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FTC warns pharma companies about sham patent listings designed to delay generics

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Re: FTC warns pharma companies about sham patent listings designed to delay generics

#71
post #64

Does this mean we can finally have the already-approved, over-17-year-old, and not-produced Lyme disease vaccine?

To do that for any drug, the FDA needs to approve the new factory setup at a minimum, and that would probably take at least 3 years in practice. Problem is, vaccines are biologicals and you don't get generics for biologicals so that's out from the start. You'd have to re-do at least part of the trials to get a biosimilar licensed.

Re: FTC warns pharma companies about sham patent listings designed to delay generics

#72
post #43

Earlier quoted context omitted.

The government isn't capable of doing the work it wants to do and so "good enough" doesn't apply. You can claim that the government was wrong in its pursuit of this case but that doesn't suddenly mean Congress has no work to do. At minimum codifying what makes it inappropriate for the government to take the action it attempted would be valuable. Congress is supposed to clarify if the Executive and Judicial do not agr…

> The government isn't capable of doing the work it wants to do Debatable. Unless you're just referring to the executive branch the government does not have a single goal, and many of the leaders of the government want opposite things. > Thus "objectively wrong" isn't about which side is right, it is that agreement doesn't exist. Sure we can agree there. The issue is that there isn't even agreement on whether there's…

You keep saying "someone might want to do a bad thing" as if it is an argument.

I never said they would do something, which is what you are arguing against. I said there isn't an excuse to not do anything based on the existing law covering what needs to be covered.

Mostly I point it out because the "X government won't do anything" is uninteresting to discuss, it is basically an impossible to defeat argument.

> Unless you're just referring to the executive branch the government

In this context the branch of the government whose job it is to take this action is taking an action and so I felt specifying Executive was needlessly specific.

It isn't like Congress is using this act to go after violators, that isn't their job.

Re: FTC warns pharma companies about sham patent listings designed to delay generics

#73
post #66

Earlier quoted context omitted.

I agree, seize the company and take ownership of all its assets, including IP, at a minimum. Fines and punishments with no teeth are not any good for the public interest.

It is easier than that. Issue nine shares of stock for every one outstanding, and split it evenly between victims (if applicable) and a new public offering. Make sure the victims have 90% control of the company after that, by giving them multiple non-transferrable votes per share. Also, make sure they are organized enough to vote as a block (to replace board members, etc).

Let's go proactive.

In exchange for the legal conveniences that being a limited-liability/stock company offers, you must issue to the state a class of shares that are nontradeable/zero-dividend (and thus do not dilute valuation) but voting, representing 49% of the voting power.

A well-behaved company would see little difference there; the state-owned shares would typically abstain or vote with management. But if they get too brazen and abusive, the board is gonna have to figure out how to handle what is effectively the ultimate hostile investor: "line goes up" means nothing to them, but "the public's pissed they still can't afford their meds" does.

Re: FTC warns pharma companies about sham patent listings designed to delay generics

#74
post #67

Earlier quoted context omitted.

It's not bizarre at all. Early hits are step 0.1 in bringing a drug to market. You patent a large space that gives you room to optimize the structure in terms of safety, efficacy, Pk, metabolites, etc. Very rarely would you ever get 1 hit in a huge combinatorial screen. You'd likely get a few dozen. But you have no idea which ones would the best. The company will usually nominate 5 or 6 hits (across the scaffold spac…

Sure, you can argue that coverage for lead optimization is an unintentional feature, not a bug of Markush. But you have to admit that the current system is leveraged in bad faith i.e. for hedging against generics, staggering patents to maximize exclusivity period, exceptional vagueness and overreach in the structure definitions. Technology and legal practices have far outpaced the USPTO. We have accidentally incentiv…

I mean, if the argument is PTO should be better resources so that patents can undergo more rigorous evaluation, you won't get an argument from me.

You're not supposed to patent anything you haven't actually made, however, there is no validation of that and as a result patent applicants are incentivized to patent as broad a space as possible.

However, if we did move to a "single molecule, single patent" approach, the workload on the PTO would skyrocket. For pharmaceutical companies the cost of a patent and its preparation is infinitesimal compared to the cost of developing a drug - pharma companies wouldn't bat an eye at submitting 1000's of patents for each discovery program.

But, as I stated above, I don't disagree the process could be made better.

Re: FTC warns pharma companies about sham patent listings designed to delay generics

#75
post #26

At first I thought this was about minor changes to formulations that can be granted new patents, a problem which seems to me to be to be outside the FTC's purview. It looks like the problem is more like out and out fraud: Brand drug manufacturers are responsible for ensuring their patents are properly listed. Yet certain manufacturers have submitted patents for listing in the Orange Book that claim neither the refere…

It is quite clearly fraud. For some reason we don't seem to prosecute companies for fraud.

Re: FTC warns pharma companies about sham patent listings designed to delay generics

#76
post #74

Earlier quoted context omitted.

Sure, you can argue that coverage for lead optimization is an unintentional feature, not a bug of Markush. But you have to admit that the current system is leveraged in bad faith i.e. for hedging against generics, staggering patents to maximize exclusivity period, exceptional vagueness and overreach in the structure definitions. Technology and legal practices have far outpaced the USPTO. We have accidentally incentiv…

I mean, if the argument is PTO should be better resources so that patents can undergo more rigorous evaluation, you won't get an argument from me. You're not supposed to patent anything you haven't actually made, however, there is no validation of that and as a result patent applicants are incentivized to patent as broad a space as possible. However, if we did move to a "single molecule, single patent" approach, the…

There is an easy solution, you already can't patent cooking recipes. So why allow chemical recipes? To those that say that would stifle innovation, well historic evidence is inconclusive at best, e.g. the development of the pharmaceutical industries in the US, Germany and Switzerland saw thr biggest industry develop in Switzerland who did not have any patent protection followed by Germany, where only processes not chemicals could be patented. The US pharmaceutical industry only become much bigger after they benefited from the harmonisation of patent systems to follow the strong protection in the US.

Re: FTC warns pharma companies about sham patent listings designed to delay generics

#77
post #74

Earlier quoted context omitted.

Sure, you can argue that coverage for lead optimization is an unintentional feature, not a bug of Markush. But you have to admit that the current system is leveraged in bad faith i.e. for hedging against generics, staggering patents to maximize exclusivity period, exceptional vagueness and overreach in the structure definitions. Technology and legal practices have far outpaced the USPTO. We have accidentally incentiv…

I mean, if the argument is PTO should be better resources so that patents can undergo more rigorous evaluation, you won't get an argument from me. You're not supposed to patent anything you haven't actually made, however, there is no validation of that and as a result patent applicants are incentivized to patent as broad a space as possible. However, if we did move to a "single molecule, single patent" approach, the…

> You're not supposed to patent anything you haven't actually made

not true. That's Actual Reduction to Practice. There is also Constructive Reduction to Practice.

I wrote about this in depth, for software:

https://albertcory50.substack.com/p/no-source-code-no-patent

This is a good place to repeat, "let's just remove software from the patent system."

If you don't, then any changes you propose will being the Big Pharma lobby down on you. Once we get our own IP protection laws (or no IP laws), the pharma companies won't care about us anymore.

Re: FTC warns pharma companies about sham patent listings designed to delay generics

#78
post #74

Earlier quoted context omitted.

I mean, if the argument is PTO should be better resources so that patents can undergo more rigorous evaluation, you won't get an argument from me. You're not supposed to patent anything you haven't actually made, however, there is no validation of that and as a result patent applicants are incentivized to patent as broad a space as possible. However, if we did move to a "single molecule, single patent" approach, the…

There is an easy solution, you already can't patent cooking recipes. So why allow chemical recipes? To those that say that would stifle innovation, well historic evidence is inconclusive at best, e.g. the development of the pharmaceutical industries in the US, Germany and Switzerland saw thr biggest industry develop in Switzerland who did not have any patent protection followed by Germany, where only processes not ch…

The Pharma lobby is one of the most powerful in DC. Zero chance of that ever happening.

So let's remove software from the list of patentable subject matter. Then Pharma won't care about us anymore. One thing at a time.

Re: FTC warns pharma companies about sham patent listings designed to delay generics

#80

I have to admit I didn't know how the Orange Book worked, so I had to do some research. Do I have this right? "An Orange Book listing shows "approved prescription drugs, related patent and exclusivity information, and therapeutic equivalence evaluations, along with other information." https://www.fda.gov/drugs/news-events-human-drugs/our-perspe... So a pharma company can insert a listing saying that, for a bogus exam…

Not only bogus, but if you get a hit on a scaffold you can combinatorially modify that scaffold and file it with the patent. This effectively blocks the small permutation space around the drug from further investigation or development. There's lot of promising science that can't be done because incumbents are so adversarial about patent space for structures they don't even care about. To make matters worse, patent da…

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