Digital Commons Network^™

Throwing Dirt On Doctor Frankenstein's Grave: Accesss To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

Abstract

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research …

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …

The Extraterritoriality Of Eu Data Privacy Law - Its Theoretical Justification And Its Practical Effect On U.S. Businesses, Dan Jerker B. Svantesson

Dan Svantesson

Due to its extraterritorial effect, the European Union’s trailblazing data privacy law has long been a major concern for U.S. businesses. With the proposal for a new data privacy framework in the EU, with potential penalties of up to 2% of an offending enterprise’s annual worldwide turnover, such concerns are justified indeed; particularly as the EU at the same time seems to be expanding the extraterritorial reach of its data privacy law.

This article examines the extraterritoriality of current and proposed EU data privacy law and analyses whether those claims of extraterritoriality can be either justified or objected to by …

Incentives Must Change: Addressing The Unpredictability Of Reasonable Royalty Damages, Daniel Mcmanus

daniel mcmanus

ABSTRACT

INCENTIVES MUST CHANGE: ADDRESSING THE UNPREDICTABILITY OF REASONABLE ROYALTY DAMAGES

Current law encourages patentees and defendants in a patent infringement suit to make the most widely varying arguments for reasonable royalty damages. The parties have so much discretion in presenting calculations for reasonable royalty damages that it is not uncommon for the patentee to request damages 80-100 times greater than the infringer’s proposed damages. Permitting so much discretion makes it highly unlikely that the resulting damages will be reasonable, and thus fails to achieve the goal of determining a reasonable royalty.

The problem is simple. Patents are difficult to …