Supreme Court Decision: Victory over biotech patenting of human DNA

by Catherine Haug, June 14, 2013

Yesterday, June 13, the US Supreme Court handed down a landmark decision about the patenting of genes or DNA. This particular case, Association for Molecular Pathology v. Myriad, concerned human DNA, but the implication of this decision could be far reaching.

The court declared, “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated…” (1)

This addresses what the court termed as only one category of DNA segment. It also identified another category of DNA segment that could be patentable. In other words, the court determined there are two categories of genes/DNA segments, and it ruled differently for each. (2)

Patent eligibility to be determined by how the DNA was created

The two categories of DNA segments (genes) considered in the case are:

  • Genomic DNA or “gDNA” constitutes the molecule as it is extracted from human cells, in its natural state;
  • Complimentary DNA or “cDNA” is created in the laboratory through a process known as reverse transcription.

It is the first category that was declared ‘un-patentable’ in a 9 – 0 decision, making all such patents invalid.

The second category, which creates the gene or DNA in a laboratory through a bio-chemical process, was determined to be “different enough to constitute patentable subject matter” (2) in another 9 – 0 decision. Existing patents in this second category will stand, and future patents in this category can still be granted.

This decision leaves the door open for more supreme court cases, as the line drawn between the two categories of DNA is not clear-cut. For example, almost all cDNA was created by copying the DNA sequence of natural or gDNA. If the parent cDNA was made in this way, is it not really gDNA?

Potential impact on DNA of other species

Is it a reasonable step to conclude that if “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated…” (1) is true for human DNA, that it would also be true for other species as well? I think so.

In other words, if natural human gDNA  is not patentable, then it is a short step to conclude that natural corn gDNA is also not patentable. Currently, Monsanto holds patents on almost all known varieties of corn. While they have not done any GE research on most of those varieties, the potential is there to turn them into GE versions. A part of the price you pay for the patented seed goes to Monsanto because they own the patent. Further, they can prosecute you for saving the seed from such crops to plant the next year, because they own the patent.

Will Monsanto’s patents on gDNA of corn varieties be invalidated as a corollary of this Supreme Court decision?

How many of the patented GMO foods (corn, soy, canola, tomatoes, summer squash etc.) involve patents of gDNA that could potentially be invalidated as a result of this decision?

What about GMO salmon? Does it involve patented gDNA? If so, then that patent could potentially be invalidated too.

It is my hope that when these biotech companies can no longer hold patents on gDNA, their financial incentive to continue to produce these GE species is lost. Of course, they could find a way to use cDNA instead.

And that makes me wonder… Now that the genomes of many species are known, replica DNA segments can be synthesized using digital techniques (kind of like 3-D copies). Are exact copies considered cDNA? Or must at least one nucleic acid in the segment be replaced with a different nucleic acid to make it unique and patentable cDNA?

Questioning long term consequences

I am curious about an implication of these two categories as addressed by the court. cDNA may have been created in a laboratory, but once inserted into the natural gDNA of a living plant or animal, making that life no longer ‘natural,’ is that living thing now considered not to be life? Yet it has the ability to breed and create subsequent generations. Is that not a vital aspect of what it means to be ‘living?’ Is that altered creature and its offspring patentable because it differs from the natural version due to the insertion of cDNA into its DNA? Just what will be considered ‘life’?

When we get to the point that our own gDNA is altered to ‘cure’ a disease, what will be the consequence to our rights as ‘humans?’ I’m talking about ‘we are endowed by our creator with certain inalienable rights’ that is guaranteed in our constitution. Once man alters human DNA, that human becomes a creation of man, not of ‘our creator.’ Will that altered human no longer be endowed with certain inalienable rights?

References

  1. Friends of the Earth: A Bad Week for Big Biotech: Supreme Court decision invalidating gene patents one of many recent major setbacks to the biotechnology industry’s control over life
  2. Global Public Square (blog): What media missed about gene patent case, by Dan L. Burke, Special to CNN

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