After the Israeli government approved licensing for a generic copy of the Kaletra HIV pill to combat the coronavirus, AbbVie (ABBV) agreed to allow the country to purchase copycat versions of its medicine from suppliers in other countries, an unusual instance in which the threat of a compulsory license prompted a drug maker to widen access.
The move came after the Israeli Justice Ministry explained AbbVie was unable to supply enough of the pill and planned to import generic substitutes from countries where the patent had already expired, even though a study published this week showed no benefit in fighting Covid-19. The AbbVie patent in Israel expires in 2024. This is the first time the government allowed the use of a generic version of a patent-protected drug (notice in Hebrew).
In a statement, an AbbVie spokeswoman wrote us that “we have spoken to the Israeli government. Given this important public health crisis, AbbVie commits that we will take all steps necessary to remove any potential barriers to alternate sources of supply, including dedicating to the public our intellectual property related to (the drug). We will communicate with generic manufacturers our intention.”
This marked the second time this week that the global spread of the novel coronavirus has prompted a country to explore licensing to make generic versions of patented brand-name medicines available to its citizens.
Earlier this week, Chile’s lower house of Congress — the Chamber of Deputies — passed nearly unanimously a resolution that would permit the government to issue compulsory licenses for any medicines, vaccines, or diagnostics for combating the pandemic. The resolution is not binding and whether the government adopts the provisions remains to be seen.
A country may grant such a license to a public agency or a generic drug maker, allowing it to copy a patented medicine without the consent of the brand-name company that owns the patent. This right was memorialized in a section of a World Trade Organization agreement known as the Trade-Related Aspects of Intellectual Property Rights, or TRIPS (here is a primer).
The move toward licensing in some countries is not new. Across the globe, a growing number of cash-strapped governments are grappling with the rising cost of medicines, which has prompted increased interest in licensing. Among those exploring licensing has been Colombia, Peru, Malaysia, and The Netherlands.
For their part, drug makers argue that licensing eviscerates patent rights and have successfully lobbied U.S. officials over the years to lean on countries that have pursued or considered compulsory licensing. The U.S. Trade Representative, for instance, has regularly cited several countries in an annual report that looks at intellectual property rights.
The pandemic appears to be the latest trigger to spur interest in compulsory licensing and is bound to spur still more countries to explore this option for obtaining medicines that are out of reach, either due to pricing or supply issues, according to various experts who track access to medicines issues and patent battles.
“Covid-19 will lead to a revival of measures to deal with patent monopolies,” said Ellen ‘t Hoen, a senior researcher in the global health unit at the University of Groningen in the Netherlands and a former executive director of the Medicines Patent Pool, who writes the Medicines Law & Policy blog.
“I hope this crisis leads to a deep rethink of how we finance and develop new essential treatments and vaccines and this goes well beyond compulsory licensing. Actually, if we do not, the experience with corona-related compulsory licenses will likely spur more rapid use in other disease areas. (It’s) all part of the rediscovery of government that is taking place.”
A key reason why some governments may take a closer look at licensing is to demonstrate to their citizens that they are being proactive in gaining access to needed therapies. Another motivation may be to take advantage of an existing domestic industry, according to Brook Baker, a professor at Northeastern University School of Law and a senior policy analyst for the Health GAP advocacy group.
He also noted, though, that AbbVie has a history of tussling over compulsory license.
The company belatedly agreed to a voluntary license with the Medicines Patent Pool for generic supply of the HIV pill to sub-Saharan Africa when it could no longer supply needed quantities, and also retaliated against Thailand when it issued a government-use license in 2007 by temporarily removing all pending regulatory approval applications from the Thai drug regulatory authority, he explained.
“I interpret that history and this new decision as reflecting AbbVie’s long-standing aversion to compulsory licenses,” he wrote. “Here it will get good publicity and the generic license will probably not be significant given the evidence that (Kaletra) is not in fact active against the new coronavirus.”
The move is reminiscent of what occurred in the U.S. in 2001, when the government threatened to break the patent on the Cipro antibiotic in the wake of the anthrax scare if Bayer did not lower its price. Shortly before the threat, the Canadian government briefly overrode the Bayer patent there.