Pharmaceutical products and processes can be patented in India for 20 years. A new chemical entity, a new process for making a drug, and a new formulation with a real benefit can all qualify. Under Section 3(d), a new form of a known substance (a salt, ester, polymorph, isomer and so on) is not patentable unless it shows significantly enhanced therapeutic efficacy, as the Supreme Court held in Novartis v Union of India (2013). Methods of treating patients are excluded under Section 3(i).
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Usually patentable
- New chemical entities (new active molecules)
- New and inventive processes for making a drug or intermediate
- Formulations with a synergistic or unexpected effect, or a technical advance such as better stability
- New forms of known drugs, only with data showing significantly enhanced therapeutic efficacy
- Drug-delivery systems and devices
Usually not patentable
- New salts, polymorphs, isomers, esters etc. of a known drug without enhanced therapeutic efficacy (Section 3(d))
- A new use of a known drug (Section 3(d))
- Simple mixtures where each ingredient just does its own job (Section 3(e))
- Methods of treatment, diagnosis or surgery on humans or animals (Section 3(i))
- Traditional knowledge, including known ayurvedic uses (Section 3(p))
Product and process patents since 2005
Since the Patents (Amendment) Act, 2005, India grants patents for pharmaceutical products as well as processes. A patent lasts 20 years from the filing date, subject to yearly renewal fees.
Section 3(d): India's 'evergreening' rule
Section 3(d) says a new form of a known substance is not an invention unless it "differs significantly in properties with regard to efficacy". Its Explanation lists the forms covered: salts, esters, ethers, polymorphs, metabolites, pure forms, particle sizes, isomers, mixtures of isomers, complexes, combinations and other derivatives.
In Novartis AG v Union of India (Supreme Court, 1 April 2013), the court refused a patent for the beta-crystalline form of imatinib mesylate (Glivec). It held that for medicines, "efficacy" means therapeutic efficacy: better physical properties such as improved bioavailability, stability or flow are not enough by themselves unless they translate into a therapeutic benefit, which must be proved with data.
What this means in practice
- Plan your comparative data early: the new form against the known form, on therapeutic endpoints where possible.
- Put the data in the specification, or be ready to file it with the examination reply.
- Claim the process of making the new form separately: process claims are not barred by 3(d).
Formulations and combinations
Under Section 3(e), a mixture whose properties are only the sum of its ingredients is not patentable. A combination or formulation needs a synergistic effect (more than additive) or a real technical advance, such as solving a stability or solubility problem. Show this with experimental data in the specification.
Other rules every pharma applicant should know
| Provision | What it means |
|---|---|
| Section 3(i) | Methods of treating, diagnosing or operating on humans or animals cannot be patented; claim the product or the composition instead |
| Section 8 | If you file the same invention abroad, you must keep the Indian Patent Office informed (Form 3) |
| Section 10(4)(d)(ii) | If the invention uses biological material, disclose its source and geographical origin, and deposit new micro-organisms with a recognised depository |
| Biological Diversity Act | Inventions using Indian biological resources or associated knowledge need National Biodiversity Authority approval before the patent is granted |
| Section 25 | Anyone can oppose before grant, and an interested person can oppose within one year after grant, which is common in pharma |
| Section 84 | Compulsory licences can be granted after three years if the drug isn't reasonably available or affordable, as in Natco v Bayer (2012) |
| Section 107A | Others can use your patented invention to develop data for regulatory approval (the 'Bolar' exemption) |
Ayurvedic and herbal products
Known uses of plants and traditional remedies are excluded under Section 3(p), and the Traditional Knowledge Digital Library (TKDL) is used by examiners to find them. A new extraction process, a standardised extract with proven new activity, or a synergistic combination backed by data can still qualify.
Frequently asked questions
Can I patent a new salt or polymorph of an existing drug in India?
Only if you can show significantly enhanced therapeutic efficacy compared with the known form, with data. Otherwise Section 3(d) excludes it. The process of making it may still be patentable.
Can a new use of an existing medicine be patented?
No. Section 3(d) excludes the mere discovery of a new use for a known substance. This is stricter than in Europe or the US.
Can I patent a combination of two known drugs?
Only if the combination shows a synergistic effect or another technical advance, proved with data. A combination where each drug simply does its own job falls under Section 3(e).
Does a patent let me sell the drug in India?
No. A patent only lets you stop others. You still need marketing approval from the drug regulator (CDSCO and the State licensing authority).
How long does a pharma patent last in India?
20 years from the filing date, provided renewal fees are paid every year after grant.
Patent guides for other technologies
Software and apps · AI and machine learning · Medical devices and diagnostics · Mechanical and product inventions · EV, battery and clean-tech · Agritech and food processing
Not sure about your invention? Try our free patentability checker.
Also read: What cannot be patented in India · How to patent an idea in India
This guide is general information, not legal advice. Whether your invention can be patented depends on its details and the prior art; speak to a registered patent agent about your case.