PRIVATE PATENTS AND PUBLIC HEALTH

of Congress wrote to President Obama complaining about the compulsory
licence for sorafenib and expressing concerns over the potential of more
compulsory licences to follow. 114 Additionally, 40 senators wrote to
Secretary of State John Kerry to express similar concerns, and business
groups established a new coalition — the Alliance for Fair Trade with
India — focussing on India’s IP policy 115 , which it called “unfair” and
harmful to American business. India’s IP policy has been the subject of
high-level discussions between India and the US and provoked an out-ofcycle
review by the US Trade Representative. 116
PRIVATE PATENTS AND PUBLIC HEALTH
COMPULSORY LICENCES ON HEPATITIS C MEDICINES IN EUROPE
In 2015, KEI-Europe petitioned the government of Romania to issue a
compulsory licence for medicines needed in the treatment of hepatitis C. 117
Romania has one of the highest hepatitis C infection rates in Europe.
New antivirals to cure hepatitis C have become available in Europe but are
priced highly. For example, the best price in France for a 12-week course
with sofosbuvir/ledipasvir fixed-dose combination sold by Gilead under
the brand name Harvoni is € 46,000 (US$ 51,500) 118 The US price for the
sofosbuvir/ledipasvir combination product (Harvoni) is US$ 94,000.
Considering that the gross domestic product per capita in Romania is
around US$ 9500, such prices will keep these lifesaving medicines out of
the hands of people with hepatitis C unless more affordable sources
become available. Generic manufacturers and global health groups have
filed patent grant oppositions to sofosbuvir patents in India and other
countries, including at the European Patent Office. 119
THE ‘ALMOST COMPULSORY LICENCES’
The decision to issue or the announcement of a compulsory licence does
not always lead to the actual granting of a compulsory licence. But this does
not mean that such decisions or announcements are without effect.
Sometimes the announcement of the intention to issue compulsory licences
can be sufficient to provoke a response from the patent holder to lower the
price or to make the product available otherwise, for example, through
voluntary licensing. Thus, the potential to issue compulsory licences can be
as important a policy tool as the compulsory licences themselves.
This happened in the case of the US and Canada 120 , both of which had
announced compulsory licences for ciprofloxacin to respond to a possible
71