throbber
Case 1:23-cv-00013-TSK Document 1-5 Filed 01/27/23 Page 1 of 27 PageID #: 225
`Case 1:23-cv-00013-TSK Document1-5 Filed 01/27/23 Page 1of 27 PagelD #: 225
`
`EXHIBIT 5
`EXHIBIT 5
`
`

`

`Case 1:23-cv-00013-TSK Document 1-5 Filed 01/27/23 Page 2 of 27 PageID #: 226
`Case 1:23-cv-00013-TSK Document1-5 La|
`WAa
`
`
`US011318191B2
`
`a2) United States Patent
`US 11,318,191 B2
`(0) Patent No.:
`May3, 2022
`(45) Date of Patent:
`Engelund etal.
`
`(54) GLP-1 COMPOSITIONS AND USES
`THEREOF
`
`(71) Applicant: Novo Nordisk A/S, Bagsvaerd (DK)
`
`(72)
`
`Inventors: Dorthe Kot Engelund, Holte (DK);
`Soeren Snitker, Holte (DK); Andrew
`Mark Louw, Vaerloese (DK)
`
`(73) Assignee: Novo Nordisk A/S, Bagsvaerd (DK)
`
`(*) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`(21) Appl. No.: 17/177,438
`
`(22)
`
`Filed:
`
`Feb. 17, 2021
`
`(65)
`
`(30)
`
`Prior Publication Data
`
`US 2021/0252111 Al
`
`Aug. 19, 2021
`
`Foreign Application Priority Data
`
`Feb. 18, 2020
`Apr. 24, 2020
`Jun. 17, 2020
`Jun. 18, 2020
`Jan. 4, 2021
`Jan. 11, 2021
`Feb. 2, 2021
`
`(EP) wee ceessseseeneceesenees 20157963
`(EP)....
`... 20171240
`(EP)....
`... 20180645
`(EP)....
`... 20180832
`(EP)....
`... 21150056
`(EP)....
`... 21151004
`(EP) wee eeceeeeeeeeneeeeenee 21154657
`
`
`
`(51)
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2017.01)
`(2006.01)
`
`Int. Cl.
`AGIK 38/26
`AGIK 9/00
`AGIK 47/02
`AGIK 47/10
`AGIK 47/22
`(52) U.S. Cl.
`CPC wee AGIK 38/26 (2013.01); AGLK 9/0019
`(2013.01); A6LK 47/02 (2013.01); A6LK 47/10
`(2013.01); A61K 47/22 (2013.01)
`(58) Field of Classification Search
`CPC vicecccscrssssecrsscnseecersetesenscnssenseeseonees A61K 38/26
`
`See application file for complete search history.
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`2,444,570 A
`2,828,742 A
`3,318,289 A
`3,758,683 A
`4,282,316 A
`4,425,346 A
`4,468,346 A
`4,470,317 A
`4,483,849 A
`4,498,904 A
`4,568,335 A
`4,585,439 A
`4,592,745 A
`4,629,455 A
`4,833,379 A
`4,865,591 A
`4,883,472 A
`
`8/1946 Lawrenceetal.
`4/1958 Ashkenaz
`5/1967 Marynissen
`9/1973 Jackson
`8/1981 Modrovich
`1/1984 Horlington
`8/1984 Paul et al.
`9/1984 Sabloewski et al.
`11/1984 Carter et al.
`2/1985 Tuer et al.
`2/1986 Updike etal.
`4/1986 Michel
`6/1986 Rex et al.
`12/1986 Kanno
`5/1989 Kaibelet al.
`9/1989 Sams
`11/1989 Michel
`
`4,917,685 A
`4,919,596 A
`4,936,833 A
`4,973,318 A
`4,994,033 A
`5,017,190 A
`5,092,842 A
`5,112,317 A
`5,114,406 A
`5,118,666 A
`5,120,712 A
`5,169,759 A
`5,169,771 A
`5,206,216 A
`5,206,219 A
`5,207,752 A
`5,216,011 A
`5,216,437 A
`5,226,895 A
`5,232,459 A
`5,232,706 A
`5,246,417 A
`5,257,987 A
`5,271,527 A
`5,272,135 A
`5,279,585 A
`5,279,586 A
`5,281,198 A
`5,284,480 A
`5,304,152 A
`5,308,340 A
`5,314,412 A
`
`4/1990 Viswanathan et al.
`4/1990 Slate et al.
`6/1990 Sams
`11/1990 Holm et al.
`2/1991 Shockeyet al.
`5/1991 Simon et al.
`3/1992 Bechtold etal.
`5/1992 Michel
`5/1992 Gabriel et al.
`6/1992 Habener
`6/1992 Habener
`12/1992 Faust et al.
`12/1992 Christneretal.
`4/1993 Yoshida
`4/1993 Desai
`5/1993 Sorensonetal.
`6/1993 Paborji et al.
`6/1993 Yamamotoetal.
`7/1993 Harris
`8/1993 Hjertman
`8/1993 Palomo Coll
`9/1993 Haak et al.
`11/1993 Athaydeet al.
`12/1993 Haberetal.
`12/1993 Takruri
`1/1994 Balkwill
`1/1994 Balkwill
`1/1994 Haberet al.
`2/1994 Porter etal.
`4/1994 Sams
`5/1994 Harris
`5/1994 Rex
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`AU
`CA
`
`611385 B2
`2223531 Al
`
`6/1991
`12/1996
`
`(Continued)
`
`OTHER PUBLICATIONS
`
`Yang et al.,“The diabetes drug semaglutide reduces infarct size,
`inflammation, and apoptosis, and normalizes neurogenesis in a rat
`model stroke”, Aug. 2019, Neuropharmacology,, vol. 158, No.
`107748, pp. 1-14.
`Doenickeet al. “Solvent for etomidate may cause pain and adverse
`effects.” British journal of anaesthesia. Sep. 1999, vol. 83, No. 3, pp.
`464-466.
`Fransson et al., “Local Tolerance of Subcuraneous Injections,”
`Journal of Pharm. Pharmacol., Oct. 1996, vol. 48, pp. 1012-1015.
`Niedermirtl et al., “Etomidate and propylene glycol activate nocicep-
`tive TRP ion channels.” Molecular pain. Nov. 2018, vol. 14, p. 1-18.
`Chen, Juilette. “The Debate About Needle Reuse” http://www.
`diabeteshealth.com/blog/the-debate-about-needle-reusel/ Accessed.
`Jan. 9, 2015.
`
`(Continued)
`
`Primary Examiner — Gyan Chandra
`(74) Attorney, Agent, or Firm — Rosemarie R.
`Wilk-Orescan
`
`(57)
`
`ABSTRACT
`
`The present invention relates to pharmaceutical composi-
`tions of the GLP-1 peptide semaglutide comprising no more
`than 0.1% (w/w) phenol and above 6.4 mg/ml sodium
`chloride, their preparation, kits comprising such composi-
`tions as well as uses thereof.
`
`26 Claims, 1 Drawing Sheet
`
`

`

`Case 1:23-cv-00013-TSK Document 1-5 Filed 01/27/23 Page 3 of 27 PageID #: 227
`Page 3 of 27 PagelD #: 227
`Case 1:23-cv-00013-TSK Document1-5 Filed 01/27/23
`
`US 11,318,191 B2
`
`Page 2
`
`
`
`PPPPrSPPEEEEEPEPEEPPSESEPEEPSEEEEELSPEEPSPEESPPEESEPEEEPSPSESPESEPPSPrereerPPS
`
`(56)
`
`5,318,540
`5,320,609
`5,331,954
`5,370,629
`5,378,233
`5,380,297
`5,383,166
`5,383,865
`5,440,976
`5,445,606
`5,447,150
`5,455,331
`5,461,031
`5,478,316
`5,478,324
`5,480,387
`5,492,534
`5,505,704
`5,512,549
`5,514,097
`5,545,147
`5,545,618
`5,546,932
`5,549,574
`5,549,575
`5,571,719
`5,574,008
`5,584,815
`5,591,136
`5,599,314
`5,611,783
`5,614,492
`5,626,566
`5,645,052
`5,652,216
`5,674,204
`5,679,111
`5,681,285
`5,685,864
`5,686,411
`5,688,251
`5,693,027
`5,693,520
`5,693,608
`5,705,483
`5,709,662
`5,716,990
`5,725,508
`5,741,688
`5,743,889
`5,750,140
`5,755,692
`5,823,998
`5,827,232
`5,843,036
`5,849,700
`5,882,718
`5,898,028
`5,908,830
`5,921,966
`5,928,201
`5,932,547
`5,938,642
`5,947,934
`5,951,530
`5,954,689
`5,961,496
`5,962,407
`5,972,873
`5,980,491
`5,981,489
`5,984,900
`5,985,629
`5,989,169
`6,003,736
`
`U.S. PATENT DOCUMENTS
`
`References Cited
`
`6/1994
`6/1994
`TN994
`12/1994
`1/1995
`1/1995
`1/1995
`1/1995
`8/1995
`8/1995
`9/1995
`10/1995
`10/1995
`12/1995
`12/1995
`1/1996
`2/1996
`4/1996
`4/1996
`5/1996
`8/1996
`8/1996
`8/1996
`8/1996
`8/1996
`11/1996
`11/1996
`12/1996
`1/1997
`2/1997
`3/1997
`3/1997
`5/1997
`TN997T
`TN997
`10/1997
`10/1997
`10/1997
`11/1997
`11/1997
`11/1997
`12/1997
`12/1997
`12/1997
`1/1998
`1/1998
`2/1998
`3/1998
`4/1998
`4/1998
`5/1998
`5/1998
`10/1998
`10/1998
`12/1998
`12/1998
`3/1999
`4/1999
`6/1999
`7/1999
`7/1999
`8/1999
`8/1999
`9/1999
`9/1999
`9/1999
`10/1999
`10/1999
`10/1999
`11/1999
`11/1999
`11/1999
`11/1999
`11/1999
`12/1999
`
`Athayde etal.
`Haberetal.
`Rexetal.
`Michel etal.
`Haberetal.
`Wadman etal.
`Gallay
`Michel
`Giuliano et al.
`Haak et al.
`Bacon
`Pearce
`DeFelippis
`Bitdingeret al.
`Meyer
`Gabrielet al.
`Athayde etal.
`Pawelkaet al.
`Chenetal.
`Knauer
`Harris
`Buckley et al.
`Galli
`Townsend
`Giambattista et al.
`Christensen et al.
`Johnsonetal.
`Pawelkaet al.
`Gabriel
`Neill
`Mikkelsen
`Habener
`Petersen et al.
`Kersey
`Kornfelt et al.
`Chanoch
`Hjertman etal.
`Ford et al.
`Shanleyet al.
`Gaeta et al.
`Chanoch
`Hansenetal.
`Branneret al.
`Bechgaardetal.
`Gallowayet al.
`Olive etal.
`Bagshaweetal.
`Chanochetal.
`Oxenbell et al.
`Sams
`Weibelet al.
`Manicom
`Kamagata
`Chanochetal.
`Olive etal.
`Sgrensen etal.
`Pommeret al.
`Jensen et al.
`Smith et al.
`Bendek etal.
`Poulsen et al.
`Stevenson etal.
`Burroughset al.
`Hansenetal.
`Steengaard etal.
`Poulsen
`Nielsen et al.
`Kelly
`Nielsen et al.
`Hansen
`Stevenson etal.
`Mikkelsen
`Aaslyng et al.
`Svendsen et al.
`Ljunggren
`
`PPPPPrrrrrrrPPS
`
`6,004,297
`6,010,485
`6,033,376
`6,033,377
`6,048,336
`6,059,616
`6,066,619
`6,074,372
`6,083,197
`6,086,567
`6,096,010
`6,110,149
`6,129,080
`6,133,229
`6,136,784
`6,146,361
`6,184,201
`6,193,698
`6,207,684
`6,221,046
`6,221,053
`6,231,540
`6,235,004
`6,245,572
`6,248,090
`6,248,095
`6,258,062
`6,268,343
`6,269,340
`6,274,553
`6,277,097
`6,277,098
`6,281,225
`6,283,941
`6,284,727
`6,287,283
`6,302,869
`6,303,661
`6,312,413
`6,340,357
`6,375,975
`6,379,339
`6,380,357
`6,384,016
`6,440,460
`6,440,930
`6,444,788
`6,458,924
`6,489,292
`6,514,230
`6,547,763
`6,547,764
`6,551,992
`6,562,006
`6,562,011
`6,569,126
`6,569,832
`6,573,237
`6,582,404
`6,586,399
`6,605,067
`6,613,019
`6,660,716
`6,663,602
`6,692,472
`6,708,846
`6,716,198
`6,726,661
`6,770,288
`6,796,970
`6,844,321
`6,893,415
`6,899,698
`6,899,699
`6,945,961
`7,008,399
`7,022,674
`7,049,284
`7,056,886
`
`12/1999
`1/2000
`3/2000
`3/2000
`4/2000
`5/2000
`5/2000
`6/2000
`7/2000
`7/2000
`8/2000
`8/2000
`10/2000
`10/2000
`10/2000
`11/2000
`2/2001
`2/2001
`3/2001
`4/2001
`4/2001
`5/2001
`5/2001
`6/2001
`6/2001
`6/2001
`7/2001
`7/2001
`7/2001
`8/2001
`8/2001
`8/2001
`8/2001
`9/2001
`9/2001
`9/2001
`10/2001
`10/2001
`11/2001
`1/2002
`4/2002
`4/2002
`4/2002
`5/2002
`8/2002
`8/2002
`9/2002
`10/2002
`12/2002
`2/2003
`4/2003
`4/2003
`4/2003
`5/2003
`5/2003
`5/2003
`5/2003
`6/2003
`6/2003
`7/2003
`8/2003
`9/2003
`12/2003
`12/2003
`2/2004
`3/2004
`4/2004
`4/2004
`8/2004
`9/2004
`1/2005
`5/2005
`5/2005
`5/2005
`9/2005
`3/2006
`4/2006
`5/2006
`6/2006
`
`Steenfeldt-Jensen et al.
`Buch-Rasmussen et al.
`Rockley
`Rasmussenetal.
`Gabriel
`Bluemmelet al.
`Stevenson etal.
`Hansen
`Umbaugh
`Kirchhoferet al.
`Walters et al.
`Klitgaard et al.
`Pitcher et al.
`Gibson etal.
`L’Italien et al.
`DiBiasi etal.
`Druckeretal.
`Kirchhoferet al.
`Aberg
`Burroughset al.
`Walters et al.
`Smedegaard
`Steenfeldt-Jensen et al.
`Wall
`Jensen et al.
`Giambattista et al.
`Thielen et al.
`Knudsenetal.
`Fordet al.
`Furuya etal.
`Mikkelsenetal.
`Klitmoseetal.
`Hearst et al.
`Schoenfeld et al.
`Kim etal.
`Ljunggreenet al.
`Klitgaard
`Demuth et al.
`Jensen et al.
`Poulsen etal.
`Modi
`Klitgaard et al.
`Hermeling et al.
`Kaarsholm
`Gumyet al.
`Rinella, Jr.
`Staby
`Knudsenetal.
`Havelundet al.
`Munketal.
`Steenfeldt-Jensen et al.
`Larsen etal.
`DeFelippis et al.
`Hjertman etal.
`Buch-Rasmussen et al.
`Poulsen etal.
`Knudsenetal.
`Rinella, Jr.
`Klitgaard et al.
`Drucker
`Larsen
`Munk
`Yakubu-Madusetal.
`Moller
`Hansenetal.
`Fuchset al.
`Larsen
`Munketal.
`Duirs
`Klitmoseetal.
`Arentsen
`Madsenetal.
`Sams
`Enggaard.
`Miller et al.
`Larsen etal.
`DeFelippis et al.
`Drucker
`Isaacs
`
`

`

`Case 1:23-cv-00013-TSK Document 1-5 Filed 01/27/23 Page 4 of 27 PageID #: 228
`Case 1:23-cv-00013-TSK Document1-5 Filed 01/27/23 Page 4 of 27 PagelD #: 228
`
`US 11,318,191 B2
` Page 3
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`7,090,662 B2
`7,094,221 B2
`7,104,972 B2
`7,112,187 B2
`7,112,567 B2
`7,133,329 B2
`7,175,055 B2
`7,202,213 B2
`7,226,990 B2
`7,235,627 B2
`7,238,663 B2
`7,241,278 B2
`7,273,921 B2
`7,632,806 B2
`
`8/2006 Wimpennyetal.
`8/2006 Veaseyetal.
`9/2006 Molleretal.
`9/2006 Karlsson
`9/2006 Bridon et al.
`11/2006 Skyggebjerg et al.
`2/2007 Hansen etal.
`4/2007 Mogensenetal.
`6/2007 Knudsenetal.
`6/2007 Knudsonet al.
`7/2007 DeFelippis et al.
`7/2007 Moller
`9/2007 Dunweberetal.
`12/2009 Juul-Mortensen etal.
`
`8,114,833 B2
`
`2/2012 Pedersenetal.
`
`RE43,834 E
`8,541,470 B2
`
`11/2012 Steenfeldt-Jensen et al.
`9/2013 Davis
`
`9,133,276 B2
`
`9/2015 Cleemann etal.
`
`9,457,066 B2
`
`10/2016 Rauet al.
`
`2001/0027180 Al
`2002/0007154 Al
`
`10/2001 Isaacs
`1/2002 Hansenet al.
`
`2002/0077852 Al
`
`6/2002.
`
`Fordet al.
`
`2003/0039679 Al
`
`2/2003 Duirs
`
`2003/0069182 Al
`2003/0092606 Al
`
`4/2003. Rinella
`5/2003. L’Italienet al.
`
`2003/0158101 Al
`
`8/2003 Drucker
`
`2003/0211047 Al
`2003/0220243 Al
`
`11/2003 Dugger
`11/2003 Glaesneret al.
`
`2004/0059299 Al
`2004/0156835 Al
`
`3/2004 Moller
`8/2004 Imoto et al.
`
`2004/0236282 Al
`
`11/2004 Braithwaite
`
`2004/0260247 Al
`2004/0267207 Al
`
`12/2004 Veaseyet al.
`12/2004 Veaseyet al.
`
`2005/0009742 Al
`2005/0019400 Al
`
`1/2005. Bertilssonet al.
`1/2005 Deveneyet al.
`
`2005/0143303 Al
`2005/0148497 AL
`
`6/2005. Quayet al.
`7/2005 Khan
`
`2009/0011976 Al
`2009/0156478 Al
`2010/0311643 Al
`2012/0208755 Al
`2012/0225810 Al
`2013/0190230 Al
`2015/0011462 Al
`2016/0235855 Al
`2019/0231876 Al
`2019/0388502 Al
`2020/0316204 Al
`2021/0379159 Al
`
`1/2009 Ludvigsenet al.
`6/2009 Lauet al.
`12/2010 Bevec etal.
`8/2012 Leung
`9/2012 Pedersen etal.
`7/2013 Casadesus Smith et al.
`1/2015 Reedtz-Runge et al.
`8/2016 Xiong etal.
`8/2019 Pedersen et al.
`12/2019 Corvari etal.
`10/2020 Pedersen etal.
`12/2021 Engelundetal.
`
`FOREIGN PATENT DOCUMENTS
`
`on
`CN
`
`CN
`
`CN
`DE
`
`DE
`
`EP
`
`EP
`EP
`
`EP
`
`EP
`
`EP
`EP
`
`EP
`
`EP
`EP
`
`EP
`EP
`
`EP
`
`EP
`EP
`
`EP
`EP
`
`EP
`EP
`
`saeouys Al
`1199339 A
`
`4ooo
`11/1998
`
`1376166 A
`
`10/2002
`
`105777872
`3546150 AL
`
`6/2019
`1/1987
`
`42 08 677 Al
`
`9/1993
`
`0037043 Bl
`
`11/1984
`
`327910
`359070 A2
`
`8/1989
`3/1990
`
`450905 Al
`
`10/1991
`
`498737
`
`8/1992
`
`0552996 Al
`0554996
`
`7/1993
`8/1993
`
`0673482
`
`9/1995
`
`0708179 A2
`747390
`
`4/1996
`12/1996
`
`0923950 A2
`0926159
`
`6/1999
`6/1999
`
`1003581
`
`8/1999
`
`1329462
`1494077
`
`1344533
`1396499
`
`10/2001
`5/2002
`
`9/2003
`3/2004
`
`1570876 A2
`1601396 A2
`
`9/2005
`12/2005
`
`3/2007
`0944648 BI
`EP
`12/2005 Wassenaar et al.
`2005/0268915 Al
`122011
`9304656 A2
`EP
`4/2006 _Engelundetal.
`2006/0084605 Al
`3/2018
`3295952 Al
`EP
`8/2006 Juul-Mortensen etal.
`2006/0178304 Al
`12/1986
`2583291
`FR
`12/2006 Sarubbi
`2006/0286129 Al
`2/1999
`2767479
`FR
`12/2006 Knudsenet al.
`2006/0287221 Al
`8/1955
`735443 A
`GB
`4/2007 Veaseyetal.
`2007/0093761 Al
`6/1965
`995065 A
`GB
`5/2008 Ludvigsen etal.
`2008/0125361 Al
`
`2008/0293814 Al=11/2008 Tiwari et al. GB 1232899 A 5/1971
`
`
`
`

`

`Case 1:23-cv-00013-TSK Document 1-5 Filed 01/27/23 Page 5 of 27 PageID #: 229
`Case 1:23-cv-00013-TSK Document1-5 Filed 01/27/23 Page 5 of 27 PagelD #: 229
`
`US 11,318,191 B2
` Page 4
`
`(56)
`
`References Cited
`
`FOREIGN PATENT DOCUMENTS
`
`4/1999
`9916487
`WO
`5/1999
`99/21888 Al
`wo
`5/1999
`9921889
`WO
`6/1999
`9929336
`wo
`6/1999
`9929337 Al
`WO
`1/1985
`2141799 A
`GB
`6/1999
`9930731
`WO
`9/1997
`213691 B
`HU
`7/1999
`99/34764 A2
`wo
`8/1998
`315007 B
`HU
`7/1999
`9934822 Al
`WO
`12/1998
`215366 B
`HU
`8/1999
`99/40788 Al
`WO
`1/1999
`215634 B
`HU
`8/1999
`99/40928 Al
`WO
`9/1990
`1222331 B
`IT
`8/1999
`9938554
`WO
`12/1993
`H05337179 A
`JP
`9/1999
`99/4334 1
`WO
`10/1994
`H06296691 A
`JP
`9/1999
`99/43705 Al
`WO
`4/1998
`10101696
`IP
`9/1999
`99/43706
`WO
`8/2000
`2000-5 10813
`JP
`9/1999
`99/43708
`WO
`12/2001
`2001-525371
`JP
`9/1999
`99/47160 Al
`WO
`1/2002
`2002501790 A
`JP
`9/1999
`9943707
`WO
`2/2002
`2002-504908
`JP
`3/2000
`0015224 Al
`WO
`3/2002
`2002-508332
`JP
`6/2000
`0037098 Al
`WO
`8/2002
`2002-524514
`JP
`
`
`
`
`JP 00/41546 A2—7/20002002532557 A 10/2002 WO
`JP
`2003519195
`6/2003
`WO
`0041546
`7/2000
`JP
`2003519195 A
`6/2003
`WO
`00/55 119
`9/2000
`JP
`3503129 B2
`3/2004
`WO
`0062847 Al
`10/2000
`
`JP 0069413 Al—11/20002004-518756 A 6/2004 WO
`
`
`
`JP
`2010528000 A
`8/2010
`WO
`200073331 A2
`12/2000
`JP
`2015522573 A
`8/2015
`WO
`01/04 156
`1/2001
`PA
`200101010
`6/2001
`WO
`0100223
`1/2001
`RU
`2111019
`5/1997
`WO
`0101774 Al
`1/2001
`RU
`2180218
`3/2002
`WO
`0102369 A2
`1/2001
`TW
`267945 B
`1/1996
`WO
`01/10484
`2/2001
`wo
`87/06941 Al
`11/1987
`WO
`0119434 Al
`3/2001
`WO
`8907463
`8/1989
`WO
`01021198 Al
`3/2001
`wo
`9000200
`1/1990
`WO
`0143762
`6/2001
`WO
`90/09202
`8/1990
`WO
`0149314
`7/2001
`wo
`9010020 Al
`9/1990
`WO
`0151071
`7/2001
`wo
`90/11296 Al
`10/1990
`WO
`0152937
`7/2001
`Wo
`9110460 Al
`7/1991
`WO
`0155213
`8/2001
`wo
`91/11457 AL
`8/1991
`WO
`0177141
`10/2001
`wo
`91/14467 Al
`10/1991
`WO
`01/98331
`12/2001
`Wo
`9217482 Al
`10/1992
`WO
`02067989
`1/2002
`Wo
`9219260
`11/1992
`WO
`02/046227
`6/2002
`WO
`9307922
`4/1993
`WO
`0247715
`6/2002
`wo
`9318785
`9/1993
`WO
`0247716
`6/2002
`WO
`9319175 AL
`9/1993
`WO
`0248183
`6/2002
`WO
`9323010
`11/1993
`WO
`02069994 A2
`9/2002
`wo
`199325579 Al
`12/1993
`WO
`2002098445
`12/2002
`Wo
`94/15120 Al
`7/1994
`WO
`03/002136 A2
`1/2003
`WO
`94/19034 Al
`9/1994
`WO
`2003002136 A2
`1/2003
`WO
`9522560
`2/1995
`WO
`03013589
`2/2003
`Wo
`95/07931 Al
`3/1995
`WO
`03020201
`3/2003
`WO
`9505848
`3/1995
`WO
`03033671 A2
`4/2003
`WO
`9510605
`4/1995
`WO
`03035099
`§/2003
`Wo
`9513825
`5/1995
`WO
`03/072195 A2
`9/2003
`wo
`95/31214 Al
`11/1995
`WO
`03084563 Al
`10/2003
`
`Wo 03/101395 A2=12/20039620005 Al 7/1996 WO
`
`
`
`WO
`9624369
`8/1996
`WO
`2004004781
`1/2004
`wo
`96/29342
`9/1996
`WO
`2004029076
`4/2004
`Wo
`96/29344
`9/1996
`WO
`04/037168 A2
`5/2004
`WO
`9626754 A2
`9/1996
`WO
`04056313 A2
`7/2004
`Wo
`96/38190 Al
`12/1996
`WO
`2004/078226
`9/2004
`WO
`9638469
`12/1996
`WO
`2004 105781
`12/2004
`WO
`9736626
`10/1997
`WO
`2005000222
`1/2005
`Wo
`98/00152 Al
`1/1998
`WO
`05/027978 A2
`3/2005
`wo
`98005351 Al
`2/1998
`WO
`2005018721 Al
`3/2005
`WO
`98/08531 Al
`3/1998
`WO
`2005021026 A2
`3/2005
`Wo
`98/08873 Al
`3/1998
`WO
`2005/046716
`§/2005
`wo
`9808871 Al
`3/1998
`WO
`2005042488
`§/2005
`WO
`9810813
`3/1998
`WO
`2005044294
`§/2005
`Wo
`98/19698 Al
`5/1998
`WO
`2005/058252 A2
`6/2005
`Wo
`9824767 Al
`6/1998
`WO
`2005049061 A2
`6/2005
`wo
`9831386
`7/1998
`wo
`2005081711
`9/2005
`wo
`98030231 Al
`7/1998
`wo
`05120492 Al
`12/2005
`wo
`98/43658 Al
`10/1998
`wo
`2005113008 Al
`12/2005
`wo
`9850059 Al
`11/1998
`wo
`06000567 A2
`1/2006
`wo
`98/55144 Al
`12/1998
`wo
`2006025882
`3/2006
`wo
`98/57688 Al
`12/1998
`wo
`2006052608 A2
`5/2006
`wo
`9856406
`12/1998
`wo
`2006055603
`5/2006
`wo
`9856436
`12/1998
`wo
`2006072065
`7/2006
`WO
`9916417
`4/1999
`WO
`2006076921 Al
`7/2006
`
`

`

`Case 1:23-cv-00013-TSK Document 1-5 Filed 01/27/23 Page 6 of 27 PageID #: 230
`Case 1:23-cv-00013-TSK Document1-5 Filed 01/27/23 Page 6 of 27 PagelD #: 230
`
`US 11,318,191 B2
`
`Page 5
`
`(56)
`
`References Cited
`FOREIGN PATENT DOCUMENTS
`
`Bahar Vardar, Incidence of lipohypertrophy in diabetic patients and.
`a study of influencing factors, Diabetes Research and Clinical
`Practice 77 (2007) 231-236.
`Pharmaceutical Preformulation and Formulation, Second Edition,
`8/2006
`2006/083254 Al
`WO
`Mark Gibson, Informa Healthcare USA,Inc., p. 328, 2009.
`9/2006
`2006/097537 A2
`WO
`Clear and colorful Figures 1-7 of the patent ZL200480034152.8,
`9/2006
`2006096461
`WO
`granted Feb. 25, 2015.
`9/2006
`2006099561
`WO
`The report excerpts including some chromatograms from patent
`2/2007
`2007014051 A2
`WO
`2L200480034152.8, granted Feb. 25, 2015.
`2/2007
`2007022518 A2
`WO
`Pharmacopoeia of China 2000 Edition, Chemical Industry Press,
`7/2007
`2007075720
`WO
`8/2007
`2007094893
`WO
`vol. 2, pp. 378-381, Apr. 2001.
`
`WO 2007/120899 A2—10/2007
`Pharmacopoeia of China 2000 Edition, Chemical Industry Press,
`WO
`2008019115
`2/2008
`vol. 2, p. 94, Jan. 2000.
`
`WO 08133908 A2—11/2008
`Pharmaceutics, Edition 4, People’s Health Publishing House, pp.
`WO
`09030771 Al
`3/2009
`198-199 and 240, Jul. 2002.
`WO
`2009051992
`4/2009
`Powell MF, Sanders LM,Rogerson A,Si V. Pharmaceutical Research,
`WO
`2009064298 Al
`5/2009
`vol. 8, No. 10, 1991 entitled “Parenteral peptide formulations:
`WO
`2009075859 A2
`6/2009
`chemical and physical properties of native luteinizing hormone-
`WO
`2010/046357 Al
`4/2010
`releasing hormone (LHRH)and nydrophobic analogues in aqueous
`WO
`2010/107874 A2
`9/2010
`solution” pp. 1258-1263.
`WO
`2010/139793 Al
`12/2010
`WO
`11050008 A2
`4/2011
`Excerpts from the file wrapper of corresponding EP applicationi.e.
`EP1687019, dated Oct. 21, 2013.
`WO
`11073328 Al
`6/2011
`WO
`2011069629
`6/2011
`Letter dated Jul. 8, 2011 submitted in response to the First Exami-
`WO
`2011/117415 Al
`9/2011
`nation Report during prosecution of the impugned. Patent applica-
`tion.
`WO
`2011104378 Al
`9/2011
`WO
`2011109784 Al
`9/2011
`E-Register of Indian Patent 257402, filed Nov. 18, 2004.
`WO
`2011109787 Al
`9/2011
`INPADOCpatent family 6683 Jun. 11, 2014.
`WO
`2012062803 Al
`$/2012
`Affidavit by Dr. Ravindra Agarwal and curriculum vitae dated Feb.
`WO
`2012104655 A2
`8/2012
`27, 2015.
`WO
`2012107476 Al
`8/2012
`Affidavit of John F Carpenter and Exhibit, dated Dec. 16, 2014.
`WO
`2012112626 A2
`8/2012
`Becton, Dickinson and Company Tokoroyo. “Injection Brush Needle.
`WO
`2012140117 Al
`10/2012
`WO
`2012151248
`11/2012
`2015. URL: https://www.bd.com/tw/diabetes/main.aspx?cat=62 11
`
`
`WO 2012168430 A2=12/2012 &id=6612. Accessed Oct. 30, 2015.
`
`WO 2012168432 Al=12/2012
`Anand and Anand “Reply Statement and Evidence under section
`WO
`2013009539 Al
`1/2013
`25(2) of the Patents (Amendment) Act, 2005 and Rule 58 of the
`WO
`2013/037690 Al
`3/2013
`Patents (Amendment) Rules 2006” for Novo Nordisk Jan. 6, 2014.
`WO
`2013072406
`5/2013
`Anand and Anand “Reply Statement and Evidence under section
`WO
`13083826 A2
`6/2013
`25(2) of the Patents (Amendment) Act, 2005 and Rule 58 of the
`WO
`13127779 Al
`9/2013
`Patents (Amendment) Rules 2006” for Novo Nordisk Dec. 30, 2014.
`WO
`2013151663
`10/2013
`Ken-Chi Izutsu et al. “Effect of Mannitol Crystallinity on the
`WO
`2013151668
`10/2013
`Stabilization of Enzymes During Freeze Drying.” Chem. Pharm
`
`WO 2013151729 Al—10/2013
`Bull. 1994 vol. 42(1) p. 5-8.
`
`WO 2013156594 Al=10/2013
`WO
`2013/167454 Al
`11/2013
`Henry Constantino et al. “Effect of Mannitol Crystallization on the
`WO
`2013/167455 Al
`11/2013
`Stability and Aersol Performance of a Spray Dried Pharmaceutical
`
`WO 2013177565 Al—11/2013
`Protein, Recombinant Humanized Anti-IgE Monoclonal Antibody.”
`WO
`2013190384
`12/2013
`Journal of Pharma. Sci. 1998 vol. 87 (11) pp. 1406-1411.
`WO
`2014005858 Al
`1/2014
`Raghu K. Cavatur et al. “Crystallization Behaviour of Mannitol in
`WO
`2014060472 Al
`4/2014
`Frozen Aqueous Solutions” Pharmaceutical Research. 2002 vol.
`WO
`14144842 A2
`9/2014
`19(6) pp. 894-900.
`
`WO 2014177683 Al=11/2014
`Somnah Singh et al. “Effects of Polyols on the Conformational
`WO
`2014182950
`11/2014
`Stability and Biological Activity of a Model Protein Lysozyme.”
`WO
`2014202780
`12/2014
`AAPS PharmSciTech 2003 vol. 4(3) article 42 pp. 1-9.
`WO
`2015000942 Al
`1/2015
`Luwei Zhao et al. “Stabilization of Eptifibatide by Cosolvents.”
`WO
`2015009616
`1/2015
`WO
`2015155151 Al
`10/2015
`International Journal of Pharmaceutics. 2001 vol. 218 pp. 43-56.
`Affidavit of Mr. R. Sukumar. Dec. 22, 2015.
`
`WO 15200324 Al=12/2015
`WO
`2016001862
`1/2016
`R. Sukumar. “Reply to the Declaration of Ms. Dorte Kot Engelund,
`WO
`2016038521 Al
`3/2016
`by way of Affidavit of Mr. R. Sukumar.” Dec. 22, 2015.
`WO
`2017009236 A2
`1/2017
`Affidavit of Omar Sherief Mohammad submitted in USV Opposi-
`WO
`2017149070 Al
`9/2017
`tion dated Jul. 7, 2015.
`
`WO 2017186896 Al=11/2017
`Federal Register/vol. 67, No. 236/2002-12-9, pp. 72965-72967.
`WO
`18096460 Al
`5/2018
`Case Law of the Boards of Appeal, I.D.9.16., Small improvementin
`WO
`18115901 Al
`6/2018
`commercially used process, p.
`| URL: https:/Avww.epo.org/law-
`WO
`2018115901 Al
`6/2018
`practice/legal-texts/html/caselaw/2013/e/clr_i_d_9_16.html Last
`WO
`18139991 Al
`8/2018
`Updated Jan. 10, 2013; Accessed Mar. 31, 2016.
`WO
`2019038412 Al
`2/2019
`WO
`2019122109
`6/2019
`Robyn Rice, Home Care Nursing Practice, Third Edition, Mosby,
`WO
`2020004368 Al
`1/2020
`Inc. 2001, pp. 270-271.
`Robyn Rice, Home Care Nursing Practice, Fourth Edition, Mosby,
`Inc. 2006, p. 273.
`Guan Ronglan, Challenging Traditional Insulin Injection Practices,
`Foreign Medical Sciences (Nursing Foreign Medical Science),
`1999, vol. 18 No. 8, pp. 367-368.
`Mary MacKinnon RGN,Providing Diabetes Care in General Prac-
`tice, Third Edition, London : Class Publishing, 1998, p. 111.
`
`”
`
`OTHER PUBLICATIONS
`
`Jiajia Ji, Qingqing Lou (2014), Insulin Pen Injection Technique
`survey in patients with type 2 diabetes in Mainland China in 2010,
`Current Medical Research and Opinion. Feb. 2014; 30(6).
`
`

`

`Case 1:23-cv-00013-TSK Document 1-5 Filed 01/27/23 Page 7 of 27 PageID #: 231
`Case 1:23-cv-00013-TSK Document1-5 Filed 01/27/23 Page 7 of 27 PagelD #: 231
`
`US 11,318,191 B2
`
`Page 6
`
`(56)
`
`References Cited
`OTHER PUBLICATIONS
`
`American Diabetes Association Complete Guide to Diabetes, Ameri-
`can Diabetes Association, 1996, pp. 105-106, 413-414.
`Karen Bellenir, Diabetes Sourcebook, Omnigraphics, Inc., 1995, pp.
`271-272.
`Brunner and Suddarth’s textbook of medical-surgical nursing, Sev-
`enth Edition, edited by Suzanne C. Smeltzer, Lippincott Company,
`1992, pp. 1122-1123.
`Cheng Qiao-yun, Discussion on the Safe Times of Repeated Uses of
`the Syringe Special for Insulin Injection at Home, Journal of
`Nursing (China), Nov. 2006, vol. 13 No. 11, pp. 87-89.
`Fleming et al.,Challenging Traditional Insulin Injection Practices,
`American Journal of Nursing, Feb. 1999, vol. 99(2), pp. 72-74.
`Cooperative Multimodal Communication, edited by Harry Bunt,
`Springer, 2001, p. 17.
`Cao Hongxia, Caring Guideline for application of Novolin by
`diabetes patient, Family Nurse, Feb. 2008, vol. 6 No 2A, pp.
`344-345.
`United States Pharmacopeia and National Formulary (USPNF),
`United States Pharmacopeial Convention, 2003, pp. 2679-2682.
`Adelhorst, et al., “Structure-activity Studies of Glucagon-like Peptide-
`1,” J. Bio. Chem. 269(9):6275-6278 (1994).
`Akers, “Excipient-Drug Interactions in Parenteral Formulations,” J.
`Pharm. Sci. 91:2283-2300 (2002).
`Avis and Levchuk,“Parenteral Preparations,” Chapter 87 in Remington’s
`Pharmaceutical Sciences, 19th ed., vol. 2, pp. 1524-1548 (1995).
`Bojesen and Bojesen, “Albumin Binding of Long-chain Fatty
`Acids: Thermodyanmics and Kinetics,”J. Phys. Chem. 100(45):17981-
`17985 (1996).
`Conlon, “Proglucagon-derived peptides: nomenclature, biosynthetic
`relationships and physiological roles,” Diabetologia 31:563-566
`(1988).
`“Parenteral Preparations” Remington, Joseph Price. Remington:
`The science and practice of pharmacy. Eds. Alfonso R Gennaro, vol.
`1.Lippincott Williams & Wilkins, 20th edition, 2000, Chapter 41,
`pp. 780-785.
`INPADOCpatent family for WO2005049061 as downloaded from
`worldwide.espacenet.com.
`Product Insert Victoza, 2012.
`Rejection Decision of the Chinese application CN201210294716.8
`as a divisional application ofthe present patent, dated Dec. 2, 2014.
`Affidavit of Omar Sherief Mohammadsubmitted in Ranbaxy Oppo-
`sition dated Jul. 7, 2015.
`International Diabetes Federation. IDF diabetesatlas. 6th ed. http://
`www.idf.org/diabetesatlas. Published 2013. Accessed Feb. 12, 2014.
`Hex N,et al., Estimating the current and future costs of type 1 and
`type 2 diabetes in the UK,including direct health costs and indirect
`societal and productivity costs. Diabetic Medicine. 2012, vol. 29 No
`7, pp. 855-862.
`Stratton IM et al., on behalf of the UK Prospective Diabetes Study
`Group.Association of glycaemia with macrovascular and microvascular
`complications of type 2 diabetes (UKPDS 35): prospective obser-
`vational study. BMJ, 2000, vol. 321 No. 7528, pp. 405-412.
`Villareal DT, et al., Weight loss therapy improves pancreatic endo-
`crine function in obese older adults, Obesity, 2008, vol. 16, No. 6
`pp. 1349-1354.
`Bron M,et al.. Hypoglycemia, treatment discontinuation, and costs
`in patients with type 2 diabetes mellitus on oral antidiabetic drugs,
`Postgraduate Medicine, 2012, vol. 124, No. 1, pp. 124-132.
`Zinman B,et al., Achieving a clinically relevant composite outcome
`ofan HbAIC ofless than 7% without weight gain on hypoglycaemia
`in type 2 diabetes: a meta-analysis of the liraglutide clinical trial
`programme, Diabetes, Obesity and Metabolisim, 2012, vol. 14, No.
`1, pp. 77-82.
`Garber A et al., for the LEAD-3 (Mono) Study Group. Liraglutide
`versus glimepiride monotherapy for type 2 diabetes (LEAD-3
`Mono): a randomised, 52 week, phase III, double-blind, parallel-
`treatmenttrial. Lancet. 2009,vol. 373, No. 9662, pp. 473-481.
`Valentine WJ, et al., Evaluating the long-term cost-effectiveness of
`liraglutide versus exenatide BID in patients with type 2 diabetes
`
`whofail to improve with oral antidiabetic agents, Clinical Thera-
`peutics, 2011, vol. 33, No. Ll, pp. 1698-1712.
`International Diabetes Federation. IDF diabetes atlas. Sth ed. http://
`www.idf.org/sites/default/files/da5/S5eDiabetesAtlas_2011.pdf. Pub-
`lished 2011. Accessed Dec. 20, 2013.
`Blundell, T.L, Lefebvre P.J (Ed), “The Conformation of Glucagon”,
`1983, vol. 66, pp. 37-55.
`Senderoff, Journal of Pharmaceutical Sciences, “Consideration of
`Conformational Transitions and... ”, 1998, vol. 87, No. 2, pp.
`183-189.
`Bailey et al. The Kinetics of Enzyme-Catalysed Reactions, Bio-
`chemical Engineering Fundamentals, 2nd Ed , pp. 129-148 (1986).
`D. Voet and J.G. Voet, Biochem, 2nd Ed., pp. 235-241 (1995).
`D.E. Smilek et al., Proc Natl Acad Sci USA,vol. 88, pp. 9633-9637,
`(1991).
`Larsen, P.J. et al., Systemic Administration of the Logn Acting
`GLP-1, Diabetes, 2000 vol. 50, pp. 2530-2539.
`Rudinger, IN: Peptide Hormones, JA Parsons, Ed., pp. 1-7 (1976).
`Shinotesuto, Patentabstracts of Japan, of JP10101696.
`Sigma,http://www.sigma-genosys.com/peptide design.asp (accessed.
`Dec. 16, 2004).
`Singh, S. et al. AAPS Pharmscitech, vol. 4(3), pp. 334-342 (2003).
`Duma et al., Pharmaceutical Dosage Forms: Parenteral Medica-
`tions, vol. 1, 2nd Edition, p. 20, 1992.
`Eli Lilly & Co., Humalog Lispro Injection, USP Product Informa-
`tion dated Nov. 2, 2010.
`European Pharmacopoeia, 3rd Edition, 2.2.3, 1997, pp. 17-18,
`Council of Europe-Strasbourg, “Physical and Physiochemical Meth-
`ods”.
`Declaration of Johnny C. Gonzalez, (Including Curriculum Vita)
`dated Nov. 1, 2010.
`Knudsen,L.B. et al., Journal of Medicinal Chemistry, 2000, vol. 43,
`pp. 1664-1669, “Potent Derivatives of Glucagon-like Peptide-1
`with Pharmacokinetic Properties Suitable for Once Daily Admin-
`istration”.
`Kristensen, H.G., Almen Farmaci, 2000, pp. 273-274, 281, “Parenteral
`Aduministration”.
`Lund, Walter, Editor, the Pharmaceutical Codex, 12th Edition, 1994,
`The Pharmaceutical Press, London, pp. 98-99, “Principles and.
`Practice of Pharmaceutics”.
`Mack Publishing Co., Remington’s Pharmaceutical Sciences, 16th
`Edition,1980, Pt. 79, p. 1406, “Undesirable Effects of Abnormal
`Osmoticity”.
`Martin A. et al., Physical Pharmacy, 1983, 3rd Edition, p. 232,
`“Physical Chemical Principles in the Pharmaceutical Sciences”.
`Sigma Product Information on Gly-Gly Buffer Mar. 16, 2010.
`United States Pharmacopoeia, 24th Edition, 1999, pp. 1977-1978,
`“Polarography—Physical Tests”.
`Weinstein, Sharon, Plumer’s Principles & Practice of Intravenous,
`2006, vol. 8 (8), pp. 124-128, “Principles of Parenteral Fluid
`Aduministration”.
`Brittain, Harry G., Buffers, Buffering Agents, and Ionic Equilibria,
`Encyclopedia of Pharmaceutical Technology, p. 385, 2007.
`Greig et al. Once daily injection of exendin-4 to diabetic mice
`achieves long-term beneficial effects on blood glucose
`concenlralions,Diabetologia, 1999, vol. 42 pp. 45-50.
`Tolman RC ,The Effect of Droplet Size on Surface Tension , Journal
`of Chemical Physics. 1949 vol. 17, p. 333 . hittp://scitation.aip.org/
`content/aip/joumal/jep/17/3/10.1063/1.1747247.
`Ashworth MRF, Analytical Methods for Glycerol, Purely Physical
`Methods, 1979, p. 63 (Academic Press).
`Glycerine, A Key Cosmetic Ingredient, (Edited by JungermannE et
`al. ,Alternatives to glycerine, Propylene Glycol, 1991, p. 409.
`Alfonso R. Gennaro, Remington : The science and practice of
`Pharmacy , 19th edition, 1995 (Mack Publishing Company).
`Names, Synonyms, and Structures of Organic Compounds, A CRC
`reference handbook,(Edited by Lide R D. etal., ) vol. 1, Year 1995,
`pp. 27 and 491.
`CRC handbook of chemistry and physics, 81st Edition, Edited by
`David R. Lide, Version 2000-2001.
`Declaration Dorthe Kot Engelund (inventor) dated Jul. 1, 2015.
`Inventor declaration—Dorthe Kot Engelund, Ranbaxy Laboratories
`Limited dated Aug. 20, 2015.
`
`

`

`Case 1:23-cv-00013-TSK Document 1-5 Filed 01/27/23 Page 8 of 27 PageID #: 232
`Case 1:23-cv-00013-TSK Document1-5 Filed 01/27/23 Page 8 of 27 PagelD #: 232
`
`US 11,318,191 B2
`
`Page 7
`
`(56)
`
`References Cited
`OTHER PUBLICATIONS
`
`Inventor declaration—Dorthe Kot Engelund, USV Limited dated
`Aug. 20, 2015.
`Ji et al. (2014) “Insulin Pen Injection Technique Survey in Patients
`with Type 2 Diabetes in Mainland China in 2010.” Current Medical
`Research and Opinion. vol. 30:6. pp. 1087-1093.
`Gibson, Mark.
`(2009) “Choice of Excipients.” Pharmaceutical
`Preformulation and Formulation. 2nd Edition. p. 328.
`BASF: “BASF Chemical Emergency Medical Guidelines,” Jan. 1,
`2016, Retrieved from the Internet: URL: https://www.basf.com/
`documents/corp/en/sustainability/employees-and-society/employees/
`occupational -medicine/medical-guidelines/Phenol_B_BASF_
`medGuidelines_E104.pdf, retrieved on Nov. 20, 2017.
`Lau et al., Journal of Medicinal Chemistry, 2015, vol. 58, No. 18,
`pp. 7370-7380.
`Marbury etal., “Pharmacokinetics and Tolerability of a Single Dose
`of Semaglutide, a Once-Weekly Human GLP-1 Analogue, in Sub-
`jects With and Without Renal Impairment,” Diabetologia, 2014, vol.
`57, Supplement: 1, pp. S358-S359.
`Gennaro, Remington Pharmacy 2003, 20th Edition, No. 1 Chapter
`38, pp. 815-837.
`Blundell, T.L., Handbook of Experimental Pharmacology, Chapter
`3, “The Conformation of Glucagon”, Springer Verlag, 1983, pp.
`37-55.
`Chou, J. Z et al., Journal of Pharmaceutical Sciences, A Radioim-
`munoassay for LY3 15902, An Analog of Glucagon-Like Insulinotropic
`Pepride, and Its Application in the Study of Canine Pharmacokinet-
`ics, vol. 86(7), pp. 768-773 (1997).
`D. Voet and J.G. Voet, “Abnormal Hemoglobins”, Biochem, 2nd
`Ed., pp. 235-241 (1995).
`D.E. Smilek etal., “A Single Amino Acid Change in a Myelin Basic
`Protein Peptide Confers the Capacity to Prevent Rather Than Induce
`Experimental Autoimmune Encephalomyelitis”, Proc Natl Acad Sci
`USA,vol. 88, pp. 9633-9637, (1991).
`Eli Lilly & Co., Humalog Lispro Injection, USP Product Informa-
`tion Dated Feb. 11, 2010.
`Entry for Glycerin in Drugs.com (www.drugs.com/ppa/glycerin-
`glycerol.html), printed Aug. 4, 2009.
`European Pharmacopoeia, 3rd. Edition, 2.2.3, 1997, pp. 17-18,
`Council of Europe-Strasbourg.
`European Pharmacopoeia, 2007, vol. 1, p. 730, Council of Europe-
`Strasbourg.
`Frokjaer & Hovgaard, Pharmaceutical Formulation Development of
`Peptides and Proteins, Chapter 8, “Peptides and Proteins as Parenteral
`Solutions”, 2000, pp. 145-148 & 150-151.
`Further Experimental Data, Part A, Physical Stability, Dated Jun.
`22, 2009.
`G.F. Stamperet al., “Accelerated Stability Testing of Proteins and
`Peptides: pH-Stability Profile of Insulinotropin Using Traditional
`Arrheneius and Non-Linear Fitting Analysis”, Drug Development
`and Industrial Pharmacy, 1995, vol. 21, No. 13, pp. 1503-1511.
`Gonzales, Johnny C., Declaration of (Including Curriculum Vita)
`Dated Nov. 1, 2010.
`H. Qi et al., “Stability and Stabilization of Insulinotropin in a
`Dextran Formulation”, PDA Jou

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket