[Lawyers Collective press release, Link] In a momentous decision that would have wide-ranging implication for access to medicines, the Supreme Court of India refused to entertain Bayer’s appeal to set aside the compulsory license (CL) on Sorafenib (Nexavar). The Supreme Court’s dismissal of Bayer’s Special Leave Petition against the Bombay High Court’s decision upholding of the CL concludes the legal proceedings on the first ever CL issued in India.
[Luz Marina Umbasia and Peter Maybarduk, Link to PDF] In July, Ecuador issued four compulsory licenses for medicines targeting cancer and arthritis treatment and immunological reception to kidney transplant. These licenses authorize cost-cutting generic competition with patented medicines, in exchange for royalty payments to the patent holders. Compulsory licensing is a crucial tool to expand access to medicines that are prohibitively expensive or whose costs place enormous burdens on budgets for health systems. Ecuador has again demonstrated international leadership by exercising its health rights.
[Lotti Rutter, Treatment Action Campaign, Link (CC-BY)] In 2011, the UN and member states set a goal of reaching 15 million people on AIDS treatment by 2015—a goal many questioned but that will be met next year. Since then, evidence and tools available have changed and it is clear that simply tracking testing and treatment is not good enough. Critically, it is now clear that suppressing the HIV virus with high-quality HIV drugs keeps people living with HIV alive and healthy while also preventing HIV transmission.
[Javier Llamoza and Ana Romero] Atazanavir is an antiretroviral, second-line medicine that is used to treat people living with HIV. In Peru, this drug is patented by Bristol Myers Squibb (BMS), ensuring exclusivity and a high price for the same in the national market. A related result of this situation is that Peru’s public health sector overspends approximately US$ 7.5 million annually, as the present patent on Atazanavir does not allow for the purchase of the generic product. In contrast, the generic version of this medicine is available in Bolivia, for example, and costs that country US$ 0.50 per 300mg tablet, while in Peru, an average of US$ 12.85 is paid for the original brand name (Reyataz tab 300mg ), 24 times more for the same product.
Pr. Françoise Barré-Sinoussi, HepCoalition, Link
185 million people across the world are infected with HCV; 150 million are chronically infected. The HCV pandemic is concentrated in middle-income countries (MICs); while 15% of the 150 million people with chronic HCV live in high-income countries (HICs), 72% live in MICs and 13% in low-income countries (LICs). It is estimated that HCV-related liver complications kill 350,000 people annually. Currently, the standard of care is injectable peg-interferon (PEG-IFN) used in combination with ribavirin (RBV). The cure rate is 50-75%, and the treatment is associated with strong side effects. Worldwide, only a tiny percentage of people with HCV have access to treatment.
Abstract: The chapter discusses the statutory and treaty basis for compulsory patent licensing, briefly reviews instances in which compulsory licenses have been issued, surveys the economic rationale behind compulsory licensing and compares the potential application of compulsory licensing in essential medicines and climate change mitigation technology.
Press release from Sen. Leahy’s office
WASHINGTON – Senate Judiciary Committee Chairman Patrick Leahy (D-Vt.) on Friday sent a letter to the National Institutes of Health (NIH) urging the agency to consider using its authority to ensure greater access to life-saving genetic testing that was developed with federal research dollars. Patents for the genetic test for the BRCA1 and BRCA2 genes associated with breast and ovarian cancers are owned by Myriad Genetics, which was the subject of a Supreme Court ruling last month that struck down some, but not all, of Myriad’s patent claims. Following the decision, Myriad this week filed infringement suits against two companies that had announced they would begin offering lower-cost tests for the BRCA genes.
On June 18, 2013, 170 Members of Congress wrote to President Obama complaining about Indian trade policy and more particularly India’s intellectual property “climate.” Under the umbrella of claiming that policies of the Government of India favor domestic producers over U.S. Exporters – in other words, that India is protectionist – the Members of Congress claimed that “the intellectual property (IP) climate has become increasingly challenging in India.”
India’s Intellectual Property Appellate Board is hearing Bayer’s appeal to the government’s compulsory license for patents on the drug Sorafenib (sold under the brand name Nexavar by Bayer). This medicine is used to treat kidney and liver cancer. The branded drug costs 2,800,000 rupees (USD 5,214) per patient per month and the generic costs 8,880 rupees (USD 165) per patient per month (USD prices based on today’s exchange rate). The compulsory license was issued under Section 84 of the Patents Act, on the grounds that the invention was “not available to the public at a reasonably affordable price,” and therefore not reasonably worked in India.
Kalyani Menon-Sen: +91 9910306382, kmenonsen[at] gmail.com
Leena Menghaney: +91 9811365412, leenamenghaney [at] gmail.com
The Campaign for Affordable Trastuzumab welcomes the news that the Government of India has started the process of issuing compulsory licences for the manufacture of biosimilars of three cancer drugs – Trastuzumab, Dasatinib and Ixabepilone. [See Govt moves to make three key cancer drugs cheaper, 12 Jan 13, New Delhi, Indian Express]
[Reposted with permission from citizen.org] 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!
It is a tremendous victory for people living with HIV in Indonesia that it has issued new compulsory licenses on seven anti-retroviral medicines, allowing the government to access generic versions of those medicines – domestically or by importation – at much cheaper prices. Indonesia now stands at the head of the pack of countries that have stood up to Big Pharma’s corporation power and to the trade and diplomatic pressure exerted by US and EU powers that consistently advance the IP monopoly rights of pharmaceutical multinationals. A little discussed aspect of the government’s compulsory license is that certain Indian generic producers will be able to supply Indonesia’s purchase of Gilead’s tenofovir + emtricitabiine and tenofovir + emtricitabine + efavirenz because of smart provisions in the Medicine Patent Pool’s voluntary license with Gilead.