[Ip-health] I-MAK Files U.S. Challenges on Hepatitis C Drug Patents
priti at i-mak.org
Wed Oct 25 18:42:30 PDT 2017
Gilead faces challenge to U.S. hepatitis C patents from advocacy group
By ED SILVERMAN @Pharmalot
OCTOBER 25, 2017
The price of Sovaldi has draw protests, including this one outside the J.P.
Morgan Healthcare Conference in January 2016.REBECCA ROBBINS/STAT
In the latest attempt to attack the cost of hepatitis C drugs, an advocacy
group is challenging several U.S. patents for the Sovaldi treatment that is
sold by Gilead Sciences (GILD).
The group wants to overturn six patents for the drug, which is the oldest
of several Gilead hepatitis C medicines, in hopes of spurring lower-cost
generic versions to become available sooner than might otherwise be
possible. The group contended that U.S. taxpayers can save $10 billion and
generics can get to market 14 years faster if it succeeds.
Although sales of Sovaldi, which was launched nearly four years ago, have
since been eclipsed by newer Gilead treatments, the patents on the medicine
serve as a foundation for the Gilead hepatitis C franchise, which includes
Harvoni and Epclusa, explained Tahir Amin, executive director at the
Initiative for Medicines, Access, & Knowledge, or I-MAK, the group that
filed the challenges.
“The problem is the options aren’t there,” he told us. “Gilead has Sovaldi
tied up and since it’s the backbone, we’ve focused on this at the outset.
If we can remove patents on Sovaldi, there are generics and other
combinations (that might be developed by still other companies) that could
potentially become available, hopefully, at more affordable prices.”
I-MAK, which has challenged Sovaldi patents in other countries, argued the
six patents are “unmerited,” because the compounds were tweaked and,
therefore, are not novel, which means they are “unnecessarily blocking
competition.” The Sovaldi patents expire at different times in coming
years, but I-MAK argued the company can ultimately thwart rival medicines
We asked Gilead for comment and will update you accordingly.
Since its launch in 2013, Sovaldi helped trigger an ongoing debate over the
cost of prescription drugs. Gilead, in particular, has been widely
criticized here and abroad, and attempted to deflect mounting complaints by
striking a licensing deal that allows several generic companies to sell
low-cost versions of Sovaldi in dozens of low-income countries.
With a cure rate exceeding 90 percent, Sovaldi was quickly embraced by
doctors and patients, whose previous option was a much less effective
treatment with debilitating side effects. But the $84,000 price tag, before
any discounts or rebates, for a 12-week course of treatment quickly
strained budgets for private and public payers alike. This occurred not
just in the U.S., but also in the U.K.
Many payers created hurdles agreeing to provide coverage for the drug and
subsequent hepatitis C treatments sold by Gilead and a rival, AbbVie
(ABBV). The move eventually prompted warnings and lawsuits directed at some
state Medicaid programs, which continue to be criticized for coverage
restrictions. A Senate Finance Committee investigation, meanwhile, accused
Gilead of placing profits before patients.
More recently, prices for hepatitis C drugs have started to come down.
There are two reasons: the first is that a large number of patients were
treated over the past four years, leaving a steady decline in the patient
population. Gilead recently estimated that the number of new patients in
the U.S. this year may fall as much as 35 percent from last year.
Meanwhile, more competition has emerged. This summer, for instance, AbbVie
began marketing Mavyret, which carries a $26,400 list price and can treat
all six types of the chronic illness, forcing Gilead to offer more
discounts to payers. Consequently, EvercoreISI analyst Umer Raffat noted
that Wall Street expects Gilead hepatitis C sales to drop about 27 percent
year over year.
Despite this trend, Amir argued that there are 3.5 million people in the
U.S. with hepatitis C and 85 percent of them will not get treated this year
due to cost. “For anybody to say people are getting treated is wrong and
that’s because of the price,” he said. “There are still people being told
they have to get to a certain stage of the disease to get treated.”
This is only the latest move by advocacy groups, including I-MAK, to
challenge Gilead patents. I-MAK has filed its own challenges, or worked
with other groups, in Europe, India, China, Brazil, Argentina, Thailand,
Egypt, and Russia. In response to criticism and legal skirmishing, Gilead
expanded its licensing deal for generic Sovaldi to four middle-income
countries — Ukraine, Belarus, Thailand, and Malaysia.
We should note that I-MAK receives financial support from the Laura and
John Arnold Foundation, which is underwriting several organizations and
academics involved in advocacy or research, respectively, concerning
prescription drug costs.
*Priti Radha Krishtel*
Co-Founder and Co-Executive Director
Initiative for Medicines, Access & Knowledge (I-MAK)
Email: priti at i-mak.org <martine at i-mak.org>
Tel: +1 9177032876
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