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

Doctors of the World - Médecins du Monde (MdM) filed an opposition before the European Patent Office against Gilead Sciences' hepatitis C therapy Sovaldi (sofosbuvir), arguing that "the molecule itself is not sufficiently innovative."

Since 2014 Sovaldi is on the market and is a blockbuster for Gilead. Due to the circumstance that a Sovaldi treatment lead to a total recovery in a high number of hepatitis C patients, it seems like a magic pill. However the price for this magic pill seems to be a miracle either. The costs for a single pill of Sovaldi in Germany is about 700 EUR (according to Spiegel Online). For a therapy of 24 weeks the costs run up to 100.000 EUR. In addition Sovaldi treatment needs a combination with other drugs such that the total costs for a 24 week therapy will reach 200.000 EUR. The cost for Solvaldi for a 12 week course of treatment in the UK are about 44 000 pounds ($67 079) (according to Reuters). Therefore the price policy of Gilead is critizised by MdM claiming that the drug maker is “abusing” its patent and charging an “exorbitant” price that hinders access for many patients.

MdM is arguing that Gilead is "abusing" its patent on Sovaldi, known generically as sofosbuvir, MdM said its challenge marked the first time in Europe a medical charity has used this method to try and improve patients' access to medicines.

"As Gilead is abusing its patent to impose prices which are unsustainable for healthcare systems, (MdM) has decided to contest it."

 According to World Health Organization data, as many as 150 million people worldwide live with chronic hepatitis C infection, most of them in low and middle-income countries. In the European Union, between 7.3 and 8.8 million people are believed to be infected with hepatitis C.

MdM decided to contest the patent of Gilead as it seems on the arguments of lack of inventive step (Art. 56 EPC) and  added subject matter (Art. 123 (2) EPC). According to MdM the actual breakthrough was previously achieved by researchers at Cardiff University.

If the patent is revoked by the EPO the price for Sovaldi will be reduced dramatically leading to an acess for many patients.


It is noteworth that last month the Indian Patent Office rejected the patent application in India stating that only minor changes in the molecule did not improve its efficacy. Gilead has filed an appeal.

German Employee Inventor Act:

ArbEG § 8, PatG § 8 S. 3 -Haltesystem für Werbeprints II

In 2013 the Higher Regional Court of  Dussseldorf issued a disicion regarding the problem of claiming of benefit of inventions which have been made by employees. According to former German Employee invention act, before 2009 the employer has the obligfation to formally claim the benefit of the invention made by the employee within four months after the invention notification.

In case the employer missed to claim the benefit of the invention within this period, the right for filing a patent application turn back to the employee. If the employer missed to claim the benefit of the invention and files a patent application,  fraudulent abstraction was the result.

For several years empolyees were entitled to file vindication actions to demand a transfer of Patent rights or for get licence fees from the employer.

In 2009 the German Employee inventor act was changed in that way that the employer has now explicit refuse the benefit of the inventio within four moths after the invention notification. The change was a resukt of the several cases of vinidcation actions issued by employee inventors.

Now the Higher regional court in Dusseldorf stated that in case of a vindication action the time limit of two years after publication of the patent application or patent have to be respected. In case of missing this deadline no vindication action could be filed by the employee.

Due to the circumstance that since 2009 all patents or patent application have been published, no vindication actions could be expected in the future for such cases according to the former German Employee Inventor Act.

However this is the first decision that considers the deadline of two years for such cases leading to an end of this vindication actions. Further to that, all cases with missed claim by the employer are therefore completed.

To be honest, it is still open, if the German Federal Court will held future decisions which are in line with that of Dusseldorf.