In this age of supercharged scientific discovery, as researchers around the world rush to unlock the secrets of our very being, the debate about patenting human genes and other aspects of our biology has been passionate. Over time, the nature of that debate has shifted from one about whether such patenting should be allowed at all to whether specific kinds of patents will help or hinder the advance of medical science.
Some critics, of course, still cling to the idea that patenting any aspect of human biology is abhorrent. Social activist Jeremy Rifkin has even likened it to slavery. But most knowledgeable observers today are more perplexed than threatened by such extreme views. They either shake their heads at the naiveté of those who imagine that today’s revolution in molecular biology could have occurred without patenting, or try to explain that a patent doesn’t give anyone the right to make another human do anything; a patent simply confers a 20-year right to keep others from commercially exploiting a product.
But medical science is an arena ripe with symbolism, so it is unlikely that even calls to completely ban gene patenting will disappear any time soon. After all, these are disconcerting times for many people: The technological forces that have hitherto so reshaped the world around us are swinging their focus back upon our own selves, and promising — some would say threatening — eventually to transform us.
That we are deciphering the blueprint of life and beginning to manipulate it will no doubt bring enormous benefit, but it will also extend our reach into the most intimate aspects of human life. The very existence of a debate about patenting “life” confirms that the lines between technology, biology and humanity are blurring as we ourselves become objects of conscious manipulation. Blocking gene patenting would have broad impacts, but it would hardly change the reality that we are beginning to redesign life, that we are modifying nature, that we are playing God. Gene patents have become just one more symbol in the struggle between those who embrace such change and those who resist it.
The most critical present debate about gene patents focuses on the nitty-gritty: which specific patents and claims to allow. Patent law is meant to provide a pragmatic framework that, in the words of the Constitution, will “promote the progress of the useful arts and sciences.” To reach this goal is no easy task. Fostering the development and dissemination of new technologies through the patent system is necessarily a balancing act. Too little protection stifles progress by removing the incentives needed to attract capital and human energy; too much stifles it by allowing the erection of patent barriers that discourage innovation by others.
The tension between these two can never be resolved and, in as dynamic an environment as today’s, the right balance can only be approximated. The key question about patenting genes should be what criteria for allowing claims will most encourage the exploration for new drugs and medical treatments.
The most threatening consequences of inopportune policies in this arena are not visible problems like the denial of a patented genetic test to someone who can’t afford it. Of far greater import are the invisible might-have-beens that are not; the medical breakthroughs delayed because no one could profit from their development; the advances held back because broad patent rights have discouraged competitors.
These tensions are evident today in the debate about expressed sequence tags (ESTs) — short sequences coding a segment of a gene. Provisional patent applications covering more than a million ESTs have been submitted and they typically try to reach through to the gene that contains them. Many scientists have loudly attacked such patents. James Watson, co-discoverer of the structure of DNA, put it bluntly when he asserted that such discovery could be “done by robotics and monkeys.”
The concern here is that EST patents would give a disproportionate reward for a rather minor step on the long road toward developing a useful product, but how much they could really stifle research remains to be seen. EST patent holders have a strong incentive to encourage, rather than discourage, further development. The big money is not in gene patents, which are basically narrow tools to help in the search for therapeutically useful pharmaceuticals and other products — it is in the patents that cover these products directly.
It would cost billions for companies to follow through on a million EST patents. So they will pick and choose, which will require further research to do intelligently. A year ago, the patent office suggested it might allow rather general EST patent protection, but now the indication is that these patents will be narrow if they are allowed at all. As important as whether something can be patented is how broad the allowed claims will be. With ESTs, for example, if the patent office uses a narrow interpretation that requires an exact sequence, such patents would be nearly worthless.
The bottom line is that patent law is working reasonably well, and it would almost certainly be a mistake to try to tinker with it much out of fear about some imagined future danger. The patent office cannot determine in advance which patents will be important, so it doesn’t squander its resources trying to do the best job on each patent, just an adequate one. This makes perfect sense. Most patents never make a penny and are unimportant to anyone but the inventor. Moreover, the few that really matter will eventually be extensively litigated to fully air the issues involved.
With a pragmatic goal like promoting progress, the best way to proceed is our current one that adheres to broad principles and moves forward with sufficient flexibility to allow us to grope for practical solutions that, though far from perfect, are at least sound, adequate and consistent. Only when administrative solutions are fully exhausted does it make sense to risk legislative remedies.
