Dr. Reddy’s Laboratories has just carved out a meaningful—if carefully fenced—path into the semaglutide opportunity. In a closely watched order, the Delhi High Court allowed the Hyderabad-based drugmaker to manufacture semaglutide in India and export its generic version to countries where Novo Nordisk does not have patent protection, while keeping the ban on selling the drug in India firmly in place until March 2026. For Dr. Reddy’s, it’s not the finish line—it’s a strategic lane opening up in one of the fastest-growing therapeutic markets in the world.

What Dr. Reddy’s Won (and What It Still Can’t Do)

The ruling effectively validates Dr. Reddy’s near-term playbook: produce domestically, sell internationally—selectively.

What Dr. Reddy’s can do now

  • Manufacture semaglutide in India
  • Export it to jurisdictions where Novo lacks patent registration/protection
  • Continue this export-led approach while the case moves toward a full trial

What Dr. Reddy’s cannot do yet

  • Sell semaglutide in India—the court reaffirmed that this remains prohibited until March 2026, when Novo’s formulation patent expires.

This matters because it keeps India’s revenue pool locked for now, but still lets Dr. Reddy’s build manufacturing readiness, supply discipline, and export relationships—advantages that can compound quickly.

The Undertaking That Strengthened Dr. Reddy’s Position

A central reason the court permitted ongoing activity is that Dr. Reddy’s offered a clear undertaking:

  • it will not sell semaglutide in India
  • it will restrict activity to exports only, and only to permitted countries

That promise did two things at once: it reduced the court’s fear of immediate market harm in India, and it framed Dr. Reddy’s as operating within a controlled, compliance-forward scope rather than pushing for a full domestic launch through the back door.

The court also directed Dr. Reddy’s to place on record manufacturing and export details since April, when production began—essentially: “Proceed, but document everything.”

How Dr. Reddy’s Successfully Framed the Patent Dispute

Dr. Reddy’s didn’t rely only on commercial arguments—it leaned into patent structure, and the court noted that its challenge had substance.

The key Dr. Reddy’s message: Novo’s primary patent has already expired, and the remaining protection rests on a formulation/delivery patent valid until March 2026—precisely the kind of secondary patent that often becomes the battleground for “evergreening” claims.

Dr. Reddy’s challenged validity under Section 64 of the Patents Act, arguing that the later patent lacks novelty and may be an attempt to extend monopoly protection. The court recorded that Dr. Reddy’s raised a credible challenge, including pointing to earlier disclosure (a 2004 patent) that could undermine novelty.

That “credible challenge” doesn’t decide the case—but it helps explain why the court refused to shut Dr. Reddy’s down at the interim stage.

Why the Court Didn’t Grant Novo an Interim Injunction—A Practical Win for Dr. Reddy’s

From Dr. Reddy’s perspective, the most valuable part of the order is what it avoids: an interim injunction that would have immediately frozen manufacturing and exports.

The judge held that Novo had not established a strong enough basis for interim restraint and noted that:

  • if Novo later wins at trial, financial losses could be compensated through damages
  • Novo imports semaglutide into India and does not manufacture it locally—context the court considered while permitting Dr. Reddy’s export-oriented production

This is not a declaration that Dr. Reddy’s is “right.” It is the court saying: “Not enough to stop you right now—continue, but under limits.”

The Risk Dr. Reddy’s Still Carries

The ruling also contains a quiet warning: Dr. Reddy’s began manufacturing in April, but challenged the patent on 12 March, meaning it proceeded “at its own risk.” If the final trial outcome goes against Dr. Reddy’s, the record of exports and manufacturing could become financially consequential.

The judge also clarified that all observations are prima facie and won’t influence the final outcome—so Dr. Reddy’s should treat this as a tactical win, not permanent certainty.

Dr. Reddy’s Bigger Strategy: Build Now, Launch Later

Even with India sales barred until March 2026, the order gives Dr. Reddy’s something powerful: time with momentum.

  • Time to optimize production
  • Time to establish export channels
  • Time to get operational muscle memory in a complex category
  • Time to prepare for a post-expiry India launch environment where speed matters

And that’s crucial because once the patent cliff arrives, the race won’t just be about who has a molecule—it’ll be about who can scale, price, supply, and distribute immediately.

What This Could Mean for Dr. Reddy’s After March 2026

The judgement keeps the door shut domestically—until it doesn’t. On expiry, multiple Indian companies have signaled intentions to launch semaglutide generics. Dr. Reddy’s will want to be among the first wave, and this export-permitted period can function like a runway: manufacturing proof, process maturity, and readiness for rapid expansion when the India market legally opens.

Takeaways: A Narrow, Valuable Green Light

For Dr. Reddy’s, this order is best understood as a court-approved, export-only wedge into semaglutide:

  • Green light for manufacturing + export to permitted countries
  • Red light for India sales until March 2026
  • A court record acknowledging Dr. Reddy’s challenge as credible enough to resist an interim shutdown

It’s a disciplined win—one that rewards restraint, documentation, and strategy. And in a market where timing is everything, Dr. Reddy’s has gained something rare: permission to move forward while the legal clock keeps ticking.


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