Charity challenges Gilead's European patent on hepatitis C therapy Sovaldi

Doctors of the World - Médecins du Monde (MdM) on Tuesday said it filed a patent challenge in Europe against Gilead Sciences' hepatitis C therapy Sovaldi (sofosbuvir), arguing that "the molecule itself is not sufficiently innovative." MdM accused Gilead of hindering access by marketing Sovaldi at "extremely high" prices, adding that the price is not justified because public funds were used to research and develop the drug.

Specifically, MdM argued that Gilead did not take "an inventive step" in developing the drug, as the actual breakthrough was previously achieved by researchers at Cardiff University. The charity also said that Gilead has claimed a more extensive patent than originally filed in 2007.

"We are defending universal access to healthcare: the struggle against health inequality involves safeguarding a healthcare system based on solidarity," remarked Jean-François Corty, MdM's French Programmes director, adding "even in a 'rich' country like France, with an annual medicines budget of 27 billion euros ($30.6 billion), it is difficult to meet this cost. We are seeing an arbitrary rationing approach that excludes patients from care, and this is unacceptable."

MdM noted that the cost of Sovaldi in the UK of 44 000 pounds ($67 079) for a 12-week course of treatment is an "exorbitant price" that could limit access to the therapy. The organisation suggested that a successful patent challenge could encourage competition from generic versions of the drug that could fuel price reductions closer to the cost of production, which it suggested was as low as $101 for a 12-week course of treatment. The National Institute for Health and Care Excellence provisionally recommended the use of the therapy to treat chronic hepatitis C in August last year, but the NHS delayed introducing the drug on concerns of its cost.

"Patent challenges have already been used by civil society in India, Brazil, the United States and around the world to remove weak or unmerited patents for drugs and to make low-cost generic versions available," commented Olivier Maguet, MdM board member delegate for hepatitis C. "This has led to a substantial reduction in the cost of treatments, enabling access to drugs of patients who would otherwise be deprived of life-saving medicines," Maguet added.

Gilead recently reported that Sovaldi, which was approved in Europe in January 2014, amassed $1.7 billion in revenue for the quarter ended December 31. Rainer Osterwalder, a spokesman at the European Patent Office, noted that Gilead's patent for the drug will remain valid until the conclusion of the challenge, which could take years.

Last month, India's patent controller declined to issue a patent to Gilead for Sovaldi after concluding that "minor changes in the molecule" did not improve its efficacy. The drugmaker has appealed the decision. Meanwhile, Gilead disclosed earlier this month that discounts in the US for Sovaldi, as well as Harvoni (ledipasvir/sofosbuvir), will be larger than expected this year.

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