Vaishali Mittal

What tips can you share for engaging – and ensuring buy-in from – key stakeholders?

My tips would be to highlight the ‘what’s in it for me’ principle and open the lines of communication to align change management, strategies and end results with the stakeholders’ wants and needs.

Key stakeholders should be identified as early as possible, as well as their main drivers/objectives. One should work closely with the most influential stakeholders and make them early adopters of ideas with high levels of engagement. Listening to stakeholders is a crucial part of engagement. One must also learn to speak the stakeholders’ language. If a stakeholder is from a non-legal team, they may not be comfortable with techno-legal jargon. In such cases, it is important to simplify the situation.

As things start to settle after the pandemic, do you think that covid-19 has permanently altered the direction of the life sciences industry, or is it a return to business as usual?

While no sector remained unaffected by the COVID-19 crisis, the life sciences industry was at its epicentre. In the pandemic’s early days, the focus shifted from normal business to crisis management. A significant part of the industry’s R&D budgets and resources got devoted to covid-19. According to a McKinsey study, certain therapeutic areas saw a near-complete disruption of clinical trials. This affected the drug release pipeline, putting pressure on existing remedies.

Many companies launched generics of patented drugs, such as the anti-diabetes drug Dapagliflozin, leading to lawsuits seeking answers to complex issues around genus and species patents. The industry is now more concerned about safety, data integrity and data privacy, and the greater fight against tech fraud in a tech-disrupted world. There are new opportunities for innovation in the industry, and the argument around intellectual property and equitable access to essential medicines has taken a fresh turn - for the better.

You have won considerable acclaim for your involvement with many landmark cases – which of your cases has been the most memorable and why?

• InterDigital Corp v Xiaomi Corp returned India’s first anti-anti-suit injunction.
• In Renaissance Hotel Holdings Inc, India’s Supreme Court clarified the legal test for trademark infringement.
• The Competition Commission’s recent ruling in favour of Vifor International AG dismissed all allegations of anticompetitive practices and abuse of its dominant position in the commercialisation of its patented product for the treatment of iron deficiency anaemia.
• Philips v Bhagirathi was India’s first SEP case recognising principles such as FRAND.
• Philips v Amaze Store recognised not only compensatory and punitive damages, but also aggravated damages - thus reconciling English and Indian law.
• John Deere recognised colour-combination trademarks.
• My pro bono matters for free medical aid for children with rare genetic disorders are extremely close to my heart.

What changes would you like to see in the FRAND/SEP landscape in India - and do you think that they will happen?

• We need more judges who are familiar with SEP law, with an in-depth understanding of FRAND jurisprudence and international developments.
• As regards security payments, arguments should not be entertained as to whether the implementer ought to secure them. At the first hearing, at the very minimum, the defendant’s last counter-offer amount should be deposited as security.
• Decision-making should be inquisitorial and not just adversarial. At the beginning of the hearing, judges must ask if the implementer is willing to license and, if so, the maximum FRAND royalty it is willing to pay. A similar exercise should be carried out with the SEP holder. This way, the gap between the parties’ positions can be bridged.
• Time limits for arguments must be strictly adhered to. Dates set for arguments should be inflexible and judgments should be pronounced within a few weeks.

Can you tell us about some of the biggest challenges you have faced in your professional life – and how you overcame them?

Explaining complex IP issues to judges with no prior experience in this area is a significant challenge. IP cases can be extremely technical, and it is very difficult to understand the nitty-gritty without the relevant background. For example, the Delhi High Court’s decision in AstraZeneca v Intas – questioning the validity of the species patent for dapagliflozin – was disappointing. We appealed, and the Supreme Court declared that the lower court’s findings would not affect the trial and final adjudication on merits. As a result, AstraZeneca – and owners of other species patents – breathed a sigh of relief.