(12) Translation of european patent specification

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1 (12) Translation of european patent specification (11) NO/EP B1 (19) NO NORWAY (51) Int Cl. A61K 9/14 ( ) A61K 9/16 ( ) A61K 9/20 ( ) A61K 31/4025 ( ) Norwegian Industrial Property Office (21) Translation Published (80) Date of The European Patent Office Publication of the Granted Patent (86) European Application Nr (86) European Filing Date (87) The European Application s Publication Date (30) Priority , US, P , US, (84) Designated Contracting States: Designated Extension States: AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR BA ME (73) Proprietor AbbVie Bahamas Ltd., Sassoon House Shirley Street & Victoria Avenue, New Providence, Nassau, BS-Bahamas (72) Inventor LIEPOLD, Bernd, Birkenweg 44, Dossheim, DE-Tyskland JUNG, Tina, Eugenie_Kaufmann-Str. 22, Mannheim, DE-Tyskland HOLIG, Peter, Hopfengarten 11, Waechtersbach, DE-Tyskland SCHROEDER, Rudolf, Brahmsstr.3, Worms-pfeddersheim, DE-Tyskland SEVER, Nancy E., 2643 N. Drury Lane, Arlington HeightsIllinois 60004, US-USA LAFOUNTAINE, Justin, 659 W. Randolph 913, ChicagoIllinois 60661, US-USA SINCLAIR, Brent D., Meander Drive, GrayslakeIllinois 60030, US-USA GAO, Yi, 210 East Baltusrol, Vernon HillsIllinois 60061, US-USA WU, Jianwei, 1520 Eric Lane, LibertyvilleIllinois 60048, US-USA ERICKSON, Bryan K., th Avenue, Pleasant PrarieWisconsin 53158, US-USA KULLMANN, Simon, Dr.-Semmelweis-Str. 27, Neustadt an der Weinstrasse, DE-Tyskland WESTEDT, Ulrich, Weinheimer Str. 2, Schriesheim, DE-Tyskland PAULI, Mirko, Wielandstr. 30, Ludwigshafen, DE-Tyskland HEITERMANN, Tanja, Klosterstrasse 39, Bruchsal, DE-Tyskland KOENIG, Renato, Meckenheimer Str. 20 e, Hassloch, DE-Tyskland THIEL, Madlen, Görlitzer Str. 27, Schifferstadt, DE-Tyskland WOEHRLE, Gerd, Seestr. 58, Eppelheim, DE-Tyskland (74) Agent or Attorney Oslo Patentkontor AS, Postboks 7007 Majorstua, 0306 OSLO, Norge (54) Title SOLID COMPOSITIONS (56) References Cited: WO-A1-2008/ WO-A1-2010/017401

2 WO-A2-2008/ WO-A2-2010/ DE FRANCESCO R ET AL: "Challenges and successes in developing new therapies for hepatitis C", NATURE, NATURE PUBLISHING GROUP, LONDON, GB, vol. 436, no. 7053, 18 August 2005 ( ), pages , XP , ISSN: , DOI: /NATURE04080

3 Enclosed is a translation of the patent claims in Norwegian. Please note that as per the Norwegian Patents Acts, section 66i the patent will receive protection in Norway only as far as there is agreement between the translation and the language of the application/patent granted at the EPO. In matters concerning the validity of the patent, language of the application/patent granted at the EPO will be used as the basis for the decision. The patent documents published by the EPO are available through Espacenet ( or via the search engine on our website here: NO/EP

4 1 Patentkrav En fast sammensetning omfattende (1) et stoff eller et farmasøytisk akseptabelt salt av stoffet, i amorf form, (2) en farmasøytisk akseptabel hydrofil polymer; og (3) alternativt et farmasøytisk akseptabelt aktivt overflatestoff, hvor det nevnte stoffet er valgt fra gruppen bestående av: dimetyl (2S,2 S)-1-1 -((2S,2 S)-2,2 -(4,4 (2S,5S)-1-(4-tertbutylfenyl)pyrrolidin-2,5diyl)bis(4,1-fenylen))bis(azanediyl)bis(oksometylen) bis(pyrrolidin-2,1-diyl))bis(3-metyl-1-oksobutan-2,1-diyl)dikarbamat (Stoff I A ), metyl [(2S)-1-{(2S)-2-[4-(4-{5-(4-{2-[(2S)-1{(2S)-2-[(metoksykarbonyl) amino]-3-metylbutanoyl}pyrrolidin-2-yl]-1a-imidazol-4-yl}fenyl)-1-[6-(piperidin-1- yl)pyridine-3-yl]-1h-pyrrol-2-yl}fenyl)-1h-imidazol-2-yl]pyrrolidin-1-yl}-3-metyl-1- oksobutan-2-yl]karbamat (Stoff I B ), metyl {(2S,3R)-1-[(2S)-2-{6-[(2R,5R)-1-(4-tert-butylfenyl)-5-(2-{(2S)-1- [N-(metoksykarbonyl)-O-metyl-L-treonyl]pyrrolidin-2-yl}-1H-benzimidazol-6- yl)pyrrolidin-2-yl]-1h-benzimidasol-2-yl}pyrrolidin-1-yl]-3-metoksy-1-oksobutan- 2-yl}karbamat (Stoff I C ), og metyl {(2S)-1-[(2S)-2-{5-[2R,5R)-1-[2,3-difluoro-4-(trifluorometyl)fenyl]- 5-{2-((2S)-1-{(2S)-2-[metoksykabonyl)amino]-3-metylbutanoyl}pyrrolidin-2-yl]- 1H-benzimidazol-5-yl}pyrrolidin-2-yl]-1H-benzimidazol-2-yl}pyrrolidin-1-yl-3- metyl-1-oksobutan-2-yl}karbamat, (Stoff I D ), og hvor det omtalte stoffet eller saltet, og den omtalte polymeren, er i en fast dispersjon Sammensetningen i krav 1, hvor den omtalte polymeren har en T g på minst 50 C. 3. Sammensetningen i krav 2, videre omfattende det omtalte overflateaktive stoffet. 4. Sammensetningen i krav 3, hvor den faste dispersjon omfatter det omtalte overflateaktive stoffet Sammensetningen i krav 3, hvor den omtalte polymeren er en homopolymer eller kopolymer av N-vinyl pyrrolidon. 6. Sammensetningen i krav 3, hvor den omtalte polymeren er kopovidon.

5 2 7. Sammensetningen i krav 6, hvor det omtalte overflateaktive stoffet er D- alfa-tokoferyl polyetylen glykol 1000 sukkinat. 8. Sammensetningen i krav 3, hvor den omtalte faste dispersjonen er en amorf fast dispersjon Sammensetningen i krav 3, hvor den faste dispersjonen er en fast løsning som omfatter det omtalte overflateaktive stoffet. 10. Sammensetningen i krav 1, videre omfattende en annen anti-hcv agent. 11. Sammensetningen i krav 1, videre omfattende en HCV protease inhibitor. 12. Sammensetningen i krav 1, videre omfattende en HCV polymerase inhibitor Sammensetningen i krav 3, hvor det omtalte stoffet er Stoff I A. 14. Sammensetningen ifølge ett av kravene 1-12, hvor det gitte stoffet er Stoff I A. 15. Sammensetningen i krav 7, hvor den omtalte faste dispersjonen omfatter det omtalte overflateaktive stoffet, og det omtalte stoffet er Stoff I A Sammensetningen i krav 15, hvor den omtalte faste dispersjonen er en amorf fast dispersjon.

(12) Translation of european patent specification

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