Patenting Life: How Treating DNA as Intellectual Property is Killing People

Tags: Patents, DNA, Influenza, World Health Organization, Myriad Genetics, Brookhaven National Laboratory, W Ned Livingston

W Ned Livingston by W Ned Livingston

If an engineer finds a software CD on the sidewalk, takes it home, and uses a process he developed to pull the program on that CD apart and examine it, should he then be able to patent portions of that program as his own?

The legal truth of the matter is yes, unless there is documented proof of legal protection against such use, the entire contents of the "found software" are fair game for anyone who finds it and claims it as his/her own. The software was clearly created by humans for humans, so a human may claim ownership. And whoever claims it first owns the intellectual property (IP) rights to that work, and all "derivative works", meaning anything based on the original.

Deoxyribonucleic acid (DNA), is at the heart of all biological processes on Earth. The various DNA molecules are the bits of "code" that, when strung together, tell cells how to grow, and what to become.

According to a press release, from the Brookhaven National Laboratory, a study by Computational biologist Sergei Maslov, and graduate student Tin Yau Pang, genetic code is remarkably like computer code. The results of the study, released March 28, 2013, draw a direct parallel between how portions of computer code and various genetic strands within single-cell bacteria operate. The study would seem to support many biotechnology companies, such as Myriad Genetics, who see DNA as "found code" that no one else is claiming rights to.

There is, however, a legal principle, in patent law, that prohibits the patenting of things found in nature. Iron, for example, occurs in nature, so a steel manufacturer may not patent the element, Fe (iron). That company may, however, patent a proprietary process it invented to purify iron, or to produce steel from iron, because those things do not happen naturally.

Surprisingly, according to an article by Lawrence Hurley, of Reuters, over 4000 patents have already been issued, for "found" genetic coding.

On April 15, 2013, however, the validity of many of those patents came into question. On that date, the U.S. Supreme Court took up the case of, Association for Molecular Pathology v. Myriad Genetics. The case will decide, for the United States, whether or not Myriad Genetics, Inc. should be allowed to hold patents on certain sequences of human DNA, called BRCA genes, which the company uses to detect what are known as the BRCA1, and BRCA2 mutations. The company has developed tests to detect those mutations, as early warning indicators for the likelihood of breast or ovarian cancer in women who carry them. Because of their patents, anyone wishing to develop any medication or test procedure that is based on the BRCA1 and BRCA2 mutations must negotiate royalty payments with Myriad Genetics.

Many companies who hold IP rights keep their royalty fees prohibitively high, in order to suppress competition. The practice is notorious within the pharmaceutical industry. So notorious that, when the H5N1 (bird flu) virus was found in Indonesia, in 2007, then-minister of health, Siti Supari, refused to send samples of the viruses abroad for analysis, claiming "viral sovereignty" - effectively claiming intellectual property rights for Indonesia. According to an article by Laurie Garrett, on the Council on Foreign Relations web site, Ms. Supari's argument against sending the viruses abroad was, "on the grounds that they would be used to manufacture patented products that would benefit foreign companies, and that the products they produced would be unaffordable to Indonesians." The struggle over H5N1 resulted in the 2011 Pandemic Influenza Preparedness (PIP) Framework, which was hammered out by members of the World Health Organization, as well as various members of the biotech and pharmaceutical industries.

And yet, the world must still endure squabbles over the ownership of deadly viruses, as witnessed currently in Saudi Arabia.

"My greatest concern right now is the novel coronavirus," said Dr. Margaret Chan, director-general of the World Health Organization, as she closed the annual World Health Assembly. The Middle East Respiratory Syndrome coronavirus (MERS-CoV) is another SARS-like virus that attacks the victim's lungs, and has already killed over 20 people in Saudi Arabia. The great concern is over the handling of research samples of the virus. When it became obvious the new disease posed a serious threat, virologist Ali Zaki mailed samples of the virus to Dutch virologist Ron Fouchier, of Erasmus Medical Center in Rotterdam. As an unintended consequence, the Medical Center immediately claimed the new virus as "found code", and is requiring all research entities who wish to use samples of the virus to sign a materials transfer agreement (MTA) with them. While not quite a patent, the MTA requires sample recipients to contractually agree not to develop products or share the sample without the permission of the Medical Center and the Fouchier laboratory. The Dutch team claims their process has not hindered research into the virus, and that every lab requesting samples has received them. But they don't have to.

Should the safety of the entire world, or the life or death of one individual, be held hostage to the whims of free-range capitalism? By the end of June, the U.S. will have its answer.

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