Gene Patents Still Valid - For Now

Wealth of Ideas, August 2011

Should human genes be patentable? That was the issue at the core of the Myriad gene patent case which was initiated in part by the ACLU. A recent appeals court ruling seems to have turned the tide back in Myriad’s favor, but this case will very likely make it to the Supreme Court before it’s resolved.

A Brief Background of the Case

Myriad Genetics took a license from the University of Utah on patents covering two genes: BRCA1 and BRCA2. These genes are associated with an increased risk of breast cancer and ovarian cancer, and Myriad used the patents to develop diagnostic tests to determine an individual’s risk for those cancers.

The Myriad tests are pricey, which is probably what raised the ire of the American Civil Liberties Union (ACLU). Gene patents had not been an object of very much controversy until the Myriad case; by 2005, according to The Economist, 20% of human genes had been patented. According to the ACLU, there are patents on about 4,000 human genes.

However, the ACLU and the Public Patent Foundation (PUBPAT, which is affiliated with the Benjamin N. Cardozo School of Law) argued that although genetic tests could be patented, the genes themselves could not be. The ACLU and PUBPAT initially filed suit against both Myriad and the United States Patent and Trademark Office (USPTO), alleging that Myriad’s patents could restrict patients’ access to medical care as well as scientific research.

A New York Federal District Court agreed with the ACLU and PUBPAT in March 2010 and granted the Patent Office’s request to be excused as a defendant on the same day.

Myriad – with a considerable investment at stake – appealed, and this month the Court of Appeals for the Federal Circuit (CAFC) overturned the lower court’s decision based on the fact that “isolated” DNA molecules don’t occur in nature and can thus be patented. So Myriad’s licensed patents, and other gene patents, are valid…at least for now. It has been widely speculated – and anticipated – that the case will make it to the U.S. Supreme Court.

The Issues

The critics of gene patents object to their patentability on three grounds: They allow something to be patented which occurs in and is found in nature; that gene patents stifle innovation and research; and that the patent monopolies created by patents such as Myriad’s will restrict accessibility to potentially life-saving diagnostic tests, essentially making them available to only the wealthiest patients.

Chris Hansen, a staff attorney with the ACLU First Amendment Working Group, said, “There is an endless amount of information on genes that begs for further discovery, and gene patents put up unacceptable barriers to the free exchange of ideas.”

However, the biotech industry argues that such patents are, in part, what makes it possible for them to develop new life-saving tests and treatments. After all, the expenditure of time, money and other resources required for genetic research are difficult to justify if there’s no guarantee of being able to patent, protect and profit from the resulting discoveries.

“The decision should be seen as promoting and protecting innovation and research in the biotech and pharmaceutical industries and the development of new life-saving technologies,” said IP attorney Erik Belt, who filed an amicus curiae brief in support of Myriad on behalf of the Boston Patent Law Association.

This decision will stimulate investment into biotech,” predicted Valeria Poltorak, Executive Vice President of Ryogen, a biotech company that has patented certain genes that are implicated in Alzheimer's disease, hepatitis, diabetes, hypertension and cardiovascular disease.

However, like most in the biotech industry, she expects that the case will go to the Supreme Court. “Even the judges couldn’t agree on this one—they were split 2-1,” she adds.

The appeals court judges were well aware of the impact their ruling could have on the biotech industry at a time when many sectors of American business are suffering.

“Judicial restraint is particularly important here because an entire industry developed in decades since the Patent Office first granted patents to isolated DNA,” wrote Judge Kimberly A. Moore, adding that “disturbing the biotechnology industry's settled expectations now risks impeding, not promoting innovation.”

The Mayo Clinic Case

Besides the Myriad case, the biotech and life sciences industries are also keeping an eye on some very similar litigation: The lawsuit between Mayo Medical Laboratories and Prometheus Laboratories Inc.

Prometheus sued Mayo in California in 2004 over two diagnostic method patents that it claimed were infringed by a test that Mayo had developed. The district court dismissed the case in 2008, ruling that the patents were invalid because they covered natural phenomena, but the CAFC reversed the district court’s decision. The Supreme Court has agreed to hear the case, which will probably happen next spring.

Whether gene patents survive all this litigation is just part of the question. As genetic research becomes more sophisticated and more genes are patented, it’s increasingly likely that researchers will encounter a thicket of patents. However, those very patents are part of the reward for the expensive and difficult work of developing genetic medicine – a Catch-22 that makes the Myriad and Mayo cases some of the ones to watch over the next year or two.