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February 13, 2007

Comments

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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