Science and Technology Law Commons^™

Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget

Seattle University Law Review

Since Congress amended the False Claims Act (FCA) in 1986, the statute has evolved into a seemingly boundless weapon for enforcing other statutes and regulations applicable to every industry that accepts any form of government funding. Use of the FCA by the Department of Justice (DOJ) and by private citizens bringing actions on behalf of the U.S. government to enforce other statutes and regulations is particularly evident in the field of health care. The FCA has been utilized in actions where the allegations include off-label promotion of drugs, kickbacks, and violations of current good manufacturing practices (cGMPs) by linking the …

International Trade Law And The U.S.-Eu Gmo Debate: Can Africa Weather This Storm?, Michelle K. Mcdonald

Georgia Journal of International & Comparative Law

No abstract provided.

3(D) View Of India’S Patent Law: Social Justice Aspiration Meets Property Rights In Novartis V. Union Of India & Others, 13 J. Marshall Rev. Intell. Prop. L. 719 (2014), Saby Ghoshray

UIC Review of Intellectual Property Law

Not many constitutional decisions from developing countries find themselves at the center of global debate like the Indian Supreme Court’s Novartis decision invalidating the Gleevec patent. The patent was invalidated under amended Section 3(d) of the Indian Patents Act, which was amended to address some of the concerns of imbalance between the maximalist and minimalist cultures in the pharmaceutical context. Section 3(d) of the Indian Patent Act introduced a new threshold of patent eligibility for pharmaceutical innovation that requires applicants to demonstrate enhanced efficacy of their products. The objective of this Article is to get beyond the reactionary reviews of …

Hatch-Waxman’S Safe-Harbor Provision For Pharmaceutical Development: A Free Ride For Patent Infringers?, 13 J. Marshall Rev. Intell. Prop. L. 445 (2014), Kate Y. Jung

UIC Review of Intellectual Property Law

The Safe-Harbor provision of the Hatch-Waxman Act allows generic drug manufacturers to use a patented invention during pre-market testing of generic drugs. However, the U.S. Court of Appeals for the Federal Circuit’s recent interpretation of the Safe-Harbor provision in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. created controversy when it extended the Safe-Harbor exemption to post-FDA approval. This extension was done in an unprecedented manner and would “allow almost all activity by pharmaceutical companies to constitute ‘submission’ and therefore justify a free license to trespass.” The U.S. Supreme Court has yet to settle this matter, and courts are now faced …

Food Art: Protecting "Food Presentation" Under U.S. Intellectual Property Law, 14 J. Marshall Rev. Intell. Prop. L. 1 (2014), Cathay Smith

UIC Review of Intellectual Property Law

In 2006, a scandal broke in the culinary world. It was alleged that Robin Wickens, chef at (now closed) Interlude restaurant in Melbourne, Australia, had copied dishes by renowned American chefs Wylie Dufresne, Jose Andres, and Grant Achatz. It is not uncommon for chefs to borrow recipes from other chefs, and there has been a long culture of sharing in the cuisine industry. However, what made Wickens’ actions scandalous was that he had purportedly copied the artistic presentation and plating of other chefs’ dishes, not just their recipes.

This Article examines whether chefs can protect the artistic presentation or plating …