Law Commons^™

Beyond Compulsory Licensing: Pfizer Shares Its Covid-19 Medicines With The Patent Pool, Chenglin Liu

Faculty Articles

On March 15, 2022, the United States, European Union, India, and South Africa reached an agreement on the waiver of intellectual property rights (IP rights) for COVID-19 vaccines. The waiver agreement has rekindled the debate on the balance between IP rights protection and equitable access to medicines during a public health crisis. India, South Africa, and other developing countries maintain that a waiver was the only way to make vaccines affordable and accessible. Leading pharmaceutical companies argue that the waiver will stifle innovation and make lifesaving medicines less accessible. Both sides have seemingly overlooked Pfizer's voluntary agreement with the Medicines …

Consolidation And Innovation In The Pharmaceutical Industry: The Role Of Mergers And Acquisitions In The Current Innovation Ecosystem, Joanna Shepherd

Faculty Articles

Recent changes in the pharmaceutical industry have spurred an unprecedented wave of mergers and acquisitions. Some researchers and agencies have questioned whether pharmaceutical consolidation could impede drug innovation. However, as I explain in this Article, these concerns are largely based on an outdated understanding of the drug innovation ecosystem. Whereas a few decades ago almost all drug discovery took place inside traditional pharmaceutical companies, today most drug innovation is externally-sourced from biotech companies and smaller firms. Internal R&D is no longer the primary source, or even an important source, of drug innovation. As a result, analyses that focus on the …

Deterring Innovation: New York V. Actavis And The Duty To Subsidize Competitors' Market Entry, Joanna Shepherd

Faculty Articles

This Article examines a relatively new business strategy in the pharmaceutical market -- "product hopping" or "product replacement" -- in which brand pharmaceutical companies shift their marketing efforts from a drug nearing the end of its patent period to a new, substitute drug with a longer patent life. In July 2015, the Second Circuit issued an opinion in the first appellate case addressing pharmaceutical product replacement, New York ex rel. Schneiderman v. Actavis PLC. This Article explains that product replacement is the predictable business response to the incentives created by patent law and state substitution laws, and withdrawing an …

A Continuing Plague: Faceless Transactions And The Coincident Rise Of Food Adulteration And Legal Regulation Of Quality, Denis Stearns

Faculty Articles

Over two decades ago, the Jack in the Box E. coli outbreak, in which five victims died, and hundreds more were seriously injured, dramatically changed the way the world looked at food and food safety. Although deemed “trivial” by tort scholars, who nonetheless used legal doctrines first developed in food cases to justify the extension of strict liability to all products, this article uses the Jack in the Box outbreak as a point of departure for exploring not only the relationship between food, being, and knowledge, but to posit that commerce in food, and the inevitability of profit-motivated food adulteration, …

Prosser’S Bait-And-Switch: How Food Safety Was Sacrificed In The Battle For Tort’S Empire, Denis Stearns

Faculty Articles

In this article, Professor Stearns discusses the legal history of the development of the rules that govern liability for selling unsafe food.

Is Usda Organic A Seal Of Deceit: The Pitfalls Of Usda Certified Organics Produced In The United States, China And Beyond, Chenglin Liu

Faculty Articles

American consumers' appetite for organic foods (organics) has dramatically increased since Congress passed the Organic Foods Production Act (OFPA) in 1990. Because the domestic organic food industry has been unable to meet the growing demand for these products, U.S. groceries have increasingly relied on imported organics. Studies show that 40% of organic foods consumed in the United States are imported from over 100 foreign countries.

To regulate organic food production, the United States Department of Agriculture (USDA) accredits certifying agents, which in turn certify organic farms and handlers according to U.S. organic standards. Certifying agents can be state agencies or …