The Indian generic medicine sector, which literally saves lives across the world, has scored a big win in recent days, as Swiss pharma giant Roche has lost its case in the Supreme Court of India, filed against Indian drug manufacturer Natco, over a much cheaper generic version of an SMA medicine.
Roche reportedly holds the India patent until May 2035 for the medicine Risdiplam (marketed as Evrysdi), which sells at more than INR Rs 6 lakh per bottle, compared to the Natco generic version that costs about INR 16,000 per bottle.
The Swiss company had gone to the Supreme Court with a petition to challenge a Delhi High Court order in favour of the Indian company. The HC order of October 9 allowed Hyderabad-based Natco to market its generic version of the patented Roche drug.
However, things did not go well for Roche, as the SC bench of Justices PS Narasimha and AS Chandurkar declined to interfere with the HC ruling, “which had reaffirmed public health must take precedence over monopolistic practices and evergreening”, as reported by the Times of India. The Roche petition in SC was dismissed on October 17.
“Patent evergreening” is the strategy of patent-holder pharmaceutical companies to keep their grip on the market beyond the 20-year patent period by making very small changes in the patented formula and then passing off existing products as something new. This delays and/or prevents the manufacture and sale of cheaper generic medicines that can benefit the masses.
Natco had argued in HC that Roche was resorting to “evergreening”. The court agreed and refused to give the injunction on the generic drug sought by the patent-holder.
SMA incidence is 1 in 10,000 live-born babies
To put things in perspective, SMA or spinal muscular atrophy is a condition that affects many individuals — some estimates put it at 1 in every 10,000 people — and it is often diagnosed during infancy.
The Cleveland Clinic explains: “Spinal muscular atrophy (SMA) is a genetic condition that causes worsening muscle weakness. There are five subtypes, which range in severity and age of onset. There’s no cure for SMA, but certain therapies and medications can help manage symptoms.”
Research available in the National Library of Medicine explains: “The most severe form is the SMA type 1, with infantile-onset, where the infants die or are ventilator-dependent by two years of age. Children with SMA type 2 are sitters, and [those with SMA] type 3 are able to walk independently for some time but eventually are wheelchair bound. SMA type 4 is adult-onset with progressive weakness in later life.”
The research adds: “The incidence of SMA is one in 10,000 live-born babies and is the most common cause of death in the infantile age group. In the West, the carrier frequency of the SMA is 1 in 50. In a recent Indian study, however, the SMA carrier frequency was 1 in 38.”
That demonstrates how common SMA is in India — though public awareness levels are low, as yet — and how vital it is for families to be able to access relatively cheap generic drugs.
The 2 million-dollar SMA babies
One of the most expensive therapies for SMA is the highly advanced injected drug Zolgensma, made by another Swiss pharma giant, Novartis.
This is a cutting-edge gene therapy primarily administered to infants up to 2 years of age. But the absolutely prohibitive cost, about USD 2 million (or INR 17 crore approximately at current conversion rates), puts this injection out of the reach of most people in the world.
Indian parents have been known to crowdfund with the help of celebrities to raise the cost of one dose of Zolgensma for their babies, before the infants’ bodies shut down altogether.
In this scenario, the Natco generic SMA orally-administered drug that can be purchased for a fraction of the patented Roche medication comes as a godsend for affected Indian families. The disease makes no distinction between the rich and the poor, and the masses need an affordable remedy.
