4 ms·

I have to admit I didn't know how the Orange Book worked, so I had to do some research. Do I have this right? "An Orange Book listing shows "approved prescript

I have to admit I didn't know how the Orange Book worked, so I had to do some research. Do I have this right? "An Orange Book listing shows "approved prescription drugs, related patent and exclusivity information, and therapeutic equivalence evaluations, along with other information." https://www.fda.gov/drugs/news-events-human-drugs/our-perspective-orange-book-40-valued-fda-resource-continually-enhanced-user-input https://www.fda.gov/drugs/news-events-human-drugs/our-perspe... So a pharma company can insert a listing saying that, for a bogus example, "Vioxx has no approved generics, because all substitutes are under patent or patent pending." when that is untrue. This seems clearly illegal and abusive. From the headline, I thought Kahn was saying that filing a trivial patent "improving" Vioxx would be illegal. But that's not it.

pixl97 3y ago
I believe the word you are looking for is fraudulent. And yea, why aren't we prosecuting for that.
whymauri 3y ago
Not only bogus, but if you get a hit on a scaffold you can combinatorially modify that scaffold and file it with the patent. This effectively blocks the small permutation space around the drug from further investigation or development. There's lot of promising science that can't be done because incumbents are so adversarial about patent space for structures they don't even care about. To make matters worse, patent data and notation is: * Poorly structured and defined, * Difficult to parse, * Uses combinatorial/wildcard notation (Markush structures [0], which is what modern drug patent law is based on). So it's a total mess. The best analogy I could give for software is: imagine if you could patent closed source code (the literal code) and also attach a wildcard to every branch in logic within that closed source code, but all you publish are the filenames (as screenshots of directories, not text). You don't have to run due diligence that the permutations are run to spec or even compile, but now nobody can write logic infringing on your hypothetical code (which you never wrote). If your reaction is 'what the fuck?', yes I agree. [0] https://en.wikipedia.org/wiki/Markush_structure https://en.wikipedia.org/wiki/Markush_structure
- AlbertCory 3y ago
  Thanks, let's leave out software. Not that it's not relevant, but it's a black hole for this crowd. One should not try to understand everything by analogy with software.
  - dllthomas 3y ago
    Cars, then?
    - lotsofpulp 3y ago
      Analogies are not necessary all the time.
      - dllthomas 3y ago
        Indeed. My intent with my comment was to jokingly nod in that direction.
    - AlbertCory 3y ago
      No analogies. It is what it is. Markush groups, as GP mentioned, are there specifically for chemical patents. So that's what's shaped the patent law, not software or cars.
      - TeMPOraL 3y ago
        It's purposefully a kind of algebraic notation. Algebra is math, particularly a kind of math that maps really well to software (less so, cars). Hence the analogy makes sense.
        AlbertCory 3y ago
        "Everything can be mapped to software" Perhaps, but chemistry is chemistry. It existed before software did, and you need to understand it on its own terms.
0xcde4c3db 3y ago
If I understand things correctly (not assured by any means, as I've only skimmed some of the sources), the abuse vector looks something like this: 1) A company files that trivial "improvement" patent, or simply picks a recent patent out of its portfolio whose applicability to the drug is unclear. Hilariously, in the linked example from the article, the "improvement" was merely to claim that a metabolite was the active molecule rather than the drug per se, and thus change the instructions for when to take the pill relative to mealtimes. 2) The company files for an Orange Book listing asserting that the new patent applies to the old drug. 3) A generic manufacturer seeking approval disputes this assertion in its ANDA (abbreviated new drug application) filing. 4) The FDA provisionally approves the generic. 5) The generic manufacturer starts tooling up for manufacturing and taking orders for the product. 6) The brand-name manufacturer sues the generic manufacturer, which automatically triggers a 30-month stay on the approval.

pixl97 3y ago

I believe the word you are looking for is fraudulent. And yea, why aren't we prosecuting for that.

whymauri 3y ago

Not only bogus, but if you get a hit on a scaffold you can combinatorially modify that scaffold and file it with the patent. This effectively blocks the small permutation space around the drug from further investigation or development. There's lot of promising science that can't be done because incumbents are so adversarial about patent space for structures they don't even care about. To make matters worse, patent data and notation is: * Poorly structured and defined, * Difficult to parse, * Uses combinatorial/wildcard notation (Markush structures [0], which is what modern drug patent law is based on). So it's a total mess. The best analogy I could give for software is: imagine if you could patent closed source code (the literal code) and also attach a wildcard to every branch in logic within that closed source code, but all you publish are the filenames (as screenshots of directories, not text). You don't have to run due diligence that the permutations are run to spec or even compile, but now nobody can write logic infringing on your hypothetical code (which you never wrote). If your reaction is 'what the fuck?', yes I agree. [0] https://en.wikipedia.org/wiki/Markush_structure https://en.wikipedia.org/wiki/Markush_structure

AlbertCory 3y ago
Thanks, let's leave out software. Not that it's not relevant, but it's a black hole for this crowd. One should not try to understand everything by analogy with software.
- dllthomas 3y ago
  Cars, then?
  - lotsofpulp 3y ago
    Analogies are not necessary all the time.
    - dllthomas 3y ago
      Indeed. My intent with my comment was to jokingly nod in that direction.
  - AlbertCory 3y ago
    No analogies. It is what it is. Markush groups, as GP mentioned, are there specifically for chemical patents. So that's what's shaped the patent law, not software or cars.
    - TeMPOraL 3y ago
      It's purposefully a kind of algebraic notation. Algebra is math, particularly a kind of math that maps really well to software (less so, cars). Hence the analogy makes sense.
      - AlbertCory 3y ago
        "Everything can be mapped to software" Perhaps, but chemistry is chemistry. It existed before software did, and you need to understand it on its own terms.

0xcde4c3db 3y ago

If I understand things correctly (not assured by any means, as I've only skimmed some of the sources), the abuse vector looks something like this: 1) A company files that trivial "improvement" patent, or simply picks a recent patent out of its portfolio whose applicability to the drug is unclear. Hilariously, in the linked example from the article, the "improvement" was merely to claim that a metabolite was the active molecule rather than the drug per se, and thus change the instructions for when to take the pill relative to mealtimes. 2) The company files for an Orange Book listing asserting that the new patent applies to the old drug. 3) A generic manufacturer seeking approval disputes this assertion in its ANDA (abbreviated new drug application) filing. 4) The FDA provisionally approves the generic. 5) The generic manufacturer starts tooling up for manufacturing and taking orders for the product. 6) The brand-name manufacturer sues the generic manufacturer, which automatically triggers a 30-month stay on the approval.