[Drugs for Neglected Diseases press release, Link (CC-BY-NC-SA)] Malaysia has issued a “government use” licence enabling access to more affordable versions of an expensive and patented medicine to treat hepatitis C. This landmark decision should help the more than 400,000 people living with hepatitis C in Malaysia access sofosbuvir, and could have important repercussions in the global effort to secure access to expensive treatments for this viral disease.
[Fifa Rahman for IP-Watch, Link (CC-BY-SA)] Gilead’s announcement today that they would include four middle-income countries (Malaysia, Thailand, Belarus, Ukraine) in their sofosbuvir voluntary licence was a welcome surprise, and will enable millions access to their highly effective, but exorbitantly priced, drug.
The decision to include these countries, however, no doubt is a response to increasing pressure from within these countries to either issue a compulsory licence (CL) or a government use licence (GUL), invalidate the sofosbuvir patents, or block data exclusivity for the drug.
[Mark Schweizer for IP Kat, Link (CC-BY)] According to its media release of 11 July 2017, the German Federal Court of Justice confirmed the decision of the Federal Patent Court granting Merck a compulsory license to EP 1 422 218 owned by Shionogi. This allows Merck the continued distribution of its antiretroviral drug Isentress, an approved medication for treatment of HIV-patients, on the German market.
The case is highly unusual not only because compulsory licenses are exceptionally rarely granted under German law, but also because the license was granted in preliminary proceedings, which is a first.
[House Ways and Means Committee Democrats, Link] A group of 15 House Democrats today sent a letter to U.S. Trade Representative (USTR) Michael Froman urging the Administration to clarify its position on compulsory licensing for generic medicines in Colombia.
The letter was led by Ways and Means Committee Ranking Member Sander Levin (D-MI), and also signed by Reps. Jim McGovern (D-MA), Jim McDermott (D-WA), Jan Schakowsky (D-IL), Eddie Bernice Johnson (D-TX), Peter Welch (D-VT), Rosa DeLauro (D-CT), John Lewis (D-GA), Barbara Lee (D-CA), Chris Van Hollen (D-MD), Peter DeFazio (D-OR), Lloyd Doggett (D-TX), David E. Price (D-NC), Carolyn B. Maloney (D-NY), and Sam Farr (D-CA).
[Joint Letter Signed by 122 Experts – PDF in English and Spanish, with Signatures] Dear President Santos: We are lawyers, academics and other experts specializing in fields including intellectual property, trade and health, writing to affirm that international law and policy support Colombia´s right to issue compulsory licenses on patents in order to promote public interests including access to affordable medicines.
Dear Mr. Bhanu Pratap Sharma, Chairman.
We would like to transmit to you and all assistants our best wishes for the success of this session, where governments, intergovernmental bodies and non-state actors are trying to get one step closer on mechanisms that will address the well known inefficiencies of the R&D model based on monopoly prices, inefficiencies that have caused innumerable harmful effects on people’s health and well-being.
But we need to put under your consideration, and the consideration of delegates and assistants, a special situation we are currently facing that reflects both the urgency and the interests that are preventing nations from reaching a global solution promptly.
Jahan ‘Harry’ Taubman-Rezakhanlou for Intellectual Property Watch
More than 50 members of the United States Congress today sent a letter urging the US Department of Health and Human Services (HHS) and National Institutes of Health (NIH) to exercise their legal authority to require medical patents that have emerged from government-funded medical research projects to be licensed on reasonable and affordable terms for public use.
Abstract: This paper investigates whether compulsory licensing – which allows governments to license patents without the consent of patent-owners – discourages invention. Our analysis exploits new historical data on German patents to examine the effects of compulsory licensing under the US Trading-with-the-Enemy Act on invention in Germany. We find that compulsory licensing was associated with a 28 percent increase in invention. Historical evidence indicates that, as a result of war-related demands, fields with licensing were negatively selected, so OLS estimates may underestimate the positive effects of compulsory licensing on future inventions.
I am writing to urge you to use your authority as Secretary of Veterans Affairs to break the patents on Hepatitis C medications for the treatment of veterans suffering with the disease.
Last December, as Chairman of the Senate Committee on Veterans’ Affairs, I held a hearing about the high price of Hepatitis C drugs and the impact of those high prices on access to treatment for veterans. At the time, I raised concerns that the price of these new Hepatitis C drugs, specifically Sovaldi, which is manufactured by Gilead Sciences, even when discounted, would preclude veterans from accessing these life-changing drugs.
[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.