Q15 · UPSC Civil Services Mains 2019 · GS III · 15 marks · 3 min read

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

Topic: Indian Economy. Syllabus: Indian Economy and issues relating to planning, mobilization of resources, growth, development and employment. Same official PYQ from year-wise 2019 and Indian Economy.

Revision summary

TKDL puts classical Indian medical texts in a form patent examiners can search, so claims fail for lack of novelty. The Patents Act excludes traditional knowledge as such and limits evergreening of known substances. The Biological Diversity Act requires approval and benefit-sharing for many uses of Indian bio-resources and associated knowledge. Turmeric, neem, and Basmati disputes showed why a defensive library was built. Undocumented folk knowledge and a fair commercial share remain weaker than the patent shield.

Model answer

Copper italics in this answer — like this — are the key facts. Each one is unpacked in the Facts & figures rail.

Introduction

Indian medicine — Ayurveda, Siddha, Unani, Yoga, folk healing — is old public knowledge. A firm that patents a turmeric wound use or a neem extract as a “new invention” can lock others out. India fights that with a defensive database, with what the Patents Act refuses to grant, and with biodiversity access rules. The aim is not to stop honest research. It is to stop biopiracy: private monopoly over what communities already knew.

Body

Traditional Knowledge Digital Library (TKDL)

  • TKDL is a joint Council of Scientific and Industrial Research (CSIR) and Ministry of AYUSH project. It transcribes formulations from classical texts into structured, searchable, multilingual records (including patent-examiner languages).
  • India has access agreements with major patent offices (including the European Patent Office and others) so examiners can find prior art and refuse or narrow claims.
  • This is defensive publication: the knowledge is documented so it is not “novel”. It does not by itself pay the village that kept the plant.
  • Documented wins after earlier disputes: turmeric (wound healing), neem (fungicidal properties), and Basmati rice lines were fought in foreign offices; TKDL was built so the next examiner sees the text before a grant.

Patent law inside India

  • Patents Act, 1970 (as amended): section 3(p) excludes an invention which in effect is traditional knowledge or an aggregation of known properties of traditionally known components.
  • Section 3(d) blocks evergreening of known substances unless there is a new therapeutic efficacy — relevant when a firm slightly modifies a known plant isolate.
  • Section 3(e) and other clauses limit mere admixtures. Pre-grant and post-grant opposition let CSIR, AYUSH, or public-interest groups challenge a claim.
  • Disclosure of biological material and geographical origin in the application supports examination.

Biodiversity and community tools

  • Biological Diversity Act, 2002: National Biodiversity Authority and State boards regulate access to Indian biological resources and associated knowledge; prior approval and benefit-sharing are required for certain research, patents, and commercial use, especially involving foreigners or specified firms.
  • People’s Biodiversity Registers record local knowledge at panchayat scale — a grassroots prior-art layer if they are actually maintained.
  • Geographical Indications (for example on some agricultural and traditional goods) protect names, not medical formulae, but they stop a foreign brand from capturing a place-linked product.
  • Nagoya Protocol on access and benefit-sharing sits behind the same logic internationally.

Institutions and positive protection

  • Ministry of AYUSH, pharmacopoeias, and research councils (CCRAS and others) standardise and clinically test, so the knowledge can be used as a public system, not only as a patent shield.
  • Yoga and some well-known practices were also the target of foreign patent attempts; documentation and diplomatic protest were the response.

Limits and recommendations

  • TKDL covers codified classical texts better than undocumented tribal medicine. Expand community registers with consent and benefit-sharing, not extraction.
  • Defensive protection stops a bad patent; it does not create an Indian product or a royalty for the holder of the knowledge. Pair TKDL with NBA contracts and public-sector formulation brands.
  • Watch evergreening of isolates and process patents that skirt 3(p).
  • Harmonise speed of NBA clearance so genuine research is not driven underground while pirates still file abroad.
  • Train more examiners on TKDL and keep the library updated in more languages and oral traditions (with ethics).

Flow diagram

flowchart TD
  TK[Traditional medical knowledge] --> TKDL[TKDL prior art]
  TK --> PA[Patents Act 3p 3d opposition]
  TK --> BDA[Biodiversity Act NBA ABS]
  TKDL --> X[Refuse biopiracy patent]
  PA[PA] --> X[X]
  BDA --> SHARE[Benefit sharing]

Conclusion

India protects traditional medical knowledge mainly by TKDL prior art in foreign and Indian examination, by Patents Act exclusions such as section 3(p), by Biodiversity Act access and benefit-sharing, and by AYUSH documentation. Turmeric and neem taught the cost of arriving late. The remaining gap is undocumented community knowledge and a fair share when a real product is made — not only a refused patent.

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  1. 2015 · Q14 · GS III · 12 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 country's fight against erroneous patents. Discuss the pro and cons of making the database available publicly available under open source licensing.

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