AbbVie Waives Kaletra Patent Rights Amid Unproven Efficacy Against COVID-19

YiOu Healthcare, March 24 – According to a report by the Financial Times,U.S. Pharmaceutical Company AbbVie to Abandon Patent on Combination Drug Under Investigation for Treating Novel Coronavirus, becoming the first to have originally been expected toEpidemicMajor pharmaceutical companies that relinquished rights to best-selling drugs during the period.

Introduction to the Medicines Patent Pool (MPP): This US pharmaceutical company will no longer enforce any Kaletra-related patents on any formulations anywhere in the world.Patent Right. The MedsPaL database shows that Kaletra was originally under patent protection in certain jurisdictions until at least 2026.

Kaletra is a combination formulation of two antiviral drugs, lopinavir and ritonavir. As an anti-AIDS"legacy" drug, which unexpectedly gained prominence during the COVID-19 pandemic. As the pandemic spread globally, many countries expressed demand for this medication. Previously, in the fight against the coronavirus, Israel hadKaletraIssued a compulsory license.

However, the efficacy of this drug in treating patients with COVID-19 remains to be proven.

The latest trial results come from China. On March 19, Beijing time, the New England Journal of Medicine (NEJM) published online the results of the first clinical trial of a drug for COVID-19. The study showed that in patients with severe COVID-19, the research team did not observe any benefit from lopinavir/ritonavir treatment compared to standard care. Lopinavir/ritonavir failed to significantly accelerate clinical improvement, reduce mortality, or decrease viral load detected in the throat.

However, Lindsey Baden, an infectious disease specialist at Brigham and Women’s Hospital, affiliated with Harvard Medical School, and Eric Rubin, Editor-in-Chief of the NEJM, pointed out that the team selected a challenging population for their study—enrolling patients whose disease had progressed to an advanced stage, with severe lung tissue damage. “Even highly potent antimicrobial agents have limited efficacy in late-stage bacterial pneumonia,” they wrote.

Perhaps even more concerning is the inability of Kaletra to reduce viral load. On day 28 of treatment, SARS-CoV-2 RNA was still detected in 40.7% of patients receiving Kaletra. They pointed out that these data suggest Kaletra may be ineffective against the virus, as the drug is designed to directly target the virus rather than alleviate associated symptoms.

According to foreign media reports, the drug is currently undergoing multiple clinical trials to evaluate its efficacy in treating patients with COVID-19; therefore, AbbVie itself may not exercise its global patent rights on all Kaletra formulations. Nevertheless, waiving this patent remains a positive development for patients.

"Given the current situation where countries have found this drug effective in treating COVID-19 patients or are experiencing shortages, purchasing generic versions of Kaletra will become possible. 'AbbVie did the right thing,' said Alan Horn, head of the non-governmental organization Medicines Law & Policy, in an interview with the media. 'This will immediately benefit people living with HIV, as generic drugs can now be supplied worldwide.'"

As of press time, AbbVie had not yet provided further response to this move.

Editor: Wu Dandan

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