Why warn them? Just do it already.
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FTC warns pharma companies about sham patent listings designed to delay generics
31–40 of 101 posts
Re: FTC warns pharma companies about sham patent listings designed to delay generics
#32Why warn them? Just do it already.
I like the sentiment - but this is probably the "just do it already". Real warnings happen behind closed doors - this is probably a "We're going to create a PR nightmare if you don't fix your act, this is the first step on the public being very very mad. And we'd rather like to avoid going to court against your super-lawyers."
Re: FTC warns pharma companies about sham patent listings designed to delay generics
#33Earlier quoted context omitted.
Key phrase from the first paragraph: > ... FTC is now warning pharma that it might finally start cracking down. Sounds like a fishing expedition.
Regulatory agencies have a knack for warning market players to clean up their act before stepping in.
It legitimately tends to be the cheaper way to regulate. You've basically got two options: 1) give a big warning and hope you get a majority change in the industry because they can see the writing on the wall or 2) change the rules and, as immediately as is appropriate, open a bunch of lawsuits... then spend the next decade in the courts spending immense amounts of money while every one of the offending parties runs a big PR campaign about being singled out to comply with a rule that most of the other companies aren't complying with.
Politics is ugly and rarely will the straightforward approach be the easiest and cheapest.
Re: FTC warns pharma companies about sham patent listings designed to delay generics
#34These people won't stop lobbying to have this kind of exclusivity respected in other jurisdictions as well. Whether through the US government or directly, they've constantly pressured us here in Australia to "respect" the same privileges they enjoy in the US. Thank God we have largely resisted these efforts so far. Generics here are highly available for almost anything at the consumer level. Those who can afford to often buy name brand anyway, because of psychological reasons I guess, so pharmaeceutical companies still make stacks of cash, without poor people jeeding to spend half their weekly income on basic meds.
I understand and appreciate that the US government doesn't arbitrarily begin semi-retributive campaigns, and instead attempts to have companies self-correct. But in instances like this of obvious, wilful abuse of the law, there should be some drawing of blood frankly. It strikes me as a little pathetic that these agencies are always issuing "warnings" that they might actually start enforcing regulations. It's exactly this that makes these companies feel they have license to behave this way, because they know they'll have plenty of time to clean up if the laws actually start getting enforced, and they'll have made a tidy profit at everybody else's expense in the meantime.
Re: FTC warns pharma companies about sham patent listings designed to delay generics
#35Why warn them? Just do it already.
I like the sentiment - but this is probably the "just do it already". Real warnings happen behind closed doors - this is probably a "We're going to create a PR nightmare if you don't fix your act, this is the first step on the public being very very mad. And we'd rather like to avoid going to court against your super-lawyers."
Just revoke a corporate charter or two of the most frequent abusers. That will certainly get the attention of those that remain. Then you can warn them that they're next if they don't change tack pronto. Big companies are next to invulnerable when you treat them using the same playbook as you would a jaywalker or a person the runs a red light. They love their court cases because they have lawyers on retention and it helps them build an even stronger moat: the moat made up out of negligible legal costs at scale that would criple smaller players. So only large players remain. But revoking a corporation's charter instantly crushes that angle of defense and it is used far too sparingly.
After that the shareholders get to pick over the leftovers. It's the corporate equivalent of the death penalty and since these companies are responsible for the lives of those that depend on affordable medication this sort of money grab is a reason people have reduced quality of life or die. It's beyond disgusting and such abuses deserve the harshest penalties available, not a slap on the wrist or a 'stop being soooo naughty' message.
Corporations exist by the grace of governments recognizing them as such. They want to be 'people' when it suits them and eternal constructs with zero responsibility when that suits them instead. I think we should treat them a bit more like people and kill a couple of the worst abusers. See if that angle yields the right response.
Re: FTC warns pharma companies about sham patent listings designed to delay generics
#36I've been taking the "blockbuster drug", Humira/Adalimumab, for more than 10 years. Humira alone is estimated to have generated US$200 billion in profits for a single company. Its history, its legal and commercial maneuvers are appalling and possibly the poster child for what is wrong with the patent system. And how public money originally funds much of the research into these drugs.
This year I finally started taking a biosimilar. Still extremely expensive. I don't have to pay for it, I sued the government to get it, here in Brazil. Unfortunately, this is not an uncommon situation. Our constitution guarantees our right to health and the government's obligation to provide it.
https://www.npr.org/sections/health-shots/2023/07/20/1188745...
Re: FTC warns pharma companies about sham patent listings designed to delay generics
#37I have to admit I didn't know how the Orange Book worked, so I had to do some research. Do I have this right? "An Orange Book listing shows "approved prescription drugs, related patent and exclusivity information, and therapeutic equivalence evaluations, along with other information." https://www.fda.gov/drugs/news-events-human-drugs/our-perspe... So a pharma company can insert a listing saying that, for a bogus exam…
If I understand things correctly (not assured by any means, as I've only skimmed some of the sources), the abuse vector looks something like this:
1) A company files that trivial "improvement" patent, or simply picks a recent patent out of its portfolio whose applicability to the drug is unclear. Hilariously, in the linked example from the article, the "improvement" was merely to claim that a metabolite was the active molecule rather than the drug per se, and thus change the instructions for when to take the pill relative to mealtimes.
2) The company files for an Orange Book listing asserting that the new patent applies to the old drug.
3) A generic manufacturer seeking approval disputes this assertion in its ANDA (abbreviated new drug application) filing.
4) The FDA provisionally approves the generic.
5) The generic manufacturer starts tooling up for manufacturing and taking orders for the product.
6) The brand-name manufacturer sues the generic manufacturer, which automatically triggers a 30-month stay on the approval.
Re: FTC warns pharma companies about sham patent listings designed to delay generics
#38I have to admit I didn't know how the Orange Book worked, so I had to do some research. Do I have this right? "An Orange Book listing shows "approved prescription drugs, related patent and exclusivity information, and therapeutic equivalence evaluations, along with other information." https://www.fda.gov/drugs/news-events-human-drugs/our-perspe... So a pharma company can insert a listing saying that, for a bogus exam…
Not only bogus, but if you get a hit on a scaffold you can combinatorially modify that scaffold and file it with the patent. This effectively blocks the small permutation space around the drug from further investigation or development. There's lot of promising science that can't be done because incumbents are so adversarial about patent space for structures they don't even care about. To make matters worse, patent da…
Thanks, let's leave out software. Not that it's not relevant, but it's a black hole for this crowd. One should not try to understand everything by analogy with software.
Re: FTC warns pharma companies about sham patent listings designed to delay generics
#39Earlier quoted context omitted.
Not only bogus, but if you get a hit on a scaffold you can combinatorially modify that scaffold and file it with the patent. This effectively blocks the small permutation space around the drug from further investigation or development. There's lot of promising science that can't be done because incumbents are so adversarial about patent space for structures they don't even care about. To make matters worse, patent da…
Thanks, let's leave out software. Not that it's not relevant, but it's a black hole for this crowd. One should not try to understand everything by analogy with software.
Cars, then?
Re: FTC warns pharma companies about sham patent listings designed to delay generics
#40If they were serious then they would put the CEOs in jail.