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Supreme Court Nixes Patenting Human Genes

The Justices have decided that isolated sequences of human DNA are not eligible for patent protection, but rules that artificial sequences can be patented.
 

By | June 13, 2013

WIKIMEDIA

The United States Supreme Court has today (June 13) unanimously ruled that isolated human genes cannot be patented, but the Justices also ruled that synthetic DNA sequences—known as complimentary DNA (cDNA)—are eligible for protection. “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” wrote Justice Clarence Thomas, “but cDNA is patent eligible because it is not naturally occurring.”

The decision throws out patents held by Utah-based Myriad Genetics on two genes—BRCA1 and BRCA2—that when mutated cause breast and other types of cancer. Researchers, physicians, and patients who sued Myriad are claiming victory because the ruling means that the company no longer has a monopoly on diagnostic tests based on these two genes. This could result in increased competition, falling costs, and greater access for low-income patients.

“The Court struck down a major barrier to patient care and medical innovation,” Sandra Park, an attorney with the American Civil Liberties Union Women’s Rights Project, told USA Today. “Myriad did not invent the BRCA genes and should not control them. Because of this ruling, patients will have greater access to genetic testing, and scientists can engage in research on these genes without fear of being sued.”

Francis Collins, Director of the National Institutes of Health, added: "The decision represents a victory for all those eagerly awaiting more individualized, gene-based approaches to medical care. The right to control exclusively the use of a patient's genes could have made it more difficult to access new tests and treatments."

The decision is also something of a compromise, however, because it allows biotech companies to patent artificial DNA sequences. Myriad and other companies had argued that a ruling against gene patenting would undermine billions of dollars of investment from the biotech industry and impede medical progress. With this ruling, they still have ways to profit from their research.

Update (June 13): This article has been update to include a quote from NIH Director Francis Collins.

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Comments

Avatar of: FrankieK

FrankieK

Posts: 2

June 14, 2013

This is a winning descision that keeps the costs down by  eliminating a monopoly on research and development.

Avatar of: jtrott

jtrott

Posts: 6

June 14, 2013

Why has the Supreme Court ruled that cDNA is not naturally occuring?  It's just the compliment of mRNA which is naturally occurring and directly transcribed from a natural gene.  cDNA sequences are determined by naturally occuring gene sequences.  Companies can get past this patent ruling by saying they sequenced the cDNA of a gene and they're patenting that, rather than the gDNA sequence - but it's exactly the same thing!

Avatar of: FJScientist

FJScientist

Posts: 24

June 14, 2013

As a thought experiment, exchange 'hormone' for 'gene'. If I purify the hormone, can I patent that hormone as a novel composition of matter (no). Can I obtain use patents on the hormone for the treatment of specific diseases (yes). Can I patent a technique to measure the hormone (yes). Can I stop others from applying alternative methods to measure or use the hormone (no).

So, it is with a gene. There is no 'composition of matter' patent possible because it is not a novel item that I have manufactured. But, I can define uses for the gene, validate that specific use in extensive studies and expect that the risk I take in that validation for a specific use will be covered under a patent. However, I do not 'own' the gene and can not prevent others from developing alternative methods that they also will validate and apply.  

In the case before the Court, the question then is who defined that BRCA1 and BRCA2 were associated with breast cancer (I tend to remember the laboratory of Mary Claire King at Univ of California Berkeley, but do not quote me on that). Myriad developed a commercial test based on that prior art. If Myriad employed a generally used method for detecting a mutant that is in the public domain, then they have done little more than create a kit. One can patent that kit and ensure that someone else doesn't replicate it.  But they can not claimi ownership of the gene and hinder others from detecting it by alternative means. Of course, I do not know what patents were filed by whom for what in this particular case. But the general outline above is what makes sound scientific and legal sense.

I agree with the comment from 'jtrott' that the distinction between cDNA and gene is utter nonsense and just reflects a Court ruling on an item that was beyond its understanding. Unfortunately that bogus distinction is now ensconced in a flawed legal interpretation and I think scientists everywhere should be howling. I think the justices (and the persons arguing the case), got confused by the notion that a gene is somehow different than any other biologic. It is not and there is ample precedent patent law relevant to other biologics (like hormones) that the court's decisions and distinctions should have drawn upon.

 

Avatar of: Márcia

Márcia

Posts: 1

June 16, 2013

Thanks for the article. I have to say that I agreed with de Court decision.

My doctoral thesis  Juridical and Bioethical approach
about the patents related to human stem cells (from Federal University in Porto Alegre, Brazil – UFRGS, defended in 2008), supervise by Dr. Jur. Judith Martins-Costa and co-supervised by a medical doctor Dr. MD. Mariano da Rocha Lucia Lucia Silla),  today object of my book Bioethics and Medical Law (FERNANDES, M.S.. Bioética, Medicina e Direito de Propriedade Intelectual – Relação entre patentes e células-tronco humanas, São Paulo: Editora Saraiva, 2012), was very similar the position of the U.S. Supreme Court in the case of the ban on gene patents.

The Brazil prohibits the patenting of body parts or goods of life and also understand that patents must be connected to inventions and not pure discoveries. In fact the rank of cells and human genes is not the appropriate legal instrument to ensure the incentive to R & D, to safeguard public health or even create opportunities for the democratization of knowledge acquired through cell or human genes research.

For this reason, however, the Brazilians should not allow the change of the Industrial Property Law, the Legislature's proposal to change specifically articles 10, section IX, and 18, III of Law (Act) No. 9.279/1996, in order to authorize patents cells or genes. The Bill 4.961/2005 is under evaluation by the Commission of Science and Technology, Communication and Informatics (CCTCI) of the brazilian Congress.

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