15th October 2005

Prior Art

A study out in Science this week* reveals that about 1/5 of the human genome (4382 of 23,688 genes) has patents on it. Is this a good thing? Is this driving innovation or stifling it?

From the perspective of a university researcher, where information is freely shared as a rule and the greater the dissemination of knowledge the more research it stimulates, patents can only inhibit. There’s no monetary incentive involved, since research is all (or, mostly) publicly supported.

However, private-sector innovation might depend on patents for survival. This is the argument advanced by, for example, Incyte Genomics, which itself holds over 2000 patents on human genes. They point to the temporary loss of $5 billion in market cap for the biotech industry in 2000 when Clinton gave the mistaken impression that he opposed patents on human genes; patents on genes attract investment, investment spurs innovation. Therefore, stopping patents will result in less innovation. Q.E.D.

Of course, this is a fallacy. We could as well make the opposite argument: patents impede research, research provides the basis for innovations. Therefore, stopping patents will result in less innovation. Both of these situations can be true, acting in opposition.

In 1998 Rebecca Eisenberg and Michael Heller outlined in Science the possibility of patent regimes resulting in a sort of “anticommons”, stifling innovation, through several mechanisms. As an academic (and a communist) this sort of argument is obviously appealing to me, but there’s a dearth of empirical evidence on the subject. Time will tell.

Weighing in on the negative column, however, is the startling breadth of patents on genes. Until very recently patents on genes required very little demonstration of usage; you only had to describe the sequence and show how to isolate it (or its product). And as John Doll points out in a review on the subject:

A patent might be granted for compound X, which is disclosed to have a specific use (such as a headache remedy). If other investigators find that X has a new and unexpected use, perhaps in combination with compound Y, for treatment of heart arrhythmias, they may have to obtain a license from the individual who first patented compound X in order to sell XY.

In summary, once a product is patented, that patent extends to any use, even those that have not been disclosed in the patent. A future nonobvious method of using that product may be patentable, but the first patent would have been dominant.

Broad patents on genes implies more potential for infringement, which suggests less innovation. This is very different from patents designed to protect an innovator’s right to profit from a product; it suppresses more than it produces.

Patent litigation is expensive for both sides. On the one hand this might mean that both sides are more likely to reach an agreement rather than go to court. But on the other, it means agreements are more likely to fail and promising research avenues more likely to be abandoned, especially with increasingly layered license agreements involving multiple parties as patents insinuate themselves further into the research process.

At any rate we can be sure that we’re going to need a whole lot more patent lawyers. Wee.

Incidentally, I should give a nod to the implication of the subject line of this article itself, namely that the concept of patenting the gene sequences of living things is a questionable enterprise by its nature. Incyte, for example, claims that there is a substantial amount of effort involved in discovery and characterization of new genes that constitutes “invention”. I say balls, especially these days. If they’re really spending hundreds of millions of dollars as they claim, they’re morons. And even so, the breadth of the patents granted is far more in line with “privatization of the genome” than with protection of innovators’ rights. Genes are informational; patents should be applied to, if anything, techniques that employ genes (e.g. using single nucleotide polymorphisms to identify disease susceptibility) rather than the genes themselves. This, however, seems not to be the dominant paradigm for reasons that escape my understanding. I quote a RAND study on the subject:

Because pharmaceuticals require such intensive research and testing before they enter the market, it is broadly accepted that they require (and receive) stringent patent protection to allow that investment to be recouped… Firms that make truly gene-based drugs – drugs that consist of the “natural” protein prepared through use of an isolated gene [ed - e.g. human insulin] – do require patent protection like any other pharmaceutical firm to protect their products and methods of production… What is not clear, however, is whether this requires protection of the entire gene or whether a more narrowly drawn protection – on the optimized, commercialized protein drug itself and its production method – would suffice from society’s point of view… The argument for gene IP protection based on the high investments required for pharmaceutical development is also undermined by the many other products that could be derived from genome information that require less investment for commercialization.

* Jensen and Murray, “Intellectual Property Landscape of the Human Genome”, Science, 310(5746):239-240

Putting them in the lead for number of patents along with Celera, whose public announcement of their intention to patent large portions of the genome after sequencing it alarmed many researchers and spurred the drive to complete the public mapping project in time with Celera’s sequencing.

This raises the interesting question of how multiple patents on the same gene are going to clash with each other. The new Jensen and Murray study in Science finds that some genes have as many as 20 different patents on them.

posted by saurabh in Uncategorized | 1 Comment

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