The penicillin story is well known. For those that need reminding, the mother of all antibiotics was discovered in 1928 by Alexander Fleming. On his return from holiday, he noticed that in one of his agar plates, bacteria had not grown. He obtained an extract from the mould in the plate, naming it ‘penicillium‘. The rest is history…or is it?
…actually, no. The REAL story goes like this[i].
Fleming did not have the wherewithal to properly identify the mould strain or make it in any quantity. It took a team at Oxford University, headed by a gentleman named Howard Florey, to purify enough penicillin to run pre-clinical (1939) and clinical (1941) studies. They were a great success, but they didn’t know how to make sufficient quantities to supply the market.
In 1941, Florey and a fungal expert, Norman Heatley, visited the US to mull over the problem. The scenario was put to a microbiologist named Andrew J Moyer, an expert in moulds, working at USDAs Northern Regional Research Laboratory in Peoria, Illinois. He and his team came up with the idea “to culture the penicillin in a mixture of corn steep liquor and lactose, thereby greatly increasing the yields and production rate.”[ii]
Moyer applied for a patent in May 1945, which was awarded three years later.[iii] He was inducted into the National Inventors Hall of Fame in 1987.
So why did the myth persist?
An article in The Times reported the breakthrough in Oxford, but failed to mention Fleming or Florey. Fleming’s boss wrote to The Times, extolling his virtues and Fleming talked freely to the press at the time. Florey didn’t say a dicky bird to the press. So the real account of it was never told.
To paraphrase, the whole story goes like this:
- Fleming discovered a mould he called penicillium, but couldn’t characterize it.
- Florey’s team in Oxford isolated and purified enough to make test quantities, but they couldn’t make it any more than gram quantities
- A J Moyer’s team devised the commercial process to make penicillin in exponentially greater quantities, and patented THE PROCESS NOT THE MOLECULE.
So what is the takeaway here? Patenting a process seems fair, as a lot of work had gone into proving it could work. Until then, awarding patents for molecules is bad for patients, if no effort has gone into collecting evidence the molecule could get to market.
The other important takeaway is if Fleming, Florey’s team and Moyer’s team had been together from the start, it would have taken roughly three years from start to finish, instead of the fifteen years it actually took – five times faster!
Fast forward to the industry as it is today. Based on his discovery, Fleming would have patented as many molecular structures as he possibly could, in the hope that one of them was the magic bullet. His chances of finding it would have been almost zilch; one in 10,000 according to the US Government Accountability Office. He would have selected 250 of those molecules and got five to testing in the clinic (the other 245 go in the bin). The one that got to market would probably not have been penicillin, rather a poor relation with the bones marketed out of it.
Let’s reflect on this then.
If Fleming HAD patented his discovery, penicillin and all its many derivatives would not have seen the light of day. He didn’t have the faintest idea how to identify the active ingredient (molecule) or make it for patient use.
Ask yourself, based on the evidence above, does it REALLY make sense to award patents to molecules? How many other ‘penicillin’s’ remain unavailable to the world because a patent stopped others having a go with that same molecule?
We have to change patent law. find out more in Taming the Big Pharma Monster, by Speaking Truth to Power
[i] Gaynes R. The Discovery of Penicillin—New Insights After More Than 75 Years of Clinical Use. Emerg Infect Dis. 2017;23(5):849-853.
[ii] “Historical Patents – The Automobile and Penicillin”, Article One Partners
[iii] “Method for production of penicillin: US 2442141 A”, Google