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

Filing 637

DECLARATION re #630 Opposition to Motion, For Summary Judgment That Dr. Lin's Asserted Claims Are Definite, Adequately Described And Enabled, By Keith E. Toms by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc.. (Attachments: #1 Exhibit A# 2 Exhibit B#3 Exhibit C, part 1#4 Exhibit C, part 2#5 Exhibit C, part 3#6 Exhibit C, part 4#7 Exhibit C, part 5#8 Exhibit C, part 6#9 Exhibit C, part 7#10 Exhibit C, part 8#11 Exhibit D, part 1#12 Exhibit D, part 2#13 Exhibit D, part 3#14 Exhibit D, part 4#15 Exhibit D, part 5#16 Exhibit D, part 6#17 Exhibit D, part 7#18 Exhibit D, part 8#19 Exhibit D, part 9#20 Exhibit D, part 10#21 Exhibit D, part 11#22 Exhibit E#23 Exhibit F, part 1#24 Exhibit F, part 2#25 Exhibit G# 26 Exhibit H#27 Exhibit I#28 Exhibit J)(Rizzo, Nicole) Additional attachment(s) added on 7/16/2007 (Paine, Matthew).

Case 1:05-cv-12237-WGY

Document 637-29

Filed 07/05/2007

Page 1 of 2

McLawhon, Ronald W. CONFIDENTIAL

EXHIBIT B

5/17/2007

Page 1 UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS AMGEN, INC., Plaintiff, v. F. HOFFMANN-LA ROCHE, LTD., a Swiss Company, ROCHE DIAGNOSTICS GmbH, a German Company, and HOFFMANN-LA ROCHE, INC., a New Jersey Corporation, Defendants. ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ CONFIDENTIAL VIDEOTAPED DEPOSITION OF RONALD W. MCLAWHON, M.D., PH.D. SAN DIEGO, CALIFORNIA MAY 17, 2007 (This transcript contains testimony designated confidential as per Section 5(c) of the Amended Protective Order. Please treat the entire transcript in accordance with the protective order.) Reported by: Harry Alan Palter, CSR NO. 7708 Civil Action No. 05-CV-12237-WGY

LiveNote World Service

800.548.3668 Ext. 1

Case 1:05-cv-12237-WGY

Document 637-29

Filed 07/05/2007

Page 2 of 2

McLawhon, Ronald W. CONFIDENTIAL
Page 266

5/17/2007
Page 268

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 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

Dr. Goldwasser the individual who established RIA to be used in assaying EPO samples? A. He's one of the earlier leaders, yes. Q. If you could direct your attention to McLawhon Exhibit 18 -- I'm looking at paragraph 96. You state there, "The unit was originally designated by Dr. Goldwasser and his colleagues to represent a selected amount of erythropoietic activity, i.e., a certain degree of erythropoietic response in a 'starved' rat equivalent to the response solicited by the administration of five micromoles of cobaltous chloride." So as designated by Dr. Goldwasser, did the unit refer to biological activity? A. It was an arbitrary unit based on the biological activity in the starved rat, at that time. It was later, then, adopted by international committees as the standard -as the unit of measure that is subsequently referenced in later publications.
Page 267

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 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

"concentration in RIA" refer to the same thing? A. Hmm-hmm. Q. Now, if you could direct your attention back to McLawhon Exhibit 27, the second page, which is page 866, under "Bioassay Methods." The last line of that section says, "A unit of EPO is defined as the activity contained in 1/10 of an ampule of the international reference preparation." What does that refer to? A. (Examining document) This would be 1/10 the ampule of the international reference preparation and, and at that time, that would be the -- it would be the second international reference preparation. Q. So that's referring to the second international reference preparation? And that international reference preparation -- strike that. So when Dr. Goldwasser stated that a unit of EPO is defined as the activity contained in 1/10 of an ampule of the international reference preparation, isn't he
Page 269

So at some point, it started out as an arbitrary unit because there was nothing prior to that, and then this became the definition for the unit -- now it was accepted as a convention for biological activity. Q. You go on to state, however, once that unit was agreed upon by the international community to represent an EPO activity or concentration in an RIA in vitro or in vivo bioassay, it was no longer arbitrary and misleading to call it arbitrary. What's the difference between an EPO activity or a concentration in an RIA? A. There would be no difference. You're talking about a concentration measure that's representing activity per units of volume, units in milliliters or liters, if you look at the publication. So it is a concentration measure, in this case, using the reference standard material that was in units. Q. So "EPO activity" or

defining unit as "activity"? A. Restate that. Q. Doesn't this statement say that a unit of erythropoietin is defined as the activity of the erythropoietin? A. It is the activity, and it's in the bioassay. Q. So unit used in the bioassay measures the activity in the EPO? A. In this particular instance, yes. They also use the terminology for units for the radioimmunoassay. Q. What antibodies were used in this paper in the radioimmunoassay? A. Dr. Goldwasser's? Q. Yes. A. The Sherwood and Goldwasser paper? Q. What's been marked as McLawhon Exhibit 27. A. If you go under the immunization paragraph on page -- is it 886. "Antibodies to EPO were raised in four male New Zealand white rabbits."

68 (Pages 266 to 269) LiveNote World Service 800.548.3668 Ext. 1