Granted Patent
B2
US 12,290,598 · App. 17/569,047 · Granted May 6, 2025
Orally administered corticosteroid compositions
Inventors:
Stephen Perrett (Princeton, NJ); Fredric Jay Cohen (Washington Crossing, PA); Gopi M. Venkatesh (Vandalia, OH)
Assignee:
Ellodi Pharmaceuticals, L.P.
A61K9/0065A61K9/0053A61K9/0056A61K9/006A61K9/08A61K31/56A61K31/569A61K31/58A61K45/06A61K47/38A61K9/06
View Patent ↗
Loading inventors, assignments & file history…
Abstract
The present invention is directed to orally administered corticosteroid compositions. The present invention also provides a method for treating a condition associated with inflammation of the gastrointestinal tract in an individual. The method comprises administering to an individual in need thereof a pharmaceutical composition of the present invention.
Claims (39)
1. An orally disintegrating tablet comprising:
(i) about 0.5 mg to about 6 mg of a corticosteroid selected from fluticasone propionate or budesonide; and
(ii) at least one disintegrant;
wherein upon administration a therapeutically effective amount of the corticosteroid is deposited topically in the esophagus,
wherein the orally disintegrating tablet disintegrates within 60 seconds when tested using the USP <701> Disintegration Test, and
wherein the orally disintegrating tablet has a hardness of 4-48 N or a friability of not more than 1%.
2. The orally disintegrating tablet of claim 1 , comprising about 0.5 mg to about 2 mg of the corticosteroid.
3. The orally disintegrating tablet of claim 1 , comprising about 3 mg of the corticosteroid.
4. The orally disintegrating tablet of claim 1 , comprising a sugar alcohol and/or saccharide.
5. The orally disintegrating tablet of claim 1 , wherein the orally disintegrating tablet comprises drug particles and rapidly dispersing granules, wherein the drug particles comprise the corticosteroid and at least one excipient, and the rapidly dispersing granules comprise the disintegrant and a sugar alcohol and/or saccharide.
6. The orally disintegrating tablet of claim 5 , wherein the rapidly dispersing granules have an average particle size of less than about 300 μm, and each of the disintegrant and sugar alcohol and/or saccharide have an average particle size of about 1-30 μm.
7. The orally disintegrating tablet of claim 5 , wherein the drug particles have an average particle size of about 100-400 μm.
8. The orally disintegrating tablet of claim 5 , wherein the drug particles have an average particle size of about 100-400 μm, the rapidly dispersing granules have an average particle size of less than about 300 μm, and each of the disintegrant and sugar alcohol and/or saccharide have an average particle size of about 1-30 μm.
9. The orally disintegrating tablet of claim 2 , wherein the corticosteroid is budesonide.
10. The orally disintegrating tablet of claim 5 , wherein the orally disintegrating tablet comprises about 3 mg of fluticasone propionate.
11. The orally disintegrating tablet of claim 3 , wherein the corticosteroid is fluticasone propionate.
12. The orally disintegrating tablet of claim 8 , wherein the orally disintegrating tablet comprises about 3 mg of fluticasone propionate.
13. The orally disintegrating tablet of claim 1 , wherein the disintegrant is crospovidone, sodium starch glycolate, crosslinked carboxymethyl cellulose, low-substituted hydroxylpropylcellulose, mannitol, xylitol, sorbitol, maltol, maltitol, lactose, sucrose, maltose, or combinations thereof.
14. The orally disintegrating tablet of claim 13 , wherein the disintegrant is crospovidone.
15. The orally disintegrating tablet of claim 5 , wherein the sugar alcohol and/or saccharide is mannitol, sorbitol, xylitol, maltitol, arabitol, ribitol, dulcitol, iditol, isomalt, lactitol, erythritol, lactose, sucrose, maltose, or combinations thereof.
16. The orally disintegrating tablet of claim 15 , wherein the sugar alcohol is mannitol.
17. The orally disintegrating tablet of claim 5 , wherein the ratio of disintegrant to sugar alcohol, saccharide or mixture thereof in the rapidly dispersing microgranules ranges from about 90/10 to about 99/01.
18. The orally disintegrating tablet of claim 1 , wherein the orally disintegrating tablet disintegrates within 60 seconds when tested in simulated saliva fluid using the USP <701> Disintegration Test.
19. The orally disintegrating tablet of claim 1 , wherein the orally disintegrating tablet disintegrates within 30 seconds when tested using the USP <701> Disintegration Test.
20. A method for treating eosinophilic esophagitis comprising administering to a patient in need thereof the orally disintegrating tablet according to claim 1 .
21. The method of claim 20 , wherein the orally disintegrating tablet comprises about 3 mg of fluticasone propionate.
22. The method of claim 20 , wherein the orally disintegrating tablet comprises about 0.5 mg to about 2 mg of budesonide.
23. The orally disintegrating tablet of claim 1 , wherein the orally disintegrating tablet has a hardness of 4-48 N.
24. The orally disintegrating tablet of claim 1 , wherein the orally disintegrating tablet has a friability of not more than 1%.
25. The orally disintegrating tablet of claim 1 , wherein the orally disintegrating has a hardness of 4-48 N and a friability of not more than 1%.
26. The orally disintegrating tablet of claim 1 , wherein the orally disintegrating tablet has a friability of not more than 0.6%.
27. The orally disintegrating tablet of claim 25 , wherein the orally disintegrating tablet has a friability of not more than 0.6%.
28. The orally disintegrating tablet of claim 27 , wherein the orally disintegrating tablet has a thickness of 2-2.8 mm.
29. The orally disintegrating tablet of claim 14 , wherein the orally disintegrating tablet comprises about 3 mg of fluticasone propionate.
30. The orally disintegrating tablet of claim 16 , wherein the orally disintegrating tablet comprises about 3 mg of fluticasone propionate.
31. The method of claim 20 , wherein the orally disintegrating tablet disintegrates within 60 seconds when tested in simulated saliva fluid using the USP <701> Disintegration Test.
32. The method of claim 20 , wherein the orally disintegrating tablet disintegrates within 30 seconds when tested using the USP <701> Disintegration Test.
33. The orally disintegrating tablet of claim 28 , wherein the orally disintegrating tablet comprises about 3 mg of fluticasone propionate.
34. The orally disintegrating tablet of claim 28 , wherein the orally disintegrating tablet comprises about 0.5 mg to about 2 mg of budesonide.
Assignments (6)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Feb 4, 2022
From: PERRETT, STEPHEN; COHEN, FREDRIC JAY; VENKATESH, GOPI
To: EURAND, INC.
Reel/Frame 058888/0668 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Feb 4, 2022
From: ADARE PHARMACEUTICALS, INC.
To: ADARE DEVELOPMENT, I L.P.
Reel/Frame 058888/0812 →
CHANGE OF NAME
Recorded Feb 4, 2022
From: APTALIS PHARMATECH, INC.
To: ADARE PHARMACEUTICALS, INC.
Reel/Frame 058956/0679 →
CHANGE OF NAME
Recorded Feb 4, 2022
From: ADARE DEVELOPMENT I, L.P.
To: ADARE PHARMACEUTICALS US, LP
Reel/Frame 058957/0210 →
CHANGE OF NAME
Recorded Feb 4, 2022
From: ADARE PHARMACEUTICALS US, L.P.
To: ELLODI PHARMACEUTICALS, L.P.
Reel/Frame 058957/0658 →
CHANGE OF NAME
Recorded Feb 4, 2022
From: EURAND, INCORPORATED
To: APTALIS PHARMATECH, INC.
Reel/Frame 058959/0338 →
Continuity (7)
References Cited (400)
US 3705172A
· Buchel et al.
· 1972
[cited by applicant]
US 3929768A
· Brattsand et al.
· 1975
[cited by applicant]
US 4080448A
· Mirsky
· 1978
[cited by applicant]
US 4335121A
· Phillipps et al.
· 1982
[cited by applicant]
US 4363806A
· Bergstrom et al.
· 1982
[cited by applicant]
US 4472393A
· Shapiro
· 1984
[cited by applicant]
US 4985418A
· Richards
· 1991
[cited by applicant]
US 5135740A
· Katz et al.
· 1992
[cited by applicant]
US 5252337A
· Powell
· 1993
[cited by applicant]
US 5278175A
· Ray et al.
· 1994
[cited by applicant]
US 5403893A
· Tanaka et al.
· 1995
[cited by applicant]
US 5446070A
· Mantelle
· 1995
[cited by applicant]
US 5482934A
· Calatayud et al.
· 1996
[cited by applicant]
US 5639475A
· Bettman et al.
· 1997
[cited by applicant]
US 5776433A
· Tzou et al.
· 1998
[cited by applicant]
US 5863910A
· Bolonick et al.
· 1999
[cited by applicant]
US 6139865A
· Friend et al.
· 2000
[cited by applicant]
US 6171617B1
· Gruber
· 2001
[cited by applicant]
US 6316027B1
· Johnson et al.
· 2001
[cited by applicant]
US 6495160B2
· Esposito et al.
· 2002
[cited by applicant]
US 6534549B1
· Newton et al.
· 2003
[cited by applicant]
US 6596298B2
· Leung et al.
· 2003
[cited by applicant]
US 6596311B1
· Dobetti
· 2003
[cited by applicant]
US 6740332B2
· Zyck et al.
· 2004
[cited by applicant]
US 7033606B1
· Besse et al.
· 2006
[cited by applicant]
US 7122198B1
· Singh et al.
· 2006
[cited by applicant]
US 7125564B2
· Chen et al.
· 2006
[cited by applicant]
US 7229641B2
· Cherukuri
· 2007
[cited by applicant]
US 8077288B2
· Kawashima
· 2011
[cited by applicant]
US 8545881B2
· Venkatesh et al.
· 2013
[cited by applicant]
US 8580300B2
· Wilhelm et al.
· 2013
[cited by applicant]
US 8679545B2
· Dohil et al.
· 2014
[cited by applicant]
US 8771729B2
· Perrett et al.
· 2014
[cited by applicant]
US 8932596B2
· Benhamou et al.
· 2015
[cited by applicant]
US 9387167B2
· Perrett et al.
· 2016
[cited by applicant]
US 9486407B2
· Perrett et al.
· 2016
[cited by applicant]
US 9782347B2
· Dohil et al.
· 2017
[cited by applicant]
US 9849084B2
· Perrett et al.
· 2017
[cited by applicant]
US 9867780B2
· Greinwald et al.
· 2018
[cited by applicant]
US 20010006625A1
· Bohn et al.
· 2001
[cited by applicant]
US 20010014340A1
· Ohta et al.
· 2001
[cited by applicant]
US 20030050312A1
· Hjorth et al.
· 2003
[cited by applicant]
US 20030054036A1
· Liggins et al.
· 2003
[cited by applicant]
US 20030099701A1
· Takaishi et al.
· 2003
[cited by applicant]
US 20030215500A1
· Ohta et al.
· 2003
[cited by applicant]
US 20040009212A1
· Tsai
· 2004
[cited by applicant]
US 20040053902A1
· Smith
· 2004
[cited by applicant]
US 20040106663A1
· Talley et al.
· 2004
[cited by applicant]
US 20040228919A1
· Houghton et al.
· 2004
[cited by applicant]
US 20040265375A1
· Platteeuw et al.
· 2004
[cited by applicant]
US 20050009848A1
· Brantl
· 2005
[cited by applicant]
US 20050112188A1
· Eliaz et al.
· 2005
[cited by applicant]
US 20050232988A1
· Venkatesh et al.
· 2005
[cited by applicant]
US 20060051414A1
· Ramalho et al.
· 2006
[cited by applicant]
US 20060105038A1
· Lai et al.
· 2006
[cited by applicant]
US 20060134054A1
· Kulkarni et al.
· 2006
[cited by applicant]
US 20060292099A1
· Milburn et al.
· 2006
[cited by applicant]
US 20070020330A1
· Dang et al.
· 2007
[cited by applicant]
US 20070059361A1
· Rawas-Qalaji et al.
· 2007
[cited by applicant]
US 20070111978A1
· Dohil et al.
· 2007
[cited by applicant]
US 20090074862A1
· Schioppi et al.
· 2009
[cited by applicant]
US 20090123390A1
· Hill
· 2009
[cited by applicant]
US 20090123550A1
· Phillips et al.
· 2009
[cited by applicant]
US 20090123551A1
· Phillips et al.
· 2009
[cited by applicant]
US 20090131386A1
· Phillips
· 2009
[cited by applicant]
US 20090149433A1
· Phillips
· 2009
[cited by applicant]
US 20090155360A1
· Venkatesh et al.
· 2009
[cited by applicant]
US 20090169620A1
· Venkatesh et al.
· 2009
[cited by applicant]
US 20090181099A1
· Dohil et al.
· 2009
[cited by applicant]
US 20090191275A1
· Dohil et al.
· 2009
[cited by applicant]
US 20090264392A1
· Warndahl et al.
· 2009
[cited by applicant]
US 20100034894A1
· Szymczak et al.
· 2010
[cited by applicant]
US 20100215753A1
· Sherwood et al.
· 2010
[cited by applicant]
US 20100216754A1
· Hill
· 2010
[cited by applicant]
US 20110081411A1
· Perrett et al.
· 2011
[cited by applicant]
US 20110097401A1
· Phillips et al.
· 2011
[cited by applicant]
US 20110123460A1
· Wilhelm et al.
· 2011
[cited by applicant]
US 20110129530A1
· Venkatesh et al.
· 2011
[cited by applicant]
US 20120128764A1
· Venkatesh et al.
· 2012
[cited by applicant]
US 20120164080A1
· Hill et al.
· 2012
[cited by applicant]
US 20120282335A1
· Venkatesh et al.
· 2012
[cited by applicant]
US 20130296286A1
· Dohil et al.
· 2013
[cited by applicant]
US 20130310661A1
· Jedwab et al.
· 2013
[cited by applicant]
US 20140187523A1
· Dohil et al.
· 2014
[cited by applicant]
US 20140228714A1
· Chau et al.
· 2014
[cited by applicant]
US 20140287051A1
· Perrett et al.
· 2014
[cited by applicant]
US 20140303131A1
· Perrett et al.
· 2014
[cited by applicant]
US 20150209432A1
· Konda et al.
· 2015
[cited by applicant]
US 20150231156A1
· Phillips et al.
· 2015
[cited by applicant]
US 20160045518A1
· Dohil et al.
· 2016
[cited by applicant]
US 20160078186A1
· Hill et al.
· 2016
[cited by applicant]
US 20160206627A1
· Gosselin et al.
· 2016
[cited by applicant]
US 20160213681A1
· Santus et al.
· 2016
[cited by applicant]
US 20160324772A1
· Greinwald et al.
· 2016
[cited by applicant]
US 20170071855A1
· Perrett et al.
· 2017
[cited by applicant]
US 20170183719A1
· Rothenberg et al.
· 2017
[cited by applicant]
US 20180071211A1
· Dohil et al.
· 2018
[cited by applicant]
US 20180133145A1
· Meltzer et al.
· 2018
[cited by applicant]
US 20180153802A1
· Perrett et al.
· 2018
[cited by applicant]
US 20190008760A1
· Meltzer et al.
· 2019
[cited by applicant]
US 20190201333A1
· Dohil et al.
· 2019
[cited by applicant]
US 20200016171A1
· Gosselin et al.
· 2020
[cited by applicant]
US 20200214979A1
· Perrett et al.
· 2020
[cited by applicant]
US 20200368147A1
· Meltzer et al.
· 2020
[cited by applicant]
US 20200381097A1
· Meltzer
· 2020
[cited by applicant]
US 20210205328A1
· Gosselin et al.
· 2021
[cited by applicant]
US 20210244660A1
· Perrett et al.
· 2021
[cited by applicant]
US 20210275438A1
· Meltzer et al.
· 2021
[cited by applicant]
US 20210346278A1
· Meltzer et al.
· 2021
[cited by applicant]
US 20220347189A1
· Nezamis et al.
· 2022
[cited by applicant]
US 20230414498A1
· Meltzer et al.
· 2023
[cited by applicant]
US 20240207288A1
· Eagle
· 2024
[cited by applicant]
CA 1027864A
· 1978
[cited by applicant]
CA 2430481A1
· 2002
[cited by applicant]
CA 2704946A1
· 2009
[cited by applicant]
CA 2776164A1
· 2011
[cited by applicant]
CL 38272008
· 2007
[cited by applicant]
CN 1186428A
· 1998
[cited by applicant]
CN 102665722A
· 2012
[cited by applicant]
CN 105392497A
· 2016
[cited by applicant]
DE 2323215A1
· 1973
[cited by applicant]
DE 4129535A1
· 1992
[cited by applicant]
DE 60202794T2
· 2006
[cited by applicant]
DE 202010018594U1
· 2018
[cited by applicant]
EP 0057401A1
· 1982
[cited by applicant]
EP 0440372A1
· 1991
[cited by applicant]
EP 1310243A1
· 2003
[cited by applicant]
EP 1323417A1
· 2003
[cited by applicant]
EP 1595533A1
· 2005
[cited by applicant]
EP 2886108A1
· 2015
[cited by applicant]
EP 2211896B1
· 2018
[cited by applicant]
EP 2482822B1
· 2018
[cited by applicant]
EP 2214679B1
· 2019
[cited by applicant]
EP 3041476B1
· 2019
[cited by applicant]
EP 3354276B1
· 2020
[cited by applicant]
JP S56138200A
· 1981
[cited by applicant]
JP 11130679A
· 1999
[cited by applicant]
JP H11511162A
· 1999
[cited by applicant]
JP 2001524094A
· 2001
[cited by applicant]
JP 2002521321A
· 2002
[cited by applicant]
JP 2003509359A
· 2003
[cited by applicant]
JP 2003261439A
· 2003
[cited by applicant]
JP 2003292459A
· 2003
[cited by applicant]
JP 2006077018A
· 2006
[cited by applicant]
JP 2006516616A
· 2006
[cited by applicant]
JP 2006516646A
· 2006
[cited by applicant]
JP 2006524650A
· 2006
[cited by applicant]
JP 2009519793A
· 2009
[cited by applicant]
JP 2009521523A
· 2009
[cited by applicant]
JP 2009173552A
· 2009
[cited by applicant]
JP 2011503073A
· 2011
[cited by applicant]
JP 2013506683A
· 2013
[cited by applicant]
KR 20060123160A
· 2006
[cited by applicant]
KR 20100087007A
· 2010
[cited by applicant]
KR 20120104975A
· 2012
[cited by applicant]
KR 20160058829A
· 2016
[cited by applicant]
RU 2011134040A
· 2013
[cited by applicant]
RU 2016104400A
· 2017
[cited by applicant]
WO WO9632095A1
· 1996
[cited by applicant]
WO WO9706786A1
· 1997
[cited by applicant]
WO WO9847535A1
· 1998
[cited by applicant]
WO WO9947144A1
· 1999
[cited by applicant]
WO WO0044351A1
· 2000
[cited by applicant]
WO WO0064450A1
· 2000
[cited by applicant]
WO WO0119342A2
· 2001
[cited by applicant]
WO WO02092057A1
· 2002
[cited by applicant]
WO WO03039520A1
· 2003
[cited by applicant]
WO WO03093344A1
· 2003
[cited by applicant]
WO WO2004064810A1
· 2004
[cited by applicant]
WO WO2004067004A1
· 2004
[cited by applicant]
WO WO2004069225A1
· 2004
[cited by applicant]
WO WO2004091585A1
· 2004
[cited by applicant]
WO WO2005087194A1
· 2005
[cited by applicant]
WO WO2007071179A1
· 2007
[cited by applicant]
WO WO2007074472A2
· 2007
[cited by applicant]
WO WO2008098634A1
· 2008
[cited by applicant]
WO WO2009064457A2
· 2009
[cited by applicant]
WO WO2009064458A2
· 2009
[cited by applicant]
WO WO2009064819A2
· 2009
[cited by applicant]
WO WO2009086046A1
· 2009
[cited by applicant]
WO WO2009098595A2
· 2009
[cited by applicant]
WO WO2010021636A1
· 2010
[cited by applicant]
WO WO2010144865A2
· 2010
[cited by applicant]
WO WO2011041509A1
· 2011
[cited by applicant]
WO WO2015006571A1
· 2015
[cited by applicant]
WO WO2015034678A2
· 2015
[cited by applicant]
WO WO2015035114A1
· 2015
[cited by applicant]
WO WO2017189805A1
· 2017
[cited by applicant]
WO WO2018035393A1
· 2018
[cited by applicant]
WO WO2019165138A1
· 2019
[cited by applicant]
WO WO2021067585A1
· 2021
[cited by applicant]
WO WO2022020464A1
· 2022
[cited by applicant]
WO WO2022225892A1
· 2022
[cited by applicant]
ZA 6805392
· 1969
[cited by applicant]
U.S. Appl. No. 12/896,005, filed Oct. 1, 2010, US 2011-0081411 A1, Apr. 7, 2011, U.S. Pat. No. 8,771,729, Jul. 8, 2014.
[cited by applicant]
U.S. Appl. No. 14/294,660, filed Jun. 3, 2014, US 2014-0287051 A1, Sep. 25, 2014, U.S. Pat. No. 9,486,407, Nov. 8, 2016.
[cited by applicant]
U.S. Appl. No. 14/311,732, filed Jun. 23, 2014, US 2014-0303131 A1, Oct. 9, 2014, U.S. Pat. No. 9,387,167, Jul. 12, 2016.
[cited by applicant]
U.S. Appl. No. 15/205,390, filed Jul. 8, 2016, US 2017-0071855 A1, Mar. 16, 2017, U.S. Pat. No. 9,849,084, Dec. 26, 2017.
[cited by applicant]
U.S. Appl. No. 15/816,154, filed Nov. 17, 2017, US 2018-0153802 A1, Jun. 7, 2018, U.S. Pat. No. 10,632,069, Apr. 28, 2020.
[cited by applicant]
U.S. Appl. No. 16/821,464, filed Mar. 17, 2020, US 2020-0214979 A1, Jul. 9, 2020, U.S. Pat. No. 11,246,828, Feb. 15, 2022.
[cited by applicant]
U.S. Appl. No. 17/236,295, filed Apr. 21, 2021, US 2021-0244660 A1, Aug. 12, 2021, U.S. Pat. No. 11,266,598, Mar. 8, 2022.
[cited by applicant]
Sodikoff et al., “Therapeutic strategies in eosinophilic esophagitis: Induction, maintenance and refractory disease”, Best Pract Res Clin Gastroenterol. (Oct. 2015); 29(5): 829-839.
[cited by applicant]
Straumann et al., “Budesonide is effective in adolescent and adult patients with active eosinophilic esophagitis”, Gastroenterology (Nov. 2010); 139(5): 1526-1537.
[cited by applicant]
Straumann et al., “Long-term budesonide maintenance treatment is partially effective for patients with eosinophilic esophagitis”, Clin Gastroenterol Hepatol. (May 2011); 9(5): 400-409.
[cited by applicant]
Gentile et al., “Oesophageal narrowing is common and frequently under-appreciated at endoscopy in patients with oesophageal eosinophilia”. Alimentary Pharmacology & Therapeutics (Dec. 2014); 40(11-12): 1333-1340. Epub O…
[cited by applicant]
German Patent Complaint Proceedings in the Regional Court, Mannheim,
[cited by applicant]
German Utility Model Cancellation Proceedings DE 20201 018594 U1,
[cited by applicant]
German Utility Model Cancellation Proceedings DE 20201 018594 U1,
[cited by applicant]
Opposition Proceedings in European Patent No. EP 2482822, Appeal No. T1954/21-3.3.01 (Appln. No. 10821232.5), filed by Dr. Falk Pharma GmbH on Mar. 1, 2019; EPO Communication dated Jul. 25, 2022 regarding Termination of…
[cited by applicant]
Opposition Proceedings in European Patent No. EP 3086782 (Appln. No. 14814872.9), (in the name of Dr. Falk Pharma GmbH) filed by Ellodi Pharmaceuticals, L.P. on Jun. 26, 2019; Written decision on rejection of the opposi…
[cited by applicant]
Opposition Proceedings in European Patent No. EP 3403654 (Appln. No. 18178891.0), filed by Dr. Falk Pharma GmbH; Decision to discontinue the opposition proceedings dated Sep. 5, 2022, 2 pages.
[cited by applicant]
PCT/US2022/025297, International Search Report and Written Opinion mailed Jul. 29, 2022, 10 pages.
[cited by applicant]
Takita et al., “Successful esophageal endoscopic submucosal dissection with a transoral endoscope after stepwise scope bougienage of post-endoscopic submucosal dissection stricture”. JGH Open (Oct. 22, 2020); 5(1): 163-…
[cited by applicant]
Dellon E.S., “Safety and Efficacy of Budesonide Oral Suspension Maintenance Therapy in Patients With Eosinophilic Esophagitis”, Clin Gastroenterol Hepatol. Mar. 2019; 17(4): 666-673.e8. Epub Jun. 12, 2018.
[cited by applicant]
Extended European Search Report for European Application No. EP 20873169.5 dated Sep. 22, 2023, 9 pages.
[cited by applicant]
Hirano, I., et al. “Randomised clinical trial: the safety and tolerability of fluticasone propionate orally disintegrating tablets versus placebo for eosinophilic oesophagitis”, Aliment Pharmacol Ther. Apr. 2020;51(8):7…
[cited by applicant]
Konikoff, et al., “A Randomized, Double-Blind, Placebo-Controlled Trial of Fluticasone Propionate for Pediatric Eosinophilic Esophagitis”. Gastroenterology. Nov. 2006; 131(5): 1381-1391. Epub Aug. 16, 2006.
[cited by applicant]
Schoepfer, et al., “Delay in diagnosis of eosinophilic esophagitis increases risk for stricture formation in a time-dependent manner”. Gastroenterology. Dec. 2013; 145(6): 1230-1236. Epub Aug. 13, 2013.
[cited by applicant]
Straumann et al., “Budesonide Orodispersible Tablets Maintain Remission in a Randomized, Placebo-Controlled Trial of Patients With Eosinophilic Esophagitis”. Gastroenterology. Nov. 2020; 159(5): 1672-1685. e5. Epub Jul.…
[cited by applicant]
Aceves, et al., “Oral viscous budesonide: a potential new therapy for eosinophilic esophagitis in children”. Am J Gastroenterol. (Oct. 2007); 102(10): 1-9. Epub Jun. 20, 2007.
[cited by applicant]
Aceves, et al., “Topical viscous budesonide suspension for treatment of eosinophilic esophagitis”. The Journal of Allergy and Clinical Immunology (Sep. 1, 2005); vol. 116, Issue 3, pp. 705-706. Epub Jul. 1, 2005.
[cited by applicant]
Ahmed and Shah, “Formulation of low dose medicines—theory and practice.” Am. Pharm. Rev (2000); 3(3): 9-14.
[cited by applicant]
Ahmed, Monjur, “Eosinophilic esophagitis in adults: An update”. World J Gastrointest Pharmacol Ther. (May 6, 2016); 7(2): 207-213.
[cited by applicant]
Alexander, et al., “Review. Therapeutic Options for Eosinophilic Esophagitis”. Gastroenterology & Hepatology (Jan. 1, 2011); 7(1): 59-61.
[cited by applicant]
Auszug von European Pharmacopeia 6.0 (English language) 2.9.8; Jul. 23, 2007, 2 pages.
[cited by applicant]
Auszug von European Pharmacopeia 8.0 (German language) 2.9.8; Jul. 15, 2013, 1 page.
[cited by applicant]
Auszug von US Pharmacopeia 35 1217; May 1, 2012, 3 pages.
[cited by applicant]
[Author Unknown] Definition of slow-release (downloaded from Merriam-Webster online athttps://www.merriam-webster.com/medical/slow-release); accessed Jul. 31, 2019, 1 page.
[cited by applicant]
[Author Unknown] Definition of sustained-release (downloaded from Merriam-Webster online athttps://www.merriam-webster.com/dictionary/sustainedrelease#medicalDictionary); accessed Jul. 31, 2019, 1 page.
[cited by applicant]
[Author unknown] DrugBank Accession Number, first approved 1990, DrugBank Accession No. DB00588, https://go.drugbank.com/drugs/DB00588, 14 pages.
[cited by applicant]
[Author Unknown] Jorveza package leaflet (downloaded from the European Medicines Agency atwww.ema.europa.eu/en/medicines/human/EPAR/jorveza#product-informationsection); accessed Aug. 1, 2019, 8 pages.
[cited by applicant]
[Author Unknown] Jorveza package leaflet, Jorveza 1mg orodispersible tablets, tablets package leaflet (PIL) for United Kingdom-Ireland, Mat-No. 1147370 (Losan Pharma), Dated Mar. 15, 2018, Date Code Falk: GB-IE/03.18, 2…
[cited by applicant]
[Author Unknown] Jorveza summary of product characteristics (downloaded from the European Medicines Agency atwww.ema.europa.eu/en/medicines/human/EPAR/jorveza#product-informationsection); first published Jan. 18, 2018, …
[cited by applicant]
[Author Unknown] Povidone (polyvinylpyrrolidone (PVP)) compound summary (downloaded from Wikipedia at https://en.wikipedia.org/wiki/Polyvinylpyrrolidone); accessed Jul. 31, 2019, 5 pages.
[cited by applicant]
[Author Unknown] Solubility of budesonide (downloaded fromhttps://pubchem.ncbi.nlm.nih.gov/compound/Budesonide#section=Solubility&fullscreen=true); information available as of Oct. 15, 2015, accessed Aug. 1, 2019, 1 pag…
[cited by applicant]
Author Unknown, WHT 3ME brochure Version 2.0; Fully Automated 4 in 1 Tablet Testing Instrument Pharma Test; publication date unknown.
[cited by applicant]
Bauer, et al., “106 Chapter 5 Methods and Basic Operations”. Lehrbuch der Pharmazeutischen Technologie (Textbook of pharmaceutical technology), With an introduction to biopharmacy (2006); (eds) Lippold, et al., 8th revi…
[cited by applicant]
Beveridge, et al., “Novel Therapeutic Approaches to Eosinophilic Esophagitis”. Gastroenterology & Hematology (Jun. 2020); 16(6): 294-301.
[cited by applicant]
Bonnet, et al., “Formulation of a 3-months Stability Oral Viscous Budesonide Gel and Development of an Indicating Stability HPLC Method”, Pharm Technol Hosp Pharm (2018); 3(2): 91-99.
[cited by applicant]
Bower et al., “Manifestations and Treatment of Laryngeal Sarcoidosis”. Am. Rev. Respir. Dis., 122(2): 325-332 (1980).
[cited by applicant]
Breuer, et al., “Glossary of Terms Related to Pharmaceutics (IUPAC Recommendations 2009)” Pure Appl. Chem. (2009); 81 (5): 971-999.
[cited by applicant]
Brunner, et al., “Gastrointestinal transit, release and plasma pharmacokinetics of a new oral budesonide formulation.” British Journal of Clinical Pharmacology (2005); 61(1): 31-38.
[cited by applicant]
Buckton, G., “Water sorption and near IR spectroscopy to study the differences between microcrystalline cellulose and silicified microcrystalline cellulose before and after wet granulation.” International Journal of Pha…
[cited by applicant]
Budesonid, https://www.chemie.de/lexikon/Budesonid.html, Jul. 12, 2019, and English version, Sep. 10, 2020, 3 pages.
[cited by applicant]
Campieria et al., “Oral budesonide is as effective as oral prednisolone in active Crohn's disease,” Gut, 41: 209-214 (1997).
[cited by applicant]
Certified copy of Priority Document U.S. Appl. No. 61/186,777, filed Jun. 12, 2009, 104 pages.
[cited by applicant]
Daley-Yates, Peter T. “Inhaled corticosteroids: potency, dose equivalence and therapeutic index.” British Journal of Clinical Pharmacology (2015); 80(3): 372-380.
[cited by applicant]
Declaration of Stephen Perrett, MBA, Ph.D. dated Jul. 16, 2020, 6 pages.
[cited by applicant]
Dellon, et al., “Efficacy of Budesonide vs Fluticasone for Initial Treatment of Eosinophilic Esophagitis in a Randomized Controlled Trial”. Gastroenterology (2019); 157: 65-73.
[cited by applicant]
Dilger, K., et al. “Active eosinophilic esophagitis is associated with impaired elimination of budesonide by cytochrome P450 3A enzymes.” Digestion (2013); 87(2):110-117. Epub Jan. 25, 2013.
[cited by applicant]
Dohil, et al., “Oral Viscous Budesonide is Effective in Children With Eosinophilic Esophagitis in a Randomized, Placebo-Controlled Trial”. Gastroenterol. (Aug. 2010); 139(2): 418-429.
[cited by applicant]
Dolo-Dobendan®, 1.4 mg/10 mg lozenges package insert, Reference ID 3030657, Revised: Jan. 2015, with English translation, 7 pages.
[cited by applicant]
Dr. Schleuniqer, “Key factors influencing measured tablet hardness”; Pharmatron; 2011, 5 pages.
[cited by applicant]
EPO Communication dated Apr. 25, 2019 in connection with Application No. EP 08848597.4, 13 pages.
[cited by applicant]
Eurasian Application No. 201491358, Search Report (with English translation), issued Jan. 22, 2015, 4 pages.
[cited by applicant]
European Application No. EP 19757814.9, Extended European Search Report dated Nov. 4, 2021, 11 pages.
[cited by applicant]
European Application No. EP 10821232.5, Extended European Search Report dated Feb. 6, 2014, 10 pages.
[cited by applicant]
European Application No. EP 14184844.0, Extended European Search Report dated Feb. 9, 2015, 7 pages.
[cited by applicant]
European Application No. EP 14842811.3, Extended European Search Report dated Mar. 23, 2017, 6 pages.
[cited by applicant]
European Application No. EP 17842162.4, Extended European Search Report dated Apr. 1, 2020, 8 pages.
[cited by applicant]
European Application No. EP 18178891.0, Extended European Search Report dated Aug. 13, 2018, 3 pages.
[cited by applicant]
European Application No. EP 19189185.2, Extended European Search Report dated Aug. 29, 2019, 9 pages.
[cited by applicant]
European Application No. EP 19207287.4, Extended European Search Report dated Apr. 6, 2020, 9 pages.
[cited by applicant]
Falcoz, et al., “Bioavailability of Orally Administered Micronised Fluticasone Propionate.” Clinical Pharmacokinetics (2000); 39 Suppl. 1: 9-15.
[cited by applicant]
Forum of the National Formulary of Japan, compilation, Drugs in Japan, 2009 edition, published 2008, p. 2161-2165 (and English translation/summary of pertinent paragraphs), 8 pages.
[cited by applicant]
Furuta, et al., “Review article: the pathogenesis and management of eosinophilic oesophagitis”. Alimentary Pharmacology & Therapeutics (2006); 24: 172-182.
[cited by applicant]
Furuta, Glenn T., “Eosinophils in the Esophagus: Acid is Not the Only Cause”. Journal of Pediatric Gastroenterology & Nutrition (Apr. 1998); 26(4): 468-471.
[cited by applicant]
Furuta, Glenn T., et al. “Eosinophilic esophagitis in children and adults: a systematic review and consensus recommendations for diagnosis and treatment: sponsored by the American Gastroenterological Association (AGA) I…
[cited by applicant]
Georgia Application No. AP 2010012674, Search Report (with English translation) dated Nov. 28, 2013, 11 pages.
[cited by applicant]
German Patent Complaint Proceedings in the Regional Court, Mannheim,
[cited by applicant]
German Patent Complaint Proceedings in the Regional Court, Mannheim,
[cited by applicant]
German Patent Complaint Proceedings in the Regional Court, Mannheim,
[cited by applicant]
German Patent Complaint Proceedings in the Regional Court, Mannheim, Germany,
[cited by applicant]
German Patent Complaint Proceedings in the Regional Court, Mannheim, Germany,
[cited by applicant]
German Patent Complaint Proceedings in the Regional Court, Mannheim, Germany,
[cited by applicant]
German Patent Complaint Proceedings in the Regional Court, Mannheim, Germany,
[cited by applicant]
German Patent Complaint Proceedings in the Regional Court, Mannheim, Germany,
[cited by applicant]
German Patent Complaint Proceedings in the Regional Court, Mannheim, Germany,
[cited by applicant]
German Patent Complaint Proceedings in the Regional Court, Mannheim, Germany,
[cited by applicant]
German Patent Complaint Proceedings in the Regional Court, Mannheim, Germany,
[cited by applicant]
German Patent Infringement Proceedings in the Regional Court, Mannheim, Germany,
[cited by applicant]
German Utility Model Cancellation Action, Request for Cancellation, filed by Dr. Falk Pharma GmbH on Mar. 1, 2019 with the German Patent Office, in connection with DE Patent No. 202010018594 U1 in the name of Adare Phar…
[cited by applicant]
German Utility Model Cancellation Proceedings DE 20201 018594 U1,
[cited by applicant]
German Utility Model Cancellation Proceedings,
[cited by applicant]
German Utility Model Cancellation Proceedings,
[cited by applicant]
German Utility Model Cancellation Proceedings,
[cited by applicant]
German Utility Model Cancellation Proceedings,
[cited by applicant]
German Utility Model Cancellation Proceedings,
[cited by applicant]
German Utility Model Cancellation Proceedings,
[cited by applicant]
German Utility Model Cancellation Proceedings,
[cited by applicant]
German Utility Model Cancellation Proceedings,
[cited by applicant]
German Utility Model Cancellation Proceedings,
[cited by applicant]
German Utility Model Cancellation Proceedings,
[cited by applicant]
Hahm and Augsburger, Orally Disintegrating Tablets and Related Tablet Formulations, Pharmaceutical Dosage Forms: Tablets, Third Edition, Ch. 9, vol. 2, Herausgeber: (eds) Larry L. Augsburger, Stephen W. Hoag, CRC Press …
[cited by applicant]
Ham, et al., “Quantitation of esophagal transit by means of 81mKr.” European Journal of Nuclear Medicine (1984); 9: 362-365.
[cited by applicant]
Handbook of Pharmaceutical Excipients (2009); Sixth Edition, ISBN 978 1 58212 135 2, (eds.) Rowe, et al., Cover Page, Print/Copyright and Preface Pages, 4 pages.
[cited by applicant]
International Preliminary Report on Patentability for International Application No. PCT/US2017/047474, dated Feb. 19, 2019, 8 pages.
[cited by applicant]
Jorveza (budesonide) Update by the Committee for Medicinal Products for Human Use (CHMP), Summary of opinion1 (post authorisation) dated Mar. 26, 2020, European Medicines Agency, 1 page.
[cited by applicant]
Katdare and Chaubal (eds)., Excipient Development for Pharmaceutical, Biotechnology and Drug Delivery Systems, Herausg. CRC Press, Taylor & Francis Group, Boca Raton, USA, 2006; dart: Excipients for Oral Liquid Formulat…
[cited by applicant]
Khan and Orenstein, “Eosinophilic Gastroenteritis: Epidemiology, Diagnosis and Management.” Paediatr Drugs. (2002); 4(9): 563-570.
[cited by applicant]
Koukourakis, et al., “Oral Administration of Recombinant Human Granulocyte Macrophage Colony-stimulating Factor in the Management of Radiotherapy-induced Esophagitis”, Clinical Cancer Research (Dec. 1999); 5(12): 3970-3…
[cited by applicant]
Krishna, et al., “Treatment of Eosinophilic Esophagitis is Oral Viscous Budesonide Superior to Swallowed Fluticasone Spray?” Gastroenterol Hepatol (Jan. 2011); 7(1): 55-59.
[cited by applicant]
Kumari and Rajendran, “Effect of topical nasal steroid spray in the treatment of non-specific recurrent/chronic pharyngitis—a trial study.” Indian Journal of Otolaryngology and Head & Neck Surgery, 60(3): 199-201 (2008).
[cited by applicant]
Langdon, BA and Mullamey, (2006) Handbook of Pharmaceutical Excipients. (eds.) Rowe, R.C., Sheskey, PJ and Owen, S.C., London: Pharmaceutical Press and American Pharmacists Association (extract—pp. 53-55 and 742-743), 1…
[cited by applicant]
Lee, Geoffrey, Professor, Report of Professor Geoffrey Lee, Ph.D. on measurement of disintegration time of “Jorveza 1 mg orodispersible tablet” dated Nov. 15, 2019, 16 pages.
[cited by applicant]
Li, Xiaowei, et al., “Advances in Injectable Thermosensitive Polymers”. Polymer Bulletin, No. 3, pp. 109-115, Jun. 30, 2015 (with English Abstract), 7 pages.
[cited by applicant]
Liacouras, et al., “Primary Eosinophilic Esophagitis in Children: Successful Treatment with Oral Corticosteroids”. Journal of Pediatric Gastroenterology & Nutrition (1998); 26(4): 380-385.
[cited by applicant]
Mahmoudi et al. “Effect of drug particle size on blend segregation and content uniformity”. Contributed poster, AAPS Annual Meeting (USA) 2010, 1 page. (non-English).
[cited by applicant]
Mahmoudi et al. “Influence of filler in blend uniformity of micronized drugs”. Contributed poster, AAPS Annual Meeting (USA) 2010, 1 page.
[cited by applicant]
Malaysian Application No. PI 2012001434, Search Report dated Jan. 29, 2016, 1 page.
[cited by applicant]
Martin, et al., “Pediatric Eosinophilic Esophagitis Symptom Scores (PEESS® v2.0) identify histologic and molecular correlates of the key clinical features of disease”. J Allergy Clin Immunol. (Jun. 2015); 135(6): 1519-1…
[cited by applicant]
McGinity, J. W., et al. “Dissolution and uniformity properties of ordered mixes of micronized griseofulvin and a directly compressible excipient.” Drug Development and Industrial Pharmacy, 11(4): 891-900 (1985).
[cited by applicant]
Merck Index, “Budesonide,” 14th Edition, p. 240 (2006).
[cited by applicant]
Merck Index, “Ciclesonide,” 14th Edition, p. 376 (2006).
[cited by applicant]
Merck Index, “Clotrimazole,” 14th Edition, p. 407 (2006).
[cited by applicant]
Merck Index, “Mometasone Furoate,” 14th Edition, pp. 1077-1078 (2006).
[cited by applicant]
Merck Index, “Voriconazole,” 14th Edition, p. 1728 (2006).
[cited by applicant]
Miehlke, et al., “A randomised, double-blind trial comparing budesonide formulations and dosages for short-term treatment of eosinophilic oesophagitis”, Gut (2016); 65: 390-399.
[cited by applicant]
Moreton, R. Christian, “Disintegrants in Tableting”. In book: Pharmaceutical Dosage Forms: Tablets, vol. 2, Herausgeber Augsburger & Hoag, CRC Press, Taylor and Francis Group (2008); Ch. 6, pp. 217-249, 33 pages.
[cited by applicant]
New World Encyclopedia, “Gastrointestinal tract”, https://web.archive.org/web/20090917122455/https://www.newworldencyclopedia.or . . . , Jul. 8, 2019, 7 pages.
[cited by applicant]
New World Encyclopedia, “Gastrointestinal tract”, https://www.newworldencyclopedia.org/entry/Gastrointestinal_tract, Jul. 8, 2019, 6 pages.
[cited by applicant]
Nishimura, S., et al. “Factors associated with esophageal candidiasis and its endoscopic severity in the era of antiretroviral therapy.” PLoS One (2013); 8(3): e58217, 6pgs.
[cited by applicant]
Novopulmon E Novolizer, Instructions for the medical use of the medicament, [Instrukciya po medicinskomu primeneniyu preparata Novopulmon Novolizer (international nonproprietary name: budesonide), registracionniy nomer …
[cited by applicant]
“NUROFEN” tablet package insert, 200 MG Tablets and Capsules, Date of revision: Feb. 2018, Reference ID 3039860, and English version, 2 pages.
[cited by applicant]
Opposition Proceedings in European Patent No. 2886108 (Appln. No. 13199278.6), filed by Adare Development, I, L.P on Nov. 6, 2019, EPO Communication dated Apr. 6, 2021, enclosing Patentee's Response to Submissions dated…
[cited by applicant]
Opposition Proceedings in European Patent No. EP 2482822 (Appln. No. 10821232.5), filed by Dr. Falk Pharma GmbH on Mar. 1, 2019; Appeal No. T1954/21-3.3.01 dated Jan. 4, 2022, 20 pages.
[cited by applicant]
Opposition Proceedings in European Patent No. EP 2886108 (Appln. No. 13199278.6), filed by Ellodi Pharmaceuticals, L.P., on Nov. 6, 2019, Interlocutory Decision dated Jan. 5, 2022, and English translation, 43 pages.
[cited by applicant]
Opposition Proceedings in European Patent No. EP 2886108 (Appln. No. 13199278.6), filed by Ellodi Pharmaceuticals, L.P., on Nov. 6, 2019, Minutes of Oral Proceedings dated Jan. 5, 2022, and English translation, 25 pages.
[cited by applicant]
Opposition Proceedings in European Patent No. EP 3041476 (Appln. No. 14842811.3), filed by Dr. Falk Pharma GmbH on Jul. 22, 2020; EPO's Communication dated Nov. 18, 2021 enclosing Opponent's, Dr. Falk Pharma GmbH's Furt…
[cited by applicant]
Opposition Proceedings in European Patent No. EP 3041476 (Appln. No. 14842811.3), filed by Dr. Falk Pharma GmbH on Jul. 22, 2020; Interlocutory Decision dated Feb. 14, 2022, 61 pages.
[cited by applicant]
Opposition Proceedings in European Patent No. EP 3041476 (Appln. No. 14842811.3), filed by Dr. Falk Pharma GmbH on Jul. 22, 2020; Minutes of Oral Proceedings dated Feb. 14, 2022, 15 pages.
[cited by applicant]
Opposition Proceedings in European Patent No. 2482822 (Appln. No. 1082123205), filed by Dr. Falk Pharma GmbH on Mar. 1, 2019, D18—Dr F's novelty table 2020, 2 pages.
[cited by applicant]
Opposition Proceedings in European Patent No. 2482822 (Appln. No. 1082123205), filed by Dr. Falk Pharma GmbH on Mar. 1, 2019, EPO Communication—communication of notice of opposition dated May 13, 2019, 1 page.
[cited by applicant]
Opposition Proceedings in European Patent No. 2482822 (Appln. No. 1082123205), filed by Dr. Falk Pharma GmbH on Mar. 1, 2019, EPO Communication dated Nov. 5, 2019, enclosing Opponent's Further Written Submissions dated/…
[cited by applicant]
Opposition Proceedings in European Patent No. 2482822 (Appln. No. 1082123205), filed by Dr. Falk Pharma GmbH on Mar. 1, 2019, EPO Communication dated Sep. 26, 2019, transmitting Adare's submission filed Sep. 20, 2019, 8…
[cited by applicant]
Opposition Proceedings in European Patent No. 2482822 (Appln. No. 1082123205), filed by Dr. Falk Pharma GmbH on Mar. 1, 2019, Notice of Opposition dated Mar. 1, 2019, and English translation, 23 pages.
[cited by applicant]
Opposition Proceedings in European Patent No. 2482822 (Appln. No. 1082123205), filed by Dr. Falk Pharma GmbH on Mar. 1, 2019, Patentee, Adare Development I, L.P.'s Response dated Dec. 16, 2019 in response to further sub…
[cited by applicant]
Opposition Proceedings in European Patent No. 2482822 (Appln. No. 1082123205), filed by Dr. Falk Pharma GmbH on Mar. 1, 2019, Submission filed by Adare Development I, L.P., on Sep. 20, 2019, 91 pages.
[cited by applicant]
Opposition Proceedings in European Patent No. 2482822 (Appln. No. 10821232.5), filed by Dr. Falk Pharma GmbH on Mar. 1, 2019, EPO Communication dated Nov. 5, 2019, forwarding Letter from Opponent dated Oct. 29, 2019, 24…
[cited by applicant]
Opposition Proceedings in European Patent No. 2886108 (Appln. No. 13199278.6), filed by Adare Development, I, L.P on Nov. 6, 2019, Consolidated List of Cited Opposition Documents, 1 page.
[cited by applicant]
Opposition Proceedings in European Patent No. 2886108 (Appln. No. 13199278.6), filed by Adare Development, I, L.P on Nov. 6, 2019, EPO Communication dated Jul. 24, 2020 regarding oral proceedings, 6 pages.
[cited by applicant]
Opposition Proceedings in European Patent No. 2886108 (Appln. No. 13199278.6), filed by Adare Development, I, L.P on Nov. 6, 2019, EPO Communication dated Mar. 25, 2020 transmitting communication from Dr. Falk Pharma Gm…
[cited by applicant]
Opposition Proceedings in European Patent No. 2886108 (Appln. No. 13199278.6), filed by Adare Development, I, L.P on Nov. 6, 2019, EPO Communication re Summons to Attend Oral Proceedings and Preliminary Opinion, dated J…
[cited by applicant]
Opposition Proceedings in European Patent No. 2886108 (Appln. No. 13199278.6), filed by Ellodi Pharmaceuticals, L.P., on Nov. 6, 2019, Adare's Written Submissions in Preparation for Oral Proceedings on Apr. 23, 2021, da…
[cited by applicant]
Opposition Proceedings in European Patent No. 3086782 (Appln. No. 14814872.9), filed by Adare Development, I, L.P on Jun. 26, 2019, EPO Communication dated Jul. 2, 2019, transmitting Notice of Opposition filed Jun. 26, …
[cited by applicant]
Opposition Proceedings in European Patent No. 3086782 (Appln. No. 14814872.9), filed by Adare Development, I, L.P on Jun. 26, 2019, EPO Communication dated Jul. 22, 2020 regarding date of oral proceedings, 3 pages.
[cited by applicant]
Opposition Proceedings in European Patent No. 3086782 (Appln. No. 14814872.9), filed by Adare Development, I, L.P on Jun. 26, 2019, EPO Communication dated Nov. 19, 2019, with Patentee's response to Opposition dated Nov…
[cited by applicant]
Opposition Proceedings in European Patent No. 3086782 (Appln. No. 14814872.9), filed by Adare Development, I, L.P on Jun. 26, 2019, EPO Communication to Adare regarding oral proceedings dated Mar. 2, 2020, and English t…
[cited by applicant]
Opposition Proceedings in European Patent No. 3086782 (Appln. No. 14814872.9), filed by Adare Development, I, L.P on Jun. 26, 2019, Patentee, Dr. Falk's Written Submissions, Auxiliary Request I and Test Report Jorveza® …
[cited by applicant]
Opposition Proceedings in European Patent No. EP 2482822, Appeal No. T1954/21-3.3.01 (Appln. No. 10821232.5), filed by Dr. Falk Pharma GmbH on Mar. 1, 2019; communication from the European Patent Office (EPO) dated May …
[cited by applicant]
Opposition Proceedings in European Patent No. EP 2482822, Appeal No. T1954/21-3.3.01 (Appln. No. 10821232.5), filed by Dr. Falk Pharma GmbH on Mar. 1, 2019; Ellodi's Withdrawal of Appeal dated Jul. 11, 2022, 3 pages.
[cited by applicant]
Opposition Proceedings in European Patent No. EP 2482822, Appeal No. T1954/21-3.3.01 (Appln. No. 10821232.5), filed by Dr. Falk Pharma GmbH on Mar. 1, 2019; EPO's Communication—Minutes of Oral Proceeding, dated Aug. 25,…
[cited by applicant]
Opposition Proceedings in European Patent No. EP 2482822 (Appln. No. 1082123205), filed by Dr. Falk Pharma GmbH on Mar. 1, 2019, Adare—Letter to EPO re Oral Proceedings dated Jul. 17, 2020, 5 pages.
[cited by applicant]
Opposition Proceedings in European Patent No. EP 2482822 (Appln. No. 1082123205), filed by Dr. Falk Pharma GmbH on Mar. 1, 2019; Adare's Communication to the EPO re oral proceedings, dated Aug. 11, 2020, 4 pages.
[cited by applicant]
Opposition Proceedings in European Patent No. EP 2482822 (Appln. No. 1082123205), filed by Dr. Falk Pharma GmbH on Mar. 1, 2019; EPO Communication dated Jul. 23, 2020, with Written Submission from Adare (Proprietor) dat…
[cited by applicant]
Opposition Proceedings in European Patent No. EP 2482822 (Appln. No. 1082123205), filed by Dr. Falk Pharma GmbH on Mar. 1, 2019, EPO Communication dated Mar. 8, 2019 regarding notice of opposition, 1 page.
[cited by applicant]
Opposition Proceedings in European Patent No. EP 2482822 (Appln. No. 1082123205), filed by Dr. Falk Pharma GmbH on Mar. 1, 2019; EPO's Communication re oral proceedings, dated Aug. 5, 2020, 1 page.
[cited by applicant]
Opposition Proceedings in European Patent No. EP 2482822 (Appln. No. 1082123205), filed by Dr. Falk Pharma GmbH on Mar. 1, 2019, EPO Communication re Oral Proceedings dated Jul. 13, 2020, 3 pages.
[cited by applicant]
Opposition Proceedings in European Patent No. EP 2482822 (Appln. No. 1082123205), filed by Dr. Falk Pharma GmbH on Mar. 1, 2019; EPO's consolidated list of cited opposition documents, Jul. 18, 2020, 1 page.
[cited by applicant]
Opposition Proceedings in European Patent No. EP 2482822 (Appln. No. 1082123205), filed by Dr. Falk Pharma GmbH on Mar. 1, 2019, Summons to Attend Oral Hearing and Preliminary Opinion in opposition dated Feb. 13, 2020, …
[cited by applicant]
Opposition Proceedings in European Patent No. EP 2482822 (Appln. No. 1082123205), filed by Dr. Falk Pharma GmbH on Mar. 1, 2019, Summons to attend oral proceedings dated Feb. 13, 2020, 13 pages.
[cited by applicant]
Opposition Proceedings in European Patent No. EP 2482822 (Appln. No. 1082123205), filed by Dr. Falk Pharma GmbH on Mar. 1, 2019; Written Submissions of the Patentee in Preparation for Oral Proceedings on Mar. 8, 2021, d…
[cited by applicant]
Opposition Proceedings in European Patent No. EP 2482822 (Appln. No. 10821232.5), filed by Dr. Falk Pharma GmbH on Mar. 1, 2019; EPO Communication in connection with Summons to attend oral proceedings, dated Nov. 20, 20…
[cited by applicant]
Opposition Proceedings in European Patent No. EP 2482822 (Appln. No. 10821232.5), filed by Dr. Falk Pharma GmbH on Mar. 1, 2019; Falk's Communication to the EPO re oral proceedings, dated Aug. 12, 2020, 3 pages.
[cited by applicant]
Opposition Proceedings in European Patent No. EP 2482822 (Appln. No. 10821232.5), filed by Dr. Falk Pharma GmbH on Mar. 1, 2019, Opponent's response to Summons dated Jul. 17, 2020, and English translation, 15 pages.
[cited by applicant]
Opposition Proceedings in European Patent No. EP 2482822 (Appln. No. 10821232.5), filed by Dr. Falk Pharma GmbH on Mar. 1, 2019; Opponent's submissions dated Mar. 1, 2021, and English translation, 11 pages.
[cited by applicant]
Opposition Proceedings in European Patent No. EP 2482822 (Appln. No. 10821232.5), filed by Dr. Falk Pharma GmbH on Mar. 1, 2019; Written Submissions of the Opponent in response to the Summons to attend Oral Proceedings,…
[cited by applicant]
Opposition Proceedings in European Patent No. EP 2886108, Appeal No. T0611/22-3.3.07 (Appln. No. 13199278.6), (in the name of Dr. Falk Pharma GmbH) filed by Ellodi Pharmaceuticals, L.P. on Nov. 6, 2019; EPO Communicatio…
[cited by applicant]
Opposition Proceedings in European Patent No. EP 2886108 (Appln. No. 13199278.6), filed by Adare Development I, L.P., on Nov. 6, 2019, Dr. Falk Pharma's Response to Summons and Adare's Written Submissions and clean and …
[cited by applicant]
Opposition Proceedings in European Patent No. EP 2886108 (Appln. No. 13199278.6), filed by Ellodi Pharmaceuticals, L.P., on Nov. 6, 2019, Datasheet for the decision of Oct. 14, 2019, Case Number T 1621/16-3.3.06, Applic…
[cited by applicant]
Opposition Proceedings in European Patent No. EP 2886108 (Appln. No. 13199278.6), filed by Ellodi Pharmaceuticals, L.P., on Nov. 6, 2019, Ellodi's Notice of Appeal against decision filed Mar. 4, 2022, 5 pages.
[cited by applicant]
Opposition Proceedings in European Patent No. EP 2886108 (Appln. No. 13199278.6), filed by Ellodi Pharmaceuticals, L.P., on Nov. 6, 2019, Ellodi's Withdrawal of Appeal filed May 16, 2022, 3 pages.
[cited by applicant]
Opposition Proceedings in European Patent No. EP 3041476, Appeal No. T1007/22-3.3.07 (Appln. No. 14842811.3), filed by Dr. Falk Pharma GmbH on Jul. 22, 2020; EPO Communication dated Jul. 22, 2022 confirming withdrawal o…
[cited by applicant]
Opposition Proceedings in European Patent No. EP 3041476, Appeal No. T1007/22-3.3.07 (Appln. No. 14842811.3), filed by Dr. Falk Pharma GmbH on Jul. 22, 2020; EPO Communication dated Jun. 20, 2022 enclosing Opponent's Gr…
[cited by applicant]
Opposition Proceedings in European Patent No. EP 3041476, Appeal No. T1007/22-3.3.07 (Appln. No. 14842811.3), filed by Dr. Falk Pharma GmbH on Jul. 22, 2020; Withdrawal of Appeal filed by Ellodi Pharmaceuticals, L.P. da…
[cited by applicant]
Opposition Proceedings in European Patent No. EP 3041476 (Appln. No. 14842811.3), filed by Dr. Falk Pharma GmbH on Jul. 22, 2020; EPO Communication dated Feb. 22, 2021 enclosing Opponent's Submissions (and English trans…
[cited by applicant]
Opposition Proceedings in European Patent No. EP 3041476 (Appln. No. 14842811.3), filed by Dr. Falk Pharma GmbH on Jul. 22, 2020; EPO Communication dated Jul. 29, 2020 advising of and enclosing Notice of Opposition file…
[cited by applicant]
Opposition Proceedings in European Patent No. EP 3041476 (Appln. No. 14842811.3), filed by Dr. Falk Pharma GmbH on Jul. 22, 2020; Notice of Appeal filed by Ellodi Pharmaceuticals, L.P. dated Apr. 22, 2022, 5 pages.
[cited by applicant]
Opposition Proceedings in European Patent No. EP 3041476 (Appln. No. 14842811.3), filed by Dr. Falk Pharma GmbH on Jul. 22, 2020; Notice of Opposition and Statement of Grounds of Opposition (with English translation of …
[cited by applicant]
Opposition Proceedings in European Patent No. EP 3041476 (Appln. No. 14842811.3), filed by Dr. Falk Pharma GmbH on Jul. 22, 2020; Patentee Adare's Response to Opposition dated .Jan. 11, 2021, 15 pages.
[cited by applicant]
Opposition Proceedings in European Patent No. EP 3041476 (Appln. No. 14842811.3), filed by Dr. Falk Pharma GmbH on Jul. 22, 2020; Patentee Ellodi Pharmaceuticals, L.P.'s Written Submission in Preparation for Oral Procee…
[cited by applicant]
Opposition Proceedings in European Patent No. EP 3403654 (Appln. No. 18178891.0), filed by Dr. Falk Pharma GmbH; Adare's Response to the Grounds of Opposition, filed Nov. 2, 2020, 78 pages.
[cited by applicant]
Opposition Proceedings in European Patent No. EP 3403654 (Appln. No. 18178891.0), filed by Dr. Falk Pharma GmbH; Consolidated List of References dated and filed Dec. 8, 2020, 1 page.
[cited by applicant]
Opposition Proceedings in European Patent No. EP 3403654 (Appln. No. 18178891.0), filed by Dr. Falk Pharma GmbH; EPO Communication of a notice of opposition dated Jun. 22, 2020, 1 page.
[cited by applicant]
Cited By (2)