O2024_002 — Bundespatentgericht 12.08.2025 O2024_002

Bundespatentgericht Trib un a l fédéral d e s b r ev e t s Trib un a l e federale d e i brevetti Trib un a l federal d a p a t en t a s Federal Patent Court

O2024_002 Urteil v o m 1 2 . August 2025 Besetzung Präsident Dr. iur. Mark Schweizer (Vorsitz), Richter Dr. chem. Michael Kaufmann (Referent), Richter Dr. phil. II, Dipl. Biochem. Andreas Schöllhorn Savary Erster Gerichtsschreiber MLaw Sven Bucher

Verfahrensbeteiligte Samsung Bioepis CH GmbH, Werftestrasse 4, 6005 Luzern, vertreten durch Rechtsanwalt Dr. iur. Thierry Calame und/oder Rechtsanwältin Dr. iur. Barbara Abegg, Lenz & Staehelin, Brandschenkestrasse 24, 8027 Zürich, patentanwaltlich beraten durch Dipl. Natw. ETH Christoph Fraefel, Schaad Balass Menzl & Partner AG, Bellerivestrasse 20, 8034 Zürich, Klägerin gegen

Janssen Biotech, Inc., 800/850 Ridgeview Drive, 19044 Horsham, Pennsylvania, USA vertreten durch Rechtsanwalt Dr. iur. Andri Hess und/oder Rechtsanwalt lic. iur. Julian Schwaller, Homburger AG, Prime Tower, Hardstrasse 201, 8005 Zürich, patentanwaltlich beraten durch Dr. Stephen Duffield und Dr. Daniel Goodman, Carpmaels & Ransford LLP, One Southampton Row, GB- WC1B 5H London, Beklagte Gegenstand Patentnichtigkeit (EP 3 883 606); Ustekinumab

O2024_002 Das Bundespatentgericht erwägt: 1. Mit Nichtigkeitsklage vom 31. Januar 2024 stellte die Klägerin folgende Rechtsbegehren: «(1) The Swiss and Liechtenstein part of EP 3 883 606 entitled ‹safe and effective method of treating ulcerative colitis with anti-IL12/IL23 antibody› shall be declared invalid (‹Feststellung der Nichtigkeit›). (2) Court fees and Claimant’s legal fees (including patent attorney fees as well as other expenses) shall be borne by Respondent.» 2. Mit Klageantwort vom 21. Mai 2024 beantragte die Beklagte, dass auf die Klage nicht einzutreten sei; eventualiter sei die Klage abzuweisen. 3. Mit Eingabe vom 31. Juli 2024 übermittelte die Klägerin ein Urteil des High Court of Justice von England und Wales vom 30. Juli 2024, das die Nichtigkeit des britischen Teils von EP 3 883 606 feststellte. 4. Die Instruktionsverhandlung fand am 26. August 2024 statt. 5. Am 7. Oktober 2024 erstattete die Klägerin die Replik mit unveränderten Rechtsbegehren. 6. Mit Duplik vom 20. November 2024 stellte die Beklagte folgende Rechtsbegehren (Hervorhebungen im Original; in Grün Ergänzungen zu den erteilten Ansprüchen, in Rot Streichungen aus den erteilten Ansprüchen): «1. The nullity action shall be rejected as inadmissible (‹Nichteintreten›). 2. In the alternative, the nullity action shall be dismissed in its entirety. 3. Auxiliary Request 1: Auxiliary to Prayer for Relief nos. 1 – 2 hereinbefore, the Claimant’s nullity action shall be dismissed, and the Swiss and Liechtenstein part of EP 3 883 606 shall be maintained in the following version:

O2024_002 ‹1. An anti-IL-12/IL-23p40 antibody for use in a method of treating moderately to severely active ulcerative colitis (UC) in a human subject in need thereof, wherein the antibody comprises a heavy chain variable region of the amino acid sequence of SEQ ID NO:7 and a light chain variable region of the amino acid sequence of SEQ ID NO:8, wherein the method comprises: a. intravenously administering to the subject the antibody in a first pharmaceutical composition at week 0 of the treatment at a dosage of 260 mg for subjects with body weight ≥35 kg and ≤55 kg, 390 mg for subjects with body weight ˃55 kg and ≤85 kg, and 520 mg for subjects with body weight ˃85 kg, wherein the subject is in clinical response by week 8 of the treatment, as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from baseline in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1, and b. subcutaneously administering to the subject the antibody in a second pharmaceutical composition at a dosage of 90 mg per administration, at week 8 of the treatment, and in a maintenance dose every 8 weeks or every 12 weeks after the treatment at week 8, wherein the subject is in corticosteroid-free clinical remission at least 44 weeks after week 0. 2. The antibody for use of claim 1, wherein the antibody is a human IgG antibody. 3. The antibody for use of claim 1, wherein the antibody is a fully human IgG1κ monoclonal antibody. 4. The antibody for use of any preceding claim, wherein the antibody comprises a heavy chain of the amino acid sequence of SEQ ID NO:10 and a light chain of the amino acid sequence of SEQ ID NO:11. 5. The antibody for use of claim 1, wherein the antibody is ustekinumab. 6. The antibody for use of any one of claims 1-5, wherein the maintenance therapy comprises subcutaneously administering to the subject the anti- IL-12/IL- 23p40 antibody at a dosage of 90 mg per administration, once every 8 weeks or once every 12 weeks, and wherein the maintenance therapy is provided for 44 weeks. 7. The antibody for use of any one of claims 1-6, wherein: a. the first pharmaceutical composition further comprises a solution comprising 10 mM L-histidine, 8.5% (w/v) sucrose, 0.04% (w/v) polysorbate 80, 0.4 mg/mL L-methionine, and 20 µg/mL EDTA disodium salt, dehydrate, at pH 6.0; or

O2024_002 b. the second pharmaceutical composition further comprises a solution comprising 6.7 mM L-histidine, 7.6% (w/v) sucrose, 0.004% (w/v) polysorbate 80, at pH 6.0. 8. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is: a. identified as having an endoscopic healing continuing at least 44 weeks after week 0; and/or b. identified as achieving a clinical response based on the Mayo endoscopy subscore continuing at least 44 weeks after week 0; and/or c. identified as having a change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score continuing at least 44 weeks after week 0; and/or d. identified as having a mucosal healing continuing at least 44 weeks after week 0; and/or e. identified as having a decrease from baseline in Mayo score continuing at least 44 weeks after week 0; and/or f. identified as having a normalization of one or more biomarkers selected from the group consisting of C-reactive protein, fecal lactoferrin and fecal calprotectin continuing at least 44 weeks after week 0; and/or g. in clinical response as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from baseline in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1 continuing at least 44 weeks after week 0. 9. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is identified as having a clinical remission based on at least one of the global definition and the US definition by week 16, preferably by week 8, more preferably by week 2, of the treatment and the clinical remission continues at least 44 weeks after week 0. 10. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is identified as having a statistically significant improvement in disease activity as determined by an Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score of ≤4 by week 8 of treatment with the antibody. 11. The antibody for use of any preceding claim, wherein the subject had previously failed or was intolerant of at least one therapy selected from the group consisting of: an anti-TNF, vedolizumab, corticosteroids, azathioprine (AZA), and 6 mercaptopurine (6 MP), or the subject had demonstrated corticosteroid dependence.

O2024_002 12. The antibody for use of any preceding claim, wherein the subject is: a. identified as having a clinical remission based on at least one of: i. the global definition, wherein the global definition is the global definition of clinical remission with Mayo score ≤2 points with no individual subscore >1; and ii. the US definition, wherein the US definition is the US definition of clinical remission with absolute stool number ≤3, rectal bleeding subscore of 0 and Mayo endoscopy subscore of 0 or 1; and/or b. identified as having an endoscopic healing, optionally wherein the subject is identified as having an endoscopic healing with a Mayo endoscopy subscore of 0 or 1; and/or c. identified as achieving a clinical response based on the Mayo endoscopy subscore; and/or d. identified as having a change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score; and/or e. identified as having a mucosal healing; and/or f. identified as having a decrease from baseline in Mayo score; and/or g. identified as having a normalization of one or more biomarkers selected from the group consisting of C-reactive protein, fecal lactoferrin and fecal calprotectin; and/or h. in clinical response as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from baseline in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1; optionally by week 16, preferably by week 8, more preferably by week 2, of the treatment. 13. The antibody for use of claim 11 or claim 12, wherein the subject is not a responder to the treatment with the antibody by week 8 and is a responder to the treatment by week 16 of the treatment.› 4. Auxiliary Request 2: Auxiliary to Prayer for Relief nos. 1 – 3 hereinbefore, the Claimant’s nullity action shall be dismissed, and the Swiss and Liechtenstein part of EP 3 883 606 shall be maintained in the following version: ‹1. An anti-IL-12/IL-23p40 antibody for use in a method of treating moderately to severely active ulcerative colitis (UC) in a human subject in need thereof,

O2024_002 wherein the antibody comprises a heavy chain variable region of the amino acid sequence of SEQ ID NO:7 and a light chain variable region of the amino acid sequence of SEQ ID NO:8, wherein the method comprises: a. intravenously administering to the subject the antibody in a first pharmaceutical composition at week 0 of the treatment at a dosage of 260 mg for subjects with body weight ≥35 kg and ≤55 kg, 390 mg for subjects with body weight ˃55 kg and ≤85 kg, and 520 mg for subjects with body weight ˃85 kg, and b. subcutaneously administering to the subject the antibody in a second pharmaceutical composition at a dosage of 90 mg per administration, at week 8 of the treatment, and in a maintenance dose every 8 weeks or every 12 weeks after the treatment at week 8, wherein the subject is in corticosteroid-free clinical remission at least 44 weeks after week 0, and wherein clinical remission is based on at least one of the global definition and the US definition. 2. The antibody for use of claim 1, wherein the antibody is a human IgG antibody. 3. The antibody for use of claim 1, wherein the antibody is a fully human IgG1κ monoclonal antibody. 4. The antibody for use of any preceding claim, wherein the antibody comprises a heavy chain of the amino acid sequence of SEQ ID NO:10 and a light chain of the amino acid sequence of SEQ ID NO:11. 5. The antibody for use of claim 1, wherein the antibody is ustekinumab. 6. The antibody for use of any one of claims 1-5, wherein the maintenance therapy comprises subcutaneously administering to the subject the anti- IL-12/IL- 23p40 antibody at a dosage of 90 mg per administration, once every 8 weeks or once every 12 weeks, and wherein the maintenance therapy is provided for 44 weeks. 7. The antibody for use of any one of claims 1-6, wherein: a. the first pharmaceutical composition further comprises a solution comprising 10 mM L-histidine, 8.5% (w/v) sucrose, 0.04% (w/v) polysorbate 80, 0.4 mg/mL L-methionine, and 20 µg/mL EDTA disodium salt, dehydrate, at pH 6.0; or b. the second pharmaceutical composition further comprises a solution comprising 6.7 mM L-histidine, 7.6% (w/v) sucrose, 0.004% (w/v) polysorbate 80, at pH 6.0. 8. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is:

O2024_002 a. identified as having an endoscopic healing continuing at least 44 weeks after week 0; and/or b. identified as achieving a clinical response based on the Mayo endoscopy subscore continuing at least 44 weeks after week 0; and/or c. identified as having a change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score continuing at least 44 weeks after week 0; and/or d. identified as having a mucosal healing continuing at least 44 weeks after week 0; and/or e. identified as having a decrease from baseline in Mayo score continuing at least 44 weeks after week 0; and/or f. identified as having a normalization of one or more biomarkers selected from the group consisting of C-reactive protein, fecal lactoferrin and fecal calprotectin continuing at least 44 weeks after week 0; and/or g. in clinical response as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from baseline in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1 continuing at least 44 weeks after week 0. 9. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is identified as having a clinical remission based on at least one of the global definition and the US definition by week 16, preferably by week 8, more preferably by week 2, of the treatment and the clinical remission continues at least 44 weeks after week 0. 10. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is identified as having a statistically significant improvement in disease activity as determined by an Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score of ≤4 by week 8 of treatment with the antibody. 11. The antibody for use of any preceding claim, wherein the subject had previously failed or was intolerant of at least one therapy selected from the group consisting of: an anti-TNF, vedolizumab, corticosteroids, azathioprine (AZA), and 6 mercaptopurine (6 MP), or the subject had demonstrated corticosteroid dependence. 12. The antibody for use of any preceding claim, wherein the subject is: a. identified as having a clinical remission based on at least one of: i. the global definition, wherein the global definition is the global definition of clinical remission with Mayo score ≤2 points with no individual subscore >1; and

O2024_002 ii. the US definition, wherein the US definition is the US definition of clinical remission with absolute stool number ≤3, rectal bleeding subscore of 0 and Mayo endoscopy subscore of 0 or 1; and/or b. identified as having an endoscopic healing, optionally wherein the subject is identified as having an endoscopic healing with a Mayo endoscopy subscore of 0 or 1; and/or c. identified as achieving a clinical response based on the Mayo endoscopy subscore; and/or d. identified as having a change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score; and/or e. identified as having a mucosal healing; and/or f. identified as having a decrease from baseline in Mayo score; and/or g. identified as having a normalization of one or more biomarkers selected from the group consisting of C-reactive protein, fecal lactoferrin and fecal calprotectin; and/or h. in clinical response as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from baseline in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1; optionally by week 16, preferably by week 8, more preferably by week 2, of the treatment. 13. The antibody for use of claim 11 or claim 12, wherein the subject is not a responder to the treatment with the antibody by week 8 and is a responder to the treatment by week 16 of the treatment.› 5. Auxiliary Request 3 Auxiliary to Prayer for Relief nos. 1 – 4 hereinbefore, the Claimant’s nullity action shall be dismissed, and the Swiss and Liechtenstein part of EP 3 883 606 shall be maintained in the following version: ‹1. An anti-IL-12/IL-23p40 antibody for use in a method of treating moderately to severely active ulcerative colitis (UC) in a human subject in need thereof, wherein the antibody comprises a heavy chain variable region of the amino acid sequence of SEQ ID NO:7 and a light chain variable region of the amino acid sequence of SEQ ID NO:8is ustekinumab, wherein the method comprises: a. intravenously administering to the subject the antibody in a first pharmaceutical composition at week 0 of the treatment at a dosage of 260 mg for subjects with body weight ≥35 kg and ≤55 kg,

O2024_002 390 mg for subjects with body weight ˃55 kg and ≤85 kg, and 520 mg for subjects with body weight ˃85 kg, and b. subcutaneously administering to the subject the antibody in a second pharmaceutical composition at a dosage of 90 mg per administration, at week 8 of the treatment, and in a maintenance dose every 8 weeks or every 12 weeks after the treatment at week 8, wherein the subject is in corticosteroid-free clinical remission at least 44 weeks after week 0. 2. The antibody for use of claim 1, wherein the antibody is a human IgG antibody. 3. The antibody for use of claim 1, wherein the antibody is a fully human IgG1κ monoclonal antibody. 4. The antibody for use of any preceding claim, wherein the antibody comprises a heavy chain of the amino acid sequence of SEQ ID NO:10 and a light chain of the amino acid sequence of SEQ ID NO:11. 5. The antibody for use of claim 1, wherein the antibody is ustekinumab. 62. The antibody for use of any one of claims 1-5, wherein the maintenance therapy comprises subcutaneously administering to the subject the anti- IL-12/IL- 23p40 antibody at a dosage of 90 mg per administration, once every 8 weeks or once every 12 weeks, and wherein the maintenance therapy is provided for 44 weeks. 73. The antibody for use of any one of claims 1-6 or claim 2, wherein: a. the first pharmaceutical composition further comprises a solution comprising 10 mM L-histidine, 8.5% (w/v) sucrose, 0.04% (w/v) polysorbate 80, 0.4 mg/mL L-methionine, and 20 µg/mL EDTA disodium salt, dehydrate, at pH 6.0; or b. the second pharmaceutical composition further comprises a solution comprising 6.7 mM L-histidine, 7.6% (w/v) sucrose, 0.004% (w/v) polysorbate 80, at pH 6.0. 84. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is: a. identified as having an endoscopic healing continuing at least 44 weeks after week 0; and/or b. identified as achieving a clinical response based on the Mayo endoscopy subscore continuing at least 44 weeks after week 0; and/or c. identified as having a change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score continuing at least 44 weeks after week 0; and/or

O2024_002 d. identified as having a mucosal healing continuing at least 44 weeks after week 0; and/or e. identified as having a decrease from baseline in Mayo score continuing at least 44 weeks after week 0; and/or f. identified as having a normalization of one or more biomarkers selected from the group consisting of C-reactive protein, fecal lactoferrin and fecal calprotectin continuing at least 44 weeks after week 0; and/or g. in clinical response as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from baseline in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1 continuing at least 44 weeks after week 0. 95. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is identified as having a clinical remission based on at least one of the global definition and the US definition by week 16, preferably by week 8, more preferably by week 2, of the treatment and the clinical remission continues at least 44 weeks after week 0. 106. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is identified as having a statistically significant improvement in disease activity as determined by an Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score of ≤4 by week 8 of treatment with the antibody. 117. The antibody for use of any preceding claim, wherein the subject had previously failed or was intolerant of at least one therapy selected from the group consisting of: an anti-TNF, vedolizumab, corticosteroids, azathioprine (AZA), and 6 mercaptopurine (6 MP), or the subject had demonstrated corticosteroid dependence. 128. The antibody for use of any preceding claim, wherein the subject is: a. identified as having a clinical remission based on at least one of: i. the global definition, wherein the global definition is the global definition of clinical remission with Mayo score ≤2 points with no individual subscore >1; and ii. the US definition, wherein the US definition is the US definition of clinical remission with absolute stool number ≤3, rectal bleeding subscore of 0 and Mayo endoscopy subscore of 0 or 1; and/or b. identified as having an endoscopic healing, optionally wherein the subject is identified as having an endoscopic healing with a Mayo endoscopy subscore of 0 or 1; and/or

O2024_002 c. identified as achieving a clinical response based on the Mayo endoscopy subscore; and/or d. identified as having a change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score; and/or e. identified as having a mucosal healing; and/or f. identified as having a decrease from baseline in Mayo score; and/or g. identified as having a normalization of one or more biomarkers selected from the group consisting of C-reactive protein, fecal lactoferrin and fecal calprotectin; and/or h. in clinical response as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from baseline in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1; optionally by week 16, preferably by week 8, more preferably by week 2, of the treatment. 139. The antibody for use of claim 117 or claim 128, wherein the subject is not a responder to the treatment with the antibody by week 8 and is a responder to the treatment by week 16 of the treatment.› 6. Auxiliary Request 4: Auxiliary to Prayer for Relief nos. 1 – 5 hereinbefore, the Claimant’s nullity action shall be dismissed, and the Swiss and Liechtenstein part of EP 3 883 606 shall be maintained in the following version: ‹1. An anti-IL-12/IL-23p40 antibody for use in a method of treating moderately to severely active ulcerative colitis (UC) in a human subject in need thereof, wherein the subject had demonstrated corticosteroid dependence, wherein the antibody comprises a heavy chain variable region of the amino acid sequence of SEQ ID NO:7 and a light chain variable region of the amino acid sequence of SEQ ID NO:8, wherein the method comprises: a. intravenously administering to the subject the antibody in a first pharmaceutical composition at week 0 of the treatment at a dosage of 260 mg for subjects with body weight ≥35 kg and ≤55 kg, 390 mg for subjects with body weight ˃55 kg and ≤85 kg, and 520 mg for subjects with body weight ˃85 kg, and b. subcutaneously administering to the subject the antibody in a second pharmaceutical composition at a dosage of 90 mg per administration, at week 8 of the treatment, and in a maintenance dose every 8 weeks or every 12 weeks after the treatment at week 8,

O2024_002 wherein the subject is in corticosteroid-free clinical remission at least 44 weeks after week 0. 2. The antibody for use of claim 1, wherein the antibody is a human IgG antibody. 3. The antibody for use of claim 1, wherein the antibody is a fully human IgG1κ monoclonal antibody. 4. The antibody for use of any preceding claim, wherein the antibody comprises a heavy chain of the amino acid sequence of SEQ ID NO:10 and a light chain of the amino acid sequence of SEQ ID NO:11. 5. The antibody for use of claim 1, wherein the antibody is ustekinumab. 6. The antibody for use of any one of claims 1-5, wherein the maintenance therapy comprises subcutaneously administering to the subject the anti- IL-12/IL- 23p40 antibody at a dosage of 90 mg per administration, once every 8 weeks or once every 12 weeks, and wherein the maintenance therapy is provided for 44 weeks. 7. The antibody for use of any one of claims 1-6, wherein: a. the first pharmaceutical composition further comprises a solution comprising 10 mM L-histidine, 8.5% (w/v) sucrose, 0.04% (w/v) polysorbate 80, 0.4 mg/mL L-methionine, and 20 µg/mL EDTA disodium salt, dehydrate, at pH 6.0; or b. the second pharmaceutical composition further comprises a solution comprising 6.7 mM L-histidine, 7.6% (w/v) sucrose, 0.004% (w/v) polysorbate 80, at pH 6.0. 8. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is: a. identified as having an endoscopic healing continuing at least 44 weeks after week 0; and/or b. identified as achieving a clinical response based on the Mayo endoscopy subscore continuing at least 44 weeks after week 0; and/or c. identified as having a change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score continuing at least 44 weeks after week 0; and/or d. identified as having a mucosal healing continuing at least 44 weeks after week 0; and/or e. identified as having a decrease from baseline in Mayo score continuing at least 44 weeks after week 0; and/or f. identified as having a normalization of one or more biomarkers selected from the group consisting of C-reactive protein, fecal lac-

O2024_002 toferrin and fecal calprotectin continuing at least 44 weeks after week 0; and/or g. in clinical response as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from baseline in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1 continuing at least 44 weeks after week 0. 9. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is identified as having a clinical remission based on at least one of the global definition and the US definition by week 16, preferably by week 8, more preferably by week 2, of the treatment and the clinical remission continues at least 44 weeks after week 0. 10. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is identified as having a statistically significant improvement in disease activity as determined by an Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score of ≤4 by week 8 of treatment with the antibody. 11. The antibody for use of any preceding claim, wherein the subject had previously failed or was intolerant of at least one therapy selected from the group consisting of: an anti-TNF, vedolizumab, corticosteroids, azathioprine (AZA), and 6 mercaptopurine (6 MP), or the subject had demonstrated corticosteroid dependence. 12.11. The antibody for use of any preceding claim, wherein the subject is: a. identified as having a clinical remission based on at least one of: i. the global definition, wherein the global definition is the global definition of clinical remission with Mayo score ≤2 points with no individual subscore >1; and ii. the US definition, wherein the US definition is the US definition of clinical remission with absolute stool number ≤3, rectal bleeding subscore of 0 and Mayo endoscopy subscore of 0 or 1; and/or b. identified as having an endoscopic healing, optionally wherein the subject is identified as having an endoscopic healing with a Mayo endoscopy subscore of 0 or 1; and/or c. identified as achieving a clinical response based on the Mayo endoscopy subscore; and/or d. identified as having a change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score; and/or e. identified as having a mucosal healing; and/or

O2024_002 f. identified as having a decrease from baseline in Mayo score; and/or g. identified as having a normalization of one or more biomarkers selected from the group consisting of C-reactive protein, fecal lactoferrin and fecal calprotectin; and/or h. in clinical response as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from baseline in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1; optionally by week 16, preferably by week 8, more preferably by week 2, of the treatment. 13.12. The antibody for use of claim 11 or claim 12, wherein the subject is not a responder to the treatment with the antibody by week 8 and is a responder to the treatment by week 16 of the treatment. 7. Auxiliary Request 5: Auxiliary to Prayer for Relief nos. 1 – 6 hereinbefore, the Claimant’s nullity action shall be dismissed, and the Swiss and Liechtenstein part of EP 3 883 606 shall be maintained in the following version: ‹1. An anti-IL-12/IL-23p40 antibody for use in a method of treating moderately to severely active ulcerative colitis (UC) in a human subject in need thereof, wherein the antibody comprises a heavy chain variable region of the amino acid sequence of SEQ ID NO:7 and a light chain variable region of the amino acid sequence of SEQ ID NO:8is ustekinumab, wherein the method comprises: a. intravenously administering to the subject the antibody in a first pharmaceutical composition at week 0 of the treatment at a dosage of 260 mg for subjects with body weight ≥35 kg and ≤55 kg, 390 mg for subjects with body weight ˃55 kg and ≤85 kg, and 520 mg for subjects with body weight ˃85 kg, wherein the subject is in clinical response by week 8 of the treatment, as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from baseline in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1, and b. subcutaneously administering to the subject the antibody in a second pharmaceutical composition at a dosage of 90 mg per administration, at week 8 of the treatment, and in a maintenance dose every 8 weeks or every 12 weeks after the treatment at week 8, wherein the subject is in corticosteroid-free clinical remission at least 44 weeks after week 0.

O2024_002 2. The antibody for use of claim 1, wherein the antibody is a human IgG antibody. 3. The antibody for use of claim 1, wherein the antibody is a fully human IgG1κ monoclonal antibody. 4. The antibody for use of any preceding claim, wherein the antibody comprises a heavy chain of the amino acid sequence of SEQ ID NO:10 and a light chain of the amino acid sequence of SEQ ID NO:11. 5. The antibody for use of claim 1, wherein the antibody is ustekinumab. 6.2. The antibody for use of any one of claims 1-5, wherein the maintenance therapy comprises subcutaneously administering to the subject the anti- IL-12/IL- 23p40 antibody at a dosage of 90 mg per administration, once every 8 weeks or once every 12 weeks, and wherein the maintenance therapy is provided for 44 weeks. 7.3. The antibody for use of any one of claims 1-6 or claim 2, wherein: a. the first pharmaceutical composition further comprises a solution comprising 10 mM L-histidine, 8.5% (w/v) sucrose, 0.04% (w/v) polysorbate 80, 0.4 mg/mL L-methionine, and 20 µg/mL EDTA disodium salt, dehydrate, at pH 6.0; or b. the second pharmaceutical composition further comprises a solution comprising 6.7 mM L-histidine, 7.6% (w/v) sucrose, 0.004% (w/v) polysorbate 80, at pH 6.0. 8.4. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is: a. identified as having an endoscopic healing continuing at least 44 weeks after week 0; and/or b. identified as achieving a clinical response based on the Mayo endoscopy subscore continuing at least 44 weeks after week 0; and/or c. identified as having a change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score continuing at least 44 weeks after week 0; and/or d. identified as having a mucosal healing continuing at least 44 weeks after week 0; and/or e. identified as having a decrease from baseline in Mayo score continuing at least 44 weeks after week 0; and/or f. identified as having a normalization of one or more biomarkers selected from the group consisting of C-reactive protein, fecal lactoferrin and fecal calprotectin continuing at least 44 weeks after week 0; and/or

O2024_002 g. in clinical response as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from baseline in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1 continuing at least 44 weeks after week 0. 9.5. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is identified as having a clinical remission based on at least one of the global definition and the US definition by week 16, preferably by week 8, more preferably by week 2, of the treatment and the clinical remission continues at least 44 weeks after week 0. 10.6. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is identified as having a statistically significant improvement in disease activity as determined by an Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score of ≤4 by week 8 of treatment with the antibody. 11.7. The antibody for use of any preceding claim, wherein the subject had previously failed or was intolerant of at least one therapy selected from the group consisting of: an anti-TNF, vedolizumab, corticosteroids, azathioprine (AZA), and 6 mercaptopurine (6 MP), or the subject had demonstrated corticosteroid dependence. 12.8. The antibody for use of any preceding claim, wherein the subject is: a. identified as having a clinical remission based on at least one of: i. the global definition, wherein the global definition is the global definition of clinical remission with Mayo score ≤2 points with no individual subscore >1; and ii. the US definition, wherein the US definition is the US definition of clinical remission with absolute stool number ≤3, rectal bleeding subscore of 0 and Mayo endoscopy subscore of 0 or 1; and/or b. identified as having an endoscopic healing, optionally wherein the subject is identified as having an endoscopic healing with a Mayo endoscopy subscore of 0 or 1; and/or c. identified as achieving a clinical response based on the Mayo endoscopy subscore; and/or d. identified as having a change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score; and/or e. identified as having a mucosal healing; and/or f. identified as having a decrease from baseline in Mayo score; and/or

O2024_002 g. identified as having a normalization of one or more biomarkers selected from the group consisting of C-reactive protein, fecal lactoferrin and fecal calprotectin; and/or h. in clinical response as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from baseline in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or ; optionally by week 16, preferably by week 8, more preferably by week 2, of the treatment. 13. The antibody for use of claim 11 or claim 12, wherein the subject is not a responder to the treatment with the antibody by week 8 and is a responder to the treatment by week 16 of the treatment.› 8. Auxiliary Request 6: Auxiliary to Prayer for Relief nos. 1 – 7 hereinbefore, the Claimant’s nullity action shall be dismissed, and the Swiss and Liechtenstein part of EP 3 883 606 shall be maintained in the following version: ‹1. An anti-IL-12/IL-23p40 antibody for use in a method of treating moderately to severely active ulcerative colitis (UC) in a human subject in need thereof, wherein the subject had demonstrated corticosteroid dependence, wherein the antibody comprises a heavy chain variable region of the amino acid sequence of SEQ ID NO:7 and a light chain variable region of the amino acid sequence of SEQ ID NO:8is ustekinumab, wherein the method comprises: a. intravenously administering to the subject the antibody in a first pharmaceutical composition at week 0 of the treatment at a dosage of 260 mg for subjects with body weight ≥35 kg and ≤55 kg, 390 mg for subjects with body weight ˃55 kg and ≤85 kg, and 520 mg for subjects with body weight ˃85 kg, and b. subcutaneously administering to the subject the antibody in a second pharmaceutical composition at a dosage of 90 mg per administration, at week 8 of the treatment, and in a maintenance dose every 8 weeks or every 12 weeks after the treatment at week 8, wherein the subject is in corticosteroid-free clinical remission at least 44 weeks after week 0. 2. The antibody for use of claim 1, wherein the antibody is a human IgG antibody. 3. The antibody for use of claim 1, wherein the antibody is a fully human IgG1κ monoclonal antibody.

O2024_002 4. The antibody for use of any preceding claim, wherein the antibody comprises a heavy chain of the amino acid sequence of SEQ ID NO:10 and a light chain of the amino acid sequence of SEQ ID NO:11. 5. The antibody for use of claim 1, wherein the antibody is ustekinumab. 6.2. The antibody for use of any one of claims 1-5, wherein the maintenance therapy comprises subcutaneously administering to the subject the anti- IL-12/IL-23p40 antibody at a dosage of 90 mg per administration, once every 8 weeks or once every 12 weeks, and wherein the maintenance therapy is provided for 44 weeks. 7.3. The antibody for use of any one of claims 1-6 or claim 2, wherein: a. the first pharmaceutical composition further comprises a solution comprising 10 mM L-histidine, 8.5% (w/v) sucrose, 0.04% (w/v) polysorbate 80, 0.4 mg/mL L-methionine, and 20 µg/mL EDTA disodium salt, dehydrate, at pH 6.0; or b. the second pharmaceutical composition further comprises a solution comprising 6.7 mM L-histidine, 7.6% (w/v) sucrose, 0.004% (w/v) polysorbate 80, at pH 6.0. 8.4. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is: a. identified as having an endoscopic healing continuing at least 44 weeks after week 0; and/or b. identified as achieving a clinical response based on the Mayo endoscopy subscore continuing at least 44 weeks after week 0; and/or c. identified as having a change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score continuing at least 44 weeks after week 0; and/or d. identified as having a mucosal healing continuing at least 44 weeks after week 0; and/or e. identified as having a decrease from baseline in Mayo score continuing at least 44 weeks after week 0; and/or f. identified as having a normalization of one or more biomarkers selected from the group consisting of C-reactive protein, fecal lactoferrin and fecal calprotectin continuing at least 44 weeks after week 0; and/or g. in clinical response as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from baseline in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1 continuing at least 44 weeks after week 0.

O2024_002 9.5. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is identified as having a clinical remission based on at least one of the global definition and the US definition by week 16, preferably by week 8, more preferably by week 2, of the treatment and the clinical remission continues at least 44 weeks after week 0. 10.6. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is identified as having a statistically significant improvement in disease activity as determined by an Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score of ≤4 by week 8 of treatment with the antibody. 11. The antibody for use of any preceding claim, wherein the subject had previously failed or was intolerant of at least one therapy selected from the group consisting of: an anti-TNF, vedolizumab, corticosteroids, azathioprine (AZA), and 6 mercaptopurine (6 MP), or the subject had demonstrated corticosteroid dependence. 12.7. The antibody for use of any preceding claim, wherein the subject is: a. identified as having a clinical remission based on at least one of: i. the global definition, wherein the global definition is the global definition of clinical remission with Mayo score ≤2 points with no individual subscore >1; and ii. the US definition, wherein the US definition is the US definition of clinical remission with absolute stool number ≤3, rectal bleeding subscore of 0 and Mayo endoscopy subscore of 0 or 1; and/or b. identified as having an endoscopic healing, optionally wherein the subject is identified as having an endoscopic healing with a Mayo endoscopy subscore of 0 or 1; and/or c. identified as achieving a clinical response based on the Mayo endoscopy subscore; and/or d. identified as having a change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score; and/or e. identified as having a mucosal healing; and/or f. identified as having a decrease from baseline in Mayo score; and/or g. identified as having a normalization of one or more biomarkers selected from the group consisting of C-reactive protein, fecal lactoferrin and fecal calprotectin; and/or h. in clinical response as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from base-

O2024_002 line in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1; optionally by week 16, preferably by week 8, more preferably by week 2, of the treatment. 13.8. The antibody for use of claim 11 7or claim 12, wherein the subject is not a responder to the treatment with the antibody by week 8 and is a responder to the treatment by week 16 of the treatment.› 9. Auxiliary Request 7: Auxiliary to Prayer for Relief nos. 1 – 8 hereinbefore, the Claimant’s nullity action shall be dismissed, and the Swiss and Liechtenstein part of EP 3 883 606 shall be maintained in the following version: ‹1. An anti-IL-12/IL-23p40 antibody for use in a method of treating moderately to severely active ulcerative colitis (UC) in a human subject in need thereof, wherein the antibody comprises a heavy chain variable region of the amino acid sequence of SEQ ID NO:7 and a light chain variable region of the amino acid sequence of SEQ ID NO:8is ustekinumab, wherein the method comprises: a. intravenously administering to the subject the antibody in a first pharmaceutical composition at week 0 of the treatment at a dosage of 260 mg for subjects with body weight ≥35 kg and ≤55 kg, 390 mg for subjects with body weight ˃55 kg and ≤85 kg, and 520 mg for subjects with body weight ˃85 kg, wherein the subject is in clinical response by week 8 of the treatment, as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from baseline in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1, and b. subcutaneously administering to the subject the antibody in a second pharmaceutical composition at a dosage of 90 mg per administration, at week 8 of the treatment, and in a maintenance dose every 8 weeks or every 12 weeks after the treatment at week 8, wherein the subject is in corticosteroid-free clinical remission at least 44 weeks after week 0, and wherein clinical remission is based on at least one of the global definition and the US definition. 2. The antibody for use of claim 1, wherein the antibody is a human IgG antibody. 3. The antibody for use of claim 1, wherein the antibody is a fully human IgG1κ monoclonal antibody.

O2024_002 9.5. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is identified as having a clinical remission based on at least one of the global definition and the US definition by week 16, preferably by week 8, more preferably by week 2, of the treatment and the clinical remission continues at least 44 weeks after week 0. 10.6. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is identified as having a statistically significant improvement in disease activity as determined by an Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score of ≤4 by week 8 of treatment with the antibody. 11.7. The antibody for use of any preceding claim, wherein the subject had previously failed or was intolerant of at least one therapy selected from the group consisting of: an anti-TNF, vedolizumab, corticosteroids, azathioprine (AZA), and 6 mercaptopurine (6 MP), or the subject had demonstrated corticosteroid dependence. 12.8. The antibody for use of any preceding claim, wherein the subject is: a. identified as having a clinical remission based on at least one of: i. the global definition, wherein the global definition is the global definition of clinical remission with Mayo score ≤2 points with no individual subscore >1; and ii. the US definition, wherein the US definition is the US definition of clinical remission with absolute stool number ≤3, rectal bleeding subscore of 0 and Mayo endoscopy subscore of 0 or 1; and/or b. identified as having an endoscopic healing, optionally wherein the subject is identified as having an endoscopic healing with a Mayo endoscopy subscore of 0 or 1; and/or c. identified as achieving a clinical response based on the Mayo endoscopy subscore; and/or d. identified as having a change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score; and/or e. identified as having a mucosal healing; and/or f. identified as having a decrease from baseline in Mayo score; and/or g. identified as having a normalization of one or more biomarkers selected from the group consisting of C-reactive protein, fecal lactoferrin and fecal calprotectin; and/or h. in clinical response as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from base-

O2024_002 line in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1; optionally by week 16, preferably by week 8, more preferably by week 2, of the treatment. 13. The antibody for use of claim 11 or claim 12, wherein the subject is not a responder to the treatment with the antibody by week 8 and is a responder to the treatment by week 16 of the treatment.› 10. Auxiliary Request 8: Auxiliary to Prayer for Relief nos. 1 – 9 hereinbefore, the Claimant’s nullity action shall be dismissed, and the Swiss and Liechtenstein part of EP 3 883 606 shall be maintained in the following version: ‹1. An anti-IL-12/IL-23p40 antibody for use in a method of treating moderately to severely active ulcerative colitis (UC) in a human subject in need thereof, wherein the subject had demonstrated corticosteroid dependence, wherein the antibody comprises a heavy chain variable region of the amino acid sequence of SEQ ID NO:7 and a light chain variable region of the amino acid sequence of SEQ ID NO:8is ustekinumab, wherein the method comprises: a. intravenously administering to the subject the antibody in a first pharmaceutical composition at week 0 of the treatment at a dosage of 260 mg for subjects with body weight ≥35 kg and ≤55 kg, 390 mg for subjects with body weight ˃55 kg and ≤85 kg, and 520 mg for subjects with body weight ˃85 kg, wherein the subject is in clinical response by week 8 of the treatment, as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from baseline in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1, and b. subcutaneously administering to the subject the antibody in a second pharmaceutical composition at a dosage of 90 mg per administration, at week 8 of the treatment, and in a maintenance dose every 8 weeks or every 12 weeks after the treatment at week 8, wherein the subject is in corticosteroid-free clinical remission at least 44 weeks after week 0. 2. The antibody for use of claim 1, wherein the antibody is a human IgG antibody. 3. The antibody for use of claim 1, wherein the antibody is a fully human IgG1κ monoclonal antibody. 4. The antibody for use of any preceding claim, wherein the antibody comprises a heavy chain of the amino acid sequence of SEQ ID NO:10 and a light chain of the amino acid sequence of SEQ ID NO:11.

O2024_002 5. The antibody for use of claim 1, wherein the antibody is ustekinumab. 6.2. The antibody for use of any one of claims 1-5, wherein the maintenance therapy comprises subcutaneously administering to the subject the anti- IL-12/IL-23p40 antibody at a dosage of 90 mg per administration, once every 8 weeks or once every 12 weeks, and wherein the maintenance therapy is provided for 44 weeks. 7.3. The antibody for use of any one of claims 1-6 or claim 2, wherein: a. the first pharmaceutical composition further comprises a solution comprising 10 mM L-histidine, 8.5% (w/v) sucrose, 0.04% (w/v) polysorbate 80, 0.4 mg/mL L-methionine, and 20 µg/mL EDTA disodium salt, dehydrate, at pH 6.0; or b. the second pharmaceutical composition further comprises a solution comprising 6.7 mM L-histidine, 7.6% (w/v) sucrose, 0.004% (w/v) polysorbate 80, at pH 6.0. 8.4. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is: a. identified as having an endoscopic healing continuing at least 44 weeks after week 0; and/or b. identified as achieving a clinical response based on the Mayo endoscopy subscore continuing at least 44 weeks after week 0; and/or c. identified as having a change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score continuing at least 44 weeks after week 0; and/or d. identified as having a mucosal healing continuing at least 44 weeks after week 0; and/or e. identified as having a decrease from baseline in Mayo score continuing at least 44 weeks after week 0; and/or f. identified as having a normalization of one or more biomarkers selected from the group consisting of C-reactive protein, fecal lactoferrin and fecal calprotectin continuing at least 44 weeks after week 0; and/or g. in clinical response as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from baseline in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1 continuing at least 44 weeks after week 0. 9.5. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is identified as having a clinical remission based on at least one of the global definition and the US definition by week 16, preferably by week 8, more preferably by

O2024_002 week 2, of the treatment and the clinical remission continues at least 44 weeks after week 0. 10.6. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is identified as having a statistically significant improvement in disease activity as determined by an Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score of ≤4 by week 8 of treatment with the antibody. 11. The antibody for use of any preceding claim, wherein the subject had previously failed or was intolerant of at least one therapy selected from the group consisting of: an anti-TNF, vedolizumab, corticosteroids, azathioprine (AZA), and 6 mercaptopurine (6 MP), or the subject had demonstrated corticosteroid dependence. 12.7. The antibody for use of any preceding claim, wherein the subject is: a. identified as having a clinical remission based on at least one of: i. the global definition, wherein the global definition is the global definition of clinical remission with Mayo score ≤2 points with no individual subscore >1; and ii. the US definition, wherein the US definition is the US definition of clinical remission with absolute stool number ≤3, rectal bleeding subscore of 0 and Mayo endoscopy subscore of 0 or 1; and/or b. identified as having an endoscopic healing, optionally wherein the subject is identified as having an endoscopic healing with a Mayo endoscopy subscore of 0 or 1; and/or c. identified as achieving a clinical response based on the Mayo endoscopy subscore; and/or d. identified as having a change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score; and/or e. identified as having a mucosal healing; and/or f. identified as having a decrease from baseline in Mayo score; and/or g. identified as having a normalization of one or more biomarkers selected from the group consisting of C-reactive protein, fecal lactoferrin and fecal calprotectin; and/or h. in clinical response as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from baseline in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1; optionally by week 16, preferably by week 8, more preferably by week 2, of the treatment.

O2024_002 13. The antibody for use of claim 11 or claim 12, wherein the subject is not a responder to the treatment with the antibody by week 8 and is a responder to the treatment by week 16 of the treatment.› 11. Auxiliary Request 9: Auxiliary to Prayer for Relief nos. 1 – 10 hereinbefore, the Claimant’s nullity action shall be dismissed, and the Swiss and Liechtenstein part of EP 3 883 606 shall be maintained in the following version: ‹1. An anti-IL-12/IL-23p40 antibody for use in a method of treating moderately to severely active ulcerative colitis (UC) in a human subject in need thereof, wherein the subject had demonstrated corticosteroid dependence, wherein the antibody comprises a heavy chain variable region of the amino acid sequence of SEQ ID NO:7 and a light chain variable region of the amino acid sequence of SEQ ID NO:8is ustekinumab, wherein the method comprises: a. intravenously administering to the subject the antibody in a first pharmaceutical composition at week 0 of the treatment at a dosage of 260 mg for subjects with body weight ≥35 kg and ≤55 kg, 390 mg for subjects with body weight ˃55 kg and ≤85 kg, and 520 mg for subjects with body weight ˃85 kg, wherein the subject is in clinical response by week 8 of the treatment, as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from baseline in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1, and b. subcutaneously administering to the subject the antibody in a second pharmaceutical composition at a dosage of 90 mg per administration, at week 8 of the treatment, and in a maintenance dose every 8 weeks or every 12 weeks after the treatment at week 8, wherein the subject is in corticosteroid-free clinical remission at least 44 weeks after week 0, and wherein clinical remission is based on at least one of the global definition and the US definition. 2. The antibody for use of claim 1, wherein the antibody is a human IgG antibody. 3. The antibody for use of claim 1, wherein the antibody is a fully human IgG1κ monoclonal antibody. 4. The antibody for use of any preceding claim, wherein the antibody comprises a heavy chain of the amino acid sequence of SEQ ID NO:10 and a light chain of the amino acid sequence of SEQ ID NO:11. 5. The antibody for use of claim 1, wherein the antibody is ustekinumab.

O2024_002 62. The antibody for use of any one of claims 1-5, wherein the maintenance therapy comprises subcutaneously administering to the subject the anti- IL-12/IL-23p40 antibody at a dosage of 90 mg per administration, once every 8 weeks or once every 12 weeks, and wherein the maintenance therapy is provided for 44 weeks. 73. The antibody for use of any one of claims 1-6 or claim 2, wherein: a. the first pharmaceutical composition further comprises a solution comprising 10 mM L-histidine, 8.5% (w/v) sucrose, 0.04% (w/v) polysorbate 80, 0.4 mg/mL L-methionine, and 20 µg/mL EDTA disodium salt, dehydrate, at pH 6.0; or b. the second pharmaceutical composition further comprises a solution comprising 6.7 mM L-histidine, 7.6% (w/v) sucrose, 0.004% (w/v) polysorbate 80, at pH 6.0. 84. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is: a. identified as having an endoscopic healing continuing at least 44 weeks after week 0; and/or b. identified as achieving a clinical response based on the Mayo endoscopy subscore continuing at least 44 weeks after week 0; and/or c. identified as having a change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score continuing at least 44 weeks after week 0; and/or d. identified as having a mucosal healing continuing at least 44 weeks after week 0; and/or e. identified as having a decrease from baseline in Mayo score continuing at least 44 weeks after week 0; and/or f. identified as having a normalization of one or more biomarkers selected from the group consisting of C-reactive protein, fecal lactoferrin and fecal calprotectin continuing at least 44 weeks after week 0; and/or g. in clinical response as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from baseline in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1 continuing at least 44 weeks after week 0. 95. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is identified as having a clinical remission based on at least one of the global definition and the US definition by week 16, preferably by week 8, more preferably by week 2, of the treatment and the clinical remission continues at least 44 weeks after week 0.

O2024_002 106. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is identified as having a statistically significant improvement in disease activity as determined by an Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score of ≤4 by week 8 of treatment with the antibody. 11. The antibody for use of any preceding claim, wherein the subject had previously failed or was intolerant of at least one therapy selected from the group consisting of: an anti-TNF, vedolizumab, corticosteroids, azathioprine (AZA) and 6 mercaptopurine (6 MP), or the subject had demonstrated corticosteroid dependence. 127. The antibody for use of any preceding claim, wherein the subject is: a. identified as having a clinical remission based on at least one of: i. the global definition, wherein the global definition is the global definition of clinical remission with Mayo score ≤2 points with no individual subscore >1; and ii. the US definition, wherein the US definition is the US definition of clinical remission with absolute stool number ≤3, rectal bleeding subscore of 0 and Mayo endoscopy subscore of 0 or 1; and/or b. identified as having an endoscopic healing, optionally wherein the subject is identified as having an endoscopic healing with a Mayo endoscopy subscore of 0 or 1; and/or c. identified as achieving a clinical response based on the Mayo endoscopy subscore; and/or d. identified as having a change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score; and/or e. identified as having a mucosal healing; and/or f. identified as having a decrease from baseline in Mayo score; and/or g. identified as having a normalization of one or more biomarkers selected from the group consisting of C-reactive protein, fecal lactoferrin and fecal calprotectin; and/or h. in clinical response as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from baseline in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1; optionally by week 16, preferably by week 8, more preferably by week 2, of the treatment.

O2024_002 13. The antibody for use of claim 11 or claim 12, wherein the subject is not a responder to the treatment with the antibody by week 8 and is a responder to the treatment by week 16 of the treatment.› 12. Auxiliary Request 10: Auxiliary to Prayer for Relief nos. 1 – 11 hereinbefore, the Claimant’s nullity action shall be dismissed, and the Swiss and Liechtenstein part of EP 3 883 606 shall be maintained in the following version: ‹1. An anti-IL-12/IL-23p40 antibody for use in a method of treating moderately to severely active ulcerative colitis (UC) in a human subject in need thereof, wherein the antibody comprises a heavy chain variable region of the amino acid sequence of SEQ ID NO:7 and a light chain variable region of the amino acid sequence of SEQ ID NO:8is ustekinumab, wherein the method comprises: a. intravenously administering to the subject the antibody in a first pharmaceutical composition at week 0 of the treatment at a dosage of 260 mg for subjects with body weight ≥35 kg and ≤55 kg, 390 mg for subjects with body weight ˃55 kg and ≤85 kg, and 520 mg for subjects with body weight ˃85 kg, wherein the subject is in clinical response by week 8 of the treatment, as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from baseline in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1, and b. subcutaneously administering to the subject the antibody in a second pharmaceutical composition at a dosage of 90 mg per administration, at week 8 of the treatment, and in a maintenance dose every 8 weeks or every 12 weeks after the treatment at week 8, wherein the subject is in corticosteroid-free clinical remission at least 44 weeks after week 0, and wherein clinical remission is based on at least one of the global definition and the US definition. 2. The antibody for use of claim 1, wherein the antibody is a human IgG antibody. 3. The antibody for use of claim 1, wherein the antibody is a fully human IgG1κ monoclonal antibody. 4. The antibody for use of any preceding claim, wherein the antibody comprises a heavy chain of the amino acid sequence of SEQ ID NO:10 and a light chain of the amino acid sequence of SEQ ID NO:11. 5. The antibody for use of claim 1, wherein the antibody is ustekinumab.

O2024_002 106. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is identified as having a statistically significant improvement in disease activity as determined by an Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score of ≤4 by week 8 of treatment with the antibody. 117. The antibody for use of any preceding claim, wherein the subject had previously failed or was intolerant of at least one therapy selected from the group consisting of: an anti-TNF, vedolizumab, corticosteroids, azathioprine (AZA), and 6 mercaptopurine (6 MP), or the subject had demonstrated corticosteroid dependence. 128. The antibody for use of any preceding claim, wherein the subject is: a. identified as having a clinical remission based on at least one of: i. the global definition, wherein the global definition is the global definition of clinical remission with Mayo score ≤2 points with no individual subscore >1; and ii. the US definition, wherein the US definition is the US definition of clinical remission with absolute stool number ≤3, rectal bleeding subscore of 0 and Mayo endoscopy subscore of 0 or 1; and/or b. identified as having an endoscopic healing, optionally wherein the subject is identified as having an endoscopic healing with a Mayo endoscopy subscore of 0 or 1; and/or c. identified as achieving a clinical response based on the Mayo endoscopy subscore; and/or d. identified as having a change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score; and/or e. identified as having a mucosal healing; and/or f. identified as having a decrease from baseline in Mayo score; and/or g. identified as having a normalization of one or more biomarkers selected from the group consisting of C-reactive protein, fecal lactoferrin and fecal calprotectin; and/or h. in clinical response as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from baseline in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1; optionally by week 16, preferably by week 8, more preferably by week 2, of the treatment.

O2024_002 13. The antibody for use of claim 11 or claim 12, wherein the subject is not a responder to the treatment with the antibody by week 8 and is a responder to the treatment by week 16 of the treatment.› 13. Auxiliary Request 11: Auxiliary to Prayer for Relief nos. 1 – 12 hereinbefore, the Claimant’s nullity action shall be dismissed, and the Swiss and Liechtenstein part of EP 3 883 606 shall be maintained in the following version: ‹1. An anti-IL-12/IL-23p40 antibody for use in a method of treating moderately to severely active ulcerative colitis (UC) in a human subject in need thereof, wherein the subject had demonstrated corticosteroid dependence, wherein the antibody comprises a heavy chain variable region of the amino acid sequence of SEQ ID NO:7 and a light chain variable region of the amino acid sequence of SEQ ID NO:8is ustekinumab, wherein the method comprises: a. intravenously administering to the subject the antibody in a first pharmaceutical composition at week 0 of the treatment at a dosage of 260 mg for subjects with body weight ≥35 kg and ≤55 kg, 390 mg for subjects with body weight ˃55 kg and ≤85 kg, and 520 mg for subjects with body weight ˃85 kg, wherein the subject is in clinical response by week 8 of the treatment, as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from baseline in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1, and b. subcutaneously administering to the subject the antibody in a second pharmaceutical composition at a dosage of 90 mg per administration, at week 8 of the treatment, and in a maintenance dose every 8 weeks or every 12 weeks after the treatment at week 8, wherein the subject is in corticosteroid-free clinical remission at least 44 weeks after week 0, and wherein clinical remission is based on at least one of the global definition and the US definition. 2. The antibody for use of claim 1, wherein the antibody is a human IgG antibody. 3. The antibody for use of claim 1, wherein the antibody is a fully human IgG1κ monoclonal antibody. 4. The antibody for use of any preceding claim, wherein the antibody comprises a heavy chain of the amino acid sequence of SEQ ID NO:10 and a light chain of the amino acid sequence of SEQ ID NO:11. 5. The antibody for use of claim 1, wherein the antibody is ustekinumab.

O2024_002 62. The antibody for use of any one of claims 1-5, wherein the maintenance therapy comprises subcutaneously administering to the subject the anti- IL- 12/IL-23p40 antibody at a dosage of 90 mg per administration, once every 8 weeks or once every 12 weeks, and wherein the maintenance therapy is provided for 44 weeks. 73. The antibody for use of any one of claims 1-6 or claim 2, wherein: a. the first pharmaceutical composition further comprises a solution comprising 10 mM L-histidine, 8.5% (w/v) sucrose, 0.04% (w/v) polysorbate 80, 0.4 mg/mL L-methionine, and 20 µg/mL EDTA disodium salt, dehydrate, at pH 6.0; or b. the second pharmaceutical composition further comprises a solution comprising 6.7 mM L-histidine, 7.6% (w/v) sucrose, 0.004% (w/v) polysorbate 80, at pH 6.0. 84. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is: a. identified as having an endoscopic healing continuing at least 44 weeks after week 0; and/or b. identified as achieving a clinical response based on the Mayo endoscopy subscore continuing at least 44 weeks after week 0; and/or c. identified as having a change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score continuing at least 44 weeks after week 0; and/or d. identified as having a mucosal healing continuing at least 44 weeks after week 0; and/or e. identified as having a decrease from baseline in Mayo score continuing at least 44 weeks after week 0; and/or f. identified as having a normalization of one or more biomarkers selected from the group consisting of C-reactive protein, fecal lactoferrin and fecal calprotectin continuing at least 44 weeks after week 0; and/or g. in clinical response as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from baseline in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1 continuing at least 44 weeks after week 0. 95. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is identified as having a clinical remission based on at least one of the global definition and the US definition by week 16, preferably by week 8, more preferably by week 2, of the treatment and the clinical remission continues at least 44 weeks after week 0.

O2024_002 106. The antibody for use of any preceding claim, wherein the subject is a responder to the treatment with the antibody and is identified as having a statistically significant improvement in disease activity as determined by an Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score of ≤4 by week 8 of treatment with the antibody. 11. The antibody for use of any preceding claim, wherein the subject had previously failed or was intolerant of at least one therapy selected from the group consisting of: an anti-TNF, vedolizumab, corticosteroids, azathioprine (AZA), and 6 mercaptopurine (6 MP), or the subject had demonstrated corticosteroid dependence. 127. The antibody for use of any preceding claim, wherein the subject is: a. identified as having a clinical remission based on at least one of: i. the global definition, wherein the global definition is the global definition of clinical remission with Mayo score ≤2 points with no individual subscore >1; and ii. the US definition, wherein the US definition is the US definition of clinical remission with absolute stool number ≤3, rectal bleeding subscore of 0 and Mayo endoscopy subscore of 0 or 1; and/or b. identified as having an endoscopic healing, optionally wherein the subject is identified as having an endoscopic healing with a Mayo endoscopy subscore of 0 or 1; and/or c. identified as achieving a clinical response based on the Mayo endoscopy subscore; and/or d. identified as having a change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score; and/or e. identified as having a mucosal healing; and/or f. identified as having a decrease from baseline in Mayo score; and/or g. identified as having a normalization of one or more biomarkers selected from the group consisting of C-reactive protein, fecal lactoferrin and fecal calprotectin; and/or h. in clinical response as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from baseline in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1; optionally by week 16, preferably by week 8, more preferably by week 2, of the treatment.

O2024_002 13. The antibody for use of claim 11 or claim 12, wherein the subject is not a responder to the treatment with the antibody by week 8 and is a responder to the treatment by week 16 of the treatment.› 14. Court costs and the Respondent’s legal fees (including patent attorney fees as well as other expenses) shall be borne by the Claimant.» 7. Am 12. Dezember 2024 reichte die Beklagte die vorläufige Einschätzung der Einspruchsabteilung des EPA vom 9. Dezember 2024 im Einspruchsverfahren gegen die Erteilung von EP 3 883 606 sowie das Urteil des Tribunale Ordinario di Milano vom 4. Dezember 2024, mit dem dieses gestützt auf den italienischen Teil von EP 3 883 606 vorsorgliche Massnahmen erliess. 8. Der Präsident verfügte am 13. Januar 2025, dass an der Hauptverhandlung Thomas Ochsenkühn und Sunghun Son als Zeugen der Klägerin zu den Tatsachenbehauptungen, zu denen sie angerufen wurden, einvernommen werden. 9. Mit Eingabe vom 6. Januar 2025 nahm die Klägerin Stellung zu den Dupliknoven. Die Beklagte nahm dazu ihrerseits mit Eingabe vom 28. Januar 2025 Stellung, mit folgendem prozessualen Antrag: «All statements and exhibits included in the Plaintiff’s submission dated January 6, 2025, which do not directly address new allegations first presented in the Defendant’s Statement of Rejoinder, shall be rejected as untimely filed and therefore disregarded. This includes, but is not limited to, the following statements: - paragraphs 56-75 of act. 46; - paragraphs 85-90 of act. 46; - paragraphs 111-136 of act. 46 as well as act. 46_04; - paragraphs 137-180 of act. 46; - paragraphs 181-195 of act. 46; - paragraph 229 of act. 46 as well as act. 46_12; - paragraphs 262-268 of act. 46; and - paragraphs 269-274 of act. 46.»

O2024_002 Die Klägerin nahm dazu mit Eingabe vom 10. Februar 2025 Stellung und beantragte die Abweisung des beklagtischen Antrags vom 28. Januar 2025 und die vollständige Berücksichtigung ihrer Eingabe vom 6. Januar 2025. 10. Mit Noveneingabe vom 21. Januar 2025 reichte die Klägerin Beweismittel aus dem norwegischen Parallelverfahren ein und stellte für den Fall, dass das Gericht nicht überzeugt sei, dass der wissenschaftliche Inhalt des Ochsenkühn-Posters an der Digestive Disease Week Konferenz 2018 präsentiert wurde, folgenden subsidiären prozessualen Antrag: «Respondent shall be ordered, under the threat of appropriate enforcement measures pursuant of Article 343 para. 1 and 2 CPC in the event of noncompliance, to provide the Court and Claimant with all correspondence (i) to/from Prof. Ochsenkühn and any representative of a company belonging to the Janssen group and/or face to face Event GmbH (acting on behalf of Janssen), (ii) to/from any representative of a company belonging to the Janssen group and face to face Event GmbH and (iii) between any representatives of companies belonging to the Janssen group regarding Prof. Ochsenkühn’s attendance and presentations at the DDW Conference 2018 in Washington D.C., exchanged between 1 Dezember 2017 and 30 September 2018.» 11. Die Beklagte nahm dazu mit Eingabe vom 4. Februar 2025 Stellung, mit folgenden prozessualen Anträgen: «1. The Plaintiff’s submission dated January 21, 2025, along with the exhibits filed on January 21, 2025, shall not be admitted into the case file and shall be disregarded. 2. The Plaintiff’s procedural request regarding the production of documents by the Defendant shall be dismissed. 3. The Defendant’s Exhibit 105 and Exhibit 107 shall be treated confidentially and the Plaintiff (including the Plaintiff’s attorneys-at-law, patent attorneys and other representatives) shall be prohibited, under the threat of a penalty (fine) according to Art. 292 StGB in the event of noncompliance, from disclosing or using these exhibits or their content in its pleadings at the main hearing and for purposes other than the present proceedings O2024_002.»

O2024_002 Mit Verfügung vom 4. Februar 2025 wies der Präsident Thierry Calame und Barbara Abegg an, die Urkunden einstweilen vertraulich zu behandeln. 12. Die Klägerin nahm mit Eingabe vom 18. Februar 2025 Stellung, mit folgenden prozessualen Anträgen: «1. Respondent’s Procedural Motion no. 1 in act. 57 shall be fully dismissed and Claimant’s submission dated 21 January 2025 (act. 50) including the exhibits act. 50_1 and act. 50_2 shall not be deemed untimely filed, but shall be admitted. 2. Respondent’s Procedural Motion no. 2 in act. 57 shall be fully dismissed and Claimant’s document disclosure request shall be admitted. 3.1 The order dated 4 February 2025 shall be revoked and Respondent’s Procedural Motion no. 3 in act. 57 shall be fully dismissed. 3.2 In the alternative to 3.1: In the unlikely event that the Federal Patent Court deems certain protective measures necessary, it should revoke its procedural order dated 4 February 2025 and should permit Thierry Calame and Barbara Abegg to share act. 57_105 and act. 57_107 with the following individuals: • Sooyeon Jung, Samsung Bioepis • Sunghun Son, Samsung Bioepis • Eunji Choi, Samsung Bioepis • Christoph Fraefel, Schaad, Balass, Menzl & Partner AG • Scott Parker, Simmons & Simmons LLP • Sebastian Versaevel, Simmons & Simmons LLP, • Fergus Brown, Simmons & Simmons LLP». 13. Mit Verfügung vom 20. März 2025 erwog der Präsident, dass es sich bei act. 57_105 um einen Dienstleistungsvertrag zwischen der Janssen-Cilag GmbH, Neuss, Deutschland, und Thomas Ochsenkühn, Wörthsee, Deutschland, handle. Der Vertrag sei weitgehend geschwärzt. Aus der Präambel gehe hervor, dass es sich bei Thomas Ochsenkühn um einen angestellten Arzt/Heilberufler handle und dass die Janssen-Cilag GmbH als forschendes Unternehmen an einer evidenzbasierten, wissenschaftlichen und/oder gesundheitsökonomischen Beratung zur Sicherung einer

O2024_002 stetigen Weiterentwicklung und Innovation seiner Produkte interessiert sei. Vertragsgegenstand (§1) sei eine Dienstleistungserbringung im Rahmen des Kongresses Digestive Disease Week 2018 (DDW 2018), die bis zum 4. Juni 2018 erfolge; die restlichen Passagen des Vertragsgegenstands seien geschwärzt. Die Janssen-Cilag GmbH sei berechtigt, die im Rahmen dieses Vertrags gewonnenen Daten und Erkenntnisse frei zu publizieren; Veröffentlichungen von Thomas Ochsenkühn, die mit den vertraglich geschuldeten Leistungen im Zusammenhang stehen, bedürften der schriftlichen Einwilligung der Janssen-Cilag GmbH (§8). Zahlreiche Bestimmungen des Vertrags seien vollumfänglich geschwärzt, ebenso die Unterschriften der für die Janssen-Cilag GmbH unterzeichnenden Personen. Bei act. 57_107 handle es sich um den Auszug aus ihrer Datenbank betreffend die Anwesenden anlässlich der DDW 2018. Aus diesem Datenbankauszug sei ersichtlich: eine «Event Attendee ID», ein «Name», ein «Jj Attendee Cods», die «Event Number», eine «User Vod C», eine «Medical Event Vod C», ein «Jj Local Hcp Identifier 1 C» und weitere Variablen, je bestehend aus einer alphanumerischen Zeichenfolge. Der einzige nicht geschwärzte Teilnehmer sei Thomas Ochsenkühn, München, Deutschland.

Abbildung 1: Auszug aus der geschwärzten Dienstleistungsvereinbarung zwischen Janssen-Cilag AG und Thomas Ochsenkühn Der Präsident wies in der Folge den prozessualen Antrag Nr. 3 gemäss Eingabe vom 3. Februar 2025 der Beklagten ab, da nicht erkennbar sei, wieso die Beklagte, insbesondere fast sieben Jahre nachdem die DDW 2018 stattgefunden habe, ein schutzwürdiges Interesse daran habe, dass nicht allgemein bekannt werde, dass Thomas Ochsenkühn an der Konferenz nicht näher bekannte Leistungen für die Janssen-Cilag GmbH erbracht habe.

O2024_002 Damit konnte auch offenbleiben, ob Art. 68 PatG überhaupt eine gesetzliche Grundlage für den Schutz von Geschäftsgeheimnissen Dritter ist, spricht Art. 68 PatG – anders als Art. 156 ZPO – doch nur davon, dass Fabrikations- oder Geschäftsgeheimnisse der Parteien zu wahren sind. Art. 156 ZPO erwähnt zwar auch die schutzwürdigen Interessen Dritter, aber eine auf Art. 156 ZPO gestützte strafbewehrte Geheimhaltungspflicht kann gemäss BGE 148 III 84 nur für die Dauer des Prozesses angeordnet werden. Nachdem die vertraulich zu behandelnde Information damit nach Verfahrensende ohnehin öffentlich gemacht werden darf, fragt es sich, ob die Anordnung einer Geheimhaltungspflicht während des Verfahrens gestützt auf Art. 156 ZPO verhältnismässig sein kann, da sie nicht geeignet ist, die Vertraulichkeit zu gewährleisten. 14. Am 18. März 2025 erstattete der technisch ausgebildete Richter Michael Kaufmann das Fachrichtervotum. Die Parteien nahmen dazu je mit Eingabe vom 15. Mai 2025 Stellung, wobei die Beklagte mit dem Hilfsantrag 12 beantragte, das Patent in einer weiteren eingeschränkten Fassung aufrecht zu erhalten. 15. Die Beklagte stellte mit Eingabe vom 26. Mai 2025 folgenden prozessualen Antrag: «The decision of the Oslo District Court dated February 27, 2025, as well as all related allegations made by Plaintiff in act. 70 (including, but not limited to, those set out in paragraphs 7, 8, 11-17, 21, 35, 38, 39, 119, 155, 179, 257, and footnote 2), shall be rejected as late-filed and disregarded.» 16. Die Hauptverhandlung fand am 4. Juni 2025 statt, wobei die Klägerin geltend machte, dass der beklagtische Hilfsantrag 12 verspätet und daher nicht zu beachten sei. Aufgrund der Vertraulichkeit des Beweisthemas, zu dem Zeuge Son angerufen wurde, nämlich den Vertriebsvertrag zwischen der Samsung Bioepis-Gruppe und der Sandoz-Gruppe betreffend den Vertrieb des Stelara®-Generikums «SB 17», wurde die Öffentlichkeit von der Befragung des Zeugen Son ausgeschlossen.

O2024_002 Prozessuales Zuständigkeit und anwendbares Recht 17. Die Klägerin ist eine Gesellschaft mit beschränkter Haftung mit Sitz in Luzern. Die Beklagte ist eine Gesellschaft nach US-amerikanischem Recht mit Sitz in Horsham, Pennsylvania, USA. Die Klägerin verlangt die Feststellung der Nichtigkeit des schweizerischen und liechtensteinischen Teils des EP 3 883 606 (Streitpatent), dessen eingetragene Inhaberin die Beklagte ist. Für Klagen, die die Gültigkeit von Patenten zum Gegenstand haben, sind ohne Rücksicht auf den Wohnsitz die Gerichte jenes Staates ausschliesslich zuständig, in dessen Hoheitsgebiet die Hinterlegung oder Registrierung vorgenommen worden ist (Art. 22 Nr. 4 LugÜ, Art. 109 Abs. 1 IPRG). Nachdem die Beklagte keinen Sitz in der Schweiz hat, sind die Gerichte am Geschäftssitz des im Register eingetragenen Vertreters zuständig (Art. 109 Abs. 1 IPRG); im vorliegenden Fall Lugano. Das Bundespatentgericht ist für Bestandesklagen innerhalb der Schweiz ausschliesslich zuständig (Art. 26 Abs. 1 lit. a PatGG). Das Bundespatentgericht ist mithin sachlich und örtlich zuständig. Es ist Schweizer Recht anwendbar (Art. 110 Abs. 1 IPRG). Die Parteien haben Englisch als Parteisprache vereinbart; Verfahrenssprache ist Deutsch (Art. 36 PatGG). Feststellungsinteresse 18. Gemäss Art. 28 PatG steht die Nichtigkeitsklage jedermann zu, der ein Interesse nachweist, wobei die Rechtsprechung geringe Anforderungen an dessen Nachweis stellt.1 Es genügt, wenn die Parteien in einem Wettbewerbsverhältnis stehen und der Schutzbereich des Streitpatents sich auf das Tätigkeitsgebiet der Klägerin erstreckt.2 19. Die Beklagte bestreitet das Rechtsschutzinteresse der Klägerin, da

1 BGE 116 II 196 E. 2 – «Doxycyclin III». 2 BPatGer, Urteil O2012_030 vom 7. September 2013, E. 16.3 f.

O2024_002 «SB17», ein Biosimilar des beklagtischen Referenzprodukts Stelara®, von Samsung Bioepis Co., Ltd., mit Sitz in der Republik Korea, entwickelt worden sei (unbestritten). Weder die Klägerin noch Samsung Bioepis,Co., Ltd. beabsichtigten, SB17 in der Schweiz in den Verkehr zu bringen. Vielmehr habe Samsung Bioepis Co., Ltd., die Muttergesellschaft der Samsung Bioepis Gruppe, mit der Sandoz Group AG, Basel, eine Entwicklungs- und Vermarktungsvereinbarung («SB17-Vereinbarung») abgeschlossen, mit der sie der Sandoz-Gruppe das ausschliessliche Recht zur Vermarktung von SB17 in verschiedenen Ländern, unter anderem in der Schweiz und Liechtenstein, übertragen habe. Folglich sei die Klägerin nicht in die Entwicklung und Vermarktung von SB17 in der Schweiz involviert und es könne nicht angenommen werden, dass die Klägerin, die nicht Partei der SB17-Vereinbarung zwischen Samsung Bioepis Co., Ltd. und der Sandoz Group AG sei, irgendwelche Vorteile aus dieser Vereinbarung für sich ziehe. Die Klägerin habe daher kein eigenes Interesse daran, den Weg für die Markteinführung von SB17 zu ebnen. Es könne auch nicht die Rede davon sein, dass die Klägerin das vorliegende Verfahren als vorsorgliche Verteidigung gegen mutmassliche Verletzungsansprüche angestrengt habe, da sie aufgrund der exklusiven Lizenz selber keine möglichen Verletzungshandlungen vornehmen dürfe. Die Klägerin wendet ein, dass die Anforderungen an das Feststellungsinteresse in Nichtigkeitsverfahren tief seien. So genüge es, dass die klägerische Gruppe in einem Wettbewerbsverhältnis zur beklagten Gruppe stehe. Entgegen der Darstellung der Beklagten sei die klägerische Gruppe, einschliesslich der Klägerin, in die Kommerzialisierung von SB17 in der Schweiz involviert. So halte die Klägerin insbesondere die Marktzulassung für SB17 unter dem Markennamen Pyzchiva® und sei für alle regulatorischen Angelegenheiten in der Schweiz zuständig. Weiter sei die Samsung Bioepis Gruppe unter der streng vertraulichen Vereinbarung mit Sandoz verantwortlich für Rechtsstreitigkeiten mit Dritten betreffend Immaterialgüterrechte und werde an den Gewinnen von Sandoz aus dem Verkauf von SB17 beteiligt. In der Duplik weist die Beklagte darauf hin, dass nicht die Samsung Bioepis Gruppe, sondern Samsung Bioepis Co., Ltd., Partei der Vereinbarung mit Sandoz sei, weshalb die Klägerin keine Rechte oder Pflichten aus dieser Vereinbarung ableiten könne. Weiter genüge es nicht, dass die Klägerin die Marktzulassung für SB17 innehabe. Die Klägerin müsse ein eigenes (persönliches) Interesse an der Feststellung der Nichtigkeit des

O2024_002 Streitpatents haben; ein Konzerninteresse sei dem Schweizer Recht fremd und genüge den gesetzlichen Anforderungen nicht. 20. Wie die Befragung des Zeugen Son, Leiter der Rechtsabteilung von Samsung Bioepis Co. Ltd., Incheon, Korea, ergeben hat, wurde der Vertrag betreffend die Vermarktung von SB17 durch die Sandoz Gruppe zwischen Samsung Bioepis Co. Ltd. und einer nicht näher bestimmten Gesellschaft der Sandoz-Gruppe abgeschlossen. Die Klägerin ist nicht Partei des Vertrages. Gemäss dem Vertrag wird das Biosimilar SB17 durch Samsung Bioepis entwickelt, hergestellt und regulatorisch zugelassen, während Sandoz das Produkt kommerzialisiert. Die Klägerin ist eine 100%-ige Tochtergesellschaft der Samsung Bioepis Co. Ltd. und hält die Marktzulassung für SB17 in der Schweiz. Die Klägerin ist nicht operativ tätig. Samsung Bioepis Co. Ltd. erhält einen Anteil des von Sandoz mit der Vermarktung von SB17 erzielten Umsatzes. Falls SB17 Schutzrechte Dritter verletzt und Sandoz dadurch ein Schaden entsteht, ist Samsung Bioepis Co. Ltd. haftbar. 21. Es ist damit erstellt, dass die Klägerin eine 100%-ige Tochtergesellschaft der Samsung Bioepis Co., Ltd. mit Sitz in Incheon, Republik Korea (im Folgenden auch «Muttergesellschaft») ist und dass die Muttergesellschaft, nicht die Klägerin, Vertragspartei der SB17-Vereinbarung ist. Aus der SB17-Vereinbarung entsteht der Muttergesellschaft ein Anspruch auf einen Anteil des mit der Vermarktung von SB17 erzielten Umsatzes und die Pflicht, Sandoz schadlos zu halten, wenn SB17 Schutzrechte Dritter verletzt. Es ist nicht erstellt, dass die Klägerin einen Anteil des mit SB17 erzielten Umsatzes erhält, und nicht erstellt, dass die Klägerin eine Obliegenheit trifft, Schutzrechte Dritter zu beseitigen, die der Vermarktung von SB17 entgegenstehen könnten. Die Klägerin ist Inhaberin der Swissmedic-Marktzulassung für den Vertrieb von Pyzchiva®, einem Biosimilar des Originalpräparats Stelara®. Sie kann Pyzchiva® in der Schweiz aber nicht vertreiben, ohne die Rechte von Sandoz aus der SB17-Vereinbarung zu verletzen, und es gibt keine Anhaltspunkte, dass die Klägerin in das ausschliessliche Recht von Sandoz, SB17 in der Schweiz und in Liechtenstein zu vertreiben, eingreifen wird.

O2024_002 22. Im Gegensatz zur Klage auf Feststellung der Nichtigkeit ergänzender Schutzzertifikate (Art. 140k Abs. 2 PatG)3 ist die Klage auf Feststellung der Nichtigkeit von Patenten nicht als Popularklage ausgestaltet. Obwohl die Popularklage zur Feststellung der Nichtigkeit ergänzender Schutzzertifikate bereits seit dem 1. Mai 1999 existiert4, hat der Gesetzgeber bei der Revision des Patentgesetztes 2008 zwar den Wortlaut von Art. 28 PatG angepasst,5 aber darauf verzichtet, das Recht zur Klage auf Feststellung der Nichtigkeit eines Patents jeder Person ohne Nachweis eines Interesses einzuräumen. Ein gesetzgeberisches Versehen ist darin nicht zu erkennen. Dass der Rechtsbestand von Patenten nicht ohne Nachweis eines Interesses möglich ist, ist als gesetzgeberischer Entscheid hinzunehmen. Gleichzeitig ist aber zu berücksichtigen, dass es im Interesse der Allgemeinheit liegt, zu Unrecht patentierten Erfindungen den Schutz zu entziehen.6 Das Bundesgericht stellt an den Nachweis des Interesses dementsprechend keine hohen Anforderungen7, was in der Lehre nicht auf Kritik gestossen ist und bisweilen begrüsst wird.8 Das Bundespatentgericht stellt gestützt auf die bundesgerichtliche Rechtsprechung ebenfalls geringe Anforderungen an das eigene Interesse der Klägerin. So genügt ein Wettbewerbsverhältnis zwischen den Parteien und ein Schutzbereich des Streitpatents, das im Bereich der wirtschaftlichen Tätigkeit der Nichtigkeitsklägerin liegt.9 Es braucht keine Absicht, eine patentgemässe Ausführungsform tatsächlich zu verwenden, sondern

3 BPatGer, Urteil O2022_007 vom 5. März 2024, E. 13 – «Abixaban». 4 AS 1999 1363; BBl 1998 1633. 5 AS 2008 2551; BBl 2006 1. 6 BGE 116 II 196 E. 2a – «Doxycyclin». 7 BGE 116 II 196 E. 2a – «Doxycyclin». 8 HEINRICH, PatG/EPÜ, 3. Aufl. Bern 2019, Art. 28 N 2; HILTI/STAUBER, in: Hilti/Köpf/Stauber/Carreira (Hrsg.), Schweizerisches und europäisches Patentund Patentprozessrecht, 4. Aufl. Bern 2021, S. 465; GICK-KOMONDY, Schweizerische Patengerichtsbarkeit, Zürich 2010, S. 83; SCHMID, Negative Feststellungsklagen, AJP 2002 S. 774, 777; SIEVI, Die negativen Feststellungsklagen des schweizerischen Rechts im Anwendungsbereich des Lugano-Übereinkommens, Zürich 2017, Rz. 183; SHK PatG-SCHWEIZER, Art. 28 N 6; ZELLWEGER, Patentzivilprozessrecht, ZZZ 32/2013 S. 276, 316; HAAS, in: Adolphsen et al. (Hrsg.), Festschrift für Peter Gottwald zum 70. Geburtstag, Das Feststellungsinteresse, S. 215-232, S. 230, vertritt einen allgemein grosszügigen Massstab beim Feststellungsinteresse. 9 BPatGer, Urteil O2012_030 vom 17. September 2013, E. 16.3 – «selbstklebendes Band».

O2024_002 es genügt, dass der Bestand des Patents der Nichtigkeitsklägerin im Wettbewerb zum Nachteil gereichen könnte.10 23. Die Klägerin ist eine nicht operativ tätige Gesellschaft, die keine Einnahmen generiert. Ihr Zweck liegt darin, die Marktzulassung für Pyzchiva® in der Schweiz zu halten, was ihre Muttergesellschaft aus verwaltungsrechtlichen Gründen nicht kann (die Zulassungsinhaberin muss ihren Sitz in der Schweiz haben, Art. 10 Abs. 1 lit. c Heilmittelgesetz, HMG, SR 812.21). Da die Klägerin keine Einnahmen generiert, werden ihre Kosten – und solche fallen in einem gewissen Umfang auch bei einer nicht operativ tätigen Gesellschaft an, zumal die Klägerin die Marktzulassung hält – durch ihre Muttergesellschaft getragen. Die Klägerin ist vom wirtschaftlichen Schicksal ihrer Muttergesellschaft abhängig und hat daher ein eigenes Interesse, dass es ihrer Muttergesellschaft wirtschaftlich gut geht. Wie vorne dargelegt, erhält die Muttergesellschaft aus der Vertriebsvereinbarung mit Sandoz einen Anteil des Umsatzes, den Sandoz mit dem Vertrieb von SB17 unter anderem in der Schweiz erzielt. Die Einnahmen der Muttergesellschaft sind entsprechend höher, wenn Sandoz in der Schweiz mehr SB17 verkauft. Das Streitpatent steht dem Vertrieb von SB17 in der Schweiz potenziell entgegen; wenn die Beklagte gestützt auf das Streitpatent (erfolgreich) gegen den Vertrieb von SB17 in der Schweiz vorgeht, wird Sandoz weniger Umsatz und die Muttergesellschaft der Klägerin weniger Einnahmen generieren. Da es wie ausgeführt im Interesse der Klägerin liegt, dass es ihrer Muttergesellschaft wirtschaftlich gut geht, hat sie ein schutzwürdiges Interesse daran, die Nichtigkeit des dem Vertrieb von SB17 in der Schweiz potenziell entgegenstehenden Streitpatents f

Bundespatentgericht 12.08.2025 O2024_002

Zusammenfassung

Volltext