PCT and convention patent filings MCQs With Answer

This set of MCQs on PCT and Convention patent filings is designed specifically for M.Pharm students studying Pharmaceutical Validation. It covers essential international filing concepts such as Paris Convention priority, PCT international applications, timelines for national phase entry, International Searching and Preliminary Examination Authorities, and key procedural documents like the ISR and IPRP. Questions emphasize pharmaceutical-relevant issues—claims for salts, polymorphs, methods of treatment, and enablement—so you can connect patent procedure to drug development and validation. Use these MCQs to test and deepen your understanding of strategic filing decisions, patentability criteria, and procedural steps encountered when protecting pharmaceutical inventions across multiple jurisdictions.

Q1. What is the priority period granted under the Paris Convention for filing a subsequent patent application claiming priority from an earlier application?

• 6 months
• 12 months
• 18 months
• 24 months

Correct Answer: 12 months

Q2. Which statement best describes the PCT (Patent Cooperation Treaty) application?

• It directly grants an international patent enforceable in all member states
• It is a single international patent that replaces national patents
• It is a unified filing system providing an international search and optional preliminary examination but not a grant
• It only covers trade secrets and not patentable inventions

Correct Answer: It is a unified filing system providing an international search and optional preliminary examination but not a grant

Q3. What is published at 18 months from the earliest priority date in a PCT application?

• The national phase entry documents
• The international application as a WO publication
• The grant certificate for each contracting state
• The final national patent claims

Correct Answer: The international application as a WO publication

Q4. Which body performs the international search for a PCT application?

• World Intellectual Property Organization (WIPO)
• International Searching Authority (ISA)
• International Preliminary Examination Authority (IPEA)
• European Medicines Agency (EMA)

Correct Answer: International Searching Authority (ISA)

Q5. The International Search Report (ISR) primarily provides information about:

• The commercial viability of the invention
• Prior art relevant to novelty and inventive step
• Regulatory approval timelines for pharmaceutical products
• The enforceability of future national patents

Correct Answer: Prior art relevant to novelty and inventive step

Q6. Under PCT, to enter the national phase in most jurisdictions, you must do so within:

• 12 months from priority date
• 18 months from priority date
• 30 months from priority date
• 48 months from filing date

Correct Answer: 30 months from priority date

Q7. Which of the following is true about the International Preliminary Report on Patentability (IPRP) under Chapter II?

• It is issued automatically with the ISR and cannot be requested
• It is produced only if the applicant files a Demand for international preliminary examination
• It grants provisional patent rights in member states
• It replaces the need to file national phase applications

Correct Answer: It is produced only if the applicant files a Demand for international preliminary examination

Q8. In pharmaceutical patents, which type of claim typically requires careful disclosure to satisfy sufficiency of disclosure/enablement during PCT examination?

• Claims to broad therapeutic use without experimental data
• Claims to simple chemical elements like oxygen
• Claims to printed matter unrelated to biological function
• Claims to natural phenomena without modification

Correct Answer: Claims to broad therapeutic use without experimental data

Q9. Which document often accompanies a PCT application to evidence the earlier filing when claiming Paris Convention priority?

• Assignment deed
• Priority document (copy of the earlier application)
• Marketing approval letter from a regulatory agency
• Manufacturing batch record

Correct Answer: Priority document (copy of the earlier application)

Q10. The Written Opinion of the ISA typically addresses which patentability criteria?

• Novelty, inventive step (non-obviousness), and industrial applicability
• Commercial value and market size only
• Environmental impact of the claimed invention
• Clinical efficacy data for pharmaceutical formulations

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

Q11. Which is a key advantage of filing a PCT application for a pharmaceutical inventor?

• Immediate grant of patent rights worldwide
• Extended time to decide and prepare national phase filings in multiple countries
• Automatic regulatory approval in all member states
• Waiver of all national patent office fees

Correct Answer: Extended time to decide and prepare national phase filings in multiple countries

Q12. If an applicant wants a substantive international preliminary examination under PCT, they must file a:

• Demand
• Priority waiver
• Patent Term Adjustment request
• Patent assignment record

Correct Answer: Demand

Q13. Which aspect makes a polymorph of a known drug potentially patentable under PCT and national laws?

• Being discovered after generic patents expire automatically grants novelty
• If it shows unexpected technical advantages such as improved stability or bioavailability
• Polymorphs are always considered obvious and unpatentable
• Polymorphs cannot be claimed because they are natural forms

Correct Answer: If it shows unexpected technical advantages such as improved stability or bioavailability

Q14. The international publication number of a PCT application typically begins with which prefix?

• EP/
• US/
• WO/
• IN/

Correct Answer: WO/

Q15. Which of the following is NOT a function of the International Searching Authority (ISA)?

• Conducting an international search and issuing the ISR
• Preparing the Written Opinion on patentability
• Granting national patents in contracting states
• Providing a basis for applicant’s decision to enter national phase

Correct Answer: Granting national patents in contracting states

Q16. Claiming priority from a provisional application under the Paris Convention means the PCT filing must occur within:

• 6 months from provisional filing
• 12 months from provisional filing
• 18 months from provisional filing
• 36 months from provisional filing

Correct Answer: 12 months from provisional filing

Q17. Which type of prior disclosure will generally destroy novelty worldwide and can affect PCT filings?

• A confidential laboratory notebook not publicly accessible
• A public presentation, publication, or patent application published before the priority date
• An undisclosed internal memo
• A sealed clinical report not released to the public

Correct Answer: A public presentation, publication, or patent application published before the priority date

Q18. During PCT international phase, unity of invention requirement means:

• All claims must cover completely unrelated technical fields
• Claims should relate to a single general inventive concept, otherwise additional inventions may require restrictions or additional fees
• Only one claim is allowed per application worldwide
• Unity is assessed only during national phase by each patent office

Correct Answer: Claims should relate to a single general inventive concept, otherwise additional inventions may require restrictions or additional fees

Q19. If an applicant misses the 12-month Paris Convention priority period, what is the usual consequence?

• The applicant can still claim priority retroactively without penalty
• The earlier filing date is lost and the subsequent application will have a later effective date for novelty purposes
• The patent application is automatically granted with reduced term
• The priority period can be extended indefinitely by filing a Demand

Correct Answer: The earlier filing date is lost and the subsequent application will have a later effective date for novelty purposes

Q20. Which action is recommended for pharmaceutical inventors to strengthen a PCT filing when claiming broad therapeutic uses?

• Include only a single example and omit experimental support to speed filing
• Provide multiple working examples, experimental data, and clear dosage/formulation details to satisfy enablement and support claims
• Rely solely on claims without detailed description since PCT examiners do not check enablement
• File only regional patents to avoid PCT complexity

Correct Answer: Provide multiple working examples, experimental data, and clear dosage/formulation details to satisfy enablement and support claims

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