Skip to main content
Malcolm Stewart

Malcolm Stewart

Malcolm L. Stewart, Deputy Solicitor General at the U.S. Department of Justice who has argued many Supreme Court cases, including as amicus in Hikma v. Amarin.

Apr 29, 2026

17:37
We -- they -- it's ba- it's the generic of the drug, and so if they're also liable, absent active inducement for people taking their generic and using it in an infringing way, you would think that could happen a fair amount, and it would really be a risk to the bottom line of this generic company.
17:57
Yes.
17:57
I mean, there, there is an intimation, more than an intimation in the respondent's brief that Hikma was doing something wrong by describing its drug in press releases as a generic version or a generic equivalent of, of Vascepa.
18:14
But in fact, that's a, a, a normal thing to say.
18:17
It, it really refers to two different things.
18:19
One of them is under the abbreviated new drug application process, the generic comes on the market not by conducting independent studies of safety and efficacy, but by showing that it is equivalent to a drug that's already been found safe and efficacious.
18:34
And so when Hikma says, "We're the generic version of Vascepa," they just mean- Vascepa is what's called the reference listed drug.

6 MINS LATER

24:57
So what's the answer to that question?

We value your privacy

We use cookies to understand how you use our platform and to improve your experience. Click “Accept All” to consent, or “Decline non-essential” to opt out of non-essential cookies. Read our Privacy Policy.