Ask HN: Opinion on efforts to find prior art on outrageous priced drugs

Dear HNers,

You may have read this article:

https://www.cnn.com/2025/02/17/health/zolgensma-sma-gene-therapy-drug-pricing-propublica/index.html

To over-simplify the article, it's about a non-profit that financed pre-clinical studies on a genetic disease that strikes infants: SMA.

https://en.wikipedia.org/wiki/Spinal_muscular_atrophy

Once the pre-clinical studies were finished, contacts with the non-profit were much less frequent, and in the end, the drug was approved by the FDA. The price is more than $2 million per dose.

This drug, Zolgensma, involves administering an AAV9 virus capsid containing an SMN1 transgene. Today, commercial companies have mastered this technology, are very efficient, and can produce it at little cost.

I wonder if there could be a collaborative effort to lower the price of such drugs. One way would be to find alternate providers but a main roadblock is the intellectual property.

The first patents on this drug will expire in a few years (they were written in the mid-2000).

I know it's possible to make three kinds of attacks on PI:

- One would be to find an alternative PI not related to the original patents, but it requires pre-clinical studies. The competition of the patent holder would be pleased to finance such pre-clinical studies.

Another option is to find prior art to invalidate the patent. This seems weird, as there should have been at least prior art research before accepting a patent, yet it's feasible. I had the honor of participating in one.

- Then it's possible to evade a PI because the system of claims has a weak point. For example, let's say the administration of the drug is part of the claims, and that several claims depend on that particular. Then it would be trivial to create another patent with the same efficacy but with another administration route. Indeed this is only an example to make this last point clear, I don't claim it has some validity.

I assume there is no need to sue the patent holder as the mere existence of such a website would lower prices.

What do you think of the idea of creating a sort of website where a challenge will be presented: Find a strategy to enable lowering the price on this or that drug, and contributors could discuss and propose solutions. It would be a sort of GitHub project.

Thanks for your comments!

8 points | by JPLeRouzic 1 day ago

2 comments

  • PaulHoule 1 day ago
    The cost isn't justified by the cost of producing the dose, it's justified by the cost of testing a drug like that divided by the small number of recipients. Other gene therapies for rare diseases are priced accordingly, insurance companies will pay because they a worth a lot.
    [-]
    • JPLeRouzic 1 day ago
      Paul,

      If you read the article carefully, you will note that AveXis has spent roughly $13M on preclinical and clinical trials, while the drug costs more than $2M per dose.

      Jean-Pierre

      [-]
      • Two4 12 hours ago
        Jean-Pierre,

        This is an internet forum. Structuring your replies like an email is entirely too formal and comes across as stilted. Please feel free to treat it like a text message thread.

        Two4

  • costco 1 day ago
    If you can successfully challenge pharma patents you can get rich by shorting the stock. A hedge fund manager named Kyle Bass tried this with a couple dozen drugs to varying degrees of success. But also, a patent being invalidated doesn't mean prices come down immediately. ANDAs still take 3-4 years to get approved on average.
    [-]
    • RestartKernel 1 day ago
      Why doesn't that count as market manipulation / insider knowledge? Genuinely asking, I thought the U.S. prosecuted any position based on non-public knowledge (such as the upcoming release of a competing product).
      [-]
      • DontchaKnowit 17 hours ago
        Basically the provinenance of non-public info has to be from a company insider. If the information is generated outside the company then it is not considered non public. So if you find a patent thats invalide, you take steps to get the patent recalled, and you short the stock, at no point have you acted on information which originated from inside the company. Youve made decisioms based only on publically available information.
    • JPLeRouzic 1 day ago
      I wonder if traders could incentivize such searches. I would appreciate pointers.
      [-]
      • costco 16 hours ago
        Going through the IPR process will cost half a million and a year of time at least. The filing fees alone are in the tens of thousands. It's unlikely anyone would pursue a case unless thought they had a good chance of winning. Kyle Bass's strategy was just to hope that filing the patent dispute would cause the share price of the manufacturer to decline, which it did not in many cases. He ultimately lost most of the time in court, so I don't know how much he actually profited.

        Have you heard of Cloudflare's Project Jengo [0] [1]? They were sued by Sable, a patent troll. So they made a website where anyone could submit prior art for any of Sable's patents and they would pay I think around $1000-2000 if it helped their case. Imagine if you had a website where you listed drugs alongside their patents, and a bounty in dollars if you found prior art. The bounty could be funded by hedge funds, generics companies, or other competitors. If the submissions were solid enough, they would take the case to lawyers and hopefully win.

            KEYTRUDA® (pembrolizumab)
    - Bounty: $100,000 
    - Patents:
        - U.S. Patent No. 8,354,509
        - U.S. Patent No. 8,900,587
        - U.S. Patent No. 9,834,605
        - U.S. Patent No. 11,117,961
        - U.S. Patent No. 9,220,776

    ...
        You would probably need a lot of connections to make this work. You would also basically create a side hustle for bored patent lawyers or people with a lot of time on their hands. Though the people who are really good at this sort of work probably already make a lot of money, so maybe it wouldn't work.

        This is basically your original idea, but there's a monetary incentive. I don't think people with the level of expertise needed to do this would do it for free.

        [0] https://www.cloudflare.com/jengo/sable-prior-art-search/

        [1] https://blog.cloudflare.com/the-project-jengo-saga-how-cloud...

        Edit: but maybe I'm wrong. The CEO of Cloudflare says most of the people who submitted probably would have done it for free: https://news.ycombinator.com/item?id=41732580. But then again, Cloudflare was able to publicize their cause easily among technical people who can understand software patents on places like HN, and there was a moral righteousness element to it because patent trolls are parasites. It might be difficult to inspire the same level of enthusiasm about orphan drugs, and there is also likely a smaller number of people who have the skill to review drug patents.