Law Commons^™

Risk Regulation And Innovation: The Case Of Rights-Encumbered Biomedical Data Silos, Arti K. Rai

Faculty Scholarship

Recent Supreme Court cases on patent-eligible subject matter are likely to exacerbate the longstanding problem of biomedical data fragmentation. For each data silo, multiple overlapping legal claims and claimants must be addressed to achieve the benefits of pooling.

Commentators who have discussed the data aggregation challenge have generally focused on possibilities created through public funding, through collective action by research participants, or through pressure by payers. This Article emphasizes the important role of risk regulators, most notably the precedent offered by risk regulation in the area of clinical trial data.

While U.S. risk regulators have taken some positive steps, the …

Functionality Screens, Christopher Buccafusco, Mark A. Lemley

Faculty Scholarship

Among intellectual property (IP) doctrines, only utility patents should protect function. Utility patents offer strong rights that place constraints on competition, but they only arise when inventors can demonstrate substantial novelty after a costly examination. Copyrights, trademarks, and design patents are much easier to obtain than utility patents, and they often last much longer. Accordingly, to prevent claimants from obtaining “backdoor patents,” the other IP doctrines must screen out functionality. As yet, however, courts and scholars have paid little systematic attention to the ways in which these functionality screens operate across and within IP law.

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