Patent details 
	
	
	
		
		
			300991
		 
		
			
			
				Product Name:
				
					golimumab
				 
			
		
	
	
		
		
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				Basic Information 
				
					Publication number: 
					300991 
					
					Type: 
					
						
						
							Certificate 
						
						
						
						
					
					
					
						SPC Type: 
						Medical 
						Basic Patent Number: 
						
							
								
									
								
								
							
							
								
									EP3118318 
								
								
							
						 
					
					Status: 
					
						
						
							Refused Art. 10 of the EC Regulations 
						
						
						
					
					
					
				 
				
					Application number: 
					300991 
					
					
						Procedural language: 
						Dutch 
					
					
					
					
					
					First Applicant Residence Country: 
					United States of America (US) 
					
				 
				
				
				
				
					Marketing Authorization 
					
						
						
							Marketing Authorization Number: 
							 (2016)4081 
							Marketing Authorization Type: 
							 EEA 
							
						 
						
							Marketing Authorization Date: 
							 28/06/2016 
							
							Marketing Authorization Country: 
							 European Union (EU) 
						 
					
				
				
				
				Dates 
				
					Filing date: 
					23/05/2019 
					
					
						First Marketing Authorization date: 
						28/06/2016 
					
					Grant date: 
					Activation date: 
						Lapsed By Non Payment Annual Fee Date: 
					Renunciation Date: 
					NullificationDate: 
					 
				
					Registration date: 
					27/05/2019 
					
					
						
							SPC/SPC Extension Expiration Date: 
						
						
					
					Lapsed By Expiration Date: 
					Withdrawal date: 
						Revocation Date: 
						Invalidity Date: 
						Withdrawal Market Authorization Date: 
						Refusal Date: 
						05/02/2021 
					
					
					
				 
				
				
				
					Applicant/holder  
					
						
						
							From: 
							23/05/2019 
						 
						
							  
							  
						 
						
							  
							
								Name: 
								Janssen Biotech, Inc. 
							 
							
								Address: 
								800/850 Ridgeview Drive, HORSHAM, PA 19044, United States of America (US) 
							 
						
						
					
				
				
				
				
				
					Agent 
					
						
						
							Name: 
							ir. H.A. Witmans c.s. 
							From: 
							23/05/2019 
						 
						
							Address: 
							V.O.
Postbus 87930, 2508 DH, Den Haag, Netherlands (NL) 
							To: 
							 
					
				
				
				
				
				
				
				
				
				
				
				
				
				
				
				
				
				
				
				
					Publication 
					
						Bulletin 
						
							
								1 
							
							
								Bulletin Heading: 
								VRV 
								Journal edition number: 
								06/21 
							 
							
								Publication date: 
								10/02/2021 
								Description: 
								Lapse or annulment 
							 
						
							
								2 
							
							
								Bulletin Heading: 
								SPC 
								Journal edition number: 
								22/19 
							 
							
								Publication date: 
								29/05/2019 
								Description: 
								Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates) 
							 
						
					
					
				
				
				
				
				
				
				
				
				
				
				
				
				
				
				
			 
			
			
				
					
					
						Filing date 
						Document type 
						Document Description 
						Number of pages 
						File Type 
						 
					 
					
					
						
							
								05/02/2021 
									
								
									
										
										
											
												
													
													
														 Outgoing Correspondence
													
												
											 
										
									
									 
								 Decision refusal 
								
									
										
										
											 3
										
									
								 
								
									
										
										
											
												PDF
											
										
									
								 
								/0/0/5/5/1/0800415500/docs/300991_6_393294l527a.pdf 
							 
						
							
								07/10/2020 
									
								
									
										
										
											
												
													
													
														 SPC Documents
													
												
											 
										
									
									 
								 Annex SPC 
								
									
										
										
											 4
										
									
								 
								
									
										
										
											
												PDF
											
										
									
								 
								/0/0/5/5/1/0800415500/docs/300991_0_supplprotectioncertificate20201007105925755.pdf 
							 
						
							
								07/10/2020 
									
								
									
										
										
											
												
													
													
														 Outgoing Correspondence
													
												
											 
										
									
									 
								 Letter to applicant 
								
									
										
										
											 1
										
									
								 
								
									
										
										
											
												PDF
											
										
									
								 
								/0/0/5/5/1/0800415500/docs/300991_4_370822l173.pdf 
							 
						
							
								05/10/2020 
									
								
									
										
										
											
												
													
													
														 SPC Documents
													
												
											 
										
									
									 
								 Annex SPC 
								
									
										
										
											 11
										
									
								 
								
									
										
										
											
												PDF
											
										
									
								 
								/0/0/5/5/1/0800415500/docs/300991_2_supplprotectioncertificate20201006093258681.pdf 
							 
						
							
								05/10/2020 
									
								
									
										
										
											
												
													
													
														 SPC Documents
													
												
											 
										
									
									 
								 Accompanying letter SPC 
								
									
										
										
											 3
										
									
								 
								
									
										
										
											
												PDF
											
										
									
								 
								/0/0/5/5/1/0800415500/docs/300991_5_supplprotectioncertificate20201006093258608.pdf 
							 
						
							
								29/07/2020 
									
								
									
										
										
											
												
													
													
														 Outgoing Correspondence
													
												
											 
										
									
									 
								 Letter to applicant 
								
									
										
										
											 3
										
									
								 
								
									
										
										
											
												PDF
											
										
									
								 
								/0/0/5/5/1/0800415500/docs/300991_1_357094l173.pdf 
							 
						
							
								28/05/2019 
									
								
									
										
										
											
												
													
													
														 Outgoing Correspondence
													
												
											 
										
									
									 
								 Confirmation receipt request 
								
									
										
										
											 1
										
									
								 
								
									
										
										
											
												PDF
											
										
									
								 
								/0/0/5/5/1/0800415500/docs/300991_10_276581l174.pdf 
							 
						
							
								23/05/2019 
									
								
									
										
										
											
												
													
													
														 SPC Documents
													
												
											 
										
									
									 
								 Annex SPC 
								
									
										
										
											 111
										
									
								 
								
									
										
										
											
												PDF
											
										
									
								 
								/0/0/5/5/1/0800415500/docs/300991_3_supplprotectioncertificate20190527020304725.pdf 
							 
						
							
								23/05/2019 
									
								
									
										
										
											
												
													
													
														 Application Form
													
												
											 
										
									
									 
								 First filed application form 
								
									
										
										
											 3
										
									
								 
								
									
										
										
											
												PDF
											
										
									
								 
								/0/0/5/5/1/0800415500/docs/300991_7_applicationform20190527020304278.pdf 
							 
						
							
								23/05/2019 
									
								
									
										
										
											
												
													
													
														 SPC Documents
													
												
											 
										
									
									 
								 Accompanying letter SPC 
								
									
										
										
											 2
										
									
								 
								
									
										
										
											
												PDF
											
										
									
								 
								/0/0/5/5/1/0800415500/docs/300991_8_supplprotectioncertificate20190527020304433.pdf 
							 
						
							
								23/05/2019 
									
								
									
										
										
											
												
													
													
														 SPC Documents
													
												
											 
										
									
									 
								 Summary of the characteristics of the product 
								
									
										
										
											 113
										
									
								 
								
									
										
										
											
												PDF
											
										
									
								 
								/0/0/5/5/1/0800415500/docs/300991_9_supplprotectioncertificate20190527020304573.pdf 
							 
						
							
								23/05/2019 
									
								
									
										
										
											
												
													
													
														 SPC Documents
													
												
											 
										
									
									 
								 Annex SPC 
								
									
										
										
											 3
										
									
								 
								
									
										
										
											
												PDF
											
										
									
								 
								/0/0/5/5/1/0800415500/docs/300991_11_supplprotectioncertificate20190527020304652.pdf 
							 
						
							
								23/05/2019 
									
								
									
										
										
											
												
													
													
														 SPC Documents
													
												
											 
										
									
									 
								 Marketing Authorization SPC 
								
									
										
										
											 3
										
									
								 
								
									
										
										
											
												PDF
											
										
									
								 
								/0/0/5/5/1/0800415500/docs/300991_12_supplprotectioncertificate20190527020304502.pdf