Genes are patented. Not Lee's or Levi's — not those jeans. Sequences composed of adenine, thymine, guanine, and cytosine — those genes. How absurd. How cunningly reductionistic. How indirectly nihilistic. Camus, Beckett, Ionesco, and Vonnegut are laughing up their ghostly sleeves.
Only in America. Well not quite only here. But close. The sad part is that patenting gene sequences is not the worst demonstration of capitalism behaving badly. But it is still very bad behavior indeed.
An ACLU lawsuit is challenging the legality of such gene patents.1 On March 29, 2010 a New York federal court ruled that the patents on two specific genes, BRCA1 and BRCA2, are invalid. Myriad Genetics, the company that "owns" BRCA1 and BRCA2 and holds patents for breast cancer gene analysis, appealed the ruling. The U.S. Court of Appeals for the Federal Circuit heard Myriad's appeal in April 2011.
The ACLU has it right. Any patenting of organisms or an organism's parts restricts the advancement of science. In the case of medical science the unfortunate consequences can be deadly. One of the key workers on The Human Genome Project makes the ridiculous statement that "The goal of patenting a gene is not to make anyone rich, but to force disclosure of secret information." I don't think so. The goal of patenting is exclusively relates to the hope of becoming rich.
This is an ethical issue. Patenting pieces of a human being directly violates the bioethical principle of respect for persons. Patenting part of the human organism directly treats humans as means to an end — that end being the ever-increasing bank account of biotechnology (there's a misnomer!) venture capitalists and executives.
It has been naively suggested that the provisions of the Bayh-Dole Act could intervene when biomedical research is impeded. It is the Bayh-Dole Act itself that spurred the explosion of patent-seeking activity on the part of universities. Bayh-Dole led directly to the notorious epidemic of conflicts-of-interest between universities and the corporations they were so happy to jump in bed with.
A professor of law at Columbia University has stated "When you isolate something as it appears in its natural state you change it, even if the only change is the isolation." This statement is disingenuous, as gene patents apply directly to the in situ DNA sequences themselves.
Companies such as Myriad Genetics hold the entire world hostage. Responsibility for the consequences must be shared by the U.S. Patent and Trademark Office. The USPTO played with fire and patients are left scrambling for their literal lives while their metaphorical houses burn to the ground.
A company receives a patent for a gene sequence. Fees are now due that company, paid by all other companies that wish to design a diagnostic test related to that sequence, manufacture proteins coded by that sequence, or generate proteins produced by another gene which is regulated by the patented gene. From my perspective, such patents violate the common law doctrine of restraint of trade. They impede the freedom of others to conduct business.
This is the root of the problem, of course. Medicine is no longer a profession. Medicine is a business. That transformation is the source of all the trouble relating to patents concerning medical practice.
The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.