Law Commons^™

The Trade Origins Of Privacy Law, Anupam Chander

Georgetown Law Faculty Publications and Other Works

The desire for trade propelled the growth of data privacy law across the world. Countries with strong privacy laws sought to ensure that their citizens’ privacy would not be compromised when their data traveled to other countries. Even before this vaunted Brussels Effect pushed privacy law across the world through the enticement of trade with the European Union, Brussels had to erect privacy law within the Union itself. And as the Union itself expanded, privacy law was a critical condition for accession.

But this coupling of privacy and trade leaves a puzzle: how did the U.S. avoid a comprehensive privacy …

Data Privacy, Human Rights, And Algorithmic Opacity, Sylvia Lu

Fellow, Adjunct, Lecturer, and Research Scholar Works

Decades ago, it was difficult to imagine a reality in which artificial intelligence (AI) could penetrate every corner of our lives to monitor our innermost selves for commercial interests. Within just a few decades, the private sector has seen a wild proliferation of AI systems, many of which are more powerful and penetrating than anticipated. In many cases, AI systems have become “the power behind the throne,” tracking user activities and making fateful decisions through predictive analysis of personal information. Despite the growing power of AI, proprietary algorithmic systems can be technically complex, legally claimed as trade secrets, and managerially …

Achieving Privacy: Costs Of Compliance And Enforcement Of Data Protection Regulation, Anupam Chander, Meaza Abraham, Sandeep Chandy, Yuan Fang, Dayoung Park, Isabel Yu

Georgetown Law Faculty Publications and Other Works

Is privacy a luxury for the rich world? Remarkably, there is a dearth of literature evaluating whether data privacy is too costly for companies to implement, or too expensive for governments to enforce. This paper is the first to offer a review of surveys of costs of compliance, and to summarize national budgets for enforcement. The study shows that while privacy may indeed prove costly for companies to implement, it is not too costly for governments to enforce. This study will help inform governments as they fashion and implement privacy laws to address the “privacy enforcement gap”—the disparity between the …

Innovation And Tradition: A Survey Of Intellectual Property And Technology Legal Clinics, Cynthia L. Dahl, Victoria F. Phillips

All Faculty Scholarship

For artists, nonprofits, community organizations and small-business clients of limited means, securing intellectual property rights and getting counseling involving patent, copyright and trademark law are critical to their success and growth. These clients need expert IP and technology legal assistance, but very often cannot afford services in the legal marketplace. In addition, legal services and state bar pro bono programs have generally been ill-equipped to assist in these more specialized areas. An expanding community of IP and Technology clinics has emerged across the country to meet these needs. But while law review articles have described and examined other sectors of …

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 …

The Myths Of Data Exclusivity, Erika Lietzan

Faculty Publications

This article contributes to an ongoing academic and public policy dialogue over whether and on what terms U.S. law should provide “data exclusivity” for new medicines. Five years after a new drug has been approved on the basis of an extensive application that may have cost more than one billion dollars to generate, federal law permits submission of a much smaller application to market a duplicate version of the drug. This second application is a different type of application, and it may cost no more than a few million dollars to prepare. A similar sequence is true for biological medicines: …

A New Framework For Assessing Clinical Data Transparency Initiatives, Erika Lietzan

Faculty Publications

Biopharmaceutical companies submit vast amounts of clinical data and analysis to support approval of their medicines, expecting the information to be kept confidential, as has been the practice of regulators around the world for decades. Over the last ten years, however, pressure has been mounting for regulators or industry to release this information. Legal scholars have generally taken the view that no relevant doctrines or bodies of law preclude the release of this material and that public policy considerations compel its release. This article argues that the scholarship to date has overlooked key considerations: the special issues presented by operation …

Rethinking The Role Of Clinical Trial Data In International Intellectual Property Law: The Case For A Public Goods Approach, Jerome H. Reichman

Faculty Scholarship

This article is a later version of the author's presentation at the Eleventh Annual Honorable Helen Wilson Nies Memorial Lecture March 26, 2008. Clinical trials are currently used to test drugs; however, the risk and cost of clinical trials are increasing so drastically that the clinical trials may become unsustainable. This article evaluates the legal and economic trends of intellectual property protection for pharmaceutical clinical trial data. The protection of clinical trials has become an alternative to patents as market exclusivity encourages the development and testing of unpatentable pharmaceuticals. This author argues that clinical trials should be treated as a …

Le Droit Et Les Reseaux Internationaux D'Information, Joel R. Reidenberg

Faculty Scholarship

Travaux pour obtenir le grade de Docteur De L'Universite Paris I. Discipline: Droit. Sujet des publications: Le Droit Et Les Reseaux Internationaux D'Information