[Ip-health] Novartis faces fresh patent fight in India... re: Glivec

[Joana Ramos]

http://www.livemint.com/2008/01/10000215/Novartis-faces-fresh-patent-fi.htm=
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Posted: Thu, Jan 10 2008. 12:02 AM IST
www.livemint.com

Novartis faces fresh patent fight in India

Novartis is still challenging Indian patent laws after the first patent
application it filed for the drug which was a beta crystal form, was
rejected by the Chennai patent office in 2006
By C.H. Unnikrishnan

Mumbai: Having failed so far to secure an Indian patent for Glivec, its
blood cancer drug, Swiss drug giant Novartis AG appears set to face a
similar battle over another pending 2004 patent application for a
different form of the same drug.

Novartis=92 patent filing in the Chennai patent office, for an alfa
crystal form, or another modified form of its cancer drug imatinib
mesylate, has come to light only now following a pre-grant opposition
filed by Okasa Ltd, a Mumbai-based small pharmaceuticals company.
Novartis is still challenging Indian patent laws after the first patent
application it filed for this drug, which was a beta crystal form, was
rejected by the Chennai patent office in 2006 on the grounds that a mere
modification of a pre-1995 invention does not qualify for a patent grant
in the country.

Novartis, which holds a patent for the beta crystal form in several
international markets at present, appears to have filed the patent
application for the alfa crystal form in India toward the end of 2004.
=93It was yet another frivolous patenting attempt by Novartis in India,
since the company was not very sure about a patent grant on the first
application,=94 insists R.K. Dewan, a patent attorney with RK Dewan and
Co., who filed the pre-grant opposition to Novartis=92 application on
behalf of Okasa.

A Novartis India spokesperson said, she =93is unable to comment on the
matter as the patents are handled by the parent company.=94 At the time of
going to print, Mint was yet to hear from Novartis.

Dewan said the Chennai patent office had scheduled two hearings on the
Okasa filing, but added that Novartis had sought an adjournment on both
occasions, citing an inability to send a representative to the hearing.
Although Novartis is yet to launch a brand of the alfa crystal form of
this cancer drug in India, a local drug maker, Cipla Ltd, has been
selling a generic version of the drug here the last couple of years.

Cipla chairman Yusuf K Hamid said: =93We are holding a process patent for
this particular product globally through a Patent Cooperative Treaty or
PCT filing. The Novartis move to file a product patent in India will not
hold merit not only because of mere modification, but also owing to the
prior knowledge of the product in the public domain.=94

Rajiv Nannapaneni, chief operating officer, Natco Pharma Ltd, which
opposed Novartis=92 first patent application, claims: =93Novartis did not
apply for a patent for the alfa crystal form of imatinib mesylate
elsewhere because it was considered inferior to the beta crystal form as
far as the treatment efficacy is concerned.=94

Still, Mumbai patent consultant Gopakumar Nair notes that, =93the original
patent document for imatinib mesylate (filed in) 1993 in the US by
Novartis has mentioned that a beta crystal form of the drug was found
more efficacious.=94

Novartis is fighting a case at the country=92s Intellectual Property
Appellate Board, where it challenged the Chennai patent office=92s
decision to reject its first patent application for Glivec.
The company, which was granted an exclusive marketing right, or EMR, for
the cancer drug, which is marketed here under the brand name Glivec,
first invited controversy when it secured a court order to restrict
manufacturing and marketing of the generic version of the same by local
drug makers.

But, the patent application was rejected under India=92s newly amended
patent rule=97Section 3 (d), which was triggered by a pre-grant opposition
filed by mainly six Indian drug makers including Ranbaxy Laboratories
Ltd, Cipla, Natco and Sun Pharmaceuticals Industries Ltd.
Novartis challenged India=92s patent law, which does not allow a pre-1995
invention or a mere modification of known drug to be granted a patent
unless the modification claims for enhanced efficacy for the treatment,
in the Madras high court, saying that the country=92s law does not comply
with the World Trade Organization=92s trade related intellectual property
rules.

The court rejected the case in April 2007.

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Joana Ramos, MSW
Cancer Resources & Advocacy
Seattle WA USA
+1-206-229-2420
http://ramoslink.info/
www.bmtbasics.org