The stage is poised for a verdict from the Supreme Court on a patent-related case involving Novartis’ cancer drug Glivec. Final hearings on the case, over the last three months, concluded this week.
Novartis is contesting the rejection of its patent application on the beta crystalline form of imatinib mesylate, sold under the brandname Glivec.
The final decision on Glivec will be a landmark, bringing in clarity on the interpretation and implementation of the amended Patents Act. It will also be the first case on medicines under the changed patent regime to get resolved.
Ever since Novartis’ patent application on Glivec was rejected in 2006, the case has traced the contours of the amended Patents Act. In 2005, the Patents Act had been amended to bring in a framework that would honour product patents.
A company or individual is guaranteed 20 years of exclusive rights to market a product if it is found to be innovative and is granted a product patent.
The discussion on product patents, though, takes a different pitch when it comes to patents on medicines. The concern voiced by pro-health groups is that companies with exclusive rights could keep prices high on patent-protected products, medicines in this case.
Fighting the Swiss drug-maker, Novartis, on Glivec is the Cancer Patients Aid Association and domestic drug-makers including Natco and Cipla. Their contention was that product lacked novelty, was obvious, and was not patentable under section 3(d).
In fact a key issue in Novartis’ fight over Glivec revolves around Section 3 (d) of the Patents Act,that prevents what is called “ever-greening”. Drug companies are known to tweak existing molecules and get a fresh lease of patent-protected life.
Novartis on its part points out that Glivec has a patent in 40 countries. Novartis scientists had developed the mesylate salt of imatinib and then the beta crystal form of imatinib mesylate to make it suitable for patients to take in a pill form that would deliver consistent, safe and effective levels of medicine, officials have explained in the past.
Price is another key factor that cropped up in the case, with Glivec costing about Rs one lakh a month when the case got underway, even as its generically-similar versions were priced at Rs 10,000. Novartis, though, has maintained that they have a patient support programme for needy patients.
With stakeholders having placed their arguments before the Apex Court, the stage is now set for a final, path-breaking decision on the case.