Michael Chrichton on Gene Patenting
The best selling novelist Michael Chrichton's most recent novel, Next, pokes hard at the business of biotechnology. He has also written this op/ed piece against gene patenting, a subject we have considered from time to time here at Secondhand Smoke. The following is part of what Chrichton writes:"You, or someone you love, may die because of a gene patent that should never have been granted in the first place. Sound far fetched? Unfortunately, it's only too real.
"Gene patents are now used to halt research, prevent medical testing and keep vital information from you and your doctor. Gene patents slow the pace of medical advance on deadly diseases. And they raise costs exorbitantly: A test for breast cancer that could be done for $1,000 now costs $3,000.
Why? Because the holder of the gene patent can charge whatever he wants, and does. Couldn't somebody make a cheaper test? Sure, but the patent holder blocks any competitor's test. He owns the gene. Nobody else can test for it. In fact, you can't even donate your own breast cancer gene to another scientist without permission. The gene may exist in your body, but it's now private property...One fifth of your genes are privately owned."
I don't know if this is true. Royale, a frequent commentator here with whom I frequently disagree but who I hold in very high repute, has indicated (if I understand him correctly), that Chrichton might be misstating the case. I think this question gets to the crux of the issue.
Chrichton concludes with a call to support a bill to outlaw gene patenting that I referenced here a bit ago."Fortunately, two congressmen want to make the full benefit of the decoded genome available to us all. This past Friday, Xavier Becerra, a Democrat of California, and Dave Weldon, a Republican of Florida, sponsored the Genomic Research and Accessibility Act, to ban the practice of patenting genes found in nature. Becerra has been careful to say the bill does not hamper invention, but rather promotes it. He's right. This bill will fuel innovation, and return our common genetic heritage to us. It deserves our support."
For me, supporting the latter affirmation will depend on the veracity of Chrichton's earlier assertions. More here when I learn more.
posted by Wesley J. Smith @ 12:40 PM
8 Comments
8 Comments:
Although it is true that patents ensure that the manufacturer has a monopoly, research is not infringement.
In fact, Crichton's statements are just plain fraudulent.
Below is 35 USC 271(e)(1):
It shall not be an act of infringement to...use...a patented invention... solely for uses reasonably related to.... submission of information under a Federal law which regulates the manufacture (i.e. the FDA)
In other words, research that might reasonably be sent to the FDA is not patent infringement. This covers many, many areas of drug and biotech research.
http://www.uspto.gov/web/offices/pac/mpep/documents/appxl_35_U_S_C_271.htm
To be honest, I didn't have much desire to read "Next," based on his book on global warming.
But...I think I will.
Also, in actual practice, doctors and pharmacists sometimes do use medicines in off-label uses that might violate some patent somewhere. But most drug companies look the other way because they don't want to sue their customers. That makes bad business.
I'd like to know how they think this will promote invention.
This, from a different reader, pointing to an article that claims Chrichton is right. Is it possible that this area is vague and that more clarification is needed?
"I too am interested in learning more about gene patenting, so that I can have an informed opinion on the subject. FYI, this IP law prof backs Crichton: http://www.tcsdaily.com/article.aspx?id=012307A.
Some of the profs points are just subjective policy points. For instance, the discussion of cDNA. Even still, that issue is completely irrelevant to this particular bill as natural processes are not patentable. We don't need a new law if that's really the issue.
But I wonder if the scope of the research exception. I suppose if the researcher stipulates that he has no desire to submit his findings to the FDA, then that might be infringement. If that's the case, then I think the exception should be broader general research.
I don't know if he is right about the specific claims, but I deal with patent hassles all the time at work when we are designing new computer products. The patent system is now regularly being used to stifle innovation and hamper progress and is in need of urgent review.
This from a reader sent via e-mail:
"Just a comment on the gene patenting issue. I have to say that I am with Crichton on this one. My lab performs clinical genetic testing. We are limited in what tests we can offer because of gene patents, some royalities are just too expensive to justify bringing the test online. This certainly limits choice and access to such tests for patients in our area. Also, we pay royalities to companies that own the genes for the tests we do offer. This certainly drives up the cost for us and we pass that cost on to our patients.
Also it is my experience that when we share samples with other labs, we find that different kinds of test uncover different mutations in the same gene, especially when polymerase chain reaction (PCR) is used. Recently, we had a patient with two separate mutations in the same gene. We found one mutation, and the other lab found the other mutation because their assay was designed differently. This simply means that by limiting novel approaches to testing certain genes with gene patents, we may be limiting mutation detection. Which in turn may limit progress toward treatments or cures."
I wrote another response but the website crashed before it was properly published.
Anyway, I think a good balance that would solve the public health and competitiveness concerns of Critchton and these other readers would be to expand the scope of allowable research.
Plus, I suspect (but don't know) that the Patent will office will grant less, maybe even zero, patents for cDNA simply because they are routine and "obvious." It should anyway. If so, that would solve many of these concerns, but would do nothing for the patents that are already granted.
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