[ur-whale]

> IMHO the answer is some kind of regulation

IMHO, the solution is actually less regulation.

If any company could enter that market with being sued into the ground, you'd get top notch a quality product for a fraction of the price before you could finish spelling epinephrine.

[tablespoon]

> IMHO, the solution is actually less regulation.

> If any company could enter that market with being sued into the ground, you'd get top notch a quality product for a fraction of the price before you could finish spelling epinephrine.

I doubt it. IIRC, EpiPens are off-patent, and the only thing holding back competition is the need to demonstrate the competing product is safe, reliable, and equivalent. I even believe a competitor product was withdrawn from the market because it was delivering an unreliable dosage.

So if you remove the regulations, you'll probably get a flood of corner-cutting crap that's dangerous. That's likely especially true for an emergency use item like an EpiPen, which literally sits on a shelf unused unless there's an emergency (leaving a big opportunity to sell defective items undetected by consumers).

[wizzwizz4]

The computer market is not particularly regulated, yet we still have international big tech monopolies stifling competition. I think the US simultaneously needs:

• less regulation, to reduce barriers-to-entry

• more regulation, to allow competition

Normally, I'd be concerned about reduced regulations having safety implications, but the existing situation is already unsafe.

[waterhouse]

Patents are a big part of how the stifling is done. Getting rid of them, or at least cutting their term by a factor of 3-4, would help a great deal.

[kragen]

While I agree that patents are net harmful, especially in software, if you cut their term by a factor of 4 to 5 years, many of them would expire before being granted, which would be a hard policy to defend.

[waterhouse]

Heh, interesting. Perhaps that problem would self-correct after a while; if the payoff for a patent was lower, fewer would apply and there would be less of a backlog... Hmm, looking into it, https://www.uspto.gov/dashboard/patents/pendency.html measures a bunch of different things, but it seems "traditional total pendency" is the main metric, and it seems to be about 2 years on that at the moment. Of course, if there's high variance, then that could mean that a bunch do take 5 years.

That said, if a patent is pending and no one knows when it'll be granted, is that not enough? Would competitors really introduce their own patent-violating version, knowing they may have to suddenly cut production if the patent goes through? Do they do that today?

At any rate, those delays seem absurd; presumably they're due to having a backlog, due to the USPTO not employing enough people, due presumably to them not having enough of a budget. Not that I'm in favor of giving money to patent-granters, though. I wonder if a fee paid by the patent-holders—say, a small percentage of the revenue from selling patented products—would be a reasonable way to fund it.

[kragen]

Competitors might have a bigger incentive to try to delay the granting of the patent with red tape.

I don't know how common it is today to introduce a product while planning to cancel it if a competitor's pending patent gets granted.

The funding of the PTO has been a contentious political issue for decades.

[denton-scratch]

Not with epinephrine, because it's out-of-patent. For clarity, I very much dislike the patent system.

[waterhouse]

Epinephrine itself, sure. Epipens, though? Looking at https://en.wikipedia.org/wiki/Epinephrine_autoinjector , I see "In 2009, Teva Pharmaceuticals filed an ANDA to market a generic EpiPen in collaboration with Antares Pharma Inc, a maker of injection systems; Pfizer and King sued them for infringing US Patent 7,449,012 that was due to expire in 2025", and "In 2010, Pfizer and King sued Novartis' Sandoz generic unit for patent infringement after Sandoz submitted an ANDA to sell a generic EpiPen."

You need a delivery mechanism that can be used quickly and reasonably safely, ideally by someone in the early stages of anaphylaxis. Taking out a vial and a syringe, and carefully extracting the epinephrine from the vial with the syringe, are not things you'd want to be doing under those circumstances. Hence the invention of better approaches.

But epipens were originally "brought to market in 1983". How are there still active patents for it? "Kaplan continued to improve his designs over the years, filing for example US Patent 6,767,336 in 2003." I wonder if the new patents cover the 1983 devices. If so, that seems like an obvious abuse of the system: keep filing a new patent for different aspects of or variations on the device, and you can multiply the duration of your monopoly grant.