Introduction
In this case Imagine a drug company holding a patent on a blockbuster diabetes medicine that is due to expire in just two months. It rushes to court asking for an order to stop a generic competitor from selling the same drug. The lower court says no because the patent looks weak. The company appeals. The High Court listens, but then asks a blunt question: why should we spend court time on a case that will become pointless the moment the patent dies?
This is exactly what happened in the fight between Novo Nordisk and Dr. Reddy’s Laboratories over the patent for Semaglutide.
The Division Bench of the Delhi High Court dismissed the appeal on 9 March 2026, agreeing that the patent was open to a strong challenge because the invention was obvious from an earlier patent. The story is not just about one drug; it tells how Indian courts balance patent protection, public interest and the limited life of every patent.
Factual Background
Novo Nordisk owns Indian Patent No. 262697 (IN’697), granted for “Acylated GLP-1 Analogs Comprising Non-Proteogenic Amino Acid Residue”. The patent claims Semaglutide as one of its specific compounds (Claim 23). The priority date is 18 March 2005. Semaglutide is a once-weekly injection or tablet used to treat type-2 diabetes and obesity. Novo sells it in India under the brand names Wegovy and Rybelsus.
In December 2024 Novo learned that Dr. Reddy’s was importing and exporting Semaglutide. Novo believed this infringed its patent. It sent a cease-and-desist notice in May 2025. When Dr. Reddy’s did not stop, Novo filed a commercial suit in May 2025 asking the court to stop Dr. Reddy’s from making or selling the drug and also sought an immediate temporary order (interlocutory injunction) to protect its rights until the full trial.
Key Facts Summary
| Particular | Details |
|---|---|
| Patent Number | IN’697 |
| Drug | Semaglutide |
| Use | Type-2 diabetes and obesity |
| Brand Names | Wegovy, Rybelsus |
| Priority Date | 18 March 2005 |
| Legal Action | Suit filed in May 2025 with injunction request |
Procedural Background
The single judge of the Intellectual Property Division heard the injunction application and rejected it on 2 December 2025 after a detailed order. She found that Dr. Reddy’s had raised a credible challenge to the validity of Novo’s patent.
Novo filed an appeal before the Division Bench (FAO(OS)(COMM) 204/2025). By the time the appeal was argued and judgment reserved, only about two months remained before the patent would expire on 20 March 2026. The Division Bench reserved judgment on 19 January 2026 and delivered it on 9 March 2026.
Procedural Timeline
- 2 December 2025: Single judge rejects injunction
- 19 January 2026: Judgment reserved by Division Bench
- 9 March 2026: Appeal dismissed
- 20 March 2026: Patent expiry
Reasoning
The Division Bench began with some strong prefatory thoughts. The judges openly wondered whether they should even spend precious court time on a patent that was about to die. They noted that after 20 March 2026 anyone could make Semaglutide. There was no allegation that Dr. Reddy’s was selling sub-standard medicine. They asked what real harm Novo would suffer in the last two months.
Still, because the matter had already been argued, the judges decided they must give a judgment. They made clear they would not re-try the entire case from scratch; they would only check whether the single judge had made any basic legal error (following the famous Wander Ltd principle).
Legal Principles Explained
The judges then explained the law in simple terms.
- A patent can be challenged on several grounds listed in Section 64 of the Patents Act.
- The most important for this case were:
- Prior claiming (Section 64(1)(a))
- Lack of novelty (Section 64(1)(e))
- Obviousness (Section 64(1)(f))
- At the stage of a temporary injunction the defendant does not have to prove the patent is definitely invalid.
- It only has to show a “credible challenge”.
- If such a challenge exists, the court usually refuses to stop the defendant until the full trial.
Comparison of Patents
The court carefully compared Novo’s patent (IN’697) with an earlier patent owned by Novo itself – Indian Patent IN’964 (the “Genus Patent”). IN’964 covered a broad family of GLP-1 compounds and specifically described a compound called Example 61 (Ala Semaglutide).
The only difference between that compound and the Semaglutide claimed in IN’697 was the replacement of one amino acid (Ala) with another (Aib) at position 8.
Section 64 Analysis
- The single judge had treated this as prior claiming under Section 64(1)(a).
- The Division Bench disagreed on that exact legal label.
- Section 64(1)(a) needs the claims to be identical; it is a strict claim-to-claim match.
- Here the claims were not exactly the same.
- However, the judges said the single judge’s detailed analysis actually proved something even stronger – that Semaglutide was obvious to a skilled person from the teachings of IN’964.
- That made the patent vulnerable under Section 64(1)(f).
“Person In The Know” Test
The court added an important new point. Five inventors were common to both patents. In such cases earlier Division Bench decisions (AstraZeneca AB v Intas and F Hoffmann-La Roche v Natco) say the court should use the stricter “person in the know” test instead of the ordinary “person skilled in the art”.
Because the inventors themselves knew the earlier patent inside out, it was even easier for them (or someone like them) to see that changing Ala to Aib would give Semaglutide. The Supreme Court had refused to interfere with those earlier rulings, so the test is now settled law.
The judges found that even under this tougher test a credible challenge of obviousness existed.
Urgency And Balance Of Convenience
The Division Bench also looked at the urgency issue again. It said that directing Dr. Reddy’s to keep accounts of sales for the last two months would have been enough protection. There was no need to stop sales completely when the patent was dying anyway.
Judgments With Complete Citation And Their Context Discussed
The court relied on several key decisions and explained them in easy language.
Wander Ltd v Antox (India) Pvt Ltd (1990 Supp SCC 727)
First came Wander Ltd v Antox (India) Pvt Ltd (1990 Supp SCC 727). This Supreme Court case says that in appeals against temporary injunction orders the higher court should not replace the lower court’s view with its own unless the lower court made a clear legal mistake. The Division Bench said it was bound by this rule and would only check for error of principle.
The Roche Cases
- F Hoffmann-La Roche Ltd v Cipla Ltd (Roche-I) (2009) 159 DLT 243 (DB)
- Roche-II (2016) 65 PTC 1 (DB)
Next the court discussed the two Roche cases – F Hoffmann-La Roche Ltd v Cipla Ltd (Roche-I) (2009) 159 DLT 243 (DB) and the later Roche-II (2016) 65 PTC 1 (DB). These explain what a “credible challenge” means and lay down the five-step test for deciding obviousness. The Division Bench praised the single judge for following those steps but gently noted that at the injunction stage a full five-step mini-trial is not needed; the judge can simply put himself in the shoes of the skilled person and see whether the invention looks obvious.
Novartis AG v Union of India (2013) 6 SCC 1
The court also referred to Novartis AG v Union of India (2013) 6 SCC 1 (the famous Glivec case) while discussing genus versus species patents. It explained that when a broad patent already teaches a specific compound, a later narrow patent cannot claim the same thing again.
AstraZeneca And Natco Cases
- AstraZeneca AB v Intas Pharmaceuticals Ltd (2021 SCC OnLine Del 3746)
- F Hoffmann-La Roche AG v Natco Pharma Limited (2025 SCC OnLine Del 6390)
Importantly the judges cited their own earlier Division Bench rulings – AstraZeneca AB v Intas Pharmaceuticals Ltd (2021 SCC OnLine Del 3746) and F Hoffmann-La Roche AG v Natco Pharma Limited (2025 SCC OnLine Del 6390). These introduced the “person in the know” test when inventors overlap. Both judgments have been upheld by the Supreme Court (SLPs dismissed). The court said this test applies here because the same inventors filed both patents.
Pernod Ricard v Karanveer Singh Chhabra (2025 SCC OnLine SC 1701)
Finally the court mentioned Pernod Ricard v Karanveer Singh Chhabra (2025 SCC OnLine SC 1701) to repeat that appellate courts must be slow to interfere with discretionary injunction orders.
The Final Decision Of Court
The Division Bench dismissed the appeal in its entirety. It held that the single judge’s order refusing the injunction was correct. The patent was prima facie vulnerable to revocation on the ground of obviousness under Section 64(1)(f) because of the earlier genus patent IN’964. The court made clear that everything said in the judgment was only a prima facie view and would not bind the single judge when the full trial takes place later.
Point Of Law Settled In The Case
This judgment settles three important practical points for patent lawyers.
| Point | Explanation |
|---|---|
| Prior Claiming vs Obviousness | First, it draws a clear line between prior claiming under Section 64(1)(a) (which needs identical claims) and obviousness under Section 64(1)(f) (which looks at what a skilled person would find obvious). |
| Person In The Know Test | Second, when the same inventors file a genus patent and a later species patent, courts must apply the stricter “person in the know” test rather than the ordinary skilled-person test. |
| Injunction Despite Expiry | Third, even when a patent is about to expire, courts can still refuse an injunction if a credible challenge to validity is shown; keeping accounts may be enough protection in such short-life cases. |
Case Details
- Case Title: Novo Nordisk Vs Dr.Reddy Laboratories Limited and another
- Date of Order: 9 March 2026
- Case Number: FAO(OS) (COMM) 204/2025
- Neutral Citation: 2026:DHC:1911-DB
- Name of Court: High Court of Delhi
- Name of Hon’ble Judges: Hon’ble Mr. Justice C. Hari Shankar and Hon’ble Mr. Justice Om Prakash Shukla
Disclaimer: Readers are advised not to treat this as substitute for legal advise as it may contain errors in perception, interpretation, and presentation
Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi
