By Kevin Noonan --
The New York Times continued its recent campaign against patents this week, running an Op-Ed piece by Denise Caruso on gene patenting. Perhaps this attack is rooted in the Times loss before the Supreme Court a few years ago when it tried to usurp copyright from authors for online versions of articles. New York Times Co. v. Tasini, 533 U.S. 483 (2001). Or perhaps the Times takes the European view that patents are just the way "big business" frustrates entrepreneurship (despite plenteous evidence to the contrary). Whatever its motivation, the latest Times jeremiad is full of the usual falsehoods and half-truths.
This begins with the title of the piece, "Re: Framing: Someone (Other Than You) May Own Your Genes." Readers of this space will recognize the falsity of this statement: no one (other than you) owns your genes. Patent offices around the world, including in the U.S., require that a gene be "isolated and purified" by a scientist before patent rights will attach. Moreover, this is but the threshold for patenting in the U.S.; in addition, the nucleic acid sequence of the gene must be new (meaning that it wasn't disclosed previously by anyone), and the function of the gene product must be known (or the gene lacks utility). No one would probably wish to own "your" genes, since it is highly likely that at least one of the copies of any particular one of "your" genes is a variant, or even a mutant, that would not perform as does the genetically "wildtype" version of the gene. Finally, the title implies that someday a patent holder will knock on your door and ask for royalties because they "own" the gene for alcohol dehydrogenase, and since there is a bottle of wine in your garbage, the patent holder knows your liver must be busy using this gene to make the enzyme that detoxifies the alcohol in the wine. Hogwash, to quote our current Vice-President.
The subtitle is in some ways worse: "Is it time to consider an alternative to patenting life forms." This is part of a new "vitalism" expressed by some writers (such as Lori Andrews (at right) of Chicago-Kent College of Law) when it comes to DNA patenting. DNA "is a chemical, albeit a complex one" according to the Federal Circuit, and as such is no different than other biological substances such as vitamins and proteins that are non-controversial subjects of patent protection. But there is something about DNA, perhaps because its status as the "genetic material" that is so compelling, that renders irrational otherwise sober discussion. Western science rejected the concept of vitalism -- that biological molecules or processes are not subject to the chemical and physical laws that govern other matter -- late in the 19th century when Pasteur and Wohler and others showed that there was no scientific basis for the concept. Rapid progress in biology and biochemistry followed. Yet the framing of the issues in the new vitalism seems to revive these simply incorrect views for political rather than scientific reasons (since there are no scientific reasons to support them).
The body of the piece discusses the ideas of an academic (notably, not one with any scientific or legal background) who believes that there is an "acceptable" level of intellectual property, by analogy to an "acceptable" level of risk. The semantic implications are clear, since most readers will not think of risk as a good thing; of course, there would be little money made in a reader's 401(k) account without it. Professor Stephen Hilgartner (at left), according to the author, suggests somehow that intellectual property rights need to be restricted much like real property rights are restricted, for example, by zoning ordinances. A review of his paper reveals much talk about the crisis in patenting "life" but little critical thinking about whether there is, in fact, a crisis that needs correcting.
Conflated throughout the Times article are issues surrounding genetically modified foods; rights of indigenous societies when traditional flora, fauna, or methods are expropriated; and how corporations own 20% of the human genome. A prominent example cited in the piece is Canavan disease, where a group of parents of children carrying a mutation that caused the disease challenged the researchers who patented their identification of the mutation (for use in a diagnostic test). What the piece downplays is that the parents were able to get the patent holder to settle, in view of their unique financial and biological contributions to the discovery. All of which could have been avoided by having a good patent attorney involved on the parents' behalf in the first place.
And nowhere in any of this discussion is there a mention of the fundamental qualities of patents: limited rights for limited times. Limitations in scope arise from the duality of DNA as both chemical and information. As a chemical, DNA can be protected by patent rights. However, as part of the quid pro quo of the patent system, the nucleotide sequence of a patented gene must be disclosed, and that information is not patentable. So even while a patent is in force, every researcher in the world can work to "design around" the gene sequence to avoid infringement. Limitations in time result from the Constitutional mandate that the "exclusive rights" granted to inventors for their discoveries not be perpetual: currently the patent term is 20 years from filing, and for many patents the effective term is much less. Thereafter, of course, the patent "monopoly" is done, and the researcher's work is freely available to all.
There is a great deal to be discussed about patents and their application to the life sciences, but most of what is current is political not rational. An article (usually from the popular press) about this "crisis" is used as a reference to support another article about that "crisis," and soon everyone is shouting fire in a crowded theatre without knowing what caused the "crisis" in the first place. Biotech patenting has allowed a generation of (predominantly) U.S. companies to bring diagnostic tests and therapeutic agents to market and to attack diseases that were death sentences just a few short years ago. As Professor Hal Wegner (at right) notes in his recent Patently-O piece, it is just those parties that have provided these benefits (universities, small start-up biotech companies, and pharma) that have the most need for the limited exclusivity provided by patents. Political Cassandras do us no service with their misinformed cries that the sky is falling; we listen to them at our peril.
For additional information on this topic, please see:
• "In Support of Gene Patents," December 7, 2006