Myriad Supreme Court Decision: BIO’s Statement

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Statement On U.S. Supreme Court Review Of Isolated DNA Patents

Washington, D.C. (June 13, 2013) Jim Greenwood, President and CEO of the Biotechnology Industry Organization (BIO), today issued the following statement on  the U.S. Supreme Court’s decision regarding Myriad Genetics’ patent claims on isolated DNA molecules:

“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.

“In other respects, however, the Supreme Court’s decision today represents a troubling departure from decades of judicial and Patent and Trademark Office precedent supporting the patentability of DNA molecules that mimic naturally-occurring sequences.  In addition,  the Court’s decision could unnecessarily create business uncertainty for a broader range of biotechnology inventions.

“The United States is now the only developed country to take such a restrictive view of patent eligibility, signaling an unjustified indifference towards our global economic and scientific leadership in the life sciences.

“The term ’gene patent’ is misleading, because patents cannot cover the genes that exist in humans, plants, animals or microbes.  Patents have never conferred ownership over genes.  Nor have they stifled research, harmed patients, or interfered with medical care, as numerous independent studies have repeatedly confirmed over the years.  The past 25 years have seen an unprecedented explosion of research and scientific publication on the human genome and the genomes of bacterial and viral pathogens.  New biologic medicines, vaccines and tests have become available to treat previously untreatable conditions, benefit patients and improve medical care.  These developments were not impeded by patents – they were aided by patents.

“While Myriad Genetics is not a member of BIO, we do represent companies that research, develop and use modern biotechnology to produce products ranging from life-saving medicines and vaccines to renewable fuels, industrial enzymes and disease-or pest-resistant crops.  Such companies have long relied on patents on preparations of DNA molecules and other biological chemicals in order to bring innovative, socially beneficial products to the marketplace.  BIO will continue its efforts to ensure that these companies and our partners in research universities around the globe can secure the patent protection necessary to continue our common mission to help fuel, feed and heal the world.

Supreme Court Decision in Association for Molecular Pathology v. Myriad Genetics

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2 Responses to Myriad Supreme Court Decision: BIO’s Statement

  1. Thomas Primiano says:

    One could argue that siRNA and mRNA are found naturally in cells and therefore use of said molecules as inhibitors of gene function may not be patentable. While such extension of the ruling, if upheld, would not greatly affect use of siRNAs in research, it would greatly impact their use as therapeutic agents. Perhaps chemical modifications of the “natural” siRNAs to make them more biologically available and stable may provide biopharmaceutical companies engaged in clinical development of siRNAs avenues to overcome the Myriad ruling.

  2. David Dodds says:

    Time to start thinking about DNA and RNA of all types (including those mentioned in the previous comment) as chemical entities, i.e. molecule(s), and do so in the manner of synthetic organic chemists. Many therapeutics (over half – even today) are either found in nature, or are very closely related derivatives of naturally occurring compounds. If Claim 1 of US7250497 had been written (and examined!) from the perspective of a chemist claiming a new therapeutic based on a naturally occurring compound, none of the effort of the past few years would have been necessary. I will blame the (very human, but incorrect) view that because a molecule is a gene (or a protein, etc etc) it is somehow different than a non-biologically derived molecule. It is a shame that so much effort was spent on an issue that should have been seen by all parties as a solved problem with decades of precedent.

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