US Supreme Court Restricts Gene Patents … A Little

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On 13 June, the United States Supreme Court overturned more than 30 years of precedents and ruled that isolated genes cannot be patented. They are products of nature and thus not patent-eligible subject matter, the court unanimously held in Assoc. for Molecular Pathology v. Myriad Genetics, Inc. This ruling puts the US at odds with most other nations, which allow genes to be patented. But because other major nations grant narrower gene patents, the net effect of Myriad will be to shift the US position on gene patents closer to that of other nations.

The Myriad case focused on two human genes, BRCA 1 and BRCA 2. Mutations of these genes dramatically increase a woman’s risk of developing breast and ovarian cancer.

Not surprisingly, women with a family history of cancer are keenly interested in learning whether they carry mutated versions of these genes. And Myriad can tell them.

The company, a biotech firm specialising in genetic testing and personalised medicine, performs genetic tests to identify whether patients have mutated BRCA 1/2 genes. The company has found this work to be quite profitable.

The University of Pennsylvania and other entities wanted to offer these genetic tests, too, but at lower prices. Some planned to provide more accurate tests. But Myriad scared off all these potential competitors by claiming its patents would be infringed if the rivals performed the genetic tests.

Myriad has three patents which cover, among other things, the isolated form of the BRCA 1/2 genes (i.e., the molecules that result when these genes are removed from the rest of the chromosome). The patents also claim a complementary DNA version of these genes. This man-made “cDNA” molecule is not found in nature; it contains the same genetic information as an isolated DNA molecule, but without some extraneous material found in DNA.

In 2009, a group of patients, researchers, genetic counselors, medical associations, and breast cancer and women’s health groups challenged Myriad’s patents in court. The district court struck down the patents on the isolated DNA and the cDNA molecules, finding they were unpatentable products of nature. Myriad appealed, and the Federal Circuit reversed. That appellate tribunal, which is sometimes called the country’s “patent court,” upheld the patents on two separate occasions.

The Supreme Court wound up disagreeing with all the lower courts. The high court struck down Myriad’s patents on the isolated BRCA genes but upheld the patents on the cDNA versions. “[W]e hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring,” Justice Clarence Thomas wrote in the court’s opinion.

A Fuzzy Standard

The court, however, was less than clear on the dividing line between naturally occurring and man-made molecules. Consider the fact that the court found isolated BRCA genes are not patentable, even though these molecules do not occur in nature. Moreover, the isolated and naturally occurring versions of BRCA have different chemical structures because, in nature, the chemical material in BRCA genes is part of a much longer chromosomal molecule.

Nevertheless, the court found the isolated BRCA genes to be products of nature, in part because of the way Myriad drafted its patent claims. Myriad’s “claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule,” Justice Thomas stated. Both the isolated and chromosomal versions of the BRCA genes have the identical genetic information, so Myriad’s patent on the isolated form really didn’t claim anything different than what was found in nature.

But what if Myriad had drafted its patent differently, describing isolated BRCA in purely chemical terms – detailing a smaller molecule that is not found in nature? Would that be patentable subject matter? Maybe, according to some experts. “It may be possible to claim isolated genes if it is done in a chemical way, without referencing the gene sequence,” said Jorge Goldstein, PhD and a partner in the law firm of Sterne Kessler Goldstein & Fox.

Patent drafting isn’t everything, however. The Supreme Court upheld Myriad’s patents on the cDNA version of the BRCA genes even though these patents claimed the molecules in terms of their genetic sequence. The court upheld these patents because cDNA molecules are man-made creations that are not identical to anything in nature; some extraneous material found in natural DNA is omitted in cDNA. So even though the genetic information is the same in both molecules and the patent claims were drafted in terms of this information, the small chemical differences in these man-made molecules were sufficient to render them patent eligible subject matter.

Those small differences are key. Without them, the cDNA molecules could not be patented. If a cDNA molecule simply mimucs a snippet of naturally occuring DNA that contains no extraneous material – so the cDNA is identical to an isolated version of the DNA snippet – the cDNA is not patent eligible, the court stated.

Less of an Outlier

The US Supreme Court went out of its way to stress the narrowness of its decision. The court expressly left open the possibility that recombinant DNA could be patented, as could new uses for natural DNA.

This latter rule is the one adopted in Europe. The EU allows gene patents but only for claimed, specific uses, Goldstein said. The Myriad decision thus effectively pushes the US position on gene patents closer to that of Europe.

Unlike the US, however, Europe imposes additional, important restrictions on patents. Some European nations, for instance, prevent patents from affecting research or diagnostic uses, noted Prof. Rochelle Dreyfuss of NYU School of Law.

In short, although the US has become the only major country to outlaw gene patents, the US seems as willing as other countries to grant gene-related patents. And compared with Europe, the US gives those gene patents greater scope. Myriad has cut back on patentability somewhat, but creators of gene-related inventions will find that, compared with Europe, US law is still more pro-patentee.

Steven Seidenberg is a freelance reporter and attorney who has been covering intellectual property developments in the US for more than 15 years. He is based in the greater New York City area and may be reached at info@ip-watch.ch.

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  1. […] US Supreme Court Restricts Gene Patents… IP Watch … puts the US at odds with most other nations, which allow genes to be patented. But because other major nations grant narrower gene patents, the net effect of Myriad will be to shift the US position on gene patents closer to that of other nations. […]

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