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AbbVie waives all worldwide restrictions
on making generic copies of its Kaletra HIV pill
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By Ed Silverman
March 23, 2020
In an unexpected development, AbbVie (ABBV) is waiving restrictions on licenses held by a nonprofit for its Kaletra HIV pill so that other companies can supply the medicine anywhere in the world. As part of the decision, the drug maker will no longer enforce patent rights relating to adults or children.
Notably, the move by AbbVie came after the Israeli government last week approved a license to purchase a generic copy of Kaletra after speculation rose that the pill could be used to combat the novel coronavirus, even though a paper published a few days earlier in the New England Journal of Medicine raised doubts about its effectiveness to do so.
The Israeli Justice Ministry explained that AbbVie was unable to supply enough of the pill and planned to import generic substitutes from countries where the patent had already expired. The drug maker quickly agreed to remove any obstacles for the government and agreed to dedicate intellectual property rights to the public, although the company initially did not say whether such a move would extend elsewhere.
The license was issued five years ago to the Medicines Patent Pool, a nonprofit that works with drug makers to widen access to medicines and that has struck similar deals with various companies over HIV and hepatitis C pills. Like other such arrangements, the license was designed to ensure that a life-saving drug could be made by generic companies and made available to poor countries.
The licensing agreements were reached as public health officials and patient advocacy groups pressured drug makers to widen access to life-saving treatments. This has been a sore spot for the pharmaceutical industry after sustaining reputational damage two decades ago in South Africa over litigation surrounding access to costly AIDS medicines.
Some companies, however, have been criticized for excluding still other countries where a disease has become a health and economic burden, as well. For instance, Gilead Sciences (GILD) encountered pushback over a license for its Sovaldi hepatitis C pill, and so did ViiV Healthcare, which is largely controlled by GlaxoSmithKline (GSK), concerning a license for an HIV drug.
AbbVie was in the crosshairs, too. A licensing deal signed with the MPP in 2019 allowed a generic version a hepatitis C pill to be made and sold in dozens of countries. Yet the agreement was criticized for limiting availability compared with similar arrangements reached by other companies. The licensing deal for Kaletra, which is on the World Health Organization list of essential medicines, also faced criticism.
"The big win here may be for people for HIV. Access to (the drug) has been a battle for years," 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. "The MPP licenses had serious restrictions and, of course, high-income countries were excluded."
We asked AbbVie for comment and will update you accordingly.
The decision to waive restrictions on the MPP licenses may pay public relations dividends, given the tussle over access for HIV patients and the goodwill some companies are gaining by ramping up production of some medicines or running tests of others in response to the pandemic. Kaletra sales, by the way, have been steadily declining, dropping to $283 million last year, from $423 million in 2017.
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