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by nnnnnnnn 5004 days ago
Funding the expensive regulatory process (which includes clinical trials and all the rest) is very easy to legislate. For example, grant a company some limited exclusive rights for commerce/sale of a drug they have funded through clinical trials.

A commercial restriction on the sale of a drug would be far less onerous and legally problematic than the current patent system.
1 comments
tsotha 5003 days ago
>For example, grant a company some limited exclusive rights for commerce/sale of a drug they have funded through clinical trials.

Eh, isn't that the textbook definition of a patent?

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cwp 5003 days ago
Not quite.

A patent is granted for the invention of a drug, not the testing. If the monopoly were tied to the approval process, it would be limited to the country where the approval was granted. So shepherding a drug through the FDA approval process would get you a monopoly in the US, but not other countries.

Also, you can patent drugs that haven't been approved, which makes it basically impossible for anyone else to do the clinical trials. Breaking the link between the research and the approval process would make it easier for effective drugs to get tested and approved.

Finally, sure, that scheme would be a lot like patents. But at the very least it would be specific to the drug industry, where they are (maybe) useful, and wouldn't distort other industries where patents are actively harmful.

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refurb 5002 days ago
They do that now (to an extent).

If you get your drug approved by the FDA, you get 5 years of market exclusivity (12 years of it's a biologic). However, it has to be determined by the FDA to be a NCE (new chemical entity). Right now, a company called Amarin is trying to get a drug approved that has no patent and they are hope to get the FDA to recognize their drug as an NCE.

If it for a very rare disease (orphan drug), you get 7 years of exclusivity (still 12 if it's a biologic).

During that time, no other application for the same NCE and indication will be approved by the FDA, giving the first applicant de facto market exclusivity in lieu of a actual patent.

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cwp 5002 days ago
That's awesome. In my mind, that lets a lot of air out of the pharmaceutical argument for patents.
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tsotha 5003 days ago
Ah, I see what you're saying now. That makes quite a bit of sense, especially if it applied only to drugs and medical devices.
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