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17 September 2018Big Pharma

MSF critical of EPO decision to uphold Gilead’s hepatitis C patent

The European Patent Office (EPO) has upheld a patent covering Gilead’s hepatitis C medicine sofosbuvir, despite opposition from humanitarian organisation  Médecins Sans Frontières (MSF).

Speaking to LSIPR, the EPO confirmed that it has “maintained in an amended form” European patent number 2,604,620 on Thursday, September 13.

The decision was announced following oral proceedings in Munich, Germany. The EPO advised that it will publish the full decision here once the Opposition Division has written its ruling.

In March 2017, MSF and other healthcare organisations filed an opposition against the ‘620 patent, which was granted in 2016. The organisations, which included the non-profit public health group European Health Alliance, asked the EPO to revoke the patent.

Gilead’s ‘620 patent relates to sofosbuvir, which is included in a number of hepatitis C treatments including Gilead’s Sovaldi (sofosbuvir), Harvoni (ledipasvir and sofosbuvir), and Epclusa (sofosbuvir and velpatasvir).

Hepatitis C, an infectious virus that primarily affects the liver, can be spread through blood-to-blood contact.

MSF’s opposition claimed that the ‘620 patent does not involve an inventive step; is not new; does not disclose the invention in a clear and complete matter; and contains subject matter which is beyond the scope of the application.

The humanitarian organisation’s filing said that more than 700,000 people die each year as a result of the hepatitis C virus, and at least 80 million people worldwide are living with the disease.

Gilead allegedly launched sofosbuvir, “the backbone of most treatment regimes”, in 2013 at a cost of $1,000 per pill. MSF claimed that the drug can be mass produced for less than $1 per pill, and the high price of the treatment has limited the number of patients that have access to it.

MSF emphasised the “global health significance” of the hepatitis C treatment and said that the ‘620 patent hinders competition and the affordability of sofosbuvir in the market.

In addition, MSF said that the patent does not disclose the synthesis of the patent’s compounds in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art.

However, last week, the EPO upheld the ‘620 patent, with amendments. MSF told LSIPR that the amendments are the “cancellation, and not additions, of claims covering the existence of pharmaceutical compositions”.

MSF claimed that Gilead’s “monopoly” on sofosbuvir will continue to prevent access to affordable generic treatments in Europe as a result of the decision.

Gaelle Krikorian, head of policy of MSF’s access campaign, said that the organisation will be appealing against the decision.

She said: “Any patent granted in Europe not only affects access to medicines for Europeans, but also impacts people in many developing countries that lack the resources to perform careful patent examination, and instead follow the EPO’s decisions.”

MSF also challenged Gilead’s patents covering hepatitis C drugs in China earlier this year and, in 2016, MSF challenged Gilead’s hepatitis C treatment in India.

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More on this story

Asia
21 December 2017   Médecins Sans Frontières has challenged a patent application filed by Gilead in China, claiming that the rejection of the patent would “pave the way towards the availability of affordable generic versions”.
Americas
26 September 2018   Gilead is set to produce cheaper authorised generic versions of its branded hepatitis C treatments from 2019.
Big Pharma
10 December 2018   Six organisations have appealed against the European Patent Office’s decision to uphold a patent for a key hepatitis C drug.

More on this story

Asia
21 December 2017   Médecins Sans Frontières has challenged a patent application filed by Gilead in China, claiming that the rejection of the patent would “pave the way towards the availability of affordable generic versions”.
Americas
26 September 2018   Gilead is set to produce cheaper authorised generic versions of its branded hepatitis C treatments from 2019.
Big Pharma
10 December 2018   Six organisations have appealed against the European Patent Office’s decision to uphold a patent for a key hepatitis C drug.