4 ms·

The simplest solution would be to significantly shorten the patent duration for pharmaceuticals, and start it the day a drug gets FDA approval. This would uncou

The simplest solution would be to significantly shorten the patent duration for pharmaceuticals, and start it the day a drug gets FDA approval. This would uncouple two things that should have never been coupled in the first place: development time and window of exclusivity in the market.

xaa 12y ago
Companies would (justifiably) still want provisional patent protection for the very long period between the idea's conception and FDA approval, to reduce the risk on their huge investment. Thus, wouldn't this idea exacerbate the already rampant abuse of provisional patents? Or if long provisional patents weren't allowed, then companies probably would avoid products with long FDA approval times, which is the very problem you're trying to solve.
- skybrian 12y ago
  Early-phase development would be better funded through a different mechanism. (For example, prizes for key achievements.)
  - xaa 12y ago
    It already is, because the way many drugs are developed is that the NIH funds the basic research behind it, and early-stage in-vitro trials and maybe some mouse trials. Usually it is only when the drug is ready for clinical trials that pharma steps in (doing 20% of the work and claiming 100% of the profit).
- michaelq 12y ago
  I imagine the costs of trials, and who paid them, are well documented. In the event of a dispute about which company discovered which drug, could a company not point to its investment in research or funding of a specific trial as evidence of its discovery, rather than trying to spam system with provisional patent applications? (By the way, there's no such thing as a "provisional patent" http://en.wikipedia.org/wiki/Provisional_patent#cite_note-1 http://en.wikipedia.org/wiki/Provisional_patent#cite_note-1)
  - teachingaway 12y ago
    >> By the way, there's no such thing as a "provisional patent" Right. But its just shorthand for "provisional patent application". Maybe its sloppy, but I don't think its a big deal.
    - xaa 12y ago
      Actually, I guess what I meant is that there can be a massive delay between the time that the patent is filed and when it is granted (or rejected), during which time you are protected, and it doesn't count against the patent life. My boss, who is a biomedical researcher, has had a patent in this kind of limbo for 11 years. He's long since moved on (he doesn't even work at that institution any more), but the university's IP lawyers have been playing ping-pong with the patent office for over a decade. If he can achieve this without caring at all, imagine what well-funded pharma lawyers could do.
- mcherm 12y ago
  > Companies would (justifiably) still want provisional patent protection for the very long period between the idea's conception and FDA approval I disagree. For drugs this wouldn't be a problem. The company that invented it is forbidden from making money off a drug that is not approved, so they have every incentive to get the approval as soon as possible. Other companies would not be prevented by patent law from producing the drug during the time, but they would be prevented by FDA regulation. And they would not be inclined to invest since they would know that the patent would issue as soon as the drug was approved.
  - xaa 12y ago
    Well, the international enforceability of US patents is already sketchy at best, and if the phamaceutical doesn't even have a patent at all, there's absolutely nothing stopping a company from producing and selling it in a country that doesn't have standards quite as tight as the FDA. Also, your comment > The company that invented it is forbidden from making money off a drug that is not approved raises another interesting issue. In the current system, a company CAN in fact make money off of such a drug, by selling the patent to someone else. Actually, many drug patents originate in universities, and then are sold to drug companies. I doubt the university lobby would be keen on losing that major revenue stream.
danielweber 12y ago
Or prizes. If the NPV of treating, say, stomach cancer is $5 billion, the parties involved can offer to pay a prize of $4.7 billion to someone who shows up with a cure. Every party is better off in that scenario.
- spacehome 12y ago
  Cures aren't really binary things. Something like "stomach cancer" is probably a whole bunch of (perhaps at present indistinguishable) diseases. Add to that that event amongst cures for the exact same malady, there can be differences in side effects, efficacy, and treatment length.
- pessimizer 12y ago
  http://www.huffingtonpost.com/2012/05/19/bernie-sanders-prescription-drug-prices_n_1528332.html http://www.huffingtonpost.com/2012/05/19/bernie-sanders-pres... "Sanders has introduced legislation that would offer companies a big up-front prize for developing new, innovative AIDS drugs. In return for the big payday, pharmaceutical firms would agree to allow generic versions of their medicines to hit the market immediately. The fund would total $3 billion for its first year. "'Moving from a patent system to an effective prize system, using the power of the competitive marketplace to ensure the efficient dissemination of medicines, is a critical step in creating [a] more efficient innovation system,' Nobel Prize-winning economist Joseph Stiglitz said at Tuesday's hearing."

xaa 12y ago

Companies would (justifiably) still want provisional patent protection for the very long period between the idea's conception and FDA approval, to reduce the risk on their huge investment. Thus, wouldn't this idea exacerbate the already rampant abuse of provisional patents? Or if long provisional patents weren't allowed, then companies probably would avoid products with long FDA approval times, which is the very problem you're trying to solve.

skybrian 12y ago
Early-phase development would be better funded through a different mechanism. (For example, prizes for key achievements.)
- xaa 12y ago
  It already is, because the way many drugs are developed is that the NIH funds the basic research behind it, and early-stage in-vitro trials and maybe some mouse trials. Usually it is only when the drug is ready for clinical trials that pharma steps in (doing 20% of the work and claiming 100% of the profit).
michaelq 12y ago
I imagine the costs of trials, and who paid them, are well documented. In the event of a dispute about which company discovered which drug, could a company not point to its investment in research or funding of a specific trial as evidence of its discovery, rather than trying to spam system with provisional patent applications? (By the way, there's no such thing as a "provisional patent" http://en.wikipedia.org/wiki/Provisional_patent#cite_note-1 http://en.wikipedia.org/wiki/Provisional_patent#cite_note-1)
- teachingaway 12y ago
  >> By the way, there's no such thing as a "provisional patent" Right. But its just shorthand for "provisional patent application". Maybe its sloppy, but I don't think its a big deal.
  - xaa 12y ago
    Actually, I guess what I meant is that there can be a massive delay between the time that the patent is filed and when it is granted (or rejected), during which time you are protected, and it doesn't count against the patent life. My boss, who is a biomedical researcher, has had a patent in this kind of limbo for 11 years. He's long since moved on (he doesn't even work at that institution any more), but the university's IP lawyers have been playing ping-pong with the patent office for over a decade. If he can achieve this without caring at all, imagine what well-funded pharma lawyers could do.
mcherm 12y ago
> Companies would (justifiably) still want provisional patent protection for the very long period between the idea's conception and FDA approval I disagree. For drugs this wouldn't be a problem. The company that invented it is forbidden from making money off a drug that is not approved, so they have every incentive to get the approval as soon as possible. Other companies would not be prevented by patent law from producing the drug during the time, but they would be prevented by FDA regulation. And they would not be inclined to invest since they would know that the patent would issue as soon as the drug was approved.
- xaa 12y ago
  Well, the international enforceability of US patents is already sketchy at best, and if the phamaceutical doesn't even have a patent at all, there's absolutely nothing stopping a company from producing and selling it in a country that doesn't have standards quite as tight as the FDA. Also, your comment > The company that invented it is forbidden from making money off a drug that is not approved raises another interesting issue. In the current system, a company CAN in fact make money off of such a drug, by selling the patent to someone else. Actually, many drug patents originate in universities, and then are sold to drug companies. I doubt the university lobby would be keen on losing that major revenue stream.

danielweber 12y ago

Or prizes. If the NPV of treating, say, stomach cancer is $5 billion, the parties involved can offer to pay a prize of $4.7 billion to someone who shows up with a cure. Every party is better off in that scenario.

spacehome 12y ago
Cures aren't really binary things. Something like "stomach cancer" is probably a whole bunch of (perhaps at present indistinguishable) diseases. Add to that that event amongst cures for the exact same malady, there can be differences in side effects, efficacy, and treatment length.
pessimizer 12y ago
http://www.huffingtonpost.com/2012/05/19/bernie-sanders-prescription-drug-prices_n_1528332.html http://www.huffingtonpost.com/2012/05/19/bernie-sanders-pres... "Sanders has introduced legislation that would offer companies a big up-front prize for developing new, innovative AIDS drugs. In return for the big payday, pharmaceutical firms would agree to allow generic versions of their medicines to hit the market immediately. The fund would total $3 billion for its first year. "'Moving from a patent system to an effective prize system, using the power of the competitive marketplace to ensure the efficient dissemination of medicines, is a critical step in creating [a] more efficient innovation system,' Nobel Prize-winning economist Joseph Stiglitz said at Tuesday's hearing."