Novo Nordisk v. Dr. Reddy was a dispute over the drug ‘semaglutide’, also marketed as Ozempic. In September 2025, WHO included semaglutide in the essential medicine list for treatment of type-2 diabetes. The patent over this drug is registered with Novo Nordisk which is yet to launch Ozempic in India. Although the Court upheld prima facie invalidityof Novo’s patent over semaglutide, it has, curiously, declined to allow the Defendant to sell the drug in India. Expectedly, Novo has rushed to launch the Ozempic in India this month itself. The pricing of the drug is not yet finalized. Since the suit patent expires on 20th March 2026, it can be expected that the pricing will remain high to recoup profits before launch of generics. For the time being, this blockbuster medicine may remain elusive for the patients.
To me, this case is wrong both on outcome and reasoning. Let me illustrate.
Bolar Exception
Why did the Court not allow Dr. Reddy to sell the drug in India? Remember, the Court decided that the suit patent itself was invalid. If the patent itself is invalid, why, then, tie the Defendant’s hands? The answer- failure to clear the way.
The Defendant, in this case, had commenced manufacturing the drug in April 2025 and began exporting the same to countries where Novo did not have a patent. Is this activity covered under the Bolar exception?
The court, in the 99-page order, does not express an opinion on this. If the activity of the Defendant is protected u/s 107A, there is no need to clear the way.
In Para 150, it notes- “Defendants have failed to clear the way before they started manufacturing, which showed their procedural mala fide.” Thus, the Defendant’s act of- (i) setting up manufacturing facilities and (ii) manufacturing (semaglutide) without challenging the suit patent was not covered by sec.107A.
As pointed out here, sec. 107A is aimed at ensuring “that generic drugs are introduced into the market as soon as the patent expires or is invalidated.” Is the act of setting up manufacturing facilities and commencing manufacturing outside the scope of 107A? Bayer v. UOI is useful to quote here-
“If the purpose of the sale is to be prepared to apply for the patent for approval to market it once the patent tenure ends, there can be no impairment of the patentee’s rights.” (Para 91)
“A patent owner’s interests are clearly injured if the invention…is worked for purely commercial purposes and the ensuing product is offered in the market. Such products would be competitors to the patented invention and….one can reasonably expect them to be significantly lower in cost, in the marketplace.” (Para 93)
Thus, for sec. 107A, an important consideration is the end-use or purpose of manufacturing. If it is merely to stockpile and launch after expiry of patent term, there is no injury to the patent owner. Further, the manufacturing of the generic drug while the patent is subsisting does not violate sec. 48- 107A is not subject to any section of the Patent Act. (Para 88 of Bayer)
Although, in this case, Dr. Reddy was exporting the drug to countries where Novo did not hold a patent, admittedly a commercial purpose (Para 15.30), the Court does not discuss it.
I would have conceded that the act of export for sale abroad took Dr. Reddy out of 107A’s scope had the Court even discussed or weighed it as a factor. As it did not, it is reasonable to argue that mere act of setting up manufacturing facilities and commencing manufacturing, without sale, is covered by 107A.
Since the Defendant’s act are covered by 107A, there was no need to ‘clear the way’ and file revocation petition before commencing manufacturing.
Clearing the Way and Balance of Convenience
Assuming the Dr. Reddy failed to clear the way, did it constitute a sufficient reason to bar them from selling the drug in India despite prima facie invalidity of suit patent?
The same issue arose in Astrazeneca v. Torrent Pharmaceuticals where although the patent was prima facie invalid, the Defendant had failed to clear the way. The Court, there, had held that “prima facie vulnerability of the validity of the suit patent outweighs these factors (irreparable harm and balance of convenience).”
Further, the decisions cited by in this case- Merck Sharp and Dhome and FMC Corporation– also do not support the conclusion that mere failure to clear the way is conclusive to grant an injunction. Remember, in effect, Dr. Reddy is injuncted to sell the drug in India.
In Merck Sharp, a prima facie case of infringement had been made out. It had held-
“Ultimately, the Court must look to the combination of the three primary factors. A strong case can in some instances offset an equal balance of conveniences between parties.”
In FMC Corporation, too, the Court had never said that mere failure to clearing the way is conclusive as to grant of interim injunction.
In the present case, few things stand out-
- Dr. Reddy had not launched the drug in the Indian market without clearing the way. It had merely commenced manufacturing
- The suit patent was prima facie invalid
- The drug was not manufactured in India; Novo only imported the drug. This is relevant to assess accessibility of the drug in India. (15.31)
- Defendant’s generic version had a lower price which enhanced public access (relevant factor as per Merck Sharp)
- The damage, if infringement was proved after trial, was not irreparable; Para 149 records that Plaintiff can be compensated if it succeeds at trial
- The Defendant had invested in infrastructure, regulatory compliance and commercial arrangements, with investments in its manufacturing facilities worth 1000 crores. ( relevant factor in Para 109; FMC)
On combination of the above factors, despite failure to clear the way, the Defendant should have been allowed to sell the drug in India. If the Plaintiff succeed at trial, as the Court notes, the Plaintiff can be compensated by damages. Further, Dr. Reddy had never launched the product unlike previous cases on clearing the way. It had merely commenced manufacturing, which, as I showed earlier, is covered u/s. 107A.
The Court, in this case, has set a wrong precedent with potential for scuttling access to essential medicine in future.
Parallel Import
Since Dr. Reddy, until expiry of the Patent, are not allowed to sell the drug in India, what should the diabetic community expect? As pointed out in the beginning, Novo has geared up to launch Ozempic in December. The prices, expectedly, will remain high for this blockbuster drug so that Novo can recoup profits before expiry of the patent. Since Novo does not manufacture the drug in India, import costs may be passed on to the consumer.
Is Parallel Import a feasible option?
Dr. Reddy is allowed to sell the drug in countries where Novo does not have subsisting patent over the drug. Sec. 107A(b) allows any person to import patented products as long as the product is sold by a person authorized under law. As Pankhuri points out, the condition of authorization from patentee was removed after the 2005 amendment.
Late Prof. Basheer, here, had written that a company, injuncted from selling the drugs in India, can “cleverly relocate its operations to Bangladesh (since it does not have patens for pharmaceuticals) and begin exporting the drug out to India.”
In this case, the Defendant are authorised by the Court to export and sell the drugs in other countries. Surely, this comes within the scope of ‘duly authorised by law.’ It is possible for other companies to import the drugs from these countries and sell it in India. Customs Circular no. 13/2020, too, allows parallel import of patented products for production, sale or distribution. (here)
Parallel imports, thus, remains the only hope for now.
A second part of this post will follow soon discussing the issue of genus-species disclosure which led to the invalidity of the genus patent in this case.