The Big Secret Behind the Proposed TRIPS Waiverhttps://www.ipwatchdog.com/2021/05/25/big-secret-behind-proposed-trips-waiver/id=133905/All the fuss surrounding the proposal by India and South Africa to suspend the TRIPS Agreement to help them produce vaccines to fight COVID-19 has obscured some critical truths. In spite of the rallying cry “Patents versus People,” it’s not really about patents. And merely lifting TRIPS obligations will do nothing to address the current suffering of the world’s poorer populations. In fact, it would hamper efforts to secure global distribution of vaccines, as well as cause real harm in the long term.
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When I managed the PCT in Geneva, I heard a lot about this from developing country delegates to WIPO. They expressed great disappointment in how TRIPS seemed to be a “bait and switch” scam, in which the promised benefit never materialized. Patents are fine, but that doesn’t tell you how to adjust the dials on the machines to get the best outcomes. They thought they would be getting all that “know-how,” too.
For some traditional pharmaceuticals, this lack of know-how may not be a showstopper. The patent claims may describe a particular small molecule that provides a certain therapeutic effect. If you already know how to make pills, then manufacturing it can sometimes be relatively straightforward. Sometimes, but not always.
Moreover, biopharma generally, and mRNA vaccine technology in particular, are quite different from traditional drugs. Developing a process to reliably produce these medications at scale is astonishingly difficult and depends on years of experimentation involving cell growth times, temperatures, and other variables. That body of knowledge represents the trade secrets of the developers. It is enormously valuable, and not just for making COVID-19 vaccines. Creating other therapeutics based on the mRNA platform would be much easier and quicker with the benefit of knowing what tends to work and what doesn’t.
The Importance of the Entire Pharmaceutical Cookbook
So, this is why a temporary waiver of TRIPS—which would suspend national obligations to enforce IP rights—can’t possibly help countries like India get more vaccines to its citizens. The know-how required to manufacture at scale is owned by the companies like Pfizer and Moderna that are producing doses in record volumes. To effect the demanded “technology transfer,” governments would have to secure the agreement of those companies not just to hand over their entire “cookbook” but also to send qualified scientists and technicians to spend time at the foreign facilities, basically consulting on how to implement the secret processes to produce a safe vaccine. And even if that transfer happened tomorrow, getting to the point of actually manufacturing in volume would take more than a year.
The ignorance of things Covid and vaccine in
LIEden's
Covid Team appears to approach systematic. They do not realize that the Pfizer and Moderna vaccines are the first two - and for now, only two - mRNA vaccines approved for use anywhere. The J&J vaccine technology is only a little less new (and AZ uses the same technology). None of them are the traditional inactivated virus technology whose production techniques are well known worldwide.
LIEden would not be stealing their cows, but their whole farm with all its equipment and supplies.
The equipment base and knowledge base to produce either mRNA vaccine are between scarce and non-existent. Production of the Pfizer or Moderna vaccine would require equipping a facility from bare floors up, and training operators from near zero.
This means that not just the "recipe" would have to be stolen from P and M, but also stealing the knowledge of their fundamental process. Thus the theft would not be temporary, but a permanent transfer of the whole knowledge base of what BioNTech and Moderna strove for some 10 years to take from paper concept to an approved vaccine in production.
