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US Supreme Court stops patenting of human genes

US Supreme Court stops patenting of human genes

US Supreme CourtThe US Supreme Court unanimously ruled on June 13 that human genes cannot be patented, drawing a red line between “naturally occurring” DNA sequences and similar, artificial genes created in the biotech laboratory. So, natural genes are no longer patentable in the United States, while potentially allowing inventors to retain rights to artificially created DNA.

The issue at question is whether genes, when isolated from the chromosomes in which they reside, are an invention, and therefore eligible for a patent, or a product of nature, which, regardless of the effort or expense involved in its discovery, cannot be patented.

The decision overturns years of policy at the US Patent and Trademark Office in favor of gene patents and could endanger many other granted patents. On the other hand, many of such patents are old and already expired. In recent years The US Patent Office has been less inclined to issue gene patents, especially since researchers have sequenced the entire human genome.

The European patent law has been traditionally more restrictive, allowing only application based, biotechnological patenting of human genes[1].

angelina-jolie

Actress Angelina Jolie

The verdict of the US Supreme Court applied to the case of Association for Molecular Pathology v. Myriad Genetics regarding genetic testing to identify women at risk for breast cancer. The case involved two genes, known as BRCA1 and BRCA2, which Myriad had identified and isolated, where mutations can indicate significant likelihood of breast and ovarian cancer. A popular recent case was actress Angelina Jolie who was diagonized for the genes.

Noah Feldman, professor of constitutional and international law at Harvard University[2], calls it “the Supreme Court’s Bad Science on Gene Patents “, and “shaky reasoning”. He explains “As sensible as this compromise sounds, it doesn’t reflect scientific logic. The court is trying to protect big pharma and our economy without offending basic principles of ethics and law. It may succeed in doing neither”.

Moreover, the ruling contained several scientific inaccuracies[3], as geneticist Dr Ricki Lewis puts it  “the science in something as important as a Supreme Court decision should accurately use the language of the field under discussion”.

It’s not clear yet what will happen in the biotech world. The verdict has also clarified the legal position for the commercially more important complementary DNA (cDNA). cDNA was essentially the backbone for the biotechnology revolution in the 1980s which has since fuelled the rise of multibillion-dollar businesses in gene-based medicine and agriculture, from Amgen, Pfizer to Monsanto.

There are literally tens of thousands of patents claiming DNA that we would not consider to be a product of nature,” and which therefore are not affected by the court´s  decision, according to Prof. Gregory Graff of  Colorado State University, who led an analysis of gene patents published recently in Nature Biotechnology.

Most importantly, even after the Supreme Court ruling, cDNA´s are still eligible for patenting. Jim Greenwood, President and CEO of the Biotechnology Industry Organization (BIO), although not happy with the ruling, issued the following statement[4]:

The Supreme Court today summarily ruled that so-called cDNA remains eligible for patenting.  cDNA is the commercially most important form of DNA used in biotechnology.  Today’s decision offers urgently-needed certainty for research-driven companies that rely on cDNA patents for investment in innovation”

The Supreme Court ruling will quickly open competition in gene testing, breaking the monopoly position of Myriad Genetics. Their share price has already declined by 20% since the verdict.

Myriad GeneticsSuch competition should lower the costs for genetic testing for breast cancer, perhaps dramatically. The price of the test, often more than $3,000, was partly a product of Myriad’s intellectual property. “That price “should come down significantly,” said Dr. Harry Ostrer[5], one of the plaintiffs in the case, as competitors start to offer their own tests. The ruling, he said, “will have an immediate impact on people’s health.”

Yet Myriad, as a result of their previous monopoly position, hold the largest database which still keeps them in leading position in breast cancer diagnostics.

 

 

Christian Schumacher

Dr. Christian Schumacher is the founder and managing director of StepChange Innovations GmbH, a technology development and consulting firm based in Germany. He has more than 20 years of experience in the chemical industry with global players such as Hoechst AG and DyStar Textilfarben GmbH as head of R&D, senior regional business manager Asia Pacific, head of e-commerce, head of marketing services, new product development manager and R&D chemist.

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