What’s happening?

Last week, Natco Pharma filed six lawsuits in the Delhi High Court against Danish drugmaker Novo Nordisk for its popular anti-obesity drug semaglutide, sold as Wegovy in India. The Hyderabad-based drugmaker contended that its versions of semaglutide and the delivery device do not infringe on Novo Nordisk’s patented drug or devices, meaning it could launch them even before the patent expires.

Natco had issued notices to Novo Nordisk over this on 30 June but did not get a response, a person familiar with the case told Mint. The court heard the matter on 20 August and referred both sides to pre-suit mediation to try and resolve the matter amicably, the person said.

In May, Hyderabad-based Dr Reddy’s Laboratories challenged the validity of Novo Nordisk’s second patent on semaglutide, contending that it lacks novelty. This patent is set to expire in India in March, opening the floodgates for a wave of cheaper generic copies to come in.

Subsequently, Novo Nordisk filed a patent infringement suit against Dr Reddy’s.

Why the rush?

At the heart of this saga is the booming global demand for drugs that mimic a hormone that regulates hunger and insulin and can help people lose 15-23% of their weight over six months. Semaglutide injections, sold under the brands Wegovy and Ozempic, turned Novo Nordisk into a global powerhouse, clocking over $25 billion in sales last year.

Novo Nordisk launched Wegovy in India in July, following competitor Eli Lilly, which introduced its drug Mounjaro (tirzepatide) in March. Both companies are racing to grab a strong market share before generics fill in once Novo’s patent expires. India, with over 254 million obese people, and over 100 million diabetics, is a lucrative market.

The market for weight-loss drugs could grow to ₹8,000 to ₹10,000 crore in the next two to three years, estimated Vishal Manchanda, a pharma equities analyst at Systematix Group.

“This would probably be the largest category being created in the India pharma market so far,” he said. This, even as prices are expected to fall by over 80% as generics come in.

Almost every large generic drugmaker in the country is gearing up to launch the drug next year. They include Sun Pharmaceutical Industries, Cipla, Lupin, Zydus, Eris Lifesciences and Mankind Pharma. Some are attempting to grab the first-mover advantage.

Why Natco and Dr Reddy’s?

Weight-loss drugs are sold most popularly as injectables, and innovators like Novo and Eli Lilly have leveraged their diabetes-treatment leadership to grab the market.

“This is a very big opportunity, which we haven’t seen in the past,” said Manchanda. “Companies that don’t have a very strong marketing presence [in this market] are trying to get the first-mover advantage so that they can make up for their lack of strength in marketing.”

For Natco or Dr Reddy’s, winning a patent war against the innovator would mean entering the market ahead of their competitors.

How would a lawsuit help?

A patent war, or litigation, can create a buzz around a company, even if the outcome is delayed.

“In the interim dates, they might want a favourable order or even a favourable statement that would highlight them in their circle of competitors, market buyers and investors,” Amit Panigrahi, partner and head of trademarks at Kochhar & Co, pointed out.

Pursuing a patent war may force the innovator to stop its delaying tactics, and allow a generic launch faster, according to legal experts.

Has this happened before?

Natco has a track record of challenging patents, particularly for highly priced lifesaving drugs such as Bayer’s kidney and lung cancer drug Nexavar or Roche’s Risdiplam for spinal muscular atrophy.

While semaglutide is more of a weight-management drug than a lifesaving medicine, the sheer demand and anticipated size of the market make it a rare opportunity for pharma companies.

In 2019, Natco pursued a similar strategy against Bristol-Myers Squibb’s (BMS) anticoagulant Apixaban. It launched its generic version Apigat in June 2019, challenging the innovator’s patent validity. While it was initially given interim relief against an injunction filed by BMS by the Delhi high court, it was later asked to halt sales.

Later in 2020, the Delhi high court barred Cipla, Torrent and Alkem from launching generic versions too.