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Why Michael Crichton Is Wrong About Patenting Genes Font Size: 
By Michael Rosen : BIO| 20 Dec 2020
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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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