For decades, a common refrain in alternative medicine circles and even among frustrated clinicians has been: "We can't run trials on this substance because there's no patent protection." This claim has become the go-to excuse for why promising older drugs or unconventional therapies never make it through FDA approval, never enter formal clinical use, and remain on the fringes of medicine.
For those evaluating the commercial prospects of NP001 (sodium chlorite for ALS), it’s important to note that the core patent application US20230190790A1 appears, in my personal opinion, unlikely to be granted.
The claims primarily cover:
• Diluting a sodium chlorite solution with saline
• Administering to ALS patients (with a ≥12-month symptom history)
These features largely represent routine clinical procedures or obvious formulation choices, with minimal inventive step. Prior literature already discusses sodium chlorite’s immune-modulating properties, and even earlier ALS use cases exist. Therefore, the patent’s novelty and non-obviousness are questionable.
Without patent protection, commercial success will depend solely on regulatory exclusivity (e.g., Orphan Drug Act, 5-year FDA exclusivity), not intellectual property.
I would be against patents so long as regulatory bodies stayed clear. We don't patent surgical procedures, yet successful innovations become accepted best practice.
Comment Addition:
For those evaluating the commercial prospects of NP001 (sodium chlorite for ALS), it’s important to note that the core patent application US20230190790A1 appears, in my personal opinion, unlikely to be granted.
The claims primarily cover:
• Diluting a sodium chlorite solution with saline
• Administering to ALS patients (with a ≥12-month symptom history)
• Standard infusion parameters (e.g., 2 mg/kg, 0.45% NaCl, pH 7.5–9.5)
These features largely represent routine clinical procedures or obvious formulation choices, with minimal inventive step. Prior literature already discusses sodium chlorite’s immune-modulating properties, and even earlier ALS use cases exist. Therefore, the patent’s novelty and non-obviousness are questionable.
Without patent protection, commercial success will depend solely on regulatory exclusivity (e.g., Orphan Drug Act, 5-year FDA exclusivity), not intellectual property.
I would be against patents so long as regulatory bodies stayed clear. We don't patent surgical procedures, yet successful innovations become accepted best practice.