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« If the Devil of the WTO IP Waiver Is in the Details, What Are the Details? | Main | Sen. Daines Urges Biden Administration to Withdraw Support for COVID-19 IP Waiver »

May 10, 2021

Comments

Unmentioned - unsurprisingly - is the difficulty in distributing a vaccine that needs to be stored at -20 degrees C to many parts of the world, e.g. rural India. An IP waiver will do nothing to help that.

Than you Pfizer for the approach you are taking to make the Covid-19 vaccine available to any country in need. I agree 100% that innovator companies are incentivized and protected by their IP rights.

Dr. Bourla did not mention the several billion $ that Pfizer received from the Trump administration. But revoking patent rights is absurd & will backfire big time. Inventions will become trade secrets, yet patent Applicants will still file. They will omit the critical details that make the inventions work, the preferred embodiments, so that they have nothing to lose.
Omitting/hiding preferred embodiments in the spec is easy in chemical & biotech cases. Chemical compounds have a core structure with many R groups. Each R group is a variable corresponding to a set of substituents. Each R group is many R1 groups, each R1 group being another set of variables, R2s, etc. Each compound is millions of compounds. Applicants would simply indicate as preferred the specific compounds that do not work very well and keep the preferred embodiment (or 2) well hidden in the background. DNA and protein sequences also have variable positions & will be disclosed & hidden likewise; vector constructs will be partial disclosures. Deposited/claimed cell lines will be the worst embodiments. And forget tech support w/o exclusive rights. It would be much better to encourage the vaccine companies to offer free/low-cost licenses to third world countries. As Joe Biden wants huge tax hikes, he could offer big tax credits to companies that send doses of corona virus vaccines to third world countries. And why obliterate the patent rights for patents to products that cannot be used in the third world (mRNA vaccines) or that are not FDA-approved (AZ vaccine)? Biden needs better advisors. When the Govt takes away private property, it's beyond socialism.

"Biden needs better advisors. When the Govt takes away private property, it's beyond socialism."

Just to be clear, *no one* in the administration has floated the idea of taking private property. The administration has expressed public support for the idea of a *TRIPS* waiver, not for the idea of waiving *US* IP rights.

US patent holders will have all of the same patent rights after a TRIPS waiver as they have before a TRIPS waiver. US trade secret holders will have all of the same trade secret rights after a TRIPS waiver as they have before a TRIPS waiver. A TRIPS waiver will not affect any US IP rights.

"Dr. Bourla also suggests that 'waiving of patent protection will disincentivize anyone else from taking a big risk.'"

I call bull$#!+. I simply do not believe that any pharma innovator anywhere in the world takes more than a microsecond to consider the implications of IN or ZA patent protection when making investment decisions.

Folks, almost everyone reading this blog works in this industry. You *know* how often your clients want you to file in India or South Africa. How often? Once every 100 applications? Once every 500 applications? These markets are *irrelevant* to the pharma innovator business models. Be serious, do.

The US is not proposing to waive any patent rights. No EP country (even the small ones) is proposing to do so. China is not proposing to do so. Really, in every single country in which your clients regularly file, everyone knows that IP rights are going to be just as secure post-TRIPS waiver as they ever were.

The whole premise of the argument that we should be concerned about this is that a TRIPS waiver for COVID is just the thin edge of the wedge, or the first step onto the slippery slope. But *why* should we think this? Does anyone seriously believe that the COVID-19 pandemic is *not* an exceptional circumstance? The argument that it *is* an exceptional circumstance is a thousand times more compelling than the argument to the contrary.

We are talking about a meaningless gesture, that arises from a uniquely serious set of circumstances that are wholly unlikely to occur again in our lifetimes. There is no real cause for concern here.

"The restriction is the scarcity of highly specialized raw materials needed to produce our vaccine. These 280 different materials or components are produced by many suppliers in 19 different countries... Right now, virtually every single gram of raw material produced is shipped immediately into our manufacturing facilities... The proposed waiver for COVID-19 vaccines, threatens to... unleash a scramble for the critical inputs we require in order to make a safe and effective vaccine."

This is far and away Dr. Bourla's most compelling argument. In a functioning market, a rise in demand should drive up prices, which in turn should incentivize new market entrants to increase available supply. Hopefully, then, the long term result of the supply disruptions that Dr. Bourla predicts should be that the market adjusts to reach an equilibrium in which even more vaccines are produced. Even then, however, this will possibly mean some short term (1 month?, three months?, six months?) period during which supply chain disruptions crimp vaccine production. That would be bad.

Of course, this bad scenario will only come into play if there are actually new manufacturers who plan to launch operations once a TRIPS waiver is granted. Color me skeptical on that point. As already discussed, there are no IP obstacles to launching vaccine manufacturing operations in IN or ZA *right now*. Therefore, it is hard to see why a waiver of IP rights in those jurisdictions would change anything.

More likely, a TRIPS waiver will have no effect on supply chains. It will be an empty gesture, and nothing more.

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