Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

Autm Resolving Ip Issues Related To University Agreements(2)


Published on

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

Published in: Technology
  • Be the first to comment

  • Be the first to like this

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>