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Case 1:17-cv-11008-MLW Document 227 Filed 04/06/18 Page 1 of 39 UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS JANSSEN BIOTECH, INC., Plaintiff, No. 1:17-cv-11008 v. CELLTRION HEALTHCARE CO., LTD., CONFIDENTIAL CELLTRION, INC., and FILED UNDER SEAL HOSPIRA, INC. Defendants. MEMORANDUM IN SUPPORT OF DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT OF NON-INFRINGEMENT BASED ON ENSNAREMENT [Leave to File 30 Page Brief Granted April 4, 2018, Dkt. 224] Case 1:17-cv-11008-MLW Document 227 Filed 04/06/18 Page 2 of 39 TABLE OF CONTENTS Page I. Introduction ....................................................................................................................... 1 II. Factual Background.......................................................................................................... 3 A. Scientists Have Been Developing And Optimizing Cell Culture Media For Decades Before The ’083 Patent ............................................................................. 3 B. Janssen’s ’083 Patent Is Not New, Especially Under Its Unprecedented Dozen-Way Doctrine Of Equivalents Theory ......................................................... 5 1. Janssen removed the purported benefits of the patent by successfully arguing against construing the claims as chemically defined. .................... 5 2. None of the ingredients were new to cell culture media. ............................ 6 3. Janssen argues the ranges are not critical. ................................................ 12 4. The Prior Art is closer to the asserted claims than the accused products. .................................................................................................... 13 III. Legal Standards .............................................................................................................. 15 A. Summary Judgment .............................................................................................. 15 B. The “Ensnarement” Principle Is A Fundamental Limit On The Doctrine Of Equivalents ............................................................................................................ 15 IV. Argument ......................................................................................................................... 16 A. A Hypothetical Claim That Literally Encompasses the Accused Media Is Unpatentably Obvious In View Of GSK .............................................................. 17 1. GSK’s Concentration Of L-histidine.HCl.H2O Is Closer To The Claimed Range Than The Accused Products Are..................................... 18 2. The ’083 Patent’s Composition Merely Recites Obvious Variants Of Two Ingredients Expressly Disclosed In The Prior Art GSK Reference .................................................................................................. 20 3. There Is No Evidence Of Secondary Considerations That Could Legally Avoid Obviousness ...................................................................... 25 4. Claim 2 Is Likewise Unpatentable Over GSK .......................................... 26 i Case 1:17-cv-11008-MLW Document 227 Filed 04/06/18 Page 3 of 39 B. A Hypothetical Claim That Literally Encompasses the Accused Media Is Unpatentably Obvious In View Of Life Technologies Inc. .................................. 27 V. Conclusion ....................................................................................................................... 30 ii Case 1:17-cv-11008-MLW Document 227 Filed 04/06/18 Page 4 of 39 TABLE OF AUTHORITIES Page(s) Cases Abbott Labs. v. Dey, L.P., 287 F.3d 1097 (Fed. Cir. 2002)................................................................................................18 Apple Inc. v. Samsung Elecs. Co., 816 F.3d 788 (Fed. Cir. 2016)..................................................................................................24 In re Applied Materials, Inc., 692 F.3d 1289 (Fed. Cir. 2012)..........................................................................................19, 20 Bayer Pharma AG v. Watson Labs., Inc., 874 F.3d 1316 (Fed. Cir. 2017)..........................................................................................24, 25 Celotex Corp. v. Catrett, 477 U.S. 317 (1986) .................................................................................................................15 Comark Commc’ns, Inc. v. Harris Corp., 156 F.3d 1182 (Fed. Cir. 1998)................................................................................................27 Conroy v. Reebok Int’l, Ltd., 14 F.3d 1570 (Fed. Cir. 1994)....................................................................................................1 Cortland Line Co. v. Orvis Co., 203 F.3d 1351 (Fed. Cir. 2000)................................................................................................16 Depuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314 (Fed. Cir. 2009)......................................................................................1, 16, 17 In re Geisler, 116 F.3d 1465 (Fed. Cir. 1997)......................................................................................2, 19, 20 Gemalto S.A. v. HTC Corp., 754 F.3d 1364 (Fed. Cir. 2014)............................................................................................1, 16 Great Atlantic & Pacific Tea Co. v. Supermarket Equip. Corp., 340 US. 147 (1950) ..................................................................................................................20 In re Gurley, 27 F. 3d 551 (Fed. Cir. 1994)...................................................................................................24 Icon Health & Fitness, Inc. v. Octane Fitness, LLC, 496 Fed. App’x 57 (Fed. Cir. 2012) .........................................................................................16 iii Case 1:17-cv-11008-MLW Document 227 Filed 04/06/18 Page 5 of 39 Ineos USA LLC v. Berry Plastics Corp., 783 F.3d 865 (Fed. Cir. 2015)..................................................................................................20 Intendis GmbH v. Glenmark Pharms. Inc., USA, 822 F.3d 1355 (Fed. Cir. 2016)................................................................................................17 Jang v. Boston Sci. Corp., 872 F.3d 1275 (Fed. Cir. 2017)....................................................................................15, 16, 17 In re Johnston, 435 F.3d 1381 (Fed. Cir. 2006)..................................................................................................5 K-2 Corp. v. Salomon S.A., 191 F.3d 1356 (Fed. Cir. 1999)................................................................................................16 KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) .................................................................................................3, 20, 21, 28 In re Lackey, 371 Fed. Appx. 80 (Fed. Cir. 2010) .........................................................................................21 Marquip, Inc. v. Fosber Am., Inc., 198 F.3d 1363 (Fed. Cir. 1999)................................................................................................16 Mendes v. Medtronic, Inc., 18 F.3d 13 (1st Cir. 1994) ........................................................................................................15 Morris v. Gov’t Dev. Bank of P.R., 27 F.3d 746 (1st Cir. 1994) ......................................................................................................15 In re Mouttet, 686 F.3d 1322 (Fed. Cir. 2012)................................................................................................24 In re Omeprazole Patent Litig., 483 F.3d 1364 (Fed. Cir. 2007)..........................................................................................21, 25 Ormco Corp. v. Align Tech. Inc., 463 F.3d 1299 (Fed. Cir. 2006)................................................................................2, 18, 19, 26 In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003)............................................................................................2, 18 Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005)................................................................................................27 Wilson Sporting Goods Co. v. David Geoffrey & Assocs., 904 F.2d 677 (Fed. Cir. 1990)......................................................................................15, 16, 20 iv Case 1:17-cv-11008-MLW Document 227 Filed 04/06/18 Page 6 of 39 Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356 (Fed. Cir. 2012)................................................................................................21 Wyers v. Master Lock Co., 616 F.3d 1231 (Fed. Cir. 2010)..........................................................................................17, 26 v Case 1:17-cv-11008-MLW Document 227 Filed 04/06/18 Page 7 of 39 I. Introduction The Court should end this case as a matter of law based on ensnarement—”the longstanding principle that the prior art restricts the scope of equivalency that the party alleging infringement under the doctrine of equivalents can assert.” Conroy v. Reebok Int’l, Ltd., 14 F.3d 1570, 1576 (Fed. Cir. 1994). To maintain its 12-way doctrine-of-equivalents theory, Janssen—not the Defendants—have the “burden of persuasion” to establish “that the asserted scope of equivalency would not ensnare the prior art,” such that the “equitabl[y]” expanded claims are patentable inventions over the prior art. Depuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1323-24 (Fed.