Case: 15-2066 Document: 146 Page: 1 Filed: 09/15/2017
`
`Nos. 2015-2066, 2016-1008, -1009, -1010, -1109, -1110, -1283, -1762
`United States Court of Appeals for the Federal Circuit
`__________
`MILLENNIUM PHARMACEUTICALS, INC.,
`PLAINTIFF-APPELLANT,
`v.
`SANDOZ INC., ACCORD HEALTHCARE, INC., ACTAVIS LLC, MYLAN LABORATORIES
`LIMITED, AGILA SPECIALTIES INC., DR. REDDY’S LABORATORIES, LTD., DR.
`REDDY’S LABORATORIES, INC., SUN PHARMACEUTICAL INDUSTRIES, LIMITED, SUN
`PHARMA GLOBAL FZE, APOTEX CORP., APOTEX INC., TEVA PHARMACEUTICALS
`USA, INC., GLENMARK PHARMACEUTICALS LTD., GLENMARK GENERICS LTD.,
`GLENMARK GENERICS INC., USA, HOSPIRA, INC., WOCKHARDT BIO AG,
`WOCKHARDT USA LLC,
`DEFENDANTS-APPELLEES
`__________
`APPEALS FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF
`DELAWARE IN CASE NOS. 1:12-CV-01011-GMS, 1:12-CV-01490-GMS,
`1:12-CV-01750-GMS, 1:13-CV-01874-GMS, 1:14-CV-01156-GMS,
`1:15-CV-00040-GMS, 1:15-CV-00539-GMS, 1:15-CV-00540-GMS,
`1:15-CV-00804-GMS, AND 1:16-CV-00034-GMS, JUDGE GREGORY M. SLEET
`__________
`
`GEORGE C. LOMBARDI
`MAUREEN L. RURKA
`KATHLEEN B. BARRY
`Winston & Strawn LLP
`35 W. Wacker Drive
`Chicago, IL 60601
`(312) 558-5600
`glombardi@winston.com
`mrurka@winston.com
`kbarry@winston.com
`
`
`COMBINED PETITION FOR
`PANEL REHEARING OR REHEARING EN BANC
`__________
`STEFFEN N. JOHNSON
`ANDREW C. NICHOLS
`EIMERIC REIG-PLESSIS
`Winston & Strawn LLP
`1700 K Street, N.W.
`Washington, DC 20006
`(202) 282-5000
`sjohnson@winston.com
`anichols@winston.com
`ereigplessis@winston.com
`
`Counsel for Defendant-Appellee Sandoz Inc.
`[ADDITIONAL COUNSEL LISTED ON INSIDE COVER]
`
`
`
`
`

`

`Case: 15-2066 Document: 146 Page: 2 Filed: 09/15/2017
`
`
`
`GARY E. HOOD
`MARK T. DEMING
`KHURRAM NAIK
`Polsinelli PC
`150 North Riverside Plaza, Suite 3000
`Chicago, IL 60606
`(312) 819-1900
`ghood@polsinelli.com
`mdeming@polsinelli.com
`knaik@polsinelli.com
`
`
`
`ROBYN AST-GMOSER
`Polsinelli PC
`100 S. Fourth Street, Suite 1000
`St. Louis, MO 63102
`(314) 622-6614
`rastgmoser@polsinelli.com
`
`
`
`
`Counsel for Defendant-Appellee Actavis LLC
`
`
`
`
`THOMAS J. MELORO
`MICHAEL W. JOHNSON
`Willkie Farr & Gallagher LLP
`787 Seventh Avenue
`New York, NY 10019
`(212) 728-8000
`tmeloro@willkie.com
`mjohnson1@willkie.com
`
`Counsel for Defendant-Appellee
`Hospira, Inc.
`
`
`
`STUART D. SENDER
`LOUIS H. WEINSTEIN
`ELLEN T. LOWENTHAL
`Budd Larner, P.C.
`150 John F. Kennedy Parkway
`Short Hills, NJ 07078
`(973) 379-4800
`ssender@buddlarner.com
`lweinstein@buddlarner.com
`elowenthal@buddlarner.com
`
`Counsel for Defendants-Appellees
`Dr. Reddy’s Laboratories, Ltd. and
`Dr. Reddy’s Laboratories, Inc.
`
`
`
`PAUL A. BRAIER
`P. BRANKO PEJIC
`Greenblum & Bernstein, P.L.C.
`1950 Roland Clarke Place
`Reston, VA 20191
`(703) 716-1191
`pbraier@gbpatent.com
`bpejic@gbpatent.com
`
`Counsel for Defendant-Appellee
`Accord Healthcare Inc.
`
`
`
`JAY P. LESSLER
`PAUL M. ZAGAR
`Blank Rome LLP
`405 Lexington Avenue
`New York, NY 10174
`(212) 885-5176
`jlessler@blankrome.com
`pzagar@blankrome.com
`
`Counsel for Defendants-Appellees
`Glenmark Pharmaceuticals Ltd.,
`Glenmark Generics Ltd., and
`Glenmark Generics Inc., USA
`
`

`

`Case: 15-2066 Document: 146 Page: 3 Filed: 09/15/2017
`
`
`KEVIN M. NELSON
`PATRICK GALLAGHER
`Duane Morris LLP
`190 South LaSalle Street
`Chicago, IL 60603
`(312) 499-600
`kmnelson@duanemorris.com
`pcgallagher@duanemorris.com
`
`Counsel for Defendants-Appellees
`Wockhardt Bio AG and
`Wockhardt USA LLC
`
`
`
`
`
`
`
`
`CHRISTOPHER J. SORENSON
`RACHEL C. HUGHEY
`AARON M. JOHNSON
`Merchant & Gould
`IDS Center 3200
`80 South Street
`Minneapolis, MN 55402
`(612) 332-5300
`csorenson@merchantgould.com
`rhughey@merchantgould.com
`ajohnson@merchantgould.com
`
`Counsel for Defendants-Appellees
`Sun Pharmaceutical Industries Limited
`and Sun Pharma Global FZE
`
`
`
`TUNG-ON KONG
`ELHAM F. STEINER
`Wilson Sonsini Goodrich
`& Rosati P.C.
`One Market Street
`Spear Tower, Suite 3600
`San Francisco, CA 94105
`(415) 947-2000
`tkong@wsgr.com
`esteiner@wsgr.com
`
`Counsel for Defendants-Appellees
`Mylan Laboratories Limited
`and Agila Specialties Inc.
`
`
`
`
`
`
`
`

`

`Case: 15-2066 Document: 146 Page: 4 Filed: 09/15/2017
`
`CERTIFICATE OF INTEREST
`Counsel for Petitioner Accord Healthcare, Inc. certifies the following:
`
`1.
`
`The full name of every party or amicus represented by me is:
`
`The name of the real party in interest represented by me is:
`
`
`
`
`
`Accord Healthcare, Inc.
`
`2.
`
`N/A
`
`All parent corporations and any publicly held companies that own 10
`3.
`percent or more of the stock of the party or amicus curiae represented by me are:
`
`Intas Pharmaceuticals Ltd.
`
`The names of the law firms and the partners or associates that appeared
`4.
`for the party or amicus now represented by me in the trial court or agency or are
`expected to appear in this court are:
`
`Greenblum & Bernstein, P.L.C. – Paul A. Braier, P. Branko Pejic, Neil F.
`Greenblum, Michael J. Fink, Jill M. Browning, and Jeffrey Handelsman
`Young Conaway Stargatt & Taylor, LLP – Adam W. Poff and Monté T.
`Squire
`
`
`
`Dated: SEPTEMBER 15, 2017 By: /s/ Paul A. Braier
`PAUL A. BRAIER
`Greenblum & Bernstein, P.L.C.
`1950 Roland Clarke Place
`Reston, VA 20191
`(703) 716-1191
`
`Counsel for Defendant-Appellee
`Accord Healthcare Inc.
`
`
`
`

`

`Case: 15-2066 Document: 146 Page: 5 Filed: 09/15/2017
`
`CERTIFICATE OF INTEREST
`Counsel for Petitioner Actavis LLC certifies the following:
`
`1.
`
`The full name of every party or amicus represented by me is:
`
`Actavis LLC
`
`2.
`
`The name of the real party in interest represented by me is:
`
`N/A
`
`All parent corporations and any publicly held companies that own 10
`3.
`percent or more of the stock of the party or amicus curiae represented by me are:
`
`Allergan plc
`
`The names of the law firms and the partners or associates that appeared
`4.
`for the party or amicus now represented by me in the trial court or agency or are
`expected to appear in this court are:
`
`Polsinelli PC - Gary E. Hood, Pamela Avallone (formerly Fekete), Robyn Ast-
`Gmoser, Mark T. Deming, Khurram Naik, and Christine M. Cochran; Richards Lay-
`ton & Finger - Steven J. Fineman and Jason J. Rawnsley; Duane Morris LLP - Matt
`Neiderman, Anthony J. Fitzpatrick, Vincent L. Capuano, and Laura A. Vogel.
`
`
`
`Dated: SEPTEMBER 15, 2017 By: /s/ Gary E. Hood
`GARY E. HOOD
`Polsinelli PC
`150 N. Riverside Plaza, Suite 3000
`Chicago, IL 60606
`(312) 819-1900
`
`Counsel for Defendant-Appellee
`Actavis LLC
`
`
`
`ii
`
`

`

`Case: 15-2066 Document: 146 Page: 6 Filed: 09/15/2017
`
`CERTIFICATE OF INTEREST
`
`Counsel for Petitioners Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s La-
`boratories, Inc. certifies the following:
`
`
`
`1.
`
`The full name of every party or amicus represented by me is:
`
` Dr. Reddy’s Laboratories, Ltd.; Dr. Reddy’s Laboratories, Inc.
`
`
`
`The name of the real party in interest (Please only include any real party
`2.
`in interest NOT identified in Question 3. below) represented by me is:
` N/A
`
`3. All parent corporations and any publicly held companies that own 10
`percent of the stock of the party or amicus curiae represented by me are listed below.
`(Please list each party or amicus curiae represented with the parent or publicly held
`company that owns 10 percent or more so they are distinguished separately.)
` Dr. Reddy’s Laboratories, Inc. is wholly owned by Dr. Reddy’s Laboratories,
` Ltd. No publicly held company owns 10 percent or more of the stock of Dr.
` Reddy’s Laboratories, Ltd.
`
`The names of all law firms and the partners or associates that appeared
`4.
`
`for the party or amicus now represented by me in the trial court or agency or are
`expected to appear in this court are:
` Budd Larner, P.C.: Louis H. Weinstein, Stuart D. Sender, Ellen T. Lowenthal
` Philips, Goldman & Spence, P.A.: John C. Philips, Jr., David A. Bilson
`
`Dated: SEPTEMBER 15, 2017 By: /s/ Stuart D. Sender
`STUART D. SENDER
`Budd Larner, P.C.
`150 John F. Kennedy Parkway
`Short Hills, NJ 07078
`(973) 379-4800
`
`Counsel for Defendants-Appellees
`Dr. Reddy’s Laboratories, Ltd. and
`Dr. Reddy’s Laboratories, Inc.
`
`iii
`
`

`

`Case: 15-2066 Document: 146 Page: 7 Filed: 09/15/2017
`
`CERTIFICATE OF INTEREST
`
`Counsel for Petitioners Glenmark Pharmaceuticals Ltd., Glenmark Generics
`Ltd., and Glenmark Generics Inc., USA certify the following:
`
`
`
`1.
`
`The full name of every party or amicus curiae represented by me is:
`
` Glenmark Pharmaceuticals Ltd., Glenmark Generics Ltd., and Glenmark Generics
`Inc., USA.
`
`The name of the real party in interest (if the party named in the caption
`2.
`
`is not the real party in interest) represented by me is:
`
`Glenmark Generics Inc., USA has changed its name to Glenmark Pharmaceu-
`
`ticals Inc., USA, which is wholly owned by Glenmark Pharmaceuticals Ltd.
`
`Glenmark Generics Ltd. has merged into Glenmark Pharmaceuticals Ltd.
`
`All parent corporations and any publicly held companies that own 10
`3.
`
`percent or more of the stock of the party or amicus curiae represented by me are:
`
`(a) Glenmark Generics Inc., USA (now known as Glenmark Pharmaceuticals
`Inc., USA) is wholly owned by Glenmark Pharmaceuticals Ltd.
`
`(b) Glenmark Generics Ltd. has merged into Glenmark Pharmaceuticals Ltd.,
`a corporation duly formed and publicly traded under the laws of India.
`
` (c) Glenmark Pharmaceuticals Ltd. has no parent company, and no publicly
`traded company owns 10% or more of Glenmark Pharmaceuticals Ltd.
`
`The names of all law firms and the partners or associates that appeared
`4.
`
`for the party or amicus now represented by me in the trial court or agency or are
`expected to appear in this court are:
`
`
`
`
`
`
`
`Jay P. Lessler
`Paul M. Zagar
`BLANK ROME LLP
`
`
`
`iv
`
`

`

`Case: 15-2066 Document: 146 Page: 8 Filed: 09/15/2017
`
`Dated: SEPTEMBER 15, 2017 By: /s/ Jay P. Lessler
`JAY P. LESSLER
`Blank Rome LLP
`405 Lexington Avenue
`New York, NY 10174
`(212) 885-5176
`
`Counsel for Defendants-Appellees
`Glenmark Pharmaceuticals Ltd.,
`Glenmark Generics Ltd., and
`Glenmark Generics Inc., USA
`
`v
`
`

`

`Case: 15-2066 Document: 146 Page: 9 Filed: 09/15/2017
`
`CERTIFICATE OF INTEREST
`Counsel for Petitioner Hospira, Inc. certifies the following:
`
`1.
`
`The full name of every party or amicus represented by me is:
`
`Hospira, Inc.
`
`2.
`
`The name of the real party in interest represented by me is:
`
`N/A
`
`All parent corporations and any publicly held companies that own 10
`3.
`percent or more of the stock of the party or amicus curiae represented by me are:
`
`Hospira, Inc. is an indirect, wholly-owned subsidiary of Pfizer Inc.
`
`The names of the law firms and the partners or associates that appeared
`4.
`for the party or amicus now represented by me in the trial court or agency or are
`expected to appear in this court are:
`
`Willkie Farr & Gallagher LLP – Thomas J. Meloro and Michael W. Johnson
`
`Proctor Heymen Enerio LLP: Dominick T. Gattuso
`
`
`
`Dated: SEPTEMBER 15, 2017 By: /s/ Thomas J. Meloro
`THOMAS J. MELORO
`Willkie Farr & Gallagher LLP
`787 Seventh Avenue
`New York, NY 10019
`(212) 728-8000
`
`Counsel for Defendant-Appellee
`Hospira, Inc.
`
`
`
`
`
`vi
`
`

`

`Case: 15-2066 Document: 146 Page: 10 Filed: 09/15/2017
`
`CERTIFICATE OF INTEREST
`Counsel for Petitioners Mylan Laboratories Limited and Agila Specialties Inc.
`
`certifies the following:
`
`
`
`
`
`
`
`
`
`1.
`
`The full name of every party or amicus represented by me is:
`
`Mylan Laboratories Limited and Agila Specialties Inc.
`
`2.
`
`The name of the real party in interest represented by me is:
`
`N/A
`
`All parent corporations and any publicly held companies that own 10
`3.
`
`percent or more of the stock of the party or amicus curiae represented by me are:
`
`Mylan Laboratories Limited and Agila Specialties Inc. are wholly owned sub-
`sidiaries of Mylan Inc., which is indirectly wholly owned by Mylan N.V., a
`publicly held company. No publicly held company owns 10% or more of
`Mylan N.V.’s stock.
`
`The names of the law firms and the partners or associates that appeared
`4.
`
`for the party or amicus now represented by me in the trial court or agency or are
`expected to appear in this court are:
`
`Wilson Sonsini Goodrich & Rosati P.C. – Tung-On Kong and Elham F. Stei-
`ner; Potter Anderson & Corroon – Richard L. Horwitz; David E. Moore, and
`Bindu A. Palapura.
`
`Dated: SEPTEMBER 15, 2017 By: /s/ Elham F. Steiner
`ELHAM F. STEINER
`Wilson Sonsini Goodrich
`& Rosati P.C.
`One Market Street
`Spear Tower, Suite 3600
`San Francisco, CA 94105
`(415) 947-2000
`
`Counsel for Defendants-Appellees
`Mylan Laboratories Limited and
`Agila Specialties Inc.
`
`
`
`vii
`
`

`

`Case: 15-2066 Document: 146 Page: 11 Filed: 09/15/2017
`
`CERTIFICATE OF INTEREST
`Counsel for Petitioner Sandoz Inc. certifies the following:
`
`1.
`
`The full name of every party or amicus represented by me is:
`
`Sandoz Inc.
`
`2.
`
`The name of the real party in interest represented by me is:
`
`N/A
`
`All parent corporations and any publicly held companies that own 10
`3.
`percent or more of the stock of the party or amicus curiae represented by me are:
`
`Novartis AG is the ultimate parent company and owns 100% of Sandoz Inc.
`
`The names of the law firms and the partners or associates that appeared
`4.
`for the party or amicus now represented by me in the trial court or agency or are
`expected to appear in this court are:
`
`Winston & Strawn LLP—George C. Lombardi, Maureen L. Rurka, Kathleen
`B. Barry, Steffen N. Johnson, Andrew C. Nichols, and Eimeric Reig-Plessis. The
`following attorneys, who represented Sandoz in the trial court, are no longer with
`Winston & Strawn LLP: James F. Hurst, Raymond C. Perkins, John K. Hsu, Mary
`T. McCarthy, and Michelle Munoz Durk.
`
`Phillips Goldman, McLaughlin & Hall (formerly Phillips Goldman &
`Spence)—John C. Phillips Jr. and Megan C. Haney.
`
`
`Dated: SEPTEMBER 15, 2017 By: /s/ Steffen N. Johnson
`STEFFEN N. JOHNSON
`Winston & Strawn LLP
`1700 K Street, N.W.
`Washington, DC 20006
`(202) 282-5879
`
`Counsel for Defendant-Appellee
`Sandoz Inc.
`
`
`
`
`
`viii
`
`

`

`Case: 15-2066 Document: 146 Page: 12 Filed: 09/15/2017
`
`CERTIFICATE OF INTEREST
`Counsel for Petitioners Sun Pharmaceutical Industries Limited and Sun
`Pharma Global FZE certifies the following:
`
`1.
`
`The full name of every party or amicus represented by me is:
`
`Sun Pharmaceutical Industries Limited and Sun Pharma Global FZE
`
`2.
`
`The name of the real party in interest represented by me is:
`
`Sun Pharmaceutical Industries Limited and Sun Pharma Global FZE
`
`All parent corporations and any publicly held companies that own 10
`3.
`percent or more of the stock of the party or amicus curiae represented by me are:
`
`No publicly held entity holds 10% or more stock in either Sun party named.
`Sun Pharma Global FZE is wholly owned by Sun Pharma Industries Limited.
`
`The names of the law firms and the partners or associates that appeared
`4.
`for the party or amicus now represented by me in the trial court or agency or are
`expected to appear in this court are:
`
`Kelly Farnan and Lori Brewington of Richards, Layton & Finger PA(Wil-
`mington, DE)
`
`B. Jefferson Boggs of Merchant & Gould (Alexandria, VA)
`
`Christopher Sorenson, Rachel Hughey, and Aaron Johnson of Merchant &
`Gould (Minneapolis, MN)
`
`
`
`
`
`
`
`ix
`
`

`

`Case: 15-2066 Document: 146 Page: 13 Filed: 09/15/2017
`
`Dated: SEPTEMBER 15, 2017 By: /s/ Rachel C. Hughey
`RACHEL C. HUGHEY
`Merchant & Gould
`IDS Center 3200
`80 South Street
`Minneapolis, MN 55402
`(612) 332-5300
`
`Counsel for Defendants-Appellees
`Sun Pharmaceutical Industries Limited and
`Sun Pharma Global FZE
`
`x
`
`

`

`Case: 15-2066 Document: 146 Page: 14 Filed: 09/15/2017
`
`CERTIFICATE OF INTEREST
`
`Counsel for Petitioners Wockhardt Bio AG and Wockhardt USA LLC certi-
`fies the following:
`
`1.
`
`The full name of every party or amicus represented by us is:
`
`Wockhardt Bio AG and Wockhardt USA LLC
`
`2.
`
`The names of the real party in interest represented by us is:
`
`Not applicable
`
`All parent corporations and any publicly held companies that own 10
`3.
`percent or more of the stock of the party or amicus curiae represented by me are:
`
`Wockhardt Ltd.
`
`The names of all law firms and the partners or associates that appeared
`4.
`for the party or amicus now represented by me in the trial court or agency or are
`expected to appear in this court are:
`
`DUANE MORRIS LLP: Frederick R. Ball; Kevin M. Nelson; Patrick C. Gal-
`lagher; Richard W. Riley
`
`Dated: SEPTEMBER 15, 2017 By: /s/ Patrick Gallagher
`PATRICK GALLAGHER
`Duane Morris LLP
`190 South LaSalle Street
`Chicago, Illinois 60603
`(312) 499-6700
`
`Counsel for Defendants-Appellees Wock-
`hardt Bio AG and Wockhardt USA LLC
`
`
`
`xi
`
`

`

`Case: 15-2066 Document: 146 Page: 15 Filed: 09/15/2017
`
`TABLE OF CONTENTS
`
`Page
`
`TABLE OF AUTHORITIES ................................................................................. xiii
`
`CIRCUIT RULE 35(b) STATEMENT ...................................................................... 1
`
`INTRODUCTION ..................................................................................................... 1
`
`STATEMENT OF THE CASE .................................................................................. 4
`
`POINTS OF LAW MISAPPREHENDED BY THE PANEL ................................... 6
`
`REASONS FOR GRANTING PANEL OR EN BANC REHEARING ................... 6
`
`I.
`
`Rehearing is needed because the panel decision conflicts with binding
`precedent that restricts the patentability of inherent results. ........................... 6
`
`A.
`
`B.
`
`The panel broke from settled law that an inherent claim element
`need not be known or expected in the prior art. .................................... 7
`
`Left uncorrected, the panel decision threatens to allow patentees
`to expand patent protection without real innovation by re-
`claiming the inherent results of otherwise known and obvious
`processes. ............................................................................................. 10
`
`II.
`
`By rigidly imposing a “lead compound” analysis focused on the
`motivation to create a new compound, the panel disregarded the
`Supreme Court’s and this Court’s precedents mandating flexibility in
`obviousness. ................................................................................................... 12
`
`A.
`
`The panel broke with precedent by recasting the obviousness
`inquiry as a search for a modified compound instead of
`recognizing that any motivation that leads to the claimed
`invention is sufficient. ......................................................................... 12
`
`B.
`
`The panel decision encourages claim draftsmanship and
`elevates form over substance in the chemical arts. ............................. 14
`
`CONCLUSION ........................................................................................................ 15
`
`
`
`
`
`
`
`xii
`
`

`

`Case: 15-2066 Document: 146 Page: 16 Filed: 09/15/2017
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`CASES
`Alcon Research, Ltd. v. Apotex Inc.,
`687 F.3d 1362 (Fed. Cir. 2012) .................................................................. 6–7, 13
`
`Allergan, Inc. v. Sandoz Inc.,
`726 F.3d 1286 (Fed. Cir. 2013) .......................................................................... 13
`
`Atlas Powder Co. v. Ireco, Inc.,
`190 F.3d 1342 (Fed. Cir. 1999) .......................................................................... 11
`
`Bancorp Servs., L.L.C. v. Sun Life Assurance Co.,
`687 F.3d 1266 (Fed. Cir. 2012) .......................................................................... 15
`
`In re Baxter Travenol Labs,
`952 F.2d 388 (Fed. Cir. 1991) ............................................................................ 11
`
`In re Beattie,
`974 F.2d 1309 (Fed. Cir. 1992) .......................................................................... 13
`
`Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc.,
`246 F.3d 1368 (Fed. Cir. 2001) .......................................................................... 11
`
`Bristol-Myers Squibb Co. v. Teva Pharm. USA, Inc.,
`752 F.3d 967 (Fed. Cir. 2014) ............................................................................ 14
`
`In re Cruciferous Sprout Litig.,
`301 F.3d 1343 (Fed. Cir. 2002) ............................................................................ 7
`
`In re Dillon,
`919 F.2d 688 (Fed. Cir. 1990) (en banc) .............................................................. 8
`
`In re Donohue,
`632 F.2d 123 (C.C.P.A. 1980) ............................................................................ 11
`
`EMI Grp. N. Am., Inc. v. Cypress Semiconductor Corp.,
`268 F.3d 1342 (Fed. Cir. 2001) ............................................................................ 7
`
`Gilead Sciences, Inc. v. Natco Pharma Ltd.,
`753 F.3d 1208 (Fed. Cir. 2014) .......................................................................... 12
`
`xiii
`
`

`

`Case: 15-2066 Document: 146 Page: 17 Filed: 09/15/2017
`
`In re Johnson,
`589 F.2d 1070 (C.C.P.A. 1978) .......................................................................... 14
`
`In re Kahn,
`441 F.3d 977 (Fed. Cir. 2006) ............................................................................ 13
`
`In re Kao,
`639 F.3d 1057 (Fed. Cir. 2011) .................................................................... 6, 8–9
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) .............................................................................. 2–3, 12–15
`
`In re Kubin,
`561 F.3d 1351 (Fed. Cir. 2009) ........................................................................ 8–9
`
`Mayo Collaborative Servs. v. Prometheus Labs., Inc.,
`132 S. Ct. 1289 (2012) ........................................................................................ 10
`
`In re Napier,
`55 F.3d 610 (Fed. Cir. 1995) ................................................................................ 7
`
`PAR Pharm., Inc. v. TWI Pharm., Inc.,
`773 F.3d 1186 (Fed. Cir. 2014) .............................................................. 2, 7–8, 13
`
`Parker v. Flook,
`437 U.S. 584 (1978) ............................................................................................ 15
`
`Santarus, Inc. v. Par Pharm., Inc.,
`694 F.3d 1344 (Fed. Cir. 2012) .......................................................................... 10
`
`Schering Corp. v. Geneva Pharm., Inc.,
`339 F.3d 1373 (Fed. Cir. 2003) .................................................................. 2, 7, 11
`
`In re Skoner,
`517 F.2d 947 (C.C.P.A. 1975) ............................................................................ 15
`
`Williamson v. Citrix Online, LLC,
`792 F.3d 1339 (Fed. Cir. 2015) ............................................................................ 2
`
`In re Wiseman,
`596 F.2d 1019 (C.C.P.A. 1979) ............................................................................ 8
`
`xiv
`
`

`

`Case: 15-2066 Document: 146 Page: 18 Filed: 09/15/2017
`
`In re Woodruff,
`919 F.2d 1575 (Fed. Cir. 1990) .......................................................................... 11
`
`STATUTES
`
`35 U.S.C. § 103 ........................................................................................................ 12
`
`OTHER AUTHORITIES
`
`Dennis Crouch, When is an inherent, but unexpected result obvious?,
`Patently-O (July 17, 2017), available at
`https://patentlyo.com/patent/2017/07/inherent-unexpected-
`obvious.html .......................................................................................................... 4
`
`Fed. R. App. P. 35(a) ................................................................................................. 4
`
`Mark A. Lemley, Expecting the Unexpected, 92 Notre Dame L. Rev.
`1369 (2017) ......................................................................................................... 15
`
`Don Mizerk and Rachael Casey, Fed. Circ. Resurrects Hindsight Bias
`In Post-KSR World, Law360 (Aug. 23, 2017), available at
`https://www.law360.com/ip/articles/956635/fed-circ-resurrects-
`hindsight-bias-in-post-ksr-world .......................................................................... 3
`
`Warren Woessner, Millennium Pharm. v. Sandoz, Inc. – Revenge of
`the Chemical Judges, Patents4Life (July 19, 2017), available at
`http://www.patents4life.com/2017/07/millennium-pharm-v-
`sandoz-inc-revenge-chemical-judges/ .................................................................. 3
`
`
`
`xv
`
`

`

`Case: 15-2066 Document: 146 Page: 19 Filed: 09/15/2017
`
`CIRCUIT RULE 35(b) STATEMENT
`
`A.
`
`Based on my professional judgment, I believe the panel decision is con-
`
`trary to the following decisions of the Supreme Court and this Court:
`
`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007);
`PAR Pharm., Inc. v. TWI Pharm., Inc., 773 F.3d 1186 (Fed. Cir. 2014);
`Alcon Research, Ltd. v. Apotex, Inc., 687 F.3d 1362 (Fed. Cir. 2012);
`In re Kao, 639 F.3d 1057 (Fed. Cir. 2011);
`In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009);
`Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373 (Fed. Cir. 2003);
`Atlas Powder Co. v. Ireco, Inc., 190 F.3d 1342 (Fed. Cir. 1999).
`
`B.
`
`Based on my professional judgment, I believe this appeal requires an-
`
`swers to the following precedent-setting questions of exceptional importance:
`
`1. Where it would have been obvious to use a process that inherently re-
`sults in the formation of a chemical compound, is the compound pro-
`duced by the obvious use of that process patentable?
`
`
`2.
`
`To prove the obviousness of a chemical compound, is it necessary to
`prove that a person of ordinary skill in the art would have specifically
`intended to make that compound, when a different motivation would
`have led the skilled person to take steps that result in that compound?
`
`/s/ Steffen N. Johnson
`STEFFEN N. JOHNSON
`Attorney of Record
`
`Dated: SEPTEMBER 15, 2017
`
`
`
`
`
`INTRODUCTION
`
`Appellees seek review of a ruling that sharply conflicts with precedent on two
`
`critical rules: (1) inherent results of obvious methods are unpatentable; and (2) any
`
`motivation that leads to a claimed invention can prove obviousness. Commentators
`
`have denounced the “muddled decision” for making “somewhat of a mess” of these
`
`
`
`

`

`Case: 15-2066 Document: 146 Page: 20 Filed: 09/15/2017
`
`rules, which ensure that patents are not granted for obvious experimentation. Re-
`
`hearing is needed to confirm the non-patentability of inherent results—especially in
`
`the chemical arts—and to maintain the uniformity of this Court’s precedent.
`
`First, the decision breaks from decades of inherency law that the panel was
`
`powerless to overrule. E.g., Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1347
`
`n.3 (Fed. Cir. 2015) (en banc). The panel upheld claims to a compound that is “the
`
`‘natural result’ of a chemical procedure” taught by the prior art. Op. 8. Although
`
`the compound itself was not previously disclosed, it was obvious to use the well-
`
`known process in a way that inevitably produces the claimed compound. That is all
`
`the law requires: This Court’s precedents hold that “inherency may supply a missing
`
`claim limitation in an obviousness analysis” where, as here, it is “the ‘natural result’
`
`of the combination of prior art elements.” PAR Pharm., Inc. v. TWI Pharm., Inc.,
`
`773 F.3d 1186, 1194-95 (Fed. Cir. 2014). By definition, moreover, inherency “does
`
`not require that a person of ordinary skill in the art at the time would have recognized
`
`the inherent disclosure.” Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373,
`
`1377 (Fed. Cir. 2003). Yet the panel found the claimed compound patentable pre-
`
`cisely because no one “foresaw, or expected” that it would form. Op. 17. That
`
`requirement threatens to gut the inherency doctrine by allowing claims to the inher-
`
`ent results of the prior art—i.e., “advances that would occur in the ordinary course
`
`without real innovation.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007).
`
`2
`
`

`

`Case: 15-2066 Document: 146 Page: 21 Filed: 09/15/2017
`
`Second, the decision squarely conflicts with Supreme Court and Federal Cir-
`
`cuit precedent on the necessary motivation to combine the prior art. Here, the moti-
`
`vation to take steps that led to the claimed compound was undisputed—it forms
`
`spontaneously when performing a procedure to improve stability called “lyophiliza-
`
`tion,” which “‘was well-known.’” Op. 7. Even the patentee admitted that “there
`
`‘was nothing inventive about thinking to lyophilize bortezomib.’” A14 n.9. But the
`
`panel disregarded the undisputed motivation to use an obvious process by requiring
`
`an explicit “reason to make this specific new chemical compound.” Op. 11. That
`
`requirement conflicts with KSR’s holding that “any need or problem … can provide
`
`a reason for combining the elements in the manner claimed”—“neither the particular
`
`motivation nor the avowed purpose of the patentee controls.” 550 U.S. at 419-20.
`
`Post-KSR, this Court has steadfastly adhered to that view. Until now.
`
`Commentators note that this ruling “resuscitat[es] arguments repudiated by
`
`[precedent],” and thus “should be reconsidered by the panel or reheard en banc.”1
`
`Others note that it creates confusion by failing to “distinguish earlier decisions” with
`
`which it conflicts.2 And even those who are not critical of the result decry the panel’s
`
`
`1 https://www.law360.com/ip/articles/956635/fed-circ-resurrects-hindsight-bias-in-
`post-ksr-world
`2 http://www.patents4life.com/2017/07/millennium-pharm-v-sandoz-inc-revenge-
`chemical-judges/
`
`3
`
`

`

`Case: 15-2066 Document: 146 Page: 22 Filed: 09/15/2017
`
`“muddled opinion” for “creat[ing] somewhat of a mess” of the law.3
`
`One panel may not upset the uniformity of the Court’s precedent in an excep-
`
`tionally important area of obviousness law. FRAP 35(a). En banc review is needed.
`
`STATEMENT OF THE CASE
`
`This case involves a patent on the D-mannitol “ester”—a compound derived
`
`from an acid—of bortezomib, a “previously known” acid with “known efficacy
`
`against various cancers.” Op. 5. A known difficulty in formulating bortezomib was
`
`“its instability,” including “in liquid formulations” that are necessary to administer
`
`drugs intravenously. Id. To solve that known problem, Millennium’s patent claims
`
`both the stable D-mannitol ester of bortezomib and its “method of preparation,”
`
`which involves “lyophilizing” (freeze-drying) bortezomib with “mannitol, a known
`
`bulking agent” that was commonly used for lyophilization. Op. 5-6. The freeze-
`
`dried powder can then be “reconstitut[ed] with a pharmaceutically acceptable car-
`
`rier” (e.g., saline) into an injectable dose. Op. 5. All of this is undisputed.
`
`The district court invalidated the patent “[based] on the testimony of Sandoz’s
`
`[expert],” finding that “lyophilization was well-known,” and that the claimed “ester
`
`is the ‘natural result’ of freeze-drying bortezomib with mannitol.” Op. 7, 8. Indeed,
`
`“both parties’ experts” agreed that “lyophilizing (or freeze-drying) is one of the ‘top
`
`two’ choices a formulator would consider,” and the prior art unambiguously taught
`
`
`3 https://patentlyo.com/patent/2017/07/inherent-unexpected-obvious.html
`
`4
`
`

`

`Case: 15-2066 Document: 146 Page: 23 Filed: 09/15/2017
`
`that “‘lyophilization has become the most important method for the stabilization of
`
`labile pharmaceutical products.’” A13 (emphasis added). In fact, in an earlier arbi-
`
`tration, Millennium admitted that the process of making the ester was obvious,
`
`“argu[ing] that there ‘was nothing inventive about thinking to lyophilize borte-
`
`zomib,’” which “‘required the exercise of only ordinary skill.’” A14 n.9.
`
`Nor was there anything inventive about selecting mannitol. One of the named
`
`inventors “conceded at trial that [m]annitol was an ‘obvious option’ as the ‘most
`
`popular’ bulking agent” for lyophilization, and agreed that it was “simply ‘not inno-
`
`vative’ to ‘suggest using mannitol to freeze-dry bortezomib.’” A15. “Even [Mil-
`
`lennium’s expert] conceded that a skilled formulator would im