Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

Filing 485

DECLARATION re #482 MOTION for Summary Judgment That Claim 1 of the '422 Patent is Invalid Under 35 U.S.C. Sec. 112 of Krista M. Rycroft by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc.. (Attachments: #1 Exhibit 1#2 Exhibit 2#3 Exhibit 3#4 Exhibit 4 (part 1 of 4)#5 Exhibit 4 (part 2 of 4)#6 Exhibit 4 (part 3 of 4)#7 Exhibit 4 (part 4 of 4)#8 Exhibit 5#9 Exhibit 6#10 Exhibit 7#11 Exhibit 8#12 Exhibit 9#13 Exhibit 10 (part 1 of 4)#14 Exhibit 10 (part 2 of 4)#15 Exhibit 10, part 3 of 4#16 Exhibit 10 (part 4 of 4)#17 Exhibit 11#18 Exhibit 12#19 Exhibit 13#20 Exhibit 14#21 Exhibit 15#22 Exhibit 16#23 Exhibit 17)(Rizzo, Nicole)

Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

Doc. 485 Att. 3

Case 1:05-cv-12237-WGY

Document 485-4

Filed 06/11/2007

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UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS Civil Action No. 05-12237-WGY ***************** * AMGEN, INC., * * Plaintiff, * * v. * * F. HOFFMANN-LA ROCHE LTD, * ROCHE DIAGNOSTICS GmbH and * HOFFMANN-LA ROCHE, INC., * * Defendants. * * ***************** BEFORE: APPEARANCES: DUANE MORRIS LLP (By Michael R. Gottfried, Esq.), 470 Atlantic Avenue, Suite 500, Boston, Massachusetts 02210 - and DAY CASEBEER MADRID & BATCHELDER, LLP (By Lloyd R. Day, Jr., Esq., Linda A. Sasaki-Baxley, Esq. and Jonathan Loeb, Ph.D.) 20300 Stevens Creek Boulevard, Suite 400, Cupertino, California 95014 - and McDERMOTT WILL & EMERY (By William G. Gaede, III, Esq.), 3150 Porter Drive, Palo Alto, California 94304 - and WENDY A. WHITEFORD, ESQ., Of Counsel, Amgen, Inc., One Amgen Center Drive, Thousand Oaks, California 91320-1789, on behalf of the Plaintiff 1 Courthouse Way Boston, Massachusetts April 17, 2007

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MARKMAN HEARING

The Honorable William G. Young, District Judge

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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 is predicated on an expert report not before the Court, is inconsistent with what they acknowledge. This -THE COURT: Well, we're trying to get at the best construction. MR. DAY: I understand. THE COURT: You do have, you do have a problem with that position 166. I mean, her argument does resonate. MR. DAY: No, we don't have a problem with that. THE COURT: All right, tell me why. MR. DAY: And the reason we don't have -- because these are -- this is human erythropoietin purified from mammalian cells grown in culture. And the cells cleave off the 166 amino acids. And Lin produced and made and had in his possession an EPO that was produced by mammalian cells grown in culture. So he possessed a 165 species of human erythropoietin when he filed his application. THE COURT: But he didn't know it. MR. DAY: Oh, did he, did he know it? THE COURT: Well -MR. DAY: He possessed it. THE COURT: Well, let's just go back. MR. DAY: But, no, your Honor, this is an important point. THE COURT: Go ahead. MR. DAY: You asked a very good question and it's

MR. DAY: That's correct. She will, she will disagree. It has been many, many years since this invention was made and nobody has yet found another way to do what Lin did. So, in the case of a pioneering patent, then in a pioneering patent claims are ordinarily entitled to a broader scope. Amgen's claims are both broad and they are narrow. They are not uniformly broad. The impulse to claim broad is not unchecked. There is also a reason to claim narrowly, and Amgen claims narrowly as well. THE COURT: To, to avoid anticipation. MR. DAY: Not to avoid anticipation. By claiming narrowly, you can delimit what it is that an accused embodiment must have in order to infringe. If you claim a lot then the accused embodiment has to have all of those things. And that, of course, is what's going on here. Roche is trying to blow this claim out to include more and more things in the meaning of human EPO in order to argue we don't have this, we don't have that, we don't have that. So you can claim both broadly and you can claim narrowly. So the question is in the context of this claim, '422, claim 1, where you have to look at the entire claim language, in the context of this claim what does the claim term human erythropoietin mean. That's the issue for the Court. I have some binders, too, that I would like to hand

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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 an important point. But it's irrelevant. It's irrelevant whether he knew it. What is relevant is whether he possessed it and he taught others how to get the same thing. That it was later discovered to be 165 and not 166, not what he had deduced it to be, is irrelevant. THE COURT: Well, I understand that's your position. MR. DAY: Okay. The second thing is, that Roche seeks to add to this claim is having the structure that would be produced in mammalian cells as of the invention date. Now, let me ask you to turn the page and I'll illustrate for you what the difference is first of all between these two constructions. On the left you have a picture of Amgen's construction. Amgen construes human erythropoietin as referring to the amino acid sequence of human erythropoietin as isolated from urine. Roche construes human erythropoietin as referring not only to the amino acid sequence but also to all of the glycosylation that's attached to that sequence by the cells. And they say there is one structure. They call it the structure. And so there's only one such structure. Now, what's wrong with Roche's construction? Why is it inconsistent with the other claims, with the

up to the Court, if I may. Could you give them some to opposing counsel. Okay. And these are simply the slides that I will be talking about. The first thing that I want to illustrate for the Court is the difference in the claim construction that Roche proposes and Amgen proposes. Amgen's construction is a protein having the amino acid sequence of human EPO, such as the amino acid sequence of EPO isolated from human urine. Now, the question for the Court in considering that, is that consistent with the other claim language, is that consistent with the specification, is that consistent with the prosecution history, as to what that term human erythropoietin means in the context of the entire claim, '422, claim 1. Roche's construction differs. And I've highlighted on the right what is importantly different about Roche's construction. First of all, they say it's not a protein. They say it's a glycoprotein. That means that it must have glycosylation. It has the amino acid sequence of erythropoietin isolated from human urine. So they agree with us about the amino acid sequence. This argument you just heard from Ms. Ben-Ami, which was not in their papers, was made for the first time this morning on oral argument,

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specification, with the prosecution history? Okay, the first thing is they would require that the human erythropoietin be glycosylated. That, that structure is not provided by the term human erythropoietin as the Court will see. That structure is provided by the fact that it's produced in mammalian cells. And that's why the source limitation in this claim is so important. As Roche's own expert, Dr. Kadesh, in the declaration that Roche submitted in support of their claim construction, describes in detail glycosylation is a cell by cell dependent function. The cell determines what glycosylation goes on a protein. The glycosylation that will be put on a protein varies by cell species. Different species of cells will glycosylate proteins differently. That's all laid out very clearly by Dr. Kadesh. This was well understood by those of ordinary skill in the art. It's the fact that the protein is produced in a mammalian cell that gives it certain types of glycosylation. A certain structure beyond the amino acid sequence. Roche then says it must have the identical glycosylation as originally attached by the cell. So, in other words, there can't be any post-expression changes in the molecule. That's the other thing they're trying to do. They're trying to narrow the scope of this claim so that human erythropoietin, that amino acid sequence, which is Page 31

erythropoietin glycoprotein shows that when Lin is referring to human erythropoietin he is saying nothing about whether it's glycosylated or not. The second thing is that Lin's specification makes clear that the polypeptides of the invention may or may not be glycosylated. There's no necessary requirement. The only thing that requires in '422, claim 1 the human erythropoietin to be glycosylated is the fact that it is produced in mammalian cells and purified from mammalian cells grown in culture. And that step, that source from which the EPO's obtained imparts a structure in addition to the amino acid sequence of human erythropoietin. The last thing in the specification that is critical to understand is that when Lin took his DNA, he did not express it only in mammalian cells. As described in Examples 11 and 12 of the patent he also expressed it in E.coli. E.coli does not glycosylate. There is no glycosylation on human erythropoietin. And yet Lin still describes that as human erythropoietin. The human erythropoietin that Lin is talking about in his patent is the amino acid sequence that is produced by the DNA that encodes human erythropoietin. And when that DNA is placed into a mammalian cell and the cells are produced in mammalian cell culture, the cells cleave off the 166 and they may or may not glycosylate the cell, the protein.

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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 This was all brought out in the prosecution history specifically with reference to the amendment of an allowance of '422, claim 1. In Exhibit 8 of Amgen's original claim submission, claim brief, we attached the prosecution history for this claim. And in that prosecution history Amgen explained what human erythropoietin means. It defined the term. Human erythropoietin is understood to include any polypeptide having amino acid sequence of EPO isolated from human urine and may be produced in human cells or other mammalian cells. And so, what does that necessarily mean? That language means that human EPO includes any, any polypeptide having the amino acid sequence of EPO. If a polypeptide has the amino acid sequence of EPO it is by definition human erythropoietin as the claim term reads. Having is open-ended. It's a tern of art in patent law, which means an open-ended construct. It's not limited. And so it doesn't exclude additional elements. There's no reference to glycosylation in the prosecution history, let alone any specific glycosylation, any statement that it must have the structure. And there's no limitation on the mammalian cells that can be used to produce it. THE COURT: All right, I think I have it. Brief rebuttal, Ms. Ben-Ami. MS. BEN-AMI: Well, I have an extensive rebuttal.

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then glycosylated by the cell, can't be modified in any way, has to be exactly as produced by the cell. And then what they're trying to do, then what they say is that it must be produced in cells that were available as of 1983. In other words, any mammalian cell that was adapted for growth in culture after 1983 couldn't be used. Couldn't be used to make this product. And if it was, if it was it wouldn't infringe according to that. And then they say that there has to be no alteration in the secreted glycoprotein due to post-expression modification. It's a point I made earlier. Now, what's wrong with all that? Why is all of that not correct as a matter of law and as a matter of claim construction? Claim construction. Construing what this claim means. Well, the first thing is that their construction would be inconsistent with Lin's other claims. When Lin claimed a human erythropoietin that was a glycoprotein he said so expressly. Take a look at '933, claim 4 where he refers to human erythropoietin glycoprotein. Roche's construction would render the word glycoprotein irrelevant. And for that reason it is erroneous as a matter of law. Every word in a claim must be given meaning. Where related claims from a single application use the same terms they should be given consistent meanings. The use of human

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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 What if we modified yours, I'm still working with Amgen's, but called it a glycoprotein. Is that a problem? Isn't that -- that's the, that's the most accurate and we're going to hear a lot about glycosylation. So it would seem to me that that would be both accurate and fair. MR. DAY: Your Honor, I think it would be -- I don't think it's a problem. I think it would be an erroneous claim construction. And I think it would be erroneous for the reasons I cited. Because the claims differentiation -- and your Honor may have noticed when, when Ms. Ben-Ami flashed that specification up, she didn't point to the fact that it denominates the EPO as hEPO. H stands for human. THE COURT: Well, no, she said it was a different -MR. DAY: No. No. H, little h stands for human. Amgen identified the EPO that's being produced in this E.coli as human EPO, and then it made a number of alterations to the amino acid sequence. It made a number of analogs to that human sequence and said, well, we take this out, we put this in, we take this out, we put this in. These are all the changes from the human EPO. It would be wrong as a matter of claim construction, your Honor, because you would be reading out of the definition of human EPO human EPO produced in E.coli cells. It would be wrong as a
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Roche's contention that the limitation cannot define the structure of the claim product. And let me -THE COURT: Well, I'm not, I'm not proposing that. What I'm proposing is the Court's language. MR. DAY: That's fine. THE COURT: Purified from mammalian cells grown in culture means obtained in substantially homogenous form from mammalian cells, using the word "from" in the sense that it originates in mammalian cells, without limitation to, without limitation to it only taking it directly out of the interior of the cells which have been grown in the in vitro culture. MR. DAY: And that's fine. And we merely offered an alternative -THE COURT: All right. MR. DAY: -- clarifying statement to that. THE COURT: Then we'll stick with my language for now. But that's without prejudice to revisiting it if I think I can explain it to the jury better. Then, next, a non-naturally occurring glycoprotein product of the expression, et cetera. Now, here it seems that Amgen's proposal makes the most sense. And of course we're bound by the Federal Circuit. Non-naturally occurring means not occurring in nature, but that makes perfect sense and we'll follow it. And that's, that's in the Amgen

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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 proposal. What's the matter with that, Ms. Ben-Ami? They're a glycoprotein product not occurring in nature that is expressed in a mammalian cell from a DNA sequence that does not originate in the genome of the host and comprises a DNA sequence encoding human erythropoietin. MS. BEN-AMI: Well, first of all, your Honor, I think non-naturally occurring is a separate element. And so I do think that's important. THE COURT: Well, non-naturally occurring, aren't we bound by the Federal Circuit? It means not occurring in nature. MS. BEN-AMI: I agree with that, but that's a separate element than glycoprotein product of the expression of a mammalian cell. That's all I'm saying. In other words, you'd have to break down the claim. And I think non-naturally occurring is one element. Glycoprotein product of the expression of mammalian host cell, et cetera, is a different product. Element. That's my first fundamental difference. THE COURT: Well, all right. But in trying to explain it to the jury I say, I come to this and I say, now, non-naturally occurring, what that means is it does not occur in nature. Now -MS. BEN-AMI: That means --

matter of claim construction because you would be construing human EPO in a way that renders human erythropoietin glycoproteins redundant and unnecessary. So as a matter of claim construction you would be making a mistake. That's Amgen's position. THE COURT: Thank you. Here's what we're going to do. At this stage and for these purposes we're going to adopt Amgen's proposed construction. I'll reflect on whether I'll add the glycoprotein before the word, substitute it for protein. Turning now to purified from mammalian cells grown in culture. Now, Roche's proposed construction comes straight out of this Court's own analysis of this subject. And why ought I not stick with it? I've analyzed this and I see -- so I'll hear from you, Mr. Day. What's the matter with that? MR. DAY: Okay. First of all, I don't think Roche's construction comes right out of the Court's construction. I will certainly grant you that the first part of their construction is a verbatim recitation and Amgen offered an alternative, if this is to be a jury trial, Amgen offered an alternative statement of that which I think says the same thing. The difference between the parties in claim construction here is what I have highlighted. And that is

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