IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS AMGEN, INC. Plaintiff, v. F. HOFFMANN-LA ROCHE LTD, ROCHE DIAGNOSTICS GmbH, and HOFFMANN-LA ROCHE INC. Defendants. Civil Action No. 05 CV 12237 WGY
ORAL ARGUMENT REQUESTED MEMORANDUM IN SUPPORT OF ROCHE’S MOTION FOR SUMMARY JUDGMENT THAT CLAIM 1 OF U.S. PATENT NO. 5,995,422 IS INVALID FOR INDEFINITENESS AND LACK OF WRITTEN DESCRIPTION
Leora Ben-Ami (
pro hac vice
) Mark S. Popofsky (
pro hac vice
) Patricia A. Carson (
pro hac vice
) Thomas F. Fleming (
pro hac vice
) Howard S. Suh (
pro hac vice
) Peter Fratangelo (BBO# 639775) K
AYE
S
CHOLER LLP
425 Park Avenue New York, New York 10022 Tel. (212) 836-8000 Lee Carl Bromberg (BBO# 058480) Julia Huston (BBO# 562160) Keith E. Toms (BBO# 663369) Nicole A. Rizzo (BBO# 663853) B
ROMBERG
&
S
UNSTEIN
LLP 125 Summer Street Boston, MA 02110 Tel. (617) 443-9292
Counsel for Defendants, F. HOFFMANN-LA ROCHE LTD, ROCHE DIAGNOSTICS GmbH, and
Dated: July 3, 2007
HOFFMANN-LA ROCHE INC.
Case 1:05-cv-12237-WGY Document 615 Filed 07/03/2007 Page 1 of 19
TABLE OF CONTENTS
I. INTRODUCTION..............................................................................................................1 II. STATEMENT OF FACTS.................................................................................................4 A. The ‘422 Claim At Issue.........................................................................................4 B. Amgen Maintains That “Purified From Mammalian Cells Grown In Culture” Recites A Structural Distinction...............................................................4 C. The Impact Of The
Litigation On Claim 1 Of The ‘422 Patent.....................5 III. ARGUMENT......................................................................................................................6 A. The Summary Judgment Standard..........................................................................6 B. Claim 1 Of The ‘422 Patent Is Invalid As Indefinite..............................................6 1. Standard For Indefiniteness Under 35 U.S.C. § 112, ¶2.............................7 2. The Pharmaceutical Composition of Claim 1 Must Be Structurally Distinct........................................................................................................8 3. The ‘422 Patent Distinguishes The Claimed EPO From Prior Art EPO Based Only On Glycosylation............................................................9 4. Amgen’s Experts Distinguish The Claimed EPO Products On The Basis Of Glycosylation.............................................................................10 5. Claim 1 Of the ‘422 Patent Is Indefinite...................................................12 6. Amgen Is Collaterally Estopped from Disputing that Glycosylation Is an Indefinite Standard For Distinguishing Its Claimed EPO From EPO Isolated From Natural Sources...............................................13 C. Claim 1 Of The ‘422 Patent Is Invalid For Failure To Comply With The Written Description Requirement.........................................................................14 IV. CONCLUSION.................................................................................................................15 i
Case 1:05-cv-12237-WGY Document 615 Filed 07/03/2007 Page 2 of 19
TABLE OF AUTHORITIES
Cases
Amgen v. Hoechst Marion Roussel, Inc.,
339 F. Supp. 2d 202 (D. Mass 2004).............................2
Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd
, 1989 U.S. Dist. LEXIS 16110 (D. Mass., December 11, 1989)..................................................................................................................12
Amgen, Inc. v. Hoechst Marion Roussel, Inc.
, 457 F.3d 1293, 1303 (Fed. Cir. 2006)...............1, 3
Boston Sci. Corp. v. SciMed Life Sys., Inc
., 983 F. Supp. 245, 255 (D. Mass. 1997)..................13
Cochrane v. Badische Anilin & Soda Fabrik
, 111 U.S. 293, 311, 4 S.Ct. 455, 28 L.Ed. 433 (1884))........................................................................................................................................2
Default Proof Credit Card Sys., Inc. v. Home Depot U.S.A., Inc.
, 412 F.3d 1291, 1298 (Fed. Cir. 2005)...........................................................................................................................................7
Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co
., 535 U.S. 722, 730-31 (2002).................7
General Electric Co. v. Wabash Appliance Corp.
, 304 U.S. 364, 373 (1938)...........................2, 8
Invitrogen Corp. v. Biocrest Mfg
.
, L.P.
, 424 F.3d 1374, 1383 (Fed. Cir. 2005)............................7
NLRB v. Donna-Lee Sportswear Co.
, 836 F.2d 31, 34 (1st Cir. 1987)........................................13
Oakley, Inc. v. Sunglass Hut Int’l
, 316 F.3d 1331, 1340 (Fed. Cir. 2003).....................................7
Personalized Media Commc’ns, LLC v. ITC
, 161 F.3d 696, 705 (Fed. Cir. 1998)).......................7
SmithKline Beecham Corp. v. Apotex Corp.,
439 F.3d 1312, 1319 n.7 (Fed. Cir. 2006)...............8
United Carbon Co. v. Binney & Smith Co.
, 317 U.S. 228, 233 (1942)..........................................3
Univ. of Rochester v. G.D. Searle & Co.
, 358 F.3d 916, 927 (Fed. Cir. 2004)............................14
Vardon Golf Co. v. Karsten Mfg. Corp.
, 294 F.3d 1330, 1333 (Fed. Cir. 2002)..........................13
Vas-Cath Inc. v. Mahurkar
, 935 F.2d 1555, 1561 (Fed. Cir. 1991).............................................14
Statutes
35 U.S.C. § 112.........................................................................................................1, 2, 4, 7, 8, 14 ii
Case 1:05-cv-12237-WGY Document 615 Filed 07/03/2007 Page 3 of 19
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