Science & Tech· Prelims · GS-III
Owning Ideas: Intellectual Property Rights
Patents, copyright, GI tags, Section 3(d), the Glivec judgment, compulsory licensing, and the National IPR Policy 2016: the complete GS-3 guide to intellectual property rights.
Intellectual property rights (IPR) are the rights given to creators over the creations of their minds: inventions, literary and artistic works, designs, symbols, and names used in commerce. They give the creator an exclusive right over the use of the creation for a fixed period of time. The idea is simple and the tension is permanent: society wants to reward innovation, but it also needs affordable access to its fruits. That tension, between a patent holder's monopoly and a patient's right to medicine, is exactly what UPSC has probed in 2013, 2014, 2015, and 2024.
What intellectual property rights are
The World Intellectual Property Organization (WIPO) defines intellectual property as creations of the mind: inventions, literary and artistic works, designs, and symbols, names, and images used in commerce. WIPO itself is the UN specialized agency for IP, created by convention in 1967. An IPR converts an intangible idea into a legally enforceable asset: the creator can stop others from copying it, license it for a fee, or sell it outright.
The economic logic is the incentive theory: inventing a drug can cost billions, while copying it costs almost nothing, so without temporary exclusivity nobody would invest in the first place. The counter-logic is the access concern: exclusivity means monopoly pricing, which can put life-saving drugs, seeds, and textbooks out of reach. Every IPR debate, from Section 3(d) to compulsory licensing, is this balance being renegotiated. Note also that IPRs are territorial: a patent granted in India protects only in India, which is why firms file separately in each market.
The main types of IPR
IPR is an umbrella, not a single right. Each type protects a different kind of creation, for a different term, under a different Indian law:
Type | What it protects | Indian law and term |
|---|---|---|
Patent | New inventions: products or processes | Patents Act, 1970; 20 years from filing |
Copyright | Literary, artistic, musical, and dramatic works; films and software | Copyright Act, 1957; life of author plus 60 years |
Trademark | Brand names, logos, and symbols that distinguish goods | Trade Marks Act, 1999; 10 years, renewable indefinitely |
Geographical Indication (GI) | Products whose quality flows from their place of origin | GI of Goods Act, 1999; 10 years, renewable |
Industrial design | The ornamental or aesthetic appearance of an article | Designs Act, 2000; 10 years, extendable by 5 |
Trade secret | Confidential business information and know-how | No specific statute; protected by contract |
Semiconductor layout design | The topography of integrated circuits | SICLD Act, 2000; 10 years |
Two distinctions carry marks. A patent protects the idea behind an invention, while copyright protects only its expression: you can copyright a textbook but not the scientific fact inside it. A geographical indication is a collective right owned by a community of producers in a region, unlike a trademark, which belongs to one firm. UPSC's 2014 question asked precisely for the copyright-patent-trade secret distinction, so learn it as definitions, not labels.
Patents: the workhorse of the system
A patent is an exclusive right granted for an invention, which is a product or process that provides a new way of doing something or a new technical solution to a problem. To earn one, an invention must clear three tests. Novelty means it is not already known anywhere in the world. Inventive step means it is not obvious to a person skilled in that field. Industrial application means it can actually be made or used in industry. The standard term is 20 years from the filing date, a floor set by the TRIPS Agreement (Trade-Related Aspects of Intellectual Property Rights), the WTO's 1995 IP treaty that all members must honour.
India's patent history explains its pharma strength. From 1970 to 2005, India granted only process patents on drugs, not product patents: a company could not patent the medicine itself, only its method of manufacture. Indian firms therefore reverse-engineered drugs through new processes and became the world's generic-drug factory. In 2005, to comply with TRIPS, India amended the Patents Act to allow product patents. The same amendment inserted the provision that would define Indian patent law's global identity: Section 3(d).
Patenting life itself. The outer limit of patentability was drawn by the United States Supreme Court in 2013 in the Myriad Genetics case: naturally occurring DNA sequences, such as the BRCA1 and BRCA2 genes linked to hereditary breast cancer, are products of nature and cannot be patented, although artificially made cDNA can be. India's Section 3(c) reaches a similar answer by excluding the discovery of any living or non-living substance occurring in nature. The question examiners keep asking is exactly where discovery ends and invention begins.
Section 3(d): India's shield against evergreening
Evergreening is the strategy of extending a patent monopoly beyond its 20 years by filing secondary patents on minor modifications of an existing drug: a new salt form, a new crystalline polymorph, a new dosage, with no genuine therapeutic improvement. Each secondary patent can block generics for years more. Section 3(d) of the Patents Act answers it bluntly: the mere discovery of a new form of a known substance is not patentable unless it results in significantly enhanced therapeutic efficacy. The key word is efficacy, meaning real clinical benefit, not just better absorption or stability.
The provision faced its ultimate test in Novartis v. Union of India (2013). The Swiss firm sought an Indian patent for the beta-crystalline form of imatinib mesylate, the blood-cancer drug sold as Glivec. Novartis showed about 30 percent better bioavailability, meaning more of the drug reached the bloodstream. On 1 April 2013, the Supreme Court rejected the patent, ruling that improved bioavailability is not enhanced therapeutic efficacy under Section 3(d). The decision kept cheap generics (about Rs 8,000 a month against Novartis's Rs 1.2 lakh) on the market and became the global precedent for using TRIPS flexibilities to protect public health.
Compulsory licensing: when patents bend for public health
Compulsory licensing is a government authorisation allowing a third party to manufacture a patented product without the patent holder's consent, in exchange for a royalty. It is the emergency brake of patent law. Under Sections 84 and 92 of the Patents Act, a licence can issue when the reasonable requirements of the public are not met, the invention is not available at a reasonably affordable price, or it is not worked commercially in India. TRIPS expressly permits such flexibilities.
India pulled the brake for the first time in March 2012, when the Controller of Patents granted Natco Pharma a compulsory licence for sorafenib tosylate, Bayer's kidney and liver cancer drug sold as Nexavar. Bayer's price was about Rs 2.8 lakh a month; Natco's generic cost Rs 8,880, a cut of over 95 percent, with a 6 percent royalty to Bayer (later raised to 7 percent on appeal). The IP Appellate Board upheld the licence in 2013 and the Bombay High Court confirmed it, cementing India's reputation as the developing world's pharmacy and its willingness to use the flexibilities it negotiated.
India's IPR policy architecture
The National IPR Policy, 2016, adopted on 12 May 2016 under the slogan Creative India; Innovative India, is India's first unified IP vision document. It lays down seven objectives: IPR awareness and outreach, generation of IPRs, a sound legal framework, modernised administration, commercialisation, enforcement and adjudication, and human capital development. Implementation sits with the Cell for IPR Promotion and Management (CIPAM) under the Department for Promotion of Industry and Internal Trade (DPIIT), the nodal department for IP.
Protecting traditional knowledge is the distinctly Indian plank. The Traditional Knowledge Digital Library (TKDL), launched in 2001, has documented over 2.9 lakh formulations from Ayurveda, Siddha, Unani, and Yoga, translating them into patent-office languages so examiners worldwide can spot biopiracy, the misappropriation of traditional knowledge. TKDL evidence helped India get the turmeric and neem patents revoked abroad. The Patents Act reinforces this: Sections 3(d) and 3(p) bar patents on mere discoveries of known substances and on traditional knowledge itself.
The GRATK Treaty (2024). In May 2024, after more than two decades of negotiation, WIPO members concluded a treaty on intellectual property, genetic resources and associated traditional knowledge. It requires anyone filing a patent based on genetic resources to disclose the country of origin of those resources and, where the invention rests on associated traditional knowledge, the Indigenous Peoples or local community that provided it.
Why India backed it. Disclosure creates a paper trail: a patent quietly built on a medicinal plant or a tribal remedy now risks refusal or invalidation for hiding its source. The treaty thus strengthens, in binding form, the defensive shield that the Traditional Knowledge Digital Library already provides, and answers the biopiracy grievances behind the turmeric, neem and basmati cases.
Recent reforms try to make the system faster and friendlier. The Patents (Amendment) Rules, 2024 expanded expedited examination and cut the Form 27 working-statement filing from every year to once in three years. The Jan Vishwas (Amendment of Provisions) Act, 2023 decriminalised minor offences under the Patents Act and the Trade Marks Act, converting them into monetary penalties to improve ease of doing business.
India's most cited biopiracy case is basmati rice: in 1997 the US firm RiceTec won an American patent on basmati-type rice lines, triggering protests that India was losing control of a heritage grain. India challenged the claims with evidence of prior cultivation, and the patent's broadest claims were withdrawn; the fight then moved to geographical indication protection, with basmati's GI tag securing the name for rice grown in the Indo-Gangetic plains. The lesson the sources draw is institutional: documentation of traditional knowledge, as the Traditional Knowledge Digital Library does, is what turns heritage into defensible prior art.
A system under strain: the numbers
The statistics reveal a paradox: India files enormously but commercialises thinly. The Indian Patent Office received over 66,000 patent applications in 2021-22, placing India among the world's top six filers, yet only about 5 percent mature into commercially viable products. The reasons UPSC expects you to cite: weak industry-academia linkages (fewer than 10 percent of IIT and CSIR patents reach industry), thin incubation infrastructure, regulatory drag, and public resistance to technologies like GM seeds.
The surge, dated. In 2023-24 India recorded over 90,000 patent applications, the highest in two decades, and granted more than 1,03,000 patents in a single year as the backlog was attacked. Resident applicants filed over half of all applications, which matters because home filings track domestic research output more honestly than grant counts swollen by clearing old files.
Capacity is the deeper constraint. Some 1.64 lakh applications were pending as of March 2022, and disposal takes nearly three times as long as in the US or China. India staffs its patent office with just 956 personnel, against about 13,700 in China and 8,100 in the US. Research intensity is low: India spends only 0.65 percent of GDP on R&D, with the private sector contributing barely 36 percent, far below the 75-plus percent seen in the US, Japan, and China. Add weak enforcement (India stays on the US Priority Watch List), no data-exclusivity law, and new pressure points like the India-UK trade agreement's IP chapter, whose emphasis on voluntary licensing critics (notably the Global Trade Research Initiative) say subtly curtails compulsory-licensing flexibility, a charge the government rejects, insisting sovereign compulsory-licensing rights and the Doha Declaration are fully preserved, and the reform agenda writes itself.
Who gets to file. Women accounted for only about 10.2 per cent of patent filings in India between 2019 and 2021, a reminder that the surge is narrow at its base. Expedited examination for women applicants and lower fees for startups and small entities are attempts to widen the circle of who gets to own ideas.
Way forward: balance as policy
A mains answer should refuse the false choice between innovation and access. The way forward has five planks: cut pendency with fixed examination timelines and more examiners; build IP-backed financing and technology-transfer offices so patents become products; enforce seriously through dedicated IP benches and police IPR cells; defend the TRIPS flexibilities, Section 3(d) and compulsory licensing, in every trade negotiation; and expand TKDL-style protection as AI-generated works and digital piracy raise questions the 2016 policy never imagined. The goal is the policy's own slogan: creative India must also be an India where creations reach the people.
What is evergreening of patents?
Evergreening is the practice of extending a drug's patent monopoly beyond 20 years by patenting minor modifications, like a new salt form or dosage, without real therapeutic improvement. India's Section 3(d) blocks it by demanding significantly enhanced efficacy for any new form of a known substance.
What is the difference between a patent and a copyright?
A patent protects the idea behind an invention, such as a new drug molecule, for 20 years. Copyright protects only the expression of an idea, such as the text of a book or the code of software, typically for the author's life plus 60 years. You cannot copyright a scientific fact.
When was the National IPR Policy adopted and what does it aim to do?
It was adopted on 12 May 2016 as India's first unified IP vision document, with the slogan 'Creative India; Innovative India'. Its seven objectives span awareness, IP generation, legal reform, administration, commercialisation, enforcement, and human capital, implemented by CIPAM under DPIIT.
What is a compulsory licence?
It is a government authorisation letting a company make a patented product without the patent holder's consent, against a royalty. India used it first in March 2012 for Bayer's cancer drug Nexavar, cutting the monthly price from about Rs 2.8 lakh to Rs 8,880 under Sections 84 and 92 of the Patents Act.
Key Terms
- incentive theory: Incentive theory is the economic justification for intellectual property rights: inventing something new costs far more than copying it, so without exclusive rights few would invest in research and innovation. Patents give inventors a temporary monopoly to earn back their investment, creating an incentive to invent. The theory is balanced against the access concern, that monopolies raise prices and restrict who can use the invention. Example: The standard 20-year patent term under the TRIPS Agreement, which rewards the inventor while ensuring the invention eventually enters the public domain.
- access concern: The access concern is the classic counter-argument in the intellectual property debate: while patents and other exclusive rights incentivise innovation by letting inventors recoup high research costs, exclusivity also permits monopoly pricing. Monopoly pricing can place life-saving drugs, climate technologies, improved seeds and textbooks beyond the reach of the poor, especially in developing countries. The negotiated middle ground is TRIPS flexibilities such as compulsory licensing, which let governments permit generic production in public-interest situations. Example: Compulsory licensing of patented cancer drugs or affordable generic versions of HIV medicines illustrates the tension between incentive and access.
- territorial: In intellectual property law, 'territorial' means that IP rights exist only within the jurisdiction that grants them. A patent granted in India protects the invention only in India, which is why firms must file separately in each country where they want protection. International systems such as the Patent Cooperation Treaty exist to simplify this multi-country filing. Example: A company that patents a drug in India must file a separate application in the United States to stop copying there.
- patent: A patent is an exclusive legal right granted by the state to an inventor for an invention that is new, involves an inventive step, and is capable of industrial application, typically lasting 20 years. In exchange for publicly disclosing how the invention works, the patentee can exclude others from making, using, or selling it. In India the system is governed by the Patents Act, 1970, as amended to meet TRIPS obligations. Example: Pharmaceutical product patents, which let a company exclusively market a new drug for 20 years before generic versions can enter.
- copyright: Copyright is a bundle of legal rights granted to creators of original literary, dramatic, musical and artistic works, cinematograph films and sound recordings, covering reproduction, adaptation, distribution and public communication. In India, under the Copyright Act, 1957, it generally lasts for the life of the author plus 60 years. Example: A novelist's exclusive right to authorise translations and film adaptations of her book is protected by copyright.
- Trademark: A trademark is a distinctive sign, word, logo, shape, colour or sound that identifies a business's goods or services and distinguishes them from competitors. Registered under India's Trade Marks Act of 1999, it gives the owner exclusive rights for renewable ten-year terms and can be enforced against infringement and passing off. Trademarks protect brand identity and consumer trust in the marketplace. Example: Registered brand marks such as the Amul girl logo or the Tata wordmark.
- Industrial design: The ornamental or aesthetic aspect of a useful article, covering features of shape, configuration, pattern, ornament or composition of lines and colours applied to an article by an industrial process. In India, designs are protected under the Designs Act, 2000, which gives the owner exclusive rights, separating design protection from patent protection for functional inventions. Example: The distinctive shape of a smartphone handset or the pattern woven into a textile can be protected as an industrial design.
- Trade secret: A trade secret is confidential business information, such as a formula, process, design or customer list, that derives commercial value from being secret and is protected by the owner's reasonable efforts to keep it so. Unlike patents, trade secrets need no registration and have no fixed term, but protection evaporates if the secret is independently discovered or reverse-engineered. Indian law protects them mainly through contracts and breach-of-confidence actions. Example: The Coca-Cola recipe, guarded as a trade secret for well over a century instead of being patented.
- Semiconductor layout design: Semiconductor layout design refers to the three-dimensional topography of a chip, the arrangement of transistors and interconnections, which is protected in India as a sui generis intellectual property right under the Semiconductor Integrated Circuits Layout-Design Act, 2000. Registration gives the creator exclusive rights for ten years against unauthorised reproduction of the layout. It is one of the lesser-known IP categories asked in prelims alongside patents, trademarks and geographical indications.
- geographical indication: A geographical indication is an intellectual property tag granted to a product whose quality, reputation, or special character comes essentially from the place where it is made. It assures buyers of authenticity and stops producers elsewhere from free-riding on the region's name. In India, GI tags are registered under the Geographical Indications of Goods (Registration and Protection) Act, 1999. Example: Darjeeling tea, the first Indian product to receive a GI tag, can only be labelled Darjeeling if it is grown in the Darjeeling region.
- Novelty: In patent law, novelty is one of the three core conditions for patentability, alongside inventive step and industrial applicability. An invention is novel if it does not form part of the prior art, meaning no identical invention has been disclosed publicly anywhere in the world before the application's priority date. Even a single prior publication or public use can destroy novelty. Example: A drug molecule whose exact chemical structure was already published in a research paper would fail the novelty test and could not be patented.
- Inventive step: One of the three requirements for a patentable invention, defined in Section 2(1)(ja) of the Patents Act, 1970 as a feature of an invention that involves technical advance or economic significance and is not obvious to a person skilled in the art. It distinguishes genuine inventions from trivial or routine modifications of existing knowledge. Example: A minor change in a drug's dosage form that any skilled pharmacist would find obvious lacks an inventive step and cannot be patented.
- Industrial application: In patent law, one of the three requirements for a patentable invention, alongside novelty and inventive step, meaning the invention can be made or used in some kind of industry. Under the Patents Act, 1970, an invention is defined as a new product or process involving an inventive step and capable of industrial application. Example: A new manufacturing process for solar cells is capable of industrial application, while a purely abstract mathematical method is not.
- TRIPS Agreement: The TRIPS Agreement, or the Agreement on Trade-Related Aspects of Intellectual Property Rights, is a WTO agreement that came into force in 1995 setting minimum global standards for intellectual property protection, including patents, copyrights and trademarks. It also contains flexibilities, affirmed by the 2001 Doha Declaration, letting countries protect public health, which India used to build its affordable generic medicines industry. Example: India amended its Patents Act to comply with TRIPS while using its public-health flexibilities for affordable medicines.
- process patents: A process patent protects only the method or process of making a product, not the product itself. Under this regime, a competitor can legally sell the same product if it manufactures it through a different process. India granted only process patents for pharmaceuticals and agrochemicals from 1970 until the TRIPS-mandated shift to product patents in 2005. Example: Before 2005, Indian generic drug makers reverse-engineered patented medicines through alternative manufacturing processes, which let them sell affordable versions of the same drug.
- product patents: A product patent protects the product itself, regardless of how it is made, giving the holder a monopoly over the invention for 20 years. No one may make, use or sell the patented product without a licence, even through a different process. India introduced product patents for pharmaceuticals and agrochemicals through the Patents (Amendment) Act, 2005, to comply with the WTO's TRIPS Agreement. Example: A patented cancer drug under product-patent protection cannot be copied by generic firms in India, though compulsory licensing under Section 84 of the Patents Act remains available in the public interest.
- Evergreening: Evergreening is the practice of extending a drug patent's monopoly life through minor, incremental modifications to an existing medicine rather than a genuine new invention. India's Patents Act counters it through Section 3(d), which denies patents to new forms of known substances unless they show significantly enhanced therapeutic efficacy. The Supreme Court's 2013 ruling in Novartis v. Union of India is the landmark Indian case upholding this provision. Example: Novartis's bid to patent the beta-crystalline form of imatinib mesylate (Glivec) was rejected under Section 3(d) as evergreening.
- efficacy: Efficacy is the capacity of a drug or treatment to produce a real therapeutic (clinical) benefit in patients, as distinct from merely improving properties like absorption or stability. In Indian patent law it is the decisive test under Section 3(d) of the Patents Act, which bars patents on new forms of known substances unless they show significantly enhanced therapeutic efficacy, a provision aimed at preventing evergreening. The Supreme Court's Novartis v. Union of India judgment of 1 April 2013 held that the improved bioavailability of imatinib mesylate (Glivec) was not enhanced therapeutic efficacy, keeping affordable generics on the market. Example: In the Glivec case, the Court ruled that a new salt form's better absorption did not amount to enhanced therapeutic efficacy, so no patent was granted.
- imatinib mesylate: Imatinib mesylate is a targeted cancer drug that blocks a faulty protein driving the uncontrolled growth of white blood cells. It is the standard treatment for chronic myeloid leukemia and is sold by Novartis under the brand name Glivec (Gleevec). In India it became famous through a landmark patent ruling on evergreening. Example: In 2013 the Supreme Court of India rejected Novartis's patent on the beta crystalline form of imatinib mesylate under Section 3(d) of the Patents Act, holding that it showed no enhanced therapeutic efficacy, a decision that kept affordable generic versions available.
- Glivec: Glivec is the brand name of imatinib, a targeted therapy developed by Novartis that transformed chronic myeloid leukaemia from a fatal disease into a manageable condition. In Novartis v. Union of India (2013), the Supreme Court of India rejected a patent for Glivec's beta-crystalline form under Section 3(d) of the Patents Act, ruling it was not a genuine invention but a mere new form of a known substance. Example: The 2013 Supreme Court verdict on Glivec kept affordable generic imatinib available in India and is a landmark in the balance between patent rights and public health.
- Compulsory licensing: Compulsory licensing is the grant by a government of a licence to make a patented product without the patent holder's consent, on payment of a royalty. In India it is governed by Sections 84 and 92 of the Patents Act, 1970: Section 84 allows a licence three years after grant if the reasonable requirements of the public are not satisfied, the invention is not available at a reasonably affordable price, or it is not worked in India, while Section 92 covers national emergencies and public non-commercial use. The power flows from the flexibility in Article 31 of the WTO's TRIPS Agreement, affirmed by the 2001 Doha Declaration on public health. Example: In 2012 India issued its first compulsory licence to Natco Pharma for Bayer's cancer drug Nexavar (sorafenib), cutting the monthly treatment cost from over Rs 2.8 lakh to about Rs 8,880, with the royalty fixed at 6 percent and later raised to 7 percent.
- Sections 84 and 92: Sections 84 and 92 of the Patents Act, 1970 provide for compulsory licensing, allowing the government to permit production of a patented invention without the patent holder's consent. Section 84 allows any person to seek a compulsory licence three years after grant if the patent's reasonable requirements are unmet, it is not available at a reasonably affordable price, or it is not worked in India. Section 92 provides a faster route on notification by the central government in cases of national emergency, extreme urgency or public non-commercial use. Example: The 2012 compulsory licence granted to Natco for Bayer's cancer drug Nexavar (sorafenib) under Section 84.
- Natco Pharma: Natco Pharma is an Indian pharmaceutical company headquartered in Hyderabad, known for affordable generic versions of cancer and hepatitis medicines. It made history in 2012 when India granted its first-ever compulsory licence, to Natco, to manufacture Bayer's patented cancer drug Nexavar (sorafenib), bringing the monthly treatment cost down from about Rs 2.8 lakh to Rs 8,800. The case is a landmark example of India's use of TRIPS flexibilities to balance patent rights with public health. Example: Natco's compulsory licence for generic sorafenib, used in kidney and liver cancer, cut the monthly cost to Rs 8,800.
- sorafenib tosylate: Sorafenib tosylate is a targeted anti-cancer drug sold by Bayer as Nexavar for advanced liver and kidney cancer, working by blocking the growth of tumour blood vessels. It became famous in India when the Patent Office granted Natco Pharma the country's first compulsory licence in March 2012 under Section 84 of the Patents Act, because Bayer's price of about Rs 2.8 lakh a month put the drug beyond the reach of most patients. Natco sold its version at about Rs 8,800 a month while paying Bayer a six percent royalty. Example: India's first compulsory licence (2012) let Natco Pharma make a generic version of sorafenib at one-thirtieth of Bayer's price.
- Nexavar: The brand name of sorafenib tosylate, Bayer's patented drug for kidney and liver cancer, which became the subject of India's first compulsory licence in March 2012. The Controller General granted Natco Pharma a licence under Sections 84 and 92 of the Patents Act, 1970, after finding Bayer's price unaffordable and its supply inadequate, letting Natco sell the generic at about Rs 8,880 a month against Bayer's roughly Rs 2.8 lakh. Example: The licence, upheld by the Intellectual Property Appellate Board in 2013 and the Bombay High Court in 2014, is the landmark Indian test of TRIPS flexibilities for public health.
- National IPR Policy, 2016: The National IPR Policy, 2016, titled 'Creative India: Innovative India', is India's comprehensive framework for promoting innovation and intellectual property awareness. It seeks to strengthen IP administration, modernise patent and trademark offices, encourage IP commercialisation and foster IP as a marketable financial asset. It also reaffirms India's commitment to balancing IP rights with public interest, including flexibilities under the TRIPS agreement for public health. Example: The policy led to the SIPP scheme, under which startups get expedited patent examination and fee concessions.
- Creative India; Innovative India: Creative India; Innovative India is the national slogan adopted by India's first National Intellectual Property Rights Policy, approved by the Cabinet in May 2016. It is the banner for the policy's first objective, IPR awareness and outreach, and is used in campaigns linking intellectual property to national initiatives such as Make in India, Digital India, Skill India and Start-Up India. The policy is implemented by the Cell for IPR Promotion and Management (CIPAM) under the Department for Promotion of Industry and Internal Trade. Example: IP awareness programmes in schools and universities run under the Creative India; Innovative India slogan to encourage students to protect and commercialise their innovations.
- Traditional Knowledge Digital Library (TKDL: The Traditional Knowledge Digital Library (TKDL) is a digital repository created in 2001 by the Council of Scientific and Industrial Research with the Department of AYUSH to document India's traditional medicinal knowledge, including Ayurveda, Unani, Siddha and Yoga formulations, in five international languages. It exists to prevent biopiracy by giving patent offices prior-art evidence against wrongful patents on Indian knowledge. For UPSC it links intellectual property, traditional knowledge and biodiversity questions in prelims and GS-3. Example: set up in 2001 by CSIR and the Department of AYUSH
- Biopiracy: Biopiracy is the unauthorized commercial exploitation of a country's biological resources or the traditional knowledge of its indigenous and local communities, typically by foreign corporations patenting products derived from them without sharing benefits. It raises issues of intellectual property rights, benefit-sharing and biodiversity conservation under the Convention on Biological Diversity and India's Biological Diversity Act, 2002. For UPSC, it links environment, science and technology, and IPR in both prelims and mains. Example: the patent on turmeric's wound-healing properties, revoked by the US Patent Office in 1997 after India's challenge
- Patents (Amendment) Rules, 2024: Notified on 15 March 2024, these rules amend the Patents Rules, 2003, to speed up and simplify India's patent system. The deadline for a Request for Examination fell from 48 to 31 months; foreign-filing disclosures (Form 3) are needed only twice; the patent working statement (Form 27) is filed once every three years instead of annually; a 10 percent renewal-fee discount rewards advance electronic payment; and a new Certificate of Inventorship formally recognises inventors. Example: An applicant filing a patent after March 2024 must request examination within 31 months of the priority date or the application lapses.
- Form 27: Form 27 is the statutory statement regarding the working of a patented invention on a commercial scale in India, filed with the Indian Patent Office under Section 146(2) of the Patents Act, 1970 and Rule 131(1) of the Patents Rules. It requires the patentee or licensee to declare whether the patent has been commercially worked in India, the reasons if not, and whether it is available for licensing. Under the Patents (Amendment) Rules, 2024, it is now filed once every three financial years instead of annually, and non-filing can invite penalties and compulsory licensing risk. Example: A pharmaceutical company holding an Indian drug patent must file Form 27 declaring whether the drug is manufactured or sold in India.
- Jan Vishwas (Amendment of Provisions) Act, 2023: The Jan Vishwas (Amendment of Provisions) Act, 2023, notified on 11 August 2023, decriminalised 183 provisions across 42 Central Acts administered by 19 ministries and departments, replacing imprisonment for minor, technical, or procedural defaults with monetary penalties. It matters for UPSC as the centrepiece of the ease-of-doing-business and trust-based-governance reform push. Example: Minor offences under laws such as the Patents Act shifted from jail terms to civil penalties.
- Priority Watch List: The Priority Watch List is a category in the United States Trade Representative's annual Special 301 Report, which reviews how trading partners protect and enforce intellectual property rights. Countries placed on it are judged to have serious problems with IP protection, enforcement, or market access for IP-dependent goods and services. India has remained on the Priority Watch List since the 1990s, and was retained in the 2026 report alongside China, Russia, Indonesia, Chile, and Venezuela. Example: The USTR Special 301 Report 2026 retaining India on the Priority Watch List over pharmaceutical patent and piracy concerns
- India-UK trade agreement's: The India-UK trade agreement is the Comprehensive Economic and Trade Agreement (CETA) between India and the United Kingdom, signed on 24 July 2025 and in force from 15 July 2026. Its intellectual property chapter has drawn criticism for nudging India from compulsory toward voluntary licensing, a pressure point for India's access-to-medicines stance. Example: Critics argue the agreement's IP chapter could constrain India's use of compulsory licensing to keep medicines affordable.
- Key takeaways: Key takeaways is a quick-revision summary box placed at the end of each article, listing the most exam-relevant points in a short numbered list. It distils definitions, dates, figures, provisions and examples into a form suited for last-minute revision before Prelims and Mains. Together with the article's practice questions, it turns every topic into a self-contained study unit.
- Intellectual property rights (IPR): Legal rights granted to creators and inventors over their intellectual creations, giving them exclusive control over the use of their inventions, literary and artistic works, designs, symbols, names and trade secrets for a defined period. The main forms are patents, copyright, trademarks, industrial designs, geographical indications and plant variety protection, governed internationally by the WTO's TRIPS Agreement. Example: A pharmaceutical company's patent on a new drug molecule is an intellectual property right that lets it exclusively market the drug for the patent term.
- World Intellectual Property Organization (WIPO): The World Intellectual Property Organization (WIPO) is the United Nations specialised agency for intellectual property, established by the WIPO Convention in 1967 (becoming a UN agency in 1974) and headquartered in Geneva with 193 member states. It administers the global IP registration systems and key treaties, including the Patent Cooperation Treaty for international patents, the Madrid System for trademarks, the Hague System for industrial designs, and the Paris and Berne Conventions. Its mission is to lead the development of a balanced and effective international IP system that enables innovation and creativity for the benefit of all. Example: A company files one PCT application through WIPO to seek patent protection in multiple countries instead of filing separately in each.
- Section 3(d): Section 3(d) of the Patents Act, 1970 (inserted by the 2005 amendment) bars patents for the mere discovery of a new form of a known substance unless it shows significantly enhanced efficacy, a provision aimed at preventing evergreening of pharmaceutical patents. It became famous when Novartis's patent application for the beta-crystalline form of imatinib mesylate (Glivec) was rejected, a decision upheld by the Supreme Court in 2013. It is a key safeguard for India's generic drug industry. Example: The Supreme Court's 2013 rejection of Novartis's Glivec patent under Section 3(d).
- Novartis v. Union of India (2013): A landmark Supreme Court of India judgment interpreting Section 3(d) of the Patents Act, 1970, which bars patents for mere new forms of known substances unless they show significantly enhanced therapeutic efficacy. The court rejected Novartis's patent claim on the beta crystalline form of imatinib mesylate (sold as Glivec/Gleevec, a blood cancer drug), holding that improved bioavailability alone did not prove enhanced efficacy. The ruling set the legal test against evergreening and preserved access to affordable generic medicines in India. Example: After the 2013 ruling, Indian generic manufacturers continued producing low-cost versions of the leukaemia drug imatinib mesylate instead of it being locked behind a patent monopoly.
- Cell for IPR Promotion and Management (CIPAM): The Cell for IPR Promotion and Management (CIPAM) is a professional body set up under the Department for Promotion of Industry and Internal Trade (DPIIT) to implement the National Intellectual Property Rights Policy of 2016. It spreads awareness about intellectual property among startups, universities and MSMEs and facilitates the protection and commercialisation of Indian IP. It runs outreach programmes including IPR awareness campaigns in schools and support for patent filing by startups.
- GRATK Treaty: The WIPO treaty on intellectual property, genetic resources and associated traditional knowledge, concluded in May 2024, which requires patent applicants whose inventions are based on genetic resources to disclose the resources' country of origin and, for associated traditional knowledge, the Indigenous Peoples or local community that provided it. Example: India championed the GRATK Treaty as a treaty-level check on biopiracy of resources such as neem and turmeric.
Prelims practice
Test yourself with these prelims-style questions.
With reference to Section 3(d) of the Patents Act, 1970, consider the following statements:
1. It prevents evergreening by barring patents on new forms of known substances without enhanced therapeutic efficacy.
2. It was upheld by the Supreme Court in Novartis v. Union of India (2013).
Show answer
Answer: (C) Both statements are correct: Section 3(d) targets evergreening and was upheld in the 2013 Novartis judgment.
India's first compulsory licence was granted in 2012 to Natco Pharma for:
Show answer
Answer: (B) The 2012 compulsory licence covered Bayer's Nexavar (sorafenib); Glivec was the Novartis Section 3(d) case.
Consider the following statements about intellectual property rights in India:
1. Copyright protects the expression of an idea, not the idea itself.
2. A geographical indication is a collective right of producers in a region, unlike a trademark.
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Answer: (C) Both are correct: copyright covers expression, and GIs are collective regional rights.
The National IPR Policy, 2016:
Show answer
Answer: (A) The policy was adopted 12 May 2016 with that slogan; patent term remains 20 years.
The Traditional Knowledge Digital Library (TKDL) is best described as:
Show answer
Answer: (B) TKDL documents traditional knowledge so patent offices can reject biopiracy claims.
Answer key
- (c): Both statements are correct: Section 3(d) targets evergreening and was upheld in the 2013 Novartis judgment.
- (b): The 2012 compulsory licence covered Bayer's Nexavar (sorafenib); Glivec was the Novartis Section 3(d) case.
- (c): Both are correct: copyright covers expression, and GIs are collective regional rights.
- (a): The policy was adopted 12 May 2016 with that slogan; patent term remains 20 years.
- (b): TKDL documents traditional knowledge so patent offices can reject biopiracy claims.
Mains Practice question
Q1. Intellectual property rights must balance private profit with public health. Discuss in the context of Section 3(d) and compulsory licensing in India. (250 words)
- Balance frame: incentive theory vs access concern; TRIPS flexibilities as the negotiated middle.
- Section 3(d): evergreening defined; Novartis Glivec 2013, efficacy vs bioavailability; kept generics affordable.
- Compulsory licensing: Sections 84/92; Natco-Bayer 2012, Rs 2.8 lakh to Rs 8,880; upheld by IPAB and Bombay HC.
- Counterpoints: industry fears, R&D investment, trade pressure (USTR Priority Watch List, India-UK FTA's IP chapter).
- Conclusion: calibrated use, not abandonment; India as pharmacy of the developing world.
Q2. UPSC's 2024 paper premised that India is 'second in the world to file patents', yet few are commercialised. Examine the reasons and suggest measures. (150 words)
- Paradox data: over 66,000 filings in 2021-22 (among the world's top six filers), ~5 percent commercialised.
- Reasons: weak industry-academia links, funding gaps, regulatory hurdles, thin incubation, 1.64 lakh pendency.
- Measures: TTOs, IP-backed financing, Patent Facilitation Centres, Atal Innovation Mission, faster examination.
Q3. How is India protecting its traditional knowledge from biopiracy? Evaluate the role of TKDL. (150 words)
- Threat: turmeric, neem patents abroad; 90 percent of biodiversity-linked TK unprotected globally.
- TKDL: 2001, 2.9 lakh formulations, multilingual, prior-art evidence for examiners.
- Legal backing: Patents Act Sections 3(d)/3(p), Biological Diversity Act 2002.
- Evaluation: defensive success vs commercialisation gap; open-source licensing debate from 2015 PYQ.
Asked in the mains
Previous-year questions from this topic
How UPSC has actually asked this topic — with the year and marks for each question.
- 201310 marks
Bring out the circumstances in 2005 which forced amendment to section 3(d) in the Indian Patent Law, 1970. Discuss how it has been utilized by Supreme court in its judgment rejecting Novartis patent application for “Glivec”. Discuss briefly the pros and cons of the decision. [10] 92
- 201412.5 marks
In a globalised world, intellectual property rights assume significance and are a source of litigation. Broadly distinguish between the terms – copyrights, patents and trade secrets.
- 201512.5 marks
India’s Traditional Knowledge Digital Library (TKDL) which has a database containing formatted information on more than 2 million medicinal formulations is proving a powerful weapon in the country’s fight against erroneous patents. Discuss the pros and cons making this database publicly available under opensource licensing.
- 201915 marks
How is the government of India protecting traditional knowledge of medicine from patenting by pharmaceutical companies?
- 202410 marks
What is the present world scenario of intellectual property rights with respect to life materials? Although India is second in the world to file patents, still only a few have been commercialized. Explain the reasons behind this less commercialization.
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