Table 1.
Selected antibody dosage patents or patent applications that reflect the approved dosage.
| Approved antibody | Patent | Status | Claimed dosage | Respective dosage in the EMA label |
|---|---|---|---|---|
| Rituximab | EP1616572B1 (Biogen) | Revoked in first instance opposition proceedings, appeal pending | Use of rituximab for treatment of CLL at a first dose of 375 mg/m2 and subsequent dosage of 500 to 1500 mg/m2 | CLL: The recommended dosage of MabThera in combination with chemotherapy (…) is 375 mg/m2 (…) on day 0 of the first treatment cycle followed by 500 mg/m2 (…) on day 1 of each subsequent cycle for 6 cycles in total. Chemotherapy should be given after MabThera infusion |
| Etanercept | WO2013059405, WO2013059408, WO2013059410 (Coherus) | Pending (basic patent has no dosage instruction) | Stabilized etanercept formulation comprising xylitol and optionally meglumine (WO’410), meglumine with optionally sucrose and/or sodium chloride (WO’408) or serine, with proline and/or glutamate (WO’410) Preferably, the formulation comprises about 25 to about 75 mg/ml etanercept | RA: 25 mg Enbrel administered twice weekly is the recommended dose. Alternatively, 50 mg administeredonce weekly has been shown to be safe and effective |
| Infliximab | US7179466 (Centocor) | Granted | Method of treating RA comprising a single or divided 3–5 mg/kg dose at least once every 6 weeks of an anti-TNF antibody that competitively inhibits binding of A2 (ATCC Accession No. PTA-7045) to human TNF | *RA: The recommended dose of Remicade is 3 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 3 mg/kg every 8 weeks thereafter for the treatment of moderately to severely active RA |
| Adalimumab | EP1406656B1 (AbbVie) | Withdrawn by patentee in opposition proceedings | Composition comprising 40 mg of adalimumab | RA: The recommended dose of Humira for adult patients with RA is 40 mg administered every other week as a single dose via subcutaneous injection |
| Bevacizumab | EP2478114B1 (Roche) | Granted | Method of identifying a patient with a lung cancer who may benefit from anti-angiogenic therapy comprising an anti-VEGF antibody and at least one chemotherapeutic agent. Preferably, the anti-angiogenic therapy comprises 7.5 mg/kg of bevacizumab | NSCLC: Avastin is administered in addition to platinum-based chemotherapy for up to 6 cycles (…) followed by Avastin as a single agent until disease progression. The recommended dose (…) is 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion |
| Trastuzumab | EP1210115B1 (Roche) | Revoked by EPO in first instance opposition proceedings, appeal pending; UK part finally revoked by UK Court | Use of huMab 4D5-8 for treating breast cancer characterized by overexpression of ErbB2, comprising an initial dose of 8 mg/kg; and a plurality of subsequent doses of 6 mg/kg, wherein the doses are separated by 3 weeks | Breast cancer: Triweekly schedule; The recommended initial loading dose is 8 mg/kg (…). The recommended maintenance dose at 3-weekly intervals is 6 mg/kg (…), beginning 3 weeks after the loading dose |
*
FDA label. Abbreviations: CLL: Chronic Lymphocytic Leukemia; EPO: European Patent Office; NSCLC: Non Small Cell Lung Cancer, RA: Rheumathoid Arthritis; TNF: Tumor Necrosis Factor; VEGF: Vascular Endothelial Growth Factor.