Refusing to grant an interim injunction sought by Danish pharmaceutical giant Novo Nordisk, the Delhi High Court on Tuesday allowed Dr Reddy’s Laboratories (DRL) to continue manufacturing and exporting its version of the drug containing semaglutide.
API is the chemical in a medicine that produces the intended therapeutic effect. Semaglutide is the API for a new class of revolutionary drugs to treat Type 2 diabetes and obesity; it is marketed by Novo Nordisk as Ozempic for diabetes, and as Wegovy for weight loss.
Novo Nordisk took DRL to court after it refused to comply with a cease-and-desist notice; not only did DRL continue to manufacture semaglutide, it doubled down by filing a suit seeking revocation of the patent protection granted to Novo Nordisk for the compound in India.
By rejecting Novo Nordisk’s demand for a temporary injunction, the court has essentially sided with DRL, allowing it to continue manufacturing and exporting its semaglutide drug. The court has also held that DRL’s challenge to Novo Nordisk’s patent to be prima facie valid, although final adjudication is pending on this matter.
Tale of two patents
Novo Nordisk’s semaglutide products are covered by two main Indian patents.
Indian Patent No. 275964 covers the composition of semaglutide itself. It was filed in March 2006, granted in September 2016, and expired in September 2024.
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Indian Patent No. 262697 covers specific formulations and delivery devices designed to improve stability and administration. It was filed in March 2007, granted in March 2014, and is scheduled to expire in March 2026.
The expiry of the basic composition patent in 2024 opened the door to potential generic development. However, the formulation patent remains in force and continues to confer exclusive rights on Novo Nordisk.
After the Central Drugs Standard Control Organization (CDSCO) in September cleared DRL’s semaglutide injection in India for grant manufacturing and marketing, the Indian company has been manufacturing the drug to be sold in international markets, beginning with Canada.
Arguments & counters
Novo Nordisk filed a patent infringement suit in the Delhi HC alleging that DRL imported substantial quantities of semaglutide API and manufactured finished formulations without its permission, thereby infringing Indian Patent No. 262697. On the other hand, DRL’s patent revocation petition claimed that the second patent was for an analogue of the previously patent-protected product, and that it lacked novelty and inventive step.
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In patent law, inventive step means that a patented creation must involve a creative leap beyond what an average expert could figure out from existing knowledge. DRL claimed that the tweaks made to the earlier compound would be “obvious” to anyone skilled in the domain, and thus should not be provided patent protection.
Novo Nordisk countered by saying that the compound for which it held the second patent had shown “exceptionally higher efficacy” compared to the prior versions of the compound, which made it “novel”. It also said that the formulation of the compound was not publicly known at the time it had filed a patent for the derivative compound in India, meaning the tweaks made would not have been “obvious”.
Delhi HC’s ruling
The court agreed with DRL’s assertion that there is no novelty in Novo Nordisk’s second GLP-1 formulation, and thus concluded that the company had obtained two patents for the same compound. This double patenting resulted in “evergreening”, the court said.
Evergreening involves drugmakers making only minor changes to an existing medicine and then seeking new patents. This does not reflect any significant innovation but prolongs a company’s monopoly over a drug and keeps low-cost generics out of the market. Evergreening is prohibited by Section 3(d) of Indian Patents Act, 1970.
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The court also noted how Novo Nordisk had strategically filed for patents in order to extend its monopoly over semaglutide.
In 2004 (2006 in India), Novo Nordisk filed a genus patent for “NOVEL GLP-1 DERIVATIVES”. This was a genus patent covering a whole class of drugs rather than a particular compound from the class.
Then, in 2007, it filed a separate formulation patent for semaglutide, essentially creating a new patent clock to extend its monopoly over the drug, the court concluded. Notably, while filing the original patent, Novo Nordisk did not disclose the development of the newer version of the drug.
The court thus held DRL’s challenge to Novo Nordisk’s patent to be prima facie valid. DRL has been allowed to continue manufacturing and exporting semaglutide, although the court made it clear that the drug cannot be sold in India until Novo Nordisk’s patent expires in March next year.
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Major implications
Treatment for diabetes and obesity has emerged as an extremely lucrative market for drug makers worldwide. The new class of GLP-1 drugs such as semaglutide, developed by Novo Nordisk, and tirzepatide, developed by Eli Lilly and marketed as Mounjaro and Zepbound, has created ripples in this market.
Notably, it has triggered a global battle over the rights to manufacture and sell these drugs. While the pharma giants have sought to enforce and extend their patents over the drugs and thus protect their bottomline, other manufacturers, including of generics, have sought to grab a share of the pie — and the profits.
In this context, Delhi HC’s ruling is a setback for Novo Nordisk and a victory for other drug makers. Apart from DRL, companies like Mankind Pharma, Cipla and Sun Pharma are contemplating introducing GLP-1 products in India. Cipla, in its October earnings call, said that it sees “big volume opportunities” in the semaglutide space. Sun Pharma, in a November earnings call, termed the GLP-1 market as “exciting”, adding that it wants to “participate in the market whenever the first opportunity is available.”
According to an IQVIA report from August, “over 10 companies have filed Subject Expert Committee (SEC) submissions in India to conduct Phase III studies for semaglutide.” With Novo Nordisk’s patent over semaglutide set to expire soon in several big markets, including Canada, China, Brazil, India and Turkey, massive opportunities are likely to open up for generic drug makers, who can sell the drug for cheaper.
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The IQVIA report notes that Canada, China, Brazil and Turkey, which make up 40% of the world’s population and an estimated 33% of the world’s population of adults living with obesity, “a lower-cost off-patent semaglutide could dramatically increase patient access” and with a dozen manufacturers developing off-patent semaglutide, “this could create a surge in demand and expand the private market.”
