Amgen Inc. v. Sanofi (21-757)

argument 21-757

Amgen Inc. v. Sanofi

Supreme Court of the United States 1h 39m 8 speakers 8 chapters transcribed 7 days ago official recording ↗

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What is the invention that Amgen claims and how is it described?

John G. Roberts 0:00

We'll hear argument first this morning, case twenty one seven five seven, Amgen versus Sanufi. Mr Lamkin?

William A. Lamkin 0:09

Thank you, Mr Chief Justice, and may it please the court. Mgen invented a new class of antibodies that lower cholesterol, that bind to a small spot on PCS canine, the sweet spot, and thereby block that protein from binding to and destroying LDL receptors that remove cholesterol. Amgen had in hand three hundred and eighty four examples before the Texas article Sanafi sites as hypothesizing such antibodies. before Sanafi began researching PCS canine. This case concerns the reasonable the requirement that patents enable skilled artisans to make and use the invention. The roadmap and Matt Mgen's patents allow skilled artisans to easily make those antibodies every time. Using two new anchor antibodies that cover the entire sweet spot so skilled artisans can be certain to make all the claims antibodies, including defendants' examples.

William A. Lamkin 0:57

The Federal Circuit here never identified a single actual antibody that's in the claims that can't be made or requires undue experimentation. Instead, it invoked something that no one will defend as even relevant here the cumulative effort to make all or some large group of an invention's potentially myriad variations. This Court's cases, however, reflect the Act's pragmatic, boots on the ground focus on enabling skilled artisans who want to practice the invention, on a concrete action making and using the invention. Patents thus satisfy the law when sufficiently definite to guide artisans to successful application of the invention. then there's some practical way of putting them into operation. requiring reasonableness with due regard to the patent subject matter.

William A. Lamkin 1:40

In concrete terms, that means that those who are seeking to over the P overturn the PTO's issuance of a patent and verdicts upholding there here, two verdicts, have to do two things. one, at least have evidence of some variant of the invention, some category that require what this court has called painstaking experimentation. And two, if they identify that Show why that matters to skilled artisans. Because the statue is about skilled artisans seeking to make and use the invention. And reasonableness, not theoretical far corners never shown to affect the ability to do so. I of course welcome the Court's questions.

Clarence Thomas 2:17

Mr. Lampkin, uh would you take a minute and tell us exactly what the invention is?

William A. Lamkin 2:24

Yes, it is the class of antibodies that bind to a particular spot.

Clarence Thomas 2:28

Well let's let's uh uh deal with that. The you only uh uh have twenty-six that you uh have invented, right?

William A. Lamkin 2:38

No, that's not correct. The patent states that there that Amgen had three hundred and eighty-four. There are only twenty-six that are specified by amino acid structure, where you put out in the patent as an example, here's the structure of the um of the um anti-

Clarence Thomas 2:54

So uh d does this process only produce three hundred and eighty six.

William A. Lamkin 2:58

No, Your Honor. It w the the testimony was that it will produce every antibody within the claims. And there's a reason for that. Our expert explained that first, you get a if you do the superimmunization protocol, you get a robust response across the spectrum. And in addition, if the mouse, this is a humanized um uh transgenic mouse, if it has the DNA in it to produce that antibody, it will produce that antibody. antibody. And that uh there was no evidence that there was some particular antibody that was harder to make, that for some reason you would expect it more difficult to come out of that.

Clarence Thomas 3:33

So in other words, you can't say how many.

William A. Lamkin 3:36

No, Your Honor, I think we can say how many, and I think there's two things. Well first, the evidence shows in this art that about four hundred you would get from coming out of the mouse. That's the number that we came up with, the com the number that Sanafi came up with, and anybody else came up with. That's all that's known to date. And you wouldn't expect it to be a large number because it's a very tight, small um sweet spot. It's got unusual hills and valleys.