Subject: Re: Examples needed against Soft Patents
From: "Stephen J. Turnbull" <stephen@xemacs.org>
Date: Sun, 02 Jan 2005 16:10:41 +0900

>>>>> "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.

    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.

    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.

    kms> It does imply that testing or testing data be available to
    kms> multiple entities, preferably with at least independent, if
    kms> not non, biases.

    >> What makes you think any such multiple testing will be done?

    kms> Well, I know that if the data *aren't* available, it _won't_
    kms> be done.  That's a given.

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.

    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?

    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?

    >> 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?

    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?

    kms> The economic rewards come from low-risk situations: take an
    kms> existing product (no research costs), look for a chronic
    kms> condition (obesity, heart disease, diabetes, depression)
    kms> associated with a wealthy (and insured) population.
    kms> Wonderful business case.  From a public health perspective,
    kms> somewhat less desireable.

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.

    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.

-- 
Institute of Policy and Planning Sciences     http://turnbull.sk.tsukuba.ac.jp
University of Tsukuba                    Tennodai 1-1-1 Tsukuba 305-8573 JAPAN
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