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Full-Text Articles in Law
The Patent Option, Daniel J. Gervais
The Patent Option, Daniel J. Gervais
Vanderbilt Law School Faculty Publications
There is a shift in the shape of intellectual property (IP) tools used to strengthen and lengthen the right of pharmaceutical companies to exclude others from making and marketing their products. Patents have traditionally been the tool of choice. Over the past two decades, however, pharmaceutical companies have increased their degree of reliance on a right known as “data exclusivity.” This right, which now exists in most major jurisdictions, is the right to prevent third parties from relying on the clinical trial data submitted by another pharmaceutical company to obtain marketing approval for a bioequivalent or biosimilar product. The right …
Patenting The Unexplained, Sean B. Seymore
Patenting The Unexplained, Sean B. Seymore
Vanderbilt Law School Faculty Publications
It is a bedrock principle of patent law that an inventor need not understand how or why an invention works. The patent statute simply requires that the inventor explain how to make and use the invention. But explaining how to make and use something without understanding how or why it works yields patents with uninformative disclosures. Their teaching function is limited; one who wants to understand or figure out the underlying scientific principles must turn elsewhere. This limited disclosure rule does not align with the norms of science and tends to make patent documents a less robust form of technical …