PATENT CLAIM ANALYSIS

Application Number: 15869499
Application Type: Utility
Filing Date: 2018-01
Publication Date: 2018-05
Patent Classification: ["544", "251000"]

Abstract:
The invention is directed towards stable formulations of 5,10-methylene-(6R)-tetrahydrofolic acid and its hemisulfate salt as well as pharmaceutical compositions and uses thereof in therapy, preferably chemotherapy.

Claim (Index 23):
A method for treating breast cancer, esophageal cancer, gastric cancer, gall bladder cancer, bile duct cancer, colon cancer, rectal cancer, colorectal cancer (CRC) including metastatic CRC, osteosarcoma, liver cancer, pancreatic cancer, ovarian cancer, head and neck cancer, mesotheolioma cancer, stomach cancer, bowel cancer, or lung cancer (specifically adenocarcinoma), comprising administering an effective amount of a pharmaceutical composition to a patient in need thereof, which composition comprises a lyophilized formulation A, B, C, D or E, or a method for methotrexate therapy, comprising administering methotrexate to a subject in need thereof, and additionally administering a pharmaceutical composition comprising a lyophilized formulation A, B, C, D or E, which\n A) is prepared from a hemisulfate salt of 5,10-methylene-(6R)-tetrahydrofolic acid, \n B) comprises 5,10-methylene-(6R)-tetrahydrofolic acid and/or 5,10-methylene-(6R)-tetrahydrofolate resulting from a hemisulfate salt of 5,10-methylene-(6R)-tetrahydrofolic acid, \n C) comprises about two moles of 5,10-methylene-(6R)-tetrahydrofolic acid and/or 5,10-methylene-(6R3-tetrahydrofolate to one mole of sulfate ions, \n D) comprises about 1 mole of 5,10-methylene-(6R)-tetrahydrofolic acid and/or 5,10-methylene-(6R)-tetrahydrofolate to one mole of sulfate ions without the presence of citrate, or \n E) comprises 5,10-methylene-(6R)-tetrahydrofolic acid and/or 5,10-methylene-(6R)-tetrahydrofolate having a chemical purity of greater than 99%, and sulfate with the presence of citrate or without the presence of citrate; or \n which is a stable pharmaceutical composition X or Y comprising\n X) a lyophilised hemisulfate salt of 5,10-methylene-(6R)-tetrahydrofolic acid, which has such stability that the composition maintains greater than or equal to 95% of purity of the 5,10-methylene-(6R)-tetrahydrofolic acid for at least 24 months at +25\u00b0 C./60% relative humidity; or for at least 12 months at +40\u00b0 C./75% relative humidity, or for at least 24 months at +5\u00b0 C., or for at least 24 months at \u221220\u00b0 C.; or \n Y) a reconstituted lyophilised hemisulfate salt of 5,10-methylene-(6R)-tetrahydrofolic acid, which has such stability that the composition maintains greater than or equal to 95% of purity of the 5,10-methylene-(6R)-tetrahydrofolic acid for at least 200 minutes at 2-8\u00b0 C., or for at least 2 hours at room temperature.

Metadata:
- Claim Count in Document: 17.0
- Percentile: 86.0
- Lexical Diversity: 1.06667
- Patent Class: 544.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: False
- Related Applications: ['15435787', '10562200', '14787980', '15865847', '10377618']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.7790662935189664
- 35 USC 102 Novelty (BERT): 0.6208553887207786
- Combined Prediction Score: 0.7632452030391477
- Mean Citation Score: 385.050542
- Max Citation Score: 734.84546
- Similarity Product: 500.464794217267

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

Dataset: test