International patent regulations for herbal drugs MCQs With Answer

Introduction

This quiz set on International patent regulations for herbal drugs is designed specifically for M.Pharm students studying Herbal and Cosmetic Analysis (MPA 204T). It covers core international legal frameworks—such as TRIPS, the Nagoya Protocol, PCT procedures—and practical issues that affect patentability of herbal products: novelty, inventive step, disclosure of origin, traditional knowledge, TKDL, benefit-sharing, and national differences (India, EU, US). The questions focus on real-world implications for herbal formulations, extracts and processes, and on how prior art from ethnobotanical sources or pharmacopeias influences patent outcomes. Use these MCQs to sharpen exam readiness and practical understanding of intellectual property challenges in herbal drug development.

Q1. Which international agreement requires WTO members to provide patent protection for inventions in all fields of technology, subject to certain exceptions, affecting herbal drug patents?

• World Health Organization (WHO) Framework
• Trade-Related Aspects of Intellectual Property Rights (TRIPS)
• Convention on Biological Diversity (CBD)
• Nagoya Protocol

Correct Answer: Trade-Related Aspects of Intellectual Property Rights (TRIPS)

Q2. Under Article 27(3)(b) of TRIPS, WTO members may exclude which subject matter from patentability, which is relevant when considering protection for plants and biological processes used in herbal drugs?

• Pharmaceutical formulations
• Traditional knowledge databases
• Plants and essentially biological processes for the production of plants
• Chemical synthesis methods

Correct Answer: Plants and essentially biological processes for the production of plants

Q3. The Nagoya Protocol primarily addresses which of the following issues relevant to herbal drug development and patenting?

• Global harmonisation of patent examination standards
• Access to genetic resources and fair and equitable benefit-sharing
• Compulsory licensing of patented drugs during pandemics
• Patent term extensions for slow regulatory approvals

Correct Answer: Access to genetic resources and fair and equitable benefit-sharing

Q4. Which tool was created in India to prevent wrongful patents on traditional medicinal knowledge by providing searchable prior art to patent examiners?

• Indian Patent Gazette
• Traditional Knowledge Digital Library (TKDL)
• Biodiversity Heritage Archive
• National Herbarium Index

Correct Answer: Traditional Knowledge Digital Library (TKDL)

Q5. In patent law, why are many herbal remedies often refused patents based on ‘lack of novelty’?

• Herbal remedies cannot be chemically analysed
• Traditional uses and publications may form prior art that discloses the same invention
• Patents are not available for natural products anywhere
• They always lack industrial applicability

Correct Answer: Traditional uses and publications may form prior art that discloses the same invention

Q6. Which international treaty facilitates filing a single international patent application that can later enter national phases in member countries, useful for applicants seeking protection for herbal formulations globally?

• Paris Convention
• Budapest Treaty
• Patent Cooperation Treaty (PCT)
• Helsinki Protocol

Correct Answer: Patent Cooperation Treaty (PCT)

Q7. Disclosure of origin in patent applications for inventions derived from genetic resources is most directly aimed at addressing which concern?

• Accelerating grant procedures
• Preventing double patenting
• Ensuring compliance with Access and Benefit-Sharing (ABS) obligations
• Guaranteeing market exclusivity

Correct Answer: Ensuring compliance with Access and Benefit-Sharing (ABS) obligations

Q8. Which of the following is a common defensive strategy used by countries to prevent misappropriation of indigenous herbal knowledge through patents?

• Granting automatic patents for all traditional formulations
• Creating national databases of traditional knowledge as prior art
• Prohibiting any research on native plants
• Requiring all researchers to assign IP to the government

Correct Answer: Creating national databases of traditional knowledge as prior art

Q9. For a herbal extract claim to meet the sufficiency (enablement) requirement, what must the patent application typically provide?

• A list of countries where the plant grows
• A detailed method to obtain the extract and evidence of how to use it for the claimed therapeutic effect
• Only the common name of the plant
• Evidence of traditional use without experimental data

Correct Answer: A detailed method to obtain the extract and evidence of how to use it for the claimed therapeutic effect

Q10. Which of the following can be considered prior art that may invalidate a patent application for a herbal formulation?

• Unpublished laboratory notebooks held by the inventor
• Traditional pharmacopeia entries, published ethnobotanical literature, or TKDL entries
• Internal corporate memos not publicly disclosed
• Oral secret remedies communicated after filing

Correct Answer: Traditional pharmacopeia entries, published ethnobotanical literature, or TKDL entries

Q11. Which principle allows a government to authorize production or use of a patented herbal drug without the consent of the patent holder under certain conditions?

• Sui generis protection
• Compulsory licensing
• Patent term adjustment
• Exclusive marketing rights

Correct Answer: Compulsory licensing

Q12. What is a common reason national patent offices refuse claims directed to mere discovery of an existing natural substance used traditionally?

• Because discoveries cannot be commercialized
• Because discovering something existing in nature lacks inventive step and is non-patentable subject matter in many jurisdictions
• Because single compound claims are always allowed
• Because traditional use counts as novelty enhancement

Correct Answer: Because discovering something existing in nature lacks inventive step and is non-patentable subject matter in many jurisdictions

Q13. Which mechanism enables third parties to challenge the validity of a granted patent for a herbal drug shortly after grant in many jurisdictions?

• Post-grant opposition or re-examination
• Patent term restoration
• Patentability fast track
• Data exclusivity extension

Correct Answer: Post-grant opposition or re-examination

Q14. How does the concept of ‘novel use’ of a known herbal substance affect patentability in some jurisdictions?

• Novel therapeutic uses of known substances are never patentable anywhere
• Certain jurisdictions allow new, inventive medical uses to be claimed, often as second medical use claims or Swiss-type claims
• Novel use is considered the same as manufacturing process and is ignored
• It automatically grants international protection without filing

Correct Answer: Certain jurisdictions allow new, inventive medical uses to be claimed, often as second medical use claims or Swiss-type claims

Q15. When drafting patent claims for multi-herb formulations, which practice improves chances of grant and enforcement internationally?

• Using extremely broad, vague functional language only
• Drafting both composition and process claims with specific ingredient ranges, preparation steps, and therapeutic indications supported by data
• Filing only in one jurisdiction and relying on trade secrets elsewhere
• Omitting any experimental examples to keep claims general

Correct Answer: Drafting both composition and process claims with specific ingredient ranges, preparation steps, and therapeutic indications supported by data

Q16. Which international organization provides global services like international search and preliminary examination under the PCT that are useful for herbal drug patent applicants?

• World Health Organization (WHO)
• World Intellectual Property Organization (WIPO)
• United Nations Environment Programme (UNEP)
• International Union for Conservation of Nature (IUCN)

Correct Answer: World Intellectual Property Organization (WIPO)

Q17. Why is disclosure of the method of extraction and standardization important for pharmaceutical patentability of herbal extracts?

• Because regulators require secret formulas
• Because patents require sufficient disclosure enabling a skilled person to reproduce the invention and ensure reproducible biological activity
• Because it reduces the patent term
• Because disclosure prevents others from publishing

Correct Answer: Because patents require sufficient disclosure enabling a skilled person to reproduce the invention and ensure reproducible biological activity

Q18. Which of the following best describes a sui generis system that some countries may adopt instead of patents for protecting plant varieties or traditional knowledge?

• A one-size-fits-all international patent law
• Custom, national law designed specifically to protect local varieties or traditional knowledge outside standard patent regimes
• A global database of pharmaceutical ingredients
• A trade agreement to ban all patents on natural products

Correct Answer: Custom, national law designed specifically to protect local varieties or traditional knowledge outside standard patent regimes

Q19. In the context of international patent filings for herbal drugs, what is the main benefit of conducting a TKDL search before filing?

• It guarantees patent grant
• It helps identify existing traditional disclosures as prior art and reduces risk of rejection or opposition
• It replaces the need for clinical data
• It allows unilateral appropriation of indigenous knowledge

Correct Answer: It helps identify existing traditional disclosures as prior art and reduces risk of rejection or opposition

Q20. Which requirement is commonly scrutinized by examiners for claims covering active constituents isolated from plants used in herbal medicine?

• The number of inventors listed
• Demonstration of novelty, inventive step and sufficient experimental data showing the specific activity and reproducible isolation method
• Whether the plant name is in English only
• Whether the inventor has commercialized the product before filing

Correct Answer: Demonstration of novelty, inventive step and sufficient experimental data showing the specific activity and reproducible isolation method

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