Liquidia Gets Supreme
UTHR S.Ct. petition has a non-zero grant chance that could delay LQDA launch further
Just when I thought I was out of writing about Liquidia, it pulls me back in. But that’s ok because this is probably one of the most interesting areas of the law at the moment, despite being historically one of the most tedious.
Yes, we’re talking about admin law!
Many folks probably saw the recent Loper-Bright Supreme Court decision overturning 40 years of federal agency deference called Chevron deference (named after the 1984 Chevron U.S.A., Inc. v. Natural Resources Defense Council case). The Chevron case, at its core, gave federal agencies—who often confront issues of statutory interpretation due to imperfectly-crafted legislation—the ability to interpret the scope of their own powers in applying such legislation, within reason.
Chevron was controversial, to say the least, with many dubbing the ensuing years of agency actions “the Administrative State.” Those on the other side now decry the chaos that may follow the Loper decision, particularly because of language in the decision that seems to leave open the door to challenging prior, upheld decisions. In other words, there will probably be a lot of challenges to agency actions in the near future.
But regardless of your opinion on Chevron deference, one thing is certain: the dismantling of Chevron places quite a bit more pressure on the legislative branch, and that could be good, or it could be bad. The crux is whether or not unelected officials who may have subject-matter expertise should be allowed to interpret poorly crafted laws—laws which, if we’re being honest, are probably unlikely to get any more clear after Chevron.
So what does this have to do with Liquidia?
United Therapeutics, in a move shocking literally no one, appealed the recent Federal Circuit decision to the Supreme Court. United has used every avenue of challenging Liquidia’s entry to the pulmonary hypertension market, and it certainly wasn’t going to stop now. But an appeal to the Supreme Court requires a Constitutional/federal law issue. This is not UTHR asking the Supreme Court to say “we disagree with the PTAB’s evaluation of the evidence.” This is UTHR asking the Supreme Court two things:
to rule that the IPR statute (that thing allowing for the mini litigation at the USPTO) requires de novo review (i.e., no deference to the PTAB’s findings) of the PTAB’s reliance on new grounds and new printed publications, and
to overrule Chevron in the event § 312 (describing petitions for inter partes reviews) is ambiguous (i.e., to ensure the USPTO, as a federal agency, doesn’t get to craft its own interpretation of the patent statute)