Facts and Background

The Plaintiffs, AstraZeneca, filed a suit (CS (Comm.) 101/2022) at the Delhi High Court seeking a permanent injunction to restrain the Defendant, Westcoast Pharmaceutical Works Limited from infringing their patent IN 297581. The Patent was for the novel compound Osimertinib, used for treating specific types of non-small cell lung cancer.

In January 2022, AstraZeneca discovered that the Westcoast was offering to manufacture and sell Osimertinib in large quantities, which led to the filing of the present suit. The court issued an ex parte ad-interim injunction on 11th February 2022, restraining the Defendant from dealing in Osimertinib.

Despite being served with summons, the Defendant failed to file a written statement ( reply to the infringement claim) within the statutory period of 120 days , leading to the injunction being made absolute on 30th November 2022

Parties Contentions

Westcoast Pharmaceutical (Defendant) did not file their response (written statement) but raised following contentions in an affidavit to explain their position

1. Mistaken Belief: The Defendant claimed that they obtained regulatory approval to manufacture Osimertinib under the mistaken belief that it was not patented in India. They attributed this error to the Government authorities responsible for preventing approvals for patented drugs.
2. No Legal Mechanism: They argued that there is no legal mechanism in India to verify patent protection during regulatory licensing.
3. No Manufacturing: The Defendant asserted that they had only published a promotional flyer post-approval. They had not manufactured Osimertinib, and did not intend to do so until the expiry of the suit patent on 25th July, 2032. They also mentioned that they had requested the cancellation of the regulatory approval on 10th August, 20222.
4. Jurisdiction and Mediation: The Defendant raised objections regarding the court’s territorial and pecuniary jurisdiction and non-compliance with pre-litigation mediation.
5. Undertaking: An undertaking was given by the Defendant not to launch any infringing product during the patent’s term

AstraZeneca moved an application for Summary judgement

• No Prospect of Defense: The Plaintiff’s argued that the defendants had no real prospect of successfully defending the claims made by the Plaintiffs.
• Infringement of Patent: The Plaintiff’s novel compound, Osimertinib, protected by patent IN 297581, was being infringed by the defendant’s offer to manufacture and sell Osimertinib.
• Failure to File Written Statement: The Defendant failed to file a written statement within the statutory period, leading to the closure of their right to file it and the confirmation of the ex parte ad interim injunction.
• Undertaking by Defendant: The Defendant had given an undertaking not to launch any infringing product during the patent’s term

Court Ruling

• History of Infringing Activities: The court noted that the Defendant had a history of similar infringing activities. The Plaintiffs provided evidence of the defendant’s prior infringements, establishing a pattern of unlawful behaviour. For instance, the Defendant had previously been involved in litigation with AstraZeneca over the anti-diabetes drug Dapagliflozin, which was also protected by AstraZeneca’s patents.
• Legal Expenses: The Plaintiff’s were compelled to incur significant legal expenses due to the defendant’s infringing activities and their subsequent conduct in these proceedings. The Plaintiffs filed a statement of costs, showing that they had incurred costs of ₹7,19,145.
• Curbing Vexatious Litigation: The court emphasized that costs should be realistic and serve the purpose of curbing frivolous and vexatious litigation. This principle was reiterated by the Supreme Court in the case of Uflex Limited Versus Government of Tamil Nadu and Ors

Decree Issued: The court decreed the suit in favour of the Plaintiffs and directed that a decree sheet be drawn up and awarded cost of’ ₹ 7,00,000/- ( approx. Us $ 8300).

Our comment

The Court in awarding the cost considered conduct of the Westcoast before and during the proceedings, including the extent to which they followed any relevant pre-action protocol.