Recent Developments in the Life Sciences: The Continuing Assault on Innovation by Antitrust Plaintiffs in Lantus

By Erika Lietzan In February, the U.S. Court of Appeals for the First Circuit held, in a direct purchaser antitrust action, that an innovative pharmaceutical company marketing an injectable drug product had “improperly listed” in FDA’s Orange Book a patent claiming a mechanism used in the drug’s delivery device. As I explain below, the ruling … Continue reading “Recent Developments in the Life Sciences: The Continuing Assault on Innovation by Antitrust Plaintiffs in Lantus

IP Industries Step Up in This Time of Crisis

The global COVID-19 pandemic has challenged multiple aspects of modern society in a short time. Health and public safety, education, commerce, research, arts, and even basic government functions have had to change dramatically in the space of a couple months. Some good news in all this is the response of many companies in the intellectual … Continue reading “IP Industries Step Up in This Time of Crisis”

The Tradeoffs Involved in New Drug Approval, Expanded Access, and Right to Try

The following post comes from CPIP Senior Fellow for Life Sciences Erika Lietzan, and it is cross-posted here from the Objective Intent blog with permission. This note explains some of the concepts swirling around in the media right now, relating to medicine approval. Much of what follows appears (or will appear) in an article on … Continue reading “The Tradeoffs Involved in New Drug Approval, Expanded Access, and Right to Try”

CPIP Affiliate Scholar Erika Lietzan Testifies at HJC Hearing on FDA Approval Process

On July 27, 2017, CPIP Affiliate Scholar and Associate Professor of Law at the University of Missouri–Columbia Erika Lietzan testified before the House Judiciary Committee’s Subcommittee on Regulatory Reform, Commercial and Antitrust Law in a hearing on Antitrust Concerns and the FDA Approval Process. The hearing was an attempt by lawmakers to better understand the … Continue reading “CPIP Affiliate Scholar Erika Lietzan Testifies at HJC Hearing on FDA Approval Process”

Innovate4Health: Meeting the Needs of Rural Africa with Fyodor’s Point-of-Care Testing for Malaria

This post is one of a series in the #Innovate4Health policy research initiative. By Jaci Arthur Every year, more than 200 million cases of malaria are reported worldwide. It can often be mistaken for a less serious malady, as symptoms include “fever, chills, and flu-like illness.” If quickly identified, the disease is treatable. Yet more … Continue reading “Innovate4Health: Meeting the Needs of Rural Africa with Fyodor’s Point-of-Care Testing for Malaria”

Proposed CREATES Act Threatens Patent Owners’ Rights

By Erika Lietzan, Kevin Madigan, & Mark Schultz Earlier this month, a bipartisan group of Senators introduced the Creating and Restoring Equal Access to Equivalent Samples Act (or CREATES Act). The proposed bill is aimed at deterring what the bill’s author, Sen. Patrick Leahy, claimed were “inappropriate delay tactics that are used by some brand-name … Continue reading “Proposed CREATES Act Threatens Patent Owners’ Rights”