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Preview: Supreme Court Could Determine Biotechnology Industry's Future

Posted 15 April 2013 | By Alexander Gaffney, RAC

Depending upon whom you ask, a case to be heard by the US Supreme Court on Monday will either mark a massive blow to the biotechnology industry and its regulated products or a massive blow to the practice of science, including the ability to use a genetic marker to determine the best course of treatment for a patient. Regardless of the veracity of either side's claim, one thing is clear: the case of Association for Molecular Pathology, et al vs. Myriad Genetics will be enormously important.


The case concerns two well-known genetic patents used in the detection of breast and ovarian cancer, BRCA1 and BRCA2, held by Myriad Genetics, a biotechnology company.

Unlike other patents, where a company might own rights to the patent in its use in a particular diagnostic tool or therapeutic treatment, Myriad patented the genes directly. That's raised some novel-and to some, troubling-legal questions regarding whether those patents ought to be valid.

At issue: Is the genetic code of the human body a patentable entity? If not, will incentives exist to permit investment in the biopharmaceutical and biotechnology sectors? May a patent on a single gene control or prohibit all derivative works in that area?

Difficult questions, all, and ones set to go before the court on 10 a.m. EST on Monday, 15 April 2013.

Essential Reading

  • Argument preview: The right to study genes (SCOTUS Blog)
  • Case History: Association for Molecular Pathology v. Myriad Genetics, Inc. (SCOTUS Blog)
  • Supreme Court wrestles with right to patent human genes (The Hill)
  • Appeals Court Decision from August 2012 (Case)
  • U.S. top court weighs patentability of human genes (Reuters)
  • Will the Supreme Court end human gene patents after three decades? (Ars Technica)
  • Myriad hinges on semantic strategies (SCRIP Intelligence) ($)
  • Justices Consider Whether Patents on Genes Are Valid (NYTimes)
  • Gene Patents: Supreme Court Could Be Swayed By Impact On Research (The Pink Sheet) ($)
  • Supreme Court gene patent decision could affect every patient (NBC)
  • Can human genes be patented? Supreme Court weighs genetic test (NBC)

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