[Ip-health] article - The curious case of generic Hep C drug sofosbuvir

leena menghaney leenamenghaney at gmail.com
Fri Jun 10 04:27:45 PDT 2016

Hindu Business line


For more than a decade, an academic debate has raged among public health
experts, the World Health Organsiation and governments on the capacity,
cost effectiveness and the potential benefits of generic drug production in
developing countries other than India and China.

Hepatitis C and the revolution in the generic production and supply of new
HCV medicines changed all that.

The first approvals by the European Medicines Agency and the US Food and
Drug Administration of a new generation of HCV medicines, called
direct-acting antivirals (DAAs), started with sofosbuvir in 2013. The US
price tag of $84,000 for sofosbuvir and $47,000 in Europe brought to world
attention the spiralling cost of patented medicines.

Governments and generic companies in countries like Egypt — where millions
live with the virus and suffer from symptoms such as cirrhosis, liver
failure and cancer — have developed a strong political will to make and
market low-cost DAAs. They changed the way people think about quality

Indian manufacturers — which have a reputation for their reverse
engineering skills and were the first to market low-cost versions of
life-saving cancer (imatinib) and HIV drugs (zidovudine) within two-three
years of their US launch at the turn of the century — now face competition
from Bangladeshi and Egyptian manufacturers. They launched the generic
versions of sofosbuvir ahead of Indian companies in early 2015. Clearly,
their governments were backing them using flexibilities available under WTO

The Egyptian patent office found — after a technical examination of the
sofosbuvir compound — that it is not novel chemically, and, therefore, does
not fulfil the criteria of novelty and inventiveness, both of which are
necessary for a pharmaceutical compound to be patented. Bangladesh took
leadership in seeking as an LDC (least developed country) an extension to
enforce patents and test data obligations with regard to pharmaceutical
products until 2033 and beyond.

Some major Indian manufacturers shrugged off the competition and were
dismissive about their capacity to meet the quality requirement of
procurers and the WHO. They entered into a deal with US drugmaker Gilead,
which had filed numerous patent claims on sofosbuvir in India. Hidden in
the deal were clauses that limited their capacity to export the active
pharmaceutical ingredient (API) and supply to a number of high burden
middle-income countries.

Egyptian pharmaceutical company Pharco, in the meantime, moved ahead by
applying for WHO pre-qualification (a quality validation recognised
globally) and entering into an agreement with Drugs for Neglected Diseases
(DNDi) to supply sofosbuvir for a combination treatment trial in Thailand
and Malaysia.

Bangladeshi firms forged ahead with generic versions of other DAAs that
needed to be combined with sofosbuvir.

In Pakistan, the launch of generic versions of sofosbuvir in early 2016 led
to considerable increase in the number of people starting treatment. A
little known fact behind the revolution was the fact that a small but
growing number of API producers in India were working independent of Gilead
to establish exports of key raw materials needed to produce the drug and
other DAAs in countries such as Egypt, Bangladesh, and Pakistan as also
Latin America.

A technical partnership often talked about among developing governments but
not taken forward was being executed by this partnership between Chinese
intermediate suppliers, Indian API manufacturers, and new producers of
finished formulations across the developing world.

But with one stroke the Indian Patent Office’s decision to grant the patent
on the base compound of sofosbuvir this week has provided Gilead with the
tools to disrupt and stop future exports of the API from India, giving it
significant control on the supply of API globally.

India’s decision to reverse the patent rejection of 2015 to an order for
grant in 2016 is going to cause short-term pain to producers in Egypt and
other countries, which will now have to find alternative sources. But,
intriguingly, it also undermines the government’s recent efforts and policy
to revive and boost the domestic API industry.

*(The writer works on access to medicines in developing countries. The
views are personal)*
(This article was published on May 16, 2016)

Leena Menghaney
Mobile: 9811365412

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