The case of the patented genes

WASHINGTON

Angelina Jolie’s genes threatened to kill her. But, for the time being anyway, she doesn’t own them.

Jolie revealed last week that she chose to undergo a double mastectomy after testing positive for the BRCA1 mutation. That genetic glitch meant Jolie’s risk of developing breast cancer was as high as 87 percent;; her mother died at age 56 of ovarian cancer, which is also associated with the BRCA1 gene.

Jolie’s news highlights an arcane but increasingly important question of patent law. As the sequencing of the human genome has expanded the ability to test for such genetic susceptibilities, is the discovery of the gene itself a patentable invention?

Big questions

The practical consequences are enormous. Would allowing companies that identify such genes to hold patents on them provide an incentive to useful discoveries? Or would it have the perverse effect of impeding research by allowing one patent-holder to lock up work on the gene, and, simultaneously, hurting consumers by driving up costs and availability?

As it happens, the Supreme Court is poised to decide this issue in a case involving a Utah company, Myriad Genetics, and its patents on the BRCA1 and BRCA2 mutations. As is true of many of the cases that make their way to the high court, this is not the easiest of legal questions — except that this one also calls for an advanced degree in biology.

Patent law extends protections to “any new and useful process, machine, manufacture, or composition of matter.” But natural products or laws of nature cannot be patented. Think of the difference between gold (not patentable) and a method of extracting gold (patentable).

Those challenging Myriad’s patents, the Association for Molecular Pathology and the American Civil Liberties Union, argue that genes are more like gold, or, as Justice Samuel Alito put it when the case was argued last month, a previously unknown plant found in the Amazon. Simply because it took an explorer the effort to find that plant and bring it home does not entitle him to a patent — although a process for extracting sap from the plant, or using it to treat a disease, would be patentable. Similarly, the BRCA genes, yanked from their natural habitat, are not themselves eligible for a patent.

Moreover, they argue, Myriad’s patent in this case has frustrated scientific inquiry, not enabled it. Other labs have been blocked from studying the genes. Patients have been harmed because Myriad’s monopoly has resulted in false negatives due to the company’s decision to exclude certain mutations; the unavailability of confirmatory testing; and higher costs in the absence of competitors in the market. The mutations are “decisions that were made by nature, not by Myriad,” lawyer Christopher Hansen told the court.

Ingenuity factor

Myriad, for its part, contends that the capacity to isolate the BRCA genes was the product of “human ingenuity,” a classic test of patentability, and that figuring out where to snip the gene sequence was more like extracting sap from the plant than plucking it from the ground.

“Patients ... didn’t have the BRCA1 isolated gene before the Myriad invention,” Myriad lawyer Gregory Castanias told the justices.

Myriad asserts that it has allowed thousands of researchers to study the BRCA genes and permitted second opinions. Reversing three decades of practice by the U.S. Patent and Trademark Office that genes can be patented, it argues, would deter other companies and investors from engaging in valuable research.

This is the kind of case that makes you glad you’re not a Supreme Court justice, but there are two compelling touchstones that led me to come down against Myriad’s patent.

The first is James Watson, co-discoverer of the double helix structure of DNA and a pioneer in the human genome project. “The human genome’s ability to be our instruction book on life distinguishes human DNA from all other chemicals covered by the patent laws,” Watson wrote in a powerful friend-of-the-court brief. “The information contained in our genes lets us predict our future. ... This information should not be monopolized by any one individual, company or government.”

The second is a 51-year-old New York woman, Kathleen Maxian, who was diagnosed with late stage ovarian cancer — after her sister Eileen tested negative for the BRCA mutation. Maxian figured that her sister’s breast cancer was a sad coincidence. Then she discovered that Eileen had not been given the full BRCA screening. After extensive surgery and chemotherapy, Kathleen Maxian has suffered two recurrences.

“What if there were other labs doing this?” she wondered in a telephone conversation. “Would Eileen have been given the full test? And would you and I not be having this conversation?”

Washington Post Writers Group