[Ip-health] New patent opposition in India: Roche's Hepatitis C drug

[Judit Rius Sanjuan]

http://www.business-standard.com/common/storypage_c.php?leftnm=3D10&bKeyFla=
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Roche`s Hepatitis C drug patent challenged
P B Jayakumar / Mumbai June 12, 2007

Swiss pharmaceutical major Hoffmann-La Roche=92s patents rights over
Hepatitis C drug Pegasys has been challenged by public interest groups
at the Indian Patent Office.

This is the second post-grant opposition filed against Pegasys, after
Wockhardt, a domestic drug firm, approached the patent office with a
similar plea two months ago.

Pegasys was the first drug to receive patent production and subsequent
market monopoly according to the changed patent law of 2005. Its patent
is valid in India until May 16, 2017.

The public interest groups have said that patent protection and the
resultant high price of the drug is making it unaffordable for an
estimated 12.5 million Hepatitis C infected people in India. The groups
also argued that the product was not an innovation and hence not
eligible for patent protection.

Sankalp, a Mumbai-based non-governmental organisation that provides
treatment and rehabilitation support to injecting drug users, backed by
a group of NGOs led by Lawyers Collective, filed the opposition with the
Patent Office on May 18, citing that Roche sells the drug at a price of
Rs 2.25 lakh for a 6-month treatment course.

Absence of patent protection could help Indian pharmaceutical companies
develop cheap reverse-engineered versions of Pegasys, it said.

Roche India said its parent company Roche was assessing the post-grant
opposition filed by Sankalp and would reply to the Indian Patent Office
within the stipulated time.

India amended the Patent Act in 2005 to bring in a new product patent
regime, instead of the earlier process patents which legalised copying
of drugs. By the new rules, generics drugs cannot be manufactured by
changing the process and the product patent holder gets exclusive right
to sell the product in the country.

Under the amended Indian Patent Act 2005, an application for a patent
can be challenged within 12 months of publicising the application
(pre-grant opposition) and after grant of the patent (post-grant
opposition). The company has to respond to the challenge within a month.

Girish T Telang, managing director of Roche India, told Business
Standard that the introduction of Pegasys has seen treatment costs for
Hepatitis C patients drop to about one-third and the rate of cure has
gone up to 80-95 per cent from 30-35 per cent earlier with normal
interferons (a naturally occurring protein with antiviral effects).

=93We also give Ribavirine (an anti-viral drug) free to patients as part
of the total package. Pegasys is a technological advancement from Roche.
The drug was launched in Switzerland in 2001, in US and Europe in 2002
and in the very next year, we made it available to Indian patients,=94 he
said.

It is not fair to demand it should not be given patent protection in
India,=94 Telang said.

Earlier, in a much-publicised similar case, multinational pharma major
Novartis is fighting a case with the Indian

Government for denying it exclusive rights to market its cancer drug
Gleevec in the country.

A few months ago, Indian drug maker Cipla had filed a pre-grant
opposition against granting of patent for Gilead Life Science=92s

Viread, an HIV/AIDS drug. The NGOs also had filed opposition to the
Virea patent.

Sankalp alleges that Pegasys, a new-generation Hepatitis drug that helps
to reduce the normal three injections per week to one injection per
week, involves combining interferon with a structure called
polyethelyene glycol (PEG) which helps the interferon to remain in the
bloodstream.

The technology of combining interferon and other biologically active
proteins with PEG had been known for years prior to this patent, the NGO
says.

NGO sources said patent protection is only granted to inventions that
are new and involve an inventive step. Under some legal provisions that
are unique to Indian patent law, they said, =93Roche=92s =91invention=92 is=
 at
most a =91mere admixture=92 of known substances and thus unpatentable under
section 3(e) of the Patents Act, and it is just a =91new form of a known
substance=92 and not patentable under section 3(d) of the Act. The patent
is an attempt to obtain a monopoly over technology that existed in the
public domain,=94 they said.

--
Judit Rius Sanjuan
Attorney
judit.rius@keionline.org

Knowledge Ecology International (KEI)
www.keionline.org / www.cptech.org
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