Andrews — U.S. Supreme Court Liberates Breast Cancer Gene

By Lori Andrews [via ISLAT blog]

On Thursday the U.S. Supreme Court held in Association for Molecular Pathology v. Myriad Genetics, Inc., that human genes were not patentable since they are products of nature and not inventions. This decision is great news for patients, doctors, and scientific researchers. Some biotechnology companies might grumble about the decision, but the decision will actually stimulate innovation by pharmaceutical companies and the new generation of biotech companies.

The case involved Myriad’s patents on the human breast cancer genes known as BRCA1 and BRCA2. Those patents made your genes Myriad’s property once they were removed from your body. Consequently, the company could control all uses of the genes, including any diagnostic testing or research. The U.S. Supreme Court saw the absurdity of letting a company own your breast cancer genes.

The decision is well-founded in law. For the past 150 years, the U.S. Supreme Court has held that one cannot patent products of nature, or materials isolated from products of nature. In a 1980 biotech case, Diamond v. Chakrabarty, the Supreme Court said,

The laws of nature, physical phenomena, and abstract ideas have been held not patentable. Thus, a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E=mc²; nor could Newton have patented the law of gravity. Such discoveries are “manifestations of . . . nature, free to all men and reserved exclusively to none.”

The Supreme Court today said, “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” This decision is a good one across the board.

Good for patients.

Because of its patents on the breast cancer genes, Myriad was able to require that every person who wanted genetic testing had to get the test from Myriad. The company could charge whatever it wanted for the test—and it charged almost $4000 for a test that could be done for a fraction of that amount, were it not for the patent royalties.

If a patient (such as Angelina Jolie) had a family history of breast cancer, she had to decide whether to have her breasts removed without being able to get a second opinion since there was no alternative to the Myriad test. And, according to a 2006 article in the Journal of the American Medical Association, the Myriad test was wrong 12% of the time. That’s a tragedy, not a tenet of patent law.

Under the Court’s decision, patients will get access to the needed genetic tests at affordable rates and new treatments and therapies will emerge.

Good for researchers.

Gene patents have impeded research. If a researcher wanted to study a gene, he or she risked a multi-million dollar lawsuit. Some gene patent holders stopped research on “their” genes by researchers at top universities, such as Yale, U.C.L.A. and the University of Pennsylvania. SARS research was slowed down because of concerns about the patents on the genetic sequence of the SARS organism. In fact, prior to the Supreme Court’s decision, 53% of genetics labs had stopped doing research due to concerns about gene patents. Forty-nine percent of American Society of Human Genetics members had to limit their research due to gene patents. That’s why every major scientific and medical group in the country filed briefs in the Supreme Court urging the Court to eliminate gene patents.

Now all researchers are free to explore gene sequences—a great outcome for medicine, public health, and even for the discovery of new biotech products.

Good for pharmaceutical companies and emerging biotech companies.

Drug companies can now see if their new drugs work on different patients by using patients’ genetic sequences as a key. Before, it was costly to have to pay patent licenses for each different genetic sequence the company needed to use.

A new generation of biotech companies will be created due to the decision. Companies can offer multi-gene tests or even human genome sequencing where you can learn about all 20,000 genes in your body at a cost of $1000 or less.  Prior to the Supreme Court’s decision, such a test was impossible because gene patent holders could exclude the genes they owned from a comprehensive test, or charge thousands of dollars for information about one gene alone.

Good to obtain the trust of research subjects.

In addition to the negative impact that gene patents had on access to and the quality of genetic testing, the possibility of patenting genes caused some physicians and university researchers to view patients as treasure troves. Doctors, health care institutions, researchers and hospitals have gone to court to gain ownership of patients’ cell lines, tissue, and genes in order to commercialize them, even over the patients’ objections. Genetic research was undertaken on people without their consent as researchers prospected for genes. This deterred many people from participating in genetic research altogether.

The Supreme Court’s decision will re-establish trust of patients in researchers.

Good for international relations.

Previously, the United States was an outlier. In other countries, such as in Europe, it’s clear that patents can’t be issued on discoveries of nature, but only on human-made inventions. Companies didn’t “invent” human genes; genes have been around since the dawn of humankind.

Also, in Europe, Asia, and elsewhere, there’s a research exemption in patent law, which doesn’t exist in the United States. Prior to the Myriad decision, U.S. researchers were not able to explore genes that could readily be explored in other countries. Now they can.

Is this decision unfair to Myriad?

Some people mistakenly think that Myriad actually invented something, like a little machine or device that can test your genes. Not so. The patents are not actually on a test. They are patents on the “isolated” naturally-occurring genes. They are patents on part of your body. Myriad didn’t even invent the process for isolating the genes. In fact, removing genes from people’s bodies has routinely been done for decades.

Taxpayer money from the National Institutes of Health was used to find the breast cancer genes. You and I paid for that research. And even if Myriad had spent a lot of money, that doesn’t entitle them to patent a product of nature. If I spend a lot of money on a telescope to discover a new planet, I can’t own the planet. A brief filed by the Department of Justice said that it was an error to let Myriad have the patents in the first place. So, paying Myriad nearly $4000 for each look at your breast cancer genes was like having to pay a car thief for the right to drive your own car.

Applause to the Supreme Court for getting this one right!