The Biosimilars Act: The United States’ Entry into Regulating Biosimilars and its Implications, 12 J. Marshall Rev. Intell. Prop. L. 322 (2013)

The Patient Protection and Affordable Care Act is most well-known for creating a mandate requiring individuals to have health insurance. However, another provision of the Act, the Biologics Price Competition and Innovation Act, created a new process for companies to introduce biosimilars, products that are highly similar to licensed drugs in terms of purity, safety, and potency, but have minor differences in the inactive ingredients. This provision seeks to alleviate strain on companies introducing biosimilars by creating an abbreviated pathway for their approval by the Food and Drug Administration, similar to an Abbreviated New Drug Application under the Hatch-Waxman Act. This article provides a comprehensive overview of the Biologics Price Competition and Innovation Act and contrasts it with the Hatch-Waxman Act and European Law on Biosimilars. Strategies for patent claiming and resolving patent disputes are then discussed

From Sequential Extraction to Transport Modeling: Monitored Natural Attenuation as a Remediation Approach for Inorganic Contaminants

To quantify metal natural attenuation processes in terms of environmental availability, sequential extraction experiments were carried out on subsurface soil samples impacted by a low pH, high sulfate, metals (Be, Ni, U, As) plume associated with the long-term operation of a coal plant at the Savannah River Site in South Carolina. Despite significant heterogeneity resulting both from natural and anthropogenic factors, sequential extraction results demonstrate that pH is a controlling factor in the prediction of the distribution of metal contaminants within the solid phases in soils at the site as well as the contaminant partitioning between the soil and the soil solution. Results for beryllium, the most mobile metal evaluated, exhibit increasing attenuation along the plume flow path which corresponds to an increasing plume pH. These laboratory- and field-scale studies provide mechanistic information regarding partitioning of metals to soils at the site (one of the major attenuation mechanisms for the metals at the field site). Subsequently, these data have been used in the definition of the contaminant source terms and contaminant transport factors in risk modeling for the site