Doctors of the World opposes the patent on sofosbuvir Hepatitis C: scourge, remedy and scandal

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The patent opposition

A patent opposition is a recourse by which any interested party may contest the validity of a patent at the office that issued it.It has already been used by civil society in other countries (India, Brazil, United States) to get abusive patents removed and to authorise the production of more affordable generic medecine.
This is the first time in Europe that a medical NGO uses this juridical tool to improve patients access to treatment. The rationing in France and Europe led Doctors of the World to review the technical content of Gilead’s patent on sofosbuvir. While using sofosbuvir to treat hepatitis C is a major therapeutic advance, the molecule itself does not merit a patent because it relies on existing and commonly practised techniques in the pharmaceutical field.
In India – where an opposition has been field by our partner the Initiative for Medicines, Access, & Knowledge (I-MAK) together with the Delhi Network of Positive People (DNP+) - the patent office recently rejected one of the key patent applications on sofosbuvir, but which has since been contested by Gilead and is now being reviewed again before a final decision is issued. Egypt also decided to reject the same patent that is being opposed in Europe.

If Doctors of the World wins this opposition, will generics be available in Europe?

Gilead claims multiple patent applications pending in Europe that relate to sofosbuvir. So far only the sofosbuvir patent has been granted by the European Patent Office. Even if this legal battle is won, it is not certain that generic versions of sofosbuvir will be able in Europe because of these other patents.
Through this action Doctors of the World is furthermore warning public opinion that with such price European countries have no longer enough resources to guarantee access to sofosbuvir for all the patients in need.
Doctors of the World uses this opportunity to go on with a national debate on drug pricing mechanism and its impact on health system. It is one of the challenges of the Health Bill to be debated in French Parliament next spring.

Is Doctors of the World opposed to medical innovation?

No. Doctors of the World is a medical humanitarian organization concerned with medical innovation and acknowledges the use of sofosbuvir as a major therapeutic achievement against hepatitis C. Doctors of the World is not fighting against the pharmaceutical industry but rather its abuse of the patent system.
The social contract of the patent system is designed to reward investments that bring new inventions. Pharmasset/Gilead perverted the genuine patent system through patenting thousands of molecules with the prospect of a potential therapeutic efficiency based on science common practice. Those assumptions avoid other researchers to develop complementary and potentially more innovative drugs.
Abusive patents kill innovation whereas patent system has been devised to promote innovation.

Recommendations

Doctors of the World is demanding:

  • The dramatic reduction of the price of sofosbuvir so that it can be prescribed to all people living with chronic hepatitis C.
  • The initiation of a public debate on drug price setting methods and alternative financing mechanisms for the research and development of new drugs.
  • The representation of patient associations and organisations fighting against health inequalities within the CEPS and the Transparency Committee of the HAS (French Health Authority).
  • Transparency in the research and development costs of pharmaceutical companies and the traceability of public funding for research.

Attached documents

Patent Opposition Q&A booklet

PDF – 3.6 Mb