Introduction: Technology transfer in pharmaceuticals connects lab discoveries to commercial production and involves complex legal issues vital for B. Pharm students. This guide on legal issues related to technology transfer MCQs With Answer highlights intellectual property, patents, licensing agreements, confidentiality (NDAs), material transfer agreements (MTAs), regulatory compliance, data ownership, know-how, and due diligence. You will encounter topics like freedom-to-operate, royalty models, liability and indemnity clauses, sublicensing, and technology transfer office (TTO) roles. A clear understanding of these legal concepts helps safeguard innovations, ensure GMP-compliant scale-up, and negotiate equitable partnerships between academia and industry. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which form of intellectual property primarily protects a novel pharmaceutical compound?
- Trademark registration
- Patent
- Copyright
- Trade secret
Correct Answer: Patent
Q2. What is the main purpose of a confidentiality agreement (NDA) in technology transfer?
- To assign patent ownership
- To prevent disclosure of proprietary information
- To set manufacturing specifications
- To establish clinical trial endpoints
Correct Answer: To prevent disclosure of proprietary information
Q3. Which agreement governs the shipment and use of biological materials between institutions?
- Licensing agreement
- Material Transfer Agreement (MTA)
- Non-compete agreement
- Service-level agreement
Correct Answer: Material Transfer Agreement (MTA)
Q4. In a licensing agreement, an exclusive license means:
- Multiple licensees may use the technology
- The licensor retains rights to use the technology
- Only the licensee has the right to exploit the IP in the territory
- The license is limited to educational purposes
Correct Answer: Only the licensee has the right to exploit the IP in the territory
Q5. Which clause in a technology transfer contract addresses financial compensation based on sales?
- Confidentiality clause
- Indemnity clause
- Royalty clause
- Term and termination clause
Correct Answer: Royalty clause
Q6. Freedom-to-operate (FTO) analysis is performed to:
- Evaluate clinical efficacy of a drug
- Determine whether commercialization infringes existing patents
- Set manufacturing batch sizes
- Validate analytical methods
Correct Answer: Determine whether commercialization infringes existing patents
Q7. Which of the following is typically NOT protected by a patent?
- A novel chemical entity
- A method of manufacturing a drug
- Scientific data presented in a paper
- A unique formulation
Correct Answer: Scientific data presented in a paper
Q8. Which legal concept helps protect manufacturing know‑how that is not disclosed publicly?
- Patent prosecution
- Trademark filing
- Trade secret protection
- Mandatory publication
Correct Answer: Trade secret protection
Q9. A “sublicense” allows the licensee to:
- Terminate the original license
- Grant rights to a third party under the licensed IP
- Apply for patents on behalf of the licensor
- Convert the license to a patent assignment
Correct Answer: Grant rights to a third party under the licensed IP
Q10. Indemnity clauses in technology transfer agreements primarily serve to:
- Specify patent filing locations
- Allocate risk and protect parties from third-party claims
- Define clinical trial inclusion criteria
- Set timelines for technology handover
Correct Answer: Allocate risk and protect parties from third-party claims
Q11. Which regulatory protection grants exclusive marketing rights for clinical trial data in some jurisdictions?
- Data exclusivity
- Trademark protection
- Trade secret
- Design patent
Correct Answer: Data exclusivity
Q12. Under Bayh-Dole-like policies, inventions from government-funded research typically require:
- Immediate public disclosure with no protection
- Assignment to the funding body only
- Reporting to the funder and an option for commercialization by the institution
- Free licensing to any company
Correct Answer: Reporting to the funder and an option for commercialization by the institution
Q13. What is a key element of due diligence before entering a technology transfer?
- Designing a marketing campaign
- Assessing IP rights, regulatory status and freedom-to-operate
- Hiring clinical staff
- Publishing all development data immediately
Correct Answer: Assessing IP rights, regulatory status and freedom-to-operate
Q14. Patent term extension for pharmaceuticals is commonly sought to:
- Increase manufacturing speed
- Compensate for regulatory approval delays and restore market exclusivity
- Shorten exclusivity period for generics
- Maintain trade secret protection
Correct Answer: Compensate for regulatory approval delays and restore market exclusivity
Q15. A quality agreement in a technology transfer primarily addresses:
- IP ownership of the active ingredient
- Quality responsibilities, specifications, and release criteria between parties
- Global marketing strategy
- Employee non-compete terms
Correct Answer: Quality responsibilities, specifications, and release criteria between parties
Q16. Which party commonly holds responsibility for regulatory filings after a technology license?
- The licensor by default in all cases
- The licensee unless otherwise agreed
- The clinical trial investigator
- The contract manufacturing organization with no coordination
Correct Answer: The licensee unless otherwise agreed
Q17. In patent licensing, “field of use” restrictions define:
- Geographic territory for the license
- The specific applications or markets in which the licensee may operate
- Duration of the patent term
- Confidentiality obligations
Correct Answer: The specific applications or markets in which the licensee may operate
Q18. Which of the following best describes a technology transfer office (TTO) role?
- Clinical trial recruitment
- Negotiating IP agreements, licensing and supporting commercialization
- Conducting all lab experiments
- Regulatory inspections of manufacturing plants
Correct Answer: Negotiating IP agreements, licensing and supporting commercialization
Q19. What is a common remedy for patent infringement discovered after product launch?
- Imposing data exclusivity
- Pursuing injunctive relief and damages through litigation
- Automatic patent reassignment
- Compulsory licensing without notice
Correct Answer: Pursuing injunctive relief and damages through litigation
Q20. Which term describes transferring ownership of an invention from one party to another?
- License
- Assignment
- Sublicense
- Confidentiality
Correct Answer: Assignment
Q21. In technology transfer, “know‑how” usually refers to:
- Registered trademarks
- Practical technical knowledge and procedural information not necessarily disclosed in patents
- Patent drawings only
- Marketing materials
Correct Answer: Practical technical knowledge and procedural information not necessarily disclosed in patents
Q22. Which provision limits a party’s monetary liability in a technology transfer contract?
- Confidentiality clause
- Limitation of liability clause
- Patent prosecution clause
- Assignment clause
Correct Answer: Limitation of liability clause
Q23. When transferring process validation knowledge between sites, which legal document is most relevant?
- Manufacturing quality agreement
- Trademark application
- Clinical study report
- Employment contract
Correct Answer: Manufacturing quality agreement
Q24. What does “background IP” mean in collaborative agreements?
- IP developed during the collaboration
- Pre-existing IP each party brings to the collaboration
- All patents filed by competitors
- IP that is abandoned
Correct Answer: Pre-existing IP each party brings to the collaboration
Q25. Which factor is critical when negotiating royalties for a pharmaceutical license?
- Color of the product packaging
- Expected market size and patent strength
- The licensor’s office location
- Time zone differences between parties
Correct Answer: Expected market size and patent strength
Q26. Which action helps preserve patent rights before public disclosure?
- Filing a patent application prior to public disclosure
- Publishing full protocols immediately
- Signing a license agreement after disclosure
- Releasing samples to the public
Correct Answer: Filing a patent application prior to public disclosure
Q27. Which is a common requirement in an MTA regarding redistributed materials?
- Materials may be freely sublicensed
- Recipient must obtain provider’s permission before redistribution
- Provider loses all rights upon transfer
- Materials can be used for any commercial purpose
Correct Answer: Recipient must obtain provider’s permission before redistribution
Q28. Regulatory compliance during technology transfer mainly ensures:
- Faster patent prosecution
- Products meet safety, efficacy, and quality standards required by authorities
- Unlimited market exclusivity
- Transfer of trademarks only
Correct Answer: Products meet safety, efficacy, and quality standards required by authorities
Q29. What is the legal significance of “background” and “foreground” IP allocation?
- They determine publication schedules only
- They establish who owns pre-existing IP (background) and IP generated during collaboration (foreground)
- They are only relevant for trademarks
- They automatically assign all rights to the funder
Correct Answer: They establish who owns pre-existing IP (background) and IP generated during collaboration (foreground)
Q30. Which practice best protects trade secrets during technology transfer?
- Public disclosure in a preprint
- Detailed NDAs, access controls, and limited disclosures on a need-to-know basis
- Filing multiple patent applications revealing all details
- Uploading process details to public repositories
Correct Answer: Detailed NDAs, access controls, and limited disclosures on a need-to-know basis
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.
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