New Delhi: In a decision that is expected to benefit patients of spinal muscular atrophy (SMA) in India, the Delhi high court on Monday (March 24) refused to impose an injunction against the generic manufacture of the drug Risdiplam. It is the only approved drug in India to manage SMA.
Swiss pharma giant La Hoffman Roche developed this drug. It was successful in getting a patent and, thus, in prohibiting any generic manufacture of the drug in India.
Natco Pharma, a generic drug manufacturer in India, had moved the Delhi high court to get an injunction against the patent. The single bench of Justice Mini Puskarma ruled in favour of Natco.
“This judgement is expected to bring down the prices of the said drug by 90%, going as per the previous record of the company in making generic drugs,” Leena Menghaney, an access to drugs advocate, told The Wire.
Seba P.A. and Purva Mittal, two young women battling SMA, were intervenors in this case.
“Currently, the said medicine costs around Rs 6 lakh per bottle. For a patient weighing more than 20 kg, a bottle will last only for 12 days and over the course of the year, he/she will require approximately 30 bottles per year, amounting to Rs 1,80,00,000 a year,” Seba said in her intervention in the court.
SMA is a rare genetic disease that is debilitating to the extent that it can badly restrict mobility and the movement of muscles in the body, making even breathing and swallowing difficult.
According to the submission made in the court, SMA affects one in 10,000 live births globally and one in 7,744 live births in India.
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In another judgement last month, the Kerala high court had directed the Union government to provide the drug to Seba and others at its own expense for treatment of SMA.
The Union government challenged the order, dated February 24, in the Supreme Court.
The apex court stayed that order of the Kerala high court and asked the Union government to get in touch with the companies so that the cost of Risdiplam can be brought down. There is no final judgement in that case yet.
In the current case in the Delhi high court, Rosche contended that it already provides Risdiplam at a discounted price as part of its ‘patient assistance programme’. It said it makes the drug available at Rs 72 lakh annually for the first two years and Rs 56 lakh annually for the third year – as against the cost of more than Rs 1 crore per year, when it is sold outside this programme.
“Even if the plaintiffs [Rosche] provide the drug in question at their proposed price, as indicated to this court in a sealed cover, even then, the same would not be a viable proposition in economic terms for the patients who are suffering from SMA,” the Delhi high court said today.
“Furthermore, the said proposal would only affect the patients enrolled in the patient assistance program, leaving a broad space for the patients who are not enrolled,” it added.
The court also said that if Natco gets an opportunity to make the generic form of the drug, it would bring to effect price reduction in the drug ‘in its entirety’, which would for reasons that are apparent be applicable to all patients suffering from SMA.
“Thus, if a party is able to manufacture the drug and make it available at an affordable price, in such a case, the public interest would have to outweigh the need for grant of injunction,” the court ruled.
As an aside, the Union government, as part of the National Policy for Rare Diseases, provides financial support of up to Rs 50,00,000 per patient that covers all 63 categories of rare diseases.
The number of such patients is 1,118, as per a submission made in the court. SMA is one of the 63 rare diseases.
“It is evident that the National Policy for Rare Diseases has its limitations, on account of which, the effective need of the patients suffering from rare diseases, including SMA, is not fully addressed,” the high court said, adding that the costs involved in the purchase of Risdiplam are much larger as compared to the aid provided by the government as part of the said national policy.
And therefore, the policy was not capable of providing adequate relief, it said.
The court also directed Natco to maintain complete accounts of the manufacture, sale and supply of the product. It has also been required to file statements of accounts before the court on a quarterly basis.
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No final decision
However, it must be clarified here that in the current judgement, the court did not grant a final decision on the merit of the patent. A separate trial on that front is yet to happen.
“It is clarified that in case the plaintiffs [Roshce] ultimately succeed in the trial, the defendant [Natco] shall be liable to pay damages to the plaintiffs,” the court put a rider.
Advocate Anand Grover, who represented Seba, welcomed the Delhi high court’s ruling and emphasised that it will prevent many unnecessary SMA-related deaths.
A history of all such battles suggest that cases like these go down to the wire. Thus the petitioners and the patients have to be prepared if Rosche challenges the judgement before a larger bench of the Delhi high court or the Supreme Court, Menghaney said.
