Pharma Companies Must Factor Tough Standing Requirements Into IPR Strategies
“Companies, particularly in the generic pharma space, face a strategic decision over when to file at the PTAB,” comments Rachel Elsby of Akin Gump. “If you decide to clear the deck early, you have to bear the risk that you will not be able to appeal an adverse decision. If you wait, there are downsides to that too, because you may already be into district court litigation, which has significant costs associated with it.”
In innovator-versus-innovator disputes, where infringement questions may be less clear-cut, further risks exist. “The practical reality is that IPRs aren’t cheap, so there is almost always a real-world dispute underlying the IPR’s filing, which current IPR standing law doesn’t adequately address,” comments Grace E. Kim. “The current law puts certain petitioners in an unfortunate bind where they need to not only consider the technical merits of the IPR decision when determining whether to appeal, but also whether they want to create a record about the potential for an infringement suit,” she continues.
Source: Law Business Research