From patient groups to religious heads, the case involving Novartis’ blood cancer drug Glivec in India, has evoked strong reactions from across the world.
Some of that reaction stems from Glivec being a key drug for cancer patients. But much of the attention is also because the final judgment on Glivec will have far-reaching implications on drug companies of all hues, and the drug’s consumers – the patients. And that all-important judgment day is scheduled for Monday. When the Supreme Court rules on Glivec – it will clarify whether the medicine shows enough efficacy to deserve a patent. And in doing so, the judgment will bring in greater clarity on the yardstick against which medicines will be measured, before they are granted patents.
Novartis’ application for a patent on the beta-crystalline form of imatinib mesylate, marketed under the brand name Glivec, had been rejected by the Indian Patent Office in 2006.
The rejection was on the grounds that the product lacked novelty and an inventive step, and also failed to show an increased efficacy over the known substance. And since then, Glivec has traversed a litigation-filled landscape.
Benchmark
Since a patent protects an innovative product for 20 years, pro-health groups are worried. The exclusivity a patent grants a company in the manufacture and distribution of a drug could result in the medicine being priced beyond the reach of patients, they apprehend.
The Glivec case will be a benchmark, as it is the first drug-patent related case, after the Indian Patent Act was amended in 2005 to protect product patents.
The amended patent regime made it difficult for local companies to make similar versions of an innovative drug, protected by a patent.
At the core of the Glivec case is the interpretation of Section 3 (d) of the amended Patent Act that does not recognise incremental innovation, popular in pharma circles as “ever-greening” of the patent.
A key feature in the Act, it allows patent protection only on a totally new or better drug. So a drug company would not be able to tweak an existing or known drug and claim a fresh bout of patent exclusivity on this changed molecule.
Also, creeping into the debate is price. At the start of the case, Glivec cost patients Rs 1 lakh a month. But local companies sold their versions of the same drug at about Rs 10,000.
Novartis, though, has always maintained that Glivec is a breakthrough drug, and has got patents in 40 countries. Besides, its patient assistance programme since 2002 has distributed Glivec valued at $1.7 billion completely free to patients in India.
Other participants in the Glivec case include the Cancer Patients Aid Association, Natco and Cipla. Their contention was that the product lacked novelty, was obvious, and was not patentable under section 3(d).
On Monday, though, it will be more than just participants in the case who will be watching the Supreme Court to see how the hammer finally falls.