Part 3 of the Patents Act and Living Organisms Study Series
Quick Answer
Indian pharmaceutical patent law protects genuine inventions but limits attempts to extend monopolies through minor changes. Section 3(d) addresses evergreening, the PPVFR Act supplies sui generis protection for plant varieties, and compulsory licensing helps protect access to medicines. Together, these mechanisms balance innovation, farmers' rights, biodiversity and public health.
Pharmaceutical patents directly affect who may produce a medicine, the period of exclusivity and the availability of generic alternatives. India therefore combines product-patent protection with statutory safeguards designed for its public-health and agricultural needs.
Patents Act and Living Organisms Complete Study Series
- Biotechnology and Patentability in India
- Status of Biotechnology Patents in India
- Evergreening, Sui Generis Protection and Pharmaceutical Patents
What is evergreening of patents?
Evergreening describes strategies used to obtain further patents around an existing pharmaceutical product, often through new forms, formulations, dosages or uses, in a manner that may delay generic competition beyond the practical commercial life of the original patent.
Not every improvement is evergreening. A later pharmaceutical invention can receive protection if it independently satisfies the Patents Act. The concern arises when a claim is based on a minor change that does not make the required technical or therapeutic contribution.
How does Section 3(d) prevent evergreening?
Section 3(d) of the Patents Act, 1970 excludes the mere discovery of a new form of a known substance unless it results in enhancement of the known efficacy of that substance. Its explanation identifies forms such as salts, esters, ethers, polymorphs, metabolites and other derivatives as the same substance unless they differ significantly in properties regarding efficacy.
Section 3(d) does not prohibit all incremental pharmaceutical inventions. It requires the applicant to cross the statutory threshold where the claim concerns a new form of a known substance.
What did Novartis AG v Union of India decide?
Novartis sought a patent for the beta crystalline form of imatinib mesylate, used in the medicine Glivec. The Supreme Court examined the relationship between the definition of invention and Section 3(d).
The Court treated therapeutic efficacy as the relevant standard for a medicine and found that the material relied upon did not establish the required enhancement. Improved properties such as better flow, stability or bioavailability do not automatically prove enhanced therapeutic efficacy without the necessary evidence.
The official Supreme Court judgment is the leading authority on Section 3(d).
Exam Note: Novartis does not state that every improvement to a known medicine is unpatentable. It explains the additional statutory test applicable to a new form of a known substance.
What is sui generis protection?
Sui generis means a system of its own kind. It refers to a specialised legal framework created for subject matter that does not fit comfortably within conventional patents, copyright or trade marks.
India uses specialised systems for plant varieties, farmers' rights, biological resources and traditional knowledge because patent law excludes several forms of biological subject matter.
| Subject matter | Main protection mechanism | Purpose |
|---|---|---|
| Plant varieties | Protection of Plant Varieties and Farmers' Rights Act, 2001 | Protects eligible varieties and recognises breeders' and farmers' rights |
| Biological resources | Biological Diversity Act, 2002, as amended | Regulates access, intellectual-property applications and benefit-sharing |
| Traditional medicinal knowledge | Traditional Knowledge Digital Library | Helps patent offices identify existing knowledge and prevent wrongful patents |
How does the PPVFR Act protect plant varieties and farmers?
Section 3(j) excludes plants, seeds and varieties from patent protection. The PPVFR Act, 2001 supplies a specialised registration system for plant varieties.
It recognises the interests of plant breeders while preserving defined farmers' rights, including rights concerning seed and farm produce subject to the statutory conditions. This differs from a patent monopoly and reflects India's agricultural and social context.
How are biodiversity and traditional knowledge protected?
The Biological Diversity Act, 2002 operates alongside patent law. The 2023 amendments came into force from 1 April 2024 and changed parts of the access, approval, registration and benefit-sharing framework. The current provisions should therefore be consulted rather than relying only on the original 2002 wording.
The Traditional Knowledge Digital Library records established Indian medicinal knowledge in formats accessible to patent examiners. It helps show that a claimed use was already known and therefore may lack novelty or inventive step. The turmeric and neem controversies illustrate the problem of granting rights over knowledge that communities have used for generations.
How did pharmaceutical patent law develop in India?
The Patents Act, 1970 originally limited protection for medicines and certain chemical substances to processes. This enabled Indian manufacturers to develop alternative processes and contributed to the growth of the generic pharmaceutical industry.
Following India's WTO and TRIPS obligations, the 2005 Amendment reintroduced product patents for pharmaceuticals and chemicals. India retained safeguards including Section 3(d), compulsory licensing and the regulatory-use exception.
What is compulsory licensing?
A compulsory licence permits an authorised person to work a patented invention without the patentee's voluntary licence, subject to statutory conditions and payment to the patentee.
Under Section 84, an application may generally be made after three years from the grant of the patent. The grounds include:
- reasonable requirements of the public have not been satisfied;
- the patented invention is not available at a reasonably affordable price; or
- the patented invention is not worked in the territory of India.
The Controller must consider the statutory factors and settle the terms of any licence.
Why is Bayer v Natco important?
In 2012, the Controller granted Natco a compulsory licence concerning Bayer's patented cancer medicine sorafenib tosylate, sold as Nexavar. The decision examined unmet public requirements, affordability and working of the patent in India. Natco was permitted to sell the medicine at a substantially lower price while paying royalty to the patentee.
The case is studied as India's first compulsory licence under Section 84 and as an example of using patent-law flexibility to improve access to medicines.
What happened in Roche v Cipla?
In the interim-injunction proceedings concerning erlotinib, the Delhi High Court considered the effect of an injunction on access to treatment and refused temporary relief. The official Delhi High Court judgment dated 24 April 2009 is relevant to public-interest analysis at the interim stage.
The dispute later proceeded to a full merits decision. Students should therefore avoid treating the 2009 interim decision as the final determination of infringement.
How does India balance patents and access to medicines?
India recognises pharmaceutical product patents but subjects them to the same patentability rules and public-interest safeguards as other inventions. The principal mechanisms include:
- the patentability requirements in Section 2(1)(j);
- the Section 3 exclusions, especially Section 3(d);
- pre-grant and post-grant opposition;
- compulsory licensing under Sections 84-92;
- government-use provisions; and
- the regulatory-use exception under Section 107A.
This framework seeks to reward genuine research without automatically extending protection for minor changes or preventing lawful measures supporting public health.
Key Takeaways
- Evergreening concerns repeated protection based on insufficiently significant changes.
- Section 3(d) requires the statutory enhancement of efficacy for a new form of a known substance.
- Novartis is the leading Supreme Court authority on therapeutic efficacy.
- Sui generis protection applies to plant varieties and related interests outside patent law.
- Compulsory licensing may be used when the conditions in the Patents Act are established.
- Pharmaceutical product patents returned to India through the 2005 Amendment.
Frequently Asked Questions
Is evergreening expressly defined in the Patents Act?
The Act does not define the word evergreening. Section 3(d) is the principal provision used to prevent patents on specified new forms of known substances that do not meet its efficacy requirement.
Does Section 3(d) ban incremental innovation?
No. An incremental invention may receive a patent if it satisfies all statutory requirements, including Section 3(d) where applicable.
What does therapeutic efficacy mean after Novartis?
For a medicine, the Court focused on therapeutic efficacy. Other improved properties do not by themselves establish the required therapeutic improvement without supporting evidence.
Why are plant varieties protected through a separate law?
Section 3(j) excludes plants and plant varieties from patents. The PPVFR Act supplies a specialised system that also recognises farmers' interests.
When can a compulsory licence application be made under Section 84?
It may generally be made after three years from the date the patent was granted, subject to the grounds and factors stated in the Act.
Was Roche v Cipla finally decided only on public interest?
No. Public interest was important at the interim-injunction stage, but the litigation later proceeded to a final merits determination.
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