The following post comes from Colin Kreutzer, a 2E at Scalia Law and a Research Assistant at CPIP.
By Colin Kreutzer
While the vaccines are starting to roll out in the fight against COVID-19, the precise timelines for when they will be widely available continue to be uncertain. Read more
CPIP has published a new policy brief by Joanna M. Shepherd, Vice Dean and Thomas Simmons Professor of Law at Emory University School of Law. The brief, entitled The Legal and Industry Framework of Pharmaceutical Product Hopping and Considerations for Future Legislation, discusses the practice of so-called “product hopping,” where a pharmaceutical company turns its focus to newer versions of its existing drugs. Read more
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
By Kevin Madigan & Sean O’Connor
This week, the Senate Judiciary Committee was to mark up a bill limiting patent eligibility for combination drug patents—new forms, uses, and administrations of FDA approved medicines. While the impetus was to curb so-called “evergreening” of drug patents, the effect would have been to stifle life-saving therapeutic innovations. Read more
While recent headlines claim that rising drug prices can be easily addressed through government intervention, the procedures involved with government use of patented technologies are complex and often misunderstood. In addition to owning and practicing a vast portfolio of patents, the government has the power to procure and use patented technologies—including pharmaceutical medicines—in limited circumstances without specific authorization, license, or consent. Read more
Innovation is all around us. We love and appreciate the latest video games, software apps, and smartphones. We await the integration of self-driving cars and other forms of artificial intelligence. Beyond the gadgets and luxuries we think we can’t live without, there are even more essential products that affect the lives of millions around the world on a daily basis. Read more
CPIP has published a new policy brief entitled An Unwise Move to Discriminate Against Pharmaceutical Patents: Responding to the UN’s Guidelines for Pharmaceutical Patent Examination.
The brief, written by CPIP Senior Scholar and UMKC Professor of Law Chris Holman, analyzes the UN’s recent Guidelines for Pharmaceutical Patent Examination, which are influential in the policy debates regarding the role of patented pharmaceuticals in public health. Read more
In their new paper, Evergreening of Pharmaceutical Exclusivity: Sorting Fact from Misunderstanding and Fiction, Professors Kristina Acri née Lybecker and Mark Schultz, along with CPIP John F. Witherspoon Legal Fellow David Lund, analyze how the term “evergreening” is used in the context of pharmaceuticals. Read more
