Calls for WTO to Suspend IP Rights for Vaccine Innovation Would Jeopardize Incredible Progress

By Patrick Kilbride
December 9, 2020

“Weakening intellectual property protections, as the WTO waiver proposal would do, will not increase access to the tools we need to fight COVID-19; in fact, they would hinder access to the COVID-19 tools we’ve discovered already.”

https://depositphotos.com/24699051/stock-photo-strategy-obstruction.htmlThe biggest vaccination effort in the history of medicine is underway to eradicate the global pandemic, with several strong prospects appearing poised for regulatory approval. As of December 2020, data from the World Health Organization showed over 50 vaccine candidates in clinical research, and 163 more in the preclinical stage.

The wait could soon be over. Two separate vaccines – one from Pfizer and BioNTech and one from Moderna – are pending emergency use authorization from the U.S. Food and Drug Administration. The former is already being administered for the first time outside of clinical trials following its approval by the UK government. A third vaccine developed by AstraZeneca, which would deliver enhancements in the ease of transport and administration while remaining highly efficacious, is also on the cusp of being approved by regulators. Still others from Johnson and Johnson, Merck, and other bio-pharma companies are also in later stages of development and testing.

No Coincidence: Strong IP Systems Equal Innovation

These companies have many things in common, beginning with their commitment to scientific inquiry and innovative spirit, but that’s not all. They also all benefit from strong intellectual property (IP) protections in their home markets – a foundational element for long-term, capital intensive investments in R&D. The U.S. – home to Pfizer and Moderna – the UK – home to AstraZeneca – and Germany, home to BioNTech, boast three of the most transparent and reliable intellectual property systems in the world.

It’s no coincidence. Statistical evidence shows that countries with robust intellectual property infrastructure produce more life science innovation across the board. Research also shows that countries with weak intellectual property infrastructure not only struggle to attract investment in biopharmaceutical innovation, but also limit consumer access to biopharmaceutical products.

A Dangerous Proposal

That’s why recent calls to strip away intellectual property protections are so dangerous. Specifically, some nations have asked the World Trade Organization (WTO) to waive intellectual property protections related to COVID-19 – including not only vaccines, treatments, diagnostics, and medical technologies, but all forms of IP – until the majority of the world’s population has developed immunity. They argue that the current global intellectual property system is a barrier to accessing said COVID-19 vaccines, treatments, diagnostics, and medical technologies.

If you wonder what the effect of such a waiver might be, just look at what the intellectual property system has delivered so far: Incredible innovation, based on long term private sector investments in breakthrough technologies that are now being pushed across the finish line in record time. And also: real-time, constructive collaboration—between business, universities, NGOs, and governments—for the greater good.

Already, the world’s biggest biopharmaceutical companies have developed plans to ensure global access to their innovations; and they’ve partnered with groups such as the Gates Foundation, as well as governments, multilateral institutions, health care systems, and distribution networks to bolster financial resources, assets, infrastructure, and jurisdictional support for those efforts. Not to mention, many have already agreed to license their solutions at low – or even no – cost to manufacturers in other countries.

Impossible Without IP

But what is even more important than what’s possible under a robust intellectual property system, is what’s impossible without it.

First: continued research and development. It takes decades and often costs billions to bring a new medicine to market. The timeline for COVID-19 vaccine deployment in 2020 has been nothing short of miraculous – and it would have been impossible absent the decades of research investment it built upon. Additionally, for every 25,000 therapeutic compounds that start in the laboratory, 25 make it to clinical trial, 5 make it to market, and only one recoups the cost invested. Intellectual property protections signal to innovators and investors that shouldering this risk is worth it. Intellectual property protections promise that new ideas have tangible value. Without that signal and that promise, the business of innovation isn’t viable.

Second: build-on innovation. The intellectual property system – specifically, the patent system – promotes the public disclosure of inventions, which encourages further discovery. When an innovator applies for a patent, they’re required to describe how their invention works and what it can do. The innovator’s discovery is respected for a period before transitioning into the public domain. That means, every time a patent is granted, the global innovation knowledge pool gets a little bigger. On the flip side, if countries quit respecting patents, the global innovation information pool dries up, knowledge contracts and the amount of private investment in R&D will inevitably shrink.

Finally: A safe, legitimate marketplace. Patents facilitate a market for innovative medicines, throughout the development stage, as well as in commercialization.  Licensing arrangements facilitate the types of collaborations that have proven so successful in 2020; they also ensure that third-party manufacturers are making, using, and selling COVID-19 solutions safely and ethically. Without it, counterfeiters and other bad actors could put shoddy, unreliable, and downright dangerous dupes on the market, all the while marketing them as legitimate products. It’s literally a matter of life and death: Thousands, if not millions, of people die each year at the hands of counterfeit drugs.

Don’t Stop Life-Saving Innovation in Its Tracks

The bottom line is this: Weakening intellectual property protections, as the WTO waiver proposal would do, will not increase access to the tools we need to fight COVID-19; in fact, they would hinder access to the COVID-19 tools we’ve discovered already, and it will stop the search for new tools right in its tracks. Put simply, weakening intellectual property protections won’t help us, and it will hurt us.

Instead, we need to maintain, and even expand, the effectiveness of our global intellectual property system, so we can generate the solutions to get this pandemic under control and be better prepared to face the next one.

Image Source: Deposit Photos
Image ID:24699051
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The Author

Patrick Kilbride

Patrick Kilbride is vice president of international intellectual property for the Global Intellectual Property Center (GIPC) at the U.S. Chamber of Commerce. Kilbride oversees the center’s multilateral and international programs promoting the protection and enforcement of intellectual property (IP) rights, managing a team of country and regional experts. Previously, Kilbride was Executive Director, Americas Strategic Policy Initiatives, and Executive Vice President, Association of American Chambers of Commerce in Latin America (AACCLA), within the Chamber’s International Division. Prior to joining the U.S. Chamber, Kilbride was appointed to serve in the Bush administration as deputy assistant U.S. Trade Representative (USTR) for Intergovernmental Affairs & Public Liaison. At USTR, Kilbride worked with state and local officials, business organizations, and non-governmental organizations to advance the President’s trade policy agenda; he served as USTR liaison to the network of industry trade advisory committees (ITACs), as well as the President’s Export Council; and, he was part of a White House-led, inter-agency team that coordinated efforts to secure congressional approval of pending U.S. free trade agreements.

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Discuss this

There are currently 10 Comments comments. Join the discussion.

  1. Curious December 9, 2020 2:33 pm

    They argue that the current global intellectual property system is a barrier to accessing said COVID-19 vaccines, treatments, diagnostics, and medical technologies.
    The most significant barrier to accessing COVID-19 vaccines, treatments, diagnostics, and medical technologies is production capability, which doesn’t happen overnight (or even over the course of months or years).

    As a practical matter and in most cases, these technologies are not patented in many/most(?) of these undeveloped countries. Moreover, the ability of any company to enforce their IP in a particular country is going to be based upon that country’s laws. If they want to suspend COVID-related IP in their own country that is up to them.

    As an example, Nigeria getting Germany, France, and the UK to suspend their intellectual property laws regarding COVID isn’t going to help Nigeria. The pharma companies based in those countries are still likely to favor their own countries.

    The NY Times article cited here wrote the following:
    The proposal, put forward by India and South Africa in October, calls on the W.T.O. to exempt member countries from enforcing some patents, trade secrets or pharmaceutical monopolies under the organization’s agreement on trade-related intellectual property rights, known as TRIPs.
    It cites the “exceptional circumstances” created by the pandemic and argues that intellectual property protections are currently “hindering or potentially hindering timely provisioning of affordable medical products”; the waiver would allow W.T.O. member countries to change their laws so that companies there could produce generic versions of any coronavirus vaccines and Covid-19 treatments.

    If India and South Africa want to change their own laws, then that is up to them. Again, as a practical matter, the pace of obtaining intellectual property is so slow that any patents that result from the research performed to address COVID won’t be enforceable for years down the road.

    If AstraZeneca, for example, filed for a patent on its vaccine in South Africa and India, it would likely take years for a patent to be granted in South Africa and India. Before that time (and who really thinks that the patent offices in those respective countries won’t delay the issuance of such patent(s)?), they are free to manufacture their own vaccines.

    Again, the biggest problem isn’t IP, it is manufacturing capability. I’m sure AstraZeneca would be more than happy to distribute hundreds of millions of doses of the vaccine in India from a manufacturing facility in India. However, they need the manufacturing capability to be created in India. With that in mind, I have little doubt that AstraZeneca (and the other pharma companies) are working on that right now.

    This whole kerfuffle is simply about certain countries with weaker research infrastructure using COVID-19 as an excuse to get around the intellectual property generated by others. I see the same tactic used in entirely different contexts. Essentially, one identifies a popular cause/movement and then finds a way to hitch their pet cause onto it. This oftentimes happens in politics where a popular movement gets corrupted when other interests try to hitch their cause onto the popular movements. What starts out as a movement to do X (very popular) gets transformed into a movement to do X, Y, Z (where Y and Z are controversial).

    The entire world will eventually be vaccinated — at least those that are willing to do so. It is in the best interests of the developed countries to make this happen. One need only look at the efforts made to eradicate polio and small pox to see how this works. To get back to “normal,” it does no good to vaccinate only a subset of the world’s population only to allow COVID-19 to rage unchecked in the undeveloped corners of the world. Everybody is safer when the entire world population is vaccinated. People like the authors of the NY Times article likely know this, but they have ulterior motives.

  2. Pro Say December 9, 2020 4:33 pm

    O/T, but IP important:

    https://www.cnbc.com/2020/12/09/ftc-and-several-states-launch-antitrust-lawsuits-against-facebook.html

    About time . . . and long overdue.

  3. Tenshi December 10, 2020 8:08 am

    @Curious You claim that countries that don’t want to enforce IP laws can just do so without the waiver, but what about when America and the WTO leveled sanctions on South Africa in the middle of the AIDS crisis just because the ANC nationalized antiretroviral medicines after they couldn’t afford the extortionate prices being charged by western pharma corporations?

  4. Patrick Kilbride December 10, 2020 10:51 am

    Thanks, Curious. You put your finger on it – the TRIPS waiver proposal is a “solution” in search of a problem. Essentially, it’s political opportunism by actors with long-standing ideological objections to the very principle of intellectual property.

  5. Patrick Kilbride December 10, 2020 11:21 am

    Thanks, Seton, for your well-stated defense of the principles of intellectual property to the NYT. For the record, I will be taking an FDA-approved vaccine as soon as it is available to me. The historical record on vaccinations, the years of research behind the current innovative push, and the good governance underlying the regulatory process all give me the utmost confidence that it’s the right thing to do.

  6. Patrick Kilbride December 10, 2020 3:59 pm

    Hi,Tenshi. Interestingly, just today in the NYT the head of the International Pharmaceutical Manufacturers Association acknowledged the industry’s attempts to enforce patents at the height of the AIDS crisis as a mistake – https://www-nytimes-com.cdn.ampproject.org/c/s/www.nytimes.com/2020/12/10/opinion/coronavirus-vaccine-patents.amp.html. The reality is that the WTO has yet to become an effective mechanism for enforcement of intellectual property rights; for now, it’s enough that it provides a floor for global standards.

  7. Tenshi December 11, 2020 12:02 am

    Hi Patrick, thanks for bringing this mea culpa to my attention.

  8. Xtian December 14, 2020 9:28 am

    SquawkBox’s Andrew Ross Sorkin asks Pfizer CEO whether IP was a detriment to vaccine development, that countries like India and Africa are asking the WTO to suspend IP rights. Albert Bourla (Pfizer CEO) responds saying that he is not aware of any IP rights that would prevent companies form developing a COVD vaccine. Its just that a mRNA vaccine that codes for the virus’s spike protein and is encapsulated in a lipid nanoparticle is very difficult to make and get the raw materials for. And that Pfizer is the first of only a few umber of companies that have the means to do it. So we are getting to a point where its not the IP that allows Pfizer to monopolize market, but the complexity of the technology itself.

  9. Patrick Kilbride December 14, 2020 3:58 pm

    To your point, Xtian, IP Watch (now defunct) published a great interview a couple years ago with David Hanson of Hanson Robotics, where he says: “Some techniques… you can’t trademark or patent that very easily, yet the complexity of the intersection of different domains of knowledge makes it difficult for competitors to achieve what we may achieve.” – https://www.ip-watch.org/2018/05/29/every-great-science-discovery-invention-stuff-dreams-not-stuff-reason-interview-david-hanson-hanson-robotics/

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