On October 5, the United States Supreme Court agreed to review the case Bowman v. Monsanto Co., Docket No. 11-796 (USSC 2012). The high court will be taking on the question of patent exhaustion in seeds, specifically Monsanto’s “Roundup Ready” seeds. Monsanto sells the seeds, which grow into plants resistant to the herbicide glyphosate,

The Hatch-Waxman Act, a federal law passed in 1984, was designed to streamline the process for bringing generic drugs to market. Under the law, generic drug manufacturers may file an abbreviated new drug application (ANDA) with the FDA toward approval for generic versions of already-approved drugs.
Such filings are founded on bioequivalence studies instead of clinical studies. In the filings, generic manufactures also must certify that the listed drug is not patented, that the patent has expired or that the patent is invalid or will not be infringed by the generic drug.

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The Food and Drug Administration has issued two new guidances affecting genomic technologies and genetic testing, including one detailing its policies for making risk-based assessments of medical devices, and another covering the process for the submission of genomic biomarkers for qualification by regulatory authorities.

The guidance on biomarkers includes recommendations covering the types of information