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

Filing 579

DECLARATION of Geoffrey M. Godfrey in Support of Opposition to Roche's Motion for Summary Judgment of Invalidity for Double Patenting Over Claim 10 of the '016 Patent by Amgen Inc.. (Attachments: #1 Exhibit Ex. A#2 Exhibit Ex. B#3 Exhibit Ex. C)(Rich, Patricia)

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Amgen Inc. v. F. Hoffmann-LaRoche LTD et al Doc. 579 Att. 3 Case 1:05-cv-12237-WGY Document 579-4 Filed 06/29/2007 Page 1 of 7 EXHIBIT C Godfrey Decl. in Support of Amgen's Memorandum to it's Motion for Summary Judgment of No Obvious Type Double Patenting Dockets.Justia.com Case 1:05-cv-12237-WGY Document 579-4 Filed 06/29/2007 Page 2 of 7 USDC - Depo: Harlow, Edward 6/20/2007 8:52:00 AM 1 2 3 4 5 6 Exhibits: 1-8 Volume 1, Pages 1-281 UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS Civil Action No. 05 Civ. 12237 WGY --------------------------AMGEN INC. Plaintiff 7 vs. 8 F. HOFFMANN-LA ROCHE LTD., 9 ROCHE DIAGNOSTICS GmbH, and 10 HOFFMANN-LA ROCHE INC. 11 Defendants 12 13 VIDEOTAPED DEPOSITION OF 14 15 16 17 18 ** TRANSCRIPT DESIGNATED CONFIDENTIAL *** 19 20 21 22 23 24 Reported by: 25 ALAN H. BROCK, RDR, CRR Unsigned Page 1 ----------------------------- EDWARD E. HARLOW, JR., Ph.D. Wednesday, June 20, 2007, 8:52 a.m. ] Duane Morris LLP 470 Atlantic Avenue Boston, Massachusetts FARMER ARSENAULT BROCK LLC Reporting For: LiveNote World Service 221 Main Street, Suite 1250 San Francisco, California 94105 Phone: 415-321-2300 Fax: 414-321-2301 Amgen v. Roche Case 1:05-cv-12237-WGY Document 579-4 Filed 06/29/2007 Page 3 of 7 USDC - Depo: Harlow, Edward 6/20/2007 8:52:00 AM 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 A. Q. I don't know. Now, you've offer the opinion that Dr. Lin's claims in suit are obvious over the Strickland-Lai '016 patent; correct? A. Q. Yes. So your opinion regarding the obviousness of Lin's patents in suit is based on a one-way test; correct? A. That's my understanding. Again, I'm sort of at the edge here. Q. In other words, you offer no opinion in your report as to whether the claims of the Lai-Strickland '016 patent are obvious in light of Dr. Lin's claims in suit. A. Q. I have not offered an opinion on that. And so if the Court determines that a two- way test should apply in lieu of a one-way test, you have no opinion that addresses that scenario, do you? A. Q. I haven't formed one yet, no. You anticipated my question: Do you have an opinion as to whether the Lai patent is obvious over the Lin patents in suit? A. Q. I don't. Do you know if Dr. Lin taught a method Amgen v. Roche Unsigned Page 97 Case 1:05-cv-12237-WGY Document 579-4 Filed 06/29/2007 Page 4 of 7 USDC - Depo: Harlow, Edward 6/20/2007 8:52:00 AM 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 EPO has a definition. It demands knowledge of the clone. When you've got the clone, one of skill in the art knows how to make recombinant EPO. Q. The words "recombinant EPO" did not instruct or teach one of skill in the art how to isolate or clone the EPO gene from the human genome, did it? A. Q. A. Q. I don't know. You don't know? Don't know. You don't know if with the words "recombinant EPO" alone one of skill in the art could have isolated and cloned human EPO DNA? A. Don't know. Haven't formed an opinion. Haven't been asked to. Q. Are you aware of any disclosure other than Dr. Lin's patent that identifies the isolated EPO DNA sequence as of December 1983? A. Q. I don't know of any other. Your opinions that the claims in suit are obvious and that making a recombinant EPO protein would have been obvious assumes the availability of the EPO DNA sequence; correct? A. Q. Yes. And are you aware of any source other Amgen v. Roche Unsigned Page 163 Case 1:05-cv-12237-WGY Document 579-4 Filed 06/29/2007 Page 5 of 7 USDC - Depo: Harlow, Edward 6/20/2007 8:52:00 AM 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 than Dr. Lin's '008 patent that would have made that EPO DNA sequence available to one of skill in the art? A. Q. I don't. So you assume that Dr. Lin's '008 patent can be used as part of the prior art in assessing the obviousness of the claims in suit; correct? MR. BROMBERG: Objection. A. Let's make sure we know exactly what origin. So would you try it one more time? Q. You assume that Dr. Lin's '008 patent can be used as prior art against Dr. Lin's claims in suit for purposes of your obviousness opinions; correct? MR. BROMBERG: Objection. A. Q. A. Yes. Why do you assume that? The comparison of the claim language from the patents in suit back on '008. Q. I understand. So you understand that the '008 patent is a progenitor to each of the claims in suit; correct? A. Q. I do understand that. Okay. My question is, why do you assume that the '008 patent is available as prior art Amgen v. Roche Unsigned Page 164 Case 1:05-cv-12237-WGY Document 579-4 Filed 06/29/2007 Page 6 of 7 USDC - Depo: Harlow, Edward 6/20/2007 8:52:00 AM 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 the subject we were discussing this morning, which is your opinion that claim 10 of the '016 patent would have rendered obvious Dr. Lin's claims in suit. Okay? Do you have that in mind? A. Q. Yes. Now, your opinion that as of December 1983 one of skill in the art could have produced recombinant EPO in mammalian cell culture based only on the words of claim 10 of the '016 patent assumes the availability of the isolated EPO DNA; correct? MR. BROMBERG: Objection. A. yes. Q. And if it turns out that the '008 Assumes the availability of the EPO DNA, patent, Dr. Lin's '008 patent cannot be used as prior art, cannot be used as prior art against the claims in suit, there would be no identification or isolation of EPO DNA available as prior art to one of skill in the art for purposes of your '016 opinion; correct? MR. BROMBERG: Objection. A. that. Q. Your opinion of obviousness in light of I haven't spent any time thinking about the '016 patent depends on one of skill in the art Amgen v. Roche Unsigned Page 274 Case 1:05-cv-12237-WGY Document 579-4 Filed 06/29/2007 Page 7 of 7 USDC - Depo: Harlow, Edward 6/20/2007 8:52:00 AM 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 having available to him or her the EPO DNA sequence? A. Q. Yes. And if it turns out that the EPO DNA sequence is not part of the prior art or public knowledge as of December 1983, you have no opinion as to whether or not the claims in suit would be obvious in light of claim 10 of the '016 patent; correct? A. I haven't considered that at all. I don't know the answer to that. Q. A. Q. So you don't have an opinion on it. That's correct. Now, the '016 patent and the claims of the '016 patent are to a purification of recombinant EPO; correct? A. Q. That's correct. Before the Lai and Strickland patent, though, there were prior-art methods known for the purification of EPO from natural sources; correct? A. Q. That's my understanding, yes. The patents in suit and the '933 specification in front of you refers to a Miyaki seven-step protocol for the purification of EPO. Does that sound familiar? A. It could be. I don't recall. Amgen v. Roche Unsigned Page 275

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