In Hatch-Waxman cases, where is the act of infringement committed, and who commits it?  Allison Schmitt (BCLT) and Seth Lloyd (MoFo) discuss the Celgene v. Mylan decision (17 F.4th 1111 (Fed. Cir. 2021)). 

Featuring Seth Lloyd.

 

SPEAKERS

Seth Lloyd, Allison Schmitt

 

Allison Schmitt  00:00

Hello all 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 Program at BCLT. So today Seth Lloyd from Morrison and Foerster is joining us for our podcast series Beyond the Holding a nuanced look at the Federal Circuit's patents decisions. Thanks so much for joining us, Seth. Happy to have you back.

 

Seth Lloyd  00:20

Yeah, thanks. Awesome.

 

Allison Schmitt  00:22

So today we're going to discuss the November 5th Celgene v. Mylan decision that came down from the Federal Circuit. There's a number of issues to unpack here related to venue and pleading standards. And Seth is going to walk us through all of it. But before we dig into the substance of the decision itself, Celgene discusses a type of case that's different from most of the other cases that we've previously discussed on the podcast. So Celgene arose under the Hatch Waxman Act, which is a complex statutory framework created by Congress, with the goal of streamlining approval of generic drug products in the United States, and creating a framework for the patent challenges to the brand side company's patents prior to marketing the generic drug. So Seth, can you walk us through the background of how these Hatch Waxman cases work so that our listeners can get a sense of how these might be different from the typical patent cases that they're thinking about?

 

Seth Lloyd  01:10

Yeah, I'll give it my best shot. You weren't exaggerating when you said complex, it is a complex statutory framework. But I think there are a few key points to understand for today's case. So in general, as you said, when a completely new drug is coming to market, the party files a new drug application or an NDA, with the Food and Drug Administration. And to get an NDA approved, there's a long process. The parties have to go through clinical studies and and go through several rounds, usually with the FDA to get approval, that tends to be a very lengthy and costly process. And so the Hatch Waxman Act was designed to allow quicker approval for kind of the follow on, so parties who want to market a generic form. So basically the same pharmaceutical formula. But without going through that lengthy process. And what the Hatch Waxman Act allows them to do is to submit an abbreviated new drug application, or an ANDA, as people in the industry call it. And with the ANDA they don't have to submit all the do new clinical trials and submit new data from clinical studies. Instead, they can simply show prove to the FDA that their drug is bio equivalent to an approved drug, it's the same formula, and they can get approval much quicker and with less cost. The part that's going to be relevant to our case today is how does this all work with patents because often, if somebody's come up with a new drug, they've patented the formula or they've patented a new method for using that drug. And so the new drug applicant, that NDA filer will also tell the FDA about any of those patents that covered the drug, or methods of using it, and they'll list those patents in what's called the orange book. Now, later, the company that wants to market the generic version comes along, they have to tell the FDA, what they intend to do with regard to any patents listed in the orange book. They have