[Ip-health] Novartis not ready to give up on Glivec

[Joana Ramos]

http://tinyurl.com/l7bey3


Novartis not ready to give up on Glivec
18 Jul 2009, 1233 hrs IST, Nina Mehta, ET Bureau


MUMBAI: The Indian subsidiary of Swiss drugmaker Novartis will challenge
a decision by the Intellectual Property Appellate Board (IPAB) that said
its cancer drug Glivec was not patentable.

Addressing the company=92s annual general meeting (AGM) on Friday, its
vice-chairman and managing director Ranjit Shahani said the company
=93will appeal the decision all the way=94.

IPAB had rejected Novartis=92s appeal for patent protection for Glivec as
Section 3(d) of the Patent Act does not allow patenting of incremental
innovation, which refers to innovations based on existing knowledge and
products.

Intellectual Property law experts believe that the wording of IPAB
judgement was legally flaky and not reasoned out well, which can give
Novartis a stronger case should the company appeal further.

=93IPAB used pricing as a reason for not granting the patent, which can be
challenged. If the board had found that the patent was not inventive
that would be a separate issue. But since the board found it inventive
and still denied Novartis the patent, it can be challenged,=94 said
Shamnad Basheer, professor in IP Law at the National University of
Juridical Sciences at Kolkata.

The ideal course of action for the company would be to appeal to the
High Court, Mr Basheer said
IPAB backed a decision of the patent controller=92s office which had, in
January 2006, rejected the Swiss MNC=92s application. Novartis then filed
multiple writs in the Madras High Court challenging the rejection of its
patent application as well as Section 3(d), an appeal which was also
rejected.

Novartis could also look at taking up the matter at the WTO=92s Trade
Related Intellectual Property Rights (TRIPS) forum. The focus point of
its stand could be to question the lack of the definition of =91inventive=
=92
mentioned in the Act, which is currently an additional criteria for
granting a patent. Any action at the TRIPS forum will have to be from a
country level with Switzerland lodging a complaint against India.

According to IP lawyers, Novartis=92s immediate appeal to the HC would
focus on whether the patent fits all the criteria of the Patent Act thus
making it valid. =93The HC will not be able to use pricing as a means to
deny a patent nor can it introduce a clause of low pricing to approve a
patent. The National Pharmaceutical Pricing Authority (NPPA) will have
to take a decision on the pricing front,=94 Mr Basheer said.

Cancer patient groups and generic companies such as Cipla, which have
been challenging Novartis on scientific as well as humanitarian grounds,
feel that the company is fighting a losing battle.

=93Novartis has already lost two appeals. We have been protesting Glivec
being given a patent since it is priced exorbitantly at Rs 1.25 lakh for
a one-month course. Patients who suffer from Chronic myeloid leukaemia
(CML) have to take this medication for their lifetime,=94 said Shubha
Maudgal, executive director of the Cancer Patients Aid Association
(CPAA), an NGO that has been fighting Novartis on the issue.

However, should the courts grant Novartis the patent, patient groups
will not get any relief on the pricing front. =93Novartis has said that
they give out the drug to 99% of the patients for free. If they instead
charge a price comparable to what generic companies charge (Rs 10,000
per month), more people will buy the original,=94 Ms Maudgal said.

Meanwhile, generic companies have the option of challenging Novartis and
manufacture the drug on the grounds of affordability. =93Three years after
a patent is granted an appeal for compulsory licence can be made, but
first the patent has to be approved. The courts could rule in their
(generic companies) favour, but this would depend on the outcome of the
Roche-Cipla case which is pending in the Supreme Court,=94 Mr Basheer said.


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