How Indian Patent Law Breaks Brand Monopolies, What Happens When a Patent Is Rejected and What Restoration Really Means
The Foundation: What Is a Patent Under Indian Law
A patent in India is a statutory right granted by the government to an inventor that gives that inventor the exclusive right to make, use, sell and import the patented invention in India for a limited period. The legal authority for this comes from the Patents Act 1970 as substantially amended in 2005 when India complied with the Agreement on Trade-Related Aspects of Intellectual Property Rights or TRIPS under the World Trade Organisation.
The Controller General of Patents Designs and Trade Marks administers all patent-related matters in India through patent offices in Mumbai, Delhi, Chennai and Kolkata.
Under Section 53 of the Patents Act the term of a patent is 20 years from the date of filing of the patent application. This applies to all categories of patents including product patents and process patents for pharmaceuticals which were recognised in India only after the 2005 amendment.
Once those 20 years are up the patent falls into the public domain. Any person can then freely manufacture and sell the invention. This is what happened with semaglutide in March 2026.
But patent expiry is only one of several ways a patent can stop protecting its holder. The more legally interesting story involves what happens before that.
Section 3(d): The Provision That Changed Global Pharma
Before discussing rejection and restoration it is important to understand the provision that makes Indian patent law distinctly powerful in the pharmaceutical context.
Section 3(d) of the Patents Act provides that a new form of a known substance is not patentable unless it results in a significantly enhanced therapeutic efficacy compared to the known substance. The provision specifically bars patents on new salts, esters, ethers, polymorphs, metabolites, pure forms, particle sizes, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substances unless a meaningful improvement in efficacy is demonstrated.
This was the exact provision used in the landmark Supreme Court case of Novartis AG v. Union of India decided in 2013. Novartis had sought a patent for the beta-crystalline form of imatinib mesylate, sold as Gleevec, a cancer drug. The Supreme Court upheld the rejection of that patent under Section 3(d) because enhanced bioavailability alone does not amount to enhanced therapeutic efficacy.
The implications for the pharmaceutical industry were enormous. Section 3(d) effectively prevents what is called "evergreening" which is the practice of making minor modifications to a known drug compound and filing a new patent to extend monopoly protection beyond the original 20-year term.
For GLP-1 drugs this matters. Any future attempt by an innovator company to file derivative patents around semaglutide in India covering new crystal forms or delivery mechanisms would face immediate scrutiny under Section 3(d). The bar for patentability is not whether the derivative is new. The bar is whether it is meaningfully and therapeutically better.
When a Patent Application Is Rejected: The Full Legal Picture
A patent application in India can face rejection at multiple stages through a structured and layered process. Understanding each stage is essential.
Stage One: Examination and the First Examination Report
After filing a patent application the applicant must request examination within 48 months from the date of priority or the date of filing whichever is earlier. Once examination is requested the Controller issues a First Examination Report or FER which sets out all the objections to the application. These objections may relate to novelty, inventive step, industrial applicability or compliance with Section 3 provisions including Section 3(d).
The applicant has 12 months from the date of issuance of the FER to respond to all objections and put the application in order for grant. If the applicant fails to address the objections within this period the application is deemed abandoned under Section 21(1).
Stage Two: Pre-Grant Opposition Under Section 25(1)
At any time after the patent application is published but before the patent is granted any person can file a pre-grant opposition under Section 25(1). Notably this is not limited to companies with a commercial interest. Any person in the world can oppose.
The grounds for pre-grant opposition include prior publication, prior claiming, prior public knowledge or use in India, obviousness, insufficiency of description, non-disclosure or wrongful mention of biological material and claims that fall outside Section 3 of the Act.
The Controller must consider the representation and if satisfied that the opposition is prima facie valid will refer it to an Opposition Board. The Opposition Board gives its recommendation and the Controller then makes a final decision. If the Controller agrees with the opposition the application is refused. This is a formal rejection of the patent application and means the invention enters the public domain immediately with no exclusivity granted to the applicant.
This is precisely the mechanism that generic companies in India and non-governmental organisations have used aggressively for decades. Patents on antiretroviral drugs, cancer medicines and now GLP-1 derivatives have faced pre-grant opposition proceedings in India.
Stage Three: Post-Grant Opposition Under Section 25(2)
After a patent is granted any person interested can file a post-grant opposition within 12 months from the date of publication of the grant in the Official Gazette under Section 25(2).
The grounds for post-grant opposition are broader than pre-grant opposition and include wrongful obtaining of the patent in addition to all the grounds available for pre-grant opposition. Post-grant opposition is heard by an Opposition Board and then decided by the Controller.
If the opposition succeeds the patent is revoked. A revoked patent is treated as though it never existed from the date of grant. This means generic manufacturers can immediately enter the market.
Stage Four: Revocation Under Section 64
Separately from opposition proceedings a patent can be revoked by the High Court or by the Controller under Section 64 at any time during the life of the patent. The grounds for revocation are similar to those for opposition but this route is typically used in infringement proceedings where the alleged infringer challenges the validity of the patent as a defence.
What Happens When a Patent Is Rejected or Revoked: The Consequences
The legal consequences of a patent rejection or revocation are significant and immediate.
When a patent application is rejected after pre-grant opposition or refused after examination no patent right ever comes into existence. The invention is freely available to the public from that moment. Generic manufacturers can begin production without any licence or royalty obligation.
When a granted patent is revoked after post-grant opposition or High Court proceedings the revocation has retrospective effect. The patent is treated as void ab initio meaning from the very beginning. However any acts done in good faith under the patent before revocation such as manufacturing under a licence agreement may be treated differently depending on contractual arrangements.
In both situations the core consequence is the same: the innovator company loses all exclusivity. Competitors can legally use the patented process manufacture the patented product and sell it in India. This is precisely the legal condition that enabled dozens of Indian companies to prepare for and launch generic semaglutide the moment Novo Nordisk's patent protection ended.
It is worth understanding that in the GLP-1 case the patent was not rejected. It simply expired after 20 years. The outcome is commercially identical to rejection in that generic competition is now free and lawful. But the legal pathway is different and the distinction matters for restoration purposes as discussed below.
Compulsory Licensing: Using a Patent Without the Owner's Permission
The Patents Act contains another powerful mechanism that allows the government and third parties to use a patent even while it is still in force: compulsory licensing.
Under Section 84 of the Patents Act any person interested can apply to the Controller for a compulsory licence after three years have elapsed from the date of grant of the patent. The Controller may grant a compulsory licence if any of three conditions is satisfied:
First, the reasonable requirements of the public with respect to the patented invention have not been satisfied. Second, the patented invention is not available to the public at a reasonably affordable price. Third, the patented invention is not worked in the territory of India.
The first and only compulsory licence ever granted in India under Section 84 was in 2012 when the Controller granted Natco Pharma a compulsory licence to manufacture sorafenib, a kidney cancer drug patented by Bayer, at a fraction of the original price. Bayer had sold the drug at approximately Rs 2.8 lakh per month while Natco launched it at Rs 8,800 per month. The Intellectual Property Appellate Board upheld the grant and it was later affirmed.
Under Section 92 the government can also issue a compulsory licence in situations of national emergency, extreme urgency or for non-commercial public use without waiting for the three-year period. This provision was considered during the COVID-19 pandemic in India and remains available for any future health crisis.
For GLP-1 drugs the compulsory licensing route was never needed because the patent expired naturally. But if semaglutide had been approaching the end of its patent term with the drug priced unaffordably while millions of Indian diabetics needed it, Section 84 would have offered a legal avenue for forced generic production.
The Bolar Exemption: How Generic Companies Prepared Legally
One provision that often goes unnoticed but is critically important for India's pharmaceutical industry is Section 107A of the Patents Act. This is India's version of what is globally called the "Bolar exemption."
Section 107A provides that any act of making using constructing selling or importing a patented invention solely for uses reasonably related to the development and submission of information required under any law in India or in a country other than India that regulates the manufacture construction use or sale of any product shall not be considered infringement.
In simple terms this means that generic companies can conduct research testing and bioequivalence studies using a patented drug while the patent is still in force. They can also use the patented process to generate data required for regulatory approval from the Central Drugs Standard Control Organisation.
This is why seven Indian companies including Sun Pharma, Dr. Reddy's and Zydus Lifesciences had regulatory approvals ready and products launched within days of semaglutide's patent expiry in India. They had legally been preparing for years. Section 107A made that preparation lawful.
Restoration of a Lapsed Patent: Sections 60 to 63
Here is where one of the most misunderstood aspects of Indian patent law comes into focus.
A patent does not automatically survive its 20-year term. To keep a patent in force throughout its term the patentee must pay annual renewal fees. Under Section 53(2) these fees are payable before the expiry of each year of the patent term beginning from the second year onwards.
If the renewal fee is not paid the patent lapses. A lapsed patent is not the same as an expired patent. An expired patent cannot be restored because its full term has run. A lapsed patent can potentially be restored if the lapse occurred due to failure to pay renewal fees.
The Restoration Process Under Section 60
Under Section 60 the patentee or the legal representative of a deceased patentee can apply to the Controller for restoration of a lapsed patent. The application must be filed within 18 months from the date on which the patent lapsed.
The application must be accompanied by a statement explaining the circumstances that led to the failure to pay the renewal fee. The key legal standard is whether the failure was unintentional. If the Controller is satisfied that the failure to pay the renewal fee was unintentional and that no undue delay has occurred in applying for restoration the Controller will advertise the application in the Official Journal.
Opposition to Restoration Under Section 61
After the restoration application is advertised any person may oppose the restoration within the period specified in the advertisement under Section 61. Grounds for opposition include the assertion that the failure to pay the renewal fee was not unintentional and the claim that the patent should not be restored because the opponent or their licensee has begun manufacturing or selling the patented product or has made substantial preparations to do so during the lapse period.
This second ground is commercially powerful. If a generic manufacturer can show it made real preparations to enter the market during the period when the patent was lapsed it has a strong argument against restoration. The Court or Controller must then balance the rights of the patentee seeking restoration against the legitimate commercial activity undertaken by third parties during the lapse.
What Restoration Does Not Do
Critically a restored patent under Section 63 comes with important limitations. Under Section 63(2) a restored patent does not affect the validity of any action taken during the period of lapse. Any person who in good faith took action that would have constituted infringement after the patent lapsed but before the restoration is protected from infringement liability. Any contract entered into in good faith during the lapse period regarding the patented invention remains valid.
In practical terms this means that a company that starts manufacturing a generic version of a drug during the lapse period is not suddenly converted into an infringer just because the patent is restored. It can continue that specific use though it cannot expand to new acts after restoration.
The Time Period: A Hard 18-Month Ceiling
The 18-month window for filing a restoration application is a hard statutory deadline. There is no discretion to extend it. If a patentee misses the 18-month period from the date of lapse the patent is permanently lost. No application can be entertained after that date regardless of the reason for the delay.
This strict deadline serves a public policy purpose. It prevents patentees from indefinitely disrupting the market by seeking restoration years after competitors have built businesses around what they reasonably believed was freely available subject matter.
The Appeals Chain: Where to Challenge Patent Decisions
Understanding the appeals structure is essential to the complete picture of how patent disputes resolve in India.
Until 2021 the Intellectual Property Appellate Board or IPAB heard appeals from decisions of the Controller of Patents. The IPAB was abolished in 2021 by the Tribunals Reforms Act. Its jurisdiction was transferred to the relevant High Courts.
Today appeals from orders of the Controller of Patents lie directly to the respective High Court having jurisdiction. Decisions of the Delhi High Court in patent matters are particularly significant because it handles a large volume of pharmaceutical patent litigation and its judgments on Section 3(d) and other pharmaceutical patent questions have shaped legal practice across India.
Beyond the High Courts the Supreme Court of India has final appellate authority and its decisions including the Novartis ruling on Section 3(d) bind all courts and the Controller.
The GLP-1 Market: What Indian Patent Law Created
The current landscape of India's GLP-1 market is a direct product of this legal architecture working exactly as it was designed to work.
India's anti-obesity drug market stood at approximately Rs 628 crore in 2025 and projections suggest it could exceed Rs 25,000 crore by 2030. GLP-1 drugs like semaglutide account for a dominant and growing share of that figure. The country has approximately 89.8 million adults living with diabetes and over 254 million adults with generalised obesity. The scale of medical need is matched by the scale of market opportunity.
Novo Nordisk launched Wegovy in India in June 2025 and cut prices by 37% in November 2025 ahead of the patent cliff it knew was coming. It could see what the law would do on March 20 2026. Generic entry was not a surprise. It was a legal inevitability written into the system 20 years earlier when the patent was filed.
The moment the patent expired the legal framework did three things simultaneously. It removed exclusivity. It validated every preparation that generic companies had made under the Bolar exemption. And it enabled a price competition that Section 3(d) ensured could not be reversed through evergreening.
That is not an accident. That is Indian patent law working as intended.
What Companies Rejected Under Section 3(d) Can and Cannot Do
For any innovator company that loses a patent application because of Section 3(d) the question becomes: what now?
The company cannot simply refile the same derivative compound hoping for a different result. The rejection establishes that the compound does not meet the patentability threshold under Indian law. However the company retains several options.
It can file a new application for a genuinely distinct new compound rather than a derivative of the known substance. If the new compound has a different molecular structure and can demonstrate significantly enhanced therapeutic efficacy that new compound may qualify for protection. The law does not prevent true innovation. It prevents gaming of the system through marginal modifications.
It can protect its manufacturing process through a separate process patent even if the product compound is not patentable. This provides more limited protection but it is legally available and enforceable.
It can invest in regulatory data exclusivity which is separate from patent protection. Under Indian pharmaceutical regulations the data submitted to obtain regulatory approval for a new chemical entity may receive a period of data exclusivity during which generic applicants cannot rely on that data to obtain their own approval. However India's data exclusivity framework is less developed than those in the United States or European Union and does not provide the same length of protection.
It can compete on brand recognition price and distribution as Novo Nordisk is now attempting to do in the Indian GLP-1 market. Analysts suggest that a brand premium of 15 to 20 percent above generic prices may be sustainable if physicians and patients perceive value in the original. This is a business strategy not a legal one but the law determines the competitive conditions within which that strategy must work.
Regulatory Oversight After Patent Expiry: The DCGI's Role
The explosion of generic GLP-1 launches in India has not gone unregulated. The Drugs Controller General of India has intensified surveillance of the supply chain conducting inspections at 49 entities across the country covering online pharmacy warehouses, drug wholesalers, retailers and wellness clinics.
The Indian Medical Association has sought stricter prescription rules demanding that GLP-1 drugs be prescribed only by qualified specialists such as endocrinologists, diabetologists and MD general medicine doctors. A public interest litigation was filed in the Delhi High Court questioning approvals for GLP-1 receptor agonists for obesity without large India-specific clinical trials.
These regulatory and judicial proceedings are separate from patent law but they interact with it. A patent protects a company's commercial exclusivity. Regulatory law protects the public from harm. When patent protection ends and generic competition floods the market the burden on the regulatory system increases because more products and manufacturers require oversight.
The Patents Act and the Drugs and Cosmetics Act operate as parallel but connected systems. A generic drug company that successfully navigates patent law still must obtain independent regulatory approval from the CDSCO. The Bolar exemption helps with that preparation but it does not substitute for it.
A Summary of the Critical Time Periods Under Indian Patent Law
To bring all of this together here are the key statutory time periods that determine the fate of a patent in India.
The patent term runs for 20 years from the date of filing under Section 53. Renewal fees are payable annually from the second year of the term onward to keep the patent in force. The window to request examination of an application is 48 months from the priority date or filing date. The applicant has 12 months from the FER to respond and put the application in order. Pre-grant opposition can be filed at any time after publication and before grant under Section 25(1). Post-grant opposition must be filed within 12 months from the date of publication of the grant in the Official Gazette under Section 25(2). A compulsory licence application under Section 84 can be made after three years from the date of grant. A restoration application for a lapsed patent must be filed within 18 months of the date of lapse under Section 60 and this is a hard non-extendable deadline.
Each of these periods is a legal boundary. Miss any of them and rights are permanently lost.
Conclusion: The Law Is the Product
India's GLP-1 moment is not simply a story about cheap drugs arriving when expensive ones expire. It is a story about a legal framework that was built with deliberate intentionality to serve a country where 89 million people have diabetes and a quarter of the urban population is overweight.
Section 3(d) blocks evergreening. Section 107A enables preparation. Section 84 provides emergency leverage through compulsory licensing. Sections 60 to 63 allow restoration but within tight boundaries that protect those who acted in good faith during a lapse. And the 20-year patent term itself is the fundamental contract between the innovator and the public: you get your exclusivity and after that the world gets your invention.
Novo Nordisk knew this contract when it filed. Every generic company that launched on March 21 2026 knew it too. The only people who sometimes miss it are observers who mistake the end of a patent for the end of a story.
It is not the end. It is the design working exactly as written.
