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).

https://www.fiercepharma.com/pharma/regeneron-advances-antit...

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.

I don't disagree. That makes perfect sense. Is bad?

Most companies move to improve their product when needed to stay ahead of the competition.

That's how you get improvement.

PS, I read the rest of the paper.

Here are some choice parts:

> 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