Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S (10-844)

argument 10-844

Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S

Supreme Court of the United States 1h 1m 5 speakers 8 chapters transcribed 6 days ago official recording ↗

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What is the statutory framework governing generic drug approvals and patent listings?

John G. Roberts 0:01

We'll hear argument first this morning in case ten eight four four four four four four four four four four four Carico Pharmaceutical Laboratories versus Novo Nordisk. Mr Hearst?

Robert H. Hurst 0:10

Mr. Chief Justice, and may it please the court. Since 1984, whenever an a drug has multiple FDA-approved uses, there has been a statutory path for generic drugs to reach the market if there are specific uses not covered by a patent. Here, there is no dispute that Novo's patent does not claim the use of ripaglanide when used alone And that is an approved method of using the drug. Even though that matches the statutory language Exactly. Novo is arguing that in this case, our counterclaim to correct their blocking use code is thwarted by the fact that their patent does claim a different approved use.

Unknown 1:03

The drug itself They're not claiming that because that that patent has expired, isn't it?

Robert H. Hurst 1:10

That patent has long expired, and they also had a patent using uh for the use of the drug to treat diabetes through any method. And that patent has long expired. The only patent that's left that Novo has is specifically limited to the use of ripaglanide in combination with metformin to treat diabetes. My client, Carico, is attempting to get on the market for Admittedly, non infringing uses which occupy about seventy percent of the market place out there.

Samuel A. Alito 1:44

Suppose I said your brief does not cite a Supreme Court decision. Would that be a correct statement?

Robert H. Hurst 1:55

I believe that that if the con it depends on the the context of the sentence, but I think that would be a correct statement if I understand the way you're asking the question. You are asking the question in a way that suggests to me, by context, you're asking whether I cite any Supreme Court uh uh precedent. But the context here is a little bit different. Because the context here in the counterclaim is a situation where Drugs routinely have multiple and different distinct uses. And in that context Well,

Samuel A. Alito 2:26

we have hundreds and hundreds, probably thousands of of opinions. And you didn't cite there were many of them that you didn't cite. You cited quite a few, but you didn't cite all of them.

Robert H. Hurst 2:37

That's true. That's true. But if i i if when a s when a judge nor when a judge says to me that you know something you're gonna lose this case because you did not cite an applicable precedent, I'm gonna hear that to mean I didn't cite a specific particular case. There are many ways to use the word an after the word not, where it clearly does not mean any. For instance, the prosecutor failed to get a conviction because She did not prove an element of the offense. I got lost on my way to the party because I failed to make a turn. Uh my cake fell because I did not include an ingredient. So the context speaks volumes in terms of whether or not an means any in any particular context.

Unknown 3:22

The the context here one would expect it to say if it meant what you say it meant. uh a did did not claim a use asserted by the generic. Justice Scalia, you're not sure. That is the use asserted by the generic.

Robert H. Hurst 3:47

Well, Justice Clea, I I I I am not equivalent with the fact that this could the the uh statute could have been written more elegantly. Uh my guess is that almost every statute this court is asked to construe, there are different ways that it could have been written to resolve the issue in question.

Unknown 4:02

of elegance, it's a matter of how I would have expected it to be uh to be framed. If it meant what you what you say it means. So easy to say. Does does not claim the use asserted by the generic. My goodness.

Robert H. Hurst 4:18

If and look at the context. The statute does not ask. the brand company to identify an approved use that the patent does claim. It puts the burden on the ANDA applicant to come into court, file a counterclaim, and identify an approved use that the patent does not claim. We've carried that burden twice over. There are two approved uses that the patent does not claim. As I understand your

Samuel A. Alito 4:43

argument. you satisfy the the the ground for seeking uh deletion or correction was satisfied even before Novo wrote the new use code that you claim is overly broad.