Patenting and IPR issues for herbal products: novelty, non-obviousness, TRIPS compliance MCQs With Answer

Introduction:

This quiz set is designed for M.Pharm students studying Industrial Pharmacognostical Technology and focuses on patenting and intellectual property issues specific to herbal products. It covers key legal and practical concepts such as novelty, inventive step (non‑obviousness), sufficiency of disclosure, prior art including traditional knowledge, claim drafting challenges for botanical inventions, and TRIPS compliance. The questions aim to deepen understanding of how patent law intersects with herbal drug research, ethical access to genetic resources, and defense against biopiracy. Use these MCQs to evaluate and reinforce your ability to assess patentability and regulatory strategies when working with herbal products.

Q1. Which category does TRIPS explicitly allow member states to exclude from patentability under Article 27.3(b)?

• Computer-implemented inventions
• Plant varieties
• New pharmaceutical molecules
• Industrial chemical processes

Correct Answer: Plant varieties

Q2. In patent law the novelty requirement means the claimed invention must:

• Have never been published or made available to the public anywhere before the priority date
• Show a significant therapeutic advantage over existing products
• Be capable of industrial application only
• Be based on a traditional use described in ethnobotanical literature

Correct Answer: Have never been published or made available to the public anywhere before the priority date

Q3. Which of the following will most directly destroy novelty for an herbal patent application?

• Confidential internal lab notes documenting use of the herb
• Public presentation with slides posted online before filing
• Use of the herb in a private clinical study under confidentiality agreements
• Conceptual discussion at a closed meeting not open to the public

Correct Answer: Public presentation with slides posted online before filing

Q4. For a herbal invention, which claim is most likely to meet patentability requirements in many jurisdictions?

• A claim to a wild plant species “as found in nature”
• A claim to a traditional decoction for headache described in an ancient text
• A claim to an isolated and structurally characterized phytochemical with a newly discovered therapeutic use
• A claim to merely combining two known herbs in a commonly used ratio without evidence of synergy

Correct Answer: A claim to an isolated and structurally characterized phytochemical with a newly discovered therapeutic use

Q5. The legal test for inventive step (non‑obviousness) commonly relies on the hypothetical perspective of which of the following?

• The layperson consumer
• The inventor who filed the application
• The person skilled in the art
• A government patent examiner only

Correct Answer: The person skilled in the art

Q6. Which type of experimental evidence most strongly supports inventive step for a new combination herbal formulation?

• Showing each component has known activity individually
• Data demonstrating an unexpected synergistic effect at clinically relevant doses
• Demonstrating the combination is easier to manufacture than prior products
• Citing traditional recipes that use the same plants together

Correct Answer: Data demonstrating an unexpected synergistic effect at clinically relevant doses

Q7. Under TRIPS, the minimum patent term that member states must provide for patent protection is:

• 10 years from grant
• 15 years from filing
• 20 years from filing
• Life of the inventor plus 70 years

Correct Answer: 20 years from filing

Q8. Which of the following is considered ‘prior art’ that can be used to challenge novelty of an herbal invention?

• Information disclosed in a peer‑reviewed journal accessible to the public before the priority date
• Confidential experimental results never shared outside the company
• An unpublished doctoral thesis stored only in a private office
• Personal oral anecdotes not recorded or disseminated publicly

Correct Answer: Information disclosed in a peer‑reviewed journal accessible to the public before the priority date

Q9. Documented traditional knowledge databases such as a TKDL (Traditional Knowledge Digital Library) primarily help patent offices by:

• Replacing the need for patent examination completely
• Providing prior art evidence to prevent wrongful patents on known traditional uses
• Guaranteeing benefit‑sharing payments to traditional communities
• Automatically granting patents to indigenous knowledge holders

Correct Answer: Providing prior art evidence to prevent wrongful patents on known traditional uses

Q10. ‘Sufficiency of disclosure’ in the context of a herbal patent means the specification must:

• Provide enough detail that a person skilled in the art can carry out the invention without undue experimentation
• Include the full ethnobotanical history of the plant even if irrelevant to the invention
• List every possible plant source that could contain the active compound
• Be limited to a general statement of potential therapeutic benefits

Correct Answer: Provide enough detail that a person skilled in the art can carry out the invention without undue experimentation

Q11. A practical defensive strategy to prevent others from obtaining patents on a known herbal use is to:

• Publish a detailed scientific disclosure in a public journal or database prior to their filing
• Rely solely on trade‑secret protection without any disclosure
• File multiple vague patent applications with minimal data
• Request secrecy orders from the patent office indefinitely

Correct Answer: Publish a detailed scientific disclosure in a public journal or database prior to their filing

Q12. Access and benefit‑sharing obligations for genetic resources used in developing herbal products are primarily governed by which international instrument?

• The TRIPS Agreement alone
• The Nagoya Protocol to the Convention on Biological Diversity
• The Berne Convention on Copyrights
• The Hague Convention

Correct Answer: The Nagoya Protocol to the Convention on Biological Diversity

Q13. In patent practice a ‘selection invention’ for herbal products refers to:

• Selecting a completely new plant species never previously used
• Selecting a subset or specific ratio from known materials that shows unexpectedly improved properties
• Selecting a plant solely on the basis of folkloric mentions without experimental data
• Selecting any herb that grows in a particular geographic region

Correct Answer: Selecting a subset or specific ratio from known materials that shows unexpectedly improved properties

Q14. Which type of claim related to herbal therapeutics is commonly problematic or excluded in many national laws due to medical method exclusions?

• Composition claims for a herbal extract
• Claims for manufacture processes for an extract
• Method of treatment claims that require performing a therapeutic step on a patient
• Use claims for a new industrial non‑therapeutic application

Correct Answer: Method of treatment claims that require performing a therapeutic step on a patient

Q15. Under the TRIPS Agreement, the provision that explicitly contemplates the possibility of compulsory licensing in certain circumstances is:

• Article 27
• Article 31
• Article 7
• Article 50

Correct Answer: Article 31

Q16. Which scenario most likely indicates lack of inventive step (obviousness) for a herbal product patent claim?

• Discovery of a novel bioactive compound with a unique mechanism of action
• Routine substitution of one well‑known herb with another known to have similar constituents without unexpected effects
• Identification of a new synergistic interaction demonstrated by rigorous clinical data
• Development of a novel processing method that changes the chemical profile and activity

Correct Answer: Routine substitution of one well‑known herb with another known to have similar constituents without unexpected effects

Q17. Regarding traditional knowledge (TK) as prior art, which statement is most accurate for patent examiners?

• Oral traditional knowledge can never be considered prior art under any circumstances
• Widely available or documented TK accessible to the public before the priority date can anticipate novelty
• TK is automatically excluded from all patent searches and examinations
• Only TK recorded in modern scientific journals is admissible as prior art

Correct Answer: Widely available or documented TK accessible to the public before the priority date can anticipate novelty

Q18. Which of the following modifications to a naturally occurring phytochemical most strengthens a patentability argument?

• Claiming the unmodified natural compound as found in the plant only
• Claiming a structurally modified derivative with improved pharmacokinetics and demonstrated efficacy
• Claiming the use of the whole plant without characterization
• Claiming a vague “composition comprising a plant extract” without characterization

Correct Answer: Claiming a structurally modified derivative with improved pharmacokinetics and demonstrated efficacy

Q19. TRIPS Article 27 requires that patents be available for inventions in:

• Only pharmaceuticals and agricultural chemicals
• All fields of technology provided they meet novelty, inventive step and industrial applicability
• Only technologies that are not related to public health
• Cultural expressions and folklore

Correct Answer: All fields of technology provided they meet novelty, inventive step and industrial applicability

Q20. Under the Paris Convention for the Protection of Industrial Property, the conventional priority period for filing subsequent patent applications is:

• 6 months from the first filing date
• 12 months from the first filing date
• 24 months from the first filing date
• 36 months from the first filing date

Correct Answer: 12 months from the first filing date

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