Ibrutinib - USA

 

IPR decision: Sep. 24, 2020

 

AIA Review #	Filing Date	Institution Date	Petitioner	Patent	Respondent	Final Written Decision
IPR2019-00865	03/21/2019	09/26/2019	Sandoz Inc.	9,795,604	Pharmacyclics Inc.	Some Challenged Claims Unpatentable

US 9,795,604 (Pharmacyclics LLC; Exp: 10/24/2034):

1. A method of treating chronic graft versus host disease (GVHD) comprising administering to a patient having chronic GVHD a therapeutically effective amount of a compound of the structure: (Ibrutinib) thereby treating the chronic GVHD in the patient. 

54. A method of treating chronic graft versus host disease (GVHD) comprising administering to a patient having chronic GVHD from 140 mg/day to 840 mg/day of a compound of the structure: (Ibrutinib)

55. A method of treating chronic graft versus host disease (GVHD) comprising administering to a patient having chronic GVHD about 420 mg/day of a compound of the structure: (Ibrutinib)

 

PTAB decision summary:

PTAB found claims 1, 6–10, 24, 35, 39, 55 unpatentable & claims 4, 13, 15, 28–31, 43–46, 50–53 patentable. Petitioner primarily relied on US 2015/0140085 reference which disclosed ibrutinib, treatment of GVHD, dose range & administration part. PTAB found that US’085 anticipated those claims (1, 6–10, 24, 35, 39, and 55). With respect to other claims which PTAB found patentable were related to treatment of cGVHD where patients received prior steroid therapy. PTAB held that the field was not fully developed with respect to treatment of steroid refractory/resistant cGVHD. PTAB said that given the poor understanding of cGVHD, the lack of animal models and standardized measurement criteria, and the unpredictability in the field, it is not surprising that many potential treatments have proven unsuccessful. Therefore, POSA would not have reasonable expectation of success in treating steroid resistant/refractory cGVHD. Other prior arts also do not cure this deficiency. Thus, claims 4, 13, 15, 28–31, 43–46, 50–53 are not shown to be unpatentable.