abbreviated new drug application (ANDA)

Litigators in the life sciences field are no doubt familiar with the so-called “artificial” act of infringement established by 35 U.S.C. § 271(e)(2)(A)-(B): namely, that a party can be sued for patent infringement by merely filing an Abbreviated New Drug Application (“ANDA”) for a generic drug or a Biologics License Application (“BLA”) for a biosimilar drug. The filing of such an action can allow for, among other things, the resolution of patent infringement disputes before the generic (or biosimilar) drug enters the market. 

When a pharmaceutical company withdraws a product from the market, the basis for the withdrawal can affect whether a competitor can commercialize a generic version of that product. A generic cannot be approved if, in the FDA’s view, the product was withdrawn for “safety and effectiveness” reasons.

But how does the FDA reach that conclusion? A newly filed case may shed some light on the Agency’s decision-making process.