4 ms·

Ok - but just isolating the active part of the drug makes it patentable. Still ridiculous given how cheap Ketamine is.

marssaxman 8y ago
It is completely ridiculous. S-ketamine has been available on the black market for years - it's not like anything about this is rocket science.
- mirimir 8y ago
  If that's true, maybe their patent is invalid. But maybe there's also a patent on the delivery mechansim. Or maybe it's a process patent.
  - loeg 8y ago
    Sure; we know they have a valid patent or else it would not have been worth their time to bring the drug to market.
    - mirimir 8y ago
      Seriously? Janssen obviously believes that it's valid. Or at least, they're confident that they can defend it. Maybe they know that it's not valid, but are confident that others won't figure out why. In one case that I recall, the manufacturer bribed a chemist to retract a paper that had reported the synthesis of their drug. Many years of budget cuts have rendered the Patent Office pretty clueless about drugs. And the FDA doesn't do any independent assessment of patent validity. I've seen testimony where FDA staff said that they lack expertise for that. So basically, patents are valid if they survive litigation.
      - rjf72 8y ago
        It's not just budget cuts. It's an exploding legal system behind patents. Try to decipher the patent rules [1] sometime. It's filled with incredibly counter-intuitive self referential legalese that, even when one understand the jargon, is not entirely clear. And it regularly has very major changes made to the entire code. In general as you approach some degree of complexity in anything, the number of individuals who sufficiently grasp it approaches 0. And then as you're mentioning - that's only about the patent legalese itself. Now the patent examiners also need to be able to have an understanding of what are ideally novel new inventions in various fields, which themselves are often increasingly obfuscated. Anybody could perform a sufficiently capable of job this has way better career opportunities than earning $80k at the patent office. While this does support your notion of budgetary cuts being the primary problem, again I think that misses the core problem which is that the system has become so convoluted that actually having a meaningful holistic understanding requires immense skill and education. Systems that are supposed to be for public, and individual, use should not require a juris doctor to begin to parse. The whole system needs a major overhaul, frankly like much of our formal structures. Isn't it a bizarre system that people are expected to completely obey laws which they are in no way expected to be able to completely understand? [1] - https://www.uspto.gov/web/offices/pac/mpep/index.html https://www.uspto.gov/web/offices/pac/mpep/index.html
      - loeg 8y ago
        It's valid because USPTO approved it, yes. We're first-to-file, not first-to-invent now.
        mirimir 8y ago
        True. But there's still the on-sale bar: > "A person shall be entitled to a patent unless . . . the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention."[0] 0) https://www.whitecase.com/publications/alert/supreme-court-says-america-invents-act-did-not-alter-sale-bar https://www.whitecase.com/publications/alert/supreme-court-s...

It is completely ridiculous. S-ketamine has been available on the black market for years - it's not like anything about this is rocket science.

mirimir 8y ago
If that's true, maybe their patent is invalid. But maybe there's also a patent on the delivery mechansim. Or maybe it's a process patent.
- loeg 8y ago
  Sure; we know they have a valid patent or else it would not have been worth their time to bring the drug to market.
  - mirimir 8y ago
    Seriously? Janssen obviously believes that it's valid. Or at least, they're confident that they can defend it. Maybe they know that it's not valid, but are confident that others won't figure out why. In one case that I recall, the manufacturer bribed a chemist to retract a paper that had reported the synthesis of their drug. Many years of budget cuts have rendered the Patent Office pretty clueless about drugs. And the FDA doesn't do any independent assessment of patent validity. I've seen testimony where FDA staff said that they lack expertise for that. So basically, patents are valid if they survive litigation.
    - rjf72 8y ago
      It's not just budget cuts. It's an exploding legal system behind patents. Try to decipher the patent rules [1] sometime. It's filled with incredibly counter-intuitive self referential legalese that, even when one understand the jargon, is not entirely clear. And it regularly has very major changes made to the entire code. In general as you approach some degree of complexity in anything, the number of individuals who sufficiently grasp it approaches 0. And then as you're mentioning - that's only about the patent legalese itself. Now the patent examiners also need to be able to have an understanding of what are ideally novel new inventions in various fields, which themselves are often increasingly obfuscated. Anybody could perform a sufficiently capable of job this has way better career opportunities than earning $80k at the patent office. While this does support your notion of budgetary cuts being the primary problem, again I think that misses the core problem which is that the system has become so convoluted that actually having a meaningful holistic understanding requires immense skill and education. Systems that are supposed to be for public, and individual, use should not require a juris doctor to begin to parse. The whole system needs a major overhaul, frankly like much of our formal structures. Isn't it a bizarre system that people are expected to completely obey laws which they are in no way expected to be able to completely understand? [1] - https://www.uspto.gov/web/offices/pac/mpep/index.html https://www.uspto.gov/web/offices/pac/mpep/index.html
    - loeg 8y ago
      It's valid because USPTO approved it, yes. We're first-to-file, not first-to-invent now.
      - mirimir 8y ago
        True. But there's still the on-sale bar: > "A person shall be entitled to a patent unless . . . the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention."[0] 0) https://www.whitecase.com/publications/alert/supreme-court-says-america-invents-act-did-not-alter-sale-bar https://www.whitecase.com/publications/alert/supreme-court-s...