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Patents Act, 1970 & Trade Marks Act, 1999 For UPSC Drug Inspector Examination 2026

PCI Verified By Arvind Sharma, B.Pharm, M.Pharm, Assistant Professor, MUIT Recent 18 min read UPSC Drug Inspector Exam 2026

For UPSC Drug Inspector Examination 2026

PART A: THE PATENTS ACT, 1970

*(As amended by Patents (Amendment) Act, 2005, Patents (Amendment) Rules, 2024, and Jan Vishwas (Amendment) Act, 2023)*

1. FUNDAMENTAL CONCEPTS & DEFINITIONS

Section 2(1)(j): "Invention" means a new product or process involving an inventive step and capable of industrial application.

Section 2(1)(ja): "Inventive step" means a feature of an invention that involves technical advance as compared to existing knowledge or having economic significance or both, making the invention not obvious to a person skilled in the art.

Section 2(1)(ac): "Capable of industrial application" means capable of being made or used in an industry.

Section 2(1)(m): "Patent" means a patent granted under this Act.

Section 2(1)(n): "Patentee" means the person entered on the register as the grantee or proprietor of the patent.

Section 2(1)(y): "Person interested" includes a person engaged in, or promoting research in the same field as that to which the invention relates.

MCQ Point: The term "inventive step" was substituted in 2005 (effective 1.1.2005) to replace the old definition requiring "obviousness" test.

2. WHAT IS PATENTABLE & WHAT IS NOT

Patentable Subject Matter (Section 3):

New product or process (novelty is absolute)
Inventive step
Industrial applicability

Non-Patentable Inventions (Section 3 – Critical for Pharma Exams):

Section	Exclusion	Pharma Relevance
3(b)	Contrary to public order, morality, or causes serious prejudice to human, animal, plant life or health	Ethical drugs, dangerous substances
3(c)	Mere discovery of scientific principle or formulation of abstract theory	Natural compounds discovered, not created
3(d)	NEW FORM OF KNOWN SUBSTANCE unless it results in enhancement of known efficacy; mere discovery of new property or new use	CRITICAL: Novartis v. Union of India case – prevents "evergreening" of pharma patents
3(e)	Substance obtained by mere admixture resulting only in aggregation of properties	Simple combinations of known drugs
3(h)	Method of agriculture or horticulture	Not relevant to pharma but tested
3(i)	Any process for medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings/animals	Methods of treatment are NOT patentable (only products/compositions)
3(j)	Plants and animals in whole or any part thereof including seeds, varieties and species	Biotech drugs derived from plants

Landmark Case Law:

Novartis AG v. Union of India (2013) 6 SCC 1:

Supreme Court held that Glivec (Imatinib Mesylate) beta crystalline form was not patentable under Section 3(d)
"Efficacy" under Section 3(d) means therapeutic efficacy, not just physical or chemical properties
Prevented evergreening of drug patents

3. TYPES OF PATENT APPLICATIONS

Section 6: Person entitled to apply – true and first inventor, assignee, or legal representative.

Types:

Ordinary Application (Section 7): First filing in India
Convention Application (Section 8): Claiming priority from Paris Convention country (12 months priority period)
PCT National Phase Application (Section 8): International application filed under Patent Cooperation Treaty (31 months from priority date)
Divisional Application (Section 16): When a single application claims more than one invention
Patent of Addition (Section 54): For improvement or modification of a patented invention (no separate renewal fee)

Section 8: Duty of Disclosure – Mandatory disclosure of foreign filing information. Failure can lead to opposition or revocation.

4. SPECIFICATION & CLAIMS

Section 9: Provisional and Complete Specifications

Provisional: Describes the nature of invention (12 months to file complete)
Complete: Full description, claims, abstract, and drawings

Section 10: Contents of specification

Title of invention
Field of invention
Background/prior art
Objects of invention
Summary
Detailed description with drawings
Claims (Section 10(4)): Define the scope of protection
- Independent claims
- Dependent claims

Doctrine of Equivalents: A product/process that performs substantially the same function in substantially the same way to obtain the same result infringes the patent.

5. EXAMINATION & GRANT PROCEDURE

Section 11A: Publication after 18 months from filing (or priority date). Early publication possible on request.
Section 11B: Request for Examination (RFE) must be filed within 48 months from filing date (for applications filed after 2019; earlier it was 36 months).
Section 12: Examination by Controller – checks for compliance with Sections 3, 8, 10.
Section 13: Search for anticipation by previous publication.
Section 14: Consideration of report by Controller.
Section 15: Power of Controller to refuse or require amended applications.
Section 16: Division of application.
Section 17: Power of Controller to make orders respecting division of application (Post-dating).
Section 18: Controller's power to refuse applications in certain cases.
Section 19: Controller's power to make orders respecting dating of application.
Section 20: Duty of applicant to satisfy Controller.
Section 21: Controller's power to make orders respecting applications.
Section 22: Acceptance of complete specification.
Section 23: Advertisement of acceptance.
Section 24: Opposition to grant of patent.
Section 25: Opposition to the patent (Pre-grant and Post-grant).

6. OPPOSITION PROCEEDINGS

Pre-Grant Opposition (Section 25(1)):

Can be filed by any person after publication but before grant
Grounds: Wrongful obtainment, anticipation, obviousness, non-patentability under Section 3, insufficient description, etc.

Post-Grant Opposition (Section 25(2)):

Can be filed by "person interested" within 12 months from date of publication of grant
Grounds similar to pre-grant

Section 25(4): Opposition to be heard by Controller (now called "Opposition Board" under 2024 Rules).

7. RIGHTS OF PATENTEES & INFRINGEMENT

Section 48: Rights of patentee

Product patent: Exclusive right to make, use, offer for sale, sell, or import the patented product
Process patent: Exclusive right to use the process and to make, use, offer for sale, sell, or import products obtained directly by that process

Section 104: Jurisdiction – Suit for infringement can be filed in District Court or High Court (IPAB abolished, now IP Division of High Courts).

Section 107: Defences in suit for infringement:

Patent is invalid
Patentee is not entitled
Non-infringement

Section 107A: Bolar Exemption (Research Exemption) – CRITICAL FOR DRUG INSPECTOR

Making, using, offering to sell, or selling a patented invention solely for uses reasonably related to development and submission of information required under any law for the time being in force (like Drugs and Cosmetics Act) that regulates the manufacture, construction, use, sale or import of any product
Allows generic companies to conduct bioequivalence studies before patent expiry

Section 108: Reliefs in suit for infringement

Injunction (interim/permanent)
Damages or account of profits
Delivery up of infringing goods

8. COMPULSORY LICENSING (CRITICAL TOPIC)

Section 82: Establishment of Intellectual Property Appellate Board (IPAB) – Note: IPAB abolished by Tribunals Reforms Act, 2021; now appeals go to High Courts/Commercial Courts.

Section 84: Compulsory Licenses (CL)

Available after 3 years from grant of patent
Grounds:
1. Reasonable requirements of the public not satisfied
2. Patented invention not available to public at reasonably affordable price
3. Patented invention not worked in India

Section 92: Special provision for compulsory licenses on notifications by Central Government (for national emergencies, extreme urgency, public non-commercial use).

Section 92A: Compulsory license for export of patented pharmaceutical products to countries with insufficient manufacturing capacity (Doha Declaration implementation).

Landmark Case:

Natco Pharma v. Bayer Corporation (2012):

First CL granted in India for Sorafenib Tosylate (Nexavar) – kidney cancer drug
Controller General granted CL to Natco on grounds that Bayer's drug was not available at affordable price and not meeting reasonable requirements of public

9. GOVERNMENT USE & ACQUISITION

Section 47: Government use of patents for its own purposes (without payment of royalty in certain cases).

Section 100: Power of Central Government to use inventions for government purposes.

Section 102: Acquisition of patents by Central Government for public purpose (with compensation).

10. PATENT TERM & RENEWAL

Section 53: Term of patent

20 years from date of filing of application (not grant date)
Renewal fees payable every year (3rd year onwards)
Grace period of 6 months with late fee
Patent ceases if renewal fee not paid

Section 53(5): Patent of Addition term – co-terminus with main patent.

11. RECENT AMENDMENTS (2023-2024)

Jan Vishwas (Amendment of Provisions) Act, 2023:

Decriminalized certain offences under Patents Act
Compoundable offences now

Patents (Amendment) Rules, 2024 (Key Changes):

Certificate of Inventorship: New provision to recognize inventors (Section 28A inserted)
Grace Period: 12-month grace period for filing patent after publication (Section 31 modified) – now applicable to all types of publications, not just exhibitions
Expedited Examination: Expanded categories (now includes startups, small entities, women inventors, government departments, PSUs)
Pre-Grant Opposition: Time limit of 3 months for filing written statement (Form 7A)
Hearing: Video conferencing allowed
Renewal: E-filing mandatory in most cases
Working Statements: Form 27 filing now required only once every 3 years (previously annual)

12. PHARMA-SPECIFIC PATENT CONCEPTS

Evergreening: Strategy of extending patent life by obtaining new patents on minor modifications (new polymorphs, salts, esters, etc.). Section 3(d) prevents this.

Data Exclusivity: Not covered under Patents Act but under Drugs and Cosmetics Act (New Drugs and Clinical Trials Rules, 2019) – 4 years protection for new chemical entities.

Patent Linkage: System where drug regulatory authorities (DCGI) verify patent status before granting marketing approval. India does NOT have formal patent linkage (unlike USA).

Section 3(d) Analysis for Drug Inspectors:

New polymorphs: Must show enhanced therapeutic efficacy (Novartis case)
New salts: Unless showing unexpected therapeutic results
New formulations: Mere new formulation of known drug not patentable unless enhanced efficacy

PART B: THE TRADE MARKS ACT, 1999

*(As amended by Trade Marks (Amendment) Act, 2010 and Jan Vishwas Act, 2023)*

1. DEFINITIONS & CONCEPTS

Section 2(1)(b): "Assignment" means an assignment in writing by act of the parties concerned.

Section 2(1)(e): "Certification trade mark" means a mark capable of distinguishing goods or services certified by the proprietor as to origin, material, mode of manufacture, quality, accuracy, etc.

Section 2(1)(m): "Mark" includes a device, brand, heading, label, ticket, name, signature, word, letter, numeral, shape of goods, packaging, or combination of colors.

Section 2(1)(zb): "Trade mark" means a mark capable of being represented graphically and which is capable of distinguishing the goods or services of one person from those of others and may include shape of goods, their packaging, and combination of colors.

Key Change (1999 Act): Service marks now registrable (not possible under 1958 Act).

Section 2(1)(v): "Well-known trade mark" – mark which has become so to the substantial segment of the public (used extensively and continuously).

2. REGISTRABLE & NON-REGISTRABLE MARKS

Section 9: Absolute grounds for refusal

Devoid of distinctive character
Consists exclusively of marks designating kind, quality, quantity, intended purpose, values, geographical origin
Customary in current language or in bona fide trade practices
Deceptive, causes confusion, or hurts religious susceptibilities
Contains scandalous or obscene matter
Prohibited under Emblems and Names (Prevention of Improper Use) Act, 1950

Section 11: Relative grounds for refusal

Identical/similar to earlier mark for identical/similar goods/services (likelihood of confusion)
Identical/similar to well-known mark (even for dissimilar goods)
Application made in bad faith

Distinctiveness:

Inherent: Coined/fanciful words (e.g., "Crocin" for paracetamol)
Acquired: Through use (secondary meaning)

3. CLASSIFICATION & REGISTRATION

Section 7: Classification of goods and services

Nice Classification (NCL): 45 classes (1-34 goods, 35-45 services)
Pharmaceuticals: Class 5 (pharmaceutical and veterinary preparations, sanitary preparations, dietetic substances)
Medical instruments: Class 10
Medical services: Class 44

Section 18: Application for registration

Filed at Trade Marks Registry (TMR) – offices at Mumbai, Delhi, Kolkata, Chennai, Ahmedabad
Multi-class application allowed (since 2010 Amendment)

Section 19: Power of Registrar to withdraw acceptance.
Section 20: Advertisement of application.
Section 21: Opposition to registration (within 4 months from advertisement).
Section 23: Registration.

4. TYPES OF TRADE MARKS

Section 2(1)(e): Certification Marks (e.g., ISI, AGMARK, FSSAI for pharma quality)
Section 2(1)(z): Collective Marks (owned by association, e.g., CA logo)
Section 2(1)(zb) Explanation: Shape marks (3D marks) – e.g., unique bottle shape
Color Marks: Combination of colors (e.g., Cadbury purple – though limited)
Sound Marks: Yahoo yodel, Nokia tune (now registrable if graphically representable)

5. RIGHTS & INFRINGEMENT

Section 28: Rights conferred by registration

Exclusive right to use the mark in relation to goods/services
Right to obtain relief in respect of infringement

Section 29: Infringement of trade marks

Use of identical mark for identical goods
Use of similar mark for similar goods (likelihood of confusion)
Use of identical/similar mark for dissimilar goods (taking unfair advantage of well-known mark)
Comparative advertising (disparagement)

Section 30: Limits on effect of registered trade mark (Fair use)

Use in accordance with honest practices
Use to indicate kind, quality, quantity, intended purpose, value, geographical origin
Use for accessories/spare parts

Section 134: Jurisdiction – District Court or High Court.

Section 135: Reliefs

Injunction
Damages or account of profits
Delivery up of infringing labels and marks

Anton Piller Order: Search and seizure order to prevent destruction of evidence

6. ASSIGNMENT & TRANSMISSION

Section 37: Power of registered proprietor to assign and give effectual receipts.

Section 38: Assignability of registered trade marks (with or without goodwill).

Section 39: Assignability of unregistered trade marks.

Section 40: Restriction on assignment where multiple exclusive rights would be created (dealing with same goods, different persons).

Section 41: Restriction on assignment where different parts of India would have different rights.

Section 45: Registration of assignments and transmissions.

7. RENEWAL & RESTORATION

Section 25: Duration and renewal

10 years from date of registration
Renewable for successive 10-year terms
Renewal fee payable (Section 25(3))
Grace period: 6 months with surcharge

Section 25(4): Restoration of removed mark (within 6 months to 1 year after removal).

Section 26: Effect of removal from register.

8. OFFENCES & PENALTIES

Section 103: Penalty for falsifying trade marks

Imprisonment up to 3 years and fine up to ₹2 lakh

Section 104: Penalty for selling goods with counterfeit marks

Imprisonment 6 months to 3 years and fine ₹50,000 to ₹2 lakh

Section 105: Enhanced penalty on second conviction

Imprisonment 1 to 3 years and fine ₹1 lakh to ₹2 lakh

Jan Vishwas Act, 2023 Changes:

Decriminalized minor offences
Compounding of offences introduced
Adjudicating officers appointed for penalties

9. WELL-KNOWN TRADE MARKS

Section 11(2): Protection of well-known marks

Registrar shall refuse registration of identical/similar mark even for dissimilar goods if it would take unfair advantage of or be detrimental to the distinctive character/repute of the well-known mark

Section 11(6)-(10): Factors for determining well-known status

Knowledge/recognition in relevant public
Duration, extent, geographical area of use
Duration and extent of promotion
Value associated with the mark

Examples in Pharma:

"Crocin" (paracetamol) – well-known for antipyretics
"Dettol" – antiseptics
"Benadryl" – cough syrup

10. PHARMA-SPECIFIC TRADEMARK ISSUES

Drug Names as Trademarks:

Generic names cannot be trademarked (e.g., "Paracetamol" cannot be exclusive)
Brand names (INN stems): WHO INN (International Nonproprietary Names) stems should not be used in trademarks (e.g., "-mycin", "-cillin", "-olol")
Section 13 of Drugs and Cosmetics Act prohibits trade names that are identical/similar to INNs

Counterfeit Drugs & Trade Marks:

Selling spurious drugs with counterfeit trademarks = offence under both Drugs and Cosmetics Act (Section 17) and Trade Marks Act (Section 104)
Drug Inspector's Role: Seizure of counterfeit trademark drugs during raid

Passing Off:

Common law remedy (not dependent on registration)
Elements: Goodwill, misrepresentation, damage
Relevant for unregistered marks in pharma

QUICK REVISION MCQ POINTS

Patents Act:

Patent term: 20 years from filing date
Request for Examination: 48 months (post-2019)
Grace period for renewal: 6 months
Compulsory License: After 3 years from grant
Bolar Exemption: Section 107A
Anti-evergreening: Section 3(d)
Methods of treatment: NOT patentable (Section 3(i))
First CL in India: Natco v. Bayer (2012) – Sorafenib
Novartis case: Glivec – Section 3(d) interpretation
Working statement: Once every 3 years (Form 27)

Trade Marks Act:

Registration term: 10 years (renewable indefinitely)
Opposition period: 4 months from advertisement
Pharmaceuticals class: Class 5 (Nice Classification)
Well-known mark protection: Section 11(2)
Assignment must be in writing (Section 2(1)(b))
Service marks registrable since 1999 Act
Penalty for counterfeiting: Up to 3 years + ₹2 lakh
Restoration of mark: 6 months to 1 year after removal
Multi-class application: Allowed since 2010 Amendment
Shape marks: Registrable under Section 2(1)(zb)

PREVIOUS YEAR QUESTION PATTERNS

Frequently Asked Topics:

Difference between provisional and complete specification
Grounds for compulsory licensing (Section 84)
What constitutes infringement under Patents Act
Novartis case significance (Section 3(d))
Bolar exemption scope
Absolute vs relative grounds for TM refusal
Assignment vs License
Well-known trademark criteria
Penalties for counterfeit drugs (overlap with D&C Act)
Term of patent vs term of trademark

PHARMACEUTICAL JURISPRUDENCE – HIGH-YIELD EXAM POINTS ONLY

*Patents Act, Trade Marks Act & Copyright Act – Critical 50 Points*

PATENTS ACT, 1970 – MUST REMEMBER

Section 3(d) – Anti-Evergreening
- New form of known substance only patentable if enhanced therapeutic efficacy (Novartis v. Union of India – Glivec case)
- Prevents pharma companies from extending patents on minor modifications (salts, polymorphs, esters)
Section 3(i) – Methods of Treatment NOT Patentable
- Surgical, therapeutic, diagnostic methods cannot be patented
- Only products/compositions patentable (drugs, formulations)
Section 107A – Bolar Exemption
- Generic companies can use patented drugs for bioequivalence studies before patent expiry
- Research exemption for regulatory submissions
Section 84 – Compulsory License
- Available after 3 years from grant
- Grounds: Public need not met / Not affordable / Not worked in India
- Natco v. Bayer (2012) – First CL for Sorafenib (Nexavar)
Term & Timelines
- Patent term: 20 years from filing date
- Request for Examination: 48 months from filing
- Renewal: Annual from 3rd year (6 months grace with late fee)
Section 8 – Foreign Filing Disclosure
- Mandatory disclosure of foreign applications
- Failure = Grounds for opposition/revocation
2024 Amendments
- Certificate of Inventorship (Section 28A)
- Working statement: Once every 3 years (Form 27)
- 12-month grace period for inventor's own disclosure

TRADE MARKS ACT, 1999 – MUST REMEMBER

Section 2(1)(zb) – Definition
- Mark capable of graphical representation distinguishing goods/services
- Includes shape, packaging, color combination
Section 9 – Absolute Grounds for Refusal
- No distinctiveness
- Deceptive/scandalous
- Generic terms (e.g., "Paracetamol" cannot be TM)
Section 11 – Relative Grounds
- Similar to earlier mark = Refusal
- Well-known marks protected even for dissimilar goods (e.g., "Crocin")
Pharmaceuticals – Class 5
- All drugs in Class 5 (Nice Classification)
- Medical services: Class 44
Term & Renewal
- 10 years + renewable indefinitely
- Opposition period: 4 months from advertisement
- Restoration: 6 months to 1 year after removal
Section 29 – Infringement
- Identical mark for identical goods = Absolute infringement
- Similar mark + confusion = Infringement
Penalties (Section 103-104)
- Counterfeiting: Up to 3 years + ₹2 lakh fine
- Enhanced on second conviction: 1-3 years + ₹1-2 lakh
Assignment
- Must be in writing (Section 2(1)(b))
- Without goodwill vs. With goodwill

COPYRIGHT ACT, 1957 – MUST REMEMBER

Section 13 – Protected Works
- Literary, dramatic, musical, artistic works
- Cinematograph films, sound recordings
- Ideas NOT protected, only expression
Term of Copyright (CRITICAL)
- Literary/Dramatic/Musical/Artistic: Lifetime + 60 years
- Films/Sound recordings/Photographs: 60 years from publication
- Government works: 60 years from publication
Section 17 – First Owner
- Employee work: Employer owns (unless contract says otherwise)
- Commissioned photo/painting: Person who commissioned owns
- Government work: Government owns
Section 52 – Fair Use (Research Exemption)
- Private use, criticism, review, research = No infringement
- Educational use by teachers/pupils permitted
- Pharma research: Can copy limited portions of scientific literature
Section 57 – Moral Rights
- Right to Paternity (claim authorship)
- Right to Integrity (object to distortion)
- Cannot be waived/transferred
Assignment Rules
- Must be in writing
- If duration not specified: 5 years
- If territory not specified: India only
Compulsory License
- Withheld works: After 3 years
- Translation (science/tech): After 3 years
- Translation (others): After 7 years
Criminal Infringement
- 6 months to 3 years + ₹50,000-2 lakh fine
- Enhanced: 1-3 years + ₹1-2 lakh (second offence)
Registration
- Voluntary (not mandatory for protection)
- Copyright Office: New Delhi
Recent Changes
- IPAB abolished (2021) → IP Division of High Courts
- Jan Vishwas Act 2023: Decriminalized minor offences

OVERLAPPING CONCEPTS – TRICKY QUESTIONS

Scenario	Protection Under
New drug molecule	Patents Act
Drug brand name "Crocin"	Trade Marks Act
Research paper on drug	Copyright Act
Unique tablet shape	Design Act + TM Act
Manufacturing process	Patents Act
Packaging artwork	Copyright + TM Act
Pharmacopoeia (IP/BP)	Copyright Act

MOST FREQUENTLY ASKED MCQs

Q1. Which section prevents evergreening in pharma patents?
→ Section 3(d)

Q2. Bolar exemption is provided under:
→ Section 107A (Research exemption)

Q3. Term of patent in India:
→ 20 years from filing

Q4. Which class covers pharmaceuticals in TM classification?
→ Class 5

Q5. Copyright term for literary work:
→ Lifetime + 60 years

Q6. First owner of copyright in employee's work:
→ Employer (Section 17)

Q7. Compulsory license for withheld works available after:
→ 3 years

Q8. Which is NOT patentable?
→ Method of treatment (Section 3(i))

Q9. Well-known trademark protection extends to:
→ Dissimilar goods also (Section 11)

Q10. Fair dealing for research is under:
→ Section 52(1)(a)

Study Tip: Focus on Sections 3(d), 84, 107A in Patents Act and Sections 52, 57 in Copyright Act – these are asked every year in Drug Inspector exams.