The pharmaceutical industry is unique in its complexity. Markets are nuanced. Multiple regulatory regimes apply. Generic entry is an event with dramatic consequences. These characteristics have encouraged brand-name drug firms to engage in an array of conduct that exploits this complexity to delay generic entry. In this essay, I discuss these issues, focusing on two … Continue reading Pharmaceutical Antitrust Complexity…
Category: Blog
Sandoz v. Amgen: Why the Biologics Price Competition and Innovation Act of 2009 Allows Biosimilar Makers to Pursue Pre-Application Declaratory Judgment Actions and Will Enhance Competition
By Carl J. Minniti III (Rutgers-Camden Law Class of 2016) Biosimilar competition has finally arrived. But a pending Federal Circuit case has the potential to restrain this competition before it even starts. A Quick Recap During the 1980’s, with the emergence of biotech firms such as Genentech, pharmaceutical innovation unleashed recombinant proteins, which are also … Continue reading Sandoz v. Amgen: Why the Biologics Price Competition and Innovation Act of 2009 Allows Biosimilar Makers to Pursue Pre-Application Declaratory Judgment Actions and Will Enhance Competition…
Informational Justice as the New Media Pluralism
The London School of Economics Media Policy Project has asked scholars, industry, and policymakers to reflect on this question: what does media pluralism policy look like in the digital age? My contribution argues that we need to have a broader conception of informational justice that encompasses all the ways people circulate information and are influenced … Continue reading Informational Justice as the New Media Pluralism…
Oral argument in 1st appellate case to consider payment under Actavis
In FTC v. Actavis, the Supreme Court held that a brand payment to a generic to delay entering the market could have “significant anticompetitive effects” and violate the antitrust laws. In a narrow, formalistic ruling, the New Jersey district court in In re Lamictal held that such payments were limited to cash. On November 19, … Continue reading Oral argument in 1st appellate case to consider payment under Actavis…
How Not To Apply Actavis
One of the most pressing issues in patent and antitrust law involves agreements by which brand-name drug companies pay generic firms to delay entering the market. In FTC v. Actavis, the Supreme Court held that these settlements could violate the antitrust laws. And while the Court introduced a blueprint for analyzing the agreements, it anticipated … Continue reading How Not To Apply Actavis…