Protocols for herbal drug patent applications MCQs With Answer

Introduction: This quiz set focuses on protocols for herbal drug patent applications tailored for M.Pharm students studying Herbal and Cosmetic Analysis (MPA 204T). It covers key legal, procedural and scientific aspects necessary to draft, file and defend patent applications for herbal formulations, extracts and related innovations. Questions emphasize novelty assessment, prior art searches including Traditional Knowledge Digital Library (TKDL), specification drafting, claim strategy, regulatory and ethical considerations (e.g., access and benefit-sharing), international routes like PCT, and data requirements (standardization, pharmacology, stability). Use these MCQs to strengthen both conceptual understanding and practical decision-making required during real-world herbal patent preparation and prosecution.

Q1. What is the most essential first step when preparing a patent application for a herbal drug?

• Conducting a comprehensive prior art search including TKDL and scientific literature
• Initiating clinical trials immediately
• Preparing marketing authorization documents
• Submitting samples to manufacturing partners

Correct Answer: Conducting a comprehensive prior art search including TKDL and scientific literature

Q2. Which component is NOT strictly required in a patent specification filed at the time of filing?

• Title, abstract and detailed description
• Claims defining the invention
• Drawings or figures if necessary
• Completed clinical trial report demonstrating efficacy

Correct Answer: Completed clinical trial report demonstrating efficacy

Q3. Which specialized database is most useful in India to check prior traditional knowledge related to herbal remedies?

• PubMed Central
• Espacenet
• Traditional Knowledge Digital Library (TKDL)
• PUBCHEM

Correct Answer: Traditional Knowledge Digital Library (TKDL)

Q4. Which set of criteria are universally considered for patentability of a herbal invention?

• Novelty, inventive step (non-obviousness), and industrial applicability/utility
• Popularity, historical use, and traditional claim
• Price, market size, and therapeutic tradition
• Source plant species, geographic origin, and ethnobotanical record

Correct Answer: Novelty, inventive step (non-obviousness), and industrial applicability/utility

Q5. Under Indian patent law, which provision specifically excludes patents on plants and animals or essentially biological processes?

• Section 3(d)
• Section 3(j)
• Section 3(h)
• Section 3(k)

Correct Answer: Section 3(j)

Q6. What is the main legal advantage of filing a provisional patent application for a herbal composition?

• It grants an immediate patent without examination
• It secures an early filing date and allows 12 months to file the complete specification
• It replaces the need for any clinical or stability data
• It allows commercialization without disclosure

Correct Answer: It secures an early filing date and allows 12 months to file the complete specification

Q7. Which international mechanism helps an applicant seek patent protection in multiple countries with a single initial filing?

• NAFTA patent route
• Patent Cooperation Treaty (PCT)
• Hague Agreement
• Bremen Protocol

Correct Answer: Patent Cooperation Treaty (PCT)

Q8. TKDL (Traditional Knowledge Digital Library) primarily helps patent examiners to prevent:

• Clinical trial misconduct
• Biopiracy and wrongful patents on traditional knowledge
• Counterfeit herbal products
• Import tariffs on botanical extracts

Correct Answer: Biopiracy and wrongful patents on traditional knowledge

Q9. How should patent claims for a herbal formulation be drafted to withstand examination?

• Broad, vague and based only on traditional use
• Clear, concise, supported by the description and enabled for a person skilled in the art
• Only as method claims for use in therapy
• Using only genus and species names without composition details

Correct Answer: Clear, concise, supported by the description and enabled for a person skilled in the art

Q10. Which analytical information is critical to include in a patent application for a herbal extract to demonstrate reproducibility?

• Phytochemical fingerprinting, marker compound content and standardization parameters
• Only the botanical name and local trade name
• Market price and supplier address
• Only the traditional text citation without experimental data

Correct Answer: Phytochemical fingerprinting, marker compound content and standardization parameters

Q11. To establish the utility (industrial application) of a herbal composition in a patent, which data are most persuasive?

• Ethnobotanical anecdotes alone
• Pharmacological efficacy data and safety/toxicology studies
• Photographs of the plant in the wild
• Sales figures from local markets

Correct Answer: Pharmacological efficacy data and safety/toxicology studies

Q12. Under the TRIPS Agreement, the minimum patent term granted by member states is:

• 10 years from grant date
• 20 years from the filing date
• 7 years from filing
• Patent term is unlimited

Correct Answer: 20 years from the filing date

Q13. Which category is commonly excluded from patentability in many jurisdictions and therefore problematic for claiming in herbal patents?

• Novel botanical extracts with characterized markers
• Methods of treatment of the human body by surgery or therapy
• Composition claims with defined ingredient ratios
• Manufacturing processes for standardized extracts

Correct Answer: Methods of treatment of the human body by surgery or therapy

Q14. How does TKDL present traditional medicinal knowledge to patent examiners?

• As raw scanned pages in Sanskrit without translation
• As digitized, translated and structured, searchable entries mapped to patent terminology
• Only as audio recordings of healers
• By providing live demonstrations of remedies

Correct Answer: As digitized, translated and structured, searchable entries mapped to patent terminology

Q15. Under what circumstance can a government grant a compulsory license for a patented herbal drug?

• If the patent owner increases price moderately
• For reasons of public interest such as non-working, unaffordability or public health emergencies
• When the patent term exceeds 5 years
• If the invention is exported

Correct Answer: For reasons of public interest such as non-working, unaffordability or public health emergencies

Q16. What constitutes prior art that can destroy novelty of a herbal patent claim?

• Any public disclosure (publication, sale, patent application) made before the priority date
• Only publications in peer-reviewed journals within the last 2 years
• Unpublished lab notebooks kept by the inventor
• Internal corporate memos not released to the public

Correct Answer: Any public disclosure (publication, sale, patent application) made before the priority date

Q17. Under the PCT route, by when must an applicant normally enter national phase in most contracting states?

• 6 months from international filing
• 12 months from priority date
• 30 months from the priority date (to enter national phase)
• 5 years after international publication

Correct Answer: 30 months from the priority date (to enter national phase)

Q18. If a herbal invention requires deposit of biological material (e.g., microbial strain), what treaty often governs the accepted deposit procedure?

• Budapest Treaty on the International Recognition of the Deposit of Microorganisms
• Kyoto Protocol
• Montreal Protocol
• Helsinki Declaration

Correct Answer: Budapest Treaty on the International Recognition of the Deposit of Microorganisms

Q19. Which source is most likely to invalidate a patent claim for a traditional herbal remedy?

• A non-patent literature entry in TKDL or an ancient text describing the same formulation and use
• Internal R&D emails describing the development
• Claims filed by the same inventor at the same time
• Marketing brochures published after filing

Correct Answer: A non-patent literature entry in TKDL or an ancient text describing the same formulation and use

Q20. In India, within what period can an interested party file a post-grant opposition to a patent once it is granted?

• One year from the date of publication of grant
• 30 days from grant
• Five years from the filing date
• Only before grant, not after

Correct Answer: One year from the date of publication of grant

Download