[Yale Global Health Partnership press release] Just last week, worldwide leaders came together in Geneva, Switzerland at the World Health Organization to begin to develop a five-year strategy to combat Hepatitis C. The disease, which affects 185 million people worldwide – five times as many people as HIV, predominantly in low-and middle-income countries – has been called a silent epidemic. Now, a new report by Yale’s Global Health Partnership (GHJP), the Treatment Action Group (TAG) and the Initiative for Medicines, Access and Knowledge (I-MAK) warns that global efforts to extend treatment to millions is in peril unless key obstacles to access are confronted immediately… strategies used with other diseases, particularly HIV/AIDS, to extend treatments to millions who need it has largely depended on getting less expensive, generic versions of these drugs on the market, by pressuring companies to allow other manufacturers to produce their drugs.
[Updated Jan 5] The U.S. International Trade Commission has released its report on Indian trade, investment and industrial policies, including but not limited to intellectual property rights. The full report is here and the the press release is here.
The report was based on “a survey of U.S. companies doing business in India; a quantitative analysis of the effects on the U.S. economy; and qualitative research, including a hearing and fieldwork, to produce case studies and examples that help illustrate effects of the policies on particular companies or industries.”
[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]