Novartis AG v Mehar Pharma (2004)

Summary

“The plaintiffs submit that they are the holders of Exclusive Marketing Rights (hereinafter referred to ‘EMR’) granted under Chapter IV-A of the Patents Act, 1970” (para 2), and sought “a restraint order against the Defendants from manufacturing for sale, sell, marketing and exporting their anti cancer drug composed of the ‘B-crystalline form of imatinib Mesyiate salt’’ under the brand name ‘VEENAT’” (para 1). The defendants contended that “The sale form of the said compound is already disclosed by a Canadian patent bearing No. 2093203 dated 1st April 1993 in claim 29” (para 19), and that the drug “is a life saving drug and the only drug in the market capable of combating blood cancer” (para 20).

The Court held that “in relation to a patent, the Court will not grant an interlocutory injunction unless satisfied that (a) there is a real probability of the plaintiffs succeeding on the trial of the suit, and (b) where the patent is of a recent date, no interim injunction should be granted” (para 25), that “Beta crystals are clearly disclosed in the application” and “the EMR being of recent origin, the plaintiffs would not be entitled to the temporary injunction sought” (para 28), and that “the aspect of balance of convenience has also to be answered in favour of the defendants” (para 28). Of the Madras order in Novartis v Adarsh Pharma (2004), it was “not inclined to agree with the view that has been taken by the Madras High Court” and directed the defendants “to maintain accounts of the trade that they carry on in respect of their drug in question during the pendency of the suit and submit an undertaking” (para 29). “Notice of Motion is disposed of.” (para 29)

What the court decided

1. Exclusive marketing rights and patents. “From the rival submissions, it is clear that grant of EMR” (“Exclusive Marketing Rights”) “is a step in the direction of grant of patent.” “However, the settled law in relation to the validity of the patent granted by the authorities, which obviously is on a higher level than EMR, appears to be otherwise.” (para 24)
2. The rule for a recent patent. “Thus, the settled law appears to be that in relation to a patent, the Court will not grant an interlocutory injunction unless satisfied that (a) there is a real probability of the plaintiffs succeeding on the trial of the suit, and (b) where the patent is of a recent date, no interim injunction should be granted. More so, when there is a serious question as to validity of the patent raised by the defendants to be tried in the suit.” (para 25)
3. A grant of recent origin. “Insofar as the present case is concerned, it is an admitted position that the EMR has been granted only in the month of November 2003. Therefore, it has been granted recently.” (para 26)
4. A serious question on validity. “it is clear from the application filed in Canada for patent by the plaintiffs on 1st April 1993 that the salt form of the said compound is disclosed in that application.” (para 27) “Perusal of the application submitted by the plaintiffs in 1993 for patent in Canada shows that the plaintiffs have disclosed the compound as well as its salt. Beta crystals are clearly disclosed in the application. Therefore, in my opinion, apart from other challenges, this challenge can definitely be said to be serious insofar as the validity of EMR granted is concerned and if that be so, in terms of the law that appears to be settled referred to above, the EMR being of recent origin, the plaintiffs would not be entitled to the temporary injunction sought.” (paras 27–28)
5. Compensation in money. “it cannot be said that even if the plaintiffs ultimately succeed, the loss or injury that may be caused to the plaintiffs is not incapable of being compensated in terms of money. Indeed, in the plaint, the plaintiffs have worked out loss suffered by them and have in fact sought a monetary decree in relation thereto.” (para 28)
6. A life-saving imported drug. “the aspect of balance of convenience has also to be answered in favour of the defendants, especially because the drug in relation to which EMR is granted is a anti-cancer drug, is a life saving drug and the plaintiffs do not manufacture the drug in India but import it from foreign country.” “If due to any problem, the plaintiffs cannot make available the drug in required quantity in India, it obviously will be disastrous for the patients. This consequence is foreseeable, therefore in my opinion, the Court should not pass any interim order which may possibly lead to such a situation.” (para 28)
7. Difference in price. “In my opinion, the aspect of the difference in price of the product of the plaintiffs and the defendants also cannot be ignored, especially at the stage of considering the question whether the plaintiffs are entitled to any interim relief.” (para 28)
8. The Madras order. “With due respect to the Hon’ble Madras High Court, I find that the Madras High Court has not properly considered the settled law in the matter of grant of temporary injunction in relation to a patent of recent origin and, therefore, I am not inclined to agree with the view that has been taken by the Madras High Court.” (para 29)
9. Accounts and an undertaking. “In my opinion, therefore, the plaintiffs are not entitled to the temporary injunction sought by them. In my opinion, the interest of the plaintiffs can be safeguarded by directing the defendants to maintain accounts of the trade that they carry on in respect of their drug in question during the pendency of the suit and submit an undertaking to this Court undertaking therein to pay damages as may be awarded by this Court in case this Court decrees the suit in favour of the plaintiffs” “It is accordingly so ordered. Notice of Motion is disposed of.” (para 29)

Subsequent treatment

• Followed — In F Hoffmann-La Roche v Cipla (2008) the Delhi High Court (S. Ravindra Bhat J) held that “Although the Bombay High Court did not notice the decision in Uclaf, yet in Novartis AG (Supra) the Court held, in that case that if interim injunction were granted to the plaintiff, the manufacturing network of the defendant so far as drug is concerned would be dismantled and if due to any problem the plaintiffs could not make available the drug in required quantity in India it would be disastrous for patients. The aspect of price difference between the product of the plaintiff and defendants also influenced the Court.” (para 83)
• Followed — In F Hoffmann-La Roche v Cipla (2009) the Division Bench of the Delhi High Court, noting that “In Novartis AG the Bombay High Court was considering a case where the Defendant challenged the grant in favour of the Plaintiff of exclusive marketing rights (EMR) in respect of a drug Imatinib on the ground of lack of novelty”, reproduced para 28 of this order (para 78).

No further appeal traced as of 17 October 2026.