DRL semaglutide ruling may set precedent for generic makers: Experts

Ruling enables production for non-patented markets but bars India sales till 2026; experts say it may shape future drug access cases

The Delhi High Court’s (HC’s) ruling allowing drugmaker Dr Reddy's Laboratories (DRL) to manufacture and export its generic version of semaglutide in non-protected markets of patent holder Novo Nordisk may serve as a potential precedent for other similar cases, according to legal experts.

 

While the detailed order had not been uploaded at the time of going to print, lawyers told Business Standard that the Delhi HC ruling allows DRL to make and export semaglutide where Novo Nordisk does not have patent protection, but blocks sales in India until the patent remains valid, that is, until March 2026.

 

Both DRL and Novo Nordisk did not respond to emails until the time of going to press.

 

With the caveat that the detailed order is still awaited, Shabnam Sheikh, legal associate at Arogya Legal, said that while each case depends on its unique facts, the reasoning in this case may serve as persuasive guidance in ongoing patent disputes arguing that manufacturing solely for export should not count as infringement.

 

“This approach in this case may also guide other ongoing cases where patents are nearing expiry or where there is a strong public-interest need for cheaper generics,” she added.

 

This comes on the heels of another Delhi HC ruling that had allowed Hyderabad-based Natco Pharma to launch a generic version of Roche’s spinal muscular atrophy (SMA) drug Risdiplam, marketed as Evrysdi.

 

Natco had then said that it would price its rare disease drug, Risdiplam, used to treat SMA, at ₹15,900 per bottle, compared with ₹6.2 lakh per bottle charged by Roche under the brand Evrysdi.

 

“Generally, when medicines are expensive, such rulings in favour of generics can improve access to the medicine across all strata of society. Increased competition drives prices down,” said Abhishake Sinha, partner at Chitale & Chitale Partners.

 

Sinha added that although the Delhi HC ruling is not binding on other HCs, it definitely has persuasive value.

 

Ashwin Sapra, partner (head of pharma and healthcare) at legal firm Cyril Amarchand Mangaldas, said that, on a prima facie basis, the judgment strikes a balance between protecting the rights of a patentee during the validity of its patent and the exemption under the Bolar provision as provided under Section 107A of the Indian Patents Act, 1970.

 

The Bolar exemption allows generic companies to make, construct, use, sell, or import a patented invention solely for purposes reasonably related to the development and submission of information required under Indian law or in a country other than India that regulates the manufacture, construction, use, sale, or import of any product.

 

“If that is indeed the case, then the judgment sets a balanced precedent, showing the courts’ proclivity to adopt a mid-line approach,” he said.

 

However, experts believe that incorrect reliance on this exemption — where the intent is to manufacture for commercial gain during the subsistence of a patent with judicial approval — could be a dangerous trend, as it would dilute statutory protections under the Patents Act and render patent grants redundant in that context.

 

Sapra added that while affordability is an important consideration, so are statutory patent rights. “A balanced approach is best, and stakeholder participation in policymaking is needed,” he said. He added that simply curtailing or diluting patent rights, though the easiest solution, would be counterproductive and could reduce the availability of innovative drugs in India.

 

Sidhant Goel, senior partner at legal firm Sim and San — Attorneys at Law, added that the ruling cannot be characterised as a trend, as courts review the merits of each case and decide accordingly. “If you analyse the recent judgments that have gone in favour of generics, they have been exceptionally strong on merits, articulated in well-written judgments,” he added.