[Ip-health] Hope for hep-C patients: Patients succeed in overturning first ever product patent on medicine in India

Prathibha Sivasubramanian prathibha.siva at gmail.com
Fri Nov 2 03:07:15 PDT 2012


2 November 2012, New Delhi.

In a landmark victory for patients’ groups fighting against patents to
ensure access to medicines, the Intellectual Property Appellate Board
(IPAB) has revoked a patent granted in India to F. Hoffmann-La Roche AG
(Roche) for pegylated interferon alfa-2a (Pegasys, a medicine used to treat
Hepatitis C) as well as held that a patients’ group can challenge the
validity of granted patents.

Mr. Eldred Tellis, Director of Sankalp Rehabilitation Trust, who had
challenged the patent, said, “We hope that the absence of patent barrier
will spur generic competition to bring down the price of this much-needed
drug for those suffering from Hepatitis C. We also hope that the Government
will now take concrete steps to start providing access to this medicine. It
is unacceptable that people are dying due to Hepatitis C because they
cannot afford to buy the medicine.”

As may be recalled, this patent granted to Roche in 2006 was the first
product patent on a medicine in India under the new TRIPS-mandated product
patent regime for medicines. The patent granted a monopoly to Roche to
market pegylated interferon alfa2a. Patients with chronic Hepatitis C, who
need a six-month course of treatment of Roche’s pegylated interferon
alfa2a, have to purchase it at a cost of approximately INR 4,36,000 [USD
8,752.38] (available at a discounted price of INR 3,14,496 or USD
6,313.28). Again, it has to be taken in combination with ribavarin, which
alone costs INR 47,160 [USD 946.70].

Concerned about the impact of this patent on access to medicines,
Sankalp—an organisation that provides treatment and rehabilitation support
for injecting drug users—filed a post-grant opposition challenging the
grant of the patent with technical and legal aid from Lawyers Collective

Mr Anand Grover, senior counsel and Director of Lawyers Collective HIV/AIDS
Unit, who appeared for Sankalp in this matter, said, “This victory will
facilitate early entry of generics which is likely to lower the prices. If
this happens, millions suffering from Hepatitis C, both in India and
globally, will benefit. It is also historic because this was the first ever
product patent granted on a medicine in India since 1970.”

Hepatitis C represents a huge public health problem in India and globally.
An estimated 10–12 million people in India, including 50% of IDUs
nationally and 90% of IDUs in the northeast, are infected with the
Hepatitis C virus (HCV). Left untreated, Hepatitis C can lead to liver
cirrhosis, liver cancer or liver failure. Hepatitis C is especially of
concern for those co-infected with HIV, as several studies have shown that
HIV-HCV co-infection leads to increased rates of disease progression.
Injecting drug users are especially vulnerable to HIV-HCV co-infection with
HIV-HCV co-infection rates as high as 93% among IDUs in Manipur. However,
unlike both first- and second-line HIV treatment, which is available to all
people living with HIV who need it,   Hepatitis C treatment is not
available in government hospitals largely due to its high cost and
treatment programmes do not even bother to screen patients for HCV due to
the unavailability of treatment.

Despite Sankalp’s case that Roche’s clams did not satisfy the patentability
requirements under Indian law, in 2009, the Patent Office rejected the
post-grant oppositions filed by Sankalp and an Indian company and upheld
the validity of Roche’s patent. Sankalp then filed an appeal before the
IPAB challenging this decision.

Before the IPAB, Roche also challenged Sankalp’s standing to file the
post-grant opposition as well as the appeal. Roche argued that because
Sankalp was not a business competitor or a researcher in the sector, it
could not have challenged its patent at all. Sankalp argued that its
members were directly affected by Hepatitis C as well as that it
represented a community of drug users who are particularly at risk to
Hepatitis C. The IPAB observed that “public interest is a persistent
presence in intellectual property law” and also held that it was against
public interest to “allow unworthy patents to be on the Register”. Holding
that “the appellant who works for the community which needs the medicine,
is definitely ‘a person interested’”, the IPAB noted that a successful
challenge would “break the monopoly” and “bring the drug within reach of
the community for whom it works, not only by reduction in cost, but also
because of increase in supply”.

Mr. Grover said, “We are happy that the IPAB has recognised the element of
public interest in setting aside undeserving patents and held that
patients’ groups, who are directly impacted by patents on medicines, can
challenge granted patents. This will be of import as concerned patients’
groups will now have better clarity in challenging patents on medicines for
HIV, cancer and other diseases.”

Setting aside the patent, the IPAB held that Roche’s pegylated interferon
was obvious to a person skilled in the art. It also found that Roche has
not provided any evidence, in the specification or even otherwise, to prove
that pegylated interferon has enhanced efficacy. The IPAB, however, held
that Roche’s claims were novel.

Welcoming the findings on obviousness and section 3(d), Mr. Grover said,
“The IPAB has rightly observed that the patentee used conventional methods
to pegylate interferon and obtained predictable results, thereby rendering
it obvious to a person skilled in the art. It also correctly held that the
patentee has failed to satisfy the requirement of section 3(d) of showing
enhanced efficacy. We hope that the Patent Offices too follow these
standards while deciding pre- and post-grant oppositions.”

The text of the order <http://www.ipab.tn.nic.in/250-2012.htm> can be
accessed at the website of the IPAB.  We will upload a copy of the official
certified copy on our website as soon as we receive it.

In solidarity,

Lawyers Collective HIV/AIDS Unit and Sankalp Rehabilitation Trust, India

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