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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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« A Good Day's Work | Main | Gene Patents, Part One: Genes As Chemicals »

February 13, 2007

Crichton, Patents, and Genes

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Posted by Derek

Today's New York Times has a passionate op-ed by Michael Crichton on the subject of gene patents. Now, as my previous posts will demonstrate, I'm no fan of over-patenting. And the whole topic of gene (and protein) patents is a very interesting and important one.

Unfortunately, though, it's also very complex, and Crichton's piece manages to complete reduce the subject to tinkling fragments. The op-ed is so vigorously argued that its readers will probably come away feeling as if they've been informed, but I'm afraid that they're going to end up knowing less than when they started. I hate to be this blunt about it, but Crichton's done his cause a great disservice by spreading ignorance and confusion.

The official position of the Patent Office is that products of nature are not patentable. But. . .an isolated or purified one, in a form not found naturally, can be. Single genes, ripped out of their context in genomic DNA and expressed as a pure form, are considered to be new chemical substances, and thus can indeed be patented. We can argue about whether this is a proper interpretation or whether it's a good idea, but to ignore the point completely (as Crichton's piece does) isn't going to help anyone understand the problem.

You'd also never guess from reading Crichton that the subject of utility is of great importance in patent law. There's a profound difference between a patent on a gene, and a patent on a use for a gene. (That may sound trivial, but only if you've never been involved in writing or analyzing any patents). Ten years ago, the US Patent Office was getting swamped by gene applications with very little thought to their use (other than some pro forma statements, but they raised their standardsper se shouldn't be allowed, you'd still have the use issue to deal with. The word "utility" does not appear in today's op-ed.

You'd also never know that the whole subject is being contested, very seriously and expensively, in court cases all over the world. The Metabolite case, which the Supreme Court recently dodged, is the one with the highest recent profile, and there will be more. It's not like the topic hasn't created controversy.

If you want a thoughtful analysis of the problems of gene patenting, start with this analysis (PDF) from the Congressional Research Service. Reading and understanding it will put you way ahead of the readers of the New York Times and, it seems, way ahead of Michael Crichton.

Comments (26) + TrackBacks (0) | Category: Patents and IP | Press Coverage


COMMENTS

1. d_orbital on February 13, 2007 3:04 PM writes...

Derek,

Maybe it would be a good idea to write a reply giving a few more facts or at least centrifuging out some of the misinformation.

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2. Kevin E. Noonan on February 13, 2007 3:21 PM writes...

Derek:

One small quibble with your excellent piece. The Metabolite case, as important as it may be as a bellweather for how far the current U.S. Supreme Court is inclined to support patents, is not about genes or gene patenting. More importantly, the Metabolite case in some ways is closer to a software case, since it is really about whether a step that can be performed mentally is proper in a patent clsim.

d_orbital can get more info ay www.patentdocs.typepad.com.

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3. Jimbo on February 13, 2007 3:31 PM writes...

Looks like Crichton is doing patent law the same service as he did the global warming issues with "State of Fear". That's sad, I really liked his early books.

BTW, has anyone else noticed that MC's "Prey" was a bad ripoff of an old novel by Stanislaw Lem?

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4. RKN on February 13, 2007 3:42 PM writes...

We can argue about whether this is a proper interpretation or whether it's a good idea, but to ignore the point completely (as Crichton's piece does) isn't going to help anyone understand the problem.

On my reading Crichton didn't ignore the point, he merely chose not to elaborate the specifics of patents wrt human genes. But arguably he's correct about genes which are disease markers - getting screened to see if you have a disease gene (and thus the disease or a predisposition for it) requires a royalty to be paid to the patent holder of that gene, or the cDNA fragment(s) it contains.

There is no longer anything novel involved with identifying or synthesizing a cDNA, is there? If not, why does it continue to be a patentable product?

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5. JSinger on February 13, 2007 4:13 PM writes...

The op-ed is so vigorously argued that its readers will probably come away feeling as if they've been informed...

That's pretty much Michael Crichton in a nutshell.

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6. Scott on February 13, 2007 5:40 PM writes...

Explain how a naturally occurring gene, encoding for a naturally occurring protein could somehow be misconstrued as not a product of nature? I'm not saying it's not a valid position, but lay it out for us all.

I find it cowardly to claim Crichton is 'spreading ignorance and confusion' without backing up your side of the debate.

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7. weirdo on February 13, 2007 6:08 PM writes...

"I find it cowardly "

Stated by the anonymous Internet poster. I'm anonymous, too, but I don't throw around accusations like that.

Derek did not state, anywhere, in his post that "a naturally occurring gene, encoding for a naturally occurring protein could somehow be misconstrued as not a product of nature". That is an invention of yours. Read what he wrote again. It's the purified, or the expressed, form that the USPTO has ruled on. Pure proteins are not found in Nature, generally. And Derek expressly points out that the USPTO position is debatable.

Geez.

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8. Palo on February 13, 2007 6:18 PM writes...

Scott,
How do you know a naked piece of DNA is a naturally occurring gene? How do you know a sequence of nucleotides encodes a naturally occurring protein, or a protein at all? How do you know a naturally occurring protein has a function? How do you know what the specific function actually is?

It is not as simple as saying people are simply patenting a naturally occurring phenomenon...

I am all against gene patenting for many reasons, the most important being that patents were created to induce innovation, not hinder it. But Michael Crichton simply doesn't understand much of what he's talking about. Of course, that didn't stop him before when he told us that Global Warming is not happening.

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9. A-non-y-mous on February 13, 2007 8:04 PM writes...

Weirdo:

You take exception to Scott's opinion of "I find it cowardly", but not to Derek's opinion of "Crichton's done his cause a great disservice by spreading ignorance and confusion"?

So much for stating a personal opinion. We'll all make sure we check with you first.

Wait . . . was this comment OK?

Geez.

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10. weirdo on February 13, 2007 8:47 PM writes...

Derek's name is out there for everyone to see. Mine isn't, yours isn't, Scott's isn't. He's a real person who can be contacted in the Real World, not just cyberspace. In my opinion, that gives him a certain latitude anonymous posters (like me) have not earned.

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11. Anonymous BMS Researcher on February 13, 2007 9:55 PM writes...

Well, as one who is named as an inventor on such a patent, I don't suppose I am exactly neutral, but this is a theme on which Crichton has been pounding away for a very long time. Many of his novels (I have read most of them) employ as a major plot element the consequences of reckless science, particularly reckless biotech.

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12. Scott on February 13, 2007 10:06 PM writes...

weirdo, I really meant no offense, but I was just looking for an explanation, perhaps to eliminate my ignorance and confusion.

I don't pretend to be an expert on this. I just think in general it's probably a bad idea to bash someone's view without offering a logical explanation, of which I see none in this post.

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13. John on February 14, 2007 1:08 AM writes...

All this article does is narrow the definition of what a gene patent is; it doesn't really speak to what Crichton was saying. The point of his piece was not to discuss the legal technicalities of patent law, but instead to make the argument that patenting something that is a part of all human biology is absurd, unethical and dangerous, and it is.

This issue cannot be addressed by restricting the "use" of a gene rather than "the gene itself." The problem lies far deeper than that. We are all made from the genetic information found in the human genome. We all have a right to the unrestricted access and use of the information as we see fit.

It would be nice if members of the media could maintain a rational and focused approach with these things instead of making a response that does not appropriately address the original articles.

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14. Brian on February 14, 2007 3:06 AM writes...

As usual, Crichton is trying to be inflammatory without looking too deeply into what he is talking about. His examples give him away on this with Canavans disease. It doesn't cost $3K to test for this- you can get a test for this plus Cystic Firbrosis, Gauchers disease, and Tay-Sachs for less than $500. I'd hardly call that prohibitive.

Hep C- what researchers "choose to study something less expensive"? Academics are free to do what they will with Hep C as far as research goes. Even us in industry are fine to do pure research, the patent only comes in to play if we need to go to market. At this point in time if I started something on Hep C today I wouldn't be worried because by the time it got to market the relevant patent would be expired.

The BRCA patent test that costs $3K? It's targeting a small potential patient population. It does cost a fair bit of change to get an FDA approved test to market and you need to spend a lot of money to keep your maunfacturing plant in FDA specs. I have no clue what the profit is on this test.

And as far as some of the other assertions- "haemophilus influenza" is not privately owned. It's diagnosed and treated all the time without any royalty payments. Front what I know of SARS, IP played no role in discovery and no role in treatment.

Crichton is about as right in his conclusions here as he was about nanotechnology vs thermodynamics and global warming.

Gene patents are a sticky issue and the one thing that Crichton gets a correct answer- the Patent Office was not set up for this. The idea of a Patent as far as I have been able to determine was to both protect the inventor and to allow for others to use the disclosed info to invent new stuff. Alice makes a new mouse trap, patents it, and Bob makes a better one based on Alice's trap.

Both of Alice's and Bob's traps are based on levers, springs, weights, and maybe a small kitten. All of those are natural items. Nobody has any problem with Alice's or Bob's traps being patentable.

Yet people get a bit more nervous when XYZ corp spends considerable time, effort, and money on isolating a gene variant that causes disease in humans and also gets a patent on the same. Alice and Bob certainly spent time and effort on their works and were rewarded with a patent.

The rub is that while Bob can easily use Alice's starting work on his patentable derivative, it's a much harder thing to get a derivative on XYZ corp's patent.

As a disclosure, I work for a biotech company as a scientist so my legal opinions are worth the electrons that carry them. My company does not make diagnostic tests so my opinions are not biased finacially as far as my wllet can tell.

Brian

Permalink to Comment

15. orions55 on February 14, 2007 4:11 AM writes...

"And we’ve already mentioned that tests for the BRCA genes for breast cancer cost $3,000. Oh, one more thing: if you undergo the test, the company that owns the patent on the gene can keep your tissue and do research on it without asking your permission. Don’t like it? Too bad. "

I guess any asshole can write any lie and get away with it! He must not know about CAP, CLIA and NYS lab certifications and sample destruction requirements. Ignorance abounds in MC's fantasy world. And tissue? What tissue? lazy, lazy, lazy Mikey.

Mikey continues to spew misinformation. In his reckless article from Parade magazine, another half-baked lie was exposed. His source said 'women go to France to get access to BRCA gene testing'. ummmmm, that's about as accurate as saying Americans are queueing up to wait for Canadian mammography because they are not covered in the US. Who would travel to Europe and pay out of pocket for gene testing? American men and women who are candidates for testing are already getting 'full sequencing' with additional panels to detect rare mutations. The typical out of pocket costs for these tests are below $300. The only American getting BRCA testing in France is either rich, misinformed or anti-capitalist.

I'm finally convinced everything written is semi-BS. Therefore, one should assume a washed-up writer with a half-cocked political agenda is the most dangerous animal in America.

Sereiously---is MC really this lazy? Would you want your writing legacy hinging on this bizzare political stance? Can someone please get this man a fact checker!

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16. y on February 14, 2007 9:44 AM writes...

I've openly challenged Crichton's narrow focus before, and I'll summarize it here.

Crichton says "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."

Why don't we consider the flip-side:

"You, or someone you love, may die because of a lack of incentives for innovation."

Patents are absolutely necessary to protect innovation in biotechnology and a number of other fields. But, they're not a panacea. Some patents will be bad, some fields don't need patents. But, I ask you this: Name a country without a robust patent system that has produced medical innovations anywhere near comparable with those produced in the United States.

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17. RKN on February 14, 2007 9:53 AM writes...

American men and women who are candidates for testing are already getting 'full sequencing' with additional panels to detect rare mutations. The typical out of pocket costs for these tests are below $300. The only American getting BRCA testing in France is either rich, misinformed or anti-capitalist.

A quick web search on the cost for BRCA (isoform 1 and 2) testing indicates this is false. The cost for sequencing is ~$1300 (per isoform), and allele specific testing is another $400. Similar cost estimates for BRCA testing are reported at NCI.

Costs also vary depending on one's insurance company, and can rise if genetic counseling and follow-up tests are indicated, both of which are evidently frequent. And certainly some women may not even want their insurance company to know they're getting a test, for obvious reasons.

Someone made the analogy to a mousetrap. Levers, springs, and weights are most certainly not natural, they result from human design and production. Nevertheless, a better mousetrap that works by a novel mechanism arguably should be a patentable invention. But there is nothing novel or inventive involved with synthesizing a cDNA sequence that happens to be one or more exons of a disease gene. It seems to me this is what Crichton was getting at, and I think he's right.

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18. Wavefunction on February 14, 2007 10:20 AM writes...

Since I read "State of Fear", I have become more or less convinced that Crichton has drifted away from sound science. Sad.

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19. Anonymous on February 14, 2007 12:09 PM writes...

It's an opinion-editorial piece.

Opinion.

Editorial.

Penned by a writer of fiction.

Would you all feel better if Martha Stewart had written it? If you don't like it, blame the New York Times, they are the ones that published it

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20. Anonymous on February 14, 2007 12:11 PM writes...

"Name a country without a robust patent system that has produced medical innovations anywhere near comparable with those produced in the United States."

Those countries also don't have running water. What's your point again?

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21. y on February 14, 2007 1:34 PM writes...

There are countries without strong patent systems which have running water, but perhaps the subtext is there's a connection between having patents and having a strong economy ...

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22. wlm on February 14, 2007 6:07 PM writes...

I'm of the opinion that Derek has given us a much more informed and useful discussion than Crichton has, in a similar amount of space. I don't think the distortions and over-simplifications that Crichton uses are legitimate, even in a mass forum.

That's despite the fact that I'm sympathetic to Crichton's overall point; that the rules for genetic patents are too lax. But you have to balance that concern with the fact that the research and development of tests for disease-associated mutations is risky and expensive. So there needs to be lots of incentive for those applications.

Personally, I think it would be appropriate to restrict patents to applications based on genetic data, not to the data or genes themselves. In general, I think patents should be more about applications than ideas.

Permalink to Comment

23. Keith Robison on February 14, 2007 11:22 PM writes...

I'm not a fan of Myriad (the owners of the BRCA patent), but it should be pointed out that they didn't just pick up something easy and patent it; it was not "But there is nothing novel or inventive involved with synthesizing a cDNA sequence that happens to be one or more exons of a disease gene.". Myriad won, by a short margin, an intense race to positionally clone BRCA1 (and later BRCA2). They did pour an enormous amount of resources into the hunt, as did several public teams that were edged out.

It is also worth noting that what makes the most controversial patents controversial is precisely because applications have been created -- e.g. Myriad uses mutations in BRCA to predict disease risk.

Note: my name should be a hyperlink to my own blog entry on the subject.

Permalink to Comment

24. RKN on February 15, 2007 7:16 AM writes...

Myriad won, by a short margin, an intense race to positionally clone BRCA1 (and later BRCA2). They did pour an enormous amount of resources into the hunt, as did several public teams that were edged out.

I expect they spent a lot of money in the race to clone BRCA1&2, but spending a lot of money in and of itself isn't a justification to issue a patent. The oil and gas companies risk tremendous amounts of capital to find new oil & gas resources, but they can't patent hydrocarbon.

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25. qetzal on February 15, 2007 7:37 AM writes...

I expect they spent a lot of money in the race to clone BRCA1&2, but spending a lot of money in and of itself isn't a justification to issue a patent.
True, but for-profit organizations won't spend lots of money if they don't see a profit potential down the road.
The oil and gas companies risk tremendous amounts of capital to find new oil & gas resources, but they can't patent hydrocarbon.
But they can secure the rights to any new oil and gas resources they find, thus providing the potential for profit, and the motivation to spend those resources in the first place. How much would Shell spend to find a new oil field if they knew that Exxon and BP could come in and tap the same field, free-riding on the money Shell spent to find it?

The overall principle is the same. In either case, a key argument for granting exclusive rights is that any societal costs due to the resulting limited monopolies are offset (on the whole) by societal gains from increased innovation.

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26. RKN on February 15, 2007 1:08 PM writes...

The overall principle is the same. In either case, a key argument for granting exclusive rights is that any societal costs due to the resulting limited monopolies are offset (on the whole) by societal gains from increased innovation.

Sure, that's the putative goal of a patent, but not the basis for one. The government has no business granting exclusive rights to something which is not inventive, new, and novel. Cloning DNA, or fragments thereof, is no longer inventive or new. It may also be expensive, but we agree that's irrelevant. Discovery of a gene sequence which is statistically correlated to a disease may in fact be a "novel" discovery, but that alone is not enough to justify a patent. So-called "societal gains" notwithstanding.

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