Civil Society Pushes EPO To Invalidate Hepatitis C Patent

The European Patent Office is expected to hold oral proceedings later this week on a challenge filed against a Gilead patent on hepatitis C treatment. Invalidation of the patent would open the way to competition and lower prices, according to civil society groups which initiated the challenge. But according to an EPO source, the company is seeking at most an amendment to the patent.

Yesterday, Médecins Sans Frontières (MSF, Doctors Without Borders) and Médecins du Monde (MDM, Doctors of the World), both among the civil society groups from 17 countries which challenged the patent in March 2017, held an online press briefing to argue for the case brought to the EPO, and its rationale. The civil society groups have challenged a Gilead patent for oral hepatitis C drug sofosbuvir, commercialised under the name Sovaldi.

According to Gaelle Krikorian of MSF Access Campaign, it is the first time the organisation is involved in a patent opposition in Europe, and it is also the first time that a patent on a medication is challenged by civil society at the EPO.

The EPO is scheduled to start oral proceeding of the case on 13 and 14 September. An EPO source told Intellectual Property Watch that Gilead is asking that the patent be maintained in an amended form rather than invalidated altogether.

On 13 September, MSF and different organisations will conduct an action at 8:30 in front of the EPO in Munich to bring attention to the importance of the decision. “We need a serious public debate in Europe on those issues,” Krikorian said, adding that policymakers have to take a different attitude when allowing and granting monopoly rights, and in particular make sure there is a strict application of patentability criteria.

According to MSF, in Europe Gilead benefits from patent protection of sofosbuvir, and charges as much as €43,000 (US$ 49,800) for a 12-week treatment regimen curing hepatitis C. In the United States, they said, Gilead initially set the price at US$84,000 for the 12-week treatment.

However, in countries where the drug is not protected by a patent, according to MSF, generic competition has driven the price of generic sofosbuvir to below US$100 for the treatment.

Rationing Inevitable Given High Prices

Olivier Maguet of MDM said at the briefing that hepatitis C medications are being rationed in several countries in Europe. In France, for example, he said, when sofosbuvir became available, if the country wanted to treat all hepatitis C patients, it would have amounted to €8 billion out of a total medication budget of €28 billion. Given the high price of the drug, there is no other possibility than rationing, he said.

Clare Groves said she can confirm this. She was treated and cured of hepatitis C under the United Kingdom National Health System, but not before she had to “fight tooth and nail” to get her treatment. Diagnosed in 2008, the NHS found she was not eligible for treatment in 2014 because she was “not dying of liver cancer” or another life-threatening liver ailment.

“I knew there was a cure but I could not have it,” she said at the briefing. This led her to mental health deterioration, which led her physician to push her case in front of the health authority, so she could get the 12-week treatment. “I was finally treated and cured,” she said, without any significant side effects.

Need Strict Patentability Criteria, Start a Wider Debate

Patents need to be questioned, according to Maguet, and in particular whether patents are really given on merit. Patents should comply with strong patent requirements, he said, arguing that the Gilead patent is a weak one and has been cancelled and amended in other parts of the world.

The EPO sets norms, Krikorian explained, as most national patent offices do not have the proper resources to conduct a thorough examination. They thus rely on patentability decisions made by bigger patent offices, such as the EPO. That is a strong reason to open the debate about what the EPO is doing, and on what conditions it grants its patents, she added.

EPO entered into agreement with several developing countries, according to Krikorian, such as Morocco and Cambodia, and as a consequence of those agreements, a patent granted at the EPO would be valid in those third countries.

The new debate emerging in Europe which started because of the high price of sofosbuvir is just illustrating the trend of rising prices of new medical innovations, such as cancer drugs, she said.

Even if the rationale of patents is providing incentive for medical innovation, “we believe there are other ways than exclusive rights and monopoly,” Krikorian said.

Ruling Can Be Appealed, Patent Contested at National Level

According to an EPO source, the patent application was filed by Gilead at the EPO in April 2004, and granted in June 2016 (EP 2604620). Four oppositions were filed with the EPO in March 2017: three joint oppositions from MDM, MSF and the European Public Health Alliance, and from a patent attorney.

The opponents request revocation of the patent in its entirety for reasons of non-compliance with provisions of the European Patent Convention, the source told Intellectual Property Watch, such as lack of novelty and inventive step.

Gilead requests that the patent be maintained in an amended form, the source said.

After the decision is taken by the Opposition Division, it can be appealed by any of the parties at the EPO’s Board of Appeal, according to the source. If the European patent is maintained, it can be contested in front of national jurisdictions of the European countries where the patent was validated, the source explained.

 

Image Credits: MSF