Apotex v. Pfizer (Supreme Court)
Orange Book Games: A generic manufacturer asks for a lawsuit when it files an Abbreviated New Drug Application (ANDA) with the FDA along with an assertion that the listed patents either don’t cover the drug or are invalid. That filing gives the brand manufacturer a right to immediately sue for declaratory relief based on a theory of constructive patent infringement.
Sometimes the brand manufacturer decides not to sue immediately — leaving the generic on unsure ground because the brand mfg may be simply waiting to sue until the generic ramps up its operation and is about to go on the market.
In its petition for certiorari filed in February 2006, Apotex questioned this process — arguing that the “prospect of massive patent liability deters the generic manufacturer from entering the marketplace.” Apotex requested that the unsure situation should give the generic a right to pursue declaratory relief. The drug in question here is Zoloft.
The Supreme Court had requested input from the Solicitor General, and have been waiting for that brief since May. In a preemptive move, Pfizer has filed a new brief – asserting that facts on the ground leave the case moot. In particular, Pfizer provided Apotex with an unconditional covenant not to sue Apotex with respect to the patent-in-suit. In addition, Pfizer argues that the case is moot because generic Zoloft is already on the market.