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20 May 2019AmericasMark Remus

Marketing authorisation: Splitting the bill

When done correctly, joint representation by a single law firm of multiple defendants in a Hatch-Waxman litigation provides significant advantages.

However, it’s not without risk and there are several considerations that should be taken into account before moving forward with a joint representation.

A company seeking approval to market a generic drug product in the US must file an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration. In certain circumstances, the owner of a patent that allegedly covers the drug product or its use can then sue the ANDA filer for patent infringement.

For any given drug product, there are typically multiple ANDA filers and, therefore, multiple Hatch-Waxman litigations, all of which involve the same, or nearly the same, patents and drug products.

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