[Ip-health] Economic Times: Mashelkar Prescription May Get Second Opinion

[chan park]

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[ Picked text/plain from multipart/alternative ]
http://economictimes.indiatimes.com/Mashelkar_prescription_may_get_second_o=
pinion/articleshow/1635642.cms

  NEW DELHI: This may disappoint pharma MNCs, especially Swiss drugmaker No=
vartis, which is involved in a globally-watched legal tussle with the gover=
nment for getting patent protection for Glivec =97 a drug widely referred t=
o as a gold standard in treating blood cancer. The government is not inclin=
ed to accept the controversial view taken by Dr Mashelkar panel that the co=
untry does not meet its international obligations in protecting intellectua=
l property.

The panel had mooted a widening of the ambit of what constitutes a patentab=
le pharmaceutical substance, by allowing patenting of a slew of structural =
and physical modifications, incremental inventions, which the country=92s p=
atent law currently denies IPR as per an exclusion criteria brought in with=
 2005 amendments, unless these offer significant efficacy improvement.


  To reinforce its plea for removal of the allegedly restrictive criteria u=
nder Section 3(d) of the country=92s patent law, Novartis had referred to t=
he report at the Chennai High Court last week when it heard a writ petition=
 by the company challenging the existing law and the denial of patent to Gl=
ivec.


  The thinking in the government is clearly that the patent law should cont=
inue in the present form for a few more years. The chemicals & fertilisers =
ministry strongly feels that the report should not be accepted as =91there =
is a lot of criticism=92 about it. It thinks that the panel, which was give=
n a mandate to examine whether it would be Trips-compatible to limit the gr=
ant of patent for pharmaceutical substance to a new chemical entity or to a=
 new medical entity involving one or more inventive steps, did not =91go in=
to the depth of anything=92, in this regard.


  =93The (Mashelkar) panel has failed to differentiate between incremental =
inventions and evergreening tactics,=94 said a ministry official. Evergreen=
ing refers to unfair prolonging of patent tenure by trivial alterations of =
an entity which would otherwise go off-patent.


  An official from the department of industrial policy & promotion (DIPP) s=
aid the government would not dilute its stand that the present patent law i=
s fully Trips-compatible. Under Trips, a patentable product should be new, =
involve an inventive step and be capable of industrial utility. =93Section =
3(d) does not violate the country=92s Constitution, nor is it in conflict w=
ith Trips,=94 said the DIPP official, adding that a final view on the panel=
=92s report was yet to be taken.


  =93A large number of incremental innovations have significant practical a=
dvantages for the patient over the existing medicine, although they may not=
 qualify as scientific breakthroughs. Companies will invest in such improve=
ments only if there is an assurance of ownership at the end of costly and t=
edious research=94, Novartis international corporate research head Paul Her=
rling told ET.


  It may be noted that Mashelkar panel had said that the flexibilities allo=
wed in TRIPS or a general understanding among WTO members regarding the pre=
cedence of public health over patents should not be used by India to deviat=
e from its obligation to grant patents to all inventions.


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