In its ruling, the apex court said that Novartis’s “application for patent on the beta-crystalline salt does not meet any standard of novelty or inventiveness”, and therefore the company cannot be given any patent for this drug.
Shares of Novartis India Ltd fell as much as 7% after the Supreme Court judgement. The stock later recovered a bit to trade at Rs.577, down 3.64%, at 11:18am.
The judgement has provided clarity on the so-called evergreening and incremental innovation by pharmaceutical companies in order to retain patents.
Reacting to the ruling, Anand Grover, senior counsel appearing for Cancer Aid Patients Society, said: “It is a very good day for cancer patients. We are very happy. It is a myth spread by the company that judgement will affect research and development expenditures by companies—these companies want to make money without innovation.”
“The court noted that the product—beta crystalline—was known prior to 1995 through an earlier patent Novartis held. The implication of the judgement is that the Indian provision has been completely upheld and patents would be granted only for genuine inventions and litigative patenting will not be allowed,” said Pratibha Singh, an intellectual property lawyer who appeared for Cipla.
The ruling has been keenly followed across the world by pharmaceutical companies, humanitarian aid organizations and generic drug manufacturers as it will have far reaching implications on access to life-saving essential drugs under patents.
After a series of decisions that have gone against the big drug makers with respect to intellectual property rights in the past year, Paul Herrling, Novartis’s head of tropical disease research had said on Wednesday that the company is prepared for a negative response.
The case over patents for Glivec—a blockbuster anti-cancer drug made by Novartis—reached the courts when India denied patent for it in 2006 as the drug wasn’t considered a new molecule, but an altered version of one that had already been in the market for around 15 years. Basel-based Novartis had challenged the rejection of its patent application for Glivec by the Indian patent office and subsequently by the Intellectual Property Appellate Board.
Further, the company had challenged India’s interpretation of section 3 (d), which relates to what constitutes a new molecule, essentially to ensure that companies to not extend patents by simply modifying an already existing drug without any consequent changes in therapeutic effects.