• Regulatory NewsRegulatory News

    Asia Regulatory Roundup: China to Strengthen Oversight of Medical Device Manufacturing (13 October 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Details New Approach to Medical Device GMP in Four Guidance Documents China Food and Drug Administration (CFDA) has moved to strengthen its oversight of medical device manufacturing. The new approach is detailed in four guidance documents covering medical device good manufacturing practices (GMPs), in which CFDA explains its approach to on-site inspections. CFDA...
  • Feature ArticlesFeature Articles

    US Supreme Court Decision in Myriad: Are Genes Patentable?

    • 13 August 2013
    The pharmaceutical and life sciences industries waited anxiously for the Supreme Court's decision in Association of Molecular Pathologists v. Myriad Genetics (" Myriad") 1 The high court's decision, handed down 13 June 2013, will have a significant impact on the pharma and device industries as they relate to human genes and genetic material. The decision found that naturally occurring genes cannot be patented, but synthetically produced genetic material remains patent...
  • BREAKING: Supreme Court Rules Naturally Occurring DNA is Not Patentable

    In a landmark decision, the Supreme Court has decided in favor of the Association for Molecular Pathology in its case against Myriad Genetics, ruling that naturally occurring DNA is not patentable, while synthetic DNA is. Background The case, heard in April 2013, concerned patents held on two genes, BRCA 1 and BRCA2, which are closely linked to a woman's risk of breast and ovarian cancer. Myriad Genetics, a biotechnology company, owned the patent rights to the use of th...
  • After Prometheus Case, SCOTUS Sends Gene Patent Ruling Back to Lower Court

    • 27 March 2012
    The Supreme Court of the United States (SCOTUS) ruled Monday (26 March) to send a case by Myriad Genetics Inc. back to a lower court for review in light of its recent decision, Mayo Collaborative Services v. Prometheus Laboratories , in which the court decided Prometheus's patents on methods to determine the proper dosing for a disease were invalid . In Association for Molecular pathology v. Myriad Genetics , SCOTUS was to consider whether patents held by Myriad on t...