Gene Patents

Author: Julia Reinitz

The U.S. Court of Appeals for the Federal Circuit (a court specializing in patent hearings) was recently instructed by the Supreme Court to re-evaluate a case against Myriad Genetics’ patent on breast-cancer causing variations in the human BRCA1 and BRCA2 genes. The review is being ordered in light of the Supreme Court’s ruling against Prometheus Laboratories attempt to patent what amounted to a medical recommendation as a unique medical test. While these cases may seem at first glance to be highly technical and largely irrelevant to the average American, they point to a possible shift in the direction of genetic patent law that could have dramatic implications.

The history of gene patents in America begins with the Supreme Court ruling in Diamond v. Chakrabarty (1980), which dealt with Ananda Chakrabarty’s attempt to patent a genetically modified version of a Pseudomonas bacterium that was capable of metabolizing crude oil. In arguably the first ruling on a biotechnology issue, the Court held that “a live, human-made micro-organism is patentable subject matter.” Chief Justice Burger’s majority opinion encouraged broad interpretations of patentable material to “include anything under the sun that is made by man.”

That case, as well as the Court of Appeals for the Federal Circuit (CAFC)’s later ruling in Amgen v. Chugai Pharmaceutical Co. (which held that genes were chemical compounds), enabled the blossoming of the U.S. biotech/genetic modification industry. Companies are able to isolate nucleotide (DNA or RNA) sequences and patent both the sequences themselves, and any organisms containing the unique sequences. The result is a myriad of patented genetic compounds available for purchase by laboratories, and patented genetically modified organisms available for purchase by almost anyone.

Many groups have criticized this ability to patent genes and genetically modified organisms. Readers who have seen the popular documentary Food, Inc. will be familiar with much of this criticism, such as the inability of poor farmers to buy new GMO seeds every year or pay fines incurred from accidentally harvesting seeds from crossed-over GMO plants. In the medical realm, criticism has been leveled that patenting genes involved in gene therapy or medical tests unnecessarily increase costs at the expense of patients. On the flip side, however, advocates of broad patentability maintain that the ability to patent genes/nucleotide sequences is necessary to spur innovation.

Since O’Reilly v. Morse in 1853, the Court has maintained that natural laws or natural phenomena cannot be patented. Morse’s claim to the exclusive right to use electricity for his telegraph machine was struck down, as it was an attempt to patent a natural phenomenon. The recent Prometheus case was decided in the same vein, with Justice Breyer indicating that utilization of scientific discoveries about blood chemical indicators for appropriate dosing levels was a natural law, not a patentable medical test. Petitioners against Myriad are hoping that the appeals court will now find that their patents in regards to BRCA1 and BRCA2 are invalid because the genes are natural phenomena.

While a reversal of the CAFC’s decision in the Myriad case will not prevent biotech companies from patenting genetically modified organisms, it might have profound effects on the way future courts will consider issues of gene crossover. Much of the criticism of companies like Monsanto is that they punish (sue) innocent farmers whose crops are contaminated with modified genes through cross-pollination from neighboring fields. If the CAFC finds that Myriad’s patent of mutated BRCA1 and BRCA2 genes is invalid, it will open up space for interesting questions regarding whether a gene delivered by cross-pollination is still a man-made object or a natural phenomenon. After all, many mutations in human genes are caused by outside factors—but that does not necessarily make mutated genes patentable.

Is a gene still man-made if it has naturally disseminated into the broader gene pool, absent active human involvement? What would the biotech industry do if it couldn’t patent as many genes anymore? These are complex issues, and it’s worth paying attention to what the Court will do next.