Monetizing Your Intellectual                                                                               Kathleen Mekjia...
Kathleen Mekjian, Ph.D., J.D.©2012 Knobbe, Martens, Olson & all rights reserved.©2012 Knobbe Martens, Olson & Bear, LLPBea...
Overview    • Patents – Value/Patentable Subject Matter    • Inventorship and Ownership    • Loss of Rights and Avoiding P...
The Value of Patents    •    Bring Tremendous Value to Company           – Can be Critical to Obtaining Investment        ...
Patents - The Basics     • Patents protect (1) novel, (2) useful, and (3)       non-obvious processes, machines,       man...
Value of Patents    • “Strong” versus “Weak(er)” Patents           – Value comes from excluding                   • Lots o...
Deciding What to Claim    • Purpose of IP           – V.C. specific (clear/fast exit . . .fast approval)           – Your ...
How to Claim Strategically    • Seek protection with value           – Start with relevant market                   • Cove...
Block Competitive Alternatives                                         Patent                                         Scop...
Block Competitive Alternatives                                         Patent                  Relevant                   ...
Multi-Faceted Approach                                                                             Patent 2               ...
Directly Pursue Competition’s Space                                                                             Patent 2  ...
Inventorship    • Who is an “inventor”      – Conception = touchstone of inventorship         • Arriving at a definite and...
Ownership    • Inventors own the invention – undivided interest in the      entire patent    • Types of agreements that af...
Inventorship & Ownership - Cautionary tips    • Beware of Unintended Co-Inventors       – Contractors, Manufacturers, Coll...
Loss of Rights – “Loose Lips Sink Ships”    • Disclosure of your invention may preclude ability to      patent (novelty an...
Loss of Rights    • Abstracts    • Posters    • Oral Presentations    • Manuscripts v. Online Publication    • Grant Appli...
Loss of Rights – Precautionary Measures    •    Do Not Disclose Invention Outside of Confidentiality           – Use Confi...
Brenden Gingrich, Ph.D., J.D.©2012 Knobbe, Martens, Olson & all rights reserved.©2012 Knobbe Martens, Olson & Bear, LLPBea...
When to File – do I have enough data?    • Major issue for patents in the “unpredictable” arts    • Must describe the inve...
When to File – do I have enough data?    • Scope of protection needed is a consideration           – What is the purpose f...
When to File – now or later?    • Purpose of protection is a consideration           – Your product today                 ...
Patentability / FTO Searching    • Patentability Searching           – Optional step to gain understanding of prior art   ...
Patentability / FTO Searching    • Freedom to Operate / Right to Practice Searching           – Evaluate patent landscape ...
Patentability / FTO Searching    • §271(e)(1) “safe harbor”           – “It shall not be an act of infringement to make, u...
Filing Procedures – impact of the AIA    • America Invents Act (Patent Reform)           – File Early, File Often         ...
Filing Procedures    • Provisional Applications           – Official fees: $250 / $150 for small entity           – Establ...
Filing Procedures    • U.S. Utility Application           – Official fees:$1250 / $530 small entity           – Can claim ...
Filing Procedures    • PCT Application           – Official fees: $4154 (no small entity discount)           – “Internatio...
Timeline for Filing    • Typical Filing Strategy                             12 Months                           18 Months...
Timeline for Filing – AIA strategy  • Strategy to provide extra year of patent term in U.S.                               ...
Supreme Court’s Prometheus Decision    • Discovered correlation between specific drug      metabolite levels and safety / ...
Kathleen Mekjian, Ph.D., J.D. kathleen.mekjian@knobbe.comBrenden Gingrich, Ph.D., J.D. brenden.gingrich@knobbe.com
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Monetizing Your Intellectual Property: Protecting Ideas that Generate Income

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Knobbe Martens' attorneys Brenden Gingrich and Kathleen Mekjian conducted a workshop on Sunday, May 5, 2012 at the 99th Annual Meeting of The American Association of Immunologists (AAI), entitled "Monetizing Your Intellectual Property: Protecting Ideas that Generate Income." This presentation explores the types of research innovations that are protectable and provides practical tips for protecting innovations while avoiding some common pitfalls, which can compromise intellectual property.

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Monetizing Your Intellectual Property: Protecting Ideas that Generate Income

  1. 1. Monetizing Your Intellectual Kathleen Mekjian, Ph.D., J.D. Property: Protecting Ideas that Brenden Gingrich, Ph.D., J.D. Generate IncomeThe recipient may only view this work. No other right or license is granted.
  2. 2. Kathleen Mekjian, Ph.D., J.D.©2012 Knobbe, Martens, Olson & all rights reserved.©2012 Knobbe Martens, Olson & Bear, LLPBear, LLP all rights reserved. 2
  3. 3. Overview • Patents – Value/Patentable Subject Matter • Inventorship and Ownership • Loss of Rights and Avoiding Pitfalls • Sufficiency of Disclosure/Timing • Freedom to Operate • Procedural and Monetary Considerations • The Prometheus v. Mayo Supreme Court Decision© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 3
  4. 4. The Value of Patents • Bring Tremendous Value to Company – Can be Critical to Obtaining Investment – Can Provide Revenue – Cross-Licensing • Secure Market Position / Exclusivity – They are Swords (Offensive) • Can Exclude Competitors from your Business • Can Protect your Products from Duplication – They are Shields (Defensive) • Demonstrates sophistication and professionalism • Your Competitors (domestic and foreign) are Getting Them!© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 4
  5. 5. Patents - The Basics • Patents protect (1) novel, (2) useful, and (3) non-obvious processes, machines, manufactures, or compositions of matter • Gives the patent owner the exclusive right to exclude others from selling/offering to sell, using, making, or importing the invention • Term is 20 years from filing date • In exchange for this “legal monopoly,” inventor must disclose how to practice the invention© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 5
  6. 6. Value of Patents • “Strong” versus “Weak(er)” Patents – Value comes from excluding • Lots of alternatives = weaker patents – Antibody with a particular CDR • Critical step = very valuable – Growing antibodies in CHO cells – Humanized antibodies© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 6
  7. 7. Deciding What to Claim • Purpose of IP – V.C. specific (clear/fast exit . . .fast approval) – Your product (now or future) – Competitor’s product (now or future) – License or cross-license (scope v. fast allowance) – Litigation (focused/validity) • Protection for commercial embodiment – Link between customer demand and claims • Broad v. narrow= scope v. validity© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 7
  8. 8. How to Claim Strategically • Seek protection with value – Start with relevant market • Cover your product • Cover design-arounds© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 8
  9. 9. Block Competitive Alternatives Patent Scope Commercial Product© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 9
  10. 10. Block Competitive Alternatives Patent Relevant Scope Market Commercial Product© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 10
  11. 11. Multi-Faceted Approach Patent 2 Scope Patent 1 Scope Relevant Market Patent 3 Scope Commercial Product© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 11
  12. 12. Directly Pursue Competition’s Space Patent 2 Scope Patent 1 Patent 4 Scope Relevant Market Scope Patent 3 Scope Commercial Product© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 12
  13. 13. Inventorship • Who is an “inventor” – Conception = touchstone of inventorship • Arriving at a definite and permanent idea of the invention – Laboratory hands v. Joint inventor • A joint inventor must make a contribution to the claimed invention that is not insignificant in quality, when that contribution is measured against the dimension of the full invention – Improvements, etc. may lead to joint inventorship© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 13
  14. 14. Ownership • Inventors own the invention – undivided interest in the entire patent • Types of agreements that affect ownership rights – Employment Agreements – Consulting Agreements – Development Agreements – Manufacturing Agreements – Collaboration Agreements – Visitor’s Confidentiality Agreements – Government Interests • U.S. laws “inventor friendly” in terms of presumption of ownership© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 14
  15. 15. Inventorship & Ownership - Cautionary tips • Beware of Unintended Co-Inventors – Contractors, Manufacturers, Collaborators, etc. – Co-Inventors Own Equally & Can Dispose Unilaterally • Leaving Off Inventor Can Render Patent Unenforceable! • Illustrations of the Importance of Ownership Rights – The Google story – how Stanford was successful – Roche v. Stanford – how Stanford was unsuccessful© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 15
  16. 16. Loss of Rights – “Loose Lips Sink Ships” • Disclosure of your invention may preclude ability to patent (novelty and obviousness provisions of the patent laws) • One year grace period in U.S. (but not many foreign jurisdictions!) • America Invents Act - changes in law relevant to novelty take effect March 2013© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 16
  17. 17. Loss of Rights • Abstracts • Posters • Oral Presentations • Manuscripts v. Online Publication • Grant Applications • Theses/Dissertations • Offer for Sale© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 17
  18. 18. Loss of Rights – Precautionary Measures • Do Not Disclose Invention Outside of Confidentiality – Use Confidential Disclosure Agreements (CDAs) for discussions with potential collaborators, licensees, investors (when possible), etc. • Protect confidential information (e.g., mark it as “confidential” or don’t disseminate it) • File patent applications before presentations, talks, publishing, meeting with collaborators, licensees, investors, etc. • Maintain records of research and development (e.g., lab notebooks) • Use caution with content of submissions and reports (assume they will be publicly available immediately)© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 18
  19. 19. Brenden Gingrich, Ph.D., J.D.©2012 Knobbe, Martens, Olson & all rights reserved.©2012 Knobbe Martens, Olson & Bear, LLPBear, LLP all rights reserved. 19
  20. 20. When to File – do I have enough data? • Major issue for patents in the “unpredictable” arts • Must describe the invention – Demonstrate “possession” of the invention – Genus claims require: • Structure / Function relationship • Representative number of species • Must enable invention – Make and use without undue experimentation – In vivo treatments need in vivo data • Data from well-accepted animal model is sufficient© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 20
  21. 21. When to File – do I have enough data? • Scope of protection needed is a consideration – What is the purpose for the IP? • Protection of product – Narrower patent may be sufficient – Therapeutic, diagnostic, research tool • Blocking competitors – Broader patent may be needed – In which countries is protection needed? • Different standards in different countries© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 21
  22. 22. When to File – now or later? • Purpose of protection is a consideration – Your product today • Accelerate allowance • Parallel filings – Your product in the future • Serial filings • Maximize PTA / PTE – Funding – exit strategy items first – Litigation / Licensing© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 22
  23. 23. Patentability / FTO Searching • Patentability Searching – Optional step to gain understanding of prior art • Patents and published applications • Non-patent literature – Most useful for narrow, targeted applications • Prosecution costs reduced by focusing claims© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 23
  24. 24. Patentability / FTO Searching • Freedom to Operate / Right to Practice Searching – Evaluate patent landscape • Who are potential partners / threats – Develop strategy for blocking patents • License • Design around • Invalidity / Non-infringement opinion • Wait for expiration© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 24
  25. 25. Patentability / FTO Searching • §271(e)(1) “safe harbor” – “It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention … solely for uses reasonably related to the development and submission of information” to the FDA – Created as part of balance between brand-name and generic drug companies – Courts have extended the “safe harbor” to early product research and development© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 25
  26. 26. Filing Procedures – impact of the AIA • America Invents Act (Patent Reform) – File Early, File Often – “First to File”: increases importance of filing early • Effective March 16, 2013 Invention Invention Conception Reduction to Practice File Application 1 day 3rd Party Disclosure or Patent Filing “swear behind”© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 26
  27. 27. Filing Procedures • Provisional Applications – Official fees: $250 / $150 for small entity – Establishes priority date for disclosed material – One-year pendency, no examination – Can file numerous provisional applications – Does not publish, can re-file if more time is needed© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 27
  28. 28. Filing Procedures • U.S. Utility Application – Official fees:$1250 / $530 small entity – Can claim priority to one or more provisional applications within 1 year of filing – Examined in ~18-24 months – Issues 2-5 years© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 28
  29. 29. Filing Procedures • PCT Application – Official fees: $4154 (no small entity discount) – “International” application • Provides priority in 144 member countries • No such thing as “International Patent” – Searched and provisionally examined (non-binding) – Enter “National Phase” within 30 months of priority© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 29
  30. 30. Timeline for Filing • Typical Filing Strategy 12 Months 18 Months 1st Provisional Utility / PCT National Phase 2nd Provisional (optional) 3rd Provisional (optional)© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 30
  31. 31. Timeline for Filing – AIA strategy • Strategy to provide extra year of patent term in U.S. 12 Months 18 Months 12 Months 12 Months 1st Provisional PCT National Phase Voluntarily Publish Re-file Provisional U.S. Utility Application© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 31
  32. 32. Supreme Court’s Prometheus Decision • Discovered correlation between specific drug metabolite levels and safety / efficacy • Patentable subject matter – Exceptions: natural laws / phenomena, products of nature, abstract ideas – “Specific applications” of natural laws are patentable • Holding: administering, measuring, and then correlating metabolite level to need alter drug dose is not patentable • Implications for diagnostics – e.g., inflammation as diagnostic for heart disease© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 32
  33. 33. Kathleen Mekjian, Ph.D., J.D. kathleen.mekjian@knobbe.comBrenden Gingrich, Ph.D., J.D. brenden.gingrich@knobbe.com
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