A genome is an organism’s complete set of DNA. Each genome contains all the information needed to build and maintain that organism. Homo sapiens have about 30,000 genes in all, and each nucleus-containing cell in a human being contains an entire copy of the genome code, which consists of over 3 billion DNA base pairs.

Why are these numbers important? Well, according to the U.S. Court of Appeals for the Federal Circuit, the answer—for now—is that certain genome patents can be upheld! Given that about 20% of the genome is currently patented, the decision is a boon to those that hold the patents such as Myriad Genetics–the holders of the genome patents that are the subject of this litigation.

The BRCA1 and BRCA2 genes, which have been linked to hereditary breast and ovarian cancers, were the subject of patent litigation in Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al. The suit was filed against the Patent Office, Myriad Genetics, and the University of Utah on behalf of over 150,000 individuals (the Department of Justice filed a brief siding with the Plaintiffs, as the Obama administration is not in favor of gene patenting). The issue is that a gene patent holder has the right to prevent anyone from studying, testing or even looking at a gene.These plaintiffs argued that the patents on the human genome should not be allowed because the patents limits testing that could result in more affordable and improved care and treatments for cancer and other diseases. In 2010, the US District Court for the Southern District of New York found for the plaintiffs, finding that the genomes were too related to isolated DNA found in nature and therefore were not subject to patent protection.

Deoxyribonucleic acid

However, on July 29, 2011, the Court of Appeals for the Federal Circuit overturned that decision by a 2-1 vote (PDF). The court found for Myriad on 2 of the 4 issues in play. The plaintiffs prevailed on the issue of jurisdiction and on Myriad’s claims that it could patent a method of comparing DNA. The appellate court stated that Myriad did not take any transformative steps when it was comparing the DNA; rather it only took abstract, mental steps that are not patent eligible.

Myriad and the other defendants prevailed on the other two claims, the first of which was Myriad’s ability to patent isolated DNA molecules. The court reversed the district court’s decision, finding that Myriad could patent those DNA molecules not found in nature. “BRCA1 and BRCA2 in their isolated state are not the same molecules as DNA as it exists in the body; human intervention in cleaving or synthesizing a portion of a native chromosomal DNA imparts on that isolated DNA a distinctive chemical identity from that possessed by native DNA.” The court also found for Myriad on its method of testing potential cancer therapeutics, finding that the process is patent eligible. In addition, the Court made a point of noting that the U.S. Department of Justice’s brief contradicts the policy of the US PTO, which has backed gene patents for more than 2 decades.

The dissent argued that genomes are not patent eligible, because no one invents them. They already exist. It is expected that the decision will be appealed–likely by both sides–and it will be interesting to see whether the Supreme Court decides to take the case. The patent holders will appeal because they do not want to see courts uphold jurisdiction in this cases, and the plaintiffs will continue to file suit because they wish to see medical advances.

– Charles Michels

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