NGOs Continue Fight To Remove Key Patent On Gilead’s Sovaldi
Executive Summary
NGOs are continuing their efforts to pave the way for lower-cost generic versions of Gilead’s breakthrough hepatitis C treatment Sovaldi and have appealed a decision by the European Patent Office to uphold a key patent relating to the drug.
Six NGOs have filed an appeal against the decision by the European Patent Office to uphold a key patent relating to Gilead’s Sovaldi (sofosbuvir), the game-changing hepatitis C drug. If the appeal succeeds it could shine a light on industry abuse of the patent system, says Médecins Sans Frontières (MSF).
MSF and the other NGOs that have filed the appeal - Médecins du Monde (MdM), MSF, AIDES, Access to Medicines Ireland, Praksis and Salud por Derecho - claim that the EPO should revoke the patent in question because it does not meet the requirements for being a patentable invention from either a scientific or a legal perspective.
The appeal follows a challenge initially brought to the EPO in 2017 by the NGOs that focused on the base compound patent for sofosbuvir (EPO number: EP2604620). They claimed that the patent was unmerited and that the subject matter of the European patent was not patentable under the European Patent Convention. However, on Sept. 14, the EPO rejected the challenge and upheld the patent, albeit in a slightly amended form. (Also see "Sofosbuvir Patent Challenge Could Highlight Weaknesses In IP Systems " - Pink Sheet, 12 Sep, 2018.)
Appeal
Through their appeal, the organizations aim to remove the patent and help clear the path for generic competition, MSF told the Pink Sheet.
It explained that to be granted a patent, an invention must be a “be a technical solution to a technical problem” and must have an industrial application. “In other words, you need to be able to produce it,” said MSF. However, MSF argues that what is described in the patent is in fact a chemical reaction that occurs in the body.
According to MSF, the patent covers metabolites of sofosbuvir, the chemical compounds that are produced in the body when a person ingests sofosbuvir. Most of the metabolites produced are not relevant to the treatment of hepatitis C, but one, a triphosphate derivative, inhibits an enzyme and results in anti-HCV activity, it said. “However, the triphosphate derivative in itself has no pharmaceutical activity: this means that if you could produce it as a medicine and administer to a patient, for example as a pill, it will not treat HCV infection,” the NGO said.
“So the component has a key activity, but only when produced by the body within infected cells of the patient. The triphosphate compound does not solve the problem of providing an effective treatment of HCV infections, [which] means that the compound does not meet the requirement of inventive step,” MSF declared.
It said the patent claim describing the metabolites corresponded to a discovery - that sofosbuvir turns into several metabolites in the body – but not an invention. And according to Article 52 of the European Patent Convention, “mere discoveries are not patentable,” it pointed out.
Ramifications
MSF said that an outcome could take up to two years. If successful, the organization hopes that the appeal will put an end to pharmaceutical corporations’ abuse of medicines patenting systems to increase their own profits,” the NGO said in a statement. It also hopes that a successful appeal will have an impact beyond Europe in countries which follow EPO decisions on granting patents.
The high prices of new patented medicines, such as cancer treatments, means that patent systems need urgent reforms so that patients can access the medicines they need, it commented, it added.
“The appeal comes exactly five years after sofosbuvir was first approved for use, in the US, where Gilead launched the drug at US$1,000 per pill, or $84,000 for a 12-week treatment course. The corporation has made more than $58 billion from sales of the drug and its combinations in the last five years,” the NGO said.
From the editors of Scrip Regulatory Affairs