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

Filing 386

MEMORANDUM in Support re #385 MOTION to Strike Belately Disclosed Invalidity and Unenforceability Allegations and for More Time to Respond to Roche's Expert Reports filed by Amgen Inc.. (Attachments: #1 Appendix A#2 Appendix B#3 Appendix C)(Gottfried, Michael)

A

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

APPENDIX B

1

UNPLED ALLEGATIONS OF INEQUITABLE CONDUCT IN SOFOCLEOUS EXPERT REPORT Amgen allegedly misrepresented to the PTO that a two-way non-obviousness test applied in overcoming the Lai patent. Amgen allegedly did not disclose to the PTO EP '619's related counterpart patent U.S. 4,766,075 during the pendency of the '179 application.

ROCHE'S ACCESS TO THE FACTS Lin file histories are in the public record. Additionally, complete Lin file histories were produced to Roche by May 2006 in the ITC proceeding.

PARAGRAPH(S) IN REPORT 293

2

EP `619 and related counterpart patent U.S. 309 4,766,075 are in the public record. Additionally, EP `619 is disclosed in the Lin filed histories, which were produced to Roche by May 2006 in the ITC proceeding. (See AM-ITC 00454408) Patent that is publicly available patent. 314-16

3

Amgen allegedly failed to disclose McCormick et al., US 4,966,843, "Expression of Interferon Genes in Chinese Hamster Ovary Cells." Amgen allegedly failed to disclose the following documents stating that the apparent molecular weight of recombinant EPO is not higher than that of human urinary EPO: Egrie, Presentation Transcript "Cloning of Human & Monkey EPO" (1984) from Hemoglobin Switching Meeting, Airlie House, Virginia, September 1984.

4

This presentation was produced to Roche by May 2006 in the ITC proceeding. (See AM-ITC 00557616, AM-ITC 00557617-23)

324 (in part)

5

Amgen allegedly failed to disclose the following documents stating that the apparent molecular weight of recombinant EPO is not higher than that of human urinary EPO:

Exhibit 113 to Amgen v. HMR/TKT case, 126 F. Supp. 2d 69 (D. Mass. 2001) and cited in Judge Young's Jan. 19, 2001 decision at 143. Additionally, Amgen v. HMR/TKT proceedings, including Trial Exhibit 113, were

324 (in part)

Dockets.Justia.com

Doc. 386 Att. 2

1

6

UNPLED ALLEGATIONS OF INEQUITABLE CONDUCT IN SOFOCLEOUS EXPERT REPORT Vapnek et al., "Comparative Studies of Natural and Recombinant Erythropoietin," Banbury Reports 29: Therapeutic Peptides and Proteins, 241-56 (1988). Amgen allegedly failed to disclose to the PTO declarations by Dr. Thomas Heckler and Dr. Goldwasser regarding MW of u-EPO vs. r-EPO, filed as exhibits in the Cilag GmbH Opposition proceedings. Amgen allegedly failed to disclose to the PTO the Egrie Presentation Transcript regarding the similarity in glycosylation, MW and average carbohydrate composition of COS rEPO compared to human urinary EPO entitled: Egrie, Presentation Transcript "Cloning of Human & Monkey EPO" (1984) from Hemoglobin Switching Meeting, Airlie House, Virginia, September 1984.

ROCHE'S ACCESS TO THE FACTS produced to Roche by December 2006 in the this case. (AM-ITC 00945869) The declarations are exhibits to an Opposition proceeding that are in the public record. Additionally, those declarations were produced to Roche by May 2006 in the ITC proceeding. (See AM-ITC 00312411, AM-ITC 00311606) This presentation was produced to Roche by May 2006 in the ITC proceeding. (See AM-ITC 00557616, AM-ITC 00557617-23)

PARAGRAPH(S) IN REPORT

326

7

355

8

Amgen allegedly failed to disclose to the PTO Vapnek et al, which reported "no differences in structure have been observed" between CHO rEPO and urinary EPO: "Vapnek et al., "Comparative Studies of Natural and Recombinant Erythropoietin," Banbury Reports 29: Therapeutic Peptides and Proteins, 241-56 (1988)."

Exhibit 113 to Amgen v. HMR/TKT case, 126 F. Supp. 2d 69 (D. Mass. 2001) and cited in Judge Young's Jan. 19, 2001 decision at 143. Additionally, Amgen v. HMR/TKT proceedings, including Trial Exhibit 113, were produced to Roche by December 2006 in this case. (AM-ITC 00945869) Roche relies on documents produced to Roche by May 2006 in the ITC proceeding and by December 2006 in this case. (AM-ITC 00550777, AM-ITC

373

9

Amgen allegedly concealed the standard used to measure RIA from the '349 Examiner.

378-86

2

UNPLED ALLEGATIONS OF INEQUITABLE CONDUCT IN SOFOCLEOUS EXPERT REPORT 10 Amgen allegedly failed to disclose to the PTO their work with the 1411 cell line.

ROCHE'S ACCESS TO THE FACTS 00061675-706, AM-ITC 00558618) Trial Exhibit 2425 to Amgen v. HMR/TKT case. Litigation files from Amgen v. HMR/TKT were produced to Roche by December 2006 in this case. (See AM-ITC 01005412)

PARAGRAPH(S) IN REPORT 387-95

11

Amgen allegedly failed to disclose to the PTO the Baron-Goldwasser Clinical Study.

HMR/TKT advanced the same allegation in Amgen 419-33 v. HMR/TKT case and the argument is cited in Judge Young's Jan. 19, 2001 decision at 138.

3