[Ip-health] Politico on the EPO Sovaldi patent ruling
james.love at keionline.org
Fri Oct 7 03:48:24 PDT 2016
The article is behind a pay-wall, so I am only posting a few parts.
I will say that the case involves the most valuable patent in the history
of the pharmaceutical industry, so it is important. If sofosbuvir ends up
only protected by process patents, then generic entry is greatly
While sofosbuvir is protected in the EU by exclusive test data, there are
plently of patients using generic versions, and even new trials are short
with robust end points, so the test data is not much of an entry barrier
for this drug.
This is also one of the most litigated drugs, involving not only challenges
to the Gilead owned patents, by suits against Gilead by others in the HCV
market claiming Gilead infringes on their patents.
Sovaldi patent ruling not a game-changer, yet
-- By Carmen Paun
10/6/16, 7:53 PM CET
Doctors of the World opposed Sovaldi’s patent in February 2015,
questioning whether it was based on a new invention. Nine other entities,
including generic drug producers Teva, Mylan and Polpharma, opposed the
granting of the patent in Europe.
After receiving arguments in writing and then orally at a two-day hearing
in Munich this week, the EPO decided on Wednesday to maintain the Gilead
patent for Sovaldi but to amend it to not cover sofosbuvir, the active
chemical substance at the basis of Sovaldi. The process of creating the
chemical is covered, however.
"The most important technical aspect of the patent, about the creation of
sofosbuvir, is still covered by the patent," said Rainer Osterwalder, EPO
spokesperson. But the claim that the patent covers sofosbuvir itself has
been taken out, he said.
If generic companies want to start producing their own versions of Sovaldi
based on sofosbuvir, they could still be taken to court by Gilead, and a
judge would have to interpret whether, based on the EPO decision, they are
allowed to do so, he said.
Teva, one of the world’s biggest generic drugmakers which also opposed the
Gilead patent, did not want to comment on the ruling, saying it was
Once the EPO publishes its full decision, expected within several weeks,
each of the parties can decide to appeal. It takes an average of two years
for these processes to be concluded, he said.
“The patent is maintained — it’s true,” said Olivier Maguet, coordinator of
the drug pricing campaign at Doctors of the World. “But
sofosbuvir in itself is not covered by the patent anymore,” he said.
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