On March 29, a federal district court struck down seven patents owned by biotech firm Myriad Genetics and the University of Utah Research Foundation. The patents in question are “gene patents,” which give their owner exclusive rights to commercialize specific pieces of DNA. The Myriad patents involved two genes, BRCA-1 and BRCA-2, which when mutated often signal a strikingly elevated risk for an aggressive form of breast and ovarian cancer. These and other patents give Myriad a monopoly over the sale of diagnostic tests that screen for BRCA-1 and BRCA-2 mutations. That monopoly has been the source of criticism by patients, physicians, academics, and others. The Myriad case is essentially the first legal challenge to gene patents and their effects.

The court’s decision flew in the face of established practice at the Patent and Trademark Office (PTO) and in most other advanced nations including Canada, Japan, and most of the European Union. Although other Myriad patents will likely preserve its monopoly on BRCA-1 and BRCA-2 diagnostics, the litigation is far from over. Myriad plans to appeal to the Federal Circuit Court of Appeals, and that court’s decision is widely expected eventually to reach an uncertain fate at the Supreme Court.

The Myriad decision has been widely applauded as a pathway to abolishing human gene patents. But a closer look shows that getting rid of gene patents would probably be a big mistake.

Gene patents often provide intellectual property to motivate the expensive R&D necessary to develop medical treatments or preventatives.

Gene patents often provide intellectual property to motivate the expensive research and development (R&D) necessary to develop medical treatments or preventatives. Genentech, for example, parlayed some of its gene patents to attract early-stage investment for Herceptin, a breakthrough biotechnology drug for breast cancer. Gene patents also undergird many medical diagnostics—the development of which can also require extensive research. Myriad has spent hundreds of millions of dollars in exploring and validating the relationships between a wide variety of BRCA mutations and the incidence of breast and ovarian cancer. It has spent some of this disseminating research findings to physicians so they can tell patients why they should be screened for BRCA mutations.

Critics of gene patents usually make three arguments. One is that most if not all gene patents are for pure information—a series of letters comprising a DNA sequence—and pure information is never patentable. But the PTO has stated that, “while descriptive sequence information alone is not patentable subject matter, a new and useful purified and isolated DNA compound described by the sequence is eligible for patenting.” In other words, gene patents are for molecules that do not actually occur in nature even when they contain segments of naturally occurring DNA.

A second objection is that gene patents restrict academic research, even though many of the most important gene patents are actually owned by universities and other nonprofit research organizations. The third objection is that patent-based monopolies on diagnostics impede patient access through high prices or unreasonable restrictions on who can perform diagnostic procedures.

The Myriad decision did not address these last two issues because the judge ruled that gene patents are inherently unpatentable regardless of their practical impact. But they have been explored by the National Academy of Sciences and other organizations. Two surveys of academic researchers commissioned by NAS revealed practically no evidence that research laboratories were hemmed in by gene patents. Based on that and other data, a 2006 NAS report concluded there was little evidence that gene patents have adversely affected research. In fact, it so happens that researchers seldom worry about what is patented and what is not.

A 2006 NAS report concluded there was little evidence that gene patents have adversely affected research. In fact, it so happens that researchers seldom worry about what is patented and what is not.

Also notable is the scarcity of litigation. A 2008 review article in Science Magazine found only six lawsuits on gene-patented diagnostics, all of them dismissed or settled with little if any impact on scholarly research.

There is more. A March 26, 2009, editorial in the British journal Nature concluded that “dire predictions that patents will cripple genetics research should be viewed with skepticism on both sides of the Atlantic.” An accompanying article noted that “prices of patented and exclusively licensed tests are not dramatically or consistently higher than those of tests without a monopoly.”

This past February, the Secretary of Health and Human Services’ Advisory Committee on Genetics, Health, and Society (SACGHS) released a lengthy report on gene patents. Although it recommended that medical diagnostics and academic research be excluded from patent coverage, the report provided scant evidence of actual problems. In April, a series of detailed case studies commissioned by the SACGHS was published in the journal Genetics in Medicine. The topics ranged from breast cancer to Alzheimer’s disease, cystic fibrosis, and colon cancer. Again, almost nothing was found in the way of significant problems in pricing, patient access, or academic research. On the contrary, Myriad (along with academic researchers) has contributed thousands of entries to an avalanche of publicly available research results on the relationships between BRCA-1, BRCA-2, and cancer. Also noteworthy is that gene patent licensing practices have been flexible, often involving multiple testing facilities and practically unlimited research pursuits.

The latest fear is that gene patents could interfere with full-genome sequencing as scientists struggle to cull the elusive harvest of diagnostics and therapeutics from DNA sequencing. Perhaps that could be a problem, but the patent system has flourished through multitudes of technological revolutions before.

The costs of permitting gene patents have been far less than almost anyone imagined. The benefits, although wickedly difficult to measure, are substantial and sometimes very great indeed. History has yet to provide a reason to abolish this remarkable class of patents or even substantially restrict it. And looking forward, gene patents seem far more likely to bolster than hinder DNA-based R&D as it creates new breakthroughs in academic research and medical practice.

John E. Calfee is a resident scholar at the American Enterprise Institute. Elizabeth DuPre is the health policy program manager at AEI.

FURTHER READING: Calfee recently outlined “Something Old, Something New: Biotech’s Enormous Potential” and discussed “What Do Vitamins and Fish Oil Tell Us about Drug Research?” He advised readers to “Stop Taking R&D for Granted” and has explained why “Limiting Drug Prices Means Limiting Future Cures.” He and DuPre also coauthored “Learning a Little About Drug Companies from the Lancet.”

Image by Darren Wamboldt/Bergman Group.