Power Alley: When Is A Generic's FDA Label... "Skinny" Enough? New Cert. Granted, On The Issue, At US Supremes...

So -- back to an old topic: how to be certain that the reforms wrought about 40 years ago now, by Hatch-Waxman (to more readily encourage lower priced but safe generics to reach US shelves sooner). . . remain the effective law of our land -- even as branded manufacturers try to chip away at such competition -- in the courts around the nation?

This latest case (out of the erroneous ruling on appeal in the Federal Circuit) was just granted a review on this past Friday -- by the Supremes. We will now follow it closely, as it will without a doubt potentially impact tens of billions of dollars in savings, on genrics, to US consumers -- in the years ahead, if correctly resolved in favor of the generics, here:

. . .This case offers another chance to review the Federal Circuit’s erosion of section viii and § 271(b) -- with a much better vehicle than GSK, where the Federal Circuit credited alleged evidence that the generic drugmaker’s “partial label instructed the method of use claimed.” 7 F.4th at 1328. Here, it is undisputed that Hikma’s label is “skinny enough.” App. 13a, 17a.

This case [if not corrected at the Supremes, by a cert. petition] thus confirms what the dissent in GSK predicted: “a generic can be deemed liable for inducement for saying that its product is a ‘generic version’” -- “a drastic holding” that “makes little sense.” 7 F.4th at 1353 (Prost, J., dissenting). . . .

In short, the decision below is an imminent threat to generic competition, which is critically important to the U.S. healthcare system. And the “very permissive pleading standard for induced infringement” that the decision creates will dramatically expand the risk of inducement liability, even “outside of just the pharmaceutical context. . . .”

We will -- of course -- now keep you posted. Onward, smiling -- and do note: the experimental theater last evening was at once wildly maddening, moving, and inspiring. . . so, we will be thinking, and acting. . . on it, for many months to come, indeed.

नमस्ते