By Jack Ring
In their forthcoming paper, Solutions Still Searching for a Problem: A Call for Relevant Data to Support “Evergreening” Allegations, C-IP2 Senior Scholars Erika Lietzan of Mizzou Law and Kristina Acri of Colorado College call for relevant data to support evergreening allegations and accompanying policy proposals. Read more
Courts have recently questioned Food and Drug Administration (FDA) determinations. The FDA is the administrative agency whose job is to evaluate scientific data to determine if a drug is safe and effective enough to be approved, and post-approval, to continue to evaluate such data to determine if a drug should remain available. Read more
Professor Robin Feldman’s reply to this post, and our response, can be read read here.
The Center for Innovation, housed at the University of California Hastings College of the Law, has created an Evergreen Drug Patent Search Database (the “Evergreening Database,” or “Database”). Read more
The following post comes from Austin Shaffer, a 2L at Scalia Law and a Research Assistant at CPIP.
By Austin Shaffer
In their new paper, Distorted Drug Patents, CPIP Senior Scholar Erika Lietzan of Mizzou Law and Kristina Acri of Colorado College explore a paradox in our patent system: Innovators are less motivated to work on drugs that take more time to develop as drug research incentives are being skewed away from the harder problems (e.g. Read more
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. Read more
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 property (IP) industries: they are stepping up to make sure crucial information and materials are available to speed research and development (R&D) towards vaccines, therapeutics, and medical devices. Read more
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. Read more
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. Read more
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.” Read more
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. Read more