Gilead's Sovaldi faces renewed advocacy CL pressure, this time for China and Russia

Print 25 May 2015
EJ Lane / FeircePharmaAsia

China and Russia have become new targets for compulsory-licensing campaigns as an activist group widens its global challenge to Gilead's ($GILD) expensive Sovaldi (sofosbuvir) hepatitis C drug.

In the past two weeks, the Initiative for Medicines, Access and Knowledge (I-MAK) has filed patent challenges that argue, as an India court ruled, that the drug and therefore any combination including it is not inventive and therefore not patentable.

Separately, four AIDS activist groups pressed Thailand's Public Health Ministry to issue compulsory licenses for the drug, saying 1.3 million hep C patients in the country cannot afford it at Gilead's price.

I-MAK's goal is to get a form of compulsory licensing in some of the most-populated countries around the globe so generics could be made and sold at affordable prices.

The U.S.-based group said 50 million hep C patients live in China, Russia and three other countries where it has filed patent challenges recently: Argentina, Brazil and Ukraine.

In the United States and other developed countries, Gilead charges the equivalent of $1,000 a pill as part of a 12-week regimen costing $84,000. Gilead responded to complaints that the price made the drug inaccessible to hep C patients in poor countries by licensing generics of the drug in 91 of them.

As a nation considered middle-income, Thailand did not qualify for the list of 91 poor countries freed by Gilead for generics.

In mid-January, India's patent office denied Gilead a patent, favoring a challenge by domestic maker Natco and its generic. Gilead appealed the decision in the courts, where it remains unresolved.

"I-MAK and its partners, including people with hepatitis C and patient advocates, have filed challenges in Argentina, Brazil, China, Russia and Ukraine detailing how Gilead is abusing patent laws by claiming existing public knowledge as its own--thereby preventing people with hepatitis C from getting treatment," the advocacy group said in a May 20 news release.

"The challenges against Gilead's patent applications for sofosbuvir … build on patent challenges I-MAK filed last year in Europe with Médecins du Monde and in India with the Delhi Network of Positive People, where the patent for sofosbuvir is still pending. Following the challenges in India, Egypt in 2014 rejected the sofosbuvir patent."

In March, Cipla was among Indian companies rolling out low-cost versions of Sovaldi. The drug is sold as Hepcvir in India.

The September 2014 agreement with generics makers such as Cipla, Hetero Labs and Natco Pharma to bring low-cost versions of Sovaldi to 91 poor countries covered around 54% of the world's HCV patients. Hetero Labs was recently cleared to market its generic Sovaldi and said it would launch the drug by the end of March.

However in March, Rohit Malpani of Médecins Sans Frontières alleged that the agreements included provisions such as requiring patients to show proof of citizenship that could interfere with patients' access to the drug.

China has avoided compulsory licenses as a policy tool to get lower costs for drugs, but Thailand and Indonesia have used them in the case of HIV/AIDs drugs. Russia is also an outlier on the process which has been mainly used in India on a host of drugs.

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