[Ip-health] Business Standard (India) Editorial: Cancer patents

[Sarah Rimmington]

http://www.business-standard.com/common/news_article.php?leftnm=3D10&bKeyFl=
ag=3DBO&autono=3D318095

Cancer patents
Business Standard / New Delhi March 27, 2008

The revelation that over 85 per cent of cancer drug applications filed
in the patent office are from multinationals, albeit significant in
itself, need not be viewed as an adverse reflection on the Indian
pharmaceutical industry, which is steadily coming of age. Nor does it
mean that all the applications will end up in patents, and that the
drugs thus protected would be manufactured and marketed in India. What
matters are the merits of the products offered for patent protection.
 From that angle, analysts feel that not many of these drugs may succeed
in getting intellectual property protection, for two reasons. First, the
Indian Patent Act, as amended in 2005, does not permit patents on
medicines patented elsewhere before 1995. This is a safeguard to thwart
bids for ever-greening or back-door revival of patents by seeking
protection in other countries. Secondly, most of the applications from
the multinationals are believed to be for derivatives or minor
modifications of existing medicines and, as such, may be ineligible for
patents. Though the patentability of minor incremental modifications in
existing drugs is embroiled in controversy, especially after the
Mashelkhar Committee report (subsequently withdrawn on charges of
plagiarism), the law as it is today does not allow this. This is borne
out by the denial of patent to a cancer drug, Glivec, from Novartis
because the patent office was convinced that the medicine was nothing
more than an improvement of a known substance. The final verdict is
still to come, though, since an appeal against this decision is pending
before the Intellectual Property Appellate Board.


The multinationals=92 interest in the Indian cancer drug market is
understandable because of its huge size, reckoned at Rs 1,200 crore, and
the large number of cancer patients in the country (about 2.5 million).
However, there may be other considerations, too, for seeking patents in
India, whose patent office seems to have a rather high patent grant
rate, compared to other countries. This may be partially responsible for
the large number of applications. The patent office should, therefore,
be cautious in scrutinising these applications to ward off
ever-greening. After all, what is at stake is the interest of patients
who need cheaper medicines that are coming off patent. The courts seem
to agree with this line of reasoning, for the Delhi High Court recently
issued an interim order allowing Cipla to market Erlontinib, a lung
cancer drug, though the Indian patent on this medicine is held by Roche.
The lower cost of the Cipla product was cited by the court as the basis
for the interim ruling.


On another tack, the need for revamping the patent office and the
process of granting patents remains of critical importance. The
inadequacy of the patent office=92s infrastructure and the number of
patent examiners are among the areas that need to be looked into.
Equally important is the need to have some transparency to the procedure
of processing patent applications, by making it mandatory to disclose
reasons for the acceptance or refusal of any patent. There is at present
no proper database of patents, needed by both patent appliers and examiners=
.


--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: (202) 387-8030
Cell: (202) 422-2687
www.essentialaction.org/access/