> The administration did not immediately release details about how the process will work and how it will deem a drug costly enough to act. White House officials would not name drugs that might potentially be targeted.
> There will be a 60-day public comment period. If the plan is enacted, drugmakers are almost certain to challenge it in court.
It isn't even the role of the executive branch to address this area. It's the job of the legislative branch (ie actual patent reform). Thus, this announcement is election year posturing which will not result in meaningful change. It's not even a real threat toward pharma corps because they already know it's toothless and it's dishonest from the white house because they know the pharmas know this.
The entire point of patents is to create a limited-time monopoly which increases profits. The key to less costly drugs is real patent reform that increases free market price competition paired with streamlining onerous FDA regulations making it faster, less costly and less uncertain to develop new drugs. Pharmas are by far the largest political lobbyists/donors. They wouldn't keep spending all that money in Washington if it didn't work, thus the lack of any meaningful political lobbying reform is an upstream enabler of this problem. Legislative term limits would also help.
Even before partisanship made Congress functionally useless, they were deferring a lot of rule-making power to executive branch agencies. That was a reasonable thing to do. There are only a few hundred Congresspeople; they have neither the time nor the expertise to determine every detail of every regulation. So they set up agencies that are supposed to hire experts to provide those details.
The Patent Office is one of those agencies, and that gives the Executive Branch a fair bit of power to nudge the rules without Congress' help. It would be great if Congress weren't fundamentally useless, but it's just not the case, and so government governs with what power it has.
That comes down to a billion details by a billion different players (most notably the 800 pound SCOTUS gorilla). But it is entirely possible that the Patent Office could say, "See this rule here? Turns out we shouldn't have granted you that patent in the first place." That is very much a power they have.
They'd rather not do it that way. It's bad policy. So they're starting gently, by pointing to what weight they do have to throw around, and hoping that the pharma execs do the right thing. It might even work; we've already seen similar effects bring down the price of insulin (even if it's still three times the price of any first-world country).
It would be even better if Congress were to sit down and write decent legislation instead. But my unicorn and I won't be holding our breaths on that.
I think you overstate the power of Patent Office. I don't think they can just say "Turns out we shouldn't have granted you that patent in the first place." Without providing evidence such as prior art. I don't think the courts would tolerate they are making too much money" argument from the patent office.
There are so many things that receive patents where prior art exists. I wouldn't be surprised if someone looked just a little bit, they could find prior art for just about any drug and rule that it is close enough to invalidate the patent. All it takes is someone challenging it.
Yes, came to say this. There are mechanisms and some economic incentives for third parties to challenge issued patents leading to invalidation. Whether there is enough economic incentive is a case by case.
> The administration did not immediately release details about how the process will work and how it will deem a drug costly enough to act. White House officials would not name drugs that might potentially be targeted.
> There will be a 60-day public comment period. If the plan is enacted, drugmakers are almost certain to challenge it in court.
It isn't even the role of the executive branch to address this area. It's the job of the legislative branch (ie actual patent reform). Thus, this announcement is election year posturing which will not result in meaningful change. It's not even a real threat toward pharma corps because they already know it's toothless and it's dishonest from the white house because they know the pharmas know this.
The entire point of patents is to create a limited-time monopoly which increases profits. The key to less costly drugs is real patent reform that increases free market price competition paired with streamlining onerous FDA regulations making it faster, less costly and less uncertain to develop new drugs. Pharmas are by far the largest political lobbyists/donors. They wouldn't keep spending all that money in Washington if it didn't work, thus the lack of any meaningful political lobbying reform is an upstream enabler of this problem. Legislative term limits would also help.