A Practice Note addressing the key issues a branded drug patent owner's counsel should consider before starting a patent infringement litigation against a generic drug manufacturer under the Hatch-Waxman Act. These issues include the activities that the branded drug patent owner's counsel should perform before an Abbreviated New Drug Application (ANDA) filing and the considerations in the 45-day period after receiving a Paragraph IV Notice Letter. This Note also addresses other considerations, including possible Patent Trial and Appeal Board (PTAB) proceedings, litigation impact on the 30-month stay, and settlement issues.