Robinson Bradshaw

Topic: safe harbor

EU Adopts New Privacy Shield for Data Transfers to U.S.

Back in April, we reported on some new developments in European Union law that have implications for the life sciences industry. One of these developments was in the privacy area—the final approval of the EU’s new General Data Protection Regulation (GDPR). The GDPR will have enormous significance for medical research and practice, since it will […]

Recent Developments in European Law with Implications for the U.S. Life Sciences Industry

The last several months have seen several developments in European privacy and intellectual property that have significant implications for life sciences interests—both commercial and academic—in this country. Here is a brief review: 1. Final Approval of Pending EU General Data Protection Regulation On April 14, 2016, the Parliament of the European Union gave final approval […]

News Roundup: Patent Reform Passes House, Human Provenance Project Pulled by UK

With so many developments at the intersection of genomics and the law, there is often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. In this post we recap several recent key developments and, at bottom, round up all of […]

Update: Proposed Second Opinion Safe Harbor for Genetic Diagnostic Testing Withdrawn

We reported yesterday on a proposed Patent Act amendment that, if successful, would create a safe harbor for second opinion genetic diagnostic testing. While conceptually simple, the proposed amendment would have left genetic testing developers and providers, patent holders and courts with considerable uncertainty about the safe harbor’s appropriate interpretation and application. Initially offered by Representative Debbie Wasserman […]

House Introduces Patent Reform Proposal to Permit Second Opinions in Genetic Diagnostic Testing

When we last checked in on the state of patent reform back in March, the Senate had just passed the America Invents Act (S.23) or, as it is more commonly known, the Patent Reform Act of 2011 (pdf) by an overwhelming 95-5 vote. Following its passage in the Senate, the legislation promptly stalled in the House […]