Introduction to Intellectual Property Rights (IPR) MCQs With Answer

Introduction to Intellectual Property Rights (IPR) MCQs With Answer

Intellectual Property Rights (IPR) are legal protections essential to pharmaceutical innovation. For B. Pharm students, IPR concepts—patents, trademarks, copyrights, trade secrets, data exclusivity, and compulsory licensing—impact drug discovery, formulation, clinical data protection, licensing, and market access. Key topics include patentability criteria (novelty, inventive step, industrial applicability), patent claims and prosecution, patent term and extensions, evergreening, biosimilars, PCT filings, TRIPS obligations, and IP management strategies for freedom-to-operate and ethical access to medicines. Understanding these concepts helps pharmacists navigate commercialization and regulatory pathways while protecting public health interests. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What does IPR stand for?

• International Patent Rights
• Intellectual Property Rights
• Industrial Protection Regulations
• Information Privacy Rules

Correct Answer: Intellectual Property Rights

Q2. Which form of IPR primarily protects pharmaceutical inventions such as new drug molecules?

• Trademarks
• Copyrights
• Patents
• Geographical Indications

Correct Answer: Patents

Q3. Which three criteria are commonly required for an invention to be patentable?

• Novelty, inventive step, and industrial applicability
• Novelty, copyright, and trade secret
• Trademark registration, novelty, and utility
• Public disclosure, prior use, and novelty

Correct Answer: Novelty, inventive step, and industrial applicability

Q4. What type of IPR protects brand names, logos, and trade dress for pharmaceutical products?

• Patents
• Trademarks
• Copyrights
• Trade secrets

Correct Answer: Trademarks

Q5. Data exclusivity in pharmaceuticals primarily protects:

• Patents on the active ingredient
• Clinical trial and regulatory data submitted to authorities
• Brand names and logos
• Manufacturing equipment designs

Correct Answer: Clinical trial and regulatory data submitted to authorities

Q6. Which international agreement sets minimum standards for IP protection among member countries?

• PCT (Patent Cooperation Treaty)
• WIPO Convention
• TRIPS Agreement
• Helsinki Declaration

Correct Answer: TRIPS Agreement

Q7. In a patent, the claims define:

• The experimental data supporting the invention
• The scope of legal protection granted by the patent
• The marketing strategy for the product
• The manufacturing protocol only

Correct Answer: The scope of legal protection granted by the patent

Q8. What is the typical maximum term of patent protection for pharmaceuticals from filing?

• 10 years
• 20 years
• 5 years
• Life of the inventor

Correct Answer: 20 years

Q9. Compulsory licensing allows:

• A patent holder to extend their patent term
• A government to permit a third party to use a patent without the owner’s consent under certain conditions
• Automatic patent invalidation after 5 years
• Free global licensing of all patents

Correct Answer: A government to permit a third party to use a patent without the owner’s consent under certain conditions

Q10. “Evergreening” in pharmaceuticals refers to:

• Environmental certifications for drug manufacturing
• Strategies to extend a product’s market exclusivity by minor changes to a patented drug
• Accelerated approval of generics
• International patent harmonization

Correct Answer: Strategies to extend a product’s market exclusivity by minor changes to a patented drug

Q11. What is the Patent Cooperation Treaty (PCT) primarily used for?

• Enforcing patents across borders
• Filing a single international patent application to seek protection in multiple countries
• Registering trademarks internationally
• Resolving IP disputes

Correct Answer: Filing a single international patent application to seek protection in multiple countries

Q12. Which type of IPR is best for protecting confidential drug formulation processes not publicly disclosed?

• Patent
• Trade secret
• Trademark
• Copyright

Correct Answer: Trade secret

Q13. A generic drug can enter the market when:

• The brand product’s patent has expired or been invalidated
• The brand owner changes the trademark
• Clinical trials are incomplete
• Data exclusivity is extended indefinitely

Correct Answer: The brand product’s patent has expired or been invalidated

Q14. Biosimilars are:

• Exact chemical copies of small-molecule drugs
• Generic versions of biologic medicines that are highly similar to a reference product
• Novel vaccines only
• Trademarks for biological products

Correct Answer: Generic versions of biologic medicines that are highly similar to a reference product

Q15. “Prior art” refers to:

• Information that is publicly available before a patent’s filing date
• The bibliography in a patent application
• Only patents published after filing
• Trade secrets kept by a company

Correct Answer: Information that is publicly available before a patent’s filing date

Q16. The term “inventive step” is equivalent to which concept in some jurisdictions?

• Novelty
• Utility
• Non-obviousness
• Patentability of natural phenomenon

Correct Answer: Non-obviousness

Q17. Which document provides the technical disclosure required to support a patent’s claims?

• Patent specification
• Trademark registration
• Clinical trial protocol
• Regulatory approval letter

Correct Answer: Patent specification

Q18. Patents are granted by which authority?

• Local university technology transfer office
• Patent office of the relevant country or region
• World Health Organization (WHO)
• International Court of Justice

Correct Answer: Patent office of the relevant country or region

Q19. Which of the following is generally not patentable subject matter in most jurisdictions?

• A new synthetic drug molecule
• A novel manufacturing process
• A naturally occurring substance isolated but not modified
• A new formulation with promising utility

Correct Answer: A naturally occurring substance isolated but not modified

Q20. Which rights can provide exclusive marketing protection for a pharmaceutical product?

• Patent protection and data exclusivity
• Trademark and geographical indication only
• Trade secret alone without any regulatory filings
• Copyright and design patents only

Correct Answer: Patent protection and data exclusivity

Q21. Common legal remedies for patent infringement include:

• Injunctions and monetary damages
• Trademark registration and public apology
• Automatic revocation of the patent holder’s other patents
• Only criminal penalties

Correct Answer: Injunctions and monetary damages

Q22. Prior user rights allow a person who commercially used an invention before a patent filing to:

• Receive patent royalties from the patent owner
• Continue using the invention without infringement liability in some jurisdictions
• Claim ownership of the patent automatically
• Extend the patent term

Correct Answer: Continue using the invention without infringement liability in some jurisdictions

Q23. “Freedom-to-operate” (FTO) analysis is used to:

• Determine whether a new product will infringe existing IP rights
• Calculate tax liabilities for drug sales
• Evaluate clinical trial endpoints
• Register a trademark internationally

Correct Answer: Determine whether a new product will infringe existing IP rights

Q24. The priority date in patent law generally refers to:

• The date the invention was first publicly sold anywhere
• The date of the first filing that establishes the earliest effective filing date for patent purposes
• The date the patent was granted
• The date of the inventor’s birth

Correct Answer: The date of the first filing that establishes the earliest effective filing date for patent purposes

Q25. Patent prosecution refers to:

• The administrative and legal process of obtaining a patent through examination and responses to examiners
• The use of a patent to sue infringers
• Marketing a patented product
• Maintaining trade secrets

Correct Answer: The administrative and legal process of obtaining a patent through examination and responses to examiners

Q26. Which of the following best describes compulsory licensing in a public health emergency?

• The patent owner voluntarily waives all rights
• The government may authorize production by others to increase access to essential medicines
• Patents become permanently invalid worldwide
• Only trademarks are enforced

Correct Answer: The government may authorize production by others to increase access to essential medicines

Q27. A trademark mainly serves to:

• Protect the chemical structure of a drug
• Identify the commercial source of goods or services
• Prevent publication of clinical data
• Protect manufacturing processes

Correct Answer: Identify the commercial source of goods or services

Q28. In the pharmaceutical context, copyright typically protects:

• The active pharmaceutical ingredient
• Original literary and artistic works such as publications, manuals, and software
• The therapeutic effect of a drug
• Patent claims

Correct Answer: Original literary and artistic works such as publications, manuals, and software

Q29. A Geographical Indication (GI) protects:

• Patents for novel drugs
• Distinctive names of products originating from a specific region
• Clinical trial outcomes
• Trade secrets of pharmaceutical manufacturers

Correct Answer: Distinctive names of products originating from a specific region

Q30. Which international body administers the TRIPS Agreement and can be involved in dispute settlement related to IP?

• World Health Organization (WHO)
• World Trade Organization (WTO)
• United Nations Educational, Scientific and Cultural Organization (UNESCO)
• International Criminal Court (ICC)

Correct Answer: World Trade Organization (WTO)

G S Sachin

I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.

Mail- Sachin@pharmacyfreak.com