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Patents On Genes: Round Two
dstates writes "An industry has grown up around patents guaranteeing exclusive access to testing of mutations in specific genes, but recently the Supreme Court rejected a biotechnology patent saying laws of nature cannot be patented, and threw the issue of patents on genes back to the lower courts. The Court of Appeals is now preparing to hear arguments on whether genes can be patented. The results will have major implications. On the one hand, restricting access to whole regions of the human genome will stifle scientific progress. On the other, companies like Myriad Genetics and Optimal Medicine use the patents to protect years of work invested in research, but this also means preventing other companies from offering diagnostics based on competing faster and lower cost technologies to analyze mutations in these genes."
Unless a company/researcher can claim and show evidence that they have created a new mutation of a gene, wouldn't pretty much the entire history of the human species and human evolution be considered prior art for that gene?
The only thing necessary for evil to triumph is for it to be pitted against a slightly greater evil
... can easily be worked around regardless of what Myriad Genetics and Optimal Medicine tell you. Also, location plays a huge, huge role.
The solution is not to allow my genes to be patented but to have the government fund basic research on what genes do and let the private sector slug it out. Many companies can then produce tests that are cheaper, faster, and better. That way they would compete on price and quality, not on being first to gain a monopoly position. We have lots of public infrastructure, like roads, that companies like UPS and FedEx share. It keeps costs low. Imagine if UPS could get exclusive access to Interstate 80 while FedEx got I-75. Not an efficient system if your goal is serving society even it FedEx and UPS funded their individual highways.
Genes themselves should not be patentable. Make a different sequence synthetically, yes. Come up with a new way to sequence it, yes. Find a way to fix it if it's defective, yes. But the gene itself? No.
If Slashdot were chemistry it would look like this:Cadaverine
Why would we accept a monopoly on some natural thing just because someone spent some money on something?
Patents should never be allowed to genes, even if someone spent the whole stock of money of the plant.
Just to begin, it's not an INVENTION, so a patent should not be allowed at all.
I'm not against all patents, but patents on genes, software and business process are ridiculous. This demonstration of greed without limits should not be rewarded.
Flavio
Just scrap the "On the other" [companies like Myriad Genetics and Optimal Medicine use the patents to protect years of work invested in research] ... No one cares about that. That goes under the "ordinary risk of doing business". Built on sand. Investors/speculators didn't have, or ignored, complete picture of the situation.
http://stephan.sugarmotor.org
As I understand the case, the issue is whether genetic material is patentable at all. This is generally referred to as patentable utility or just utility for short. Questions of utility deal exclusivly with whether they fall under the statute. The questions are usually answered with a simple "yes, it is" (e.g. For an improved potato peeler) or "no," (e.g. F=ma) so no prior art would be necessary.
The problem is that the general steps are easily duplicated, once someone has determined that a disease or risk is correlated with a gene it's pretty easy for to make a test that takes advantage of that information. So you either need to patent gene sequencing in the general case, which is a genie that is already well out of the bottle thankfully, or you need to be able to patent using that gene to predict an outcome. It is the test that is being patented, or at least the correlation. The problem is twofold: one, the patent hampers other research groups looking into the gene and two, the patents just plain last too long. I don't see any problem with giving them an exclusive license to sell a test for a correlation they discovered so long as they are not allowed to prevent third party research and their monopoly lasts a reasonable amount of time (5 years after the test is FDA approved or 10 years after the patent is filed seems more reasonable than the current numbers to me).
That's not even a new case, Monsanto has already sued farmers whose crops were "infected" with their Roundup-resistant gene via natural cross pollination...
This is serious stuff. Patenting life needs to be outside the law. This is worthy of a constitutional amendment.
The Bloomberg article cited in the summary is rather one-sided in its treatment of the subject. While speaking extensively to the potential damage that invalidation of human gene patents (at least for 'isolated' DNA) may do to the industry, it does not mention the potential benefits, which include opening space for start-ups and other small business to perform research and create products which they currently cannot due to patents on human genes. Invalidation of human gene patents would, of course, not be terribly beneficial to the current big players who now tend to simply cross-license their patents and thus block new competition.
Also, the article fails to explore properly WHY there is an argument over whether human genes should be patentable subject matter. The Supreme Court has held for many decades that products of nature are not patentable subject matter--so you cannot find a new mineral in a mine and get a patent on it. The Federal Circuit (the appeals court which handles patent appeals matters) has consistently held that isolated human genes, even when the sequence is exactly that of a normal human gene's coding region, are products of human ingenuity and not products of nature as the genes have been isolated from the gene's normal context--that of the chromosome. Many research scientists find this a specious argument, as isolation of a gene is a routine practice in the field. A recent Supreme Court holding (Mayo v. Prometheus) suggested that, for some patent claims at least, a law of nature or product of nature is not transformed into a product of man by some routine or common activity. So this argument will boil down to whether isolation of a human gene and placement of that gene into a plasmid (for copying, manipulation, expression, etc.) is enough to convert a product of nature into something made by the hand of man.
Monsanto is doing this with crops already. If their gene contaminates your crop through natural means (wind pollination, direct seed drift, bees etc. You are on the hook. They can take control of the entire crop including the uncontaminated parts of your crop and the vigorously litigate these scenarios.
From a speech by Michael Crichton to congressional aides in 2006:
"Gene patents might have looked reasonable 20 years ago, but the field has changed since in ways nobody could have predicted. And we have plenty of evidence today that gene patents are bad practice, harmful, and dangerous. Gene patenting breaks all sorts of long-standing rules about what is protectable, and it does so with no countervailing benefit. "
I highly recommend reading the rest of his speech, as well as his novel on this very topic, called Next. For a fiction writer, he was a pretty smart cookie. Must have been the MD he earned from Harvard, or maybe the BA in biological anthropology, also from Harvard. I especially like how he includes bibliographical references in most of his novels, so people can read for themselves the articles that inspire his novels.
Rest in peace, sir, and know that you are mourned.
"I love animals! Some are cute, others are tasty, what's not to like?" - Betsy Schroeder, Jeopardy contestant
Too bad, it's not an invention, so you can't get a patent on it.
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