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Hacking Or Hatching The Skinny Label: How The Federal Circuit’S Decision In Gsk V. Teva Threatens Generics And Induced Infringement, Kayla Mccallum
Hacking Or Hatching The Skinny Label: How The Federal Circuit’S Decision In Gsk V. Teva Threatens Generics And Induced Infringement, Kayla Mccallum
Texas A&M Journal of Property Law
This Note focuses on the recent precedential decision handed down by the Federal Circuit in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., which impacts “one of the greatest public health inventions of the 21st century”: generic drugs. An invention that rose to prominence when former President Ronald Reagan signed into law the Hatch-Waxman Act (“the Act”), formally known as the Drug Price Competition and Patent Term Restoration Act of 1984. The Act aimed to increase competition between brand-name and generic manufacturers while balancing two seemingly opposing interests: (1) encourage and reward innovation by pioneer drug companies and (2) increase access …
Regulatory Fracture Plugging: Managing Risks To Water From Shale Development, Caroline Cecot
Regulatory Fracture Plugging: Managing Risks To Water From Shale Development, Caroline Cecot
Texas A&M Law Review
Debates about the desirability of widespread shale development have highlighted outstanding uncertainty about its health, safety, and environmental impacts—most prominently, its water-contamination risks—and the ability of current institutions to deal with these impacts. States, the primary regulators of oil and gas extraction, face pressure from the energy industry, local communities, and, in some cases, the federal government to strike the right balance between energy production and the health and safety of individuals and the environment—an elusive balance given the ongoing risk uncertainty. This dynamic is not especially unique to fracking, or even oil and gas extraction; instead, this dynamic, characterized …