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Source link: http://archive.mises.org/5216/patent-and-penicillin/

Patent and Penicillin

June 22, 2006 by

Apparently the discovery of penicillin is often trotted out as a classic case showing the importance of having the innovation-incentives of a patent system in place. The following post from Greg Aharonian’s PatNews is a letter from a medical specialist debunking some urban legends about this, including one repeated by then-US Patent Office Director Q. Todd Dickinson:

Greg,

Thought you and your readers might enjoy this comment on the twisted history of patenting and penicillin. Lots of urban myths about this story, and Q. Todd Dickinson took it to the top — citing a nonexistent patent in congressional testimony, and saying it made the world a safer place. He could have used the streptomycin example legitimately, although the success of commercializing penicillin without a patent on the penicillin molecule does detract from the drama of his (obviously suspect) point.

We have three success stories of innovation in this early antibiotic history, with penicillin driven by forced cooperation among firms with government grants for manufacturing capacity and guaranteed market through purchase contracts for successful manufacture, while streptomycin and cephalosporins are more like what we have come to see as the normal model of patenting the therapeutic and licensing to a pharma firm. This came up in review of a manuscript we sent to a journal, and one reviewer made some assertions about the role of patenting in the development of polio vaccine and penicillin. Many paths to innovation. Anyway, this is an excerpt from our cover letter in response, which I thought might be of interest to some of your readers:

“A couple of reviewer comments about the role of patents in both the
polio vaccine and penicillin stories bear some attention. We have
been reviewing the histories of intellectual property in some classic
cases of biomedical innovation, including penicillin and other
antibiotics, polio, thyroid hormone, insulin, and growth hormone.
There is a good deal of misinformation and – urban legend – that has
grown up around some of those cases. One of the reviewers makes
two statements that seem to indicate he or she has some erroneous
information about the role of patents in polio vaccine and
penicillin.

When Jonas Salk asked rhetorically “Would you patent the sun?”
during his famous television interview with Edward R. Murrow, he
did not mention that the lawyers from the National Foundation for
Infantile Paralysis had looked into patenting the Salk Vaccine and
concluded that it could not be patented because of prior art – that
it would not be considered a patentable invention by standards of
the day. Salk implied that the decision was a moral one, but Jane
Smith, in her history of the Salk Vaccine, Patenting the Sun, notes
that whether or not Salk himself believed what he said to Murrow,
the idea of patenting the vaccine had been directly analyzed and
the decision was made not to apply for a patent mainly because it
would not result in one. We will never know whether the National
Foundation on Infantile Paralysis or the University of Pittsburgh
would have patented the vaccine if they could, but the simple moral
interpretation often applied to this case is simply wrong.

The reviewer also asserts that penicillin ‘didn’t move for 14 years
due to absence of a patent.’ This is far off the mark, and a clear
case of misattribution of cause. Fleming discovered penicillin in
1928 and found it could be used as an adjunct to diagnosis of
H. influenza infection. He never tried to do clinical tests of
penicillin as a human antibiotic. It was indeed not patented, but
it was also not fully characterized and it is not clear it was
described with sufficient precision to warrant a patent. Moreover,
for the limited utility that Fleming wrote about in his papers,
there was little reason to patent penicillin. In any event, the
patent would nearly have expired by the time Florey and Chain did
their crucial clinical experiments in mice and then humans in 1941,
and would have had only a few years left when production was
sufficient to lead to broader clinical use in 1944 and 1945.
Moreover, the inducement to produce penicillin during World War II
was largely driven by the War Production Board, and far from
encouraging proprietary exclusive property rights, the U.S.
Government basically forced various pharmaceutical manufacturers to
share technology, including various manufacturing patents. It is
crystal clear that the missing element in the 1928 to 1941 gap was
not absence of patent incentive. There were four other factors much
more important in this story:

1. It took Florey and Chain to demonstrate the clinical potential.

2. It was very hard to manufacture penicillin in sufficient quantity,
and the scientific groups funding R&D strongly favored trying to
chemically synthesize penicillin, rather than producing it through
fermentation. That never became the preferred method, although it was
eventually synthesized in 1959, 30 years after Fleming’s discovery
(penicillin is made by fermentation even today). Immense sums were
wasted in the organic chemistry, when in fact it was a biological
production method that proved key to success.

3. It was a USDA government laboratory that increased yield of
penicillin and made it feasible to go to large-scale production.
USDA had real expertise in fermentation. USDA increased yield
enormously by developing vat fermentation instead of surface
fermentation, and hired out work to find mutant strains of the
fungus that produced more drug. This is what proved to be the
hard work that mattered most for penicillin – making enough of it -
not the chemical structure or chemical synthesis.

4. Government grants to build fermentation capacity proved crucial to
getting companies involved, not the absence of patent incentive on the
chemical structure. The armed forces agreed to fixed contracts to buy
penicillin as it was produced. The government thus induced innovation
by supply-push (subsidy for manufacture) and demand-pull (guaranteed
market).

Another option for government action – patenting the chemical structure
and backing up exclusive property rights – was not used in this case.
This is actually quite common in defense goods, although often forgotten
as a way to get drugs or vaccines to market. But it is simply wrong to
say that absence of a patent had much to do with why it took from 1928
to 1944 for penicillin to see widespread clinical use.

It is interesting that this reviewer apparently believes that
penicillin languished for lack of patent incentive for 14 years.
A US Patent Commissioner, Q. Todd Dickinson, testified to precisely
the opposite interpretation of events in his testimony before Congress
in July 2000, when he said “When Dr. Fleming discovered that mold in
his Petri dish had killed bacteria nearby, and then isolated
penicillin from that mold, that drug was patented, and the world was
a safer place.” It appears that penicillin is something of a
Rorschach Test for one’s underlying belief in = patents: some (such
as our reviewer) say lack of patenting explains why penicillin was
not developed earlier and others see it as a fabulous success story
of patenting (e.g., Dickinson). Both interpretations are
demonstrably wrong, at odds with the history, which has been pretty
well laid out by William Kingston (Research Policy 29 (2000): 679-710)
and Peter Neushul (Journal of the History of Medicine and Allied
Sciences 48 (1993): 371-395).

I go on at some length here, because we believe that case studies (such
as penicillin and polio vaccine) are actually quite important, as
nearly everyone is thinking of one case or another when arguing for a
preferred policy regarding intellectual property…”

Robert Cook-Deegan, MD
Director, Center for Genome Ethics, Law, and Policy
Institute for Genome Sciences and Policy
Duke University
Durham, NC

http://genomics.duke.edu/

{ 4 comments }

P.M.Lawrence June 23, 2006 at 8:01 am

The penicillin story gets even more subtle. Further to your point 3, those US patents on mass fermentation that were granted actually served to reduce the overall pace of innovation.

The full story includes the following. As with nuclear research, much small scale stuff had been done in the UK before the USA even entered the war. Subsequently, most such efforts were transferred to the USA both because of uncommitted production facilities and because of greater startegic depth (and thus safety).

It wasn’t a case of the British being unable to take things forward, but startegic tradeoffs. After all, US technology was always of a lower quality than European at that point (the USA couldn’t make the Merlin engine, for instance, since that was not designed for large production runs).

Anyhow, penicillin expertise was transferred on the condition that Britain would benefit from further development. No paperwork was signed, just as with atomic research, since it was thought that it would slow down necessary co-operation between allies.

However the result was that the US pharmaceutical industry claimed correctly that it had done the work, incorrectly claiming that it had done all the work (such as finding the false trails). The penicillin patents actually represent in part a rip-off of unacknowledged prior art that had been classified during the war.

Peter June 23, 2006 at 8:32 am

There were US-made Merlin engines (in the P51). I’m told US-built Merlins consistently rated 50 HP below the Rolls Royce ones.

Nick Robinson April 10, 2009 at 6:18 am

Hi there,

I saw your blog post very interesting.
i am Nick Robinson,a community member at Patents DOT Com(a comprehensive free patent
search engine).Will like to talk(through email) to you,is this the right time to talk about or should we talk during weekends ?

Regards,
Nick Robinson

E-nickrbson@gmail.com

Robert June 28, 2010 at 7:27 am

Flemming discovered it by chance, but did not persue it at all (he did write the observation). It took Florey and the Oxford team to isolate the drug and perform clinical tests. Flemming then store the limelight. The team had produced some penicillin (more complex story), and word was getting out a little. Then one of Flemmings close friends fell ill, he asked Florey for the drug. This was early days where mass production was not in effect. He took the penicillin (all of it) treated his friend and invited all the newspapers along for the glory, not mentioning Florey and the teama. The team had been reluctant to advertise this cure as the number of letters of people begging them to treat loved ones were too many.

As for patenting the drug. Florey and Heatley (my grandfather, 3rd member in Oxford team), went to America because in war torn Britain, all efforts were towards the war, ie making munitions etc. Therefore they went to America to teach them about this drug and how to grow it.

Chain was angry that they did not decide to patent the drug, although this was during the Second World War, when there was a huge need of an antibiotic. This is one of the biggest factors contributing to why it was not patented, aloing with the fact it was hard enough to convince the american pharmaceutical firms to grow/harvest/purify it let alone if there was a patent on it.

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