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.
The Ugandan Center for Health Human Rights and Development has published a set of Model Provisions to Promote Access to Affordable Medicines in the country’s IP legislation that has been under debate for three years. The project was done with support from UNDP Uganda.
The booklet warns that the Industrial Property Bill 2009 “unnecessarily goes over and above the minimum required standards in protection inventions, trademarks, industrial designs and other forms of industrial property,” which will impact Ugandans’ access to medicines. It contains clause by clause “some of the adjustments that are needed in the bill in line with recommendations made by stakeholders at a consultative meeting held in March 2012.
On September 3, the government of Indonesia took a quiet but exceptionally important step to expand access to medicines and help save and improve lives of people living with HIV/AIDS and hepatitis B. President Dr. H. Susilo Bambang Yudhoyono signed a decree authorizing government use of patents for seven HIV/AIDS and hepatitis medicines. If implemented to the full, the measure would introduce widespread generic competition and generate major cost savings in the world’s fourth most populous country.
This blog is a summary of a panel titled “The Future of Affordable Antiretroviral Treatment: Trends in Patents and Price” at the XIX International AIDS Conference in Washington, DC on July 25, 2012. The authors’ presentations are available on a page provided by the conference: http://pag.aids2012.org/session.aspx?s=228#4
The first speaker, Francisco Viegas Neves da Silva from the Brazilian Ministry of Health, presented “Compulsory License and Access to Medicines – Economic Savings of Efavirenz in Brazil.” The country’s compulsory license on efavirenz was issued in 2007, when there were 75,000 patients taking the medicine in the country. Prior to issuing the license, the government held more than 8 negotiations with the patent holder, and eventually was offered a reduced price of USD 1.11 per pill. However, Brazil rejected the offer, noting that the patent holder offered a price of USD 0.65 to Thailand.
In testimony before the U.S. House of Representatives Subcommittee on Intellectual Property, Competition and the Internet on 27 June 2012 (Hearing: Protecting Patents, Trade Secrets, and Market Access), the Deputy Director of the U.S. Patent and Trademark Office, who also serves as Undersecretary of Commerce for Intellectual Property, grossly misrepresented the scope of permissible compulsory licensing under the WTO TRIPS Agreement.
In her misleading testimony, Teresa Stanek Rea said: “We are consistent on our efforts … of trying to stop these compulsory licenses.” Rea said she was particularly disappointed in March, when India’s Patents Office ordered Bayer AG to grant an Indian generics maker (Natco) a compulsory license for the cancer drug Nexavar, ruling that it was too expensive for most people to afford. (Note: the generic was 3% the cost of overpriced Bayer product and reached only a tiny fraction of eligible cancer patients in India.)
The UN Development Programme and UNAIDS released a joint policy brief this week at workshop on the “Use of TRIPS Flexibilities and Access to Affordable ARVs in Asia.” The paper notes that the use of TRIPS flexibilities has expanded the number of people receiving antiretroviral therapy from 300,000 in 2002 to over 6.6 million in 2010. It warns that FTA provisions that broaden patentability, restrict patent oppositions, extend patent duration, require data exclusivity, require patent-registration linkage, and enhance IP enforcement all limit the use of these flexibilities. Therefore, these TRIPS-Plus provisions “may adversely impact medicine prices and consequently, access to treatment.”