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Subject: IPR

  • What an infrastructure of innovation depends on: a responsive legal system

    What an infrastructure of innovation depends on: a responsive legal system

    Why in the News

    The Delhi High Court’s model for intellectual property (IP) disputes has been held up as a framework for courts serving India’s other innovation and commercial hubs. Other courts can copy it only with equal investment in their infrastructure, because investors in innovation need courts that settle disputes fast.

    What changed in India’s patent regime after 2005?

    1. What a product patent is: A product patent protects the chemical itself, not just one way of making it. It is like owning the recipe, not one kitchen method.
    2. The 2005 amendment: The last major amendment to the Patents Act, 1970 restored product patents for chemicals, affecting pharmaceuticals, biotechnology and agro-chemicals.
    3. Why it came: World Trade Organization (WTO) membership bound India to the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement’s common minimum IP rules, which leave room to protect public health.
    4. Public interest guardrails: India kept safeguards so patents do not hurt the public:
      • compulsory licences, letting others make a patented product in the public interest;
      • checks on evergreening, extending a patent through minor changes;
      • a local working rule, requiring the invention to be commercially used in India;
      • competition law curbs on abuse of IP monopolies.
    5. The takeaway: Stronger rights multiplied IP, from trademarks and copyrights to geographical indications, industrial designs, semiconductor layouts and plant varieties, so disputes multiplied too.

    Why did disputes rise, and how did the legal system respond?

    1. Complex commerce: After liberalisation, Indian firms competed globally under WTO rules, so IP and commercial disputes rose sharply. Foreign investors, then Indian firms, demanded faster, skilled courts.
    2. Ranking pressure: Speed and quality of dispute resolution became a metric in global ease of doing business rankings.
    3. Alternative Dispute Resolution (ADR): The first response promoted arbitration and mediation, private settlement outside court.
    4. Commercial Courts Act, 2015: The second response let State governments set up dedicated commercial courts in consultation with their High Courts. It amended the Code of Civil Procedure to speed commercial cases.

    What is alternative dispute resolution?

    1. Meaning: ADR settles a dispute privately, outside the court system, with minimal court interference.
    2. Forms: It takes the form of arbitration or mediation.
    3. Purpose: It decongests civil courts and disposes of time-sensitive disputes quickly.

    What makes the Delhi High Court a model?

    1. Original side: The Delhi High Court is the court of first instance for civil suits above a set value, so high-stakes cases skip lower courts.
    2. Landmark rulings: Its rulings on pharmaceuticals, Standard Essential Patents (patents a telecom standard cannot work without), copyrights and IP versus fundamental rights are a benchmark for the Global South and North.
    3. Intellectual Property Division: Building on the 2015 Act, it created a division hearing only IP disputes. It framed IP Division Rules in 2022, welcomed by the World Intellectual Property Organization (WIPO).
    4. Paperless court: E-filing since the 2020 lockdown made it largely paperless, helping litigants seeking urgent relief and building stakeholder confidence.

    Can the model work beyond Delhi?

    1. Viksit Bharat link: Becoming a developed nation, Viksit Bharat, by 2047 needs a culture of innovation and entrepreneurship. A legal system that enforces rights is part of that ecosystem.
    2. Unfinished ADR: ADR has broad acceptance, yet calls for world-class ADR infrastructure show gaps remain.

    Challenges

    1. Limited original side: Only a few High Courts, such as Delhi, Bombay, Calcutta and Madras, hear civil suits at first instance.
    2. Tribunal abolition: Abolishing the Intellectual Property Appellate Board (IPAB) moved its appeals to already burdened High Courts.
    3. Patent office backlog: Slow examination and too few examiners delay patents before any dispute arises.
    4. Uneven digital capacity: Many courts lack reliable e-filing and staff trained in technical IP evidence.

    Way Forward

    1. IP Divisions elsewhere: High Courts serving major commercial hubs should set up IP Divisions with their own rules.
    2. Dedicated funding: The Union and States should fund judges, technical experts and e-courts.
    3. Examination timelines: The patent office should fix examination deadlines and hire more examiners.
    4. Institutional arbitration: Credible arbitration centres would keep more disputes out of court.

    Conclusion

    Strong IP law protects innovation only when courts can enforce it quickly, and outside Delhi that capacity is thin. Whether other High Courts create funded IP Divisions will show if one court’s success becomes a national standard.

    Government Initiatives for India’s IPR Ecosystem

    1. National IPR Policy, 2016: Aims to build a robust intellectual property rights (IPR) ecosystem that promotes innovation and entrepreneurship.
    2. Patent Facilitation Centres: Guide inventors, especially small enterprises and startups, through filing and protection.

    Matching Previous Year Question

    “[2024, GS3, 10 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.”

  • Study attempts to find out how India made diabetes medicines affordable

    Why in the News

    A study titled “Making Modern Diabetes Medications Affordable and Accessible: Lessons from India for Other Countries”, published in the journal Diabetes Care, sets out how India brought down the prices of new and expensive diabetes drugs and asks what of that is transferable to other low and middle income countries (LMICs), where 80% of the world’s 589 million adults with diabetes live. The study was led by the chairman of a Chennai diabetes specialities centre. It attributes the price fall to a legislative history of safeguards against “patent evergreening”, a large generic and biosimilar manufacturing base, competitive entry by domestic manufacturers, and public distribution through Jan Aushadhi Kendras. The tension is that the two drug classes India has made cheapest sit outside the National List of Essential Medicines (NLEM), so the price fall rests on market competition rather than on any entitlement, and the study records that rural availability, generic quality and pharmacovigilance remain unresolved.

    What is “patent evergreening”?

    1. The practice: Evergreening is the extension of a monopoly on a drug by patenting a minor variation of a known molecule, such as a new salt, polymorph or dosage form, once the original patent nears expiry.
    2. The statutory safeguard: Section 3(d) of the Patents Act, 1970 denies a patent to a new form of a known substance unless it demonstrates enhanced therapeutic efficacy, which closes that route.
    3. Why it decides price: Blocking a second monopoly on the same molecule lets generic manufacture begin at patent expiry, and it is generic entry that produces the price fall.

    Where does the world’s diabetes burden actually sit?

    1. The distribution: Of the 589 million adults living with diabetes worldwide, 80% are in low and middle income countries, which is why an Indian pricing experience is being read as a template.
    2. The modern therapies: GLP-1 receptor agonists and SGLT2 inhibitors, meaning sodium glucose cotransporter 2 inhibitors, improve cardiovascular and renal outcomes, while analogue insulins reduce the risk of hypoglycaemia.
    3. Why affordability is the binding constraint: Diabetes requires lifelong care and the management of complications, so the cost is recurring rather than one time, and a price that is merely high becomes prohibitive over a lifetime.

    What brought modern diabetes drug prices down in India?

    1. The export base: India’s ability to maintain low medication prices is closely linked to its role as a major pharmaceutical exporter, which gives domestic manufacturers scale independent of the domestic market.
    2. Generic manufacture as a legal choice: The safeguards preventing evergreening were paired with a legislative framework permitting generic manufacture of drugs, and that combination is what the study identifies as strategic.
    3. Competitive entry: Initial uptake of the newer drugs was constrained by pricing, and the price of semaglutide in India dropped considerably after multiple domestic manufacturers entered, followed by a large increase in sales.
    4. Quick generic and biosimilar availability: Rapid availability of generic and biosimilar versions is what converts patent expiry into an actual price movement rather than a nominal one.
    5. Public distribution: Deliberate regulatory and distribution strategies, principally the Jan Aushadhi Kendras, supply generics through a parallel retail channel at controlled prices.

    What has the state done on raw materials and manufacturing?

    1. The dependency being addressed: Concerns persist over global trade policies affecting both prices and the availability of raw materials, which is the upstream input a domestic formulation industry cannot substitute quickly.
    2. The incentive scheme: A government incentive scheme was introduced to promote domestic manufacturing of raw materials rather than of finished formulations alone.
    3. The result so far: As of 2025, production has commenced for 26 molecules that were previously imported.

    What does the essential medicines list still leave out?

    1. What is listed: Metformin and the sulfonylureas continue to form the foundation of type 2 diabetes management in India, and both are included in the National List of Essential Medicines.
    2. What is not: DPP-4 inhibitors, meaning dipeptidyl peptidase 4 inhibitors, SGLT2 inhibitors and GLP-1 receptor agonists have all been introduced in India but none of them is currently in the list.
    3. Why the gap matters: Inclusion in the list is what brings a formulation under a ceiling price, so the newer classes are cheap because manufacturers compete rather than because a ceiling requires it.

    Challenges to India’s affordable diabetes medicine model

    1. Rural availability lags the price fall: Distribution and availability of medicines differ sharply between urban and rural India, so a lower price at the counter does not reach a patient without a stockist nearby. Eg. The newer injectable therapies need a cold chain that rural retail pharmacies typically do not maintain.
      The Fix: Route the newer diabetes therapies through the public cold chain already built for the immunisation programme rather than through retail alone.
    2. Quality varies between generic versions: Differences in quality between generics of the same molecule undercut the substitution on which the entire price strategy depends. Eg. The Central Drugs Standard Control Organisation publishes monthly lists of drug samples declared not of standard quality.
      The Fix: Publish batch level bioequivalence data for every approved generic of a newer diabetes molecule, so substitution rests on evidence rather than on price alone.
    3. Pharmacovigilance depends on voluntary reporting: Maintaining strict pharmacovigilance is difficult at the scale at which these molecules are now dispensed, so adverse effects of newly cheap drugs go unrecorded. Eg. The Pharmacovigilance Programme of India, run by the Indian Pharmacopoeia Commission, relies on prescribers choosing to file adverse event reports.
      The Fix: Make adverse event reporting mandatory for the institutions dispensing the newer drug classes, with a fixed filing window.
    4. Price control does not reach unlisted molecules: A formulation outside the essential medicines list escapes ceiling pricing and is subject only to the annual cap on price increases. Eg. Non scheduled formulations may raise prices by up to 10% a year under the Drugs (Prices Control) Order, 2013.
      The Fix: Add the newer classes to the essential medicines list once domestic competition makes a ceiling price sustainable for manufacturers.
    5. Tight regulation weighs against innovation: The same regulatory density that keeps prices low reduces the incentive to develop a new molecule domestically, so the model depends on molecules first developed elsewhere. Eg. Indian manufacturers compete largely on generic and biosimilar versions of originator drugs rather than on new chemical entities.
      The Fix: Separate the approval pathway for a genuinely new molecule from the generic approval pathway, with a defined review timeline.
    6. Scheme performance is measured by outlets, not outcomes: Formal evaluation of the government schemes for their long term impact on clinical outcomes is limited, so the programme can report reach without reporting effect. Eg. Distribution schemes report the number of outlets and the value of medicines sold rather than glycaemic control among their buyers.
      The Fix: Link dispensing records at public outlets to a glycaemic outcome registry, so the scheme is judged on control achieved.

    Conclusion

    India’s experience suggests that affordability in a chronic disease is produced by legal design and market structure together, not by a price order alone. What remains unresolved is that the arrangement delivers cheap medicines without guaranteeing them: the classes with the steepest price falls carry no listing that would hold those prices if competition thinned. For the other low and middle income countries the study addresses, the transferable part is the patent standard and the generic manufacturing base, and neither can be adopted in isolation from the other. The measure to watch is whether the newer drug classes enter the National List of Essential Medicines at the next revision.

    Back2Basics: Jan Aushadhi Kendras

    1. What they are: Jan Aushadhi Kendras are dedicated retail outlets that sell quality generic medicines at prices well below those of branded equivalents.
    2. Who runs them: The scheme sits with the Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers, and is implemented through the Pharmaceuticals and Medical Devices Bureau of India.
    3. Its history: The campaign was launched in 2008 and was relaunched in 2015 as the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP).
    4. What it stocks: The outlets carry generic medicines across therapeutic categories along with surgical and consumable items, sourced from suppliers holding the required quality certification.

    Matching Previous Year Question

    “How is the government of India protecting traditional knowledge of medicine from patenting by pharmaceutical companies?”

  • The copyright stakes in the EU FTA

    Why in the News

    The European Commission has formally asked European Union member states to approve the signing and conclusion of the India EU Free Trade Agreement (FTA), and the commitments accepted in the covered areas, including intellectual property, have now been revealed. The draft intellectual property chapter affirms both parties’ commitments to the WIPO Copyright Treaty (WCT) and the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement, while omitting the WCT from the National Treatment clause at Article 10.8. It simultaneously carries the WCT’s enforcement mandates on technological protection measures and rights management information as binding obligations. The tension is that India would take on the treaty’s enforcement side without its public interest exceptions, which means the exceptions students, security researchers, archivists and Internet service providers currently rely on under the Copyright Act, 1957 would rest on the agreement’s own narrow test rather than on a treaty floor.

    What is the WIPO Copyright Treaty (WCT)?

    1. What it covers: The treaty was adopted specifically for the protection of works and the rights of their authors in the digital environment, with particular attention to software and databases.
    2. The enforcement side: It provides for technological protection measures (TPMs), meaning the encryption and digital access controls that restrict copying of a digital work, and for rights management information attached to that work.
    3. The balancing side: Article 10 of the treaty provides for limitations on and exceptions to copyright for digital works, which is what keeps authors’ rights balanced against public interest uses in education and research.
    4. Its place in Indian law: The Copyright Act, 1957 as it stands is in conformity with the WCT and with the TRIPS Agreement.

    What is the asymmetry inside the draft intellectual property chapter?

    1. The omission: The chapter leaves the WCT out of the National Treatment clause at Article 10.8, which means the limitations and exceptions for digital works that the treaty provides would no longer be available to India.
    2. The retained obligation: Footnote 1 of Article 10.8(1) expands “protection” to cover enforcement measures against the circumvention of technological protection measures at Article 10.18 and against interference with rights management information at Article 10.19.
    3. The narrowed exception route: Article 10.21 of the agreement supplies limitations and exceptions through a narrow “three step test” borrowed from European Union copyright statutes, which is a tighter gate than the treaty’s own Article 10.
    4. The net effect: The chapter abandons the treaty’s principle of balancing authors’ rights against public interest exceptions while keeping its enforcement mandate rigid.

    How would this reach the Copyright Act, 1957?

    1. The amendment obligation: The draft provisions would necessitate amendments to the Copyright Act, 1957, obliging Parliament to remove the exceptions covering digital works regardless of whether the user was engaged in lawful research.
    2. Fair dealing becomes challengeable: If the existing exceptions are not preserved, foreign rightsholders could challenge the exceptions for digital works available under Section 52, the fair dealing provision, including transient or incidental storage of a work purely in the technical process of electronic transmission.
    3. Civil and criminal exposure: Article 10.11 of the agreement would subject such uses to civil and criminal remedies rather than leaving them within a statutory exception.
    4. The threat to Section 65A: Section 65A of the Copyright Act, 1957 governs technological protection measures, and Section 65A(2) provides the exceptions under which a protection measure may lawfully be circumvented, so a student or researcher bypassing a digital lock to perform an act protected under Section 52 attracts no criminal liability today.
    5. Beyond the negotiating mandate: By agreeing to the draft text the negotiators have gone beyond the mandate Parliament set in the Copyright Act, 1957.

    What changes in classrooms and laboratories?

    1. The existing permission: Sections 52(1)(ab) and 52(1)(ac) permit engineering students and security researchers to observe, test and reverse engineer software, either to achieve interoperability or to uncover critical security vulnerabilities.
    2. Why the permission is conditional on circumvention: Modern software is almost universally guarded by encryption and digital access controls, so the lawful act cannot be performed without first bypassing a protection measure.
    3. The effect of a strict regime: Under a strict anti circumvention rule, a computer science student breaking a digital lock to inspect code for system compatibility or security flaws becomes a legal offender.
    4. The wider cost: Security research that depends on examining protected code is the mechanism by which vulnerabilities are found before they are exploited, and a rule that criminalises it removes that route.

    Why are libraries and archives exposed?

    1. The preservation practice: Historical documents, literature and research are increasingly distributed in digital formats burdened by Digital Rights Management (DRM), and librarians depend on format shifting to archive out of print works and preserve fragile collections.
    2. The loss of legal cover: A strict anti circumvention rule strips archivists of the legal right to bypass digital locks for preservation, which converts a routine archival act into an infringement.
    3. The reach into higher education: As higher education relies more on electronic materials, paywalls and DRM controls could effectively overwrite the public interest protections Indian courts established in rulings such as the DU Photocopy Case.

    Why are Internet service providers exposed?

    1. The existing safe harbour: Sections 52(1)(b) and 52(1)(c) shield Internet service providers (ISPs) and digital intermediaries from liability for the temporary and transient copies created in random access memory and server caches during routine data routing.
    2. What the safe harbour supports: The notice and takedown regime established under Rule 75 of the Copyright Rules, 2013 rests on those statutory safe harbours, so removing them unsettles the takedown machinery as well.
    3. The unqualified reproduction right: Article 10.11(a) of the agreement grants rightsholders an exclusive and unqualified right over all “temporary or permanent” reproductions.
    4. The treaty position it contradicts: The Agreed Statements to Articles 8 and 10 of the WCT exempt transient network copies from copyright liability, so the draft text departs from the treaty India already follows.
    5. The consequence: With the WCT excluded from the National Treatment exception, European rightsholders could expose Indian intermediaries to systemic liability for routine routing.

    Challenges to the draft intellectual property chapter

    1. Enforcement obligations travel faster than exceptions: An anti circumvention mandate is a single prohibition that applies immediately, while an exception has to be pleaded case by case in a domestic court. Eg. The Copyright (Amendment) Act, 2012 inserted Section 65A together with its express exceptions as a package, a pairing the draft chapter does not reproduce.
      The Fix: Make the agreement’s anti circumvention obligation expressly subject to the exceptions in Sections 52 and 65A(2) of the Copyright Act, 1957.
    2. India’s fair dealing is a closed list, not an open standard: Section 52 enumerates permitted purposes, so a narrowing of those purposes leaves no residual doctrine for a court to fall back on. Eg. United States law applies an open ended fair use standard that a court can extend to a new use, while Indian courts work from the enumerated purposes.
      The Fix: Insert a residual clause permitting non commercial educational and research uses that satisfy the three step test, so the list is not the outer limit.
    3. The safe harbour rests on subordinate legislation: The notice and takedown machinery sits in the Copyright Rules, 2013 rather than in the Act, and a rule can be amended by the executive without returning to Parliament. Eg. Rule 75 of the Copyright Rules, 2013 carries the takedown procedure that intermediaries follow.
      The Fix: Move the intermediary safe harbour and the takedown procedure into the Act itself, so any narrowing needs a parliamentary amendment.
    4. Cross border enforcement is asymmetric in cost: A rightsholder in the European Union can fund sustained litigation in India, while an Indian intermediary, library or university cannot mirror that in Europe. Eg. Academic publishers pursued the DU Photocopy Case in the Delhi High Court through a first instance suit and an appeal before withdrawing.
      The Fix: Negotiate a defence cost and mutual recognition provision in the agreement’s dispute chapter for non commercial educational defendants.
    5. Treaty text once signed is hard to reopen: A trade agreement is renegotiated as a whole rather than clause by clause, so a concession in the intellectual property chapter is not correctable in isolation later. Eg. The intellectual property chapter of the agreement was settled in the same package as market access and services commitments.
      The Fix: Press to re insert the WCT into the National Treatment clause before signature rather than seeking an interpretive declaration afterwards.

    Conclusion

    India’s copyright flexibilities are a policy asset rather than a bargaining chip, and the draft chapter converts them into one. What remains unreconciled is that the agreement asks India to enforce a treaty’s protections without granting India the exceptions that same treaty wrote to balance them, and no amount of domestic drafting can restore a balance that the National Treatment clause has already removed. The immediate thing to watch is whether the European Union member states approve signature with the clause as drafted, since the window for negotiators to insist on re inserting the treaty into that clause closes at signature rather than at ratification.

    Back2Basics: The DU Photocopy Case

    1. What it was: Three academic publishers sued Delhi University and a licensed photocopy shop on its campus over course packs compiled from copyrighted textbooks.
    2. The provision at issue: The dispute turned on Section 52(1)(i) of the Copyright Act, 1957, which exempts reproduction of a work by a teacher or a pupil in the course of instruction.
    3. What the court held: The Delhi High Court held that the exemption covers course packs prepared for students and read no quantitative limit into the provision, so the reproduction was not an infringement.
    4. Why it is cited here: It is the leading Indian authority for the proposition that copyright exceptions serve a public interest in access to education rather than operating as a narrow concession.

    Matching Previous Year Question

    “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.”

  • Can AI claim copyright for original work? A question of authorship

    Can AI claim copyright for original work? A question of authorship

    Why in the News

    India’s Copyright Office has rejected an application seeking copyright registration for an artwork generated by an artificial intelligence (AI) system. The application was filed by American computer scientist Stephen Thaler for a work titled ‘A Recent Entrance to Paradise’, which he said had been generated autonomously by his AI system DABUS. The application named DABUS as the author and Thaler as the owner of the copyright. The order is among the first Indian decisions to address who, if anyone, is the author when an AI system generates a work. The tension it exposes is that the Office found the image original enough to qualify for protection while holding that the entity that produced it cannot be an author.

    What is DABUS?

    1. The system: DABUS stands for Device for the Autonomous Bootstrapping of Unified Sentience, an AI system developed by Thaler.
    2. The claim made for it: The application asserted that DABUS had generated the artwork autonomously, rather than as an output directed by a human operator.

    What did the application claim and what did the Office ask?

    1. The filing: Thaler applied in 2022 to register copyright in the artwork.
    2. The first question put to him: The Copyright Office asked whether an AI system could legally be recognised as an author under the Copyright Act, 1957.
    3. The second question: It also asked who should be treated as the author if the work was indeed generated using AI.
    4. The offer he refused: During the proceedings the Office allowed Thaler to amend the application and identify himself as the author. He declined, and continued to insist that DABUS be recognised instead.

    How does the Copyright Act, 1957 treat originality?

    1. The three separate questions: The Act answers whether a work is original, who its author is, and who owns the copyright, and these are distinct questions rather than one.
    2. The protection provision: Section 13 protects original literary, dramatic, musical and artistic works.
    3. The Act does not define originality: The Copyright Office therefore interprets it from Eastern Book Company v. D.B. Modak.
    4. The judicial test: The Supreme Court in that case held that a work need not be novel or groundbreaking to receive copyright protection. It must show at least a minimum degree of creativity, and it cannot be merely copied or mechanically reproduced.

    How does the Act treat authorship and ownership?

    1. The authorship provision: Section 2(d)(vi) identifies the author of a computer generated work as “the person who causes the work to be created”.
    2. The disputed phrase: The dispute was over whether that phrase refers to the machine producing the output or to the person creating and operating the system.
    3. First ownership: Section 17 states that the author is generally the first owner of the copyright.
    4. Transfer: Sections 18 and 19 allow copyright to be assigned or transferred through legally recognised agreements.
    5. What the structure assumes: The Office noted that these provisions are built around legal persons who can hold rights, transfer them and enforce them.

    What did the Copyright Office decide?

    1. Originality was satisfied: The Office found that the image generated by the AI was original enough to qualify for copyright protection.
    2. Authorship is a legal status: The Act treats authorship as a legal status carrying rights and responsibilities, and an AI system, however sophisticated, does not presently possess such recognition under Indian law.
    3. The tool test: To interpret who “causes” a computer generated work to be created, the Office looked to American copyright cases distinguishing between a tool and the person handling it.
    4. DABUS as the tool: Although DABUS generated the final image, it did so within a system designed and set in motion by Thaler, so DABUS was treated as the tool and Thaler as the person who legally caused the work to be created.
    5. Person means natural or juristic: Where an Act refers to a “person” it usually means a natural person or a juristic person such as a company, an entity capable of owning property and entering contracts. DABUS is not a recognised juristic person.
    6. The outcome: Thaler was held to be the person capable of being identified as the statutory author, so the application as filed did not meet the criteria under the Act.

    Why was the fallback request also rejected?

    1. What was sought: Thaler asked in the alternative that DABUS be recorded as the technological generator of the work.
    2. The register cannot confer status: The Office held that the register could not be used to indirectly confer legal status on an AI system.
    3. A procedural ground as well: No proper application seeking such an entry had been made.

    What has the order left open?

    1. A future application can succeed: The order leaves open the possibility of a fresh application that identifies the author in the manner the Copyright Act, 1957 requires.
    2. The change of law is reserved: Any broader change in the law would have to come from Parliament.
    3. The stated limit on administrative power: The order records that whether legal personhood or authorship should ever be extended to autonomous artificial intelligence “remains a policy decision strictly reserved for Parliament, and cannot be introduced via administrative reinterpretation”.

    Challenges to fitting AI generated works into copyright law

    1. Human contribution is not measurable at the point of registration: A registrar cannot tell from the output whether a prompt involved creative choice or a single instruction. Eg. The United States Copyright Office refused registration for the AI generated images in the comic ‘Zarya of the Dawn’ while protecting the human written text and arrangement.
      The Fix: Require a disclosure of AI involvement and of the specific human contribution as a mandatory field in the registration application.
    2. Training data use is unresolved: Models are trained on protected works without licence, so the lawfulness of the input sits behind every question about the output. Eg. Indian news publishers and a music industry body have sought to intervene in the Delhi High Court proceedings against OpenAI on this ground.
      The Fix: Legislate a statutory text and data mining exception with a transparency obligation on training corpora, so the boundary is set rather than litigated case by case.
    3. Ownership defaults to the operator rather than the investor: Treating the person who causes creation as the author leaves the platform, the model developer and the user with competing claims over the same output. Eg. Generative service terms typically assign output rights to the user by contract, which no statute confirms.
      The Fix: Make the allocation of rights in computer generated output a default statutory rule that contracts may vary, rather than leaving it to terms of service alone.
    4. Term of protection has no anchor without a human author: Copyright duration runs from the author’s lifetime, which cannot be computed where the generating entity does not die. Eg. The United Kingdom sets a fixed 50 year term for computer generated works precisely to avoid this problem.
      The Fix: Provide a fixed term measured from the date of creation for works with no identifiable human author.
    5. Enforcement needs an accountable person: Liability for infringing output, and standing to sue over it, both require someone the law can reach. Eg. An autonomously generated image that reproduces a protected character leaves no party with a stated duty under the current provision.
      The Fix: Attach statutory responsibility for infringing output to the person who deployed the system, mirroring the authorship rule the Office has applied.

    Conclusion

    The order settles who the author is and leaves untouched what the author did. A work the law accepts as original was produced by a process its named author did not perform, and the statute has no category for that gap. Parliament is the only body that can create one. The point to watch is whether computer generated works are taken up as a legislative question, or whether the issue keeps returning through individual registration applications and appeals against their refusal.

    Back2Basics

    1. Enactment: The Copyright Act, 1957 came into force in January 1958 and is India’s governing copyright statute.
    2. Administration: It is administered through the Copyright Office, which functions under the Department for Promotion of Industry and Internal Trade.
    3. Coverage: It protects literary, dramatic, musical and artistic works, along with cinematograph films and sound recordings.
    4. Registration is optional: Copyright arises on creation of the work, and registration serves as evidence rather than as the source of the right.

    [2014, GS3, 12 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.”

  • 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.

  • 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.

  • 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 open-source licensing

  • How is the government of India protecting traditional knowledge of medicine from patenting by pharmaceutical companies?

    India’s traditional medicinal knowledge includes thousands of formulations and approximately 45,000 plant species, but faces biopiracy threats from multinational companies patenting indigenous resources without consent or compensation.

    Government Initiatives to Protect Traditional Knowledge

    Traditional Knowledge Digital Library (TKDL):

    Translates ancient medicinal texts from Sanskrit, Urdu, Tamil, Persian and other languages into English, French, German, Spanish, and Japanese for global patent examiners.

    Contains over 4.48 lakh formulations, including Ayurveda, Unani, Siddha, Sowa Rigpa, and Yoga knowledge systems.

    CSIR-TKDL actively files pre-grant oppositions and third-party observations; 283 patent applications were refused, amended, or withdrawn using TKDL evidence.

    The Biological Diversity Act, 2002: Mandates that any foreign individual or commercial entity seeking to use India’s biological resources or traditional knowledge must obtain prior approval from NBA.

    National Biodiversity Authority: NBA is a statutory body implementing the Biological Diversity Act, 2002 to protect India’s biological resources and traditional knowledge.

    People’s Biodiversity Register (PBR): Administered by the NBA, PBR serves as a formal tool for recording and maintaining comprehensive localized data on biological resources and their medicinal uses.

    Access and Benefit Sharing (ABS) agreements:

    Companies using Indian bio-resources must share royalties or benefits with the National Biodiversity Authority.

    These funds support local Biodiversity Management Committees and tribal communities.

    The Patents Act, 1970:

    States that an invention which is traditional knowledge, or an aggregation or duplication of known properties of traditionally known components, is not patentable.

    Mandates disclosure of the source and geographical origin of biological materials used in patents, with details shared with the NBA.

    Protection of Plant Varieties and Farmers’ Rights (PPV&FR) Act, 2001: Protects the rights of local communities and farmers over their traditional crop and medicinal plant varieties.

    By safeguarding indigenous medical heritage through the NBA and TKDL, India directly advances SDG 3 (Good Health and Well-being) and SDG 15 (Life on Land) while protecting local community rights.

  • 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.

    IPR grants legal rights over innovations, while life materials include genes, microorganisms, and GMOs. Their intersection determines ownership and commercialization of biological resources, shaping biotechnology, healthcare, agriculture, and innovation-driven economic growth.

    Present World Scenario of IPRs with Respect to Life Materials

    Biotechnology: Increased patents on GMOs and gene-editing technologies, though patent laws differ across countries. Eg- CRISPR-Cas9 patents in the US and restrictions in the EU.

    Ethical concerns: Patenting genes and life forms can create monopolies and limit public access to healthcare and seeds. Eg- Myriad Genetics BRCA1 gene patent case.

    Developing nations’ approach: often oppose patents on essential medicines and biological resources. Eg- India rejected Novartis Glivec patent under Section 3(d).

    TRIPS and global standards:

    The TRIPS Agreement requires patent protection but allows safeguards for public health and biodiversity.

    With the WTO moratorium ending after MC 14 Meet, countries can now challenge public-health measures like compulsory licensing for harming expected profits.

    Open-source movements: Open-access biological initiatives encourage collaborative innovation and protect farmers’ rights. Eg- Open Source Seed Initiative.

    Biopiracy: Unauthorized patenting of biological resources and traditional knowledge exploits indigenous communities without fair compensation.

    Reasons for Low Commercialization in India

    Weak industry-academia linkage: Limited collaboration between research institutions and industries restricts market adoption. Eg- About 13.8% of CSIR patents are licensed.

    “Valley of Death” funding gap: Indian universities lack sufficient funding to scale laboratory research and prototypes into commercially viable products through testing and trials.

    Weak Patent Quality: Many patents suffer from vague claims, weak disclosures, or insufficient novelty, making them vulnerable to litigation and revocation.

    Slow regulatory machinery: Patent approvals and clearances in India often take 5-7 years, delaying commercialization and reducing technological relevance.

    Complex tech-transfer policies: Fragmented institutional IP policies create legal uncertainty, discouraging industry partnerships.

    Lack of Skilled IP Management: Limited expertise in licensing, prior-art research, and market-oriented commercialization, causing many patents to remain commercially unused.

    Misaligned objectives: Universities and researchers prioritize patent filings for rankings and grants, while industries seek scalable, market-ready technologies.

    Low absorptive capacity: Most universities lack strong innovation ecosystems and technology-transfer infrastructure beyond elite institutions like IITs.

    Poor commercialization infrastructure: India lacks strong incubators and technology-transfer systems.

    Global competition: Indian innovations face competition from dominant multinational corporations. Eg- Pfizer global market dominance.

    Inadequate Innovation Ecosystem: Support systems such as advanced laboratories, industry mentors, commercialization hubs, and global market integration remain uneven across regions.

    Way Forward

    Shift from quantity-driven patenting to quality-driven innovation by rewarding commercially viable and genuinely novel research.

    Strengthen industry-academia collaboration through technology transfer offices, IP centres, and startup incubation ecosystems. E.g Bayh-Dole model of the United States.

    Emulate China’s metrics-based databases, using big data analytics to isolate high-value patents

    Develop specialized biotechnology and pharmaceutical IP commercialization hubs on the lines of innovation clusters in South Korea and Israel.

    Utilize the 2024 Patent Rules, advance renewal discounts, and expanded startup facilitator schemes to protect emerging technologies.

    Align academic incentives away from mere patent counts toward innovation impact, technology transfer, and market adoption.

    Enhance venture capital support, FDI confidence, and startup financing by ensuring strong and enforceable intellectual property rights.

    Promote uniform state-level IP policies, single-window commercialization portals, and support for SMEs and rural innovators.

    With the above measures India can convert its patents into drivers of innovation, technological self-reliance, and the vision of Viksit Bharat 2047.

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