US adds Canada to IP watch list, due to cheaper generic pharmaceuticals - Polidicks

Assume a completely new, totally synthetic, active ingredient which uses compounds heretofore never seen before. Now assert to me that anyone would find it 'trivial' to reverse engineer that pill and re-make its chemistry. That's an example of a 'novel' discovery - the sort of thing that patent offices actually want: something that hasn't before been seen. The patent itself does not have to describe the process through which the pill was made nor explain in exact detail the chemistry involved in creating the final formula(e) necessary to create the final product. If the chemistry involved was discovered through crunching chemical interactions by a supercomputer for thousands of hours to arrive at a completely new sort of chemical structure which was only found through the trial and error of trillions of variables I very much doubt that reverse engineering it would be found 'trivial'. We don't have matter-replicators or sci-fi nano-assemblers yet. You can't just feed a final compound into a computer and tell it 'make me exactly that, down to the exact arrangement of the bonds between these atoms' at enough speed to create a drug you could push to market as an alternative. Even if you did, painstakingly, you would do so with far less speed than those with the patent would be able to manufacture it - and you could be found to be in legal peril besides since you're not taking an alternative route; you're literally just copy-pasting it. As for times patents have slowed/stalled research: Myriad Genetics' de-facto monopoly on genetic testing to determine breast cancer risk when they patented the BRCA1 and BRCA2 genes. You'll find cases of this like often in 'frontier science' - which the discovery of penicillin would've very much been in its time.

Didn't see this edit before hitting reply. You're still not getting my point: even if Fleming had patented it, the Oxford team would still have been able to work on it by simply approaching Fleming to license his work. The impetus to develop penicillin as a drug was enormous: the implications for treating soldiers on the battlefield were not lost on the British and US governments, and they would have gone to great lengths to secure its development. Your point about the insane person developing a drug is honestly so out of the realm of reality that I don't see any point in discussing it further. Even if such a thing happened, the legal system isn't stupid and will respond in an appropriate way to ensure that the patent was invalidated, and similar situations could not arise in the future. Before continuing, I should point out that I'm a graduate student in organic chemistry. You sure you want to ride this train?

You MUST disclose the formula in a patent. That is the whole point to a patent; the agreement that you disclose your invention and how to recreate it in exchange for limited exclusivity. Drug patents have to be specific. You can't blanket patient a cure for such-and-such disease. People don't think "oh, this has been patented, better give up working on this area now." Companies are always trying to get around patents by looking for gaps or by, who would have thought it, innovating. There are always more drugs to be found. If a technology that's worth using is patented then you pay to licencing fee.

I know enough about chemistry to know that if someone came up with an entirely novel chemical which was derived from agents and elements that 'do not exist' and/or violate presently understood theory then it would be near-impossible to replicate it until someone figured out what the constituent compounds were made of and how they came to be. If my drug Synthall is a compound derived from Yttribium ( primarily composed of izotalyne (a chain of carbon-bonded karyons) and pakrian(a structure built from rana/mara pairs each bonded to hydrogen which themselves bond to oxygen in a tree-like pattern) ) and Rogerium (a compound of built from iinimum (chained rana/magnesium) and lyrin-substrate (pulled from a carbon-buckey-ball-bath which also contains pakrian and free karyons) ) then a chemist is going to go 'what the fuck is all this shit' not 'oh, here's how I reverse engineer these interactions'. Disclosing that formula in my patent assists no chemist because it's absolute gibberish without knowing the sub-components in it. You can't replicate what you can't understand due to a lack of fundamental knowledge.

It's certainly good then that if you proposed testing out a molecule like that (assuming it could even be made) then you'd be laughed out of your supervisors office. Remember they eventually, tons of an active compound will have to be made reliably and cheaply. The chemistry that chemical companies use is often old, well known and using the cheapest (and thus most common) starting material around.

I don't mean to be mean to chemists but I don't think they are literally wizards who can take one look at an entirely new element and go 'yes, this is how that works'.

If by element you mean molecule and by "works" you mean "how to make it" then yes, that's exactly what we do.

I elaborated. Chemistry has limits and those limits end when physics doesn't behave like it should and elements that haven't appeared before show up.

You're describing a completely hypothetical situation that exists only in Marvel comic books. Come up with something better and maybe I'll start listening again.

Alright then but who do you think is writing the patents and doing the R&D if not, well, chemists? Big Pharma isn't run by some superintelligent trans-galactic alien species with access to tech akin to magic. If they are they then they certainly haven't shared any of that tech to use bench chemists making the active compounds.

As I understand it, patents have been approved for less than even that. As far as the situation I'm describing: The material sciences are routinely making 'completely hypothetical situations' into 'actual situations'. We're beginning to understand how to manipulate things at the quantum level -- and that can open the door to entirely new sorts of man-made elements well beyond the ones we've already made. The creation of new elements is something that's happened at a fairly routine (1-8 year) frequency as we understand better and better how to work and stabilize the raw stuffs that make elements themselves. If we learn how to dictate the arrangement of electrons, protons, and atoms as well as be able to dictate all their spins and constituent mechanics the hypothetical situation I describe would not be too far behind that as it unlocks the door to the creation of utterly new elements.

In any case, the situation you're describing doesn't make a difference to your case. If the technology is far beyond the minds of everyone else then you have not stifled because nobody could use any of what you published anyway. And once again, if people cannot reproduce what has been described in your patent then the patent is invalid.

Presumably, also chemists. I'm not talking about superintelligent trans-galactic alien species. I'm talking about people who have a sudden, critical, insight that would create a fundamental change in the medical/physics/engineering disciplines were their work to spread, much as Fleming's work was.

Sorry but you're way off the mark here. The only element heavier than plutonium that sees any real-world use is Am, because almost everything else is so intensely radioactive and short-lived that you can barely do anything with it. Everything else you talked about after that is pretty much gibberish in the category of "not even wrong", I don't know how to respond to that.

Part of being able to be reproduced is to start from materials that are accessible, using known procedures. Lacking this, the patent is at high risk of being invalidated.

As I (and JaffaOrange) have said before, you're describing completely hypothetical situations that have no basis in reality. It's pretty obvious you're way out of your depth here so I don't know why you insist on arguing your case further.

My point is that patents have gaps in it - and that those gaps could be exploited to the detriment of society, especially when mixed with a patent office which may feel that whatever was submitted to it was fine. Genes have been patented for crying out loud (before, yes, being invalidated several many years later -- but all during which they were patented and a company did hold exclusive rights to perform a particular procedure). For that to have occurred to begin with requires a patent office which already did not understand what was being patented but rubber-stamped it anyway. Such a patent office does not set a high bar for invalidation as it has already demonstrated a casual disregard for verification of what was submitted to it. My theoretical compound is merely a mcguffin to prove my point: There are things that will come that are unprecedented which people will cry 'should not exist' because we already do not have a firm and complete knowledge on physics to begin with, leaving plenty of room for such accidental and turbulance-causing discovery. You may state 'but people will just figure out how to do whatever they did so it won't be a big deal' and my rebuttal is that there have been many things that have gone many years without people discovering 'how did this guy make that' - and every one of those years where there is no alternative is a year where money will rule over the collective good of society. In such times that those things come to pass, because they will, under our present system I hold no large hope that patents would nonetheless be granted and held for at least a time to the detriment of society as we live, at least in the US, in a society where corporations have more power than the people underneath them when it comes to who technology should belong to. Saying so: I find the argument that 'competition fixes everything because everything can be competed on, even if its patented' to be a false one because it presumes that everything can be competed on immediately, where many things would require first a more fundamental understanding of the thing in question - or where there is in fact exactly one valid process to achieve a thing, and that singular process is one that is patented.

But that's how a legal system works. It evolves alongside society and changes as necessary. You even described it yourself: the US Supreme Court ruled that biological patents were invalid after years of admitting them. Sure, the system as it stands has potential loopholes that don't cover certain hypothetical situations. But as it stands there is no conceivable manner by which those situations could come about, so why are you declaring the patent system broken purely on the basis of those situations?

But the alternative you're describing is one where things aren't disclosed. Where weird and new technology is not even revealed, let alone understood. Alternatively, we get competition where people make the same thing instead of competition that improves on what is there, perhaps even going so far as to figure out some of the crock you were spouting before. We only need to see what happens to drugs when they go off patent. Companies move in and drive the prices down when they capitalise on a drug's utility/popularity but they certainly aren't going out to do new R&D for new products. And if they are doing research by testing the generic in new populations where the drug hasn't been trialled before, it's because governments like the US offer market exclusivity as a reward for doing so.

You just admitted it was broken. That the patent was allowed to begin with demonstrates that it was broken at the time the patent was submitted. Keyword, again, is 'years after admitting them'; years wherein a singular company had effective control over the process which they invented which could save lives. And the price you'll pay for the present system is situations like the above, where the system is abused for the profit of some and at the expense of others. Mind, I'd be fine with that so long as those who were at the expense of the discoverer were limited to competing interests -- but not the general population at large. I haven't described any alternative, mind; I'm merely describing a big problem I have with the present system wherein people can get hurt by companies that hold medical patents over life-saving care/drugs which we allow for simple fact of 'but the money incentives'. We can provide our own money incentives by more directly funding those companies which discover drugs with monetary annual rewards rather than leaving it to exclusivity and capitalization of particular drugs which could stall or even impede the distribution of potentially life-saving/changing drugs from being both afforded to and distributed to the general population. We can do better than market exclusivity - we should do better.

It's not broken. It falls short sometimes, but a way to fix these shortcomings is built into the system by virtue of the legal process. As it stands the patent system is the most successful and enduring method of encouraging invention and innovation.

The patent having been rescinded demonstrates it didn't belong there to begin with: which means it's broken.

Should have specified, I meant in the context of the pharmaceutical industry. Tech patents are a whole different issue entirely and one that I won't discuss here not least because I'm not well-informed on the topic. Yes, patents can be abused even within the pharmaceutical industry, but the solution to that isn't "get rid of patents", it's "improve patent law to prevent abuse".

Or, instead, we could fix the system so that it doesn't require slow-acting legal injunctions which take years to get through the system and instead just simply reward those who discover a thing first and/or get them some of the profits of those (specifically in the pharma industry field of patents) who remix what they've thrown down. Tech patents just demonstrate the flaw in patents in general: overbroad allowances and poor review by people who don't have a real grasp on the subject matter within those patents. Those same issues affect all patents by necessity. The solution for that flaw shouldn't be 'well, it's just a flaw of the system we have to deal with'.

Realistically speaking, how, given how entrenched the patent system currently is in how these things work, would one set in motion a move to a better system should such an alternative be conceived by somebody? Isn't it simply easier to attempt to fix the current system, given the state of things?

But... you've just described a patent system, at least in your second part. The first part is a valid suggestion and one that has been floated before especially in the context of antibiotics development, where profits often aren't upfront and for which market exclusivity doesn't really offer a strong enough financial incentive.

It would be -- if our legal system moved faster than a tortoise in molasses. I'd put it at a toss-up as to which would arrive faster - but I know one that was built from the ground-up to try and solve all these critical problems we have with patents and patent review would at least have less things to be fixed -- given that we've had many years of experience and history to determine what was wrong with the prior system. Sort of. This would include all things that are derivative of, even if novel. Presently patents are a 1:1 thing - you either did this thing or this other thing. Right now we have stuff like license fees and whatnot - I think that should go away as it's somewhat predatory to leave it in the hands of the owners of important medical patents. Instead, it should be administered by an impartial third party who determines how much should be owed based on how much is owed to the patent in question. Patents, as envisioned at their creation anyway, were meant to be an affordable and playing-field leveling system to reward inventors of novel, specific, inventions - but now it costs some $20k to even get a real patent (incl. legal fees etc) and patents as broad as 'a display which is used to view game media' are allowed because the patent inspectors were never meant to be experts in every field of study and discipline. Part of a reinvention of the patent office - or even fixing it - must necessarily include a complete overhaul of who works in the patent office, including ensuring field-experts manning positions within it who have a high degree of technical knowledge and experience with the field in question - and that patents that fall into those fields therefore land directly in their hands and no others.

That would get very messy very fast. The impartial third party would be utterly swamped with work trying to figure out who owes whom how much. I really don't see how such a system would be an improvement over what we have now. Again, I'm not talking about patents as a whole here, I'm talking specifically about pharmaceutical patents. There are several glaring problems in this area, but they also involve the FDA approvals process and I'm not sure how relevant that is here.

Money as the only incentive to do good for society is just wrong. Patents allowing single companies to rule over a method of saving lives are evil. I'm not sure how you can defend letting companies rule over any method of doing anything as "encouraging innovation" when in reality it just encourages making money over the good of society (the worst vice).

The improvement would be that companies wouldn't be able to dictate how much their invention is worth but rather society (or representatives of it anyway) would judge how much it's worth (which, really, sounds like a better way to go about the whole thing to begin with) - and properly attribute how much should be therefore owed based on how much of the patent in question was used or was necessary in the new thing's discovery/creation. Not talking about the FDA process - that's a whole other thing that deserves its own grievances and problem-fixings - I'm specifically talking about patents. It'd cost money to run the P.O. that way, especially to guarantee it had enough staffing and support to reliably process all that stuff - but it's worth it to ensure that medical breakthroughs are delivered as fast as they prove themselves rather than as fast as money allows them to.