Private Intellectual Property

The need to discover the next breakthrough proprietary product has many corrosive effects on research. It incentivizes companies to conceal their findings from each other and from the wider scientific community, even at the cost of human health. The intellectual property–free “open-source” model aims to reverse this and turn research into a multilateral collaborative effort rather than a race to invent and reinvent the wheel.

When it comes to COVID-19 specifically, the stalling impact of the contemporary funding model is felt most acutely at the final stages: getting the finished product approved and into use. Whatever time was lost during the early days of the pandemic due to lack of collaboration and trade secrets, virologist Saksela points out, is relatively insignificant. In fact, the development of all first-generation COVID-19 shots has been straightforward.

“The background research was finished in an afternoon, which then set the direction for all of them,” Saksela says. “Based on what we already know about SARS-1 and MERS, it was all quite obvious — not some triumph of science.” Instead of introducing an inactivated or weakened germ into the human body, the new coronavirus shots train our immune system to respond to a “spike protein” — in itself, harmless — which forms the characteristic protrusions on the virus’s surface.

The widely shared understanding of this mechanism predates the pharmaceutical companies’ contributions. This raises questions about the impact of patent-driven research on the end product. To what extent is the work guided by medical efficacy, and how much is based on the need to retain proprietary ownership?

“Different biotech firms would slap the spike protein onto some type of delivery mechanism, whether it was RNA technology or something else,” Saksela explains. “And typically, the choice is based on what applications they have a patent on, whether it’s the best option or not.”

The Finnish vaccine uses an adenovirus to carry the genetic instructions for synthesizing the spike protein. One of its practical advantages is that, unlike with RNA technology based on lipid nanoparticles, it can be stored in a regular fridge, potentially even at room temperature. This makes for easier and cheaper delivery logistics with no requirement for ultra-cold storage. Beyond its stability and the convenience of nasal administration, the vaccine may have other superior qualities to many currently on the market, Saksela’s team believes. “In order to fully stop the virus from spreading and to get rid of new mutations, we need to induce sterilizing immunity,” meaning that the virus no longer replicates within the body of an otherwise healthy person. Preliminary trials seem to confirm that the nasal spray accomplishes this. “With about half the people who are exposed, even if they’re symptomless, you find that the virus is still present in the upper respiratory system. So even if it’s on the way out, it still gets to run amok by the front door, making your immune system into a training partner of sorts.”

But if the vaccine is as good as advertised, what’s holding it back? Outside of Big Pharma and venture capital, few mechanisms remain to secure funding for the large-scale patient trials necessary to carry a vaccine past the finish line. Patents are state-sanctioned monopolies that hold the promise of potentially massive returns on investment. The contemporary funding model of pharmaceutical research is almost entirely pinned on that expectation, and this is where an intellectual property–free medical product runs into serious roadblocks.

A Phase III clinical trial requires tens of thousands of human subjects and would cost around $50 million. But considering that despite Finland’s relative success in controlling the virus, the country has already had to borrow an additional €18 billion ($21 billion) to get by, the sum starts to look more like a drop in the ocean — adding up to about one quarter of a percent of the pandemic-induced public debt so far. The number becomes absurdly small when contrasted with the loss of life and economic devastation around the globe.

The State Paves the Way for Private Profit

This situation is especially absurd when we consider that so-called private pharmaceutical research is itself majority public funded. Moderna received $2.5 billion in government assistance and still attempted to fleece buyers with exorbitant prices. Pfizer has boasted not having taken any taxpayer money, but the PR campaign has little to do with reality: the vaccine is based on applications of public research developed by the German firm BioNTech, which has been additionally supported by the government to the tune of $450 million.

These numbers are only the tip of the iceberg when we consider the capital that countries pour annually into universities, scientific institutions, education, and basic research. This is how the body of knowledge and know-how that underlies all innovation is built.

“For instance, we have these new types of biological drugs, related to vaccines in a technical-scientific sense, produced with the same kind of DNA technology, where the pricing is comparable to extortion,” Saksela says. “It’s very sad. Whatever is the largest sum you can extort from a person or the state dictates the cost. And of course, they’re ultimately based on publicly financed research, just as is the case with vaccines.”

In other words, we are paying for the same shot twice: first for its development, then for the finished product. But there might be even a third price tag, since governments have agreed to assume responsibility for the potential side effects of coronavirus shots. This is a typical dynamic between large corporations and states: profits are private, risks are socialized.

“And yet, when I’ve tried to advocate for Finland to develop its own vaccine, this is the main argument I’ve kept hearing: that you need to have an entity with broad enough shoulders to take on the risk,” Saksela says. “But that’s all empty talk, turns out, since the companies are demanding, and receiving, freedom from any liability.”

The current patent monopoly–based system is a relatively recent development, not some unavoidable side effect of capitalism. Until as recently as the late 1940s, governments primarily funded medical research, while the role of pharmaceutical companies was confined mostly to manufacturing and selling drugs. Nowadays, governments support companies in the form of various subsidies and monopolistic privileges.

The damage goes well beyond shortages and high prices. For one, stopping a disease in its tracks is bad business. In one famous instance, the biotech company Gilead saw its profits fall in 2015–16 as a result of its new hepatitis C drug — because it ended up fully curing most patients. The same perverse incentive structure has sabotaged efforts to create preemptive vaccines, despite urgent calls from public health experts for the last twenty years.

By investing in predictive research, the outbreak could have been stopped in China. In an interview with the New York Times, professor Vincent Racaniello of Columbia University’s Department of Microbiology and Immunology puts it bluntly: “The only reason we didn’t is because there wasn’t enough financial backing.” Disease ecologist and public health expert Peter Daszak agrees: “The alarm went off with SARS, and we hit the snooze button. And then we hit it again with Ebola, with MERS, with Zika.”

Unfortunately, there aren’t many signs yet of political leaders waking up. There is a desperate shortage of vaccines, while pharmaceutical companies struggle to keep up even with their own production estimates. This is a direct result not only of the sanctity of patents, but of how the game is rigged against solutions created outside the profit-driven system. Because vaccines can only be produced in laboratories owned or authorized by the patent holders, most of the world’s pharmaceutical factories lie idle. An emergency solution proposed by India and South Africa, backed at the World Trade Organization by a majority of the world’s governments, sought to suspend intellectual property rights on COVID-19 shots. Rich countries, led by the United States and the European Union, categorically refused.

Meanwhile, wealthy nations have made the lion’s share of all vaccine preorders. Ethics aside, this is a catastrophic way to combat a pandemic. Inadequate amounts of vaccines are being produced to begin with and distributed based on wealth rather than a sane public health policy. Even the rich countries end up shooting themselves in the foot as the virus is allowed to keep spreading and mutating over most of the globe.

Within this global hierarchy, Finland is among the more privileged countries. But the bottleneck in vaccine production is having an adverse effect on everyone, Finns included. As Professor Saksela emphasizes, it is crucial to start taking preparedness seriously, both on the national and global levels. The world is far from getting the current pandemic under control, and the grim fact is that the next one is only a matter of time.

“That it’s all left up to market forces is a sign of the current times,” Saksela says. “Whether that’s a wholly wise approach should at least be carefully considered.”

Social-Democratic Paradise?

Finland is often portrayed in international media as a Nordic dreamland. During the pandemic, its new left-wing government has further boosted the country’s progressive image. One might expect such a government to be the most obvious advocate of publicly financed and freely shared vaccine technology. But the last few decades — the era of neoliberalism — have cast a long shadow.

Mirroring a general trend among its counterparts, the ruling Social Democratic Party began to remodel itself in the 1990s after Tony Blair’s New Labour and the Clinton Democrats. In 2003, Finland’s national vaccine development program was discontinued, after 100 years in operation, under a Social Democratic minister of health, making way for multinational drug companies.

Though the vaccine has received much attention in Finnish media, with an opposition much more hostile to the public sector than the parties in power, there is little debate about it within the political establishment. And in lieu of direct state funding, Saksela and his partners have received advice from the Ministry of Social Affairs and Health: to establish a startup and begin courting venture capitalists.

Saksela is hopeful they might yet secure the necessary funding. But it has meant embracing, at least in part, the topsy-turvy logic of market-driven medical research: however good or lifesaving your product is, unless you intend to make money, it will be very hard to get off the ground.

“A Phase III trial will still yield intellectual property around our vaccine that we believe to be potentially profitable,” Saksela says, “even if it’s not exploitatively profitable.”