In a landmark judgment on Monday, the Supreme Court dismissed
Novartis AG's plea for a patent for its blood cancer drug, Glivec.
While the details of the ruling are awaited, analysts see it having huge implications for big global pharmaceutical companies. Experts believe the ruling will stand out
as a case where India has utilised the flexibility allowed under the TRIPs agreement (Trade-Related aspects of Intellectual Property Rights, an international agreement administered by the World Trade Organization).
It has thus ensured that access to generic or cheaper versions of patented drugs
is not delayed.
The ruling could also have serious implications for global pharmaceutical companies if other emerging countries adopt similar provisions in their patent law.
India has refused protection for Glivec on the grounds that it is not a new medicine but only an amended version of a known compound.
A special clause in the Indian Patent law, Section 3(d), is the bone of contention in this case. The clause aims to ensure that pharma companies do not seek patents for amended versions of a known compound or for newer forms of an existing or known molecule. This is sometimes referred to in the industry as "evergreening" or constantly extending the life of a patent.
Novartis had first sought a patent for Glivec (imatinib mesylate) in India in 1998. India granted marketing approval for Glivec in 2001, but it was not until 2005 that the country established the Indian Patents Amendment Act and provided authorisation of pharmaceutical compound patents.
The Indian Patent Office rejected the patent
request in 2006, and the case was eventually transferred to the Indian Patent Appellate Board (IPAB). In 2009, IPAB refused to grant a patent for Glivec based on an additional requirement introduced in the law in 2005.
Novartis appealed before the Supreme Court of India. In 2011, the Supreme Court agreed to hear the case, and the hearing began on September 11, 2012. The hearing ended on December 4, 2012.Novartis India shares
, which opened at Rs 599, were trading at around Rs 574, down 4 per cent, at 11.50 am on the Bombay Stock Exchange.