Seminar 1 Flashcards
What is the primary purpose of patents in innovation?
Patents provide a 20-year monopoly on inventions in exchange for public disclosure, encouraging innovation by granting exclusionary rights to recoup R&D investments.
What does an SPC (Supplementary Protection Certificate) do for pharmaceuticals?
SPCs extend protection for pharmaceuticals beyond patent expiry, compensating for regulatory approval delays.
What does data exclusivity protect in regulatory exclusivities?
Data exclusivity protects clinical trial data from being used by competitors to gain regulatory approval.
What is the purpose of market exclusivity in drug regulation?
Market exclusivity restricts generic drug market entry for a defined period, ensuring innovators can recoup investment.
What incentive does orphan drug designation provide?
Orphan drug designation offers 10 years of exclusivity as an incentive for developing treatments for rare diseases.
How do patents interact with competition law to balance innovation and market competition?
Patents balance innovation incentives with market competition but may lead to issues like “evergreening” or “patent thickets,” which can stifle innovation.
Why is access to drugs considered a human rights issue?
Access to drugs is a human rights issue because it requires balancing innovation with affordability and availability globally.
What should you be able to do regarding IP rights and regulatory exclusivities?
Understand, apply, and critically reflect on IP rights, regulatory exclusivities, competition law, and access to medicines using statutes and case law.
What are the main stages of the drug development process?
Drug development stages: discovery, preclinical development, clinical trials (Phases 1-4), and regulatory approval, taking ~14 years plus 1-2 years for approval.
What is the “appropriability problem” in patent systems?
The appropriability problem occurs when lack of protection discourages investment in innovation due to free-riding by competitors.
What is the “fishing problem” in patent systems?
The fishing problem refers to over-investment in competing R&D for the same invention, leading to inefficiencies.
What are patent thickets, and how do they affect innovation?
Patent thickets are overlapping patents that create barriers to innovation, requiring licensing or cross-collaboration to resolve.
What are the main types of patents granted?
Types of patents: National Patents, European Patents (Traditional EP and EP with Unitary Effect), and International Patents (PCT system).
What does the European Patent Convention (EPC) provide?
The EPC provides the framework for granting European patents.
What does the SPC Regulation (EC No 469/2009) achieve?
The SPC Regulation extends patent protection for medicinal products to compensate for time lost in regulatory approval.
