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

Filing 1157

BRIEF by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc. Roche's Bench Memorandum No. 3 that Dr. Orkin Should be Precluded from Testifying That There Was No Known Source of Human EPO MRNA in 1983 Because Such Testimony Contradicts Admissions In the Specifications of Amgen's Patents. (Fleming, Thomas)

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

Doc. 1157

Case 1:05-cv-12237-WGY

Document 1157

Filed 09/26/2007

Page 1 of 3

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS

AMGEN, INC., Plaintiff, v. Civil Action No. 05-CV-12237 WGY F. HOFFMANN-LA ROCHE, LTD., ROCHE DIAGNOSTICS GMBH, and HOFFMANN-LA ROCHE, INC. Defendants. ROCHE'S BENCH MEMORANDUM NO. 3 THAT DR. ORKIN SHOULD BE PRECLUDED FROM TESTIFYING THAT THERE WAS NO KNOWN SOURCE OF HUMAN EPO MRNA IN 1983 BECAUSE SUCH TESTIMONY CONTRADICTS ADMISSIONS IN THE SPECIFICATIONS OF AMGEN'S PATENTS In his May 11, 2007 report, Dr. Orkin states that, in 1983, "there was no known source" of human erythropoietin ("EPO") mRNA. (Rebuttal Expert Statement of Stuart H. Orkin M.D. at ¶ 38). This assertion plainly contradicts what was established by Amgen's binding admission in the specifications of the patents-in-suit: that a 1983 study by Farber et al. "confirmed the human kidney as a site of erythropoietin expression" and "allowing for the construction of an enriched human kidney cDNA library from which the desired gene might be isolated"1 See, e.g., U.S. Patent No. 5,547,933 ("`933 patent") at col. 9 lns.42-63. Because such testimony would go against Amgen's binding admissions about the prior art, Dr. Orkin should be precluded from testifying as to any alleged absence of a tissue source of human EPO in 1983.

Citing Farber et al., Blood, 62, No. 5, Supp. No. 1, Abstract 392, at page 122a (1983); Farber, Clin. Res. 31(4), 769(a) (1983).

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Case 1:05-cv-12237-WGY

Document 1157

Filed 09/26/2007

Page 2 of 3

The Federal Circuit recently reiterated that, "Admissions in the specification regarding the prior art are binding on the patentee for purposes of a later inquiry into obviousness." PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1362 (Fed. Cir. 2007) (citing Constant v. Advanced Micro Devices, Inc., 848 F.2d 1560, 1570 (Fed. Cir. 1988); Sjolund v. Musland, 847 F.2d 1573, 1577-79 (Fed. Cir. 1988); In re Fout, 675 F.2d 297, 300 (CCPA 1982); In re Noyima, 509 F.2d 566, 571 (CCPA 1975)). By filing an application, identifying prior art, and making explanatory statements, a patent applicant concedes what is to be considered as prior art in determining obviousness of its improvement. In re Noyima at 571. When a patent specification admits that certain matter is prior art, the jury must accept it as prior art as a matter of law. Sjolund v. Musland at 1577-79. Consequently, testimony by Dr. Orkin that contradicts Amgen's binding admissions in the patents-in-suit, including any testimony corresponding to the assertions in paragraph 38 of his June 1, 2007 report regarding the alleged lack of a tissue source of human EPO in 1983, should be precluded. DATED: September 26, 2007 F. HOFFMANN-LA ROCHE LTD, ROCHE DIAGNOSTICS GMBH, and HOFFMANN-LA ROCHE INC. By its attorneys, /s/ Thomas F. Fleming Leora Ben-Ami (pro hac vice) Patricia A. Carson (pro hac vice) Thomas F. Fleming (pro hac vice) Howard S. Suh (pro hac vice)

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Case 1:05-cv-12237-WGY

Document 1157

Filed 09/26/2007

Page 3 of 3

Christopher T. Jagoe (pro hac vice) Vladimir Drozdoff (pro hac vice) Peter Fratangelo (BBO# 639775) Krista M. Rycroft (pro hac vice) KAYE SCHOLER LLP 425 Park Avenue New York, New York 10022 Tel. [phone] and Lee Carl Bromberg (BBO# 058480) Julia Huston (BBO# 562160) Keith E. Toms (BBO# 663369) Nicole A. Rizzo (BBO# 663853) BROMBERG & SUNSTEIN LLP 125 Summer Street Boston, MA 02110 Tel. [phone] CERTIFICATE OF SERVICE I hereby certify that this document filed through the ECF system will be sent electronically to the registered participants as identified on the Notice of Electronic Filing (NEF) on the above date. /s/ Thomas F. Fleming Thomas F. Fleming

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