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Friday, April 17, 2020

IPR and Innovation 46, IP rules and Covid-19

I am reposting a good article by my friend Philip and his buddy Mark.
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Messing with IP rules may affect COVID-19 response
April 8, 2020 | 5:20 pm

By Prof. Mark Schultz and Philip Stevens

With around a third of the world’s population in lockdown, humanity desperately needs new treatments to turn the tide against COVID-19. Our hopes depend on sensible coordination between the government and private sector.

Government and the private sector have essential roles to play. With irreplaceable expertise in practical research, clinical trials, manufacturing and distribution, the private sector knows how to take treatments from lab to bedside.

Public sector leadership, meanwhile, can direct resources where they are most needed, clearing obstacles and coordinating efforts.

Globally, researchers are racing to develop technologies to keep people out of intensive care and allow health systems to cope. Their tireless efforts fuel hopes of a treatment to ease the worst symptoms within weeks, and a vaccine within 18 months.

The private sector is rising to this Herculean research and development effort. At least 20 companies are conducting clinical trials of potential treatments, with a further six racing to be the first to find a vaccine.

Many governments are working to quickly clear the approval path for desperately needed treatments. Brazil is removing regulatory bottlenecks by relying on approvals for medicines in other major markets. We hope other countries will follow.

Crucially, public health authorities are collecting data, sharing vital information, and directing treatments where they are most needed.

Public-private coordination will give us a fighting chance.

But campaigning by health NGOs such as Médecins Sans Frontières and the UN-funded South Centre is pressuring governments into drastic action. They are calling for new legislation to pre-emptively confiscate the intellectual property (IP) of any coronavirus treatment yet to be invented, in the hope that treatment will be free for all.

This short-sightedness has struck already. Canada, Chile, Ecuador, and Israel have already moved to suspend IP rights such as patents for new COVID-19 treatments with others set to follow. The Philippines may follow.

Crisis demands extraordinary efforts, but these populist proposals risk undermining the global system for developing and delivering urgent treatments.

For instance, drug makers must spend millions to ramp up manufacture for any new treatment. Yet this is fraught with commercial risk. Kenneth Kaitin, director of the Tufts Center for the study of drug development, says: “You don’t want to invest a lot in manufacturing before you know you are going to have a drug on the market. [Yet] you want to make sure you can manufacture as much as needed, perhaps hundreds of thousands of doses at the end of the day.”

IP rights enable firms to mobilise the money for these massive manufacturing and supply chain investments and manage that risk.

IP is also vital to turning a promising idea into a real treatment. Dr. Derrick Rossi is the founder of Moderna, a young biotech company that brought the first potential COVID-19 vaccine to clinical trials in record time. We asked him recently if the government could replace the private sector in bringing treatments to patients. His response: “not a chance.”

Funding basic research is key, but just the start. “Academics are good at academia and fundamental science. They are not good at developing drugs for patients,” says Dr. Rossi. Nor do governments have the expertise, facilities, or resources to take a new treatment to market, and they usually cannot tolerate the risk of losing massive amounts of money on treatments that often don’t work out.

The existence of IP rights has enabled a rapid response to COVID-19 by the private sector. Companies are looking afresh at old drugs in their patent portfolios that never made it. Others are investigating repurposing existing medicines for other diseases. Short term, they offer the best hope of an effective COVID-19 treatment.

IP rights have not stood in the way so far. The UK will shortly make available millions of new antibody tests at minimal cost. Investigations continue into the usefulness of chloroquine, a malaria drug whose patent has long expired. A promising HIV drug has been licensed for global generic production by its US owner. And many of the other existing drugs that are being repurposed for COVID-19 are off-patent.

The private sector is mobilizing not for their share prices, but because it’s the right thing to do. But removing IP rights will only inject uncertainty into an already difficult picture.

 Technology will play the key role in allowing us to get back to our normal lives. But globally, we need governments to lead and not get distracted by counterproductive ideas.


Prof. Mark Schultz is the Goodyear Tire & Rubber Company Chair in Intellectual Property Law, University of Akron School of Law. Philip Stevens is Executive Director of the Geneva Network.
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