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Sorting Out Patent Law

June 15, 2013
A Three-Dimensional Rendering of a DNA Spiral

A Three-Dimensional Rendering of a DNA Spiral

The US Supreme Court last week handed down an important decision governing the expanded use of patents in recent years. The Court’s decision, issued in the case of the Association for Molecular Pathology v. Myriad Genetics, centered on the question of whether or not a patent held by the company Myriad Genetics over the BRCA1 and BRCA2 genes was valid. The two genes are closely connected to the development of breast and ovarian cancers, and Myriad had claimed a patent on the genes based on work they had done to discover and isolate the genes. Their patents prevented other researchers or companies from doing work on that gene sequence, and gave Myriad the ability to command higher prices for genetic tests to screen for those types of cancer.

The use of patents to protect innovation is guaranteed by the US Constitution. But the nature of those patents—and more importantly, the question of what can or cannot be patented—has long been contested. Historically, patents have been granted for innovations but not discoveries. The question, of course, is where the line between the two falls. Patent law has historically precluded patents over “products of nature.” But advocates for greater patent protection had contended that gene sequences outside the genome are not found in nature and could thus be subject to patent protection. In its ruling, the Supreme Court rejected this claim, holding that “genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.” Rather, to claim a patent there must be an “inventive step” or “apply the knowledge.”

It’s difficult to understate the importance of this decision. There are currently more than 2,000 patents for human gene sequences, many of which appear to have been invalidated by the decision. Similarly, in the field of agricultural biotechnology, broad patent claims over the genomes of plant varieties would also be unfeasible. Such patents serve no real purpose other than to enrich the first to discover or sequence the genome. At the same time, they undermine the ability of other researchers to engage in study of specific gene sequences. While the Court’s decision will likely undermine research in some areas, it will likely prove a boon to others.

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6 Comments
  1. Reblogged this on Science on the Land and commented:
    argylesock says… This is important news for farmers and growers. To see why that’s so, you can scroll down to the last paragraph of the post I’m reblogging. I wonder what lawyers will make of this ruling. Does it invalidate the new clause in US law, known as the Monsanto Protection Act? Does it invalidate the recent ruling in Bowman vs Monsanto?

    • Great questions, but no, I don’t think the decision in the Myriad case has any impact on the Monsanto Protection Act or on the Bowman decision. Both of those issues involve broader patents on non-naturally occurring DNA sequences. The Court was careful to state that non-naturally occurring DNA sequences (they specifically mentioned cDNA, but the decision was actually broader) were still patentable. What the Court rejected was the patenting of naturally occurring DNA segments, effectively ending the practice of “submarine patents,” patents on segments of DNA intended to capture a portion of profits from future research that depended on ownership of a specific gene sequence.

  2. NIce summary Noah. I did learn that the court will allow modifications of naturally occurring DNA sequences to be patented. If this is accurate, it will allow a lot of entrepreneurial developments.

    • That was my understanding as well. But the concern expressed by Myriad in the case was that the expensive part of the process was the discovery, and that the cDNA (complementary DNA) was relatively less expensive but is still patentable. Other kinds of innovation–such as modifications of naturally occurring DNA sequences–remain patentable.

      Don’t get me wrong, I think the Court made the right call here. I’ve never understood why the patent office was giving patents for discovering portions of DNA, and I think that in the longer term the decision will promote the research. But I think this decision also highlights the need for continued public funding of basic research (such as decoding DNA sequences), because it’s not profitable for the private sector to do it.

      And to make matters more interesting still, the Australian Supreme Court is scheduled to hear a similar case in a few weeks, and the lower court has already ruled in favor of maintaining the patent protection for discovered gene sequences. We could be in a very interesting case where despite efforts to create a more uniform patent system globally under the World Trade Organization’s TRIPS Agreement, we have very different interpretations of patent law in different countries…and the United States, the country that pushed hardest for a more uniform and stronger IP system in international negotiations is the country with the weaker degree of patent protection.

  3. Good concise summary of the issue.

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  1. It’s not natural! Synthetic genes, intensive farming and synthetic food | Science on the Land

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