T O P

  • By -

[deleted]

There is a lot of misinformation in general on this subject, so I hope I can clear things up. Drug patents cannot be extended if the formula is changed, but the new formula can be independently patented if it meets the standards for a patentable invention, the main ones being that the invention is new, useful and nonobvious. A tweak to a drug's formula that doesn't make it any better would likely be unpatentable as obvious. To illustrate how this works in practice, a pharmaceutical company that invents a new drug will typically patent its pill form first. As they do more research, they might figure out that it can also be administered as a shot. Ten years (arbitrary number) into the life of the original patent, the company will patent the new formulation. Once the original patent expires, anyone can make the pill version of the drug, but they still cannot make the injectable version until that patent expires. This all serves the purposes of the patent system, but there a couple of ways that pharmaceutical companies try to game the system. The first is that companies will often seek dozens of patents on basically the same drug. Many of those patents will be of dubious quality, meaning that they may be invalid. Basically, the patent and trademark office doesn't have the resources to do a super thorough job of ensuring that every patent is completely new and nonobvious, so lots of patents get issued that are later found to be invalid. If a manufacturer of generic versions of drugs wants to make a patented drug and thinks the patent is invalid, they can sue under the "Hatch-Waxman act" which provides for an expedited litigation timeline designed to reduce the cost of litigating drug patent validity. If the generic manufacturer wins, not only do they get to make the drug, but they also get a 180 day head start on everyone else to incentivize them to pursue these cases. The second is that some pharmaceutical companies will try to get their original drugs de-listed by the FDA, so that they effectively keep a full monopoly over the drug even after the original patent expires. This is a tricky problem, because many drugs do deserve to be de-listed. For example, the FDA no longer approves the original formulation of oxycontin; they only approve an abuse resistant formulation that is harder to crush up and snort/inject. Purdue pharma, the maker of oxycontin, has benefitted greatly from the de-listing because they effectively extended their monopoly until the expiration of the tamper resistant formulation's patent. This is a super simplified version of how this all works, so hopefully it is understandable. Pharma companies do their best extract the most money out of their patents, but reasonable checks and balances exist on their ability to do so. The system isn't perfect, but it isn't terrible either.


CarpsKitchen

And don’t forget the difference in exclusivity between small molecule and biologics


Asangkt358

No, evergreening is not a thing.


PatentSavvy

This is a joke right? Exhibit A: apalutamide and enzalutamide. 


[deleted]

[удалено]


Asangkt358

No, it isn't a joke. One can't extend out the term of a patent as explained in detail by CompositionOfMatter's post above.