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.

Reader Comments (rss)

(Flattened / Threaded)

  1.  
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    That One Guy (profile), Apr 17th, 2014 @ 12:55pm

    That's handy

    A nice simple list of congresscritters who obviously are just aching to exit out of that boring job and into the exciting world of lobbying, hopefully come next election people will remember this and help them out by voting for someone else.

     

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  2.  
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    Anonymous Coward, Apr 17th, 2014 @ 2:36pm

    Patented items must be useful?

    That's the first I've heard of this - I thought patents were granted based on other measurements, but whether they're useful or not seems like it has never been one of them.

    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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    kenichi tanaka (profile), Apr 17th, 2014 @ 2:41pm

    I don't know if it's me, but this sounds like Eli Lilly is throwing a temper tantrum and that the United States' 301 list is quickly becoming an impotent list in itself if Congress bows to this demand by Lilly.

     

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  4.  
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    Anonymous Coward, Apr 17th, 2014 @ 2:45pm

    Re: 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?"

    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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  5.  
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    Anonymous Coward, Apr 17th, 2014 @ 2:52pm

    Re: Patented items must be useful?

    A patented technology should meet the claims in the patent, and these drugs do not do what they are claimed to do.

     

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    Anonymous Coward, Apr 17th, 2014 @ 2:53pm

    apart from anything else, this shows how the USA does whatever it feels like just to get something for it or an industry. in other words, the Bully part of the USA is still well alive and kicking!!
    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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    Mason Wheeler (profile), Apr 17th, 2014 @ 2:59pm

    I'm all for doing away with bad patents, but have a look at the actual letter, specifically the 4th paragraph. If the claim made here is true, (which is not necessarily the case, of course, but if it is...) then this issue is not nearly as black-and-white as it is being presented here.

     

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  8.  
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    Anonymous Coward, Apr 17th, 2014 @ 3:04pm

    Re: Re: Patented items must be useful?

    Masnick's Syndrome is the compulsiveness to negatively comment with baseless facts against Mike Masnick. Those affected will comment on multiple articles either with an anonymous or an unregistered name. Some of the more extreme cases get to the point where the comments against Masnick appear even on articles that were written by a different author. There is no cure for these cases and the only solution has been for the Techdirt community to hit the report button when encountering these individuals.

     

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  9.  
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    zip, Apr 17th, 2014 @ 3:04pm

    unique-molecule patent

    While I'm certainly against the kind of stupid baloney-sandwich-with mustard-type patents that have flooded the patent office in recent years, it seems like a new drug, being a unique synthesized substance with a defined molecular structure, should be at least worthy of patent consideration on that basis alone.

    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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    Anonymous Anonymous Coward, Apr 17th, 2014 @ 3:07pm

    Re: Re: Patented items must be useful?

    "mitigate the effects of Masnick's Syndrome"

    Now that would take a placebo!

     

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  11.  
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    Anonymous Coward, Apr 17th, 2014 @ 3:13pm

    Re: Re: Patented items must be useful?

    I thought patenting a drug is more about patenting the process of creating the drug... not patenting its purpose or usage.

    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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    zip, Apr 17th, 2014 @ 3:19pm

    Re:

    It seems to me more more a case of the authorities wanting to strip a drug of its certification as an approved medicine, and in order to do that, the weapon of choice was to attack the patent.

    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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  13.  
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    Anonymous Coward, Apr 17th, 2014 @ 3:20pm

    Re: Re: Re: Patented items must be useful?

    … let's not mix things up here - the FDA is where you take a drug…

    The United Nations Food and Drug Administration operates a fleet of black helicopters in Canada.

     

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  14.  
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    Anonymous Coward, Apr 17th, 2014 @ 3:27pm

    Re: Patented items must be useful?

    While I presume you are being facetious, you should note that the second requirement for a patent is that the invention(s) are 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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  15.  
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    Anonymous Coward, Apr 17th, 2014 @ 3:32pm

    Re: unique-molecule patent

    "it seems like a new drug, being a unique synthesized substance with a defined molecular structure, should be at least worthy of patent consideration on that basis alone."

    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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  16.  
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    Anonymous Coward, Apr 17th, 2014 @ 3:33pm

    My Congressman is on There

    I wrote to him with my concerns about TPP (including the secrecy in the negotiations and the truly anti-competitive nature of the deal) and all I got back was 3 pages of spiel that DIDN'T ADDRESS THIS. Instead it was all how trade is good and that we need to lower trade restrictions on this part of the world, etc etc.

     

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  17.  
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    Imaginary, Apr 17th, 2014 @ 3:37pm

    Re:

    Agreed, I think requiring proof of usefulness before granting a patent is a generally a good idea, but there are some procedural issues here. It appears that Canada retroactively changed the standard on what evidence could be presented (to disallow evidence gathered after the patent is granted).

     

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  18.  
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    That One Guy (profile), Apr 17th, 2014 @ 3:45pm

    Re: My Congressman is on There

    So in other words you basically just got a pat on the head, told 'The grown-ups are talking, go back to your toys, there's nothing here for you', and shoo'd off.

    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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  19.  
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    Anonymous Coward, Apr 17th, 2014 @ 3:47pm

    Re: My Congressman is on There

    I remember when I wrote to my one rep about the TTP and TTIP, he gave me all the standard USTR talking points, then when Europe wanted to force us to rename cheeses and meats for the TTIP, he jumped off that ship faster than you can say "Mayday."

     

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  20.  
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    Mason Wheeler (profile), Apr 17th, 2014 @ 3:48pm

    Re: Re:

    The authorities trying to make the drug no longer be an approved medicine? Where do you get that from?

    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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  21.  
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    Anonymous Coward, Apr 17th, 2014 @ 3:51pm

    Re: Re: My Congressman is on There

    Honestly, I'm not sure if it's contempt or just flat-out ignorance as to what they are trying to unleash upon their consituents

     

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  22.  
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    Anonymous Coward, Apr 17th, 2014 @ 3:57pm

    Re: Patented items must be useful?

    " but whether they're useful or not seems like it has never been one of them."

    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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  23.  
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    Charles (profile), Apr 17th, 2014 @ 4:05pm

    Re:

    Exceedingly wealthy companies already are destroying the whole world.

     

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  24.  
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    Anonymous Coward, Apr 17th, 2014 @ 4:13pm

    Re: Re: unique-molecule patent

    I agree. Otherwise drug companies would try to get as many patents on every substance possible without doing any R&D and this will do one of two things

    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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  25.  
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    AC, Apr 17th, 2014 @ 4:38pm

    Really they outed themselves?

    Wow this will make Canadians Jobs much easier if any of these people come to Canada, we will know who's food to spit in, who's drink's to piss in and who's steak to use to wipe our asses before we serve them. Hope they come to Canada soon, I would love to serve one of them myself.

     

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  26.  
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    Anonymous Coward, Apr 17th, 2014 @ 5:54pm

    Re: Re: Patented items must be useful?

    No, I wasn't being facetious...

    And if that's true, how the fuck did we end up with so many blatantly useless patents?

     

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  27.  
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    Anonymous Coward, Apr 17th, 2014 @ 6:38pm

    Re: Re: Re: Patented items must be useful?

    The majority of patents never make it to market, at least not by the patent holder, and are thus bad patents. It's called patent phising. You throw a huge net of patents out there and something is likely to infringe. This either deters competitors from creating competing products or it allows incumbents and patent trolls to find something to sue anyone that does innovate.

     

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  28.  
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    Lawrence D’Oliveiro, Apr 17th, 2014 @ 6:41pm

    Re: Patented items must be useful?

    Nope. They don’t even have to work.

     

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  29.  
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    Anonymous Coward, Apr 17th, 2014 @ 6:51pm

    Re: Re: Re: Re: Patented items must be useful?

    err ... patent phishing *

     

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  30.  
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    TheGimp (profile), Apr 17th, 2014 @ 7:06pm

    re: Eli Lilly tantrum

    Maybe I'm being obtuse, but why would the Canadian government owe Eli Lilly a single cent for not patenting a "drug" that no doctor is going to prescribe anyway?

     

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  31.  
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    Anonymous Coward, Apr 17th, 2014 @ 7:15pm

    Re: Re: Patented items must be useful?

    Getting a patent on an 'unworkable device' should be disallowed because it enables someone to get a broad patent on something that may cover something that may work and if someone else does go through the trouble of getting it to work the patent holder will then sue the innovator. Again, this does one of two things, it deters competing innovators from innovating or it allows patent holders to steal from those that do innovate by suing them.

    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.  
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    Mark1 (profile), Apr 17th, 2014 @ 7:38pm

    32 members of congress

    You have to really owe someone to do something like this. 32 members of Congress kissing Eli Lilli's ass. Shameful

     

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  33.  
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    madasahatter (profile), Apr 17th, 2014 @ 7:38pm

    Re: Patented items must be useful?

    Check Canadian patent law on that point. I do not know Canadian patent law but if it is their law then Eli Lilly should shut up and go out of business.

     

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  34.  
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    Colin, Apr 17th, 2014 @ 7:41pm

    If I'm not mistaken, the drug it self is useful, but was at it's end of life for the patent. Eli Lilly tried to extend the patent by improving the drug with a useless improvement.

     

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  35.  
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    justok (profile), Apr 17th, 2014 @ 7:46pm

    Re: Re: Re: Re: Patented items must be useful?

    They were banned. The helicopters couldn't fly bilingually

     

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  36.  
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    Anonymous Coward, Apr 17th, 2014 @ 7:53pm

    Re:

    Which is called evergreening.

    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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  37.  
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    That One Guy (profile), Apr 17th, 2014 @ 11:39pm

    Re:

    So evergreening(believe that's the term), attempting to break the deal of patents by extending the duration with a useless bit tacked on so they could pretend it was new enough to warrant another patent, yeah, if that's the case no wonder they got it shot down.

     

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  38.  
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    Anonymous Coward, Apr 18th, 2014 @ 12:24am

    Re: Patented items must be useful?

    Health Canada reviews all drugs before allowing them to be marketed, we're talking about drugs here, things that can save you but also make you sick/kill you or just plainly do nothing special that other things in our canadian pharmacopoeia already do (they refused some companies version of extended release Tramadol, as we already have one Zytram XL, they refused the one that's in the US). And canadian health authorities really dislike tramadol due to its dangerous seizure inducing effects. So they approved Codeine Contins instead when it comes to medium strength extended release painkillers.

    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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  39.  
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    Anonymous Coward, Apr 18th, 2014 @ 12:41am

    Re:

    Probably making an extended release version of X drug. Laughable. And I don't laugh because I'm a chemist at a generics company. Big Pharma (which I don't find generics companies to be, even if 3/4 of medication served is generics here if not more) hates Canada because medical patents are made to expire very fast. Apotex and Pharmascience are 2 good examples of (non-us company owned) Canadian generic companies that just make what's tried and true and does not "innovate" only to extend patents or because a patent for a drug is about to be over so they have the whole R&D chemical engineer working their asses off to make a new molecule that does exactly nothing much different from another medication in the same family of molecules.

    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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  40.  
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    G Thompson (profile), Apr 18th, 2014 @ 1:53am

    Re: Re: Re: Re: Re: Patented items must be useful?

    Patent Pissing works too ;)

     

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  41.  
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    Anonymous Coward, Apr 18th, 2014 @ 3:46am

    Re: Re: Patented items must be useful?

    Maybe you didn't make it up.
    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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  42.  
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    Anonymous Coward, Apr 18th, 2014 @ 6:04am

    Re: Re: unique-molecule patent

    You are correct. Indeed, a statement of usefulness or benefit either needs to be made, or implied so well as to make the benefit clear. If an invention has no benefit or use, then by law it cannot be granted a patent.

     

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  43.  
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    Anonymous Coward, Apr 18th, 2014 @ 6:13am

    Re: Re: Patented items must be useful?

    This guy is alleging that these inventions do not work. I looked at a couple of these, and they seem as though they should work, but perhaps I am not understanding the allegedly unworkable portion.

    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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  44.  
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    JEDIDIAH, Apr 18th, 2014 @ 7:34am

    Re: Patented items must be useful?

    > And if that's true, how the fuck did we end up with so many blatantly useless patents?

    Our patent office sucks.

    A room full of monkeys could do a better job.

     

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  45.  
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    JEDIDIAH, Apr 18th, 2014 @ 7:42am

    You don't say.

    Well that's certainly an interesting twist on "Cheap Canadian Drugs". It certainly puts certain other things into perspective. One wonders how much money we end up wasting on this stuff...

     

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    Rex, Apr 18th, 2014 @ 10:19am

    like the US does

    Us old coots began to recognize that the trend of using IP law and inventions instead of actually making something that worked became the strategy that many (most?) US companies did back in the 1970s.

    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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  47.  
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    teka, Apr 18th, 2014 @ 6:25pm

    Re: re: Eli Lilly tantrum

    Basically, Eli Lilly is claiming that failing to approve a new drug's patent equals stealing all the money that they were going to make with it.

    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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  48.  
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    Anonymous Coward, Apr 18th, 2014 @ 7:04pm

    Re: Re: Patented items must be useful?

    I agree. A room full of monkeys wouldn't pass any patents and without patents we would be much better off.

     

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  49.  
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    TheGimp (profile), Apr 19th, 2014 @ 12:17am

    Re: re: Eli Lilly tantrum

    My comment was using something called "sarcasm." My apologies if that was not clear to some people.
    I hope this clears up any confusion.

     

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  50.  
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    Anonymous Coward, Apr 20th, 2014 @ 11:10pm

    Gotta admit, I'm surprised Ronald J. Cocksucker Riley hasn't made his scheduled appearance yet...

     

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  51.  
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    Pragmatic, Apr 22nd, 2014 @ 5:30am

    Re: Re: Re: Patented items must be useful?

    Admit it, you miss her, don't you?

     

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  52.  
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    Pragmatic, Apr 22nd, 2014 @ 5:38am

    Re: Patented items must be useful?

    http://en.wikipedia.org/wiki/Thalidomide

    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.

     

    reply to this | link to this | view in thread ]

  53.  
    identicon
    Pragmatic, Apr 22nd, 2014 @ 5:41am

    Re: Re: Re:

    If they have failed to identify the competitor, they're probably lying OR insinuating that Canada is a competitor. Assume they're telling the truth; if Canadian generic medicine manufacturers start selling a version of this stuff with the same active ingredients, they've got a case.

    If not, we know what the truth is. After all, competitors trying to undermine your credibility have something similar to sell, don't they?

     

    reply to this | link to this | view in thread ]

  54.  
    identicon
    Pragmatic, Apr 22nd, 2014 @ 5:46am

    Re: You don't say.

    I dare say we'd waste less if we made patents on medicines or medical procedures or equipment illegal. It's obscene that they're permitted in the first place.

     

    reply to this | link to this | view in thread ]

  55.  
    identicon
    Anonymous Coward, Apr 26th, 2014 @ 11:10pm

    Re: Re: Re: Patented items must be useful?

    The FDA does no testing for approvals, they merely go over the data submitted by the company when they submit a New Drug Application. All the testing is the responsibility, and financial burden, of the submitting company, which is why Eli Lilly went apeshit when they were told no. Because all they care about is profit, not if someone will actually benefit from their product.

    http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/

     

    reply to this | link to this | view in thread ]


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