On April 1, 2013, the Supreme Court rejected Novartis' final appeal for a patent on Imatinib Mesylate (Glivec), a drug that treats chronic myloid luekaemia (CML).

The patent application was rejected based on Section 3(d) of India's patent law that prevents ever-greening, that is, patents are not allowed on new forms of existing medicines unless they demonstrate a significant increase in efficacy.

At the Cancer Patients Aid Association (CPAA) offices there was jubilation and relief as our decade-long legal battle to ensure availability of generic Imatinib was finally over. In CPAA's 49 years of supporting cancer patients, this judgment was a defining moment. Our battle had started when Novartis got exclusive marketing rights (EMR) on Imatinib (2003). The impact was immediate: Six of nine generic producers stopped supply. We went to the Supreme Court in 2004 to overturn the EMR. Before the case was heard, the new patent law came into force and Novartis' patent application came up for examination.

Having experienced the impact of exclusive rights first-hand, we resolved to file a patent opposition. Imatinib itself could not be patented in India as a pre-1995 drug; so Novartis' 1998 application was for a salt form of Imatinib — a new form of an existing medicine. Precisely what Section 3(d) sought to restrict. In January 2006, the Patent Office agreed with our opposition and rejected the patent application.

Then started the exhausting, harrowing appeals that would last seven years. Suddenly the case was not only about Imatinib. Novartis challenged Section 3(d) itself; every other medicine would be affected!

The battle was not only in court. CPAA came under tremendous pressure. “Well-wishers” asked if we were wise to take on a pharma giant. We faced insinuations of acting on behalf of generic manufacturers. But through everything was the fear...what if the patent was granted. We had seen the impact.

CPAA pays for cancer medicines. So, any phenomenal increase in drug prices directly affects our support to patients. We had to fight for strict application of India's pro-health patent law. The confidence of our lawyers and support from the global health community that relied on India's generic production saw us through.

The Glivec case was an eye-opener on many fronts — weak patents, high prices, over-hyped claims on R&D costs and the reality of “compassionate access programmes”. Though Imatinib was included in the World Health Organisation's List of Essential Medicines (2015), developing countries still struggle for access. Colombia, facing considerable pressure, dropped plans to issue a compulsory licence settling instead for a 44 per cent price reduction; still nowhere close to monthly generic prices. Prices quoted to CPAA now range from ₹1,000 to ₹6,000 for a month's treatment.

Today, questionable patent applications on critical medicines have been rejected and developing countries are considering provisions like Section 3(d) for their patent laws.

This year, CPAA launched a support group for CML patients. Among our patients is Mukesh (name changed), diagnosed in 2007. Making and selling agarbattis on trains, Mukesh lives with his wife and two children in Mumbai. His earnings: ₹50 a day. Thanks to the Supreme Court decision, CPAA is able to provide Mukesh and others like him their medication, free.

That's when we know our decade-long battle has been more than worth it.

( The writer is Founder Chairman & CEO, Cancer Patients Aid Association, that fought the country's first pharma patent battle under the amended patent regime. CPAA continues to challenge patents on key cancer medicines. Views expressed are personal )

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