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Alleged Patent Infringement by a commercial rival cannot raise the please of public interest

Boehringer Ingelheim International GmbH and Boehringer Ingelheim (India) Pvt. Ltd., the plaintiffs, who hold Indian Patent No. 268846 for a pharmaceutical product called Empagliflozin. This drug is prescribed in the treatment of certain medical conditions. The plaintiffs, as the patent holders, have exclusive rights to produce, market, and sell Empagliflozin under their patented technology. They alleged that the defendant, Eris Lifesciences Limited, has infringed upon their patent by manufacturing and selling a similar product. 

 

Empagliflozin is a drug that falls under the category of sodium-glucose cotransporter-2 (SGLT2) inhibitors. It is used particularly in the treatment of type 2 diabetes mellitus. SGLT2 inhibitors work by reducing the reabsorption of glucose in the kidneys, leading to increased glucose excretion in urine and lowering blood sugar levels. It is often prescribed as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes. 

 

The plaintiffs, Boehringer Ingelheim International GmbH and Boehringer Ingelheim (India) Pvt. Ltd., filed a suit before the High Court of Himachal Pradesh in 2023 against the defendant, Eris Lifesciences Limited, seeking permanent prohibitory injunction, restraining the defendants from  infringing on their patent rights in respect of the medicinal product Empagliflozin.  

 

Arguments of the Plaintiff: 

 

The Plaintiffs inter alia presented several arguments to establish their rights as the patent holders and demonstrate that the defendant’s actions constitute infringement. Some of the key arguments put forth by the plaintiffs include: 

 

  1. Valid Patent: The plaintiffs claim to possess a valid registered patent for Empagliflozin and have successfully taken legal action against other infringers in the past. They asserted that their patent is legally enforceable and deserves protection. 

 

  1. Infringement of their Product: According to the plaintiffs, the defendant is manufacturing and selling a product called “Linares-E” that falls within the scope of their patent. They contend that this product is substantially similar to Empagliflozin and infringes on their exclusive rights to produce and sell it. 

 

  1. Inventive Step: The plaintiffs  averred that their patent involves an inventive step and represents a technical advancement. They asserted that Empagliflozin possesses unique features or improvements that distinguish it from existing products in the market. The plaintiffs submitted that their patent is innovative and deserving of legal protection. 

 

  1. History of enforcement: The plaintiffs submitted that they have successfully protected their rights against other infringers, in the past and have demonstrated their commitment to protecting their patent rights. This indicates their determination to prevent unauthorized use or infringement of their patented product. 

 

Arguments of the Defendant: 

 

The defendant’s, inter alia, argued as follows: 

 

  1. Patent Vulnerability: It was the defendants’ case that the plaintiffs’ patent was vulnerable and lacked inventive step. They contended that the subject patent is an “ever greening” of an existing patent, suggesting that it does not introduce any significant new innovation or technical advancement. 

 

  1. Credible challenge: The defendant asserted that they have raised a credible challenge to the patent’s validity. They claimed that there were serious questions regarding the patent’s legitimacy, which will have to be considered before  granting an injunction.  

 

  1. Lack of Clean Hands: The defendants pointed out that the Plaintiffs have suppressed material facts from the Court and   have not approached the court with clean hands.. They contended that this has undermined their credibility and the validity of their patent. 

 

  1. Balance of Convenience and public policy: The defendant asserted there is no balance of convenience in favour of the plaintiffs and no irreparable injury shall be caused to them if injunction is not granted in their favour pending the decision of the suit. The defendants also averred that defendant-Company’s drug is more accessible to the public at a reasonable price. At the stage of interim injunction, access to affordable medicines and public interest are important factors, which cannot be overlooked. 

 

Judegment: 

The court opined that the defendants’ allegation that the patent is ‘vulnerable’ is not enough, if it is not proved. The veracity of the experts’ affidavit filed by the Defendants’ can be established only after cross examination of the expert by the plaintiffs at the trial stage. 

 

The court considered the factum of credible challenge by the Defendant. The court held that the Court cannot not refuse interim injunction on mere allegations without any material on record 

 

With respect to the defendants’ allegations that the plaintiffs have not approached the court with clean hands, the court held that the requirement that the plaintiff should include all orders, if any, passed by any Indian or International Court or Tibunal, upholding or rejecting the validity of the suit patent or a patent which  is for the same or substantially the same invention, is mandated by the Patent Rules framed by the Delhi High Courts. And there were no such Rules governing Patent Suits as far as the present Court is concerned. The court observed that the defendants have not denied that the suit patent was successfully registered in 70 other countries and rejected in only one.  

 

According to the court, the balance of convenience was also in favour of the Plaintiffs as the plaintiffs had a valid patent in their favor while defendant did not have any registered patent pertaining to the infringing product. 

 

The court viewed the plaintiffs and the defendants as commercial rivals and held that a patent infringer cannot hide behind the plea of public interest in view of the fact that there are enough checks and balances in the Patents Act, 1970 itself to cater the public interest. 

 

Conclusion:  

The court's decision in the case of Natco Pharma v. Novartis AG 2024: DHC:3198-DB underscores the significance of transparency and full disclosure in patent disputes, particularly while seeking interim injunctions. The ruling emphasizes that to establish a case a credible challenge to the validity of a patent it is important to produce relevant documents before the court. The court will not accept mere allegations without supporting evidence.  

 

Most importantly, this decision underlines the importance of having coordinate Patent Rules in all the High Courts.  


The present decision diverged from the stand taken by the Delhi High Court as it was not bound by the High Court of Delhi Rules Governing Patent Suits, 2022. This is bound to cause confusion in the minds of the litigants and create diverse precedents creating more work for the overburdened courts.  


IN THE HIGH COURT OF HIMACHAL PRADESH, SHIMLA 

COMS No. 09 of 2023 a/w COMS No. 02 of 2024, Counter Claim (COMS) No. 01 of 2024 in COMS No. 09 of 2023 and Counter Claim (COMS) No. 07 of 2024 in COMS No. 02 of 2024 OMP No. 409 of 2023 in COMS No. 09 of 2023  

Reserved on: 03.05.2024 

Decided on: 30.05.2024 

Civil Suit (COMS) No. 09 of 2023 

(1) Boehringer Ingelheim International GmbH 55216, Ingelheim am Rhein Germany 

(2) Boehringer Ingelheim (India) Pvt. Ltd. Unit No. 202  

……Plaintiffs. 

-Versus- 

(1) Eris Lifesciences Limited,  

Through its Managing Director 

 

Civil Suit (COMS) No. 02 of 2024 

(1) Boehringer Ingelheim International GmbH 55216, 

Ingelheim am Rhein Germany 

(2) Boehringer Ingelheim (India) Pvt. Ltd. Unit No. 202  

……Plaintiffs. 

-Versus- 

(1) Eris Lifesciences Limited,  

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