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Landmark decision? US Supreme Court rules human genes cannot be patented

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June 14, 2013

The US Supreme Court has ruled that human genes cannot be patented Image: Shutterstock)

The US Supreme Court has ruled that human genes cannot be patented Image: Shutterstock)

In what is being ballyhooed as a landmark decision likely to set the course of DNA-based diagnostic and therapeutic medicine for the next several decades, the US Supreme Court unanimously decided on June 13 that human genes are not patentable. Rather than objects invented or discovered, human genes are henceforth to be treated as "naturally occurring phenomena," and hence fail the patentability test under 35 USC 101. As is usual in patent cases, however, the ruling contains delicate shades of meaning.

An obvious question concerns why the Supreme Court limited its decision only to human genes. The immediate reason is that the patents under review pertained only to human genes. However, the science is essentially the same in all eukaryotic organisms, that is, in all organisms whose cells are encompassed by a membrane, and which contain DNA-based genes (usually) confined within a cellular nucleus. Essentially all multicellular organisms are formed of eukaryotic cells. Accordingly, it is likely that the new rules regulating patenting aspects of human genetic codes will apply to multicellular organisms in general, although that is not yet established legally.

In particular, the Supreme Court's opinion, written by Justice Clarence Thomas (who has made the science relating to the decision extraordinarily clear), nowhere made note of any "special" status of humans as compared to other animals. It is amusing, however, to report that Justice Scalia, although concurring with the judgment, felt it necessary to note in reference to the testimony concerning molecular biology that he is "unable to affirm those details on my own knowledge or even my own belief."

Is "naturally occurring" far-reaching enough?

According to yesterday's Supreme Court decision, any genetic material or protein that is made through the process of gene expression is "found in nature," and is not patentable. Gene expression is the process by which genetic information is used to create a working gene product, such as RNA or a protein. A process of isolating and purifying such a material might be patentable, and applications not found in nature for such a material might be patentable, but the material itself is not.

As it happens, there are large areas of diagnostic and therapeutic genetic medicine in which the form in which the genetic material is actually used is complementary DNA (cDNA). This is a DNA strand from which all the introns, which are non-coding sections of DNA, have been removed by RNA splicing during gene expression. When the original DNA is from a living source, the corresponding cDNA is never formed in nature. As a result, cDNA was declared patentable by the Supreme Court, provided that the other requirements for patentability have been met.

Well, is cDNA useful for anything? Beyond doubt. Nearly any application in which one would use human DNA can be achieved using human-based cDNA. If you want to insert a gene from an advanced organism into a bacterium, you cannot use the original form of the DNA, because bacteria lack the ability to remove introns when their genes are expressed. Instead, you insert cDNA into the bacteria, as all introns have been excised from the cDNA version of the gene.

Complementary DNA is often used in gene cloning, as gene probes, or in forming an exon library. (Exons, unlike introns, are biologically active sections of DNA that remain present within the final mature RNA product.) In general, working with cDNA is potentially less confusing to both the cells being modified and to the biologists. Similarly, when amplifying DNA sequences, a combination of reverse transcription followed by the Polymerase Chain Reaction (PCR) is used to form cDNA sequences with which to simplify further analysis.

As so often happens, the Supreme Court has tried to draw a clear line in the sand with a feather duster. Human genes, the materials that appear in the process of gene expression, and the end proteins for which they code are no longer patentable, which is good. However, in nearly all present cases of commercially important processes, the cDNA on which they are based is patentable, even though it contains the identical genetic instructions. Still, one is "natural," and the other would not exist save for a biochemist in a laboratory.

Perhaps someday the legal world will take notice of the concept of a gene as biologically coded information, which would make cDNA based on eukaryotic DNA unpatentable, erasing the idea that other people can own your genetic information. That day is not yet here.

Source: U.S. Supreme Court (PDF)

About the Author
Brian Dodson From an early age Brian wanted to become a scientist. He did, earning a Ph.D. in physics and embarking on an R&D career which has recently broken the 40th anniversary. What he didn't expect was that along the way he would become a patent agent, a rocket scientist, a gourmet cook, a biotech entrepreneur, an opera tenor and a science writer.   All articles by Brian Dodson
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9 Comments

Not perfect but it is a step in the right direction.

Slowburn
14th June, 2013 @ 01:14 am PDT

Sounds like the US legal system just had a sudden rush of common sense to the head.

splatman
14th June, 2013 @ 06:50 am PDT

Probably someone finally drew the conclusion that if a company can own your DNA then they own you. I'm a computer person so forgive the analogy. DNA is the source code for our bodies. Everything about our bodies is determined in the DNA first and modified by environment second. That means anyone who owns the source code owns all the expression of that code which would ammount to slavery or at least indentured servitude.

For a good reason why the legal system is realizing this, just look at all the issues GE crop patents have caused. I've heard of farmers (Farmer A) being taken to civil court for million dollar judgments because their neighbor (Farmer B) employed the patented crop and polinators crossed from one farm to the next. Then when the crop company gets a broad vague warrant and tested crops all around Farmer Bs land, One or more Farmer A's crops were found to have some of the modified genes.

Personally I find that rediculous. That would be like fining a person for stealing music just because he walked past someone with an IPOD on full volume and happend to hear some music he had not paid for. You have even less control of cross polination than you would over the IPOD user. You could ask the offender to turn it down and thereby stop the infringement but the only way to prevent the cross polination would be to remove the modified crops or never plant them as wind and wild creatures would spread the genes otherwise.

If I were Farmer A in that situation I'd have then taken Farmer B to court to recover the judgement plus costs for his being so irresponsible as to plant these modified crops in a manner that didn't prevent the patented genes from leaking to the local environment. Then see how well the crop company does when all the Farmer Bs stops buying their product because he can no longer afford the liability or has gone bankrupt from paying Farmer A to pay the crop company for "unlisenced use" of the genes he never wanted in his crop to begin with.

VirtualGathis
14th June, 2013 @ 07:52 am PDT

It's about time (only 2 decades late). I wonder what's going to happen to all those Human DNA patents already filed. Zap!! wipe them out. A lot of value was just wiped out in the biotech industry by this decision, not that I empathize with anyone who was sordid enough to get a patent on any portion of the human DNA.

Matt Fletcher
14th June, 2013 @ 07:55 am PDT

Finally it is about time!!

Terrence Bailey
14th June, 2013 @ 10:35 am PDT

I am curious as to how the biotech industry will move forward, knowing they cannot patent any longer - will a company be willing to spend millions or billions in R&D if they cannot be assured of some IP protection in the end?

f8lee
14th June, 2013 @ 10:48 am PDT

re; f8lee

The complete destruction of the bioteck industry is preferable to patented human genes.

Slowburn
16th June, 2013 @ 09:47 am PDT

Ditto VirtualGathis, but why is the stinking GMO outfit(s) not being sued for contamination of Farmer As land. They are creaps profiting from their own crime, per inept application of "law". How come Farmer's A's & B's attorneys are not all over this like white on rice?

Dave B13
18th June, 2013 @ 08:29 am PDT

Don't mean to play the "I want to disagree" card, but mammals are very similar to humans genetically.

Researchers will continue their craft on genes that are almost identical to but not quite human, thereby bypassing restrictions.

Regarding being owned, its ok as long as there is an out. People get a mortgage in the hope of living in a better home. They are owned by the banks. But eventually you pay it off and become free of debt. Your family has a roof over their heads.

Same same with something like genetics. If a biologist came to me and offered a 20 year contract of gene therapy to improve my quality of life and extend my lifespan by 80 years.

..Well I might just be inclined to accept this offer.

Nairda
24th June, 2013 @ 04:10 am PDT
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