[HN Gopher] FTC challenges 'junk' patents held by 10 drugmakers,...
___________________________________________________________________
FTC challenges 'junk' patents held by 10 drugmakers, incl Novo
Nordisk's Ozempic
Author : toomuchtodo
Score : 108 points
Date : 2024-04-30 21:06 UTC (1 hours ago)
(HTM) web link (www.cnbc.com)
(TXT) w3m dump (www.cnbc.com)
| hombre_fatal wrote:
| They clarify "junk" in the article (and linked article) to mean
| "improperly listed", but what does that actually mean for a drug
| like Ozempic?
| ChrisArchitect wrote:
| Official release: https://www.ftc.gov/news-events/news/press-
| releases/2024/04/...
| andy_ppp wrote:
| I'm so impressed with the FTC lately, here is an excellent
| interview Jon Stewart did with the FTC chair Lina Khan:
| https://youtu.be/oaDTiWaYfcM
|
| I did joke I'm really surprised the vested interests selected
| someone competent who wants to hold these companies accountable
| to the public.
| germinalphrase wrote:
| There was a lot of chatter early in her tenure that she would
| be too young and inexperienced to be at all effective.
| cogman10 wrote:
| Which is a little silly given her credentials. Her antitrust
| research has been groundbreaking. She's almost single-
| handedly revitalized that area of law.
| darth_avocado wrote:
| Sometimes, the old timers get too comfortable with the status
| quo and you need someone who is too young to challenge it.
| dylan604 wrote:
| Let's try that at the top of the chart instead of a couple
| steps down.
| roughly wrote:
| There's a lot of talk about "both sides being the same", but
| the FTC alone has been a night & day difference from previous
| administrations.
| knowaveragejoe wrote:
| Nobody suggesting that "both sides are the same" has a shred
| of intellectual honesty.
| wddkcs wrote:
| Declarative moral statements like this are so vacuous. Of
| course there are intellectually honest people who believe
| both parties are the same. They may be evaluating or
| prioritizing the evidence differently, but that doesn't
| make one side or the other 'dishonest'. Casually impuning
| the morality of an entire swath of people is rhetoric that
| drives division and strife, not progress.
|
| For example, yes Bidens FTC is a standout actor, but 'both
| sides' just voted to perpetuate overseas wars with more
| American tax dollars. In terms of the American war machine,
| it's 100% accurate to say both sides are the same.
| roughly wrote:
| Then I suppose the appropriate way to phrase this would
| be "people suggesting both sides are the same need to
| qualify their statements."
| pessimizer wrote:
| You're making the assumption that they haven't, at
| length, until people got uncomfortable and wanted to
| leave.
| afavour wrote:
| The scenario you're proposing sounds like one person
| lecturing another and not listening to any counter
| points... wanting to leave feels like a natural reaction.
| toomuchtodo wrote:
| I would like to point out the administration's
| accomplishments in the last two weeks (shamelessly copied
| from Matt Stoller's recent piece "This Is What Governing
| Looks Like")
|
| * Banned non-compete agreements for 40 million workers
|
| * Raised overtime wages for 4 million salaried workers
|
| * Forced airlines to automatically offer refunds for canceled
| flights and poorly handled baggage
|
| * Banned illegal junk fees in mortgage lending
|
| * Forced divestment of TikTok from Chinese ownership
|
| * Blocked corporate merger in insulation
|
| * Filed to block a corporate merger in fashion
|
| * Announced tariff increases on steel to protect domestic
| producers
|
| * Announced an end to the duty free period on Chinese solar
| panels to encourage U.S. manufacturing.
|
| * Passed the first Federal privacy law to stop data brokers
| from selling sensitive information to China and Russia
| adventured wrote:
| Most of it needs backed up by Congress or it'll just go
| away given a few administrations.
|
| > Announced tariff increases on steel to protect domestic
| producers
|
| The Trump Admin went after China far more than Biden has so
| far, the Democrats were overwhelmingly silent about how
| that qualified as impressive governing. He needs to do a
| lot more to bolster US labor and US manufacturing, it's not
| even a good start yet.
| Retric wrote:
| Mostly people don't give praise because Trump's
| protectionism was largely ineffective.
|
| https://en.wikipedia.org/wiki/Trump_tariffs
| dylan604 wrote:
| > * Passed the first Federal privacy law to stop data
| brokers from selling sensitive information to China and
| Russia
|
| At the risk of sounding dismissive, I'd much rather they
| banned the selling of sensitive information. Full stop.
| China and Russia have much less reach into my day-to-day
| than any of the other buyers much closer to home like a
| local gov't bodies let alone private corps.
| toomuchtodo wrote:
| https://news.ycombinator.com/item?id=40203558
| bogwog wrote:
| You can tell she's doing a good job by the number of hit
| pieces in the WSJ. Just search "Lina Khan WSJ" and have fun
| scrolling through the headlines.
| roughly wrote:
| I can't find it right now, but there's a quote about being
| able to tell someone's character by whether they've made
| the right enemies.
| toomuchtodo wrote:
| "I ask you to judge me by the enemies I've made" -
| Franklin D. Roosevelt
| JumpCrisscross wrote:
| To be fair, her first two years were bunk. She had
| management and morale issues, a series of court losses
| (including one glaringly incompetent one with Facebook) and
| then a retrenchment that looked like submission.
|
| It wasn't. She was re-working her game. It looks like it
| worked and I've gone from critic to fan. But the FTC was
| mockably awful 2020 - 2022, and a non-entity early 2023.
| dylan604 wrote:
| There will always be carry over from one administration
| to the next at the bureaucratic level within the various
| agencies. It takes time to figure out how to get them
| aligned to make progress with the new administration's
| agenda.
| JumpCrisscross wrote:
| > _takes time to figure out how to get them aligned_
|
| From what I understand, Khan was learning to manage a
| large team. She failed at it. Noticed. Corrected. And
| seems to have figured it out.
|
| The early FTC was highly centralised. In its new
| iteration, staffers appear to be trusted to pursue probes
| on their own. This not only broadens their firepower, but
| brings to the table staffers' decades of experience
| around what wins in court.
| toomuchtodo wrote:
| You might say she's running the FTC like a startup: hire
| exceptional people you trust to execute with autonomy.
| JumpCrisscross wrote:
| > _she 's running the FTC like a startup: hire
| exceptional people you trust to execute with autonomy_
|
| The exceptional people were there from the start. In the
| early days, their complaint was around being locked out
| of decision making. Khan and a small group ran the FTC
| like academics.
|
| That failed both internally and in the courts. To her
| credit, she noticed the failure, regrouped and re-
| oriented. But the change wasn't in star hiring but
| recognising the talent that was being ignored.
| dylan604 wrote:
| What ever the cause of the slow start, it'll be a shame
| if it all comes to a grinding halt on Jan 20, 2025 now
| that this agency seems to be effectively doing its job.
| jtriangle wrote:
| Both sides are the same in the way that, they _generally_
| work in tandem to erode the common individual in favor of the
| wealthy. That doesn 't mean the totality of what they do is
| to that end, it doesn't mean that they aren't at odds with
| eachother as to how to reach that collective goal at times,
| just that, pragmatically, it doesn't matter anywhere but on
| very short, ultimately inconsequential time scales.
|
| These things get planned and implemented far outside of the
| normal 2/4/6 year election cycle, so it's easy to hide what's
| actually happening.
|
| Fact is, red tie, blue tie, they're all drinking and
| merrymaking together, they attend the same parties, they bang
| the same hookers, and they're in the same corporation's
| pockets. You have some outliers here and there, but, aside
| from the occasional filibuster, they do little more than
| create a spectacle.
|
| None of this is unusual, it's simply how systems of
| government have been exploited and subverted since humans had
| the idea the government should exist. That being a somewhat
| esoteric idea only serves to further the degeneration of a
| system, much in the same way doing nothing, which is likely
| what some find so offensive about the idea that "both sides
| are the same", furthers the degeneration of a system.
| blackhawkC17 wrote:
| This frankly sounds like cynical rubbish.
| kstrauser wrote:
| In the last week I've read stories here and elsewhere about
| the current administration:
|
| - Ending non-competes
|
| - Ending salaries being used to avoid paying overtime
|
| - Un-banning marijuana
|
| - Restoring net neutrality
|
| - Fining carriers for sharing location data
|
| - And now, challenging dumb patents
|
| Despite your cynical take, that looks like a lot of stuff
| that's good for me as an individual person.
| pavon wrote:
| Do they? I'm not well immersed in the socials, but I thought
| "both side are the same" peaked around 2000, and now the
| pendulum has swung to "the other side is wrong in every way".
| umanwizard wrote:
| I think for stuff controlled by the president, "both sides
| are the same" is indeed clearly false. But there's a decent
| argument to be made that it doesn't really matter who you
| vote for for Congress, since the system is structured to
| require both parties to agree on almost any controversial
| legislation.
| madeofpalk wrote:
| Challenging things like this is a great first step, but they've
| got to actually win.
| akira2501 wrote:
| Good.
|
| They patented inhalers for a second time. It's the exact same
| drug. The only thing that changed was the propellant. It went
| from R-12 to R-134a. Everyone who had to switch out R-12 from
| refrigeration to drug manufacturing switched to R-134a. There was
| absolutely _nothing_ novel about it.
|
| It was _criminal_ to allow them the second patent for just the
| propellant change. It took generic $5 inhalers off the market and
| replaced them with $95 inhalers. It was was one of the most
| corrupt swindles I've ever personally seen.
| RheingoldRiver wrote:
| > It took generic $5 inhalers off the market and replaced them
| with $95 inhalers.
|
| OOTL, what is stopping companies from making generics of the
| older version & patients just not using the new version?
| chemeng wrote:
| It is illegal to use the previous propellant, so they can't
| be manufactured anymore.
| chroma wrote:
| Where can I read more about this? If that's true, it seems
| like a problem of over-regulation, not drug companies being
| exploitative.
| hed wrote:
| R-12 is banned for manufacture by international treaty
| (which carries the force of law):
| https://en.wikipedia.org/wiki/Dichlorodifluoromethane
| striking wrote:
| https://en.wikipedia.org/wiki/Dichlorodifluoromethane
|
| > In compliance with the Montreal Protocol, its
| manufacture was banned in developed countries (non-
| article 5 countries) in 1996, and in developing countries
| (Article 5 countries) in 2010 out of concerns about its
| damaging effect on the ozone layer.
|
| Seems a reasonable regulation to me.
| prepend wrote:
| Not reasonable if it prevents the minuscule amounts
| required for inhalers.
|
| A more nuanced regulation would limit the production
| volume if there are still valid use cases.
| striking wrote:
| The sentence immediately after the quoted section
| provides additional nuance, reading as follows:
|
| > Its only allowed usage is as a fire retardant in
| submarines and aircraft.
|
| There is no reason to continue the use of R-12 in
| inhalers when R-134a is a drop-in replacement, though
| you're welcome to do your own research if you still
| disagree with the legislation.
| modriano wrote:
| You can read about it in the wikipedia page [0]. This
| refrigerant isn't manufactured anywhere anymore because
| it was creating a hole in the ozone layer.
|
| [0] https://en.wikipedia.org/wiki/Dichlorodifluoromethane
| nick__m wrote:
| The first I know about is the montreal protocol for the
| ozone. Countries (all 19X of them) agreed banned CFCs and
| pharmaceutical products weren't excluded.
| mitthrowaway2 wrote:
| Well, patents are only supposed to be granted if an idea
| is non-obvious to someone skilled in the field. Replacing
| an illegal propellant with a legal one should be obvious
| to anyone in the field, so this patent deserves to be
| challenged.
| dylan604 wrote:
| It is true, which implies your understanding of the
| situation is confused. I dislike bigPharma as well, but I
| at least point the blame canon at the right target and
| not just indiscriminately point it at the person I
| dislike the most in the fight.
| pessimizer wrote:
| That's just your bias.
|
| > Several inhaler manufacturers formed the International
| Pharmaceutical Aerosol Consortium, a lobbying group
| dedicated to, among other goals, persuading lawmakers and
| regulators to ban inhalers with CFCs. The group spent
| hundreds of thousands of dollars, and in 2005, the FDA
| ruled that CFC inhalers would be phased out beginning in
| 2009. As a result of the ban, newer albuterol products --
| including Proventil HFA (which was approved in 1996),
| Ventolin HFA (approved in 2001), and ProAir HFA (approved
| in 2004) -- would be free from competition from
| inexpensive CFC-containing generics. HFA inhalers were
| protected by new patents on both the HFA propellants and
| the devices themselves, and they generally cost much more
| than generic CFC inhalers.
|
| _" Product Hopping in the Drug Industry - Lessons from
| Albuterol"_
|
| N Engl J Med. 2022 Sep 29;387(13):1153-1156. doi:
| 10.1056/NEJMp2208613. Epub 2022 Sep 24.
|
| https://pubmed.ncbi.nlm.nih.gov/36155425/
|
| [pdf] https://wvpublic.org/wp-
| content/uploads/2023/06/Tu-2022-Wout...
| ceejayoz wrote:
| Among other things, they pay them not to.
|
| https://www.nbcnews.com/news/amp/ncna447916
|
| > Known as "reverse settlement payments," or "pay-to-delay"
| deals, the financial arrangements are a unique but common
| practice in the pharmaceutical industry. Essentially, they
| allow drug manufacturers in some instances to pay competitors
| not to manufacture generic versions of their products,
| thereby ensuring that they maintain patent protection for as
| long as possible.
| azemetre wrote:
| How is this NOT a violation of antitrust laws? How does
| this not hurt market competition or even more basic, how is
| this not collusion or a price cartel?
| observationist wrote:
| It is. They make far more money than they lose in
| penalties when officials bother enforcing on any
| technical violations. It's such a huge pain in the ass to
| try enforcing these little violations and there's so much
| corruption and bureaucracy preventing effective
| enforcement of the big ones that any action against these
| companies at all is a noteworthy accomplishment for a
| regulatory agency.
|
| Lina Khan is punching way above her weight and using the
| FTC to do the job it's ostensibly designed for. She's
| aggressively poking some very ornery and obnoxious bears,
| hopefully some precedents will be set and corruption
| repaired. Most regulators are incentivized to play within
| the whole wink-wink-nod-nod government revolving door
| system of crony capitalism, but Khan doesn't seem to be
| playing that game, which is nice.
| LeifCarrotson wrote:
| Drug salespeople, doctors, pharmacists, and insurance
| companies.
|
| If you get a prescription for a ProAir HFA inhaler, which is
| parented because it uses R134a, even if you did want to do
| your own research and evaluate whether the generic with the
| different propellant would work you can't just go buy the
| generic, you have to do extra work to get a prescription that
| applies.
|
| Doctors don't write prescriptions for albuterol sulfate, they
| write ProAir HFA and it's up to the consumer to push back.
| They don't even advise taking OTC ibuprofen or
| pseudoephedrine, they say Advil and Sudafed. It's a pet peeve
| of mine, but it seems I'm the weird one in that respect...
| transcriptase wrote:
| In Canada pharmacists will generally just ignore brand
| names written by MDs and fill with generics unless there's
| a known difference or the patient specifically asks (and is
| willing to pay more).
| haldujai wrote:
| It's similar in both countries with some slight variation
| in the US depending on the state.
|
| Unless the prescription is marked as "do not substitute"
| pharmacists generally have the discretion to substitute
| for a generic, in fact a few states require it.
| prepend wrote:
| In the US if a doctor prescribed a brand name, the Rx works
| for the generic as well. For me, it usually happens
| automatically at the pharmacy with no action on my end.
| pessimizer wrote:
| A group of pharmaceutical companies that held patents for
| non-CFC inhalers got together and created the "International
| Pharmaceutical Aerosol Consortium" to lobby in order to get
| the generic version banned.
| flipbrad wrote:
| This isn't (AIUI) relevant to that exact problem. As Wikipedia
| explains:
|
| "[T]he Orange Book lists patents that are purported to protect
| each drug. Patent listings and use codes are provided by the
| drug application owner, and the FDA is obliged to list them. In
| order for a generic drug manufacturer to win approval of a drug
| under the Hatch-Waxman Act, the generic manufacturer must
| certify that they will not launch their generic until after the
| expiration of the Orange Book-listed patent, or that the patent
| is invalid, unenforceable, or that the generic product will not
| infringe the listed patent. "
|
| It sounds like it's easy for manufacturers to.keep adding
| patents, and the onus is on the generics to make the case that
| they're not violating. Perhaps most are just scared away, until
| every listed patent expires (and no new ones are added in the
| interim)
| mynameisnoone wrote:
| The exact same refrigerants that were used in US automotive
| air-conditioning, although now they moved on or are moving from
| R-134a to HFO-1234yf.
|
| I still have a dozen vintage cans of R-12 but no vehicle that
| uses them.
| culopatin wrote:
| I replaced all my r12s with propane. Worked much better than
| the 134 and it was cheaper.
| akira2501 wrote:
| > propane
|
| a.k.a. R-290
| microtherion wrote:
| Presumably they have their grounds for the challenges, and the
| article says that each drug is covered by numerous patents, but I
| would be very surprised if Ozempic in particular lost ALL patent
| protection. Semaglutide itself seems to be a fairly revolutionary
| product, and reasonably different from Liraglutide (which I think
| predated it).
| siliconc0w wrote:
| The cost of healthcare should trend down as more and more drugs
| enter the public domain and generics become available. However
| this clearly isn't happening.
|
| It is also interesting when does the social benefit of a drug
| outweigh the benefit of creating an 'incentive' for drug
| companies. If GLP-1 drugs are worthy of the hype, we're basically
| talking about 20 years of unneeded suffering and trillions of
| dollars of avoidable damage to society all to give a drug company
| a limited monopoloy. At a certain point the US should just
| eminent domain the patent, give them some reasonable
| compensation, and make the drug broadly available to all
| Americans similar to COVID vaccines.
| chroma wrote:
| Semaglutide was invented before 2008. Its patent expires in a
| few years.
|
| It takes a long time to get drugs through trials and get the
| FDA to approve drugs for new uses. Pharmaceutical companies
| spend billions on drugs that never make it through trials. If
| you don't enforce their patents, companies won't make new
| drugs.
| bodiekane wrote:
| I wonder if a system like that could work.
|
| SpaceX and numerous other companies were able to draw in
| billions of dollars of funding for R&D to chase after US
| Government contracts that could only be won by proving massive
| technological feats (reusable rockets, etc).
|
| Hypothetically, it seems we could do something similar for
| drugs. Instead of "If you make a medicine that works, you get a
| monopoly to sell it for X years" it could just be "If you make
| a medicine that works, you get a check for $X, and then the
| drug is immediately generic".
| JumpCrisscross wrote:
| FTC announcement: https://www.ftc.gov/news-events/news/press-
| releases/2024/04/...
|
| Note that this comes following "the Commission's November
| challenges led to Kaleo Inc., Impax Labs, GlaxoSmithKline, and
| Glaxo Group delisting patents in response to the FTC's warning
| letters" and subsequently "AstraZeneca, Boehringer Ingelheim, and
| GlaxoSmithKline all announc[ing] commitments to cap inhaler out-
| of-pocket costs at $35." This process is precedented with
| delivering wins.
| superq wrote:
| Why are these junk patents, especially the Ozempic one? I want to
| believe! But I'm skeptical that it is a junk patent.
| modeless wrote:
| Novo Nordisk stock didn't fall so either this was already known
| or people don't think it will have any effect.
| dpc_01234 wrote:
| This article repeats the same thing 5 times or so. The headline
| is almost the whole article.
___________________________________________________________________
(page generated 2024-04-30 23:01 UTC)