Novartis succeeds in 37 patent infringement lawsuits related to Vidagliptin – Judge Tyagi dismisses the 38th lawsuit for lack of evidence

Starting in March, 2014 the Swiss Pharma company Novartis filed multiple qua timet patent infringement lawsuits against a number of generic companies including Biocon, Glenmark, Wockhardt Ajanta Pharma etc. and managed to secure several interim injunctions against these generics. While the lawsuits filed before the Delhi High Court got the most attention, Novartis through its counsel, Mr. Hemant Singh of Intettl Advocare, was also instituting lawsuits in courts across the country including in Hyderabad, Ahmedabad, Vadodra, Bombay, Nashik, Madras, Mohali etc. In 37 of these actions, Novartis either secured an interim injunction or a settlement from the defendant making this series of litigation one of the most successful enforcement campaigns in the 12 years since India started granting pharmaceutical patents. Mr. Hemant Singh deserves a round of applause for this achievement, especially his willingness to litigate these cases outside Delhi, something that most Delhi lawyers are extremely reluctant to do.

The only court which has denied Novartis an injunction is the Commercial Court at Vadodara, manned by Judge Moolchand Tyagi in September, 2017 dismissed a patent infringement lawsuit filed by Novartis against Triveni Chemicals Pvt. Ltd. for want of evidence. The judgment can be accessed over here.

This lawsuit was a qua timet action like most of the litigation initiated by Novartis. A qua timet legal action is initiated on the apprehension of an imminent violation of rights i.e. even before the launch of the lawsuit. As per the usual norms of litigation, a lawsuit cannot be instituted unless and until a breach of rights has been established. Innovator pharmaceutical companies have however been filing qua timet lawsuits on a regular basis on the basis of regulatory information i.e. once the DCGI has granted regulatory approval, these companies sue the generics on the grounds that patent infringement is imminent. These qua timet lawsuits are controversial and have been allowed by some courts but I think the issue needs to be relitigated in more detail. For a more detailed take on this issue of qua timet injunctions do read this article by Aparajita where she presents an excellent comparative perspective on the issue.

But let’s get back to Judge M. Tyagi’s judgment dismissing Novartis’s lawsuit. Since the defendant was a no show despite service of summons, the judge decided to proceed ex-parte and framed issues for trial. On the core issue of whether Novartis had proved patent infringement by the defendant, the trial court held that the plaintiff failed to prove the documents filed by it. In this case, Novartis had filed as evidence a printout of an extract of the defendant’s website where it claimed that it was going to make Vidagliptin available and also a report by Strategic Analysis India (SAI) (which is a market intelligence agency) stating that the defendant was going to launch the product. The court rejected this evidence on the grounds that the plaintiff failed to “prove it”. In conclusion the court states “…the plaintiffs have miserably failed to prove that at time of instituting the suit, the defendant-company was going to launch the patented drugs of the plaintiffs”. The judgement is not clear on why the plaintiff failed to prove the same but I am guessing that none of the Plaintiff’s witnesses tackled the issue in their evidence affidavits i.e. a document filed as evidence is considered to have probative value only when a witness testifies to the contents of the documents and establishes its veracity through either personal knowledge or through his expertise in the area. Very often, litigants make the mistake of filing a Section 65B affidavit under the IT Act and presume that such an affidavit will suffice to prove the contents of the document. That is a wrong approach because a Section 65B affidavit only attests the fact that the printout is authentic and not tampered with – the contents of the printout have to be proved separately through another witness either through his personal knowledge or expertise.

Since the infringement claim fell apart, the judge declined to grant damages, dismissed the lawsuit and vacated the interim injunction against the defendant.

Trial court judges in India, although often weak on substantive law, are known to be sticklers for procedural ad evidentiary law and this case is a reminder as to why Delhi lawyers need to be extra careful when appearing before other forums.