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Lucie G. L. Hattink-Roes Vice President Legal Affairs Solvay Pharmaceuticals

Areas of Potential Disputes. Lucie G. L. Hattink-Roes Vice President Legal Affairs Solvay Pharmaceuticals Marketing & Licensing AG Allschwil (Basel), Switzerland. WIPO Conference, Geneva April 2005. Areas of Potential Disputes. WHAT I SHALL FOCUS ON: POTENTIAL AREAS OF DISPUTES

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Lucie G. L. Hattink-Roes Vice President Legal Affairs Solvay Pharmaceuticals

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  1. Areas of Potential Disputes Lucie G. L. Hattink-Roes Vice President Legal Affairs Solvay Pharmaceuticals Marketing & Licensing AG Allschwil (Basel), Switzerland WIPO Conference, Geneva April 2005

  2. Areas of Potential Disputes • WHAT I SHALL FOCUS ON: • POTENTIAL AREAS OF DISPUTES • because of different EXPECTATIONS of the PARTIES • upon entering the contract • during collaboration / license • related to commercialization WIPO Conference, Geneva April 2005

  3. Areas of Potential Disputes • WHY DIFFERENT EXPECTATIONS • size of the Parties • focus of the Parties • on one product • on more products in • the same product field • more product fields • knowledge and experience • company culture WIPO Conference, Geneva April 2005

  4. Areas of Potential Disputes • EXAMPLES OF DIFFERENT EXPECTATIONS: • Upon entering the contract: • Due diligence • Long decision lines vs. short decision lines • Large complicated contract vs. simple contract • High milestones / royalties vs. market conform remuneration WIPO Conference, Geneva April 2005

  5. Areas of Potential Disputes • EXAMPLES OF DIFFERENT EXPECTATIONS: • During collaboration / license • We have (finally) an agreement, everything will be fine now • Within a few years we will be on the market • Blockbuster perception vs. realistic product potential • Why does it take so long (development) • Priority setting • Interpretation of results and dates • Coping with disappointments • 3) Upon commercialization • Realistic market assessment • Promotional efforts WIPO Conference, Geneva April 2005

  6. Areas of Potential Disputes • SOME FIGURES: • Research terminations for NCE’s by period of first IND filing and by primary reasons for abandonment • economics 33.8% • efficacy 37.6% • safety 19.6% • other 9% • Chance to reach approval / registration • preclinical 14.4% • phase I 22.6% • phase II 32.7% • phase III 78.5% • Licensed in compounds have a higher success rate WIPO Conference, Geneva April 2005

  7. Areas of Potential Disputes • SUGGESTIONS: • Be realistic, not over optimistic: • Know your risk. • Know and evaluate the risk the other party is taking. • What would you do under similar circumstances. • The chance that a product comes to the market is small. • The chance that a product turns out to be a blockbuster is much smaller. • It is better to find a solution for a problem than to say “the contract says…” • If you do not have the required knowledge and experience, the other party will take the lead. • Acquire knowledge instead of being naïve or suspicious. WIPO Conference, Geneva April 2005

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