Autm Resolving Ip Issues Related To University Agreements(2)

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Nina Ashton\'s presentation at the AUTM Annual Convention re challenges in university licensing.

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Autm Resolving Ip Issues Related To University Agreements(2)

  1. 1. Nina Ashton Vice President, Intellectual Property Elan Pharmaceuticals, Inc. [email_address] Resolving IP Issues Related to University Agreements AUTM February 13, 2009
  2. 2. License Agreements <ul><li>Potential exclusivity issues </li></ul><ul><li>Potential enforcement issues </li></ul>
  3. 3. Hypothetical University License <ul><li>Interinstitutional Agreement between A and B regarding co-invention </li></ul><ul><ul><li>Co-invention co-owned </li></ul></ul><ul><ul><li>B shall take the lead in negotiating license agreements </li></ul></ul><ul><ul><li>A will not license to anyone </li></ul></ul>
  4. 4. Hypothetical University License <ul><li>License Agreement between B and Company C </li></ul><ul><ul><li>B grants C an exclusive license </li></ul></ul><ul><ul><li>A is not a party to the License Agreement </li></ul></ul>
  5. 5. The Problem <ul><li>A covenant not to license is not the same as granting an exclusive license </li></ul><ul><li>Because A did not exclusively license its rights to B </li></ul><ul><li>C may not have an exclusive license </li></ul><ul><ul><li>C may not have standing to sue for infringement </li></ul></ul><ul><ul><li>The invention could be licensed to a third party </li></ul></ul><ul><li>License to 3P would be breach by A, but C would have no recourse against A </li></ul>
  6. 6. A Solution <ul><li>Interinstitutional agreement should include: </li></ul><ul><ul><li>an exclusive license from A to B </li></ul></ul><ul><ul><li>Cooperation and willingness to be joined in litigation </li></ul></ul><ul><li>License Agreement should include: </li></ul><ul><ul><li>Provision requiring B to take action against A to remedy breach </li></ul></ul>
  7. 7. Hatch-Waxman Law <ul><li>Balance between interests of innovator and generic </li></ul><ul><li>Orange Book </li></ul><ul><ul><li>listing of patents claiming drug or method of using drug </li></ul></ul><ul><ul><li>Listed by patentee/innovator </li></ul></ul><ul><li>ANDA applicant </li></ul><ul><ul><li>sends Paragraph IV certification to patentee </li></ul></ul><ul><ul><li>Certifying that listed patents are invalid or not infringed by subject drug </li></ul></ul>
  8. 8. Hatch-Waxman, cont. <ul><li>Patentee has 45 days to file infringement suit </li></ul><ul><ul><li>If suit is filed, 30 month stay of ANDA approval </li></ul></ul><ul><ul><li>If suit is not filed, ANDA applicant can file suit for declaratory judgment </li></ul></ul>
  9. 9. Hypothetical University License Term <ul><li>Parties will use best efforts to terminate infringement without litigation </li></ul><ul><li>If efforts are unsuccessful after 90 days, then A has 10 days to tell B what it wants to do </li></ul><ul><li>B can sue if A doesn’t want to </li></ul>
  10. 10. The Problem <ul><li>Under law, must bring suit within 45 days to get the 30 month stay </li></ul><ul><li>But under contract, must wait at least 100 days </li></ul>
  11. 11. A Solution <ul><li>Include alternative provisions for addressing infringement by an ANDA applicant </li></ul><ul><li>Licensee and patentee shall cooperate to bring suit within the legal timeframe required to preserve licensee’s exclusivity rights </li></ul>
  12. 12. Clinical Trials - IP Opportunities <ul><li>Examples: </li></ul><ul><li>Ameliorating/avoiding side effects </li></ul><ul><li>Formulations & manufacturing process </li></ul><ul><li>Dosing regimens </li></ul><ul><li>Combination therapy </li></ul><ul><li>New indications </li></ul><ul><li>Patient populations </li></ul><ul><li>Second generation or competing products </li></ul><ul><li>Routes of administration/delivery methods & devices </li></ul>
  13. 13. Clinical Trials - IP Risks <ul><li>Examples: </li></ul><ul><li>Generation of blocking IP </li></ul><ul><li>Generation of competing products then licensed to competitor instead of Sponsor </li></ul><ul><li>Generation of results that call into question Study Drug’s future success </li></ul><ul><li>Generation of information of interest to FDA </li></ul>
  14. 14. Story <ul><li>Co invests big $$ in clinical trials of drug for angina </li></ul><ul><li>Results showed NOT good treatment for angina </li></ul><ul><li>But, “interesting” side effect observed </li></ul><ul><li>Result – Viagra! </li></ul>
  15. 15. Potential problem <ul><li>Hypothetical Clinical Trial Agreement Term: </li></ul><ul><ul><li>…Inventions relating to the Protocol are solely owned by Co and all other inventions are solely owned by Inst… </li></ul></ul><ul><li>Co may not own invention relating to the interesting side effect </li></ul>
  16. 16. Hypothetical #1 <ul><li>Co invests big $$ on clinical trial for drug </li></ul><ul><li>Inst reserves right to use patient samples in research </li></ul><ul><li>Research leads to invention of competing product </li></ul><ul><li>Problem: Inst may license to Co’s competitor </li></ul>
  17. 17. Hypothetical #2 <ul><li>Co invests big $$ on clinical trial for drug </li></ul><ul><li>Inst observes negative side effect </li></ul><ul><li>Inst files patent application regarding detection, treatment or avoidance of side effect </li></ul><ul><li>Problem: Co may be blocked from marketing its own drug </li></ul>
  18. 18. A Solution <ul><li>Co owns inventions “… arising during the course of or as a result of the Study … which relate in any way to the Study Drug or Protocol, including, but not limited to …” </li></ul><ul><li>Inst owns other inventions “… arising during the course of or as a result of the Study …” </li></ul>
  19. 19. A Solution, cont. <ul><li>Inst grants Co: </li></ul><ul><ul><li>option to negotiate exclusive license </li></ul></ul><ul><ul><li>Free unblocking license for Study Drug, if needed </li></ul></ul><ul><li>…Inst will not perform any research relating to the Study Drug, the Protocol, samples of the Study Drug or samples collected from the Study Subjects… </li></ul>
  20. 20. Publication Hypothetical #1 <ul><li>Inst unilaterally publishes results of Study at its site </li></ul><ul><li>Premature conclusion regarding drug’s effects </li></ul><ul><li>Conclusion may not be sustainable upon analysis of all data from all sites </li></ul><ul><li>May dramatically affect perception of Co within investment community </li></ul>
  21. 21. A Solution <ul><li>…first publication of the results of the Study will be made in conjunction with the presentation of a joint, multicenter publication of the complete multicenter study results… </li></ul>
  22. 22. Publication Hypothetical #2 <ul><li>Inst conducts independent research with Study Drug </li></ul><ul><li>Inst’s research generally not validated or powered appropriately </li></ul><ul><ul><li>Incomplete data (i.e., small N) </li></ul></ul>
  23. 23. Potential Problem <ul><li>Results may prematurely cast doubt on drug’s success </li></ul><ul><ul><li>Suggestion of flaw in premise for efficacy (e.g., MOA, relevant biomarker) </li></ul></ul><ul><ul><li>Suggestion of possible safety issue </li></ul></ul><ul><li>Depending on Sponsor’s involvement, results may need to be submitted to FDA </li></ul>
  24. 24. A Solution <ul><li>…Inst will not use the Study Drug for any purpose other than the purposes of conducting the Study… </li></ul><ul><li>…Inst will not perform any research relating to the Study Drug, the Protocol, samples of the Study Drug or samples collected from the Study Subjects… </li></ul>
  25. 25. Conclusion <ul><li>Through healthy negotiating, companies and universities should be able to achieve their shared goals of developing good drugs for the benefit of the patients. </li></ul>
  26. 26. Thank you <ul><li>For copies of slides: </li></ul><ul><li>[email_address] </li></ul>

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