Eli Lilly Enlists Congress In Fight Against Canada For Refusing Patent On Useless Drug
from the war-on-all-fronts dept
Eli Lilly bet its entire business model on patents years back, rather than on creating useful products that people want to buy. Lately it's been having trouble getting new patents, and is reacting extremely poorly to the fact that its last-gasp efforts to get new patents aren't working. As we've noted, a few years back, Canada rejected some patent applications for some Eli Lilly drug after the Canadian patent board "determined that the drug had failed to deliver the benefits the firm promised when obtaining the patent." In other words, after realizing that the drug is not useful, Canada rejected the patent.And Eli Lilly flipped out.
Eli Lilly has sued Canada for $500 million claiming "lost profits." How is this possible, you ask? Well, it's those corporate sovereignty provisions that are finding their way into various trade agreements lately. They're usually called "investor state dispute settlement" (ISDS) provisions, because supporters know that such a phrase will bore most people to death and they won't realize what's happening. Eli Lilly is arguing that Canada's decision to check to see if a drug is actually useful somehow violates its international agreements. And thus that a sovereign decision by Canada not to patent drugs of questionable benefit is not just a violation of trade, but stomping on Eli Lilly's expected profits.
Lilly is now raising the stakes. Not only has it asked the USTR to put Canada back on the wacky "Special 301 list" of "naughty countries" that don't bow before American corporate demands, but it's convinced 32 members of Congress to out themselves as corporate shills for Eli Lilly by demanding that the USTR follow through on this request.
Eli Lilly seems to have no shame about this, happily admitting that it's behind this effort to have the US punish Canada for daring to judge whether or not a drug is useful. As he told the Wall Street Journal:
“We’ve been unsuccessful in bringing about change by other means,” said Lilly chief executive John Lechleiter. “It’s an issue right at our back door. And unfortunately, we’re afraid it can lead to other countries attempting to undermine intellectual property.”No, not "undermine intellectual property." It's about actually making sure, before giving you a decades-long monopoly right, that your drug is actually useful. Of course, if the USTR actually follows through and puts Canada on the Special 301 list, it will just cement what a complete joke the Special 301 list really is. For years, the USTR -- at the behest of Hollywood -- put Canada on the Special 301 list. Each year Canadian officials would specifically state that they "don't recognize" the process of the Special 301 list as being legitimate (because it's not) and then proceed to do nothing. Eventually, though, with a new government in place, Canada did change its copyright laws, and was "downgraded" on the Special 301 list. Upgrading them back up to a "pirate" nation will just highlight why Canada (and every other country) should totally ignore the nearly entirely arbitrariness of the list.
Meanwhile, shame on those 32 members of Congress for supporting such a blatant attempt by a company to interfere in the sovereignty of Canada and its crazy idea that drugs should actually be useful to deserve patent protection.
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Filed Under: canada, corporate sovereignty, isds, lobbying, patents
Companies: eli lilly
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That's handy
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Patented items must be useful?
It's kind of a dangerous assumption too - just because a drug has no useful benefits today doesn't mean it might not in the future?
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Re: Patented items must be useful?
That's not how the drug approval process works. You don't get to just throw stuff against the wall to see what sticks: you actually have to have (independently-verified and independently-verifiable) proof that the drug does what its maker says it does. (And a lot more of course, like "not killing most of the patients in the process".)
If we accept your hypothesis, then ANYTHING that could be administered to a human being by any means should be granted a patent because at some point in the future it might be shown to have a positive effect against some disease or condition. That way lies madness: it would permit, for example, one to patent a particular placebo because -- maybe -- in 2079, it could be shown to accidentally mitigate the effects of Masnick's Syndrome (which I just made up).
The problem here is that Lilly botched the science. If they'd actually made the case in the lab/clinic/etc., then the Canadians would have done what they always do. But they (Lilly) didn't.
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Re: Patented items must be useful?
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the hard thing to comprehend is why politicians go down the road of getting themselves a worse name than they already had, by doing something as absolutely stupid as helping a company sue a country. what is going to happen if this behavior carries on? have a planet full of bankrupt countries with an enormous number of exceedingly wealthy companies that are destroying the whole world!!
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Re: Re: Patented items must be useful?
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unique-molecule patent
And even something like "bath-salts"-type designer drugs shouldn't need a high *usefulness* threshold to deserve patent protection since --unlike most patents these days-- they are at least tangible creations that took a certain amount of time and effort to create ... even if their (currently known) usefulness to society is essentially a negative value.
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Re: Re: Patented items must be useful?
Now that would take a placebo!
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Re: Re: Patented items must be useful?
I could be completely wrong.
But let's not mix things up here - the FDA is where you take a drug for testing to verify that it does what it says. These are two completely different processes.
For an above comment - patenting a drug today that isn't useful until 2079 is fine, as the patent will have become useless for the original patent holder, wouldn't it?
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Re:
Maybe if the drug company had applied for the patent as a (expensive) industrial solvent, etc. (the route taken by more than one quack "remedy") and sold it that way, they could have dodged that bullet.
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Re: Re: Re: Patented items must be useful?
The United Nations Food and Drug Administration operates a fleet of black helicopters in Canada.
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Re: Patented items must be useful?
"Utility patents may be granted to anyone who invents or discovers any new and useful process, machine, article of manufacture, or compositions of matters, or any new useful improvement thereof."
If an item that does not work is challenged in court, which has happened in the past, and the plaintiff wins, then the patent is rendered unenforceable.
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Re: unique-molecule patent
Based on WHAT, exactly? What legal basis do you have for suggesting this?
You could synthesize any of a kazillion substances -- we do it on our computers all day every day and sometimes even in the wet lab (when something looks promising) -- but nearly all of them are useless. And some of them are poisons. If we could patent these merely because they're unique, then our lab alone could drown the patent office in applications. And there are many, many labs doing exactly the same thing.
("What did you patent?" "Two sticks and a rubberband." "What does it do?" "Nothing...well, nothing yet. But one day it might produce cold fusion.")
For a drug to be patentable, it has to actually work. I don't think that's an excessively onerous requirement.
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My Congressman is on There
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Re:
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Re: My Congressman is on There
Always nice when a politician is that open in their contempt for the intelligence of the people who voted them into office, it's a moment of honestly that's more often than not quite rare when dealing with that lot.
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Re: My Congressman is on There
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Re: Re:
What it says in the complaint is that competitors attacked the patent on grounds that it is "not useful" so that they could turn around and sell it themselves, which (if true, and I'm not accepting this whole thing uncritically) is about the most disingenuous thing ever.
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Re: Re: My Congressman is on There
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Re: Patented items must be useful?
Uhm ... the constitution says
"To promote the Progress of Science and useless Arts".
Oh, my mistake. I thought it said useful Arts.
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Re:
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Re: Re: unique-molecule patent
A: When someone else who did all the hard work independently finds a use for one of those substances some patent troll or drug company with a large patent portfolio of every substance imaginable will swoop in and sue them for infringement and take their profits
or
B: Competitors will be afraid to do R&D on anything since someone somewhere has a patent on it and will sue if they do find a use for it and market it. This will keep competition low for incumbent players and will deter innovation.
Drug companies will also like to have it both ways. They would like to get a patent on a substance for one use and when that patent expires they would like to get a patent on the same substance for another use (IIRC they have done it before or at least tried). So if they had it their way they would first get a general patent on every substance possible and later get another patent on the same substances for any specific use they can find.
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Really they outed themselves?
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Re: Re: Patented items must be useful?
And if that's true, how the fuck did we end up with so many blatantly useless patents?
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Re: Re: Re: Patented items must be useful?
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Re: Patented items must be useful?
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Re: Re: Re: Re: Patented items must be useful?
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re: Eli Lilly tantrum
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Re: Re: Patented items must be useful?
Then IP proponents will want it both ways, when the patent does expire if someone does later come up with a specific working model of the previously patented general idea they will want to get a patent on that specific implementation.
You end up with the situation that we have now where patent trolls and industry have large patent portfolios of unused patents sitting around either being used for patent cross licensing leverage or for suing anyone that does innovate or for deterring competing innovations.
Sitting around and coming up with broad ideas is not deserving of a patent. Implementing them should be a minimum requirement. We need a use it or lose it clause to stop this patent phishing nonsense (or the use it or lose it language needs to be made stronger).
Yes, you're absolutely right in saying that useless patents do exist. But the point is that they shouldn't.
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32 members of congress
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Re: Patented items must be useful?
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Re: Re: Re: Re: Patented items must be useful?
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Re:
Much of this has been covered here in the past. If I remember correctly Canada requires that you give the real ingredients, so when the patent ends generics can be made. Eli Lilly tried to BS the patent board with fake ingredients. When tested, they showed up as fake ingredients that didn't do what it was claimed. Only one ingredient was the actual active and effective part of the drug, the rest were all fake fillers to make it look like a new drug had been made.
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Re:
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Re: Patented items must be useful?
Sorry if that bore you guys, but as a generic meds chemist (aka the Evil Ones who use expired patents to save lives and not put all their money on new medication that doesnt need to exist because one of our patents for a drug with the exact same profile expired), this is straight up in my field.
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Re:
We have good laughs at lunch time about Big Pharma over here, especially whenever they make a "new" drug that's just drug X made extended-release.
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Re: Re: Re: Re: Re: Patented items must be useful?
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Re: Re: Patented items must be useful?
Maybe Masnick's syndrome causes you to lose all sense of reason and widly lash out with absurd and nonsensical posts without having actually read the article?
If so, then OOTB is patient zero....
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Re: Re: unique-molecule patent
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Re: Re: Patented items must be useful?
Having a patent on an invention that does not work is all well and fine, but if the invention truly does not work, that is one way for a defendant to win a law suit.
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Re: Patented items must be useful?
Our patent office sucks.
A room full of monkeys could do a better job.
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You don't say.
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like the US does
Seems like them 'ferrners' caught on and are now using the tools intended to protect US companies from competition are beating US companies at their own game.
Where TF do you think ISDS came from? The US government invented it when the 'ferners' started thumbing their nose at US patents.
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Re: re: Eli Lilly tantrum
How do they decide that monetary amount?
Well, someone thought up a number and then they added all the Zeroes that could be fit on the page.
In other words, they think they deserve to make a bajillion dollars and if you dare challenge them about the drug 'not working and being unprotected' or 'failing in testing' you are responsible for covering the "profit" that you "stole from them".
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Re: Re: Patented items must be useful?
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Re: re: Eli Lilly tantrum
I hope this clears up any confusion.
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Re: Re: Re: Patented items must be useful?
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Re: Patented items must be useful?
So they use it for leprosy and cancer now.
So, when mothers-to-be are not informed that it can cause birth defects, they take it and end up with kids with limbs missing, etc.
So yeah, it may turn out to be useful for something later, but that's not a good enough excuse to unleash it on the public today. Make sure it's useful for SOMETHING before it is unleashed on the public.
And for the love of God, get all patents off of drugs and medical procedures! It's morally repugnant to hold people over a barrel for necessary treatment because some profiteer wants to make a fortune off suffering. The research is already done in universities on our dime, so I fail to see why patents are necessary except to protect profits. They do little, if anything, for research.
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Re: Re: Re:
If not, we know what the truth is. After all, competitors trying to undermine your credibility have something similar to sell, don't they?
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Re: You don't say.
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Re: Re: Re: Patented items must be useful?
http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/
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