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. 2016 Apr 26;8(5):841–847. doi: 10.1080/19420862.2016.1180491

Table 5.

Time lag between filing date of dosage-related patent and onset of clinical trials (when the dosage was actually established).

Patent Number Subject matter Priority date Approval date Studies Study timeline Delay between priority date and study onset
EP1616572B1 Rituximab for treatment of CLL Nov. 9, 1998 Feb. 27, 2009 (EMA) ML17102/CLL8 (NCT00281918)
BO17072/Reach(NCT00090051)
First received: Jan. 24, 2006
Last verified: Sept. 9, 2013
First received: Aug. 23, 2004
Last verified: May 2013
8 years
EP2459167B1 Trastuzumab for breast cancer, sc administration July 31, 2009 Sept. 2, 2013 (EMA) HannaH(NCT00950300) First received: July 30, 2009 Last verified: March 2016 −1 day