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

Filing 679

DECLARATION re #678 Reply to Response to Motion, Of Krista M. Rycroft by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc.. (Attachments: # 1 Exhibit 2# 2 Exhibit 3#3 Exhibit 4 (part 1 of 2)#4 Exhibit 4 (part 2 of 2)#5 Exhibit 5)(Rizzo, Nicole) Additional attachment(s) added on 7/12/2007 (Paine, Matthew).

Case 1:05-cv-12237-WGY

Document 679-6

Filed 07/09/2007

Page 1 of 3

Page 1
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
EXHIBIT 5

MARKMAN HEARING

The Honorable William G. Young, District Judge

6da73dea-6884-48d2-9148-93a9c2849937

Case 1:05-cv-12237-WGY

Document 679-6
Page 18

Filed 07/09/2007

Page 2 of 3
Page 20

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

and impartial, most impartial trial I can. I cannot ignore the fact that there's been this related litigation to which I've paid a great deal of attention over time and have various views about these things both factual and legal. One of the things I wrestled with first time out of the box was the fact that, and I'm not asking you to concede this, but this is really a seminal patent; in other words, when this patent application was filed, the original patent now, it most assuredly was on the cutting edge. And, therefore, when it came to be examined by the Patent Office those officers did not have the background that, for instance, some slight but patentable advance in the mechanical arts would have. It didn't, it didn't have a significant body of prior art. I know we're going to find prior art, we're going to wrestle around with that. And Amgen quite properly, as any patent draftsperson would do, drafted its claims as broadly as it could and patents issued. And even first time out of the box there was various uncertainty on the part of this Court about whether Amgen had been granted a patent beyond what, its claims went beyond what in fact it had taught. Because TKT had a different way of doing it, much further upstream, but it was within, as I ruled, and by and large have been affirmed, as I ruled the claims of the patent spoke. There it all is on the record. But I had various -- the parts on which I've been reversed are the

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

it to me and a jury, about these DNA strands than we knew when this patent application was filed. But I'm not clear what difference that makes. Now, is that helpful? Go ahead. MS. BEN-AMI: Well, there, there was a lot to that and I don't know if I wrote it all down. But let me say this. We'll get to what the prior art was in another day and we'll get to -THE COURT: Right, of course we will. MS. BEN-AMI: -- how seminal this was and why Amgen did what it did. THE COURT: Exactly. Exactly. MS. BEN-AMI: So for the sake of this argument, I'll accept what your Honor said without being bounded, if that's okay. THE COURT: It is, absolutely. MS. BEN-AMI: Okay. So let's think about it for a minute. Amgen filed a group of patent applications. They knew what the DNA sequence was. THE COURT: Well, they thought they knew. MS. BEN-AMI: That was the '008 patent. Right? That's the -THE COURT: All right. MS. BEN-AMI: So this is not a situation where we're taking away from Amgen its seminal discovery, if you

Page 19
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

Page 21
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

parts where I was expressing disquiet. And, in fact, I went so far in the most recent, though, though TKT didn't get anything out of it, to explore this whole doctrine of, reverse doctrine of equivalents. And then to say, well, in this case it doesn't, it doesn't apply. That's what I thought. Then they come out with Phillips. Now, Phillips may not be the best case for this proposition. But one of the things that I read from Phillips was that when you're dealing with a seminal patent you really do have to look -- you have to take the specifications along with the claims to, better to understand what the patent applicant is in fact teaching the public. I'm sure there are other cases that say that, but Phillips was the one that, because we were all interested in what it would tell us to look at in this whole law-facts problem in doing Markman construction. So that's in my mind. MS. BEN-AMI: Well -THE COURT: Are you saying here, and I'll try to -are you arguing that -- it's not in the specifications. So, I don't think you're saying their specifications didn't teach how to do it. In this respect, they did teach how to do it. It works. It's just this 166 cleaves off. Now, yes, we know a great deal more as we're going to go into this trial today, and we'll see if you can teach

call it that, by saying they continued to try to get bigger and bigger and bigger and they got so big that they claimed something they didn't invent. Or that -THE COURT: What do you mean they got bigger and bigger and bigger? MS. BEN-AMI: In other words, the original claim of the '008 is the DNA sequence. And they knew what the DNA sequence was and they claimed it. Right? Then they go ahead and they say we're claiming human EPO. That they had not sequenced. So they didn't know what that was. Other than its three-dimensional total package of structure. And that's what I'm saying to your Honor. I want to be clear about this. I'm not saying you must define human EPO as being limited to the 166 amino acids. I'm not saying that. Quite frankly -THE COURT: And that's not true in the real world. MS. BEN-AMI: I'm not saying that. I think that the patent is ambiguous because they did not know. But what I'm saying is, if you're going to do an analysis that says it's a specific amino acid sequence then it has to be 166. The alternative approach, which I think takes into account somewhat more of your views on seminal patent, how do you deal with it, is to say human EPO must be everything that is human EPO. It must be the amino acid sequence, it must be the secondary structure, it must be the tertiary

6 (Pages 18 to 21)

6da73dea-6884-48d2-9148-93a9c2849937

Case 1:05-cv-12237-WGY

Document 679-6
Page 22

Filed 07/09/2007

Page 3 of 3
Page 24

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

structure, it must have the three-dimensional structure, it must be human EPO. What Amgen's construction is -- and I can go through this in more detail, because that was the next part of my presentation -- what Amgen's construction is it's only the specific amino acid sequence of 1 to 165. THE COURT: I follow you. MS. BEN-AMI: No glycosylation, no secondary formulation, no tertiary structure, no three-dimensional conformation. And what I'm saying is it can't be 1 to 165 alone. If it's going to be human EPO, it means human EPO, then it's got to be all human EPO. Where -THE COURT: Well, I don't know that your proposed instruction -- construction is helpful here. I have to explain this to a jury. And I take that very seriously. If you want this construed -- and, you know, I'm not going to be tautological. Human EPO is human EPO. That doesn't mean anything, to a jury. And at one time it didn't mean anything to me. MS. BEN-AMI: Well, your Honor, our construction says it has to have all the structure of human EPO, which is, and we can continue going through, I will show you that the patent tells you what these various structures are. THE COURT: Well, now, not, not in your first slide here. It doesn't say all the structure.

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

such as, your Honor. THE COURT: Well, it is including them. You would be happy, though, if I simply said human erythropoietin was a protein having the structure of human EPO. MS. BEN-AMI: Yes, the total structure of human EPO. THE COURT: Well, the structure. All right. MS. BEN-AMI: I think, your Honor, when it says such as the amino acid sequence, that's saying if you just have the amino acid sequence that's not, and I don't believe that's correct. THE COURT: Grammatically you may be, you may be right there. All right, let's hear from Mr. Day and we'll be back to you. Mr. Day, she made some headway here. What -- how do you feel about a protein having, human erythropoietin is a protein having the structure -- maybe we should call it DNA structure, if that means anything -- having the structure of human erythropoietin. MR. DAY: That would be an erroneous construction, your Honor. THE COURT: Okay. I'll hear you. MR. DAY: And your Honor was right to go to Phillips. And the reason you're right to go to Phillips is

Page 23
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

Page 25
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

MS. BEN-AMI: It says the structure. It says the structure that would be produced in mammalian cells as of the invention date. THE COURT: Well, I -MS. BEN-AMI: It's not the amino acid sequence, it's the structure of human EPO. THE COURT: Well, suppose we were to take Amgen's then and say a protein having the structure of human EPO such as the amino acid. Just have the same such as. MS. BEN-AMI: So it no longer says amino acid sequence. It says -THE COURT: Well, I'm just talking here. MS. BEN-AMI: I understand in theory. THE COURT: So what do you think about that? MS. BEN-AMI: If it had all the structure of the human EPO. THE COURT: Well, I'm not saying all. A protein having the structure of human EPO, such as the amino acid sequence of EPO isolated from human urine. MS. BEN-AMI: No, I don't think that's right, your Honor. Because such as is now saying if you only have the amino acid sequence that's out. THE COURT: That's an embodiment-- that's an aspect of it. MS. BEN-AMI: That's including them rather than

because the process of claim construction is a highly structured analysis. It's not a walk through the forest. It begins with a very structured set of principles that have been repeatedly laid out by the Federal Circuit to guide a Court through the difficult question of figuring out what does a claim mean. And the Court well appreciates the mantra. Judge Michel laid it out very clearly in Medtronic. You start with the claims. You look at the other claims in the patent. You look at the specification. You look at the prosecution history. You don't begin where Ms. Ben-Ami began with an expert report that hasn't even been submitted to the Court. THE COURT: Well, try -- what do you say about my reading of Phillips? Do you think that's right? MR. DAY: Pardon me? THE COURT: What do you say about my reading of Phillips? Do you think that's right? MR. DAY: Yes, I do think that's right. I think that Phillips, if I understand your point correctly, I think Phillips says that in the case of a seminal patent where you have a pioneering patent, which is what these patents are -THE COURT: Well, she may give you '008. MR. DAY: She will disagree. THE COURT: But the others in her view you're just getting bigger and bigger.

7 (Pages 22 to 25)

6da73dea-6884-48d2-9148-93a9c2849937