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

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.

OOTL, what is stopping companies from making generics of the older version & patients just not using the new version?

"[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)

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.

> 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.

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...

[0] https://en.wikipedia.org/wiki/Dichlorodifluoromethane

I still have a dozen vintage cans of R-12 but no vehicle that uses them.

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.

> 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...

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.

A more nuanced regulation would limit the production volume if there are still valid use cases.

a.k.a. R-290

> 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.

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.

This is why blanket bans are almost always bad.

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.

ProAir HFA is one in which the legally permissible substitutions by the pharmacist are limited, largely because the old propellant (and thus generics based on it) is not legal for sale.

We use trade names because they're shorter and easier for patients (and doctors) to remember. Outside of a few specialized areas - epilepsy, warfarin, thyroid hormone - very very few doctors use branded products when a generic is available (and there's nothing wrong with the generics there, except that you need to get the same product every time to titrate the dose, and unless you know that X pharmacy will only stock the drug from Y manufacturer, it's a crapshoot).