[Ip-health] Access victories and the Global Kaletra Campaign

Stephanie Rosenberg srosenberg at citizen.org
Tue Nov 20 17:25:46 PST 2012

Access victories and the global Kaletra campaign

November 10, 2012 marked the first anniversary of the global Kaletra campaign, a campaign comprising health groups in 12 countries challenging pharmaceutical monopolies including Abbott Laboratories' hold on HIV/AIDS treatment Kaletra and its components lopinavir and ritonavir. These groups have taken actions through compulsory license requests, patent oppositions, litigation and public campaigning to promote generic competition and lower costs. Several new significant victories have been achieved.  For example, Indonesia issued licenses for seven medicines treating hepatitis B and HIV (including lopinavir+ritonavir). Ecuador issued a second compulsory license for an ARV treatment. A Colombian appellate court ruled that the Ministry of Health violated collective rights to health by failing to require Abbott to comply with the reference price for Kaletra (the Ministry has since imposed this requirement, reducing Kaletra prices by 70%) and must maintain Kaletra on a parallel imports list. Read below a summary of the actions in each country -- and join us! 
For more information on the campaigns in each country including technical documents, statements from civil society group, media hits, and more, visit: www.citizen.org/Kaletra-campaign.  

As of 2011, more than 50,000 people were on lopinavir + ritonavir in Brazil. In Brazil, Abbott has claimed many patents on lopinavir+ritonavir, commercially known as Kaletra or Aluvia. As part of the campaign, the Working Group on Intellectual Property of the Brazilian Network for the Integration of Peoples (GTPI/ Rebrip) filed an opposition to Abbott's patent claim on lopinavir+ritonavir's heat-stable form, which is not novel and does not contribute an inventive step. Shortly thereafter, the patent office granted a priority examination for the patent. A final decision is still pending. In February, a federal judge annulled another one of Abbott's patents, allowing a local firm to produce generic versions of lopinavir + ritonavir. GTPI also previously defeated one of Abbott's patent on lopinavir+ritonavir in 2010.
China's reported HIV cases total 370,393, including 132,400 people receiving treatment and 68,315 reported deaths. The joint report of China's Ministry of Health, UNAIDS and the World Health Organization estimated 740,000 people live with HIV in China -- with 26,000 deaths in 2009. As part of the campaign, China Global Fund Watch Initiative and the Access to Medicines Research Group wrote Abbott to request an open license, which would enable China to access affordable generic lopinavir + ritonavir. In May, the Chinese government amended its patent law to facilitate the use of the compulsory licensing during a state emergency or unusual circumstances, or on the grounds of public interest.
In 2008, the price of Kaletra varied by purchaser, but was consistently very high, about $4,000 per person per year for some. A civil society compulsory license campaign initiated that year led directly to a new regulation for public interest licensing and, after some delay, government-ordered Kaletra price reductions of 54-68% (which have now reached roughly 70% across the board). This year, Colombian courts delivered their decisions on the "accion popular" filed by civil society groups in 2009 for a compulsory license for Kaletra.  In February, the 37th Administrative Circuit Court of Bogotá ruled that both Abbott Laboratories and the Ministry of Health and Social Protection threatened and violated the collective rights to public health by keeping the domestic prices of Kaletra above the international reference price. The health groups and Abbott each appealed the decision to the Supreme Administrative Court. In October, the appeals court ruled that the Ministry of Health and Social Protection's initial failure to take adequate steps to regulate the domestic prices of Kaletra, in accordance with the international reference price, threatened and violated the collective right to public health. The court ordered the Ministry to continue regulating Kaletra's price and keep the medicine on a parallel imports list.
In 2009, Ecuador inaugurated a protocol for licensing patents to protect public health. In 2010, Ecuador issued a compulsory license for ritonavir, one of Kaletra's components and an essential second-line drug in Ecuador (according to PAHO, all 12 second-line regimens in the country include ritonavir). On November 12 of this year, the Ecuadorean Intellectual Property Institute (IEPI) granted a second compulsory license, this time to Acromax to produce and import abacavir+lamivudine (ABC+3TC), another important second-line treatment in Ecuador.

In 2011, the Initiative for Medicines, Access and Knowledge (I-MAK) and several Indian generics firms defeated Abbott's patent application on heat-stable lopinavir+ritonavir through a pre-grant patent opposition, safeguarding the leading source of global generics supply for the medicine. This year, India issued its first compulsory license for a cancer medicine (sorafenib) and in November, Lawyers Collective successfully opposed a patent on a Hepatitis C treatment.
On the campaign's launch day, ITPC Indonesia, JOTI and other Indonesian civil society groups wrote to Abbott requesting an open license, which would enable Indonesia to access affordable generic lopinavir + ritonavir. The health groups also worked with the Indonesian Ministry of Health, and requested the government make use of any patents necessary to provide generic lopinavir + ritonavir among several other key medicines. The groups linked the cost-cutting power of licensing to the need to inaugurate broad publicly-subsidized second-line ARV treatment in Indonesia. On September 3, President Dr. H. Susilo Bambang Yudhoyono signed a decree authorizing government use of patents for seven HIV/AIDS and hepatitis medicines. The decree represents perhaps the broadest single use of pharmaceutical patent licensing power by a country since the World Trade Organization 1995 Agreement on Trade-Related Aspects of Intellectual Property (WTO's TRIPS). The licensed medicines include efavirenz, abacavir, didanosine, lopinavir + ritonavir, tenofovir, tenofovir + emtricitabine, and tenofovir + emtricitabine + efavirenz.
In Malaysia in 2011, Kaletra cost 11,400 MYR (~$3,585) per person per year (ppy), while per capita GDP was $9,656. On launch day, the Malaysian AIDS Council (MAC), a very influential umbrella organization that represents 49 civil society groups fighting HIV/AIDS, wrote Abbott to request an open license, which would enable Malaysia to import (or produce) affordable generic lopinavir+ritonavir in exchange for reasonable royalty payments. Abbott sent MAC a letter in reply but did not address the license request. The lack of an adequate response from Abbott led MAC to request a compulsory license from the Ministry of Health on May 1st. Prices are reportedly falling now -- the most recent negotiated price for the next public tender is $2044 per year.
Peru benefits from generic competition in the market for lopinavir + ritonavir, and has achieved comparatively low prices of $396 per patient per year by promoting competitive bidding between suppliers including Cipla and Abbott for several years. While this has enabled the government to provide treatment to more than 3,000 patients a year, there is concern that Abbott is seeking a monopoly, as it has registered several patent applications claiming some relation to lopinavir + ritonavir. As part of the campaign, Health Action International Latin America and PROSA organized demonstrations, including in plain view of delegates to the Trans-Pacific Partnership trade negotiations at the Marriott Lima, and wrote Abbott and the Ministry of Health expressing their concern and asking Abbott to retract its patent applications.  
Sint Maarten
On the Caribbean island of St. Maarten, Kaletra costs 7,644 NAf (~$4,361) per person per year (ppy). Many people living with HIV in St. Maarten are migrants, and much less economically advantaged than their Dutch counterparts. As part of the campaign, the St. Maarten AIDS Foundation has requested an open license from Abbott that would enable St. Maarten to import affordable generics. Abbott's reply failed to address the license request.
In late 2006 and early 2007, the Thai government issued several compulsory licenses facilitating imports of generic antiretrovirals (efavirenz and lopinavir + ritonavir) and medicines for cardiovascular disease and cancer. Migrant workers, however, receive limited health care services and must pay out of pocket for HIV/AIDS drugs. As part of the campaign, Thai civil society organizations are working to extend the compulsory licenses to migrant workers.
United States taxpayers helped fund the invention of ritonavir, one of the components of Kaletra, through a grant from the National Institutes of Health. Despite the taxpayer contribution to its development, Abbott charges exorbitant monopoly prices for Kaletra, and Abbott's anti-competitive tying practice has stymied the development of alternative ritonavir-based combination treatments by other pharmaceutical companies. On October 25, the American Medical Students Association (AMSA), Knowledge Ecology International (KEI), the U.S. Public Interest Research Group (PIRG) and Universities Allied for Essential Medicines (UAEM) filed a "march-in" petition, requesting that the National Institutes of Health (NIH) issue open licenses for Abbott's patents related to the manufacture and sale of ritonavir. The petition also requests that the NIH adapt two rules to create standards for future licenses in order to increase the effectiveness of policies aimed at protecting the public interest in federally-funded inventions.
In Vietnam, Kaletra costs $2,280 ppy, nearly double the country's 2010 per capita GDP of $1,191. Abbott's high cost monopoly limits the ability of the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) to expand access to treatment in Vietnam. Fifty signatories representing more than 250 Vietnamese PLHIV groups jointly wrote Abbott to request an open license that would enable Vietnam to provide affordable generics to its people. The Vietnam Network of People Living with HIV has requested the Ministry of Health make use of any patents necessary to provide generic lopinavir + ritonavir.
For more information on the campaigns in each country including technical documents, statements from civil society group, media hits, and more, visit: www.citizen.org/Kaletra-campaign.  

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