Trade secrets

In a groundbreaking deal for a promising Covid-19 treatment, the pharma firm Merck signed a licensing agreement on Oct. 27 to allow drugmakers in 105 developing countries to produce Merck’s Covid-19 pill, molnupiravir. In clinical trials, the new drug cut hospitalizations and deaths in half among patients with early Covid-19, Merck said. Unlike most licensing arrangements, Merck will not receive any royalties. As wealthy countries rush to buy up molnupiravir, drugmakers can now produce identical, generic versions for 105 countries with about half the world’s population. More than 50 companies have already inquired about obtaining a license to make generic molnupiravir for the developing world. But even as the pill and the licensing deal raise hopes of controlling the pandemic, less than half of the world’s population has received a single dose of a coronavirus vaccine. So why haven’t Pfizer, Moderna, and Johnson & Johnson made licensing deals like Merck’s?

James Love is the director of Knowledge Ecology International, a nonprofit research foundation that supports intellectual-property transfers in biotechnology. Love says the primary reason is that pharma corporations don’t want to share the new technology that underlies their vaccines, confident it will lead to the further innovation of blockbuster drugs and major profits. The Pfizer and Moderna vaccines are biologic drugs based on a new platform called messenger RNA, or mRNA, which only a few other pharmaceutical companies know how to use—and none of them are large-scale generic-drug manufacturers. For Love, even if national governments require vaccine makers to license their patents—which all countries’ laws allow their governments to do—only a handful of manufacturers worldwide could produce the vaccines without extensive training in mRNA technology. Potential generic versions of the branded drugs would require regulatory approval, which would be time-consuming, expensive, and difficult, because of the novel technology. Despite these challenges, Love says, governments could do more to promote or compel greater vaccine production, but around the world, they all tend to tread lightly with the pharmaceutical industry …

Michael Bluhm: Why is Merck giving away its breakthrough drug for free to developing countries?

James Love: Merck has a fair amount of experience in infectious disease and working with the public-health community. They’re comfortable with the idea that sometimes, it’s better to make a voluntary agreement for areas that you’re not likely to serve very well than to be involved in endless disputes about why you’re not doing a better job of serving their populations.