Indian patent laws applicable to herbal drugs MCQs With Answer

Introduction

This quiz collection is designed for M.Pharm students studying Herbal and Cosmetic Analysis (MPA 204T) to strengthen understanding of Indian patent laws as they apply to herbal drugs. It covers patentability criteria, exclusions relevant to traditional knowledge, procedural aspects such as opposition and compulsory licensing, and practical safeguards like the Traditional Knowledge Digital Library (TKDL) and the Biological Diversity Act. Questions emphasize real-world issues—prior art, benefit-sharing, evergreening, and claim drafting for herbal formulations—so students can apply legal principles when evaluating or preparing patent-related work in herbal drug research and development.

Q1. Which of the following is a fundamental requirement for a herbal formulation to be granted a patent in India?

• It must be derived solely from plants listed in classical Ayurvedic texts
• It must demonstrate novelty, inventive step and industrial applicability
• It must have been used traditionally for at least 50 years
• It must be registered with the Traditional Knowledge Digital Library (TKDL)

Correct Answer: It must demonstrate novelty, inventive step and industrial applicability

Q2. What is the primary purpose of the Traditional Knowledge Digital Library (TKDL) with respect to patenting?

• To automatically grant patents for traditional remedies
• To provide prior art documentation to prevent wrongful patents on traditional knowledge
• To certify quality of herbal raw materials for export
• To replace national patent offices for herbal drug applications

Correct Answer: To provide prior art documentation to prevent wrongful patents on traditional knowledge

Q3. Which practice aimed at extending patent life by making minor modifications to a known herbal drug is targeted by Indian law provisions preventing ‘evergreening’?

• Compulsory licensing
• Patent pooling
• Evergreening through trivial modifications of known substances
• Open-source licensing

Correct Answer: Evergreening through trivial modifications of known substances

Q4. Under Indian patent law, what impact does documented prior traditional use of a herbal ingredient have on patentability?

• It automatically qualifies the use as patentable subject matter
• It serves as prior art and can invalidate novelty or inventive step
• It requires patent applicants to get community consent before filing
• It allows exclusive community patents without examination

Correct Answer: It serves as prior art and can invalidate novelty or inventive step

Q5. Which statutory mechanism allows any person to challenge a patent application in India before it is granted?

• Pre-grant opposition
• Compulsory licensing
• Patent pooling
• Post-grant tribunal appeal

Correct Answer: Pre-grant opposition

Q6. Which of the following is generally excluded from patentability in India and is particularly relevant for plant-derived materials?

• Chemical synthesis processes
• Mathematical methods to model herb interactions
• Traditional knowledge documented and publicly available
• Novel formulations with unexpected technical effect

Correct Answer: Traditional knowledge documented and publicly available

Q7. How does the Biodiversity Act and associated regulations affect patent applications for herbal drugs in India?

• They require applicants to pay a mandatory royalty to the government for each patent
• They impose obligations to obtain permission for access to biological resources and to disclose source and benefit sharing
• They exempt herbal drug patents from examination procedures
• They allow patents only to Indian citizens or entities

Correct Answer: They impose obligations to obtain permission for access to biological resources and to disclose source and benefit sharing

Q8. Which of the following best describes the role of Section 3(d) type provisions as applied to herbal drug patent claims?

• They allow patenting of any new extraction method regardless of efficacy
• They prevent patenting of new forms of known substances unless enhanced efficacy is demonstrated
• They mandate that all herbal patents be co-owned by traditional practitioners
• They provide expedited patent grants for traditional herbal formulations

Correct Answer: They prevent patenting of new forms of known substances unless enhanced efficacy is demonstrated

Q9. What is the significance of ‘novelty’ in assessing a patent application for a herbal composition?

• Novelty only concerns manufacturing cost savings
• Novelty requires that the claimed subject matter is not already part of the public domain anywhere in the world
• Novelty refers to whether a formulation is traditional or modern
• Novelty is irrelevant if the formulation shows minor improvements

Correct Answer: Novelty requires that the claimed subject matter is not already part of the public domain anywhere in the world

Q10. Which of the following is a correct statement about compulsory licensing in India relevant to herbal medicines?

• Compulsory licenses are granted immediately upon request without conditions
• Compulsory licensing may be granted if the patented invention is not worked in India, or is unaffordable or not available to the public
• Compulsory licenses are only applicable to chemical drugs, not herbal drugs
• Compulsory licensing allows foreign companies to revoke Indian patents

Correct Answer: Compulsory licensing may be granted if the patented invention is not worked in India, or is unaffordable or not available to the public

Q11. In preparing patent claims for a herbal drug, which strategy best strengthens patentability while respecting traditional knowledge?

• Claim the herb itself in broad generic terms without data
• Focus claims on novel extraction processes, specific standardized formulations and demonstrated technical effects
• Claim traditional usage indications directly copied from classical texts
• File identical claims in all jurisdictions without considering prior art

Correct Answer: Focus claims on novel extraction processes, specific standardized formulations and demonstrated technical effects

Q12. Which action by an applicant helps prevent rejection due to prior art based on traditional texts when filing a patent on a herbal innovation?

• Intentionally omitting source information to avoid scrutiny
• Conducting thorough prior art and TKDL searches and providing data showing inventive step and efficacy
• Claiming ancient texts as their own unpublished data
• Only filing in foreign jurisdictions and not in India

Correct Answer: Conducting thorough prior art and TKDL searches and providing data showing inventive step and efficacy

Q13. Which of the following is a correct consequence if a patent examiner finds relevant entries in TKDL corresponding to a claimed herbal use?

• The examiner will ignore TKDL since it is not admissible as prior art
• The application is likely to face rejection or require amendment as TKDL constitutes recognized prior art
• The patent is automatically fast-tracked for approval
• TKDL entries can be used only after patent grant

Correct Answer: The application is likely to face rejection or require amendment as TKDL constitutes recognized prior art

Q14. Which of the following types of claims is least likely to be allowed for a plant or naturally occurring extract under Indian practice?

• A specific manufacturing process that yields a novel standardized extract
• A composition with a defined synergistic ratio and experimental efficacy data
• A claim solely to the plant species per se or essentially biological processes for propagation
• A purified novel metabolite isolated and characterized from a plant with demonstrated therapeutic effect

Correct Answer: A claim solely to the plant species per se or essentially biological processes for propagation

Q15. How does priority date affect patentability of a herbal formulation in India?

• Priority date is irrelevant if the applicant publishes data later
• Priority date determines which references count as prior art when assessing novelty and inventive step
• Priority date only applies to foreign applicants
• Priority date guarantees patent grant if filed within one year

Correct Answer: Priority date determines which references count as prior art when assessing novelty and inventive step

Q16. Which of the following best describes ‘biopiracy’ in the context of herbal drug patents?

• The legitimate commercialisation of genetically improved crops
• The unauthorized patenting or commercial exploitation of traditional knowledge and biological resources without consent or benefit-sharing
• Public-domain publication of traditional recipes
• A government program to distribute herbal medicines

Correct Answer: The unauthorized patenting or commercial exploitation of traditional knowledge and biological resources without consent or benefit-sharing

Q17. If an Indian researcher finds that a foreign company has been granted a patent overlapping a herbal invention, what recourse is most appropriate in India?

• Nothing can be done once a foreign patent is granted
• File for revocation or oppose the foreign grant at the foreign office only
• File an opposition or revocation proceedings in India if a corresponding Indian patent exists, and present TKDL or prior art evidence
• Contact the foreign company to demand immediate license fees

Correct Answer: File an opposition or revocation proceedings in India if a corresponding Indian patent exists, and present TKDL or prior art evidence

Q18. Which procedural obligation should Indian patent applicants observe when their invention involves biological materials accessed from India?

• No obligation exists to mention biological source
• Inform and obtain necessary approvals from the National Biodiversity Authority and disclose source and benefit-sharing arrangements where applicable
• Only list the scientific name of the plant without permissions
• File the patent application anonymously to protect community identity

Correct Answer: Inform and obtain necessary approvals from the National Biodiversity Authority and disclose source and benefit-sharing arrangements where applicable

Q19. Which of the following evidences strengthens a patent application for a herbal drug facing a challenge based on traditional use?

• Only anecdotal testimonials without experimentation
• Comprehensive experimental data showing standardized composition, reproducible pharmacological activity and improved efficacy
• Claims that the herb is secret and unpublished
• Broad claims without any supporting data

Correct Answer: Comprehensive experimental data showing standardized composition, reproducible pharmacological activity and improved efficacy

Q20. Which international mechanism can an Indian applicant use to seek patent protection for a herbal invention in multiple countries while preserving filing dates?

• Traditional Knowledge Digital Library (TKDL)
• Patent Cooperation Treaty (PCT) international filing
• Global herbal registry exemption
• Compulsory licensing across jurisdictions

Correct Answer: Patent Cooperation Treaty (PCT) international filing

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