Patient health body opposes move to bar generic SMA drug
Roche's bid to block a generic SMA drug risks public health by limiting affordable access, say patient groups, highlighting high costs and patent issues.
The move by Swiss multi-national, Roche (F. Hoffmann-La Roche AG) , seeking permanent injunction to prevent the introduction of a generic drug for Spinal Muscular Atrophy (SMA) jeopardises public interest by limiting access to affordable medication, patient health groups said in a briefing on Tuesday.
“Roche is seeking a permanent injunction against Natco Pharma to prevent the introduction of a generic version of Risdiplam, a Spinal Muscular Atrophy (SMA) drug, citing patent infringement. Health groups argue that Roche’s legal action to block generic supply jeopardises public interest by limiting access to affordable medication,” said Working Group on Access to Medicines and Treatments in a statement.
According to Johns Hopkins Medicine, SMA is a disorder affecting the motor neurons—nerve cells that control voluntary muscle movement. These cells are located in the spinal cord. Because the muscles cannot respond to signals from the nerves, they atrophy. The cost of drugs to keep the symptoms in check is largely prohibitive for families of patients suffering from the condition.
The group’s statement also said that the Delhi High Court has been addressing SMA-related petitions since early 2021, highlighting the need for a coordinated treatment framework amid ongoing challenges posed by high drug costs and limited access.
“Roche’s patent for Risdiplam is effective until May 2035, allowing them to charge approximately ₹6 lakhs per bottle, while production costs suggest the drug could be made available for as low as ₹3,024 annually.”
“The generic production and supply of a rare disease at a fraction of the cost of the originator is a breakthrough that needs to be promoted to meet patient needs in India and across low and middle- income countries.”
In a statement, a spokesperson for Roche said that drug innovation and its access to patients is foremost for the company.
“We are committed to deliver healthcare innovations that significantly improves patient lives in the country while ensuring that as many patients as possible have access to our products. Our focus remains on discovering and developing innovative medicines and diagnostics that will change standards of care in the future. At the same time, we are also committed to protect our innovations within the scope of applicable laws in the countries we operate and believe that laws provide sufficient safeguards for protection of innovation,” the statement said.
The generic manufacture of patented drugs is a highly complex issue that spans IP law, affordability issues, and, most importantly, the high cost of R&D, and therefore, fair returns for innovator companies.
Still , patient representatives and treatment activists highlight that the government, courts, and lawmakers need to take urgent action to address the abuse of patent monopolies in rare diseases.
To be sure, most companies have special programs in these cases.
According to the Roche spokesperson, 52 patients are currently being treated in India under its special Compassionate Use Programme (CUP).
“…For patients like me, a treatment finally exists. Risdiplam offers us hope—hope that we can slow down this relentless progression and regain a sense of stability in our lives. But there is a cruel irony in this hope: the cost of this drug is staggering. At nearly ₹6 lakhs per bottle, or around ₹70 lakh annually, Risdiplam remains entirely out of reach for most people with SMA,” said Saifullah Khalidi, a 30-year-old living with spinal muscular atrophy, in a statement.