as Dr. Crichton does here, they accuse
gene patentees of having ownership rights to "your" DNA (the DNA in
the cells of a person's body). This is
nonsense, since anyone familiar with this space or any other truthful
description of DNA patenting knows that patented DNA must be
"isolated" or "isolated and purified." In short,
no one has ownership rights over "your" DNA (or mine, or Dr. Crichton's).
Dr. Crichton chooses an easy target as "bad
guys" in his fiction: the
oft-maligned patent examiners that he holds responsible for gene
patenting. If there are culprits, of
course, it would be the U.S. Supreme Court who in the Diamond v. Chakrabarty
decision opened the doors for patenting genes and a host of other things that
have been important components of the biotech industry. Dr. Crichton would have you believe that the
"good guys" are those commercial interests in the rest of the world
who provide genetic testing using patented DNA more cheaply than in the
U.S. What Dr. Crichton doesn't say is
that these "free-riders" on American innovation only exist due to
their governments' tardiness in protecting biotechnology inventions. Dr. Crichton characterizes as a
"disaster" the decision to permit gene patents in the U.S. The real disaster has been in the rest of the
world, particularly Europe, where they are paying the price today of their
political decisions that frustrated patent protection for biotechnology. As recently reported in The Washington Post, European pharmaceutical companies have suffered both economically and
in their drug product pipeline: where a generation ago the Europeans
predominated, now it is American inventions and American companies that lead
the world. Much of this advantage stems
directly from patent protection available for the biotechnology industry.
There are a host of other pertinent facts omitted from
the piece. Examples include: that the
patent right is limited (to 20 years from the initial filing date), so that the
invention becomes freely available to the public for eternity once the patent
expires (the robust generic drug industry depends on this fact). That DNA is both a patented chemical compound
(that can be infringed) and genetic information, which information is freely
available upon publication. That no one
"owns" a disease nor has inhibited research on a disease. That DNA patenting has not encumbered
research; indeed, despite fears (voiced, famously, by Rebecca Eisenberg) that patenting
DNA would lead to a "tragedy of the anticommons," research shows that
gene patents have not impeded DNA research in academia. See "The 'Anti-Commons' Aren't So Tragic, After All."
What patents do is protect inventors from commercial
infringement of their inventions, and permit small companies to obtain the
financial backing necessary to develop the very genetic tests and therapeutic
drugs Dr. Crichton complains about. The
pages of the Times recently provided stark evidence of the economic advantages of
patents in the U.S., in a profile of Xoma Corporation. The Times writer decried the amount of
investment ($700 million) in a company that in 25 years had not developed a
successful commercial product. Paradoxically, this demonstrates the genius and strength of the patent system, since it is only
with this type of investment that companies like Xoma (and a host of more
successful biotechnology companies) have been able to survive. What the piece shows is how difficult and
expensive it is to develop a biotechnology product; no sane investor would
place his bets on such companies without patent protection, and without
investment the industry could not survive.
Dr. Crichton's attack is political, as is the bill introduced on Friday by Representatives Becerra of California and Weldon of Florida, which would ban gene patenting (more on that in a later post). This is a mistake, and there is ample evidence from our recent history that it is a mistake. At least one reason why the U.S. did not become the country Dr. Crichton described in another of his books, Rising Sun - an aging, rust-bucket, economic wreck that could not compete with the facile new democracies of Europe and Asia - is that America was quick to protect its innovators and innovative industries like telecommunications, computers and biotechnology. Thirty years ago, everyone had a Sony Walkman, today it's an iPod. And thirty years ago Europeans were producing most new drugs; today, it is America. Whether the political motivations are "Green" or religious or merely careerism (by either novelists or academics), the mistake would be to ignore the lessons of history. We shouldn't be killing the golden goose of American innovation.
Dr. Noonan has written a number of Patent Docs articles on the issue of gene patenting, including:
- "In Support of Gene Patents," December 7, 2006.
- "Anti-Patent (Sullivan?) Malice by the New York Times," January 29, 2007.
- "The Continuing Value of Biotech Patenting," February 4, 2007.
I guess I have a few questions and comments.
My understanding is that patenting dna is akin to patenting a number, in that an isolated sequence is protected. Is this correct? Why is this different than patenting a series of digits? Also is it possible this sequence exists in nature, and if so how could that possibly not be prior art?
Secondly as for the boom in biotech, while I agree that providing artificial monopolies spurs investment, I fail to see how honoring those monopolies benefits me as an individual. Currently in copyright cases, which are another form of artificial monopolies, products which are based on existing copyrighted material (Television shows which used various pieces of music) are not able to come to market because the cost of licensing the included material is prohibitive. Why would such things not happen in the patent space and how does this benefit me. I honestly believe that biotech research would occur regardless of patent protection because the payoff for the industry as a whole is just too tempting. Your example of the US vs. Europe has only shown that private interests will always flow to the government that will provide them with the most protection, not that without that protection that the industry wouldn't exist.
Posted by: Don Smith | February 13, 2007 at 01:26 PM
Don:
Not exactly. Patenting DNA is not like copyright, or a string of numbers. It is for the chemical compound that is the nucleic acid encoding a protein. You can then use this chemical to make another - the protein you want. For come proteins, like erythropoietin, tissue plasminogen activator, interferon, and others, it is difficult if not impossible to make enough by isolating the protein directly from nature. Being able to protect the way to make the protein by protecting the gene gives you the ability to have a commercial product.
But DNA is also a "string of letters," in that the sequence of the DNA encodes the protein (and, since protein sequencing is notoriously inexact, provides (often for the first time) the "correct" protein sequence). Importantly, DNA patents do not limit the use of the sequence (as a string of letters) at all. If you want to use my sequence to interrogate a database of human genes (to find related ones, to find mutations, to find gene family members) you are free to do so. There is no limitation by DNA patents on the information.
How does this benefit you? SImple - without the way to protect its investment, investors would not support biotech. Don't think so? Click on the link to the Washington Post and NYT Xoma articles. Patents are frequently the only capital a small start-up company has, and without them there would be no investment. Why should you care? Because if the inventions could not be patented, they would either be hidden as trade secrets (like the Coca Cola formula) or stolen by big companies (including foreign ones). Then you would pay, because the US pharma and biotech industries would be at the mercy of companies where they can pay their employees 10 cents a day, and you would pay because there wouldn't be any more US companies innovating to produce the next wonder drug. And finally you would pay because there would be less public disclosure, not more and the generics industry would be stifled, because they depend on expired patents (don't hear too much about patents expiring from the anti-patent crowd) that permit the fruits of all that effort to fall into the public domain within a very short time.
Hope this helps.
Posted by: Kevin E, Noonan | February 13, 2007 at 02:00 PM
Thank you for making the situation a little more clear.
Just to confirm, you're saying that no sequences are ever patented, only the process to generate various sequences? You mentioned that I could query a database with the sequence, but what about use it in a product, assuming that I generated it in a different way?
As for Xoma, as a rule I despise patent holding companies, as I am familiar with them from the software world. Too often they rush to patent a series of "inventions" which are so broad that they fail to provide what I believe you are stating Xoma has, a basis for further research. These companies then proceed to wait until the idea (or an idea similar enough that it could potentially covered by their overly broad patent) is independently reinvented and then 'shakedown' the inventor who actually turned the idea into a product.
Rather than tout the investment in Xoma, could you focus on something that they've generated that is beneficial to me as a consumer. Not what patents they've licensed but actual processes covered in their patent library which were implemented by others based on the patent disclosure rather than simply independently reinvented. I believe this would be a much more powerful argument than flag waving or counting riches.
Finally, while patents do expire, reverse engineering various processes that are not patented allows others to use the same process without infringing on the government granted monopoly, thus spreading the technology without licensing. Again, my bias is from a knowledge that most software patents are ridiculous (either overly broad, or trivial), and I am only assuming that other industries have the same problem.
Posted by: Don Smith | February 13, 2007 at 02:27 PM
Again, not exactly. DNA patents encompass the gene as a chemical compound, which is the physical embodiment of the sequence. So it isn’t the process, it is a tangible, physical object. The sequence, on the other hand, is “just” a string of letters and that isn’t patented. If you were to make the chemical compound that is the gene (whether by cloning it from a cell or synthesizing it) you would infringe; if you were to sit down at your computer with just the sequence you would not.
Xoma is actually not a patent holding company; it is just a biotechnology company that has had more than its share of disappointments in trying to commercialize a product. My point was that the only way they can continue to survive is because they can protect their intellectual property with patents. IP doesn’t mean you will get a product to market or that you will be successful, just that you will be able to protect your invention if you are.
I think the problems with software patents are different that in the biotech/pharma space. Part of that is obsolescence times and part of that is time-to-market. But my point was that patents provide the opportunity for all of us to benefit from the inventor’s discovery for the infinitely longer time that the invention is in the public domain after the patent has expired.
Posted by: Kevin E, Noonan | February 13, 2007 at 02:41 PM
Another 'misstake' in your comments is the false statement that Europe is lagging behind in biotech industry because patenting DNA has met problems in Europe. This is not correct: patenting DNA has been possible inthe procedure before the European Patent Office all along. The major problem why the biotechnology industry is less successful is on the political side: e.g. for use of transgenic ingredients in food, there has been an extensive ban from the EC and also th eindividual countries; that's why most of the major agrochemical businesses have movedtheir biotech reasearch to the US, China or South America. For use of biotech in the medical field there have not been objections, neither on the patent field or on the political field. The only difficulty there is that it is impossible in Europe to patent a method of medical treatment or a diagnostic method (where the testing is done in or on the body). However, the forbidden claims are method claims, thus product claims (like DNA) are not hampered.
The reason - probably - why the idea has set that patenting of biotech in Europe has been impossible is because of the discussion around the so-called Biotech Directive. It is true that this Directive has encountered many difficulties before being passed by the European parliament. It is also true that since enactment of the directive patenting of DNA has been legalized. However, this was a legalisation of an already exisiting phenomenon, no more.
Posted by: Bart van Wezenbeek | February 14, 2007 at 06:55 AM
Bart:
Despite your assertion that Europe may have allowed gene patents all along, the fact is that Europe lagged behind the US in supporting biotech patenting. This is way before the Harvard Oncomouse or other transgenic animal cases, and before GMO issues. Most biotech companies are not involved in GMO or transgenics, and methods of treatment aren't the issue. If I have time I'll try to reconstruct the timeline, but it is revisionist to say that Europe has been as supportive of biotech patenting in general, or gene patents in particular, as the U.S., whether for legal, political, or moral grounds.
And on another note, "another" mistake?
Thanks for your perspective.
Posted by: Kevin E. Noonan | February 14, 2007 at 08:56 AM
Your piece is interesting and informative. There are a number of points I'd like to make.
First, patents are often extended prior to their expiration. Thus, a compound that was formerly patented as a coated pill will be repatented as part of a time-release pill patent. This happens frequently, and the 20-year limitation is frequently bypassed and extended by the pharmaceutical industry. For several years, the drug Claritin came up before the Legislature in order to extend its patent; Senator Patrick Leahy had this to say on it in the year 2000: "These willey-nilley patent extension efforts will keep a handful of drugs at their current high cost." http://leahy.senate.gov/press/200006/000627.html
A good example of attempted patent extension is teh current Novartis suit against the government of India, which declared that the patent in question was a new form of an old drug and refused to approve the patent. In countries where Novartis has a Gleevec patent, the cost per patient per month is over 10 times higher: $2,600 v. $200 in India. The international humanitarian group, Doctors without Borders, has this Q&A: http://www.msf.org/msfinternational/invoke.cfm?objectid=A05B02CF-5056-AA77-6CA9A174A5C4E2F7&component=toolkit.article&method=full_html
Secondly, pharmaceuticals that come off patent routinely drop in price approximately 80%. The developing nations that cannot afford the exhorbitant prices of current pharmaceuticals must resort to patent-busting; recently, this nearly happened with AIDS drugs in Brazil - until the manufacturers backed down and reduced their price almost 50%.
You also make no answer to the points raised in Dr. Crichton's article - such as that a breast cancer test costs 3x what it could, and that the tester then has full access to your DNA and can do with it what they like without your permission. Another point that he makes is that studying Hepatitis C can be prohibitively expensive, thus scientists often choose something else to study - which then retards the progress of searching for cures and directly affects the lives of those affected by Hepatitis C. In a similar vein, he mentions that SARS research was retarded by the same methods of patent holders.
Recent examples of patent abuse include the cases eBay v. MercExchange, NTP v. RIM, Inc., and Eolas v. Microsoft. In the NTP case, the U.S. Government was ready to step in against NTP if necessary. In the Eolas case, a single individual forced a 60,000-employee corporation to make its products harder to use.
Patent holders routinely hold customers, scientists, and large corporations hostage to their terms. A perfect illustration of the problems currently existing in the patent system is the number of times the CAFC has been overturned by the Supreme Court.
I might add that in the eBay v. MercExchange case, the entire pharmaceutical industry and the entire technology industry were on opposite sides. The challenge was: "When patent infringement is found, can the judge decide whether an injunction can be made or not?" Pharma said no, an injunction is automatically in force (as agreed the CAFC); Tech said no, it's the judges call. Pharma lost.
Posted by: David | February 14, 2007 at 10:52 AM
David:
Thanks for your comments. While it is true that patent term can be extended, it isn't indefinite - in fact, the maximum term extension is 5 years, and that is only if the drug has gone through regulatory approval. Genes are not drugs (generally), and I doubt very greatly that gene patents will have the opportunity for extension. Moreover, since the maximum term without extension is 20 years from filing, and the Human Genome Project put about 98% of the sequences into public databases almost 5 years ago, the clock it ticking.
The business activities of companies overseas may be good or bad, but they are irrelevant to the discussion of whether genes should be patentable in the US. As you noted, many groups are actively working to bring down the cost in poorer countries. But patented or not, the fact is most poor countries can't afford much of what we have available in the West, and that's a problem much greater than patent policy decisions.
My response to Dr. Crichton's lament that tests cost 3X what they should is that it is fanciful - tests (and drugs) may cost less when the come off patent, but there is no objective basis for what a drug or test "should" cost. The metric Dr. Crichton uses is what the test costs in Europe, where first there is no patent protection and second there is universal health care. The costs of a patented test in the US shouldn't be divorced from the greater social context, but one thing we know for certain is that the test in question wasn't developed in Europe, and Europeans get the benefit of the lower cost because the European governments permit their pharmaceutical industry to free-ride on the innovation coming from the US biotech industry. Everyone remembers "The Little Red Hen" children's story, and it's the same here - it's nice to reap the benefits when you haven't incurred the costs. But that philosophy has consequences, one of which is lowered investment in research and development and, ultimately, fewer tests.
My point about patents hurting research is that the evidence is to the contrary. I have links to studies that show academic research is prospering. If you are talking about commercial research, we can see this as an attempt to get something for nothing, since many patents are available to license and partner. If a company decides they don't want to cooperate, the answer isn't to strip the innovator of her protection.
As for the cases you cite, one man's ceiling is another man's floor. I like the fact that "one person" can change the practices of a 60,000 person company, when that one person, against all odds, proves that the 60,000 person company stole his invention. If you think that it is OK for big companies to pillage small companies and inventors, then we part company. One of the strengths of our system is that small inventors are protected, even though it is still much tougher for all the economic reasons that big guys have an advantage. Sorry if that;s inconvenient, but the system has to work for everyone.
Posted by: Kevin E, Noonan | February 14, 2007 at 11:24 AM
Crichton's knowledge of patent law is spotty, but I think he's on the right side of the debate here. For further discussion, including some empirical studies, please see my blog at the link.
Posted by: Andrew Chin | February 15, 2007 at 07:03 PM
Andrew:
Kind of tough to get to your site, and kind of disappointing, too, once you get there. You think Congressman's Becerra's bill is "exciting," but then there's nothing except a link to the bill.
You're a law school professor, so here's what I propose: tell me why you think DNA shouldn't be patented. I'd be happy to hear your thoughts.
Thanks for the comment.
Posted by: Kevin E. Noonan | February 15, 2007 at 08:27 PM
David:
1. Why not cite some EVIDENCE that patents have inhibited hepatitis C or SARS virus research? Show me the facts. Hepatitis C virus was discovered by a private company -- no patent protection and the virus would not have been discovered. People with public money looked for it for years but failed.
2. The gene patents that concern Crichton cannot be "evergreened" by making them in e.g. delayed-release form.
3. Myriad's insisting that breast cancer samples should be supplied to them was not the fault of patent law but of their licensing system. Don't blame the patent. Patent law does not require the samples to be sent to Utah.
Posted by: Virologist | February 21, 2007 at 01:03 PM