Pharma Companies Must Factor Tough Standing Requirements into IPR Strategies

April 7, 2021 – Article
IAM Media

Grace Kim is interviewed by IAM and is quoted in an article on the Supreme Court’s recent denial of Argentum’s petition for certiorari, which removes the chance for review of the Federal Circuit’s ruling of lack of standing in Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corporation. The article discusses the tough strategic decisions would-be IPR petitioners must make:

“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 of Oblon. “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.

“For now, we are in the same place where standing is something that needs to be considered before pulling the trigger on an IPR before being sued or threatened with a suit,” Kim suggests, “and then considered again to determine if an appeal is worthwhile in view of the standing briefing that is likely to occur.”