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by junto 3795 days ago
I hate the fact that breakthroughs like this are patentable.

People need to follow Alexander Flemings lead:

  The pharmacist Sir Alexander Fleming is revered not just
  because of his discovery of penicillin – the antibiotic
  that has saved millions of lives – but also due to his 
  efforts to ensure that it was freely available to as much
  of the world’s population as possible. Fleming could have
  become a hugely wealthy man if he had decided to control 
  and license the substance, but he understood that 
  penicillin’s potential to overcome diseases such as 
  syphilis, gangrene and tuberculosis meant it had to be 
  released into the world to serve the greater good. On the
  eve of World War II, he transferred the patents to the US
  and UK governments, which were able to mass-produce 
  penicillin in time to treat many of the wounded in that 
  war. It has saved many millions of lives since.
http://www.mobileworldlive.com/blog/penicillin-the-antidote-...
8 comments

Jonah Salk, the guy who developed the polio vaccine

"When asked who owned the patent to it, Salk said, 'There is no patent. Could you patent the sun?'"

From what I've heard, he wouldn't have been the one to decide. That would have been his employer, the National Foundation for Infantile Paralysis. And its lawyers had decided that the vaccine wouldn't be patentable under the rules of that time.
Even if his employer did want to patent his work, considering Salk's huge fame at the time (the guy's a modern dragon slayer), it wouldn't have taken much to convince his employer otherwise. A few interviews here and there and the public outcry would be huge.
It would surely depend on the patent license, no? As http://www.slate.com/articles/technology/history_of_innovati... points out:

> No one knows why the lawyers considered a patent application, but it seems likely that they would only have used it to prevent companies from making unlicensed, low-quality versions of the vaccine. There is no indication that the foundation intended to profit from a patent on the polio vaccine.

Why would the public be in an uproar about using patent protections to keep low-quality vaccines out of the market, while otherwise making the license available at no cost?

> Why would the public be in an uproar about using patent protections to keep low-quality vaccines out of the market

For one thing you don't need patent protections to keep 'low quality' vaccines out of the market. To my knowledge, that's what government regulatory bodies like the FDA are for.

> while otherwise making the license available at no cost?

Even if this was the case, I'm sure that Salk knew that if it was patented, that this would be only temporary (with no guarantees on reasonable pricing in the future); and it would be an unnecessary and immediate roadblock to helping people.

That's what the FDA does now, yes. However, the polio vaccine was introduced when the FDA had weaker powers. It wasn't until after the Thalidomide tragedy and the 1962 Kefauver-Harris Amendment where pharmaceutical companies also needed to demonstrate effectiveness. Before then, companies only needed to demonstrate safety.

As it was, the Cutter polio vaccine incident shows that making the vaccine was not easy.

> I'm sure that Salk knew ...

How are you sure? Is this discussed in his biography or autobiography? I see the topic is covered in Jane S. Smith's "Patent the Sun", but I haven't read it.

Other vaccines (or vaccine preparations) at the time were patented. Was your described behavior typical for them?

There's a big difference between exclusive licensing and non-exclusive licensing. New drugs (like penicillin) tend to be exclusively licensed because of the costs involved in regulatory approval, and that can slow down technology diffusion - the wrong licensee can sink the technology.

But enabling technologies (like CRSPR) get licensed non-exclusively, particularly when the patent holder is an academic institution. If the patents around CRSPR are licensed non-exclusively, at reasonably prices, and with appropriate treatment for academic researchers, these patents aren't going to slow science down.

A good example is the original polymerase chain reaction patents, which were held by Cetus. Despite lots of legal arguments, PCR was always widely available.

Here's a nice analysis of the PCR patent situation and its effects on technology diffusion: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1523369/

There is a big difference between PCR and CRISPR though. Whilst PCR is effectively a reading technology, CRISPR is a writing technology. For many medical technologies then PCR is a standalone diagnostic tool (it is HUGE in mol. biol., pathology, biotech). However you can quite easily see CRISPR being a core tech within revolutionary deliverable medical treatments.

As Eisen points out its kind of odd that the group who rush to do the obvious human implementation should then get a share of all this potential... Not really a novel invention by that point in my opinion.

Yes, exclusively licensing CRISPR on an indication-by-indication basis as a therapeutic itself (as someone below has suggested has already happened by Broad) would be worrisome.
If CRISPR gets/stays patented, the part of the world that respects patent law is going to get left out of whatever innovations it yields. Or maybe not completely left behind, but the groups that will be able to license it will number few.

I generally agree that discoveries like this should go in the public domain as quickly as possible.

The pissing contest about "who invented what, when" is fine and good, to a point; nobody cares if "Cancer Immunity 1.0" drug has a tagline "brought to you by Lander's Finest". To the extent that success and notoriety determine careers, and so we should "get it right" so that the "right" people get credit... I think most researchers will persevere and continue to do science (for the benefit of humanity or for personal glory, or whatever) even if they get shafted for credit.

But the technology itself.. get it into everybody's hands and let the thousand flowers bloom already.

> let the thousand flowers bloom

This is a problematic phrase: https://en.wikipedia.org/wiki/Hundred_Flowers_Campaign

I think the notion that one can own facts will one day be viewed as archaic as the notion that one can own people.
Can you own a secret, though? Or is it OK for a government to force you reveal it publicly?

If people have a right to own secrets, and if NDAs can be legally enforced, then a market of (the knowledge of) facts can naturally emerge that's strictly worse than the patent system.

They don't own any facts. They own the ability to exclude others from selling, as well as importing/exporting, certain materials.
Which is going to break down quickly when anyone can replicate those materials at little cost on their workbench.
They do a pretty good job regulating drug imports that violate IP, and I suspect they will here as well. The materials in question will be complex human therapeutic compositions, not research materials. I strongly doubt people will be creating therapeutic CRISPR compositions at the workbench (which will also include sophisticated delivery and targeting molecular products).
The inventions of scientists in academia, like employees in the private sector, are owned by their employers. Universities and research institutes typically have a policy to profit from these inventions via patents in order to fund more research.

The people that need to change this are at the administrative level: laws via congress, and then chancellors of universities.

Also Banting, the discoverer of insulin (or at least its potential to treat diabetes).
It will take millions of dollars of research to turn this basic bioengineering technique into an approved (safe and effective) human therapy. How do you motivate investors to fund this research without the safety net of a patent to protect that investment from free-loaders?
The way it was done before patents -- government funded research institutions whose only motivation was to provide scientific breakthroughs so they could continue to receive government funding.
There's a huge gap between the scientific breakthrough and the work needed to create a safe and effective therapy. It's not academically interesting, and academic scientists won't do it. It's optimization, not discovery. And what about the cost of the clinical trial, which could be $500m?

Government funded research institutions will continue to provide BREAKTHROUGHS to receive funding.

> And what about the cost of the clinical trial, which could be $500m?

That's an interesting one, because that cost is entirely caused by the government. The government could for example fund clinical trials, since they're the ones who are interested in it's results (as is by extension the public).

As for the rest, if the science were freely available without a patent from the scientists, companies could still spend money making it a therapy and making a profit by doing it better and more efficiently than their competitors, and they could still get a patent on their work.

We're talking about making the science patent free, not the product.

It's an interesting distinction here. I would argue that the science is already free. The Cas9 protein is a natural product. The guide RNA can be synthesized easily. What is being patented here is use of Cas9/CRISPR to edit human cells. In a general sense that is actually the product, and not merely "the science." In other cases, where the Cas9 protein is engineered to achieve things like lower off-target cutting rate, that is a pretty classical case of human invention.
Exactly. An evaluation of the efficiency of "buying" clinical trials with patents would be very interesting.
That's a very cynical and inaccurate appraisal of "The Time Before Patents."

Most scientific breakthroughs throughout history were pursued due to simple curiosity or necessity, precisely because without an international framework of patent law "patents" and the pursuit of technology as intellectual property directly for financial gain was impossible.

The British for example attempted to control physical access to textile IP but Samuel Slater[1] memorized as much as he could and "exported it" along with himself to the Americas to reap a fortune.

[1]https://en.wikipedia.org/wiki/Samuel_Slater

What if someone want to cure a disease that the government doesn't care about?
How about the way we do it now, with patents on devices, therapies, and drugs that are approved by the FDA instead of on the techniques used to develop them? There is even a way to extend the patent life of these developments to account for the amount of time it takes to receive government approval with a maximum term of 14 years after approval [1]. Patenting such a fundamental technique as CRISPR will only set back research for more than a decade and prevent most investors from funding further research while giving companies a huge headstart if they are located outside of the USPTO's jurisdiction.

[1] http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBus...

The technique used to develop the therapy is not really what is being patented here. In practice, anyone will be able to use CRISPR for research purposes or to develop therapies. The question is, why would you invest in using this to develop a product when you can't actually sell the therapy? The product in question here is a therapeutic CRISPR composition for use in human cells. Lots of people will still invest in the technology and research because it is so valuable. If you invent a novel variant with better cutting properties, for instance, or a modification that reduces toxicity, those would be novel compositions of matter and could easily be the foundation of a new business venture.
quite simply, you don't. the motivation is to be either first to market, or have some advantage to your process. If you do the research, you can hold it tight to your chest until it's time to announce your product, by which time you will have a significant advantage over any competition, the amount of time of which is a factor of the difficulty of the subject matter... there's your graduated incentive. low hanging fruit will get plucked. good.

regarding costs of governmental approval: they are a problem. the government will need to use our tax money for this sort of activity rather than shiny new weapons, I suppose. Their fees are absurd. Approval of a specific substance as a treatment for illness ought to be borne by the same public sector that owns it in my common-sensical world i suppose...

I think that means you hate breakthroughs.