Medicines Patent Pool looks at hepatitis C

Greg Perry, Executive Director of the Medicines Patent Pool, told delegates at the World Hepatitis Summit in Glasgow this week that the organisation was considering how it could act to speed up and expand access to direct-acting antivirals for lower- and middle-income countries, where around 85% of people with hepatitis C are estimated to live.

The Medicines Patent Pool was established with the support of UNITAID, the international drug and diagnostics purchase fund for HIV, tuberculosis and malaria, to negotiate voluntary licensing agreements with pharmaceutical companies that would allow widespread access to low-cost antiretroviral drugs for HIV treatment. The Medicines Patent Pool was also designed as a mechanism to overcome barriers to the development of fixed-dose drug combinations of products from more than one manufacturer, for efficient delivery of treatment in lower- and middle-income countries.

Since its launch in 2010 the Medicines Patent Pool has negotiated voluntary licensing agreements with all the major pharmaceutical companies that allow some or all of their antiretroviral products to be copied by generic manufacturers for sale at greatly reduced prices in lower- and middle-income countries.

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China rejects patent linked to Gilead hepatitis C drug

China has rejected a Gilead Sciences Inc patent application related to its costly hepatitis C drug, a U.S. advocacy group said, adding the move may lead to other countries to consider rejecting patents for the controversial treatment.

Gilead has drawn fire for the cost of its top-selling drug Sovaldi, priced at $1,000 per pill in the United States or $84,000 for a typical 12-week course and its patents have been challenged in the U.S., India and Europe.

The application China has rejected was for a so-called prodrug, the inactive form of the drug which then converts into the chemically active compound once in the body, the New York-based Initiative for Medicines, Access & Knowledge (I-MAK) said.

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TAC, SECTION27 and MSF Applaud India’s Rejection of Patent on New Hepatitis C Medicine

JOHANNESBURG, Tuesday 20th January: The Treatment Action Campaign (TAC), Doctors Without Borders (MSF) and SECTION27 applaud India’s decision to reject a patent application on sofosbuvir, an important new treatment for Hepatitis C. Last Wednesday’s decision paves the way for increased access to more affordable sofosbuvir in India and other countries who choose to implement legal flexibilities available under international law to increase access to the drug. However, existing patents on sofosbuvir in South Africa could block access to the cheaper generic versions that will become available due to the ruling.  The government should therefore urgently finalise the national intellectual property policy to allow South Africa to better protect access to medicines.

Rejection of the patent in India will allow generic manufacturers that have not already signed restrictive licensing agreements with Gilead to produce sofosbuvir at much lower prices than currently available. Research conducted by Dr Andrew Hill at the University of Liverpool, for example, suggests that sofosbuvir can be profitably produced for as little as $102 (R1,182) per 12 week course.

However, patent protection in South Africa prevents open competition, and could block generic versions of sofosbuvir and other new HCV drugs from reaching the domestic market. The same sofosbuvir patent rejected in India was granted in South Africa, and will only expire in 2025. South Africa has also granted multiple ‘secondary’ patents on sofosbuvir, with the latest patent only expiring in 2034. If reforms proposed in South Africa’s draft intellectual property policy are implemented, the number of such secondary patents granted will be dramatically reduced.

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Gilead to appeal India patent ruling on hepatitis C drug

(Reuters) - U.S.-based Gilead Sciences Inc will appeal the Indian patent office's rejection of its application for hepatitis C drug Sovaldi, a move that could allow local drugmakers to launch cheaper generic versions of the $1,000-a-pill medicine.

The rejection relates to the patent application covering the metabolites, or small molecules, of sofosbuvir, the chemical name of Sovaldi.

Indian drugmaker Natco Pharma and the Initiative for Medicines, Access & Knowledge (I-MAK) had opposed Gilead's application on the grounds that the drug is not inventive enough compared with a previous formulation.

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Key Hepatitis C Patent Rejected In India For Lack Of Novelty, Inventive Step

Today’s rejection by the Patent Office Controller of India of a patent application by Gilead company for a key drug against hepatitis C is being hailed by advocates as a path to dramatically lower costs of treatment for the disease. Hepatitis C has made news for the emergence of exorbitantly priced medicines over the past year. A look at the decision shows that a provision in India’s law continues to stop patent applications if they fail to show sufficient novelty and inventive step – and are subject to opposition.

The patent office decision dated 13 January is available here [pdf].

The decision states that oppositions to several patent applications on sofosbuvir were filed by the Initiative for Medicines, Access & Knowledge (I-MAK), and the Delhi Network of Positive People (DNP+), in November 2013 and March 2014, arguing that they were not sufficiently novel and inventive as required for a patent. Gilead then made arguments explaining why these oppositions were not valid.

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