[Ip-health] IP Watch on Roche participating in Indian CL hearing

[Judit Rius Sanjuan]

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[ Picked text/plain from multipart/alternative ]
http://www.ip-watch.org/weblog/index.php?p=3D962

14 March 2008
Tussle Over Participation In India Compulsory Licence Hearing
By Tatum Anderson for Intellectual Property Watch

Swiss pharmaceutical company Roche is expected to appear before the
Indian Patent Office on 17 March to assert its right to attend a later
meeting that could result in one of its drugs being copied, without
its permission, by an Indian generic pharmaceutical company.

The hearing is due to be held at the country=92s patent office in Delhi
and is the result of an application made to the Indian government by
the domestic generic company Natco last September.

Natco applied to the Indian Patent Controller for a compulsory
licence, permission to copy two cancer drugs that are under patent in
India, and export them to Nepal. One drug, called erlotinib, was
patented in India last year by Swiss manufacturer Roche under the
brand name Tarceva. The other is also a cancer drug called sunitinib
and is sold by US manufacturer Pfizer under the brand name Sutent.

Under WTO rules, compulsory licences can be issued without the
authorisation of the patent holder if the country to which a drug is
being exported is deemed to have no manufacturing capacity of its own
and has declared a need for it. Such licences can be issued in special
cases, such as during a national emergency or for government use, as
deemed by the recipient government.

If the patent office agrees to the application, it would be the first
time such permission has been given in India and only the second time
in the world.

The hearings on the applications were to have been held last month.
However, when it emerged that one patent-holder, Roche, had been
invited to attend the hearing on its drug, Natco filed a so-called
interlocutory petition, an objection aimed at blocking Roche=92s
appearance.

It did so because it believes that under Indian law, Roche should not
be allowed to attend CL hearings.

=93There is no necessity for the patentee to come to the hearing,=94 said
M Adinarayana, company secretary and general manager for corporate
affairs at the Hyderabad firm. =93The CL is between the patent office
and the Natco. That is the reason why we objected.=94 It argued as such
during a hearing at the end of February.

For its part Roche, says it was invited to the compulsory licence
hearing by the Indian government. =93Originally, Roche was invited to
attend the hearings by the Patent Controller of the Indian patent
office,=94 said a spokesperson for Roche. The Indian Patent Office was
not available for comment.

On 17 March, Roche is expected to defend its right to appear at the
eventual compulsory licence hearing, possibly occurring in the coming
weeks. The company would not comment on the hearing, saying, =93We are
currently in the legal process of hearings with the Patent Controller
and therefore cannot comment on the actions of our legal team.=94

However, observers including Natco, say that Roche will put forward an
argument based one of the principles of the so-called natural justice
philosophy, which is accepted in India.

It is expected to argue the principle that proceedings should be
conducted so they are fair to all the parties - expressed in latin
audi alteram partem - essentially =93hear the other side.=94

Some Lawyers Agree with Natco=92s Assessment

Tahir Amin, a lawyer at I-MAK, a US non-profit that specialises in
combating IP obstacles for public health crises said: =93I=92m concerned
about this talk of hearings to decide the compulsory licence request
and allowing the patentee (Roche) to present a case at a hearing -
which by the Indian Patent Act=92s wording should not be permitted.=94

According to the Act, the patent office should grant a compulsory
licence on the basis that the paperwork within an application is in
order. Companies applying for a licence, in essence, require a written
request from the countries with no capacity, ordering a particular
quantity of drugs, he said.

Indeed, a recently-issued draft of the patent office=92s own =93Manual on
Practice=94 stresses that the compulsory licence should be granted
immediately on request.

Amin, who has seen the draft, said: =93While the manual is only in
draft, the nature and purpose of [the section] is such that it removes
any opportunity for the patentee to oppose or challenge the granting
of a compulsory licence for export.=94

Indeed, the patent office=92s activities so far suggest it is in favour
of Roche=92s presence at the hearing on the application, when it finally
takes place.

=93The current question mark is how is the Indian Patent Office going to
handle these requests and what will be the procedure,=94 said Amin. =93But
this is the Indian Patent Office - so we don=92t know how they are going
to work it, especially if big pharma starts kicking up a fuss.=94

Other Lawyers Agree with Roche

Krishna Sarma, managing partner at Corporate Law Group, a Delhi-based
law firm which has represented Roche in the past but not in this
particular case, said, =93Calling a hearing is the incipient right of
the Controller. If he thinks it is right, he can call for a hearing,=94
she said. =93Roche should attend the hearings to get the facts right.=94

Curiously, one industry observer suggested Natco may find it difficult
to present a compelling case for a compulsory licence at the hearing.

That is because the letter sent by the Nepalese government to Natco
requesting it to manufacture the drugs may not explicitly mention a
public health crisis nor a lack of manufacturing capacity, according
to the observer who claims to have knowledge of the letter=92s contents.

Nevertheless, once Roche has put forward its arguments, the Patent
Controller will take a decision on whether the company can attend
meetings in a matter of weeks. The hearing on the application for a
compulsory licence - and probably the contents of the letter - will
then follow.

Tatum Anderson may be reached at info@ip-watch.ch.


Judit Rius Sanjuan
Attorney at Knowledge Ecology International
www.keionline.org / www.cptech.org
Phone: +1.202.332.2670, x18
Email: judit.rius@keionline.org