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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

#91

I've been taking the "blockbuster drug", Humira/Adalimumab, for more than 10 years. Humira alone is estimated to have generated US$200 billion in profits for a single company. Its history, its legal and commercial maneuvers are appalling and possibly the poster child for what is wrong with the patent system. And how public money originally funds much of the research into these drugs. This year I finally started takin…

I have been taking Humira for close to 7 years now. What disgusted me was not just the antics of AbbVie in patent protecting Humira, but how my brother (who works at AbbVie) began justifying their acrimonious practices. Although, thankfully now there are a bunch of biosimilars coming onto the market, so we can expect to see further price decreases. For a manufacturing project, we contracted out a study recently on th…

>What disgusted me was not just the antics of AbbVie in patent protecting Humira, but how my brother (who works at AbbVie) began justifying their acrimonious practices.

"It is difficult to get a man to understand something when his salary depends upon his not understanding it."

- Upton Sinclair

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

#92
post #82

Maybe they can add a third clause to be “safe, effective, and accessible”? The history of the FDA is pretty interesting and disappointing to say the least. Especially with the supplement craze.

I don't know how the US public can take any of the federal regulatory agencies seriously, given their history of corruption[1]. We only hear about cases that happen to leak, but who knows how many go undiscovered. It's easy to be conspiratorial about this and assume that the corruption happens at the highest levels of government. [1]: https://www.businessinsider.com/fda-chief-approved-oxycontin...

Paul Offit writes about the FDA history in his book "Do you believe in Magic?". His argument is that the FDA tends to try to do what is "right" but the public opinion gets swayed to the point where it becomes political and we "do this to ourselves".

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

#93

Earlier quoted context omitted.

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

That's just not true. If you're losing on Constitutional grounds, I agree with you. But if you're losing the case on legal grounds it can absolutely be a silver lining, since it can demonstrate to Congress a need to legislate (I know, I know, a foreign concept for Congress). Consider Section 230, though. It was passed because the Supreme Court ruled on a case in a way that irritated Congress. The Courts were bound be…

>The actual rulings from the Court were horrendous precedent

Do you happen to remember that ruling? I'd be interested in reading it.

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

#94

Earlier quoted context omitted.

No analogies. It is what it is. Markush groups, as GP mentioned, are there specifically for chemical patents. So that's what's shaped the patent law, not software or cars.

It's purposefully a kind of algebraic notation. Algebra is math, particularly a kind of math that maps really well to software (less so, cars). Hence the analogy makes sense.

"Everything can be mapped to software"

Perhaps, but chemistry is chemistry. It existed before software did, and you need to understand it on its own terms.

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

#95
post #59

Also if it’s patented it cannot be made generic, if expired it can. What’s the point of using the orange book?

Yeah, I wonder too. A patent should be registered with the patent office and everyone can search there to see if there is something and what it covers and when it expires. What's this orange book all about. Some easier to search database? Why can big pharma enter stuff themselves and why does the FTC not check this? Seems absurd. Can it be that the orange book is an invention by big pharma and their lobby?

I think they modify it a bit, parent that, put it in orange book, have insurance companies recommend this instead of the original, it could deter the generic makers because patients will be looking for the modified version say(extra long release).

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

#96
post #89

Earlier quoted context omitted.

> not both[er] developing the drug further unless they were 100% certain it was the right one (which I've never seen) I don’t really understand this argument. Patent law is just another moat. If it doesn’t exist for all competitors, it’s just different baseline for calculations. The market is still big and attractive, so all those who give up will open space for those who figured out how to survive without patents. L…

Please explain how, without patents, a company would choose to invest hundreds of millions of dollars to discovery a new molecule and get it approved, when another company could start selling it as well without any of the investment at all? Financially it makes zero sense. And if the logic is - well the government can fund the research (which is a huge stretch since Pharma R&D is several multiple of gov't funding tod…

>Please explain how, without patents, a company would choose to invest hundreds of millions of dollars to discovery a new molecule and get it approved, when another company could start selling it as well without any of the investment at all?

>Financially it makes zero sense.

Innovations in funding, protection of secrets etc do happen time to time, so even if I cannot give you satisfying answer now, it does not mean such answer does not exist. It took thousands of years to invent modern corporation and stock exchange. Cryptocurrencies are recent invention. Imagine some sort of pooled research, where all competitors/partners agree to compete only after the discovery, i.e. in production efficiency and costs, marketing etc, with some . Imagine some clever chemical engineering, where a pill is such a mixture of acting substance and harmless components that reverse engineering is too hard to complete without comparable budget. Maybe it will be something completely different that we will find obvious only after it is discovered.

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

#97
So one government agency - the USPTO - grants temporary monopolies to inventors as patents. Then another government agency - the FDA - restricts the drugs people can take to those specifically prescribed by a doctor, and then restricts pharmacies to making a very limited set of substitutions as "generics".

Now since that system is messed up, we're involving yet a third agency, the FTC, to complain about companies using the letter of the law to avoid advertising the existence of competitor's products. Instead why dont we jist fix the broken USPTO and FDA systems? Shorten drug patents from 20 years to 10 or so? Stop allowing patents for trivial changes. Allow pharmacies to suggest generic substitutions. Etc. Pulling in a third government agency into the mix to fix the failures of the first two seems like the wrong approach.

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

#98
post #93

Earlier quoted context omitted.

That's just not true. If you're losing on Constitutional grounds, I agree with you. But if you're losing the case on legal grounds it can absolutely be a silver lining, since it can demonstrate to Congress a need to legislate (I know, I know, a foreign concept for Congress). Consider Section 230, though. It was passed because the Supreme Court ruled on a case in a way that irritated Congress. The Courts were bound be…

>The actual rulings from the Court were horrendous precedent Do you happen to remember that ruling? I'd be interested in reading it.

The EFF has a pretty good page that outlines the cases: https://www.eff.org/issues/cda230/legislative-history

One was Cubby v. CompuServe [1], which found that an online platform was not liable as a "distributor" (which is basically an analogy to physical books, since most of the prior case-law was based on physical printed words), because they didn't review any content on the forums before it was posted.

The other was Stratton Oakmont v Prodigy [2] (which was actually a NY court case), which found that because Prodigy performed _any_ moderation, they were more akin to a publisher, which was liable for everything they published.

Taken together, the two rulings essentially meant that any site that hosted user generated content had two options:

- Perform *no moderation at all* (no deleting Nazis, pornography, spam, etc), OR

- Assume liability for *all* user generated content on the site

Also, a final note, I was actually wrong when I invoked the Supreme Court. It was a federal district court case, and a NY state court case.

[1] https://law.justia.com/cases/federal/district-courts/FSupp/7...

[2] https://en.wikipedia.org/wiki/Stratton_Oakmont,_Inc._v._Prod... (I'm actually not finding the full text of the opinion online after a brief bit of searching. I've found a couple of sites that have links to it, but all are broken at the moment; I'm sure you can find it with some more digging, but I don't have time to find it atm)

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

#99
post #65

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.

But what about the harm that does to the shareholders? I wish I were being facetious, but while a lot of scummy people and companies own shares, a lot more just move cash in various forms out of the company into independent entities. If the company has all its assets seized by some mechanism, presumably all the large shareholders: pension funds, 401ks, etc are subject to even more penalties and there are no assets or…

You have to break some eggs to make omelettes. How many families have been broken up and sent into poverty because a white collar criminal was thrown in jail and their assets seized? Obviously I wish side effects didn't happen, but unless there are consequences it will continue to happen with impunity.

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

#100

Earlier quoted context omitted.

It's purposefully a kind of algebraic notation. Algebra is math, particularly a kind of math that maps really well to software (less so, cars). Hence the analogy makes sense.

"Everything can be mapped to software" Perhaps, but chemistry is chemistry. It existed before software did, and you need to understand it on its own terms.

Well yes, and. It's apples and oranges.

And FWIW, chemistry is only a little bit older than software. Like most other fields - there was a qualitative jump in the last ~100 years; arguably we didn't know shit about anything before the 20th century, before the theoretical and practical tools converged to allow some kind of formalized, precise knowledge and experimental work.

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