RICHARD TIMMER: Protect the next generation of pandemic drugs

In late-December, the World Trade Organization postponed a crucially important decision — one with huge implications for researchers here in Georgia, as well as for patients around the globe.

Back in June, WTO members agreed to waive intellectual property protections for COVID-19 vaccines. Some countries immediately petitioned to expand the waiver to include treatments and diagnostic tests. The global trade body was set to decide this month but just postponed the decision.

The delay is unfortunate, but it gives WTO members a chance to make the right decision by rejecting a waiver expansion.

The problem is that gutting IP rights would do nothing to combat COVID-19 in a world that already has a surplus of vaccines, tests and treatments. But expanding the waiver would undermine life-science investment and innovation. That would greatly reduce our chances of developing important new medicines — both to fight existing scourges like cancer and Alzheimer’s, and to quell the next pandemic.

To understand how IP laws enable drug invention, consider DRIVE, a not-for-profit company owned by Emory University that develops drugs to treat emerging infections. Like biotech incubators at other universities, DRIVE bridges the gap between academic research and drug commercialization.

DRIVE could not exist as a for-profit company because industry cannot develop treatments for emerging infections that lack a clear market. DRIVE was formed in 2008 to anticipate emerging infections like COVID-19, which would come along a dozen years later.

It’s practically impossible to develop vaccines against all known viruses, let alone against those we don’t yet know exist. DRIVE’s mission, therefore, was to create broad-spectrum antiviral drugs that could be ready to treat whatever new pandemic emerged.

When COVID-19 arrived, DRIVE had nearly finished developing one such drug, a compound called EIDD-2801. It was highly active against a variety of viruses, including influenza. But DRIVE had tried unsuccessfully for years to license the drug to industry to speed along development.

When COVID-19 hit, DRIVE quickly realized that EIDD-2801 had strong potential. Fortunately, experts at the small biotech firm Ridgeback Biotherapeutics also recognized this and licensed the compound. Ridgeback poured millions of dollars into developing EIDD-2801 — soon renamed molnupiravir — to treat the novel coronavirus. The company got human clinical trials underway at record speed and planned for what Ridgeback CEO Wendy Holman called “manufacturing at risk.”

That meant setting up manufacturing even before approval from the Food and Drug Administration, so that molnupiravir could be rushed to patients as soon as it received authorization.

It was a big risk. Only 12% of products entering clinical trials ultimately receive FDA approval. If molnupiravir had failed, Ridgeback’s investment would have been a total loss. The company took the chance because there was potential for a financial return, based on the exclusive patent the company had licensed from DRIVE.

As development advanced, Ridgeback partnered with Merck for later-stage clinical trials and ramped-up manufacturing. Molnupiravir won the first emergency-use authorization for a direct-acting antiviral against the new disease, in Great Britain and then from the FDA in 2021. Recognizing a moral duty to make high-demand drugs widely available, Merck, with support from Ridgeback, DRIVE, and Emory, voluntarily licensed molnupiravir — royalty free — to manufacturers in 105 low- and middle-income countries. Pfizer followed their lead and implemented a similar strategy for its antiviral Paxlovid.

This pandemic success story was made possible by intellectual property rights, without which Ridgeback and Merck couldn’t have invested in molnupiravir.

Cross-institution collaborations and partnerships occur regularly in drug development. It’s common for university-based researchers to lay the groundwork, startups to see if a compound has real-world potential, and big, established companies to bring new medicines to market.

All these relationships depend on patents and other IP, which assure all parties that their work won’t be stolen. Expanding the WTO waiver could put this balance at risk and reduce investment in life-saving new drugs. It would also have economic implications for the Peach State, which in 2021, exported $3.2 billion in immunological products and $1.9 billion in medical devices and drugs. Researchers at Emory are still working hard to develop new broad-spectrum oral antivirals, which we will desperately need when the next pandemic inevitably occurs. We shouldn’t throw up barriers that could stop their discoveries from reaching patients. Our very lives may depend on it.