Germany's Boehringer, Indian pharma in legal battle over diabetes drug

The German drug maker has obtained interim injunctions against MSN Labs and Dr Reddy's Lab

German drugmaker Boehringer Ingelheim (BI) has obtained two separate interim injunctions against two Indian drugmakers – MSN Laboratories and Dr Reddy’s Laboratories – who launched cheaper, generic versions of their anti-diabetic drug empagliflozin.

BI holds a patent for Empagliflozin under the name Jardiance in India till 2025, the company said.

A Boehringer Ingelheim India spokesperson said that it has obtained two separate orders granting ad-interim injunction that restrains the two domestic pharmaceutical manufacturers from ‘launching, making, using, offering for sale, selling, importing and/ or exporting their respective generic version of Empagliflozin drugs’.

“Boehringer Ingelheim holds a valid patent for Empagliflozin in India until 2025. These orders have been passed based on the prima facie satisfaction of the strength of Boehringer Ingelheim’s patent and on the patent infringement by the two domestic pharmaceutical manufacturing companies. Our faith in the Indian Patent system and the enforcement of patent rights is re-affirmed with this ad-interim injunction,” the spokesperson added.

DRL and MSN Labs had launched cheaper copies of BI’s Jardiance recently.

MSN Labs had said in a statement on October 18 that it has launched India’s ‘most affordable’ empagliflozin tablets under the brand name Empaone priced at Rs 15.9 and Rs 18.9 for each 10 mg and 25 mg tablet.

DRL’s brand for empagliflozin is Vicra. These generic drugs are priced at almost one-third the innovator brand Jardiance which costs Rs 51 and Rs 62 for a 10 mg and 25 mg tablet.

DRL, on the other hand, said that it was in full compliance of legal orders.

A company spokesperson told Business Standard that, “We are in full compliance of legal orders. Dr. Reddy's filed a patent revocation petition before the Hon'ble High Court of Delhi on 16th October to challenge the validity of the existing patent. The Hon’ble High Court of Delhi has issued notices accordingly to concerned parties.”

The spokesperson went on to add that they believe that the patent that has been asserted is invalid based on legal opinion sought and received.

“We are monitoring the situation closely, and will continue to take all appropriate and timely action. We believe there is a strong case for wider access to this important life-saving drug at affordable prices. In keeping with our purpose, we remain committed to ensuring affordability and access to the patient population in India and across the world in line with our credo of 'Good Health Can't Wait',” DRL said.

MSN Labs said they did not wish to comment on the matter.

In its October 18 statement, MSN had noted that Empaone is intended to provide diabetes patients in need an affordable and accessible therapeutic option.

“India being the diabetic capital of the world with over 77 million people suffering from Type 2 diabetes, this medicine will minimize the cost burden on patients and in turn improve compliance,” the company had said then.

Jardiance or empagliflozin falls in a generation of anti-diabetes drugs called SGLT-2 (sodium glucose co-transpoter-2) inhibitors. This class of drugs work by preventing the kidneys from re-absorbing glucose back into the blood. This, thereby, allows the kidneys to lower the blood glucose levels and excess glucose in the blood is removed from the body via urine.

Jardiance sales are around Rs 250 crore a year. SGLT-2 inhibitors are a popular and growing category of diabetes medicines valued roughly at around Rs 5000 crore or so.  

Gliflozins or SGLT-2  have clocked a strong double digit growth since Johson & Johnson launched its canagliflozin in April 2015. This was followed by AstraZeneca's dapagliflozin in June 2015 and Boehringer Ingelheim’s empagliflozin in November 2015. Since then, these companies have partnered with domestic majors to market their drugs. Recently Glenmark disrupted the market with its low-cost innovation remogliflozin. In December, Glenmark partnered with Mankind Pharma to market this drug.

Diabetes is a lucrative category for two reasons – one these are chronic medicines and the pandemic has shown that demand for such therapies hardly wanes, and secondly only 5 percent of this market is covered under the National List of Essential Medicines or is under a price cap.