4 ms·
This article is sort of light on substance and talks a lot about the evils of useless patents without really looking at the broader financial picture, or lookin
by aaavl2821 8y ago
This article is sort of light on substance and talks a lot about the evils of useless patents without really looking at the broader financial picture, or looking at the real bad actors
The real bad actors are companies like Martin shkrelis, or some generics companies that take advantage of regulatory loopholes to sustain monopolies long after the patent expiry. Epipen is the most well know example; acthar gel is another. However for these drugs patents aren't really as much the issue, it's more a regulatory gray area bc FDA has not provided a clear path to developing genetic versions of "complex" drugs
The "lifecycle management" patent games mentioned in the article largely no longer work. In general an insurance company won't pay a lot more for a caramel tasting biofilm vs a lime flavored one, or for other trivial innovations that don't improve clinical outcomes. Drug companies file the patents and try to squeeze out gains, but it isn't really that viable of a strategy anymore
The only time this actually results in a company being able to charge high prices after the primary patents expire is when there is a new patentable innovation that actually makes patients healthier. A good example is Raptor Pharmaceutical and their drug Procysbi. The drug treats cystinosis, a rare genetic disease that affects young children, impairing growth, and can cause rickets, blindness and acidosis and lead to complete kidney failure by age 10
A generic drug, cysteamine, was used to treat the disease. However it was not a great drug for patients, I think it required 4x day dosing so kids had to wake up like twice in the night to take their meds, resulting in a lot of missed meds, and it also smelled bad (again these are kids taking the drug, if it smells bad they will fight taking it).
Procysbi was an improved formulation of cysteamine that was easier for patients to take -- they didn't have to wake up in the night to take it. They did a clinical study showing it was just as effective as cysteamine with less nausea and vomiting but they did not design the study for superiority (ie they did not measure whether improved adherence led to better outcomes), although all but 1 patients chose to stay on Procysbi after the study
The company that developed Procysbi charged like $200k / year for it. It was a much better drug for really sick patients, and the company did actual research, but the generic was $8k a year.
By the way, the disease affects 500 people in the US / year, and the company treated a significant portion of that population for free during its clinical studies
The drug made 500 sick kids healthier, and would never have existed if the company could not charge a high price (again, total market size of 500 patients)
I think it's clear that I support this type of work but I understand that some people might rightly view this as unfair. However I think this example is a much better example of the "lifecycle management strategies" that actually work today than the ones referred to in the article
For more about Procysbi see here: https://camargopharma.com/2013/05/raptors-procysbi-costs-more-than-a-generic/ https://camargopharma.com/2013/05/raptors-procysbi-costs-mor...