TCS Daily


Why Michael Crichton Is Wrong About Patenting Genes

By Michael Rosen - December 20, 2006 12:00 AM

Michael Crichton sure can tell a darn good story.

His latest book, Next, like its immediate predecessor, State of Fear, enraptured me from the moment I cracked its spine. It's a fun read, pretty hard to put down, exciting until the end - much like the best in his oeuvre: Jurassic Park, Rising Sun, and The Andromeda Strain.

Crichton has at times leveraged the soapbox his books furnish to engage various controversial issues. In State of Fear, he challenged received wisdom on the imminence of catastrophic climate change, integrating citations from academic journals with his characters' breathless global warming-related adventures in Antarctica, the South Pacific, and the American West.

For his efforts, he has attained notoriety in many corners of the commentariat (and has apparently fictionally counterattacked at least one of his critics). He has also reportedly gained the ear of the Bush administration, which invited him to the White House to discuss his views.

In Next he enmeshes himself in the debates over genetic engineering, cloning, embryonic stem-cell research, and the human-animal divide.

The story weaves a complex tapestry of scientists, ethicists, animals, physicians, and even wildlife photographers, each pursuing some aspect of genetic research. The strands are not always interwoven and some are far longer and more textured than others. But along the way, Crichton does the general public a service by exploring issues not widely- or well-understood and by providing sources for further investigation.

One issue that seems to have piqued Crichton's curiosity involves our system of obtaining patent protection over genes. Crichton sharply criticizes the practice, asserting that it "contradict[s] long-established traditions of intellectual property protection."

Crichton raises four principal objections to gene patents: first, because "genes are facts of nature," granting patents on genes is "an undeserved monopoly." In and of itself, the practice is flawed because it requires no inventive step.

Second, Crichton contends that patenting genes offers the patentee excessive protection. As he puts it, "it's like allowing somebody to patent noses. You couldn't make eyeglasses, Kleenex, nasal sprays, masks, makeup, or perfume because they all rely on some aspect of noses...Chefs could be sued for making fragrant dishes unless they paid the nose royalty." Put differently, "if everyone has [a nose], how can anyone own it?" In short, regardless of their ontological status as "fact of nature," genes shouldn't be patentable because they are universally widespread.

Third, Crichton asserts that "gene patents are bad public policy" because they "inhibit[] creation and productivity." He cites several examples of diseases and conditions - breast cancer, Canavan, SARS (remember that?), hepatitis C, HIV, and diabetes - whose eradication is allegedly threatened due to patents on related underlying genes.

Crichton concludes his critique - which appears in the "Author's Note" following the story - with the following:

If gene patents are ended, we can expect screams of outrage and threats that businesses will abandon research, that companies will go bankrupt, the health care will suffer and the public will die. But it is more likely that an end to gene patents will be phenomenally liberating to everyone, and will result in a burst of new products for the public.

So what to make of Crichton's diatribe? Is he right?

In a word, no.

Looking at the big picture, there's a reason that the U.S. continues to lead the world in developing pioneering treatments and cures for the most devastating diseases. Actually, there are several reasons, but our patent system is one of them.

So let's take Crichton's points one-by-one. Because this isn't my specific area of expertise, I consulted with a colleague who practices in this field (although any inclarity or explanatory errors are my own).

Crichton's first argument - that one cannot, or should not, patent a "fact of nature" - rests on a false premise. Genes are not patented in the form in which they exist in nature; any attempt to obtain protection over such material would meet with a resolute rejection from the Patent Office.

Instead, according to my colleague, "genes are claimed as 'cDNA,' or complementary DNA: a highly artificial form of a gene made by reverse transcription from a naturally occurring mRNA, or messenger RNA." While cDNA "does represent, in a stylized sort of way, a sequence of a naturally occurring gene," it contains "distinct structural differences that clearly differentiate it from the naturally occurring sequence, at least insofar as higher organisms are concerned." (The differences are apparently more subtle for bacteria and viruses.)

Extracting cDNA "requires inventive input, sometimes extraordinarily so, to pull a particular, sought-after cDNA out of a 'library' of cDNAs made by reverse transcription from the entire range of mRNAs of a particular cell type." In other words, the inventive step required for patenting clearly exists when it comes to genes.

Furthermore, my colleague told me, "once a cDNA is produced and characterized, it is potentially commercially useful, in contrast to the naturally occurring gene as it exists unrecognized and buried in the genome of the natural organism. Even sequencing the entire genome of an organism does not reveal where each gene begins and ends, much less what each gene is and does." Thus, the genetic sequence itself is available for anyone to use; it cannot be patented just like no part of your body can be patented (or sold, for that matter).

In a sense, then, patenting genes is less like patenting one's nose than like patenting an artificial nose: both require significant inventive effort, both have the potential to be extremely useful, and both are based in only the broadest sense on a natural discovery. Thus, genes - as patented - are far more than mere facts of nature, pace Crichton.

But what about his second concern, namely that gene patents are too broad? Put differently, would patenting an artificial nose swallow up all possible applications for that nose? Again, the short answer is no.

If you wanted to sell, say, a Groucho Marx mustache and glasses that would rest under and above the nose (respectively), you'd be in the clear. But if you wanted to sell the whole package, including the nose, you'd be out of luck.

So, too, patenting an item does not forever bar others from creating complementary devices that work with the item. Otherwise, EA Sports could never make Madden 07 for the Nintendo Wii, since the hard-to-get gaming machine is protected by numerous patents. So Crichton's second gripe is little more than a smokescreen.

Which leads me to believe that he's placing all of his eggs in a single basket: the "public policy" argument.

But Crichton's horror stories notwithstanding, the American gene patent engine has driven many of the most important breakthroughs in the life sciences. Precisely those diseases that Crichton identifies are those that patented genes have helped conquer. That some of the patent holders behaved badly, even (allegedly) exploitatively, is an indictment of their integrity, not of that of the patent system.

Besides, the patent system has built-in mechanisms for addressing abuses of the patent monopoly: patent misuse and antitrust remedies. And it's crucial to remember that the patent term is limited by statute to 20 years; thereafter, generics can proliferate without sanction.

One commentator on a new patent blog put it nicely:

There is a balance to be struck between rewarding companies and universities that expend vast amounts of money, time and resources in discovering the genetic information necessary to produce a genetic test, and the cost of those tests to the public. The answer is not to declare the underlying technology off-limits to patent protection. That way leads to a real "tragedy of the commons" where no one has the economic incentive to develop a test that can be stolen by a competitor without compensation.

In previous articles, I devoted a great deal of attention to the "commonist" argument against patenting life forms. But in this situation, Crichton's fanciful alternative to the patent system fails even to present the basic rudiments of an argument.

He claims without any justification or support that "an end to gene patents will be phenomenally liberating to everyone, and will result in a burst of new products for the public." How? When? Why? Crichton's conclusion exceeds even the most utopian of the commons movement avatars' pronouncements for sheer audacity.

Yes, Crichton can tell a story. But he can also spin a tale. It's important to appreciate the difference.

Michael M. Rosen, TCS Daily's Intellectual Property columnist, is an attorney in San Diego.


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16 Comments

You can't own my genes
Much as it pains me to be in agreement with arch creep Michael Crichton, you can't own my genes.

Look at Basmati rice, for an example. Farmers in the Indus Valley developed Basmati four or five thousand years ago. It's theirs. And they allow anyone who wants to grow the rice to have it.

Along come the gene thieves, and they isolate the genes that make it unique among rice strains. So should they be allowed to patent those genes, and then charge the framers of Pakistan rent on them?

In the early days of genetic medicine a simple test was developed to detect the presence of a gene modification predisposing women to a form of breast cancer. This was great, finally a test for who might be likely to get breast cancer.

The gene itself was patented, not the test. And the patent was purchased by an obscure company somewhere in Oklahoma, as I recall. As a result, a test costing a couple of hundred dollars suddenly cost $14,000. The difference was the royalty on the gene.

You can't own life, and you can't own my life. I go with the fellow whose own unique genetic condition contributed toward another treatment breakthrough. Not only did he receive none of the royalties, he would have to pay the patent holder if his wife or children came down with the disease. These thieves have no right to draw a line around everything they discover and say that they own it.

Open source research is the way science has to progress. Otherwise we are in the dark ages, with every little lab and university building walls around their tiny fragments of knowledge.

Own my genes, please!
Critics of gene patents often misunderstand the issue on several levels. First, they sometimes seem to believe that a patent is forever - it's not. It is at most 20 years, and most likely practically less.

Second, they seem to think that you can just go into the Human genome, or any other genome, extract a sequence, and patent it. No, you can't. It was possible to do this in the 1980's and 1990's, because back then such an extraction truly did require inventiveness. However, many such an extractions are merely tech jobs, and do not require any expertise - and hence have become obvious.

The Patent system's internal controls - novelty, nonobviousness, and utility - if applied consistently by the office, provide all the protection needed against bad patents.

Third, the concept of Open Source Science is one that is a great white whale by many. It simply cannot be done in many contexts. Open Source is primarily a mechanism to stimulate labor, and it flourishes in fields where the capital inputs are low, but the labor inputs are high. Look at software. Anyone with $500 can get a computer, throw linux on it, and start coding. $500 won't even purchase you a decent restriction enzyme library, much less a PCR machine. The Patent system solves this problem by allowing the investors to recoup their capital costs.

In a word, no ?
Actually, there are several reasons, but our patent system is one of them.

This is crap. The US patent system is badly broken. It exists purely to keep the patent office in business.

I saw Crichton's book in a bookstore today and was wondering whether to buy it or not. Since you compare it favourably to some of his better works, I suppose I will.

You are wrong about how Genes are "patented" as well (I have worked in biotech for a small company who is heavily involved in this). You really seem to be unqualified to comment in this area and you have not done your homework on this issue. Moreover, iirc, the first gene patent (a bit less than 30 years ago) was for just the dna sequence.

I have not read your article carefully yet and leaving a comment on a blog would not do justice to this topic.

The real problem with IP laws is that there has been no careful thought about how they should work in more than 100 years. It has just been a free-for-all with the spoils going to whoever managed to buy the right politician (e.g. Sonny Bono and the Mickey Mouse copyright extensions).

As for Richard Stallman and the FSF (previous comment on "open source"). He has no interest in any rational reform as he is trying to use the system against itself to push his own political agenda.


--gh

Seed gene patents.
Back to basics. IF the companies receiving the patent were honest, that would be one thing, but what if they were crooked as a snake?
What if the patent holder developed their product using your seed which you had developed over the years, for example. What if they then took that seed, modified it slightly by say splicing in a fish gene, planted some of the resulting seed into your fields. Now some of your patented seed would have some of the fish gene showing up in it. What if the company with the patented seed with the fish gene then went to court and wiped you out financially so that you could not ever get back on your feet and start selling your seed which took you a lifetime to develop. "Competition is a sin" (quote JD Rockefeller.)
Can't happen? Already did..

Endowed by their creator with certain inalienable rights.
Much as it pains me to be in agreement with arch loon Michael aka "Roy_Bean", you can't own my genes.

The Patent system's internal controls - novelty, nonobviousness, and utility - if applied consistently by the office, should mean that anything that is a derivative of existing life is like patenting a new house with a different coat of paint or the kid next door getting a patent for putting a new V-6 in a '57 Chevy.

Not that anybody would care to consider the thoughts of the founding fathers in such an advanced cause, but consider their use of the term "inalienable" two plus centuries ago. They chose that word carefully. Inalienable means those rights attach to the person wholly. Not only are those rights supposed to be free from conscripted removal or abridgement by the government, but they are not subject to sale, exchange, loan, transfer, trade or any other voluntary surrenfder by the individual. You are a custodian or trustee with yourself as the beneficiary and no power of appointment over the corpus of that trust.

Allowing for the patenting of genes is a classic case of the IP Bar seeking to subject every one and everything to their control and it is a course fraught with danger. Maybe next we'll need to validate the rights to our genes, perhaps with a "666" conspicuously affixed to our forehead.





Hell, is this going to be a first.
I's like to also add to this comment....

"there's a reason that the U.S. continues to lead the world in developing pioneering treatments and cures for the most devastating diseases. Actually, there are several reasons, but our patent system is one of them."

Wrong there is only one reason and that's money. throughout history the bulk of new discoveries and inventions has come from the richiest nation and guess what, at the moment that is the US.

Percy Schmeisser
Yes, the Percy Schmeisser case was an egregious example. I don't think they planted anything in his fields on purpose. What you had was a wind-pollinated crop with a genetic marker on it. So that any time the wind blew, the pollen landed in fields that had not bought into the patent use rights. Percy was unlucky, in that his fields were contaminated with GM rapeseed and his legal defense team apparently did not think to mount a countersuit against Monsanto, claiming contamination.

In finding for Monsanto, I think the Canadian courts found a plausible likelihood that Schmeisser had encouraged the selective growth of the contaminated seed. But I have no idea whether they had evidence, or this was just a bogus assertion the judge bought, placed on his plate by a million dollar team of lawyers. I didn't follow the case that closely.

Infallible and unblemished, perfect, sublime...
Thank you for your (qualified) endorsement of my inerrancy.

Although
I always remain hopeful that you will exhibit rational thinking once in a while, that the hundreds of disquistions provided to you free of charge by numerous writers will finally bear fruit, your opening salvo about Crichton leads me to believe that this post is mere verisimilitude, akin to a stopped clock being correct twice daily.

I don't give endorsements easily, and unless you are seeking a nomination for intractability, none will be forthcoming your way without obtaining an extended exhibition of better analytical skills from you.

Back to basics...indeed!
First poor ol' Percy claimed that the RR seed fell off a truck, then he claimed that the wind blew the pollen in and contaminated his crop. The courts didn't buy either explanation because they're both total BS. The truck explanation is laughable. Wind probably did blow some transgenic pollen onto his crop. However, the VAST majority of the resulting seed from that crop would have been pollinated with his own pollen. From my understanding the percentage of transgenics in his field the next year was upwards of 80-90%. That doesn't happen unless you select for it!! And that is unlawful in any country that has patent protection. What EVIDENCE do you have that Monsanto "planted" RR canola in his field?

BTW, who released a fish gene??

Arguments!!
"there's a reason that the U.S. continues to lead the world in developing pioneering treatments and cures for the most devastating diseases. Actually, there are several reasons, but our patent system is one of them."

I took notice of this staement as well. The author says Crichton does not make an argument and then this without any aguments at all!!

Yeah...no kidding about that endorsement thing...
Super,

You are truly tough with this allowing anyone to have a genuine position that you don't agree with business. Without attacking that person as a fraud or worse.

Roy is rational and he works hard. He's thoughtful and his mistakes do not flow from any lack of logic. Only from his flawed assumptions.

Of course, you and I have no such prejudices, do we?

Owning commercialized genetics is going to be tricky...
If I own a high end bull then I make my money selling straws of his semen. What do I own and what do I market? His genes.

This bull's genetics were engineered the old fashioned way but not without a great deal of human intervention. Such genetics were not naturally occurring but I do not need a patent to buy or sell a bull and his goods (or services).

If someone should steal my bull or break into my barn and harvest stem cells to propagate a clone then this would be grand larceny. However, if someone could screen diploid cells out of my bull's semen in the straw I sold then that party might well duplicate my animal via a cloning technique. I do not think that I can patent a bull.

When gene therapy is perfected the corporate (biotech) entity will physically possess the living culture and the genetic material. One might come into possession of the actual genes by being treated for a genetic disease. But the cell line culture itself or the micro-organisms (the bull) would be locked away on a corporate campus. Getting to those materials would require industrial espionage. No patent should be required for criminal prosecution or to constitute a civil cause of action.

A competitor who was attacking that same genetic disease might come up with a similar engineered mechanism (his own bull) if the genetic disease is commonly understood. But the actual engineered cure would not be identical unless (again) some material was physically stolen.

Ultimately these patent issues will be resolved in court cases. Jurisdictions that get this business wrong will find biotech companies moving away.

Roy is Rational?
Among the positions he's taken and vigorously argued, which can't be ascribed to mere politics and defended as personal political taste-is that depreciation (yes a convention of financial accounting) is errant and a foolish conspiracy.

So must ask how Roy, a guy whose asserted professional training is in the mechanical trades, specifically boiler maintenance is in a position to be ranting about accounting. Perhaps you as a superior Wharton graduate can explain to Roy how it makes absolute sense to recognize the economic usage of fixed assets over time, even though payment was made at acquisition. I failed miserably in this regard.

Therefore we must ask, is it rational to argue against the conventions of a profession in which you have NO training or exhibit no discernible innate acumen? I think not.

But then again, Roy exposes his ignorance without claiming to posess credentials which Mr. Jackson so easily proved were lies, so perhaps he's more honest than you, guilty of overreach, rather than misrepresentation.

By the way "Without attacking that person as a fraud or worse." isn't a complete sentence-did they teach freshman comp at your school? Surely somebody with your haughty airs and pedantic tone can master basic rhetoric.

You don't like my verbal gymnastics? Tough.

I like everything about you...especially the part that someone else has to sleep with you...
Roy,

Our mutual best friend wants me to go over this with you.

Depreciation, as you know is a construct. Like many elements of cost accounting amortization, accelerated schedules, projected useful life of the equipment, etc are continually managed to suit our purposes as we create financial reports. The truth is that we buy something we need to perform tasks and this expense becomes part of our Cost of Goods Sold. The question is not that we need to recognize this expense. Of course, must deduct such a cost (along with material cost, labor cost and other overhead expenses) from our revenue (net sales) number in order to arrive at how much money we earned (taxable income). The question is when do we expense that cost? Which periods of revenue take the hit? When we bought the machine or when we used the machine? Do we charge off at standard or at an actual rate per hour? Do we agree with the government's guidelines or do we argue that our situation is special?

When we work on a cash basis and the capital expenditure has been taken out of cash flow (working capital) we might like to expense it all in the current period against revenues (to reduce our tax burden this year). If, on the other hand, it is a larger capital asset (and we borrowed relatively lots of money to buy it) then its cost should be (captitalized and) carried forward (amortized) into future periods to offset future taxable earnings. Of course, we are probably on an accrual basis and then lots of our current activities carry over anyway. We can better manage next year's financials with lots of accrual line items on both sides of the Balance Sheet. As long as this year's numbers did what we wanted. The IRS also has its own opinions.

This is mostly about income taxes. However, property taxes on business assets and improvements (buildings) are also subject to scheduled depreciation.

Nevertheless, this process is far from precise. Many of our fixed assets continue to produce income just fine long after they are fully depreciated. Really depends on the industry. A depreciation schedule is only an attempt to fairly represent the process of actually "using up" a productive resource or to reflect the reduced value of a tangible asset over time whether it actually "wears out" or not.

Lots of expensive machines have very little salvage value (if no one else makes what you make) and the aftermarket in older generation, commonplace, hardware might approach scrap value. The actual market value might drop away far more quickly than the government will let you depreciate such line items. Lots of machines on a 7-year straight line schedule are replaced by the next generation models in 3-4 years and the residual is simply written off against the price paid by the second-hand equipment broker.

I am going to guess that Roy's problem is that depreciation expenses reduce a company's tax burden. However, his real problem might be with income taxes themselves (although he might not know why). Income taxes are funny. They are easy for private companies to avoid but public companies must have (taxable) incomes to pay Dividends and to retain earnings as Shareholders Equity.

Property taxes are not avoidable just as Social Security contributions are hard-wired into the payroll line. For consumers the State Sales Tax is a hard number and all those hidden taxes on alcohol, tobacco and gasoline are impossible to get around legally. Only Income Taxes seem too easy for corporate entities (the dreaded Capitalists) to avoid at the expense of the innocent workers (the put upon Proletariat).

In the Philippines (where I have my manufacturing entity) there are Income Tax laws but almost everyone keeps two sets of books (the government cannot look at your bank records and almost everything is done in cash because almost no one has credit cards and absolutely no one will take a personal check) so the Philippine government has little hope of actually collecting much income tax. Instead, we have the Value Added Tax (VAT) that attaches to commercial transactions whereby the reasonable expectation is that such materials will be converted and sold at a profit. Therefore, the government is able to capture its share of the GDP and our VAT may be used to offset our income tax obligations. Recovering any resulting overpayment of VAT, however, is entirely more complex.

The point is that a VAT may be more manageable than an income tax. When combined with property taxes, Social Security taxes and various sales taxes, duties and fees the government should be able to fund itself and do away with much of the predatory behavior of the IRS.

Would this make Roy happier? One way or the other the government is going to fund itself through taxation. At the moment the various governmental bodies in the United States collect 30% of our GDP. While the GDP itself generates only a 10% profit. How can the government harvest three times the earnings of the entire economy? And how can this be sustainable? And Roy might argue that the government should take more. It is advanced financial capitalism magic (another long post) and the government is, indeed, taking about all of our working capital that we can tolerate.

In 1990, just before the Soviet Union collapsed, the US government's total tax revenues exceeded the entire GDP of the Soviet Union. The Russians could not keep up because their economy was genuinely inferior. Alternatively, if Communism worked better than free Capitalism then Washington would have opened its own gulag system long ago. That's why it was called the Communist Experiment. Who knew?

By the way, Super, if our personal negative tension has now been reduced to the point that you are pimping me about my loose (conversational) sentence structures, then I feel much better about us. Merry Christmas Mr. Heater!

Money -> Invention -> Money ... repeat
Yes, the richest nation always leads the world in invention. So, why should we mess with that? We're the richest nation, and the most inventinve. If we allow that cycle to continue, we'll all be better off. No sense in screwing that up now.

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