Podcast: Gibbons Institute Hosts Panel on Pay for Delay in Hatch-Waxman Patent Litigation

Seton Hall Law’s Gibbons Institute of Law, Science & Technology and the New Jersey Intellectual Property Law Association presented a panel discussion entitled, “Pay for Delay: Views from the FTC, Industry and Legal Economists on Reverse Payment Settlements in Hatch-Waxman Patent Litigation.”

The pay for delay debate essentially rests on two competing public interests: scientific innovation and access to medicines.  Reverse settlements, which are sometimes referred to as “pay for delay,” involve the practice of name-brand pharmaceutical companies paying would-be generic competitors to delay the entry into the market of a particular generic drug. The Federal Trade Commission and the Department of Justice decry the practice because they claim it results in higher prices for consumers who do not have access to cheaper generics. Many in the brand-name pharmaceutical industry defend the practice because, they argue, extending the patent exclusivity period of an innovator drug better allows innovator companies to improve their return on investment and thus underwrite further research and innovation.

Panelists included Michael Kades, Attorney Advisor, Federal Trade Commission; Charles A. Gallia, Counsel, Gibbons P.C.; Anastasia Winslow, Assistant General Counsel, Bristol-Myers Squibb; and David Opderbeck, Associate Professor of Law and Director, Gibbons Institute of Law, Science & Technology. You can listen to their discussion here.

Hatch-Waxman “Pay for Delay Audio

Former UN Special Rapporteur Paul Hunt on International Law & Health as a Human Right & the Human Rights Responsibilities of Pharmaceutical Companies

Professor Paul Hunt. Photo by Sean Sime Photography

During his week-long visit to Seton Hall Law School, Paul Hunt, Professor of Law, University of Essex School of Law, provided several lectures to students and faculty on international human rights law and health law.  These guest lectures included “Health as a Human Right” in Professor Elizabeth Defeis’ International Law class; “On Human Rights Guidelines for Pharmaceutical Companies” in Professor Kathleen Boozang’s Pharmaceutical and Medical Device Marketing and Compliance Class; a faculty colloquium on “GlaxoSmithKline and the Human Right to Healthcare;” and participation in classroom discussion of human rights issues raised by hospitals’ repatriation of indigent aliens in Professor Lori Nessel’s Immigration & Human Rights Clinic.

In his public presentation, “The Human Rights Responsibilities of Pharmaceutical Companies,” Professor Hunt argued that pharmaceutical companies have certain social/human rights responsibilities, including the duty to take reasonable steps to enhance equitable access to medicines. You can find an audio recording of this presentation below as well as copies of Professor Hunt’s Reports to the UN General Assembly regarding “the right of everyone to the enjoyment of the highest attainable standard of physical and mental health,” and “the responsibilities of pharmaceutical companies, including innovator, generic and biotechnology companies, with regard to the right to health in relation to access to medicines.”

Professor Hunt practiced as a litigation solicitor in London before specializing in international and domestic human rights law.  He has undertaken human rights work in Europe, the Middle East, Africa and the South Pacific.  From 2002-2008, he served as a UN Special Rapporteur on the right to the highest attainable standard of health, and in 2008, was awarded Honorary Doctorate by the Nordic School of Public Health.  He is a member of the Human Rights Centre at Essex University and Adjunct Professor at Waikato University, New Zealand.

Professor Hunt’s lecture can be streamed to your browser by clicking on the link below. Clicking on this link will also provide you with a link to download the mp3. Click here to listen to Paul Hunt’s Lecture

The two UN reports mentioned by Mr. Hunt can be accessed by clicking on the thumbnails or captions below:

UN Report on Right to Health	UN Report on GlaxoSmithKline

Recording of Sam Maizel’s Discussion of Distressed Hospitals

A noted expert in the restructuring of health care business debts, both in and out of court, Sam Maizel treated Seton Hall to a one hour crash course on the fiscal crisis encountered by many of America’s hospitals. The significant financial hurdles that the hospital industry is facing has made the bankruptcy process that many hospitals encounter one of the fastest growing fields in health law.

Mr. Maizel has represented the federal government as a trial attorney in the U.S. Department of Justice’s Commercial Litigation Branch. He also served in the JAG Corps in Operation Desert Shield and Desert Storm after serving in the 101^st Airborne Division and the 3^rd US Infantry Regiment. Mr. Maizel now practices in Los Angeles for  Pachulski Stang Ziehl & Jones LLP.

You can download Mr. Maizel’s talk here, or alternatively, you can stream it to your browser by clicking “Play” below:

Recording of Professors Tim Greaney, John Jacobi, Frank Pasquale, and Sidney Watson Discussing Health Reform

On Friday, April 9th, Seton Hall was treated to an expert round table discussion on the new health reform measures.

Visiting professor Tim Greaney, as well as Seton Hall’s John Jacobi and Frank Pasquale, joined Professor Sidney Watson from Saint Louis University School of Law, to discuss the historic health care legislation to a packed crowd.  Dean Kathleen Boozang served as the moderator of the panel discussion.

Topics discussed included a general overview of the Patient Protection and Affordable Care Act (PPACA), a discussion of the statute’s affect on Medicaid and Medicare, and the constitutionality of the individual mandate.

The panelists also discussed the strategies that they believe are required to properly implement PPACA’s immediate reforms, as well as the statute’s long term goals.

For background on PPACA, the Kaiser Family Foundation has posted a summary of the statute discussed by the panelists.

A recording of the round table discussion can be downloaded in MP3 format here. Alternatively, the recording can be streamed to your browser by clicking on the Play button below.