Healthy Skepticism Library item: 16771

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

SC issues notice to govt, others on Novartis petition
Business Standard 2009 Sep 12
http://www.business-standard.com/india/news/sc-issues-notice-to-govt-othersnovartis-petition/369855/

Full text:

The Supreme Court today issued notice to the central government, drug majors
Cipla, Ranbaxy Lab, Hetero Drugs, Natco Pharma and others on an appeal filed
by Swiss firm Novartis, challenging the denial of patent for Glivec, its
blood cancer drug in beta crystal form.

A Bench headed by Justice Dalveer Bhandari did not pass a stay order against
the order of the Intellectual Property Appellate Board (IPAB), against which
Novartis approached the Supreme Court. IPAB had rejected the Novartis appeal
against the Chennai patent office order denying patent to the multinational
firm.
The court sought replies from the Ministry of Industry and Commerce, the
Comptroller General of Patent and Design, the Cancer Patients Aid
Association (CPAA) and the four pharma companies.

IPAB in July had denied the plea for patent mainly under Sections 3(d) and
3(b) of the Indian Patents Act. Section 3(d) restricts patents for already
known drugs unless the new claims are superior in terms of efficacy. Section
3(b) restricts patents for products that are against public interest and do
not demonstrate enhanced efficacy over existing products.

The SLP filed by Novartis said that Section 3(d) was not applicable at all
to their ‘breakthrough medicine Glivec’. Novartis also said it objected to
IPA’s contention, citing Section 3(b), that the price of the drug is ‘too
unaffordable’ as 99 per cent of all Glivec patients in India – currently
more than 11,000 patients – have been receiving their medicine free of
charge through the Glivec International Patient Assistance Program (GIPAP)
since 2002’.

Petitioners such as CPAA have opposed the Novartis view by stating that a
patent on the drug will indeed affect its availability.

The battle for Glivec’s patent rights is the longest and the most
controversial intellectual property debate on medicines after India changed
its patent rules to align itself with the TRIPS (Trade Related Aspects of
Intellectual Property Rights) of the World Trade Organisation in 2005.