PATENT CLAIM ANALYSIS

Application Number: 16175261
Application Type: Utility
Filing Date: 2018-10
Publication Date: 2020-01
Patent Classification: ["424", "001690"]

Abstract:
The present invention relates to radionuclide complex solutions of high concentration and of high chemical stability, that allows their use as drug product for diagnostic and/or therapeutic purposes. The stability of the drug product is achieved by at least one stabilizer against radiolytic degradation. The use of two stabilizers introduced during the manufacturing process at different stages was found to be of particular advantage.

Claim (Index 1):
A process for manufacturing a pharmaceutical aqueous solution, comprising:\n providing a solution comprising a complex of the radionuclide  177 Lu (Lutetium-177) and a somatostatin receptor binding peptide linked to the chelating agent DOTA; a first stabilizer against radiolytic degradation, and optionally a second stabilizer against radiolytic degradation different from the first stabilizer; and diluting the solution comprising the complex with an aqueous dilution solution comprising at least one stabilizer against radiolytic degradation to obtain the pharmaceutical aqueous solution; wherein if the solution comprising the complex comprises only the first stabilizer as an stabilizer against radiolytic degradation and not the second stabilizer, then the aqueous dilution solution comprises at least one stabilizer against radiolytic degradation that is different from the first stabilizer, and in the obtained pharmaceutical aqueous solution, the radionuclide  177 Lu is present in a concentration that it provides a volumetric radioactivity of from 250 to 500 MBq/mL and the stabilizers are present in a total concentration of from 1.0 to 5.0 mg/mL.

Metadata:
- Claim Count in Document: 53.0
- Percentile: 97.0
- Lexical Diversity: 1.30769
- Patent Class: 424.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: True
- Related Applications: ['16175239', '15133623', '15133726', '13264276', '10513586']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.6973115053302554
- 35 USC 102 Novelty (BERT): 0.6041439823734847
- Combined Prediction Score: 0.6879947530345785
- Mean Citation Score: 269.07739200000003
- Max Citation Score: 542.529
- Similarity Product: 469.55725048774485

Labels:
- Claim Label 101: 1
- Claim Label 102: 1
- Claim Label 103: 0
- Claim Label 112: 1
- Combined Label: 1
- Label 101 Adjusted: 1

Dataset: test