Novartis AG holds the patent for the drug containing the active pharmaceutical ingredients vildagliptin and vildagliptin in combination with metformin hydrochloride (Indian Patent 212815), which it had sold under the Galvus and Galvus-Met brands in India since 2008. The patent was granted on December 14 2007, took effect on December 10 1998 and is valid until 2019.
In early 2014 Novartis filed suits for permanent injunctions in the Delhi High Court with respect to infringement of the vildagliptin patent against generic manufacturers Bajaj Healthcare, Alembic Pharmaceuticals, Wockhardt, Glenmark, Cadila and Biocon. Novartis obtained quia timet injunctions against some of the companies and declarations against others, stating that the generic companies would not manufacture for sale in India or abroad any product that infringed Novartis's patent. More recently, Novartis instituted a suit for permanent injunction against Ranbaxy Laboratories Ltd for infringement of the vildagliptin patent. In an order of September 8 2014 the Delhi High Court in Novartis AG v Ranbaxy Laboratories Ltd (CS (OS) 2703/2014) restrained Ranbaxy from manufacturing, selling or offering for sale by any means, directly or indirectly, compounds or formulations containing vildagliptin either alone or in combination with other compounds. The court stated that these observations were tentative and not based on the merits of the case, as the pleadings were yet to be completed by the parties.
Novartis stated that it believed that Ranbaxy proposed to manufacture, launch or sell vildagliptin in India based on:
- Ranbaxy's website listing of vildagliptin in the active pharmaceutical ingredient product category as an anti-diabetic drug; and
- a survey report from independent research firm Strategic Analysis India Pvt Ltd, dated August 26 2014.
Further, Novartis relied on previous injunctions granted with respect to the vildagliptin patent against other generic manufacturers to state that it had a prima facie case and that the balance of convenience lay in its favour.
On the other hand, Ranbaxy asserted that it intended to market vildagliptin in crystalline form (Form A). It stated that Novartis had previously applied for a patent for Form A on June 13 2007, and such application was subsequently abandoned. Hence, Ranbaxy asserted that Novartis could claim no rights with respect to Form A. Referring to the Delhi High Court's decision in F Hoffmann-La Roche Ltd v Cipla Ltd (2009 (40) PTC 125 (Delhi)), Ranbaxy also contended that Novartis had withheld information on the abandonment of the patent application for Form A from the court, thereby amounting to material concealment, and thus Novartis was not entitled to an injunction.
In response to the argument that Novartis had concealed material facts by failing to disclose its abandonment of the application for Form A, the Delhi High Court differentiated between the facts in F Hoffmann-La Roche Ltd and the case at hand. The court observed that in the former case, the plaintiff had filed a patent application for Polymorph B of the drug erlotinib, which was opposed by the defendant and ultimately rejected by the controller under Section 3(d) of the Patents Act 1970. It had been asserted that the plaintiff had failed to disclose this information, which amounted to the concealment of material facts. The patent application for Polymorph B form was pending before the Patent Office, and thus was an active application during the plaintiff's injunction suit. In regard to the instant case, the court observed that Novartis had made an application for Form A while the application for the suit patent was pending. Further, the application for Form A was abandoned before the injunction suit was commenced. Thus, the court held that at such a preliminary stage, non-disclosure of the abandonment of the Form A application did not amount to the concealment of material facts.
The court also noted that although the suit patent was granted on December 14 2007, Ranbaxy filed a revocation petition regarding the suit patent only in 2014. The court held that this was prima facie evidence that Ranbaxy proposed to launch the compound patented in the suit patent. Further, it held that the balance of convenience lay in preserving status quo, as Ranbaxy was yet to market vildagliptin, whether in crystalline form or otherwise. The case is now listed for completion of pleadings and admission or denial of the documents before the joint registrar of the Delhi High Court on October 13 2014.
Ranbaxy used similar arguments to those used by Cipla against Hoffmann La Roche, albeit with no success thus far. It will be interesting to see whether Ranbaxy uses another line of argument to target the vildagliptin patent, or whether Novartis will continue to obtain injunctions successfully.
This article first appeared in IAM magazine. For further information please visit www.iam-magazine.com.