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Everything New Is Old Again: Patentable Novelty of Nanoscale Chemical Materials Does Not Imply Newness Under the TSCA and the FDCA
Volume 4, Issue 4

Bridget A. O’Leary Smith, Knobbe, Martens, Olson & Bear

Nanotechnology poses special problems for assessing novelty and newness in the patent and in the health and safety regulatory contexts because many engineered nanoscale chemical materials are similar to, if not exactly the same as, their micro- or larger-sized counterparts. A manufacturer will sometimes argue that an engineered nanoscale chemical is “new” for patent purposes but not for other federal regulatory purposes. Whether its claim succeeds depends on whether the definition of new is the same under the Patent Act (which governs “novel” inventions) as it is under the TSCA and FDCA (which govern “new chemical substances” and “new drugs,” respectively). This article investigates what it means to be “new” in the patent, TSCA, and FDCA contexts with respect to engineered nanoscale chemical materials. This article concludes that there is a difference between patentable novelty and novelty for regulatory purposes because the statutes and regulations at issue are designed to accomplish different goals. Therefore, patentable novelty cannot be used as a measure of whether a substance is new for health and safety regulation purposes.

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