The dangers inherent in gene patents

The U.S. Supreme Court must see through flimsy justifications for genetic exclusivity rights that impede innovation, raise ethical concerns and endanger patient health.

Posted April 29, 2013.

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When the highest court in the land discussed human gene patents recently, it should have come as little surprise that the analogies used in court to try to elucidate the practice sometimes bordered on the absurd.

Can someone patent a plant discovered in the Amazon rain forest simply because it was pulled out of the ground? Does coming up with a recipe for a chocolate chip cookie give the baker the ability to patent not only the recipe but also each of the raw, natural ingredients that went into it? Can a person who cuts off a branch from a tree and does nothing else to the stick say they have a patentable baseball bat?

Each is an exceedingly dubious premise, but those are the examples that flowed forth from U.S. Supreme Court justices as a molecular diagnostic company tried to persuade them to sign off on its patent claims. In the case of Assn. for Molecular Pathology v. U.S. Patent and Trademark Office, et al., on which oral arguments were heard in mid-April, the justices must not accept the deeply flawed reasoning that resulted in the patent awards.

The case involves a set of patents that Salt Lake City-based Myriad Genetics holds on two genes that serve as vital markers in the diagnosis of certain cancer risks, largely in women. The company says its patents on BRCA1 and BRCA2 are valid because it isolated the genes from the remainder of a human genome.

But Myriad is not claiming that it invented a new scientific isolation method and attempting to patent that proprietary process. Rather, it is claiming exclusive rights to the genes themselves, sequences that naturally occur in hundreds of thousands of places in the individual DNA makeup of every human being on Earth. By making a series of snips in the strands — employing common chemical techniques used in laboratories everywhere — Myriad effectively is taking possession of the fragments and asserting a monopoly on any testing designed to confirm mutations in those fragments.

To put it another way, as the American Medical Association did in a recent statement renewing its opposition to the gene patents, the diagnostic company’s argument is akin to claiming a patent on a mineral simply by removing a chunk from the rock that surrounds it.

While the analogies cited in this case might fuel creative academic arguments, the potential adverse impact on patients of upholding such gene patents is anything but academic. The Litigation Center of the AMA and the State Medical Societies, joined by other health organizations in a friend-of-the-court brief, noted the serious stakes. This case developed when health professionals came to the legal aid of women who would be forced to go to Myriad — and pay the company roughly $3,000 — if they were to receive the breast cancer genetic screenings recommended by their physicians.

Placing such practical impediments in front of patients who are dealing with quite possibly the most frightening health episodes of their lives is not only ethically questionable, it’s also a public health danger. At the mercy of a company that effectively owns exclusive rights to parts of their own bodies, and without the possibility of obtaining second opinions or better-designed screenings, women who are misdiagnosed might end up dying of preventable cancer — or needlessly having their healthy breasts or ovaries removed. Men trying to determine their risks for breast, prostate or pancreatic cancer are at great risk for potentially disastrous health consequences as well.

That’s why the U.S. Supreme Court must realize that patent protections should be limited to true scientific advances, not to products of nature. The patent system rightly rewards the medical innovations that help physicians cure patients of their illnesses and enable longer, healthier lives. It should not be used as a restraint on innovation that stops researchers from developing better, less-costly clinical screenings and ties doctors’ hands in giving their patients the care they need.

Part of the beauty of DNA lies in its relatively simple chemical structure, but simplistic arguments as to why a company should take possession of segments of these remarkable building blocks of life are not worthy of such admiration. Our genes are part of what make us the individuals we are while also uniting us as members of one human race. They belong to all of us.

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