Dropping patents on Covid-19 vaccines will not speed up production

President Biden’s controversial decision to call for pharma companies to drop the intellectual property rights around their Covid-19 vaccines in a move to boost supplies is coming under attack on all fronts.

Britain and Germany, along with Australia, Canada and the European Union, have indicated they will resist the Biden administration’s proposal for a temporary waiver on patent rights.

Experts from around the world claim the decision by Biden to support the plea by India and South Africa last year for pharma companies to waiver their patent rights will not help countries in crisis speed up production.

Quite the reverse according to some. Dr Özlem Türeci, the brilliant chief medical officer at Pfizer partner, Germany’s BioNTech,who came up with the formula for the Pfizer vaccine, told CNN in an interview that suspending patent enforcement for vaccines will not increase the number of doses available within the next 12 months.”  She added: ‘It will probably act towards increasing chaos in production.’

Germany’s Chancellor, Angela Merkel, has also been vocal in her opposition to the US plan which was announced in a surprise move on Wednesday by US trade representative, Katherine Tai. Merkel’s spokesman said that giving up Covid patent rights will not help boost supplies to the countries where they are needed the most – such as India – and will hamper innovation in the longer-term.

The spokesman added: “The U.S. suggestion for the lifting of patent protection for COVID-19 vaccines has significant implications for vaccine production as a whole.”

“The limiting factors in the production of vaccines are the production capacities and the high quality standards, and not patents.’

Pfizer’s chief executive, Albert Bourla, said Biden’s decision was simply ‘so wrong’, adding that manufacturing difficulties and other technical issues were the problem, not patents.

Some would say Bourla is talking his own book, and that it’s no surprise that pharma companies want to protect their patent rights because they are essential in guaranteeing income from any new products they are developing.

Cutting off those profits would, they argue, mean they can’t make enough profit to fund new innovation. They also fear that such a waiver could turn out to be permanent in any new crisis. Or as one analyst said: “Why stop at Covid? What about cancer vaccines which are being worked on? Are they not vital to the future health of humanity? It’s a bonkers plan.”

More to the point, would opening up the patent books of the pharma companies actually speed up production so that supplies can get to the countries that need them most ?

In an article for Science Translational Medicine, pharma expert, Derek Lowe, claims that that patent rights are not the main bottleneck for supply constraints –  or the “rate-limiting step”, to use the language of chemistry.

Lowe points out that the bottlenecks to getting more vaccines manufactured is more complex, because of the specific hardware need such as “cell culture tanks for the adenovirus vaccines, and the right kind of filtration apparatus for both the mRNA and adenovirus ones.” He adds that manufacturers also need specialized mixing equipment for the formation of the mRNA lipid nanoparticles used in the Pfizer BioNtech vaccine.

As Lowe points out, a big proportion of the world’s supply of such hardware is already producing the vaccines while Novavax have not been able to get hold of enough cell culture bags. “These are not in short supply because of patents, and waiving vaccine patents will not make them appear. Third, you need some key reagents. Among others, there’s an “end-capping” enzyme that has been a supply constraint, and there are the lipids needed for the mRNA nanoparticles.”

Both Pfizer’s Bourla and Moderna have made similar points, arguing that it is not the patent that is limiting supplies but access to raw materials and new technology. Pfizer – like AstraZeneca- has had problems in ramping up production to scale so handing out the patent to other manufacturers is unlikely to solve the problem.

Yet there may be other ways to ramp up production, maybe some sort of partial waiver in some countries that do have manufacturing capacity. Britain and Germany, along with Australia and Canada, are the most vocal among the countries within the World Trade Organization’s (WTO)
which is pushing the  ‘free the vaccines’ campaign.

It’s no coincidence that they are the countries which have been the host of the new vaccine formulas – AstraZeneca in the UK and Germany’s BioTech – and are more loath to see the formulas duplicated. But it’s more complicated – AstraZeneca’s research has been funded by UK taxpayers as well as charities while BioNTech also received government grants. As part of the funding deal, the Anglo-Swedish pharma company is supplying its vaccines at cost and has foregone any profit. Maybe Pfizer needs to make a similar gesture ?

But what is sure that calls to free up the patents – now being backed by West Coast celebrities Harry and Meghan – is not going to lead to a sudden burst in supply. The WTO needs to come up with something more imaginative than that.