The Myriad Gene Patent Case: Who Owns Your Disease?

Today the court of appeals for the federal circuit court is hearing arguments in the Myriad gene patent case, aka Association for Molecular Pathology v. U.S. Patent and Trademark Office. It’s the latest development in the attempt to patent the human body, a long story that’s touched the lives of Chicagoans and won’t go away any time soon.

I have to admit, I was a bit surprised when The Immortal Life of Henrietta Lacks by Rebecca Skloot took off at the end of last year. It’s a great book and deserving, but it’s difficult: a story not just of race and inequality but who owns and profits from genetic information. In short, a Baltimore woman named Henrietta Lacks died of a particularly aggressive case of cervical cancer. And the isolated cells from one of her tumors refused to die, “the first immortal human cells ever grown in culture,” making them extraordinarily useful. And no one told her family, not for 25 years. Skloot’s book raises an interesting question: who owns your body? What if it’s just a little gene-sized piece? It’s not as obvious as it seems.

That’s why the court of appeals for the federal circuit court is holding arguments today in the Myriad gene patent case (Genomics Law Report has thoughtfully published a spectator’s guide). In this instance, a company claims to hold patents on isolated “breast cancer” genes (BRCA1 and BRCA2). Since the presence of mutations indicates a risk for breast cancer, holding the patent on them could guarantee substantial profits by way of screening. Here’s the rub:

Since the inception of gene patenting a generation ago, patent lawyers have taken the position that genes are just chemicals. Their information-carrying function is irrelevant to their patentability, the lawyers say. Because genes are chemically different in isolation, at least in a literal sense, they can’t be considered products of nature. The USPTO and the courts, including the Federal Circuit (the patent court of appeals), have uniformly acquiesced. Now a federal court has said that, no, genes aren’t just chemicals—precisely because they carry information. Genetic exceptionalism has become a principle of law, at least in Judge [Robert W.] Sweet’s court.

In other words, the courts have been friendly to the idea of patenting genes, so the ruling that led to today’s arguments came as a surprise to informed observers.

The surprise ruling came in part thanks to a Chicago lawyer, Lori Andrews, whom Chicago’s Bryan Smith profiled in February. The Chicago-Kent prof works at the cutting edge of science and law, bringing her in contact with some oddballs (remember the Raelians?), and it’s also put her at the forefront of gene patent law:

The capstone of her career, however, came last year with a victory in one of the thorniest, most controversial biotechnical issues in decades. For years, many researchers have argued that they should be able to patent genes, such as the breast cancer gene. That means, among other wide-reaching implications, that researchers and biotech companies can charge a royalty fee every time other scientists want to do research into the disease or test for the gene’s presence.

The issue found expression ten years ago in the case of the Greenbergs, a suburban Homewood family who had helped a doctor uncover the gene for Canavan disease (an inherited brain disorder) by providing samples of blood, urine, and tissue from two of their babies who had the condition. Four years after discovering the gene in 1993, the doctor and the hospital started enforcing the patent, reaping hundreds of thousands of dollars in royalties.

[snip]

In the Greenberg case, she only won a settlement. But last spring, in a case against a biotech firm called Myriad Genetics, a federal court weighed in. Largely as a result of Andrews’s work, a U.S. district court in New York effectively banned gene patenting, echoing her claim that genetic material couldn’t be patented.

In May 2003, Lucinda Hahn covered the Greenberg case for Chicago, about the Homewood couple whose son died of Canavan disease; his blood was used, in part, to identify the gene that causes it. Like Skloot’s book, it highlights the human side of the gene patent debate, and the experience of patients trying to grasp the moral and emotional aspect of genetic information:

The commercialization of the gene infuriated the Greenbergs and the other families who had made such painful, personal contributions to its discovery. After unsuccessfully negotiating with the hospital, they filed a lawsuit. “I gave myself and my son and anything [the doctor] wanted to help wipe out this disease,” says Frieda Eisen of Brooklyn, New York, whose son, Jacob, had Canavan. “I thought it was more of a donation for the common good of mankind, not for a hospital to profit on. Jacob was as much a part of this discovery—all the children were—as the hospital. Why should they make money on my child, on everything my child donated?”

Andrews challenged the hospital on the basis of informed consent, a theme running throughout the story of Henrietta Lacks. But if the district court judgment holds up, it will reverse the momentum of the law that Andrews ran up against:

What’s galling to Dan Greenberg and the other plaintiffs in the lawsuit is that there are any restrictions or royalties at all. “To me, a gene is like a raw material,” Green­berg says. “You can’t patent iron ore. You find it in the ground; it’s there; it’s a natural product on earth. Well, the genes in my body are also a natural product. And for somebody to be able to prevent anyone from using this raw material, even from doing tests on it—that’s what I just think is terrible and wrong.”

Unfortunately for the Greenbergs, there has been legal precedent for patenting a gene since a landmark 1980 Supreme Court ruling, which established that living organisms altered or isolated by “the hand of man” could be patented, provided that the in­ventor did something new and useful with the discovery. Since then, about 500,000 gene patents have been granted or are pending, according to the advocacy group GeneWatch UK.

And that’s the question at the heart of the district court ruling, and today’s arguments on appeal. If the genes in question are “chemicals,” that’s more favorable to Myriad. If they’re “information,” it’s more favorable to the plaintiffs. If the ruling is upheld, I can’t imagine it not going to the Supreme Court, because it’s a significant sea change in the existing but nascent law.

 

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