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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

#21

Post by jauntywundrkind »

HDThoreaun wrote: post #14
droopyEyelids wrote: post #3

I followed Lina Kahn (FTC chair) on Twitter before Biden appointed her, and I was kind of blown away that it happened. She had a very clear philosophical opposition to a lot of the way things are done in this country. And I mean, I followed her because I agreed! But my preferences are not mainstream. Amazing to see her slinging rocks at giants from this position.

Khan's utter failure to execute on her goals has imo set back the anti-trust movement in this country heavily. Now every time anti trust gets brought up people think about how the government lost 5 cases in a row and consider it a waste.

I hear this bandied about so much, but I've never heard justification that the cases weren't well built or that they weren't good cases to bring.

The wicked thing about case law is that it builds and builds. The courts have been extremely pro big business for a long time, and it's hard to figure out how anything ever changes or gets better from here.

Trying to right this hell is going to take a lot of miserable attempts that go nowhere. That's what happens when the titans already have all the case law in their favor. Yes that means we need to be very well prepared when we go to battle - try to overturn their legalistic dominance - but I'm glad we are trying, and I'm not sure what better paths are available, not sure what the actual lessons are, not sure what should have been better. It feels like such a slim chance. And trying feels necessary, feels like it has a chance, even if odds aren't great.

Something has to be done to let us revisit the past, but that's not how the courts especially operate. The courts are the primary upkeeper of existing decisions, and this feels sometimes like ossification, sometimes feels like it eats away from the flesh of the nation.

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

#22

Post by Guvante »

HDThoreaun wrote: post #14
droopyEyelids wrote: post #3

I followed Lina Kahn (FTC chair) on Twitter before Biden appointed her, and I was kind of blown away that it happened. She had a very clear philosophical opposition to a lot of the way things are done in this country. And I mean, I followed her because I agreed! But my preferences are not mainstream. Amazing to see her slinging rocks at giants from this position.

Khan's utter failure to execute on her goals has imo set back the anti-trust movement in this country heavily. Now every time anti trust gets brought up people think about how the government lost 5 cases in a row and consider it a waste.

With the current stagnated Congress session possibly but now whenever better legislation comes up any attempts to claim existing rules are "good enough" is objectively wrong.

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

#23

Post by 2OEH8eoCRo0 »

jauntywundrkind wrote: post #21
HDThoreaun wrote: post #14

Earlier quoted context omitted.

Khan's utter failure to execute on her goals has imo set back the anti-trust movement in this country heavily. Now every time anti trust gets brought up people think about how the government lost 5 cases in a row and consider it a waste.

I hear this bandied about so much, but I've never heard justification that the cases weren't well built or that they weren't good cases to bring. The wicked thing about case law is that it builds and builds. The courts have been extremely pro big business for a long time, and it's hard to figure out how anything ever changes or gets better from here. Trying to right this hell is going to take a lot of miserable attem…

It's also been a mere ~2 years since she was appointed.

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

#24

Post by HDThoreaun »

jauntywundrkind wrote: post #21
HDThoreaun wrote: post #14

Earlier quoted context omitted.

Khan's utter failure to execute on her goals has imo set back the anti-trust movement in this country heavily. Now every time anti trust gets brought up people think about how the government lost 5 cases in a row and consider it a waste.

I hear this bandied about so much, but I've never heard justification that the cases weren't well built or that they weren't good cases to bring. The wicked thing about case law is that it builds and builds. The courts have been extremely pro big business for a long time, and it's hard to figure out how anything ever changes or gets better from here. Trying to right this hell is going to take a lot of miserable attem…

cases that lose are not well built. No excuses. Losing a case further entrenches the precedent against you, there's no silver lining.

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

#25

Post by pixl97 »

AlbertCory wrote: post #20

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…

I believe the word you are looking for is fraudulent. And yea, why aren't we prosecuting for that.

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

#26

Post by adolph »

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 reference listed drug nor a method of using it.

. . . courts have recognized that improperly listing patents in the Orange Book may constitute an “improper means” of competition. Accordingly, improperly listing patents in the Orange Book may also be worthy of enforcement scrutiny from government and private enforcers under a monopolization theory.

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

#27

Post by alwayslikethis »

emodendroket wrote: post #8
throe37848 wrote: post #7

Earlier quoted context omitted.

Maybe it was her surname. This "hipster antitrust" approach is a nice smoke screen big pharma needs. India and other countries already make generics, there is no need to wait several years for US manufacturers. FTC is just a road block that prevents cheap medical imports.

Is it really though. Even with the current level of regulation we have more than enough scandals with, say, artificial tears that blinded people who used them.

It's all a trade off. We can have more affordable medicine by importing it. This means more people will be able to access it, meaning less bankruptcies, which isn't any good for one's health. Will it be less safe than the ones you can currently get for an exorbitant prices? Marginally, probably. Overall, society can benefit from letting people import their medicine. It will also drive down prices and force big pharma to drop their prices.

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

#28

Post by HDThoreaun »

Guvante wrote: post #22
HDThoreaun wrote: post #14

Earlier quoted context omitted.

Khan's utter failure to execute on her goals has imo set back the anti-trust movement in this country heavily. Now every time anti trust gets brought up people think about how the government lost 5 cases in a row and consider it a waste.

With the current stagnated Congress session possibly but now whenever better legislation comes up any attempts to claim existing rules are "good enough" is objectively wrong.

"objectively wrong" no longer exists in politics, if it ever did.

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

#29

Post by whymauri »

AlbertCory wrote: post #20

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 data and notation is:

* Poorly structured and defined,

* Difficult to parse,

* Uses combinatorial/wildcard notation (Markush structures [0], which is what modern drug patent law is based on).

So it's a total mess. The best analogy I could give for software is: imagine if you could patent closed source code (the literal code) and also attach a wildcard to every branch in logic within that closed source code, but all you publish are the filenames (as screenshots of directories, not text). You don't have to run due diligence that the permutations are run to spec or even compile, but now nobody can write logic infringing on your hypothetical code (which you never wrote).

If your reaction is 'what the fuck?', yes I agree.

[0] https://en.wikipedia.org/wiki/Markush_structure

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