Federal Circuit Snubs Pfizer On Norvasc Rehearing discusses a recent legal dispute that involves the FDA and patents and exemplifies what a mess and waste the FDA and patent system are.
So let me summarize in plain terms: Pfizer got a patent on its hypertension drug Norvasc, and also, of course, had FDA approval. So for a while it had a monopoly. As a result of a lawsuit with Apotex, who wanted to make a generic version of Norvasc, Pfizer’s patent was invalidated.
Now, because Mylan Labs already had obtained FDA approval to make the generic, as soon as the patent was invalidated, Mylan Labs ramped up plans to make a generic version of Norvasc. I.e., Apotex’s suit against Pfizer resulted in Mylan being unshackled. Meantime (from what I can tell from the convoluted reports about this), Mylan sues to try to prevent Apotex from getting FDA approval. Amazing: Apotex removes Pfizer’s patent monopoly, thus freeing up Mylan to sell the generic; while Mylan seeks to keep the FDA’s block of Apotex in place.
Can any sane person believe either the patent or FDA system does any good at all here?
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It does plenty of good to people who know who to work the system in their favor. Not so much for anyone else. But the real Statist task is selling to everyone else that they’re the ones making out.
It’s crazy, there must be thousands of intelligent people running around doing jack, actually it’s even worse, they are being restricting other people from doing their work.
My understanding of the matter, and it may be incorrect, is that the 6 month exclusionary period for the first generic supplier of an approved drug is a separate issue from the issuing of a valid, or in this case, invalid patent. In other words, if a company brought a drug forward for approval that was not patent protected, it would be given a 6 month monopoly period anyway.
Though, yes, the entire thing is a complete mess.
Mylan was the first paragraph IV filer.
It’s a morass of inefficient technological stagnation which has suffocated energetic competition from delivering the absolute best quality as the cheapest price to the most people. People are sicker at a higher cost so that a few elites can sit comforably in lush luxury doing nothing but resting on their laurels, causing net societal poverty. It’s a *massive* effect as well. Everything from health care to software to entertainment to food to transporation is far less efficient and far more costly and less technologically advanced than it otherwise would be. And yes ‘A’s are wasting energy and resources devoted solely toward preventing ‘B’s from using ‘B’s energy and resources in similar or exact ways as ‘A’s.
We need a constitutional amendment stripping all copyright and patent protection. This is something which can be reasonably accomplished. It’s proved that the original constitutional intent of patents to promote science and useful arts actually does the opposite, it hinders the promotion of science and useful arts, without exception.
rtr – I had no idea you had such communist leanings; as if information is “free” and changing things mid-stride would be fair at all.
Here come the cries of communism. How about making an argument?
as if… changing things mid-stride would be fair at all.
I wouldn’t mind a phase-out period of some kind.
rtr – Just like the cries of “statist”.
In my view, anything that is “discoverable from nature” … i.e. computer code, mechanical processes, drugs, etc. is unpatentable.
The rest of the arguments against patents are utilitarian (i.e. there is *no* possible way to non-arbitrarily decide these issues).
None of the fundamental arguments hold up.
JIMB: “In my view, anything that is “discoverable from nature” … i.e. computer code, mechanical processes, drugs, etc. is unpatentable.”
And thus *nothing* is patentable/copyrightable. Nobody can exclusively own a sound, an image, a word, or a letter. Thus, all claims which include images, sounds, or words are not exclusively ownable. An unlimited amount of people can think the same thoughts, hear the same sounds, see the same images, simulataneously. This is *indisputable* fact. When a news station broadcasts news, people see and hear it *simultaneously*.
The only thing you are advocating is violence to control what others do with their own persons and their own property. Indeed why bother with any pretend argument or justification when it’s merely a thugish call for violence.
If ideas are ownable then a person should be able to control doors and windows, and restrict others from copying doors and windows in their homes. A person should be able to control clothing, and prevent others from dressing. It doesn’t matter how simple or complex the alleged claim is either, it’s in every case hypocritically ripping off the ideas of others.
Is your argument rtr one of ‘if is one person has that right then everyone should have that right, if not then no one should have that right’? Sounds rather like communistic egalitarian stuff if you ask me. Why should any one own/control any plot of land? If people shouldn’t expect a return for the bother of an invention and they should give it as a gift to humanity, then why should a farmer expect a return on his crops and give food to humanity as a gift leading a betterment for all? Considering when someone occupies land and fences it off and threaten to kill any one who dares jumps the fence, then they too have created a monopoly with threats of violence to sustain that monopoly. Well if you then say that others should find their own plot and farm their own land why not then I.P.? Don’t like this operating system then write your own? Don’t like that treatment of cancer concoct your own brew? If there’s a patent on such stuff then make your own but don’t tell anyone what you’ve done but secretly feel proud that you are self-sufficient?
rtr – So you’ve seen a umpteen thousand authors as successful as JK Rowling’s Harry Potter series? In my view, that fact shows quite clearly that there are unique creations of people that can be sold and should be protected as their property because it is sold under those conditions to buyers.
The issue with “knowledge from nature” (such as drugs, mechanics, processes, computer code, algorithms, etc.) is that no person can own something in the public domain, and natural laws certainly qualify.
TLWP: “Is your argument rtr one of ‘if is one person has that right then everyone should have that right, if not then no one should have that right’?”
“Rights” must be universal if they are truly “rights”. Every claim of Copyright/Patent is hypocritically COPYING others. Thus the claim is invalidated on the grounds it argues. YOU CAN’T EVEN MAKE A CLAIM TO PROHIBIT COPYING WITHOUT COPYING. (That’s why I’m the *best* ever, so far ;p). By banning all copyright/patent protection, copyright/patent claimants get *exactly* what they argue for. So what’s the problem?
TLWP: “Sounds rather like communistic egalitarian stuff if you ask me. Why should any one own/control any plot of land?”
Because it’s a limited scarce physical material resource which cannot be simultaneously inhabited and controlled by all who wish whenever they wish, like ideas can.
TLWP: “If people shouldn’t expect a return for the bother of an invention and they should give it as a gift to humanity, then why should a farmer expect a return on his crops and give food to humanity as a gift leading a betterment for all?”
Growing crops is COPYING. Using wheels is COPYING. Eating food is COPYING. Thinking is COPYING. There’s no “gift”. There is what each procurs to themself through ownership of their own bodies and ownership of physical material resources.
TLWP: “Considering when someone occupies land and fences it off and threaten to kill any one who dares jumps the fence, then they too have created a monopoly with threats of violence to sustain that monopoly.”
Every person is a monopoly of themself. Violence is offensive, not defensive.
TLWP: “Well if you then say that others should find their own plot and farm their own land why not then I.P.?”
Because I.P. by defintion prohibits others from “FARM-*ING* their own land. That’s why I.P. is an absurdly violent claim restricting others action of their other persons and their other property.
TLWP: “Don’t like this operating system then write your own? Don’t like that treatment of cancer concoct your own brew? If there’s a patent on such stuff then make your own but don’t tell anyone what you’ve done but secretly feel proud that you are self-sufficient?”
The claimants of I.P. would do well to be told such. They COPY left and right, up and down, all day long. They have no basis upon which to use violence to prohibit copying. They would *necessarily* be arguing against themselves acting.
COPYING is not a “dirty” word. It’s how the species evolves within society. People trade to increase their subjective wealth. They want what others have, which is COPYING. Information flows, technology evolves, precisely because of COPYING. Ding, Nobel Prize #16. Pricing from exchange *is* the COPYING of information. Those who argue for patent/copyright protection argue against the free market. They prevent market signals of what exists and what is wanted from flowing, causing poverty.
JIMB: “So you’ve seen a umpteen thousand authors as successful as JK Rowling’s Harry Potter series? In my view, that fact shows quite clearly that there are unique creations of people that can be sold and should be protected as their property because it is sold under those conditions to buyers.”
As I’ve said before JK Rowling’s Harry Potter series has COPIED “people flying on broom sticks”, has COPIED the form of a book, has COPIED language. Just about everything which is contained in her series could be stripped by logical strict enforcement of copyright. As such copyright would preclude Harry Potter from existing. That would be an example, the erasing of Harry Potter, of what copyright/patent has already caused, but remains unseen.
JIMB: “The issue with “knowledge from nature” (such as drugs, mechanics, processes, computer code, algorithms, etc.) is that no person can own something in the public domain, and natural laws certainly qualify.”
All ideas *are* in the public domain, as soon as they are thought by more than one person, whether the means of their spreading is through observation or trade.
The FDA-Patent Pharmaceutical mess, this blogs more informative……
It’s not only FDA – it’s a general problem and strong competition between companies (i.e. large generic brands) makes it even worse. Patent strategies are getting more and more sophisticated (not only indications, polymorphs , formulations), so I think i’s very hard in general for agencies responsible for marketing authorization of medicines to involve into patent protection. I’m dealing with EU agencies and here is the same, fortunately most of agencies avoid to be involved in patent issues (despite some pressure from protected companies, so-called patent linkage) and in most cases they are taking care of data exclusivity leaving the rest to the courts.
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