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FTC challenges 'junk' patents held by 10 drugmakers, incl Novo Nordisk's Ozempic

(www.cnbc.com)
152 points toomuchtodo | 18 comments | 30 Apr 24 21:06 UTC | HN request time: 2.241s | source | bottom
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akira2501 ◴[30 Apr 24 21:33 UTC] No.40216636[source]▶
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.

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RheingoldRiver ◴[30 Apr 24 21:52 UTC] No.40216858[source]▶
> 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?

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1. chemeng ◴[30 Apr 24 21:55 UTC] No.40216891[source]▶
It is illegal to use the previous propellant, so they can’t be manufactured anymore.
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2. chroma ◴[30 Apr 24 22:00 UTC] No.40216938[source]▶
Where can I read more about this? If that’s true, it seems like a problem of over-regulation, not drug companies being exploitative.
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3. hed ◴[30 Apr 24 22:03 UTC] No.40216969[source]▶
R-12 is banned for manufacture by international treaty (which carries the force of law): https://en.wikipedia.org/wiki/Dichlorodifluoromethane
4. striking ◴[30 Apr 24 22:03 UTC] No.40216978[source]▶
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.

replies(1): >>40217286 #
5. modriano ◴[30 Apr 24 22:05 UTC] No.40216994[source]▶
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

6. nick__m ◴[30 Apr 24 22:08 UTC] No.40217022[source]▶
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.
7. mitthrowaway2 ◴[30 Apr 24 22:12 UTC] No.40217064[source]▶
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.
replies(1): >>40218285 #
8. dylan604 ◴[30 Apr 24 22:12 UTC] No.40217065[source]▶
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.
9. pessimizer ◴[30 Apr 24 22:18 UTC] No.40217119[source]▶
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...

10. prepend ◴[30 Apr 24 22:37 UTC] No.40217286{3}[source]▶
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.

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11. striking ◴[30 Apr 24 22:59 UTC] No.40217514{4}[source]▶
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.

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12. multimoon ◴[30 Apr 24 23:31 UTC] No.40217739{5}[source]▶
> 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.

I disagree with that statement. As mentioned above if it causes the drug companies to be able to re-patent the same drug again at 20x the price, then it’s not a drop-in replacement.

If this is a propellant used in life-saving medicine and this regulation increased the price then it’s a bad regulation, period. If there’s already an exception to be used as a fire retardant then medical applications can be included in there as well. The immeasurable output from an inhaler isn’t going to damage the ozone layer.

Over time you can migrate the production to the newer chemical and still achieve the same effect without hiking the price, since the drug companies won’t charge 20x the price if the cheaper generic still exists.

Politicians unfortunately do this all the time where they create a regulation without going through an analysis of tangentially related cause and effect.

replies(1): >>40217791 #
13. jncfhnb ◴[30 Apr 24 23:37 UTC] No.40217791{6}[source]▶
The problem is the patent, not the regulation
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14. multimoon ◴[30 Apr 24 23:41 UTC] No.40217824{7}[source]▶
You’re correct that the patent should’ve never been awarded, but the regulation still caused a problem today - something that could’ve been avoided if a cause-effect analysis was done. This is a problem statement that is applicable to most regulation today.

This is why blanket bans are almost always bad.

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15. jncfhnb ◴[30 Apr 24 23:53 UTC] No.40217902{8}[source]▶
That logic cuts both ways as a tool to prevent important regulation that harms a small interest for the public benefit.
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16. redeeman ◴[01 May 24 00:47 UTC] No.40218285{3}[source]▶
and while we're at it, maybe punish the ones who granted it? perhaps even make the people who did it, and anyone who knew of it, and didnt try combat it PERSONALLY liable for it?
17. CaliforniaKarl ◴[01 May 24 01:52 UTC] No.40218665{4}[source]▶
You might not get the price-benefits you expect.

If the only remaining allowed use for R-12 is in inhalers, the manufacturing volume might be so low that you end up in a similar situation to today: Fewer manufacturers (likely just one), higher prices, and supply-chain issues.

18. multimoon ◴[01 May 24 14:34 UTC] No.40223832{9}[source]▶
That’s why you an analyze cause and effect. You should target the highest driving factor and ban that, not blanket ban and catch things in the crossfire that don’t make a statistical difference to what you’re trying to improve - that way you don’t cause ill effects elsewhere.