The US Supreme Court [official website] heard arguments [day call, PDF] on Wednesday in Amgen Inc. v. Sandoz Inc. and Maslenjak v. United States [transcripts, PDF]. In Amgen Inc. v. Sandoz Inc. [SCOTUSblog backgrounder], the court is asked to determine how much patent protection should be afforded to drugs that are “biosimilar” to “biologics.” Biologics are complex bio-engineered drugs, and when their patents expire generic drug companies are usually free to enter the market with the same drug. However, because biologics are so complex, only biosimilar rather than identical drugs can be produced after the patent expires. The Affordable Care Act [HHS backgrounder] contains a biologics provision [text, PDF] that was intended to streamline the FDA approval process for biosimilar drugs.
In Maslenjak v. United States [SCOTUSblog backgrounder], the court is asked to resolve a circuit split on the question of whether naturalized US citizens can be stripped of their citizenship in a criminal proceeding based on an immaterial false statement. The case arose when Divna Maslenjak moved to the US from what is now Bosnia and became a US citizen seven years later. Recently her citizenship was revoked when it became known that she made false statements to immigration officials during the naturalization process. She argues that while she did lie, she should not be stripped of her citizenship because her false statements were not material to the decision of whether she should be granted citizenship. The question turns on whether such materiality is relevant in the determination.