Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk
Caraco filed an application with the food and drug Administration to market generic diabetes drugs Novo brought to market. Novo filed a use code claiming patent on three ways the drugs can be administered. Caraco filed a document claiming the patent did not cover two uses. Novo sued for infringement. Caraco filed a statutory counterclaim that the use code was invalid as to two methods. The district court granted judgment to Caraco. The Federal Circuit reversed holding the counterclaim was unavailable unless all methods are outside the scope of the patent. The Court unanimously reversed holding the context, regulatory scheme, drafting history and policy of allowing generics to quickly hit the market all pointed to allowing the counterclaim when one or more methods or uses are outside the scope of the patent. Justice Sotomayor added a concurrence pointing out the counterclaim does not create a smoothly function means to resolve issues form overbroad use notices and decrying the opacity of the FDA rules on use notices. (For good measure the Court also noted the New York Mets have no chance at winning the World Series as they have no hitting.)
Delia was suspected of abusing medical leave by his government employer. Filarsky was hired to run the investigation. Filarsky drafted an order for Delia to show some building supplies to his superiors. Delia sued under 42 USC 1983. All defendants except Filarsky were granted judgment based on qualified immunity. Filarsky was denied immunity on the basis he was not a full time public employee. The Court unanimously reversed holding that the common law as of 1871 did not distinguish between full time and part time public employees and no policy reason existed to recognize one. Justice Ginsburg added her view that the 9th Circuit on remand should determine if the order to produce violated clearly established law. Justice Sotomayor added her view that there may be cases where immunity for private government contractors, but, this was not such a case.
