Our Federal Circuitry blog recently discussed the Court's decision in Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc., No. 21-2342.
You should read this case if: you have an ANDA case involving “actual, real-world evidence” that might conflict with what the ANDA says
For our case of the week, we turn to the ANDA world. As readers know and in the simplest of terms, an ANDA is an Abbreviated New Drug Application, which a generic drug manufacturer (which we’ll off-and-on refer to as the ANDA applicant) files with the FDA to seek approval to sell a generic version of a brand name drug. Before the generic goes on the market, the brand manufacturer can file an action to enjoin the generic from reaching the market. Ordinarily, it does so under Section 271(e)(2), which makes it an (artificial) act of infringement for an ANDA applicant to file an ANDA that infringes the brand manufacturer’s patent claims. Section 271(e)(2) requires comparing the patent claims to the ANDA’s specification—as the proposed generic product must meet the ANDA’s specifications.