At this point in the exhausting and deadly Covid-19 pandemic, people around the globe are giving thanks for the multiple vaccines that have been produced and authorized in record time. All governments now share the goal of quick and worldwide vaccination.
To reach this goal, many are latching onto the idea of suspending intellectual property rights for Covid-19 vaccines and medicines, including more than 400 health, labor, religious, and other groups. Late last year, the governments of India and South Africa petitioned the World Trade Organization to waive patent protections for Covid-19 therapies.
To take effect, that proposal would have to be approved by member countries and, so far, the United States, the United Kingdom, the European Union, Japan, and others have withheld their approval. But international organizations, like Doctors Without Borders, as well as a number of U.S. lawmakers, support the call to strip away patent rights for Covid-19 vaccines and therapies. President Biden is reportedly weighing whether to back the waiver.
Proponents of the idea say it would boost vaccine supply and access. The problem is, there is no evidence for this claim.
Gutting patent rights is a dangerous prospect. Drug invention is highly risky: Fewer than 12% of new molecular entities that make it to the clinical trial stage get to the marketplace. The endeavor depends on $100 billion in annual private-sector investment, on top of billions in taxpayer money. Kill the patents taken out on these advances and you kill the incentive to invest. That would mean even worse trouble when the next pandemic comes around, in five, 10, or 20 years.
So before governments take the risk of waiving patents, they should evaluate whether intellectual property rights are really standing in the way of vaccine manufacturing and distribution. To do that, they need to answer two questions:
- Is there evidence that a broad range of Covid-19 vaccine developers have been asked for, and unreasonably refused, licenses to their IP?
- Are there more facilities that could manufacture a vaccine in short order if they just had the intellectual property?
The answers are no and no.
The issues about making more vaccines and distributing them to every country are far more complex than those proposing to waive intellectual property rights on these vaccines would have us believe. Manufacturing and distributing these vaccines is extremely complicated, posing issues well beyond patents.
Almost every factory on the planet that can make these vaccines is already doing so. One of the biggest, the Serum Institute in India, has contracts with AstraZeneca and others to make millions of doses. Under deals like these, manufacturing plants in India will produce 3.6 billion doses of vaccine this year, second only to the United States.
Other companies have licensed their manufacturing process to subcontractors, and even to competitors. Johnson & Johnson and Merck are teaming up to expand manufacturing capacity of the J&J vaccine. Novartis and Sanofi are using their facilities to help increase the production of the Pfizer/BioNTech vaccine.
In short, there’s robust collaboration and cooperation within the industry to ensure that vaccines are made quickly and safely. And patents actually facilitate such cooperation, because each entity can rest assured that its proprietary technology is protected in the long run.
So before rushing to disrupt the world’s intellectual property systems, governments need to identify specific evidence that intellectual property protection is actually a problem. Adar Poonawalla, CEO of the Serum Institute of India, told The Guardian that insufficient license-granting by patent holders is not an impediment to speedy vaccine rollout and that “it just takes time to scale up,” pointing to the complexity of the manufacturing process.
And Bill Gates, the mega-philanthropist whose foundation spearheads many global vaccination efforts, recently told the “Sway” podcast, “Believe me, IP did not limit anything.”
On the contrary, intellectual property rights made it possible for research scientists to make the decades of investments required to develop and deliver safe and effective Covid-19 vaccines in record time. Companies would not share such critical technology with competitors if the law didn’t protect their investments.
Some of those advocating for patent waivers have their hearts in the right place: They want to end the pandemic.
But the evidence that setting aside patent protection will do anything to boost access or expand supply just isn’t there. Removing intellectual property protections on medicines will only ensure that we have fewer of them in the future. This is not a risk worth taking, especially when the evidence suggests we don’t need to.
Andrei Iancu is a partner at Irell & Manella, a law firm based in Los Angeles, and a senior adviser to the Renewing American Innovation Project at the Center for Strategic and International Studies. He served as the undersecretary of commerce for intellectual property and director of the U.S. Patent and Trademark Office, a position to which he was confirmed unanimously by the Senate.