Injunctions Against Sale of Lingaliptin

Analysis of Boehringer Ingelheim Pharma GmbH v/s Tanmed Pharma and other orders

Plaintiffs: Boehringer Ingelheim Pharma GmbH & Co. KG & Boehringer Ingelheim (India) Pvt.Ltd. (“the plaintiff”/“Boehringer”)

Defendant:Tanmed Pharma India Private Limited(“the defendant”)

Coram: Dr. Justice G. Jayachandran

Date of Judgment: 21st January 2020

Facts of the Case:

The plaintiff is a multinational company involved in the production and manufacture of pharmaceutical drugs and had acquired patent rights for its products under Indian Patent Nos. 243301 and 227719. The defendant approached the department of Drug Control somewhere around December 2017 in order to obtain a license to manufacture the same drug i.e. “Lingaliptin”(“said drug”) and license for said drug was granted. The defendant claimed that although the license for manufacture was obtained, no production, manufacture or marketing of the said drug was undertaken by them. On the other hand, the plaintiff alleged that the defendant has infringed on its product patents and has filed the present Civil Suit no. 282 of 2019 in the High Court of Madras in its Original Jurisdiction(“said suit”) for the alleged infringement and prayed for either permanent injunction against the defendant from manufacturing the drug covered by its patent or compensate by paying all the profits received due to sale of the said drug. On receiving the summons for the said suit, the defendant surrendered the license of the said drug to the Drug Controlled on 27.05.2019. The defendant also provided an undertaking stating that he will not manufacture the said drug until the plaintiff hold exclusive rights to it. The High Court prima facie dismissed the said suit.

Issues:

Whether the defendant has infringed the patent rights of the plaintiff & cause of action lies?

Contentions raised by the parties:

The plaintiff had alleged infringement of its patent rights on the part of the defendant in the suit.

The defendant, in his written submission has contended that the plaintiff had no cause of action against the defendant and the suit should be dismissed. The defendant had reasoned this by stating that even though license for manufacturing the drug Lingaliptin was obtained, no manufacture or marketing of the said drug was carried out.

Decision:

In order to ascertain whether the manufacture of the said drug had taken place by the defendants, the Court had appointed a Commissioner who along with the officials of the Drug Control department inspected the premises of the defendant on 23.12.2019. On inspection of the findings reported by the Commissioner and the Assistant Director of the Drug Control Department who had accompanied the Commissioner for inspection, the Court came to a conclusion that the defendant had not manufactured the said drug for which the patentee had exclusive patent rights. The Court also observed that the defendants had surrendered the license to the Drug Control department and had given an undertaking stating that he will not manufacture the drug until the plaintiff held exclusive patent rights for the said drug.

In the light of these facts and circumstances, the Single Judge bench composed of Hon’ble Dr.Jusice G. Jayachandran opined that any future attempt to manufacture the said drug was not possible and held that the case was not fit for trial and dismissed the suit. Further the court also asked the respective parties to bear the costs.

Analysis:

The High Court in this case found that no prima facie case existed and proceeded to dismiss the suit. The present suit is one that deals with a question of fact and not one of law. The burden to prove that the patent rights of the plaintiff were not infringed was on the defendant. The report submitted by the Commissioner and the Drug Control department clearly established that the contentions put forth by the defendant were true and correct. The Court correctly observed that in light of the report submitted by the Commissioner, surrender of the license and the undertaking submitted by the defendant, the defendant had not manufactured the said drug and any future attempt to manufacture said drug would not be possible. Thus, the cause of action did not survive and the court was right in dismissing the suit. Any decision stating otherwise would have been a step taken to waste the time and resources of the court as well as the parties.

In earlier case a commercial court in Gujarat based on different facts had passed an ex-parte ad interim injunction against manufacture and sale of the patented drug by Cadila Healthcare Ltd, Maan Pharmaceutical Ltd and West Coast Pharmaceutical Works Ltd. (“the three pharmaceutical companies”). The three pharmaceutical companies had obtained a license to manufacture and sell the same drug i.e. Lingaliptin. Boehringer had filed a suit against the above mentioned pharmaceutical companies for infringement of their patent rights in the said drug. In the case filed by Boehringer against the three pharmaceutical companies,the judge of the commercial court, found that a prima facie case existed in favour of Boehringer. The facts obtained under the RTI laws from the controller of drugs reveal that the companies were about to launch the medicine, thus infringing on the patents of the German company. The judge held that the plaintiff had a prima facie case in its favour and balance of convenience also lied in its favour. If the ex-parte ad interim injunction was not granted, it would cause irreparable loss to the plaintiff and prejudice to the rights of the plaintiff. Further delay in granting injection would have caused hardship and defeated the object of the suit.

Conclusion:

These decisions though differ in the final verdicts, the final outcome is the same that is no manufacture or marketing of Lingaliptin by respective pharmaceutical companies.

Author: Anushka Iyer – Intern and curated by Mita Sheikh – Associate Director at Khurana & Khurana, Advocates and IP Attorneys. In case of any queries please contact/write back to us at mita@iiprd.com.

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