He’s basically suggesting Andrews could decline an immediate injunction and allow continued infringement temporarily, with money damages compensating UTHR.
That is a much better outcome for LQDA than the “NDA instantly withdrawn” interpretation we’ve been worried about.
And that opens the door to:
PH-ILD stays temporarily on the label → LQDA continues selling → potential damages/royalty accrues → PH-ILD eventually comes off → appeal proceeds. (4)
And that opens the door to:
PH-ILD stays temporarily on the label → LQDA continues selling → potential damages/royalty accrues → PH-ILD eventually comes off → appeal proceeds. (4)
If Andrews accepts that framing, the remedy becomes much more flexible.
Instead of: Patent infringement → statute requires NDA approval reset/withdrawal
you get: Patent infringement → Andrews decides whether an injunction is warranted under eBay, and how broad it should be.(3)
If Andrews accepts that framing, the remedy becomes much more flexible.
Instead of: Patent infringement → statute requires NDA approval reset/withdrawal
you get: Patent infringement → Andrews decides whether an injunction is warranted under eBay, and how broad it should be.(3)
The lawyer’s theory seems to be that because YUTREPIA is already approved and being sold, and the infringement now is actual commercial inducement under the PH-ILD label, the case has moved beyond the classic Hatch-Waxman “artificial infringement” setup. (2)
The lawyer’s theory seems to be that because YUTREPIA is already approved and being sold, and the infringement now is actual commercial inducement under the PH-ILD label, the case has moved beyond the classic Hatch-Waxman “artificial infringement” setup. (2)
So, if I understand correctly, the patent lawyer is making a non-consensus legal call: he does not think §271(e)(4)(A)’s automatic approval-reset remedy applies here. He thinks Andrews is more likely to treat this as an ordinary post-approval patent infringement case. (1)
So, if I understand correctly, the patent lawyer is making a non-consensus legal call: he does not think §271(e)(4)(A)’s automatic approval-reset remedy applies here. He thinks Andrews is more likely to treat this as an ordinary post-approval patent infringement case. (1)
$LQDA
Have to say, I’m really impressed with the Jefferies analysts. They’ve invited a KOL (U.S. patent lawyer) to discuss the case with clients today. Will share if any useful takeaway
@GravityAnalyti1 Frankly I’m more focused on the skinny label. Appeal takes a long time and winning that shouldn’t be the base case scenario here (which is not in this price anyway.) If they can score a stay that’s a win already (again don’t think that’s in the price).
$LQDA
Have to say, I’m really impressed with the Jefferies analysts. They’ve invited a KOL (U.S. patent lawyer) to discuss the case with clients today. Will share if any useful takeaway
@_Ceiv I think my point is slightly different. I’m saying LQDA may be better off starting the PAH-only label process before final judgment, rather than waiting until after and potentially getting stuck with a judgment against the current NDA. Filing now doesn’t mean giving up the appeal
My 2 cents: What $LQDA should ideally do before final judgment is two-track this aggressively: file the PAH-only sNDA with FDA as soon as possible, and ask Andrews to write the judgment in a way that expressly preserves FDA’s ability to approve that amended PAH-only label.
Self-learning on $LQDA: the Norwich precedent is less scary once you see the timing. Norwich removed the infringing indication after final judgment; LQDA is trying to skinny-label PH-ILD before judgment. Whether Andrews sees that distinction as meaningful is key. Welcome thoughts
The reason I’m still holding my positions is that management seems well aware of the best course of action and, so far, appears to be on the ball - at least based on what they’ve told sell-side analysts.
My 2 cents: What $LQDA should ideally do before final judgment is two-track this aggressively: file the PAH-only sNDA with FDA as soon as possible, and ask Andrews to write the judgment in a way that expressly preserves FDA’s ability to approve that amended PAH-only label.
Self-learning on $LQDA: the Norwich precedent is less scary once you see the timing. Norwich removed the infringing indication after final judgment; LQDA is trying to skinny-label PH-ILD before judgment. Whether Andrews sees that distinction as meaningful is key. Welcome thoughts