Delhi HC Upholds AstraZeneca's Tagrisso Patent, Imposes Rs 7L Fine on 'Habitual Infringer' for Knockoff Production

The patent (IN 297581) protects the drug’s composition and grants AstraZeneca exclusive rights to manufacture and sell Osimertinib in India until 2032.

AstraZeneca’s patented compound, Osimertinib, is used to treat specific types of non-small cell lung cancer (NSCLC) and is marketed under the brand name Tagrisso. The drug has received regulatory approval in India and is widely used for treating cancer with certain mutations.

The case began when AstraZeneca discovered that Westcoast Pharmaceutical was offering to manufacture Osimertinib in bulk, despite the drug being protected by AstraZeneca’s patent. The company was actively marketing the drug in India via flyers, offering to supply up to 1,00,000 tablets. The infringement was brought to light in early 2022, prompting AstraZeneca to file a lawsuit.

In response, the court issued an ex parte ad interim injunction on February 11, 2022, barring Westcoast from selling or manufacturing the drug. Despite being notified of the proceedings, Westcoast failed to file a written statement within the prescribed time of 120 days, which led the court to rule that the defendant had no legitimate defense. Consequently, the court made the interim injunction permanent on November 30, 2022.

Westcoast Pharmaceutical attempted to justify its actions in an affidavit, stating that the regulatory approval for Osimertinib was obtained under the belief that it was not patented in India. They also claimed they had not manufactured the drug and had filed for cancellation of the approval in August 2022. However, the court held the company accountable, citing its failure to comply with the legal process and its history of intellectual property violations in other cases.

The court also acknowledged the defendant's history of patent infringements, including past legal disputes over other patented drugs like Dapagliflozin, where they were previously restrained from selling the drug due to patent violations. The court noted that Westcoast’s pattern of infringing intellectual property rights raised serious concerns about its credibility and intent. It remarked;

“It is submitted that the Defendant is a habitual infringer, with a history of infringing upon the intellectual property rights of various patent holders. Evidence of the Defendant's prior infringements, as documented in previous cases, clearly establishes a pattern of unlawful behaviour. It is submitted that the Defendant, on its website claims to be to be in the business of pharmaceuticals since 1965. It further boasts that it has a strong oncology division and that it exports its products on a large scale. It is submitted that it is not possible for the Defendant to have not known about the Plaintiffs, its Indian patent [IN'581] and the availability of its products in India.”

“The Defendant has been involved in multiple litigations before this Hon'ble Court wherein it has submitted to the jurisdiction of this Hon'ble Court and where this Hon'ble Court has found it to be guilty of similar infringing activities.”

The court found that the defendant had no credible defense. Despite multiple opportunities to respond, the defendant failed to file a written statement within the required timeframe, thus forfeiting its right to do so. The court concluded that there was no valid argument or evidence presented by the defendant that could justify a trial. In the absence of any legitimate defense, the court ruled that the case was suitable for summary judgment, a legal procedure that allows for a quicker resolution of disputes without the need for a full trial.

It noted;

“In view of the aforesaid undertaking of the defendant and the fact that no written statement has been filed by the defendant, it is manifest that there is no defence raised by the defendant. In the absence of any credible defence, and in the absence of any argument or evidence by the defendant that could justify a trial, it is held that the present is a fit case for passing summary judgment. Accordingly, it is held that the plaintiff is entitled to decree in its favour.”

Subsequently, the court recognized the infringement and issued a summary judgment in favor of AstraZeneca, granting a permanent injunction to prevent the defendant from manufacturing or selling the drug Osimertinib.

The court also ruled that AstraZeneca was entitled to a cost award of Rs 7,00,000 to cover the legal expenses incurred due to the defendant's delays and frivolous applications.