Rachel Elsby Quoted in IAM on Issues of Standing in IPR Cases
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Rachel Elsby, an intellectual property partner at Akin Gump, has been quoted in the IAM article “Pharma companies must factor tough standing requirements into IPR strategies.” Following a decision by the U.S. Supreme Court not to review a ruling by the Federal Circuit in Argentum Pharmaceuticals v. Novartis Pharmaceuticals, the article looks at some of the issues of standing that inter partes review (IPR) petitioners face when challenging patents.
The article reports that the decision by the Supreme Court ended Argentum’s bid to overturn the outcome of a Patent Trial and Appeal Board (PTAB) ruling that it, along with several others, had failed to show that a Novartis patent protecting a multiple sclerosis treatment was invalid. Novartis subsequently sought to have Argentum’s appeal against this decision dismissed for lack of standing.
While anyone can file an IPR in an appeal of a PTAB decision, IAM notes, a party must demonstrate that it has suffered a “concrete and particularized” injury in-fact or that it is “actual and imminent, not conjectural or hypothetical.”
“Companies, particularly in the generic pharma space, face a strategic decision over when to file at the PTAB,” said Elsby. “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.”
The article says the case in question suggests that the manufacturing partner in a collaboration must take on responsibility for filing any IPRs.
“That might have changed the calculus [in the Argentum dispute], but it’s not clear whether it would have led to a different outcome in the facts of this case,” said Elsby. “Certainly, I think if you know that your partner is responsible for filing the ANDA [abbreviated new drug application], it is that party whose name should be on the IPR.”
“To me the most interesting question to come out of Argentum is: What economic investments would be enough to get standing short of filing an ANDA?” Elsby added. “The Federal Circuit’s precedent establishes that you don’t necessarily need to have filed the ANDA to have Article III standing. But where is the line that gets you there?”
Elsby co-authored a blog post about the Argentum case last year for Akin Gump’s IP Newsflash. Click here to read it.
