Very frustrating for Rs, who feel their whole industry is gaslit by generics, doctors, and governments (who like cheap drugs). But it leads to a paranoid state of pleading where brands say “the generic winked, did you see that? Did anybody see that?” Not gonna work post-Twiqbal.
Huston was excellent in advocating from a tough spot, given the SG. It did lead to a very strange argument that was super fact-laden, including secret new evidence R wants to get out. Kavanaugh and Gorsuch have no appetite for playing district judge and letting R do so.
SG did Klein a huge favor. The SG’s credibility, and Stewart’s in particular, shored-up what otherwise looked to be a “generics should get a heightened pleading standard” argument that seemed a long shot. Instead, it’s a case about how gov-mandated skinny labels can’t induce.
Some of the EU’s ideas are good. Others don’t take speech and security concerns as seriously as most U.S. users would like. To best influence tech company behavior, the U.S. needs to enter the regulatory game domestically and start to bargain with the international rules.
Gorsuch gives us the path to a bit more than a GVR: Twombly killed the “but there are questions of fact about intent!” way of beating 12b6s for plaintiffs. And Fed Cir was wrong to imply gov-mandated labels induce. Nor does repeating that you’re a generic. Remand with just that.
New paper! Taking a de-regulatory stance in the U.S. towards tech companies doesn’t do what its proponents believe it does. It doesn’t give companies freedom of action or support First Amendment values. It causes tech to defer to EU regulations.
ssrn.com/abstract=679...
That’s bad news for Rs and their secret new evidence of intent, since the D. Crt. dismissed with prejudice. Rs may not get leave to amend, putting them in the odd spot of asking SCOTUS to save that for them. Probably not gonna happen.
Barrett calls back to Alito in Chatrie’s “why are we here?” jag; I think in both cases there’s little chance of a DIG or GVR. Here, a GVR in light of Cox doesn’t quite say enough, & there *is* something to say about protection of skinny labels & repeating “I’m a generic of X”.
Otherwise, compliance in tech will implement EU rules by default. My paper, Bargaining with the Brussels Effect, discusses how the U.S. might productively enter the modern regulatory sphere in tech with proposed approaches across privacy, content regulation, antitrust, & AI. ssrn.com/abstract=679...
