US Supreme Court Poised To Rule Human Genes Are Not Patentable

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For decades, the United States has pioneered the patenting of human genes, and other countries have followed this lead. But the US will soon perform an abrupt about-face, most experts predict. When the US Supreme Court hands down its decision in Association for Molecular Pathology v. Myriad Genetics, the justices appear likely to rule that human genes are not patentable subject matter. And the ruling may go even farther, holding that other forms of human DNA are not patentable.

The case centres on two human genes, BRCA1 and BRCA2. Certain mutations of these genes produce a strong hereditary predisposition to breast and ovarian cancers.

Both the healthy and the cancer-producing versions of the BRCA genes have been patented by Myriad. These patents cover the isolated forms of the genes (i.e., they are removed from the rest of the chromosome), small snippets of the isolated genes, and cDNA versions of the genes (synthesized using messenger RNA, not DNA).

Thanks to its patents, Myriad has a monopoly in the US on using these genes. Any woman who wants a genetic test to see if she is at risk of breast or ovarian cancer must have the BRCA tests performed by Myriadand Myriad makes sure these tests are not cheap. When the University of Pennsylvania and other institutions tried to offer the tests at lower cost, Myriad shut them down by threatening to sue for patent infringement. In addition, Myriad has used its patents to stop institutions from offering second opinions on test results or improved versions of the BRCA tests.

In 2009, Myriad was sued by a collection of patients, researchers, genetic counsellors, medical associations, and breast cancer and women’s health groups. These plaintiffs asked a federal district court to invalidate Myriad’s gene patents. The court did so, holding that the genes are products of nature and thus not patent-eligible subject matter.

This decision was reversed in 2011 by the Federal Circuit Court of Appeals (often called the nation’s “patent court”). The Supreme Court, however, vacated that decision and directed the Federal Court to take a second look at the patentability of human genes. The Federal Circuit did so and, in August 2012, again upheld Myriad’s gene patents.

On 30 November, the US Supreme Court agreed to review the Federal Circuit’s latest decision in Myriad. Oral argument has not yet been scheduled, but the high court is expected to decide the case before its current term ends in June.

At first glance, it might seem that Myriad should win the case easily. The USPTO has been granting patents on human genes since the early 1980s, and these patents have been repeatedly upheld by district courts and the Federal Circuit. As a result, more than 40,000 DNA-related patents have been issued in the United States. These patents underpin much of the country’s booming biotechnology sector. If the Supreme Court were to hold human genes are unpatentable, the decision would reject decades of legal precedents and overturn settled expectations in the biotech industry.

US courts are usually reluctant to take such actions. But there are reasons to think the Supreme Court may make an exception in this case. First, the court has shown a keen interest in altering the nation’s patent law. Since 2000, the Supreme Court has reviewed an unusually large number of patent cases, and in almost every instance, the high court has overruled longstanding Federal Circuit decisions and reduced the rights of patent owners.

“The Supreme Court has been decidedly anti-patent. It has issued a series of decisions intended (in the court’s eyes) to bring the patent system back into line with its purpose of promoting innovation,” said Michael J. Shuster, a partner in Fenwick & West.

One of the court’s worries is that patent-eligible subject matter has been defined too broadly, giving patent owners exclusive rights over ideas and natural phenomena that should be available to all. “The Supreme Court has been very concerned with reinforcing the line between patentable and unpatentable subject matter,” said Prof. Eileen M. Kane of Pennsylvania State Law School.

The court has issued two decisions in the past two years narrowing the definition of patent-eligible subject matter. Bilski v. Kappos [pdf] limited the patentablity of business methods (in order to prevent the patenting of ideas). Mayo Collaborative Services v. Prometheus Labs. [pdf] restricted the patentability of methods for medical diagnosis or treatment (in order to prevent the patenting of natural phenomena).

Mayo bears directly on the Myriad case. At least, that’s what the Supreme Court has indicated. On the same day it issued its opinion in Mayo, the Supreme Court vacated the Federal Circuit’s 2011 decision upholding Myriad’s gene patents and directed the lower court to reconsider the case in light of Mayo.

Yet the Federal Circuit did little reconsidering when it upheld the gene patents a second time, according to many experts. “What the Federal Circuit judges wrote after Mayo was almost exactly the same as they wrote before Mayo. Which is not a good way to avoid further Supreme Court review,” said Prof. Timothy R. Holbrook of Emory Law School. He added, “It was a little shocking that the Federal Circuit decision did not change that much.”

Patent law experts in the US thus widely expect the Supreme Court will reverse the Federal Circuit. The question for most observers is how far the court will go in prohibiting the patentability of human DNA.

The narrowest decision would bar the patenting of isolated versions of naturally occurring human genes. “That’s consistent with Mayo. The Supreme Court has recognized that you can’t patent things that occur in nature, there has to be something more. The court has expressed this in various ways, such as: a patentable invention must show ‘the hand of man,’ or it must have an ‘inventive concept.’ The court could apply this standard to naturally occurring human DNA,” said Kevin E. Noonan, a partner in McDonnell Boehnen Hulbert & Berghoff.

The court could go farther and prohibit the patenting of any isolated snippets of human DNA. “I think they will view the snippets as patent-ineligible, because functionally they operate the same way they do in the human body, which is why we care about them,” said Holbrook.

A third option would be to create “some kind of broader product-of-nature exemption” that would find cDNA to be patent-ineligible, said Noonan. “I don’t think they will do this, because the court has already said in prior cases that you if show the hand of man, that’s enough [for patent eligibility]. cDNAs don’t occur in nature, and they have different properties than natural DNA, so there are lots of reasons why cDNA could be considered a product of human manufacture.”

It would be ironic if the Supreme Court rejects the patenting of human genes, because the US has caused many other nations to allow gene patents. “Other countries adopted their rules largely in reaction to the US,” Holbrook said.

Thus, the US could soon find itself the only industrialised country that does not allow isolated human DNA to be patented. Should that happen because of Myriad, “the Supreme Court would go rogue, basically, and economically disadvantage the US. By making it difficult or impossible to protect isolated nucleic acid molecules, the court would drive R&D investment [in biotech] outside the US,” said Shuster.

Such a flight of money and talent might be short lived, however, if other industrialised nations turn away from the patenting of human DNA. That is a possibility. After all, it wouldn’t be the first time other nations have followed the US lead in patent law.

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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Comments

  1. Tim Roberts says

    How are they going to distinguish human genes from other genes? Suggestions welcome!

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