UPSC GS Paper III: Science Tech, IPR, Patents, Trademarks, Copyrights, TRIPS, Doha Declaration

Must?Know

• TRIPS Agreement – Annex 1C of Marrakesh Agreement (1994); mandates minimum standards for IP protection in all WTO member states, including product patents for pharmaceuticals.
• India became a WTO member in 1995; implemented TRIPS through amendments to the Patents Act, 1970 via the Patents (Amendment) Act, 2005.
• Pre-1995 Indian patent law allowed process patents only for drugs and food; post-TRIPS compliance introduced product patents for pharmaceuticals from 2005.
• Section 3 of the Patents Act, 1970 – defines what is not an invention; includes frivolous inventions, methods of agriculture, atomic energy.
• Section 3(k) of Patents Act – excludes plants, animals, essentially biological processes; upheld in Novartis v. Union of India (2013).
• Compulsory licensing under Section 84 of Patents Act – after 3 years from grant, if public demand not met at reasonable price; first granted to Natco for Bayer’s Nexavar (2012).
• Evergreening – extending patent life via minor modifications; rejected in Novartis case for Glivec, as not meeting Section 3(d) criteria of enhanced efficacy.
• Section 3(d) of Patents Act – prevents evergreening by requiring significant enhancement in efficacy for derivatives; introduced via 2005 amendment.
• Doha Declaration on TRIPS and Public Health (2001) – affirms right of WTO members to issue compulsory licenses and determine national emergencies.
• Doha Declaration allows export of generic medicines to countries lacking manufacturing capacity via Paragraph 6 solution; operationalized in 2003, incorporated in TRIPS in 2005.
• India’s first compulsory license (2012) – Natco Pharma for sorafenib tosylate (Nexavar), cancer drug; Bayer charged ?2.8 lakh/month, Natco offered ?8,800/month.
• Bolar provision – Section 107A of Patents Act; allows generic manufacturers to use patented invention for regulatory approval before patent expiry.
• Trademarks governed by Trade Marks Act, 1999; replaced Trade and Merchandise Marks Act, 1958; aligns with TRIPS.
• Well-known trademarks – protected even without registration; determined by public recognition; e.g., Coca-Cola, Rolex; governed by Section 11(6) to (10).
• Geographical Indications of Goods (Registration and Protection) Act, 1999 – implements TRIPS Art. 23; first GI tag in India: Darjeeling Tea (2004–05).
• Copyright governed by Copyright Act, 1957; protects literary, dramatic, musical, artistic works, cinematograph films, sound recordings.
• Copyright duration – lifetime of author + 60 years; for films and sound recordings, 60 years from publication.
• Indian Performing Rights Society (IPRS) – manages public performance rights for music and literary works; established 1969.
• Patent Cooperation Treaty (PCT) – administered by WIPO; allows single patent application to be valid in multiple countries; India joined in 1998.
• National IPR Policy, 2016 – titled “Creative India; Innovative India”; aims to strengthen enforcement, awareness, and commercialization.
• Traditional Knowledge Digital Library (TKDL) – created by CSIR and AYUSH; translates traditional medicine knowledge into five languages to prevent biopiracy.
• TKDL helped cancel 150+ erroneous patents in USPTO and EPO between 2009–2020; e.g., turmeric wound healing, neem fungicide.
• India and Brazil proposed TRIPS waiver for COVID-19 vaccines at WTO in October 2020; supported by over 100 developing countries.
• WIPO – World Intellectual Property Organization; specialized UN agency; headquartered in Geneva; India is a member since 1975.

Difficulty Level

Intermediate – Requires understanding of legal provisions, international agreements, and landmark cases; often tested through application-based questions.

Common UPSC Traps

• Trap: TRIPS allows compulsory licensing only during war or emergency – Fact: TRIPS (Art. 31) permits compulsory licensing for public health, anti-competitive practices, national emergencies; Doha Declaration reaffirmed flexibility.
• Trap: Copyright protects ideas – Fact: Copyright protects expression of ideas, not ideas themselves; e.g., plot idea not protected, but novel text is (Copyright Act, 1957).
• Trap: Geographical Indication protection is automatic – Fact: GI protection requires registration under GI Act, 1999; unregistered GIs not enforceable in court.
• Trap: India opposed TRIPS from the beginning – Fact: India accepted TRIPS with transition period; used flexibilities like compulsory licensing and Section 3(d) to balance public health.

Practice MCQs

Question: Which of the following best describes the significance of the Doha Declaration on TRIPS and Public Health?
A) It established WIPO as the global authority on intellectual property.
B) It allowed developing countries to ignore patent rights for essential medicines.
C) It affirmed the right of WTO members to issue compulsory licenses for public health.
D) It mandated all WTO members to provide 20-year patent protection for pharmaceuticals.
Answer: C
Explanation: The Doha Declaration (2001) reaffirmed that TRIPS should not prevent members from protecting public health and promoting access to medicines.
Why others fail: D is partially true but existed in TRIPS already; C captures the core public health flexibilities affirmed in Doha.

Question: Under which provision of the Indian Patents Act can a generic drug company conduct trials using a patented drug before the patent expires?
A) Section 84
B) Section 3(d)
C) Section 107A
D) Section 3(k)
Answer: C
Explanation: Section 107A (Bolar exception) permits use of patented invention for regulatory approval of generic drugs before patent expiry.
Why others fail: Section 84 is for compulsory licensing; Section 107A is specific to pre-expiry regulatory work.

Question: The Traditional Knowledge Digital Library (TKDL) was jointly developed by which two Indian institutions?
A) CSIR and ICMR
B) AYUSH and NPCI
C) CSIR and AYUSH
D) ICMR and Ministry of Electronics and IT
Answer: C
Explanation: TKDL was created by Council of Scientific and Industrial Research (CSIR) and the Ministry of AYUSH to prevent biopiracy.
Why others fail: ICMR is not involved in TKDL; CSIR and AYUSH are the primary bodies.

Question: Which of the following is NOT protected under the Geographical Indications of Goods (Registration and Protection) Act, 1999?
A) Darjeeling Tea
B) Kanchipuram Silk Saree
C) Basmati Rice
D) Coca-Cola
Answer: D
Explanation: Coca-Cola is a trademark, not a geographical indication; GI protects goods with specific geographical origin and qualities.
Why others fail: Basmati has GI status in India; Coca-Cola is a registered trademark, not GI.

Question: The first product in India to receive a Geographical Indication tag was:
A) Alphonso Mango
B) Banarasi Brocade
C) Darjeeling Tea
D) Madhubani Painting
Answer: C
Explanation: Darjeeling Tea was the first product to receive GI registration in India in 2004–05.
Why others fail: Alphonso and Banarasi followed later; Darjeeling was first.

Question: Which of the following statements correctly describes Section 3(d) of the Indian Patents Act?
A) It allows patents on all new forms of known substances.
B) It prevents evergreening by requiring enhanced efficacy for derivatives.
C) It grants automatic compulsory licensing for life-saving drugs.
D) It excludes software from patentability.
Answer: B
Explanation: Section 3(d) bars patents on new forms of known substances unless they show significantly enhanced efficacy; used in Novartis case.
Why others fail: Software is not automatically excluded; Section 3(d) specifically targets evergreening in pharma.

Question: The National IPR Policy of India was launched in:
A) 2014
B) 2015
C) 2016
D) 2017
Answer: C
Explanation: The National IPR Policy was adopted in May 2016, titled “Creative India; Innovative India”.
Why others fail: 2014 and 2015 were years of consultation; policy was formally launched in 2016.

Last?Minute Revision

• TRIPS came into force with WTO on January 1, 1995.
• India transitioned to product patent regime for drugs in 2005.
• Doha Declaration adopted on November 14, 2001, during WTO Doha Ministerial Conference.
• Novartis v. Union of India (2013) – Supreme Court rejected patent for Glivec under Section 3(d).
• First compulsory license in India: Natco Pharma for Nexavar (2012).
• Bolar provision: Section 107A of Patents Act, 1970.
• Section 3(d) applies only to pharmaceuticals and food.
• WIPO established in 1967; India joined in 1975.
• TKDL covers Ayurveda, Unani, Siddha, and Yoga.
• GI Act, 1999 came into force in September 2003.
• First GI tag: Darjeeling Tea (2004–05).
• Copyright Act, 1957 amended most recently in 2012.
• Duration of copyright in literary works: lifetime + 60 years.
• Trademarks registered under Trade Marks Act, 1999.
• Well-known trademark status decided case-by-case (e.g., Yahoo, Google).
• IPRS – Indian Performing Rights Society; manages music copyrights.
• PCT – Patent Cooperation Treaty; India joined in 1998.
• National IPR Policy launched on May 25, 2016.
• TRIPS waiver proposal for COVID-19 vaccines: India and South Africa, October 2020.
• Paragraph 6 of Doha Declaration led to TRIPS amendment in 2005 for export of generics.
• Evergreening not allowed under Indian patent law (Section 3(d)).
• CSIR – TKDL – prevents biopiracy by sharing data with EPO, USPTO under access agreements.
• Compulsory license can be granted after 3 years under Section 84.
• Geographical Indications Registry located in Chennai.
• Traditional knowledge not protected under TRIPS unless codified or novel.