If your intuitive answer is, “Of course, they are mine”! Think again.

Did you know, for instance, that the breast cancer-causing mutations of BRCA are patented and are a private property? This means that the company that received the patent can charge whatever they please for a test to determine if a woman carries this gene.

Michael Crichton, the famous physician author, in a recent New York Times editorial (Feb.13, 2007), points out that a test that could be done for $1,000, with a handsome profit to the company, has gone up to $3,000. So, as a firm believer in the free market, you would guess that competition would see the enormous profit and move right in. Wrong! The company holding the patent is under no obligation to license it to competitors. They essentially hold a monopoly over your gene.

And I do mean a monopoly; if you thought you could simply give your gene to a competitor so that she can develop a gene assay and charge less exorbitant fees, you are wrong again. Your BRCA gene belongs to the patent holder, not to you.


The Canavan case

And if you think that this scenario is outlandish, or maybe just theoretical, here is an eye-opener. Pediatricians and some affected families know about Canavan disease. It is a devastating, genetically-based, neurological disorder that affects children starting at age 3 months, eventually ending up in paralysis and death by adolescence.

As in many other disorders, families of affected individuals have banded together, via non-profit organizations such as the Canavan Foundation, to promote research into causes and therapy of this disease. As a group, these families have engaged and provided funding for researchers, such as Dr. Reuben Matalon at Miami Children’s Hospital Research Hospital, who identified the Canavan gene in the late 1990s.

Compared to how hard it is to identify and characterize a gene that causes a disease, the path from identification to developing a genetic test to screen for the disease is almost trivial. Thanks to dedicated Canavan disease researchers, we have made one giant step forward for mankind, particularly for families affected by this disorder. But here’s the rub. The researcher and his hospital secretly patented the gene and then demanded a royalty from anybody offering the test.

At first blush, you may think, “seems fair”, a payback for the investment in research. But it is not that simple. The researchers would not have been able to do the research if it wasn’t for patients’ and their families who donated the genes, and in many cases, raised the money to pay for the research.

These dedicated folks just wanted to work for a cure. They believed genes should not be patented so they did not put their names on the patent. Naíve, you say. Maybe. But passionate, dedicated families are well passionate and dedicated!

In the case of Canavan disease, the patient groups filed suit in 2000. A confidential settlement was reached in 2003 that allowed physicians and scientists to use the patented gene sequence, whereas other laboratories would still have to pay a royalty fee.


Should we stay with the present system?

The thought that somebody can own your own genes elicits something akin to cognitive dissonance. It also flies in the face of Western liberal ideas, starting from ancient Greece through the Renaissance, the Enlightenment, and modern times, namely, the autonomy and centrality of the individual in democratic societies.

What are the arguments for maintaining the present system?

  • One argument is that isolating and sequencing the gene is key to its patentability. But gene isolation and sequencing are actually quite mechanical operations, carried out almost entirely by robotic machines, which are indeed protected by patents. Any patent attorney will tell you that quite a few “innovations” in gene patents are put in purely for the sake of “patentability”.
  • Lawyers cite Judge Learned Hand’s 1911 opinion that patents could be issued on the isolated and purified versions of substances occurring naturally in the body. Yes, but this was over 100 years ago, and since then, much has changed in science and the world. Isolation and identification of simple molecules was then a feat of ingenuity and inventiveness. Furthermore, these simple molecules did not control the essence of who we are. Neither Judge Learned Hand, nor anybody else, knew in 1911 what genes are and what their function is. In fact, in 1911, there was still a raging argument between two competing theories about Life: the mechanistic theory and the vitalistic theory, the latter positing that life was something ethereal, some “life force”, inhabiting the physical body, yet free from the laws of physics and biology.
  • Another argument is that our biotechnology industry’s success rests on the patentability of genes. This is a false argument. Nobody is contesting the patentability of modified or otherwise manipulated genes. To cite an example, Genentech isolated and sequenced the VEGF gene, but went on and developed Avastin and Lucentis based on their genetic work. Nobody is contesting their right to own the patent to the monoclonal antibodies they developed. It is the claim of ownership of natural genes or gene sequences, where no truly inventive input exists, that is objectionable.
  • And here is a truly surprising development: Novartis, which identified and patented the genes that are likely to be associated with diabetes, decided to release the gene sequences to the World Wide Web. Why would they do a thing like that? Mark Fishman, head of Novartis research, was amazingly candid: “It will take the entire world to interpret these data. We figure we will benefit more by having a lot of companies look at these data than by holding it secret.”

Although Novartis’ actions are not exactly altruistic, it is nonetheless admirable. It raises the question of how many more genes are kept secret in the vaults of drug companies, waiting to be monetized instead of being deployed for the good of society.

I think there is a more basic problem with all the arguments that I just presented. They are all based on thinking “inside the box”. The legal and commercial arguments may be compelling within the framework of our current thinking.

Patenting our genes is simply an extension of an old law that was devised in a different era during times when the distinction still existed between the discovery of natural phenomena and substances, and invention, which connoted creation of new substances, machinery, or processes.


The bottom line

Like many other social ideas and theories, our concept of patents has undergone constant extension and expansion, continuous blurring of the line separating discovery from invention, which finally put it on a collision course with social reality. This process of testing the validity of an idea by pushing it to its limits is known in philosophy as reductio ad absurdum. Indeed, a perfect description of the current state of affairs in gene patenting.

On February 9, 2 congressmen, Representative Xavier Becerra of California and Representative Dave Weldon of Florida, introduced the Genomic Research and Accessibility Act, which would ban the practice of patenting genes found in nature. This is a long overdue step in the right direction.

I urge you to express your support for this legislation by writing to your representative and senator. People with genetic diseases or conditions, their friends and families as well as health professionals and health professional societies should align themselves with the interests of individuals and families at risk for genetic disorders. As a physician (and researcher), I feel strongly that doctors and physician researchers need to add their voice in support. It is not only our moral, but also our professional duty, to protect our patients’ rights.

Dov Michaeli, MD, PhD
Dov Michaeli, MD, PhD loves to write about the brain and human behavior as well as translate complicated basic science concepts into entertainment for the rest of us. He was a professor at the University of California San Francisco before leaving to enter the world of biotech. He served as the Chief Medical Officer of biotech companies, including Aphton Corporation. He also founded and served as the CEO of Madah Medica, an early stage biotech company developing products to improve post-surgical pain control. He is now retired and enjoys working out, following the stock market, travelling the world, and, of course, writing for TDWI.