Compulsory Licensing of Kaletra

Abbott's patent for Kaletra (ritonavir/lopinavir) has been annulled by a Brazilian federal Judge Daniela Pereira on constitutional grounds, meaning that the Brazilian government will now be able to purchase and dispense generic versions of the drug for its HIV-infected population. The nullification arises from anger at the cost of Kaletra, expressed by international advocacy groups last year in a call for compulsory licensing in several countries, including the US. For details I recommend Ed Silverman's post, Activists Challenge Abbott Over Its AIDS Drug.

The importance of Kaletra for HIV-treatment lies in the fact that a small percent of infected individuals do not respond to the first anti-retroviral with which they are treated, e.g., efavirenz. The ritonavir/lopinavir combination has literally proven lifesaving to these people. Another approach to assuring access to essential medications is that of Indian patent law, under which Abbott's patent application for Kaletra was denied because it sets a higher standard for what constitutes a new invention. This has the same result as the ruling in Brazil - the government has the opportunity to purchase significantly less expensive generic versions. As of the publication of the PLoS article, Trends in Compulsory Licensing of Pharmaceuticals Since the Doha Declaration: A Database Analysis, seventeen countries have taken the compulsory license route to providing health care access.

As the table indicates, Thailand granted several compulsory licenses early on after international negotiations led to the TRIPS agreement and the DOHA declaration. In Abbott's case, retaliation took the form of refusal to sell any of its drugs in Thailand and the withdrawal of applications for Thai patents. International public pressure caused the company to relent in one instance. A later, pediatric version of Kaletra was eventually sold in Thailand