In a move hailed by consumer advocates, India has rejected a patent for an HIV med sold by Abbott Laboratories (ABT), because it was not deemed to be a novel invention (the Indian Patent Act does not permit patenting of incremental innovations). The decision is expected to give a significant boost to domestic generic drugmakers that are willing to make and sell lower-cost versions of the Kaletra protease inhibitor, which combines lopinavir and ritonavir, in India and developing countries.
“The impact of the case is tremendous,” writes Tahir Amin, co-founder and director of the Intellectual Property Initiative for Medicines, Access & Knowledge in a note to us. His group fought to reject the Indian patent and he complained that Abbott has been “gaming the patent system” with various applications. Meanwhile, he also maintains Abbott was charging higher prices in many countries, including in India - about $1,000 per patient per year - than what generic makers charge. By contrast, the Clinton Health Access Initiative recently negotiated $440 per patient per year for generics from four suppliers.
Kaletra, which is also known as Aluvia in some countries, is an important second-line AIDS med, and the ritonavir component is also widely used as a stand-alone protease booster that can be combined with other unpatented protease inhibitors. Amin posits that cost savings generated over a three-year period by introducing generic Kaletra to 43 low- and middle-income countries would be sufficient to start 130,000 new patients on HIV treatment who currently lack access.
“That is 130,000 lives that could be saved from opening up the market for this drug alone,” he writes us. Kaletra, by the way, is one of the meds that Doctors Without Borders wants licensed to the new Medicine Patents Pool (look here). So far, though, Abbott and other drugmakers have yet to embrace the initiative.
This is not the first time that Abbott has run into a roadblock over Kaletra. The drugmaker engaged in a long-running battle with Thai authorities after they issued a compulsory license (background). Abbott subsequently retaliated by withdrawing all of its unregistered new drugs from the Thai patent application process (see here). This is why “tweaking Abbott’s nose is a pretty big deal,” Brook Baker of Health GAP and a professor at the Northeastern University School of Law.
A spokesman for Abbott, which can appeal the decision, writes us to say that “new formulations of Kaletra have provided physicians and patients with real improvements in its use, dosing and convenience …The heat stable tablet solves specific convenience limitations of Abbott’s earlier version, which required refrigeration and had to be taken with food. These challenges have been resolved with the new tablet, and there is significant benefit for patients in developing countries and resource limited settings. Abbott is reviewing this decision and determining its next steps.”
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