61–70 of 101 posts
If they were serious then they would put the CEOs in jail.
If they were serious then they would put the CEOs in jail.
The point of a CEO is as a fall guy. Only going after the CEO means nothing is solved, the hydra remains. Instead you have to decapitate the company’s leading structure, such as investors and high management, then hope for a systemic change which may or may not come.
Earlier quoted context omitted.
Regulatory agencies have a knack for warning market players to clean up their act before stepping in.
It legitimately tends to be the cheaper way to regulate. You've basically got two options: 1) give a big warning and hope you get a majority change in the industry because they can see the writing on the wall or 2) change the rules and, as immediately as is appropriate, open a bunch of lawsuits... then spend the next decade in the courts spending immense amounts of money while every one of the offending parties runs…
Earlier quoted context omitted.
The point of a CEO is as a fall guy. Only going after the CEO means nothing is solved, the hydra remains. Instead you have to decapitate the company’s leading structure, such as investors and high management, then hope for a systemic change which may or may not come.
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.
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 even potential future income to compensate them. Essentially you get the Great Recession or Enron effect where large numbers of retired or near retirement people suddenly no longer had pensions or retirement savings.
Your only real option is to charge all the individuals involved and send them to jail, and fines for everyone and everything else - though the fines for the company have to be more than the potential profit by a large amount.
Otherwise you run into a problem where say one person working for the company wants a bonus and realizes a fraudulent listing would get him that bonus? In your model that one person functionally bankrupts the company vs fining and jailing that person and fining the corporation for failing to ensure adequate controls on entries to the orange book.
Earlier quoted context omitted.
The point of a CEO is as a fall guy. Only going after the CEO means nothing is solved, the hydra remains. Instead you have to decapitate the company’s leading structure, such as investors and high management, then hope for a systemic change which may or may not come.
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.
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).
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…
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 space) for further screening, then slowly whittle it down from there. By the time it hits humans, it's like 1 with 1 or 2 backups.
So you patent them all.
If you could only patent one, one of two things would happen: 1) the company would just file thousands of individual patents to accomplish the same thing or 2) not both developing the drug further unless they were 100% certain it was the right one (which I've never seen).
Earlier quoted context omitted.
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…
Thanks, let's leave out software. Not that it's not relevant, but it's a black hole for this crowd. One should not try to understand everything by analogy with software.
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…
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 the market sizes (in USD) for a number of biosimilars under development. Humira is the only one that's predicted to have a market size reduction (by 40%!) because of how much AbbVie has been milking it.
Earlier quoted context omitted.
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…
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…
Technology and legal practices have far outpaced the USPTO. We have accidentally incentivized sheer volume and intentionally poor record-keeping as a moat. This is a fundamental _inefficiency_, because it de-emphasizes property based engineering and pushes ADMET down the road. Why do so many candidates fail for ADMET reasons a few years down the line? Because people aren't thinking about the risks sooner! Why not? Because surely the patent will cover everything.
Add to everything how siloed big pharma is and it becomes impossible to coordinate across the pipeline. IANAL, but certainly there must be some middle ground here -- the last time the USPTO took a stab at redefining this mess was 2007, but they failed.
https://www.uspto.gov/sites/default/files/web/offices/com/so...
They more or less proposed what you said: file a claim for each different invention, putting the onus of proof on the filer. In the amendment, Markush is appropriate if you have evidence backing that the chemical space has a true shared utility via structure i.e. test it or forget it OR the chemical space is 'obvious'.
When you read the original intent of the Markush decision i.e. "members of [a] Markush group are alternatively usable for the purposes of the invention," it becomes clear that we have strayed waaay from this definition. A Markush can easily contain structures that are impossible to synthesize at all!