The Supreme Court will pronounce on Monday its verdict in a landmark patent case involving Swiss pharma giant Novartis AG.
The company has challenged the denial of patent to its blood cancer drug Glivec in India The verdict, which is crucial even for public health, is being watched closely by global pharmaceutical firms, who have been pushing for stronger patent protection in India to regulate the country’s $26-billion generic drug industry.
A win for Novartis will pave the way for liberal grant of patents in India. If the drug maker fails, then it will be a setback for foreign drug makers who have been accusing Indian authorities of unsatisfactory protection of their patent rights in the country.
The judgment, to be pronounced by a bench of justices Aftab Alam and Ranjana Desai, may also set a precedent for India’s predominantly generic drug market and could potentially alter its role as the supplier of cheap medicines to the world.
The Glivec case is one of the oldest patent-related ones in India. It goes back to 2003 when Novartis obtained an exclusive marketing right for the drug based on its patent application.
Novartis has argued for patent protection for Glivec, which is used to treat chronic myeloid leukaemia and some gastrointestinal cancers.
While Novartis? Glivec costs over R1 lakh a month, local companies sell similar versions of the drug at R10,000 a month.
In July 2009, the patent application for Glivec was rejected by the Intellectual Property Appellate Board (IPAB) as it failed to satisfy the efficacy requirements under Section 3(d) of the Indian Patent Act, and its high price was judged to be against ?public order”.
Section 3(d) restricts patents for already known drugs unless the new claims are superior in terms of efficacy. Section 3(b) bars patents for products that are against public interest and do not demonstrate enhanced efficacy over existing products.
Even Natco Pharma had challenged a part of IPAB’s decision that said the Swiss drug-makers? blood cancer drug Glivec (Imatinib Mesylate) was novel and inventive. However, it had given a favourable mention on novelty and innovation of Novartis? Glivec. Even Cancer Patients Aid Association has challenged Novartis’ plea in the apex court.