Delhi HC restrains Micro Lab from infringing Bristol Myers anticoagulant drug Apixaban

This comes in response to the suit filed by Bristol-Myers Squibb Ireland Unlimited (BMS), wherein the court has restrained the Micro Lab, its directors, employees, officers, servants, agents, stockists, wholesalers etc., from using, making, selling, distributing, advertising, marketing, exporting, offering for sale, any generic Apixaban product.

An application filed by BMS under Order 39 Rules 1 and 2 CPC sought an ad interim injunction to restrain Micro Labs, its directors, etc. from infringing the registered patent of Bristol-Myers Squibb Ireland Unlimited (BMS), being Patent No.247381.

The said suit patent covers a molecule having an International NonProprietary Name (INN) APIXABAN assigned to the molecule and the IUPAC name 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1- yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c] pyridine-3-carboxamide. It is used for the prevention and treatment of thromboembolic diseases. The empirical formula for APIXABAN is C17H22N2O6S2.

Previously, the Court had issued six interim injunctions against Emcure Pharmaceuticals, Torrent Pharmaceuticals, Cipla Ltd, Alkem Laboratories Ltd, Indoco Remedies Ltd, and BDR Pharmaceuticals for suspected patent infringement. In addition, a court had ordered Natco Pharma Ltd to maintain the status quo ante in the same patent case.

In continuation, recently, Bristol-Myers Squibb Ireland Unlimited learned that Micro Labs filed a petition for revocation of Patent No.247381 under Section 64 (1) of the Patents Act before this court. In the said petition, Micro Labs admitted its intention to launch the generic "Apixaban" in June 2021 during the subsistence of the suit patent.

After learning about the petition, Bristol-Myers Squibb Ireland Unlimited undertook an independent investigation, which uncovered several listings of Micro Lab's generic "Apixaban product (2.5 mg and 5 mg tablets)" on various third-party websites under the probable brand name "APIVAS."

Further, the investigation revealed that Micro Labs also recently on 24.05.2021 applied for registration of the trade mark "APIVAS" under Class 5 on a „proposed to be used basis before the Indian Trade Marks Registry.

Based on the above averments, an ad interim injunction is sought by Bristol-Myers Squibb Ireland Unlimited to restrain the defendant, its directors, etc., from using, making, selling, distributing, advertising, marketing, etc. directly or indirectly the generic "Apixaban" product under any brand name, including but not limited to "APIVAS" that infringes the subject matter of Indian Patent No. IN 247381.

In light of the above, it was suggested to the experienced senior counsel for the Micro Labs that the previous noted orders, being orders of a Coordinate Bench, this court would be bound by the same. "In any case, as there are interim ex parte orders passed in favour of the plaintiffs (BMS) for the same patent, a similar order was necessary to be passed in the present case.", the court added.

Following the above statement, pointing out various grounds to contend that this court is not bound by the earlier interim orders passed by this court, the learned senior counsel for the Micro Labs has referred to the recent case FAO(OS)(COMM) 139/2020 titled as AstraZeneca AB & ANR. vs. Intas Pharmaceutical Ltd., dated 20.07.2021, where the Division Bench observed that the suits arising from the same patent should be clubbed and heard by the same bench to save judicial time.

Additionally, it was urged by the learned senior counsel for the Micro Labs that the orders of the Coordinate Bench, relied upon by the Bristol-Myers Squibb Ireland Unlimited, were per incuriam and not binding on this court.

In line with the above, the learned senior counsel for the Micro Labs referred to the judgment of the Supreme Court in the case of Sandeep Kumar Bafna v. State of Maharashtra & Anr., 2014 (16) SCC 623.

Bristol-Myers Squibb Ireland Unlimited has confessed that it was issued Indian Patent No.243917 on 11.11.2010, which expired on 17.12.2019, according to the experienced senior counsel for Micro Labs.

Further, it is stated, "BMS wrongly claimed that IN 243917 generically covers millions of compounds, including Apixaban, by virtue of the Markush claim, which does not specifically disclose Apixaban. Hence, it is urged that BMS are seeking to claim that the product Apixaban is covered by two registered patents, namely, IN 243917, which has expired, and the present Patent IN 247381. "

Considering the contentions of the parties, the court stated, "Having noted the observations of the Division Bench, in my opinion, for the purpose of passing an interim order, the facts and circumstances of each case would be different."

After thoroughly evaluating the circumstances, the bench of Justice Jayant Nath said, "In any case, as noted above, appeals against the interim orders of the Predecessor Bench are pending before the Division Bench and are coming up for hearing on 31.08.2021."

The bench of Justice Jayant Nath added,

"The pleas which are raised by the defendant (Micro Labs) have to be considered either at the time of arguments before the Division Bench or at the time of disposal of the interim injunction applications that are pending adjudication before this court. It would be improper for this court to ignore the aforesaid injunction orders passed by the Predecessor Bench for the stated infringement of the same patent filed by the same plaintiffs (BMS). "

Finally, after a detailed analysis of the circumstances, the court noted,

"Accordingly, an ex-parte ad- interim injunction is passed restraining the defendant (Micro Labs), its directors, employees, officers, servants, agents, stockists, wholesalers etc. from using, making, selling, distributing, advertising, marketing, exporting, offering for sale in any generic Apixaban product under any brand name, including but not limited to „APIVAS‟, which infringes the suit Patent IN 247381. The defendant will also recall the impugned generic products which infringe the suit patent from its distributors, wholesalers etc.

To view the official order, click on the link below:

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