Subject: Re: Examples needed against Soft Patents
From: Simo Sorce <simo.sorce@xsec.it>
Date: Mon, 03 Jan 2005 10:35:12 +0100

On Sun, 2005-01-02 at 08:10, Stephen J. Turnbull wrote:
> >>>>> "kms" == Karsten M Self <kmself@ix.netcom.com> writes:
> 
>     kms> Are there any highly successful drugs that *don't* already
>     kms> have signficant generic competition when patent ages out?
> 
> No.  We're not talking about a marginal reduction in profits at the
> _end_ of the patent, we're talking about kneecapping it before it gets
> awarded.

The patent system may be changed to award first publisher.

>     kms> Would opening peer review change the dynamics markedly?
> 
> You're darn tootin' it would!  It would give competitors access to
> highly valuable strategic data before the monopoly is awarded.

Why is i required the data to be kept secret to award a monopoly, given
the result of the award should be publication of said secret?
Why slowing down research?
Data exchange is fundamental nowadays to speedup research.

>     kms> When you're doing generic product, you've eliiminated 1 & 2,
>     kms> *and* the current system already supports this.
> 
> We're not talking about generic product, where as you point out it's
> all ancient history.  We're talking about patent medicine.

We should be talking of lives as you point out below in this mail.

> Ie, you don't believe that any additional testing will be done, unless
> the competition sees an excellent chance to nail the innovator.
> That's like requiring the pitcher to tell the batter what pitch he's
> going to throw.

We're not playing games here. In biology it is fundamental to cross
check data. Because the body cannot (yet) be logically analyzed, it is
not perfect science, only empirical tests show evidence.

> 
>     kms> There are groups with an interest in this, ranging from
>     kms> competitors to medical researchers to public interest groups.
> 
> Sure, but you just implicitly admitted that none of them are willing
> to help pay for the testing.  So who's going to pay, and out of what
> drastically reduced revenues?

I'm in close contact with bio-researchers, they do cross test on another
people _published_ data and methodology. That way you can know if their
test were right or not and that make pressure on first scientists to do
their best to correctly test their findings or they will be soon being
proved wrong and they risk to loose credibility.

>     kms> There's a significant difference between initial FDA reviews
>     kms> and followups.  The FDA process is highly formalized and
>     kms> intensive.  Clinically and statistically valid follow-on
>     kms> studies would likely be feasible at far lower cost.
> 
> That's exactly my point.  The company developing the drug will pay for
> the expensive part, and then you'll shoot its legs off to make sure it
> can't recover the costs.  No?

Don't you think that such test could be publicly founded ?
It's just a question, but wouldn't it be in the interest of the society
to check drugs are ok, without the pressure of dollars to back and
perhaps twist findings to recover costs ?

>     >> What makes you think that making the data available is going to
>     >> be terribly useful (given the atrocious example of the way
>     >> patent claims are written)?
> 
>     kms> This flips our CALs discussion around.  I'm discussing
>     kms> general theory (publically available data), not a specific
>     kms> implemenation (patent application data and/or claims
>     kms> support).
> 
> Huh?  Either the theory applies to patent applications and claims
> support, or it's bogus.  We all want publically available data; the
> question is will early revelation cripple to the profit potential, and
> thus ensure that many fewer new drugs are produced?  Thus failing to
> save lives that could have been saved?

I hope not, does this question come out from current patent awarding
methods, or do you think it would be the same with different rules?

>     kms> There's monopoly interests, on the one hand.  There's the
>     kms> fact that the research is publicly funded, and according to
>     kms> some, should have a public interest component, other than
>     kms> monopoly market development, as a result.
> 
> Saving lives through the actual production and distribution of new
> drugs (as opposed to leaving them as pretty ink splats on the pages of
> professional journals) is not in the public interest?

It is, but do you think patents monopolies are the best method?
Should we do something similar for food and water too ?

> Exactly.  So how do you propose to get the risky business done?
> Remove the protection of the profits of those who conduct it!  Good
> move, that.

Shouldn't we protect only against risks and let see who's better in
making profits in a competitive market ?

>     kms>     Tsunamis might also come to mind.  Care to estimate the
>     kms> cost per life saved of the US Pacific tsunami detection
>     kms> network?
> 
> Would you care to estimate the number of lives that would be saved had
> the US instead contributed that tsunami detection network and the
> associated communications infrastructure to the nations around the
> Indian ocean?
> 
> Let's not trade lives against dollars just yet.  First, let's trade
> lives saved this way against lives saved that way.  Turning it into a
> dollar vs lives tradeoff too early makes it much harder to evaluate
> alternative means to the same end objectively, without adding much to
> the discussion.

Exactly, the right question is: does the patents method optimize lives
saved?
I have not enough data, but my sensation is that it optimizes only
profits right now, or to say it smoothly it optimize too much profits
with regards to lives saved. The fact that bigpharma companies 
were able to dramatically drop prices for AIDS cures in African states
let me think if they were really recovering costs or were they making
a lot of profits on the skin of people there.

If the latter then the system does not work and need a rethink in my
POV. Medicine is not just a business like others, as you said, there are
lives involved.

Simo.
-- 
Simo Sorce - simo.sorce@xsec.it
Xsec s.r.l. - http://www.xsec.it
via Garofalo, 39 - 20133 - Milano
mobile: +39 329 328 7702
tel. +39 02 2953 4143 - fax: +39 02 700 442 399