Posts Tagged: "safe harbor"

U.S., EU work towards safe harbor replacement that balances privacy, surveillance concerns

Safe harbor in the world of international digital data transfer has been a major topic of discussion in the tech world in recent weeks. Since 1998, data transferred from European citizens to American shores by U.S. tech companies have been regulated by the U.S.- EU safe harbor agreement. Under these rules, American companies have been able to make international data transfers if they can self-certify that they can keep the personal data of European citizens secure to the privacy standards of the European Union, which operates a much different data security regime than is implemented in the United States. These rules have come under the crosshairs of a recent ruling by the European Court of Justice, the EU’s highest court, which has invalidated the safe harbor agreement in light of revelations made by Edward Snowden on the data surveillance tactics of America’s National Security Agency (NSA).

CJEU declares Commission’s US Safe Harbor Decision Invalid

The decision creates significant uncertainty for organizations who rely on Safe Harbor either for their own, internal data transfers, or because they use a service provider which, in turn, relies on Safe Harbor to provide adequacy for its transfers to the US. Alternative methods of addressing data transfers will be needed – such as implementing EU Commission approved data transfer agreements, or obtaining individual consent. Although the decision has invalidated Safe Harbor – with immediate effect – organizations will need to look to the reactions of national data protection authorities to determine how urgently to implement alternative data transfer solutions.

Momenta Pharmaceuticals: The Hatch-Waxman “Safe Harbor” Widens to Include Post-FDA Approval Activity*

While the Supreme Court may have expanded the reach of the Hatch-Waxman “safe harbor,” the Medtronic and Merck cases only involved pre-marketing FDA approval activity. But the recent split Federal Circuit panel decision in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. has now (alarmingly in my view) further widened the applicability of this “safe harbor” beyond such pre-marketing FDA approval activity. In Momenta Pharmaceuticals, Judge Moore (writing for the majority joined by Judge Dyk) ruled that this “safe harbor” could also apply to post-FDA approval activity, even if that activity was at least arguably commercial in nature.

Divisional of Divisional Reaches Safe Harbor of 35 U.S.C § 121

Some may recall my “dissertation” on the case of Amgen Inc. v. F. Hoffman-La Roche Ltd. See CAFC: A Divisional By Any Other Name Is Not a Divisional .  In Amgen, the Federal Circuit made it clear that you had better characterize an application as a “divisional” if you wanted the benefit of the “safe harbor” provided by 35 U.S.C…