Yeah, the drug + the injector together are the patentable thing. When the first patent nears expiration, they work on an iteration of the injector or a time release change for the drug, then they get another few decades of product monopoly.
They have also made a business of either stifling or “catch and kill”ing of the generics for their products. It’s cheaper to pay off a generic manufacturer to not compete with the new thing than it is to lose price elasticity of the n non-generic.
I didn’t make the claim that the expired patent prevented the practice.
My comment was a quick and sloppy summary from my memory of an interview from several years ago. I think it was the EconTalk with the author of Drug Wars.
A more detailed and comprehensive list of these tactics to reduce competition either during or after patent expiry:
Patent-related strategies:
• Building “patent thickets” by filing multiple patents on different aspects of the same drug (formulation, dosing, manufacturing processes)
• “Evergreening” - seeking new patents on minor modifications to extend exclusivity periods
• Filing continuation patents and divisional applications to extend patent timelines
Product lifecycle management:
• “Product hopping” - making minor reformulations or switching to extended-release versions just before generic entry to move patients to the new version
• Discontinuing older versions that generics would reference
Legal and regulatory tactics:
• Pay-for-delay settlements where brand companies pay generics to postpone market entry
• Manipulating FDA safety programs (REMS) to make it difficult for generics to obtain necessary samples for testing
• Citizen petitions to the FDA raising questions about generic equivalence
Market-based approaches:
• Launching “authorized generics” through subsidiaries to capture generic market share
• Exclusive dealing arrangements with pharmacy benefit managers
Like I said above, they don't extend exclusivity or prevent practice of expired IP. All you have to do is not infringe the new IP. this is what the article says too. I disagree with their greater claim; The patents aren't rocket science- most are extremely easy to read, and the authors are hiding behind weasel worlds like "may" and "could"
There are some bad patents that should never have been granted, like Novartis' famous 631 patent [1]. However, those are the exception, not the rule. If you want to put a generic drug into an auto injector, there are a dozen generic autoinjector companies looking to take your money. Drug + autoinjector does not pass the US patent office non-obviousness test (for obvious reasons). What gets patents is custom design features - bells and whistles. New features are part of the roadmap because customers will prefer them over competition without them, not because it magically extends prior IP (that isn't a thing).
What I’ve noticed, is work on extended release formulations only occur close to or near the time of patent expirations.
It’s rarely because of a new technological breakthrough, but rather a way of drug companies lengthening the time they can profit off a drug.
If they released it earlier they would simply take market share from themselves, but by releasing it close to the time of generics they take market share from generics.
Why didn’t Wegovy come out 5 years sooner? Why does it use a different injector than Ozempic? I don’t know but sounds quite similar to the ER/XR strategy.
> Drug manufacturers listed 22 patents after FDA approval of the 10 products in the cohort...Post-approval patents only extended the duration of protection on 2 products (median 4.6 years.
This is makes sense if there is actually something novel to add [keeping in mind the authors are treating any IP as if it protects the entirety of the product. A sugar coating or whatever wont protect the non-sugar coated pill.
To the extent I agree with the paper, it is that the 30 month hold is weaponized and should be reviewed and the issue with settlements should be addressed
There are dozens of autoinjector manufacturers, and generics can and do change manufacturers. It looks like semaglutide uses an off the shelf Yposomate pen, although Novo Nordisk uses different injectors depending on the country and indication.
Novo Nordisk also has an in house pen, but this would not prevent someone from competing, unless patients simply prefer that design to a generic one.
While 2032 seems very far away now, its actually remarkably soon in the grand scheme of society.
My understanding is one of their defendable moats is the patent not on the compound itself, but on the injectors. Which is far longer.