When do post-marketing tests required by FDA not indicate a reasonable expectation of success for a drug combination?  And, what is the interplay between reasonable expectation of success and disclosed ranges in prior art?  Allison Schmitt (BCLT) and Brian Matsui (MoFo) discuss the Teva v. Corcept decision (18 F.4th 1377 (Fed. Cir. 2021)).

 

Featuring Allison Schmitt (BCLT) and Brian Matsui (MoFo).

 

SPEAKERS

Brian Matsui, Allison Schmitt

 

Allison Schmitt  00:00

Hello and welcome to the Berkeley Center for Law and Technology's expert series podcast. My name is Allison Schmitt, and I'm the director of the life sciences project at BCLT. Today, Brian Matsui for Morrison and Forester is joining us for our podcast series beyond the holding a nuanced look at the Federal Circuit's patent decisions. Thanks for joining us again, Brian.

 

Brian Matsui  00:19

Thanks, Ellison.

 

Allison Schmitt  00:21

So today we're going to discuss the recent Life Sciences decision. Teva Pharmaceutical versus Corcept Therapeutics. This is an appeal from a p tag decision on obviousness from a post grant review. We'll go ahead and let Brian take it, take it away. Walk me through the decision.

 

Brian Matsui  00:36

Great. Yeah. So this is a decision that came out in December 7. And it's it's an interesting obviousness decision. It's one of those decisions where you you take a look at it. And I think the first reaction that a lot of people have is there was clearly strong motivation. And it's one of those cases where people think, well, the claims here really seemed like they might be obvious, just as a bit of background. This involves the patent owner Corcept. And basically, they did a clinical trial on a drug mifepristone for Cushing syndrome. And they basically found out from their clinical trial that there are good results for dosages of 300 to 1200 milligrams per day, and they, you know, submitted a new drug application to the FDA, which got approved, but during the approval, they FDA included some post marketing requirements. They basically require the patent owner to do a clinical trial to see if there was a drug to drug interaction between Mfu Crosstown and another type of drug like a strong CYP three a inhibitor, the FDA wanted to see if there's a safety risk if you use those together. So basically, they had to do this additional clinical study. But the drug was approved for 300 milligrams all the way up to 1200 milligrams. But there was a bit of a limitation on that, that you were only supposed to dose at 300 milligrams per day with that other drug that they wanted the patent owner to do a study on. And so this is where it got interesting because course up did a study. And they found out that you could tolerate up to 600 milligrams per day with this strong CYP three a inhibitor and they got a patent on that. And so basically, the FDA told them, you know, in what would be a prior art document that you need to do this, and they did it. And they ended up getting a patent on that. So as a result, Teva sought post grant review, and they thought they had a pretty strong obviousness case, I would think, because they basically had the FDA saying do the study to the patent owner, the patent owner does the study. And then that's what leads to the actual grant of the patent. Well,