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1. Which regulatory provisions apply to the development and marketing of pharmaceutical products? Please give an overview.
2. Which authority is responsible for enforcing the regulatory regime? What powers of investigation and enforcement does it possess?
3. Are there any international initiatives to regulate the pharmaceutical industry? If so, how effective are these?
4. What compliance programs should be considered by a company engaged in the development and/or sale of pharmaceutical products? Are such compliance programs compulsory?
5. What legislation governs the grant and protection of intellectual property rights in pharmaceutical products? What have been the most important recent developments in this connection?
6. Are there any relevant international agreements relating to pharmaceutical patents? If so, what is their effect? (e.g. TRIPS?)
7. How is a patent obtained? What requirements must be satisfied, and how is the application made?
8. How effective is the patent as a means of protecting intellectual property in the pharmaceutical context? What remedies are available for breach or threatened breach of patent?
9. What particular intellectual property issues may arise at the preclinical and clinical trial stages of the development of a pharmaceutical product? How have such issues been addressed?
10. Please explain the role of licensing in the pharmaceutical industry. What are the most popular sectors for licensing agreements?
11. What due diligence checks should be performed prior to concluding a license agreement?
12. What terms should be considered for inclusion in a license agreement?
13. What particular issues are raised by trade secret licensing, and how can such difficulties best be addressed?
14. What considerations should be taken into account when formulating a patent and/or licensing strategy?
15. Please explain how antitrust issues can arise in the context of pharmaceutical patents.
16. What is “sham” patent litigation, and what problems does it present for the pharmaceutical industry?
17. What are parallel importing and parallel distribution? How have these issues been addressed, and what have been the most important recent developments in this connection?
18. What are the recent trends in pharmaceutical class action litigation?
19. To what extent is a pharmaceutical company obliged to report or share information concerning its products?
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