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Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii Jan 2014

Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii

Law Faculty Scholarship

Despite increasing recalls, contamination events, and shortages, drug companies continue to rely on outdated manufacturing plants and processes. Drug manufacturing’s inefficiency and lack of innovation stand in stark contrast to drug discovery, which is the focus of a calibrated innovation policy that combines patents and FDA regulation. Pharmaceutical manufacturing lags far behind the innovative techniques found in other industries due to high regulatory barriers and ineffective intellectual property incentives. Among other challenges, although manufacturers tend to rely on trade secrecy because of the difficulty in enforcing patents on manufacturing processes, trade secrecy provides limited incentives for innovation. To increase those …


Patent Examiners And Litigation Outcomes, Shine Tu Jan 2014

Patent Examiners And Litigation Outcomes, Shine Tu

Law Faculty Scholarship

Conventional wisdom argues that unnecessary litigation of low quality patents hinders innovation, and that the PTO could play a role with its high grant rates. Accordingly, it is important to answer these questions: (1) which patent examiners are issuing litigated patents, (2) are examiners who are "rubber stamping" patents issuing litigated patents at a disproportionately higher rate, and (3) are examiners with less experience issuing more litigated patents? In sum, do patent examiners who issue litigated patents have common characteristics? Intuition would argue that those examiners who issue the most patents (approximately one patent every three business days) would exhibit …