Patent Infringement: Import or Local Manufacture?

Patent Infringement: Import or Local Manufacture?In an infringement suit, AstraZeneca AB & Anr. (‘plaintiffs’) vs Azista Industries Pvt Ltd & Ors. (‘defendants’), the Delhi High Court, in its order dated 6th February 2024, granted interim relief to the plaintiffs based on their submissions that the defendants were engaged in clandestine operations, acting in concert to manufacture, smuggle, and sell unlawful drugs that were infringing versions of the plaintiffs’ patented drug in India.

The suit patent (IN 297581) relates to the plaintiffs’ drug comprising Osimertinib, a second-line treatment for non-small cell lung cancers with underlying mutations in a protein known as the Epidermal Growth Factor Receptor. Osimertinib is the International Nonproprietary Name (INN) assigned by the World Health Organisation to the plaintiffs’ compound. Osimertinib is protected by the suit patent, which was granted in 2018 and is valid till 2032. Plaintiffs have the exclusive right to manufacture, use, offer for sale, import, or sell Osimertinib in India.

Plaintiffs uncovered the modus used by defendants for infringing activities. Plaintiffs asserted that defendant no. 2 (Azista Bhutan Healthcare) manufactured Osimertinib in Bhutan under the brand OSITAB, and defendant no. 1 (Azista Industries Pvt. Ltd.) was involved in the marketing and selling of impugned drugs within India. As import-export data of defendants over the last few years revealed no imports of the impugned drug, and because the patent for compound Osimertinib is not registered in Bhutan, plaintiffs argued that it appeared that the drugs were manufactured locally in India. In contrast, the packaging of these drugs mentioned the place of manufacture as Bhutan.

The plaintiff averred that the sale of the infringing drugs in India was being promoted through doctors and medical practitioners by defendant nos. 3-5 (Hetero Group). Undated prescriptions without letterheads have been produced in this regard. It was also stated that defendant no. 7 (IndiaMART), an e-commerce marketplace, was facilitating the advertisement and sale of infringing drugs by third parties. These drugs are not meant for sale on online websites and require a prescription by a registered medical practitioner. Plaintiffs evidenced that defendant no. 8 (Hegde & Hegde Pharmaceutical LLP). Defendant no. 9 (Celute Lifesciences Pvt Ltd) were the third-party entities that engaged in the supply and sale of infringing Osimertinib on the merchant platform operated by defendant no. 7. Drugs were also readily available at retail outlets/ pharmacies such as those of defendant no. 6 (Mor Chemists Banjara Hills). Apart from this, several unidentified persons facilitating the smuggling of drugs across the Indo-Bhutan border and inland supply/ distribution have been impleaded as John Does.

Plaintiffs placed on record copies of three previous orders of the Delhi High Court protecting their suit patent. Plaintiffs appraised the Court that there was no pre-grant opposition to the suit patent. Out of two post-grant oppositions, one was subsequently withdrawn, and the other is pending.

The defendant nos. 1-5 denied the allegations made in the plaint as false and incorrect and assured that they would not deal with any infringing drug until the suit patent is valid and subsisting. However, it was clarified that defendant No. 2 manufactures OSITAB in Bhutan, which does not infringe the suit patent. It was also explained that the only ‘import’ the aforesaid defendants were aware of were the ones made in terms of Rule 36 of the Drugs and Cosmetics Rules, 1945, which stipulates that the import of small quantities of drugs that are otherwise prohibited can be imported for personal use, subject to certain conditions. Copies of two permits granted by the licensing authority (CDSCO) have been produced to support the submissions. Defendant No. 2 further assured that no export of OSITAB shall be made to India except under the regulatory permission granted under Rule 36. While denying the allegations, defendant No. 8 undertook appropriate action to remove the listings on the website of defendant No. 7.

On examining the contentions of both sides, the Court found a prima facie case in the plaintiffs’ favour, a balance of convenience tilting in favour of the plaintiffs, and irreparable loss would be caused if an ex-parte ad interim injunction is not granted. Accordingly, defendants nos. 6 and 9 are restrained from infringing activities directly or indirectly in relation to the suit patent. The Court also directed defendant No. 7 to delist and delete all listings on its platform that advertise and offer for sale infringing versions of Osimertinib under the brand OSITAB.

Authors: Manisha Singh and Neha Ruhela

First Published by: Lexology here