Intellectual Property

Hatch-Waxman ANDA Cases and IPRs

3:00 PM–4:00 PM Jun 5, 2018 (US - Eastern)

Room 208, Level 2


The panel will discuss how Hatch-Waxman (HW) ANDA cases (patent cases between branded and generic pharma) are being impacted by the new Inter Partes Review (IPR) procedures in the Patent Office, wherein parties can ask the Patent Office to find a granted patent invalid. The IPR procedures allow generics and others to invalidate a pharmaceutical patent under a much lower standard than exists in Federal court where HW cases play out. The presence of a parallel IPR procedure in the Patent Office during a HW Federal court lawsuit raises many questions about competing power and expertise between the Courts and the Patent Office, the propriety of the Patent Office's lower standard and whether such dual track procedures advance the goals of HW and the patent system – to promote innovation and also to expedite generic competition.

Ability Level: All

Session ID: 21172