HC restrains pharma companies from infringing Boehringer Ingelheim diabetes drug Linagliptin

New Delhi: In a major relief to pharmaceuticals major Boehringer Ingelheim, the High Court has restrained four domestic pharma companies namely, Eris Lifesciences, MSN Laboratories, Emcure Pharmaceuticals, and Optimus Pharma from infringing the patent of Boehringer Ingelheim's blockbuster diabetes drug Linagliptin.

This came after Boehringer Ingelheim, one of the world's leading, research-driven pharmaceutical companies, has obtained ad-interim injunctions against four domestic pharmaceutical companies that launched generic versions of Boehringer Ingelheim's patent-protected drug Linagliptin, which is marketed under the brand name, Trajenta.

Boehringer Ingelheim holds a valid patent for Linagliptin in India until August 2023.

The recent injunctions restrain the domestic pharma companies from infringing the patent of Linagliptin by advertising, launching, making, using, offering for sale, selling, importing and/or exporting in any form in India either by themselves or through their directors, partners licenses, stockist and distributors, agents etc., jointly and severally until the next date of hearing.

Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor developed by Boehringer Ingelheim for the treatment of type II diabetes. Linagliptin differs from other DPP-4 inhibitors in that it has a non-linear pharmacokinetic profile, is not primarily eliminated by the renal system, and obeys concentration dependant protein binding. Linagliptin was approved by the FDA on May 2, 2011.

Commenting on the above issue, Vani Manja, Managing Director, Boehringer Ingelheim India, said "The swift and just actions from the Hon'ble High Court over the past nine months have reaffirmed our faith in Indian legal system in securing the enforcement of patent rights and upholding of patient interests. This also underlines the strength of Boehringer Ingelheim's patents.

We continue to remain committed to making a positive difference in the lives of patients with our innovator drugs and expect all responsible corporate citizens to uphold Boehringer Ingelheim's valid patents for innovator drugs.

We believe that upholding patent rights encourage a culture of innovation and R&D in the country."

Boehringer Ingelheim's injunctions over the past nine months against domestic pharmaceutical manufacturers are -

• Two absolute injunctions upholding the patent rights of Empagliflozin.
  
• One absolute injunction and four ad-interim injunctions against generic versions of Boehringer Ingelheim's patented Linagliptin drug.
  

In addition, the recent four injunctions restrain domestic drugmakers from infringing the Patent of Linagliptin marketed under the trade name, 'Trajenta', in the country.

In the last nine months, Boehringer Ingelheim has received the following injunctions against generic pharmaceutical companies for patent infringement of its innovator drugs Jardiance (Empagliflozin) and Trajenta (Linagliptin):

· Ad-interim injunction granted against Dr. Reddy's Laboratories for Empagliflozin which was eventually made absolute

· Ad-interim injunction granted against MSN Laboratories for Empagliflozin which was eventually made absolute

· Ad-interim injunction granted against MacLeods for Linagliptin which eventually was made absolute

· Ad-interim injunction granted against Eris Lifesciences Ltd for Linagliptin

· Ad-interim injunction granted against MSN Laboratories for Linagliptin

· Ad-interim injunction granted against Emcure Pharmaceuticals Ltd for Linagliptin

· Ad-interim injunction granted against Optimus Pharma Pvt. Ltd for Linagliptin