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

Filing 481

DECLARATION re #478 MOTION for Summary Judgment of Non-Infringement of Claim 1 of Patent No. 5,955,422 and Claims 9 and 12 of Patent No. 5,547,933 of Howard S. Suh by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc.. (Attachments: #1 Exhibit A#2 Exhibit B#3 Exhibit C#4 Exhibit D#5 Exhibit F#6 Exhibit I#7 Exhibit J#8 Exhibit K#9 Exhibit L)(Rizzo, Nicole)

Case 1:05-cv-12237-WGY

Document 481-4

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

MARKMAN HEARING

The Honorable William G. Young, District Judge

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Case 1:05-cv-12237-WGY

Document 481-4
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Filed 06/11/2007

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you.

1 2 What does the patent tell us? If we look at the 3 specification as Dr. Torchilin did and brought to the 4 Court's attention exactly what the specification has to say 5 about this, if we look at the specification, the 6 specification is very clear that a diluent, an adjuvant or a 7 carrier can be in combination -- I'm sorry -- can be in 8 combination with or together with the erythropoietin. And 9 he points out that standard, that the patent describes standard diluents such as serum, human serum albumin and 10 11 saline, both of which one of ordinary skill in the art would 12 readily recognize are complexed with, bind to, adhere to, 13 attach to human EPO. 14 So, you know, once again, when we deviate from the 15 tried and true analysis that the Federal Circuit has laid 16 down and this Court has mastered for construing claims, 17 looking at the claim language, looking at the specification, 18 looking at the prosecution history, and asking ourselves, 19 now, does the claim necessarily require this limitation that 20 the defendant is trying to read into the claim. THE COURT: What do you say to her use of the word 21 22 mammals in place of humans in your proposal? 23 MR. DAY: Well, I think it's a question of what the 24 plain meaning of pharmaceutical composition is. And we believe that the plain meaning of pharmaceutical composition 25

proposal? MR. DAY: Because of the word comprising, to make clear that as, when you construe the word comprising that you must have at least one of these. That doesn't mean you can't have them all. That's the effect of comprising. But the claim requires -- what does the claim require? The analytical issue for the Court is what does the claim require. It requires that there be at least -THE COURT: Excuse me. MR. DAY: -- an adjuvant, a diluent or a carrier. THE COURT: Yes. But doesn't the word "or" carry that, that meaning? MR. DAY: That there can be more than one? Not necessarily. THE COURT: I see. MR. DAY: I'm just trying to make it clear. THE COURT: Containing -MR. DAY: That -THE COURT: Well -MR. DAY: -- the effect of the word comprising is that there can be more than one. That's the effect of the word comprising. In giving that word meaning in this construct that's why I put at least. THE COURT: All right, thank you. Here's, here's what we're going to go with for now.
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is a composition that's administered to humans. Dr. Flavell, defendants' expert, agrees. In his expert report he says a pharmaceutical composition is a composition that's suitable for administration to humans. THE COURT: Well, I mean now at least, so the television tells us, we have all sorts of pharmaceutical compositions being administered by veterinarians to animals of all sorts. And I had thought we were talking about mammals here. Is that a mistake? MR. DAY: Is it a mistake that we're talking about mammals? Well, in the context of a pharmaceutical composition -THE COURT: You think so. MR. DAY: Pardon me? THE COURT: You think so. MR. DAY: Well, I think, I think the specification, the specification -- we're talking about column 33. In particular in column 33 there is that very famous sentence that your Honor knows very, very well. That sentence refers to mammals. No question about it. But it doesn't talk about pharmaceutical compositions. When we get to pharmaceutical compositions the specification is very clearly talking about patients. THE COURT: Why did you put the word at least a diluent, adjuvant or carrier in your proffer, in your

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I'm going to construe the term as a composition suitable for administration to humans containing a diluent, adjuvant or carrier. As to this, as well as these other matters, I'll take what's argued under advisement. All right. Now, then we come to the '868 patent, claim 2 and the '933 patent, claim 8 wherein said cells are CHO cells. I don't see why we need the derived here. I am disposed to go with a cell from the ovary of a Chinese hamster. That's the language. I don't think we need to add in anything. The claim said host cells are CHO cells. It seems to me a cell from the ovary of a Chinese hamster. And that is what I propose to do, but I'll hear you, Mr. Day, because you have a different position. I don't know what derived from adds. MR. DAY: I think derived from is true to the specification. And let me, again, I'm not trying to read limitations into the claim. I'm trying to be true to the specification. And I'm not quite sure what defendants are arguing. And there may be no issue or no dispute here for us to resolve. But it appeared from the last submission that the defendants made they were suggesting that, the fact that the cell was taken from a Chinese hamster ovary meant that the cell must be in the form that it would be found in a Chinese hamster ovary.

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