Privately-Held Patents on the Human Genetic Code
What percentage of the human genome has now been patented by private corporations, and is this continuing to grow?
One in five, 20 percent, of the genes in the human genome are documented to have been patented, but they are not all held by corporations. The U.S. government holds a great many of these patents. It is very difficult to ascertain what percentage is held by corporations, in part because there can be multiple patents related to one gene or sequence. There might, for example, be a patent on the gene itself but also on the process for discovering it. There are examples of a corporation such as Chiron holding about 100 patents, all on one virus. Also, it’s hard to ascertain because sometimes this is proprietary information that corporations can’t be forced to reveal.
When a corporation patents a gene, what does that legally allow them to control? And does this stimulate or stifle innovation?
The second part of the question is the easiest; it stifles innovation. In broad strokes, this is very easy to see. If you ask the average person how many medications are developed and put on the market each year, the average person thinks it’s about 200-500 a year. Ten years ago, that was close to the truth. Ten years ago, we had several hundred drugs enter the market every year. The last few years, we’re talking about double digits, low double digits. Now it may be 15 or 26 in a particular year. Innovation has ground to a near-halt.
Are patents responsible for that?
Yes, patents are responsible for that. I spoke with Stephen Schondelmeyer [Pharm.D, PhD, Professor of Pharmaceutical Care & Health Systems at the University of Minnesota], a prominent expert in this field. He pointed out to me that one of the reasons that we have so few new drugs being developed, and so few drugs in development to replace drugs currently on the market, is that our system allows for 20 years of exclusivity. So when one obtains a patent, whether held by a corporation or someone else, you have 20 years during which you have exclusive use of this. Only you can license it, only you can sell it. More importantly, you can control what others do with it; you can control access to it.
So when Myriad Corporation, for example, holds patents on the BrCA1 and BrCA2 genes [BrCA is the abbreviation for breast cancer], it can contact researchers working on those genes and have its lawyers threaten them prepare a cease and desist order forcing them to stop. If you want to work on this gene for your breast cancer research, you need Myriad’s permission, which it may deny and which it certainly is going to charge you a pretty penny for. That’s what it means to hold a patent on a medically important entity. You not only control what’s done with it, you control what medications researchers can devise and you determine what price you’re going to pay for them. Significantly, you also block other people who are trying to devise treatments, based on the gene or virus that you now control. And as Professor Schondelmeyer pointed out, one of the reasons why innovation has dropped off and we have so few new drugs is that the 20-year patent period actually discourages innovation. Corporations have lacked incentives to devise these drugs, because it’s much more efficient, profitable and convenient to simply jealously guard the patents they do have and devise methods of extending the 20 years.