Patent procedure, opposition, revocation and patent search for herbal/natural products MCQs With Answer

Introduction: This quiz compilation focuses on patent procedure, opposition, revocation and patent search specifically for herbal and natural product innovations — topics essential for M.Pharm students specializing in Industrial Pharmacognostical Technology. The questions explore patentability criteria for botanicals, strategies for comprehensive prior-art and TKDL searches, claim drafting nuances for complex natural mixtures, and procedural aspects of pre‑grant/post‑grant opposition and revocation. Emphasis is on practical search tools, critical data required to establish novelty and inventive step, and legal safeguards against biopiracy and wrongful monopolies. Use these MCQs to test and strengthen your understanding of how intellectual property frameworks interact with traditional knowledge and herbal drug development.

Q1. Which of the following is the primary criterion that must be demonstrated to establish patentability of a herbal formulation?

• Traditional use in ethnobotanical literature
• Novelty over prior art and inventive step
• Safety in human clinical trials
• Presence of known phytochemicals

Correct Answer: Novelty over prior art and inventive step

Q2. Which database is specifically designed to document traditional Indian medicinal formulations to prevent wrongful patenting?

• PubMed
• TKDL (Traditional Knowledge Digital Library)
• ESPACENET
• ClinicalTrials.gov

Correct Answer: TKDL (Traditional Knowledge Digital Library)

Q3. For herbal/natural products, which search strategy is most important to capture prior art comprehensively?

• Searching only chemical structure databases
• Combining botanical names, synonyms, traditional names and chemical constituents
• Relying solely on patent title keyword search
• Searching only local language literature

Correct Answer: Combining botanical names, synonyms, traditional names and chemical constituents

Q4. Which type of patent application gives an early filing date and allows 12 months to file a complete application in many jurisdictions?

• PCT international application
• Provisional application
• Divisional application
• Utility model application

Correct Answer: Provisional application

Q5. Which of these is a common ground for opposing a patent granted on a herbal product?

• Claiming exclusive rights to a synthetic molecule
• Lack of inventive step due to prior art disclosure of identical formulation
• Failure to provide manufacturing batch numbers
• Applicant’s nationality

Correct Answer: Lack of inventive step due to prior art disclosure of identical formulation

Q6. In patent searching, what does an IPC/CPC classification search help you find?

• Clinical trial results for a herb
• Patents classified under relevant technical categories
• Natural distribution maps of plants
• Traditional recipes in local languages

Correct Answer: Patents classified under relevant technical categories

Q7. Which aspect of the patent specification is crucial for enabling reproducibility of an herbal preparation?

• Vague references to “traditional methods” without details
• Detailed description of raw material source, extraction, standardization and doses
• Only listing chemical names of active compounds
• Photographs of the plant only

Correct Answer: Detailed description of raw material source, extraction, standardization and doses

Q8. Which international service allows full-text searching of patent documents across many jurisdictions including WIPO?

• Google Scholar
• WIPO Patentscope
• UniProt
• Scopus

Correct Answer: WIPO Patentscope

Q9. What is a primary legal protection concern unique to herbal/natural product patents compared with synthetic small molecules?

• Higher filing fees
• Risk of conflicting claims with traditional knowledge and prior community use
• Inability to draft claims
• Universal patentability of all extracts

Correct Answer: Risk of conflicting claims with traditional knowledge and prior community use

Q10. Which practice helps reduce the risk of opposition based on prior traditional knowledge when filing a patent for a herbal product?

• Concealing the plant source in the specification
• Conducting TKDL and ethnobotanical prior-art searches and disclosing distinctions clearly
• Claiming overly broad monopoly over plant species
• Avoiding any mention of preparation method

Correct Answer: Conducting TKDL and ethnobotanical prior-art searches and disclosing distinctions clearly

Q11. Which ground would most likely lead to revocation of a herbal patent related to its therapeutic claim?

• Excessive experimental evidence provided
• Insufficient evidence to support claimed therapeutic efficacy (lack of enablement)
• Listing more than five claims
• Using Latin rather than common names for plants

Correct Answer: Insufficient evidence to support claimed therapeutic efficacy (lack of enablement)

Q12. Which of these search modalities is especially useful for identifying patents claiming specific phytochemicals within an extract?

• Sequence similarity search
• Structure (chemical) search and substructure searching
• Geographic distribution search
• Image-based plant identification

Correct Answer: Structure (chemical) search and substructure searching

Q13. Which statement about pre-grant and post-grant opposition is correct in general patent practice?

• Pre-grant opposition can only be filed by the patent applicant
• Post-grant opposition challenges validity after grant, while pre-grant challenges can block grant if successful
• Opposition is impossible for natural product patents
• Both pre- and post-grant opposition are anonymous and unrecorded

Correct Answer: Post-grant opposition challenges validity after grant, while pre-grant challenges can block grant if successful

Q14. When drafting claims for a herbal composition to maximize protection and minimize rejection risk, which approach is advisable?

• File only one very broad claim covering all possible uses
• Draft layered claims: broad composition claims plus narrower dependent claims with specific markers, doses and preparation steps
• Omit any mechanistic explanation
• Claim only the plant species name without composition details

Correct Answer: Draft layered claims: broad composition claims plus narrower dependent claims with specific markers, doses and preparation steps

Q15. Which of the following best describes the role of Priority Date in patentability evaluation?

• It determines the applicant’s nationality
• It is the date used to assess novelty against prior art
• It sets the patent term length to 50 years
• It is when the patent is published

Correct Answer: It is the date used to assess novelty against prior art

Q16. What is the main advantage of using PCT (Patent Cooperation Treaty) for an inventor of a herbal product?

• Instant grant of a worldwide patent
• Centralized international filing that delays national phase deadlines and allows broader prior art search
• Reduces the need for experimental data
• Exempts the invention from oppositions

Correct Answer: Centralized international filing that delays national phase deadlines and allows broader prior art search

Q17. For a patent examiner to consider a herbal extract patent non‑patentable due to “lack of inventive step,” which comparison is usually made?

• Comparison to unrelated synthetic drugs
• Comparison to closest prior art and assessment of whether the improvement would have been obvious to a skilled person
• Comparison to the applicant’s CV
• Comparison to traditional recipes only

Correct Answer: Comparison to closest prior art and assessment of whether the improvement would have been obvious to a skilled person

Q18. Which practical element strengthens a patent application for a natural product mixture to survive opposition or revocation?

• Providing ethnobotanical anecdotes without experiments
• Including quantitative analytical profiles, marker compounds and reproducible preparation methods
• Using undefined terms like “effective amount” exclusively
• Limiting the specification to a single example

Correct Answer: Including quantitative analytical profiles, marker compounds and reproducible preparation methods

Q19. In a patent search for herbal products, why is it important to include non‑patent literature (NPL) such as ethnobotanical texts and pharmacopeias?

• NPL is rarely relevant to novelty
• NPL can constitute prior art that negates novelty or inventive step even if not patented
• NPL is always proprietary and inaccessible
• NPL replaces the need to search patent databases

Correct Answer: NPL can constitute prior art that negates novelty or inventive step even if not patented

Q20. Which of the following is a legitimate ethical and legal consideration when filing patents on indigenous plant uses?

• Ignoring benefit-sharing obligations
• Ensuring prior informed consent, transparent benefit-sharing and compliance with access and benefit-sharing laws
• Claiming exclusive rights without acknowledging source knowledge
• Withholding botanical identification to prevent challenges

Correct Answer: Ensuring prior informed consent, transparent benefit-sharing and compliance with access and benefit-sharing laws

Download