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  1. 1. Patent Law Thomas Goodness, Ph.D., J.D. A Brief Overview for Clinical Research
  2. 2. Introduction <ul><li>Intellectual property (IP) will become an issue at some point in your professional life </li></ul><ul><li>Decisions must be made by you or the UK administration </li></ul><ul><li>Governing law and its application </li></ul><ul><ul><li>Federal </li></ul></ul><ul><ul><li>UK Administrative </li></ul></ul><ul><ul><li>State </li></ul></ul>
  3. 3. Purpose <ul><li>Set your expectations about the process </li></ul><ul><ul><li>Promote mutual understanding between you and UK Administration </li></ul></ul><ul><ul><li>Minimize surprise during the process </li></ul></ul><ul><li>Help you make informed decisions </li></ul><ul><li>Set your expectations about the IP process </li></ul><ul><ul><li>Promote mutual understanding between you and UK Administration </li></ul></ul><ul><ul><li>Minimize surprise during the process </li></ul></ul><ul><li>Help you make informed decisions </li></ul>
  4. 4. Outline <ul><li>When will IP become an issue? </li></ul><ul><li>For each situation </li></ul><ul><ul><li>What decisions will be made? </li></ul></ul><ul><ul><li>What law guides those decisions? </li></ul></ul><ul><ul><li>Examples </li></ul></ul>
  5. 5. Definitions <ul><li>IP = “Patent Rights” </li></ul><ul><li>“ Patent Rights” refers to a right to stop others from </li></ul><ul><ul><li>Making </li></ul></ul><ul><ul><li>Using </li></ul></ul><ul><ul><li>Selling </li></ul></ul><ul><ul><li>Importing (sometimes) </li></ul></ul><ul><ul><li>Your invention </li></ul></ul>
  6. 6. Definitions (continued) <ul><li>Clinical Research involves both </li></ul><ul><ul><li>Human subjects </li></ul></ul><ul><ul><li>Pre-Clinical research using animals </li></ul></ul>
  7. 7. When will IP become an issue? <ul><li>Terms of agreements that precede clinical research </li></ul><ul><li>IP created by you during research </li></ul><ul><li>IP (owned by others) that you use during research </li></ul>
  8. 8. When will IP become an issue? <ul><li>Terms of agreements that precede clinical research </li></ul><ul><li>IP created by you during research </li></ul><ul><li>IP (owned by others) that you use during research </li></ul>
  9. 9. Terms of agreements <ul><li>Who owns future IP developed during research </li></ul><ul><li>University owns the IP by default </li></ul><ul><li>Frequently the other party wants UK to transfer ownership to them </li></ul><ul><li>Conflict between UK and Sponsor </li></ul><ul><li>Conflict between UK and the Research Scientist </li></ul>
  10. 10. How UK Gets Ownership of IP <ul><li>Federal law, ownership of patentable inventions starts with the inventor (you). </li></ul><ul><li>UK AR’s, the University owns employee IP </li></ul><ul><ul><li>developed using University Resources, and/or </li></ul></ul><ul><ul><li>developed within the scope of employment </li></ul></ul><ul><li>This is enforceable under state contract law </li></ul><ul><li>This is a common arrangement </li></ul><ul><ul><li>At other Universities </li></ul></ul><ul><ul><li>In Industry </li></ul></ul>
  11. 11. UK’s Terms for Future IP <ul><li>UK owns IP developed solely by UK employees during sponsored research </li></ul><ul><li>Sponsor owns IP developed solely by Sponsor employees </li></ul><ul><li>If employees of UK and Sponsor jointly develop IP, the IP is owned jointly by UK and Sponsor. </li></ul>
  12. 12. Terms Proposed by Sponsor <ul><li>Sponsor owns all IP developed by Scientist during the Sponsored Research </li></ul><ul><li>All means </li></ul><ul><ul><li>Inventions necessary to use the results of research </li></ul></ul><ul><ul><li>Inventions that are only peripheral to the research </li></ul></ul>
  13. 13. The Problem: UK vs. the Sponsor <ul><li>IP is property </li></ul><ul><ul><li>Transfer of UK property is regulated by state law </li></ul></ul><ul><ul><li>Compliance with state law is impossible when transferring “future” IP to another </li></ul></ul><ul><li>UK’s IP terms are the norm, make deviations difficult to explain to the authorities </li></ul>
  14. 14. How do we resolve? <ul><li>Types of Agreements </li></ul><ul><ul><li>Federal Research Grants </li></ul></ul><ul><ul><li>Clinical Trials Agreement </li></ul></ul><ul><ul><li>Pre-clinical Research </li></ul></ul><ul><ul><ul><li>Privately Sponsored Projects Agreement </li></ul></ul></ul><ul><ul><ul><li>Material Transfer </li></ul></ul></ul><ul><li>Arranged in increasing order of conflict potential </li></ul><ul><li>Resolution differs somewhat by type of agreement </li></ul>
  15. 15. Federal Research Grants <ul><li>Applies to research sponsored, in whole or in part, by a federal agency </li></ul><ul><li>Bayh-Dole Act </li></ul><ul><ul><li>University owns IP by default </li></ul></ul><ul><ul><li>May be transferred to Principal Investigator </li></ul></ul><ul><ul><li>Federal Government reserves rights </li></ul></ul><ul><ul><li>Transfer to third parties is expressly forbidden </li></ul></ul>
  16. 16. Clinical Trials Agreements <ul><li>We may offer to transfer future IP that will never exist (Unique to CTA) </li></ul><ul><li>Scientist must perform a rigidly defined protocol, leaving little room for invention </li></ul><ul><li>We offer to transfer future IP necessary to practice Sponsors technology </li></ul>
  17. 17. Pre-clinical Research <ul><li>These solutions also apply to Clinical Trials </li></ul><ul><li>We always offer an option to license future IP to the other party </li></ul><ul><li>Rarely, we offer a royalty-free non-exclusive license to the other party </li></ul>
  18. 18. When will IP become an issue? <ul><li>Terms of agreements that precede clinical research </li></ul><ul><li>IP created by you during research </li></ul><ul><li>IP that you use during research </li></ul>
  19. 19. IP created during research <ul><li>Am I ready disclose my IP? </li></ul><ul><li>Who are the inventors? </li></ul><ul><li>Will a patent application be filed on my IP? </li></ul>
  20. 20. IP created during research <ul><li>Am I ready disclose my IP? </li></ul><ul><li>Who are the inventors? </li></ul><ul><li>Will a patent application be filed on my IP? </li></ul>
  21. 21. Am I ready disclose my IP? <ul><li>Disclose when your invention is ready for a patent application </li></ul><ul><li>Your invention has two parts </li></ul><ul><ul><li>Conception (Idea) </li></ul></ul><ul><ul><li>Reduction to practice </li></ul></ul><ul><ul><ul><li>Actual reduction to practice </li></ul></ul></ul><ul><ul><ul><li>Constructive reduction to practice </li></ul></ul></ul><ul><li>Your invention is ready to file when you have both </li></ul>
  22. 22. Actual R eduction to Practice <ul><li>Means you have data suggesting your invention works </li></ul><ul><li>Human medicine, animal/cell culture data is sufficient when there is a known reasonable correlation between models and humans </li></ul><ul><li>Actual reduction to practice is required when it is not apparent that your invention will work when you describe your idea </li></ul>
  23. 23. Example: Actual Reduction <ul><li>Sustained Release Drug Delivery Device </li></ul><ul><li>Inventors: Smith, Ashton and Pearson </li></ul>
  24. 24. Constructive R eduction to Practice <ul><li>Means you have no data, not really reduced to practice </li></ul><ul><li>Considered reduced to practice when it is described (with drawings) in a patent application </li></ul><ul><li>Constructive reduction to practice is acceptable when it is obvious that your invention will work solely from its description </li></ul><ul><li>Does not apply to most clinical inventions </li></ul>
  25. 25. Example: Constructive reduction <ul><li>Title and inventors unknown </li></ul><ul><li>Also delivers drugs to the eye </li></ul><ul><li>Description is sufficient to illustrate efficacy </li></ul>
  26. 26. Hypothetical example: Readiness <ul><li>Facts: Scientist has a great idea for a drug candidate that should ameliorate the long term effects following hemorrhagic stroke , and wants to file a patent before disclosing in a grant application </li></ul><ul><li>Result: No disclosure is necessary, the invention is not reduced to practice, so no patent application can be filed </li></ul>
  27. 27. Hypothetical example : Readiness <ul><li>Facts: Scientist has data showing that drug ameliorates the effects of hemorrhagic stroke in an accepted mouse model of human stroke </li></ul><ul><li>Result: Ready for disclosure, the data was generated in a model known to be reasonably correlated with human condition </li></ul>
  28. 28. Hypothetical example : Readiness <ul><li>Facts: Scientist has data showing that drug ameliorates the effects of hemorrhagic stroke in a controversial zebra fish model of human stroke </li></ul><ul><li>Result: Not yet ready for disclosure, but a close call </li></ul>
  29. 29. IP created during research <ul><li>Am I ready disclose my IP? </li></ul><ul><li>Who are the inventors? </li></ul><ul><li>Will a patent application be filed on my IP? </li></ul>
  30. 30. Who are the Inventors? <ul><li>Deceptively simple concept </li></ul><ul><li>University inventors often draw on their concept of authorship </li></ul><ul><li>Criteria for inventorship is different from authorship </li></ul><ul><li>Getting it wrong can have harsh consequences </li></ul>
  31. 31. Authorship of Journal Articles <ul><li>Major contributors to the content </li></ul><ul><li>Principal Investigator </li></ul><ul><li>Technical assistants performing the majority of the actual work </li></ul><ul><li>Sources of important material </li></ul>
  32. 32. Inventorship <ul><li>Definition dictated by Federal law </li></ul><ul><li>Anyone who contributed an idea </li></ul><ul><ul><li>That forms the basis of an element of the invention </li></ul></ul><ul><ul><li>Without which there would be no invention </li></ul></ul><ul><li>Correct inventorship is a precondition for a valid patent. </li></ul>
  33. 33. Inventorship <ul><li>Definition dictated by Federal law </li></ul><ul><li>Anyone who contributed an idea </li></ul><ul><ul><li>That forms the basis of an element of the invention </li></ul></ul><ul><ul><li>Without which there would be no invention </li></ul></ul>
  34. 34. Bad News about Inventorship <ul><li>A technical assistant who does all the work, but merely followed directions is not an inventor </li></ul><ul><li>A technical assistant who does all the work, but solves problems which do not relate to an element of the invention is not an inventor </li></ul><ul><li>A PI who pays for all the work, but does not contribute an idea is not an inventor </li></ul>
  35. 35. Bad News about Inventorship <ul><li>An inventor is often presented with the difficult choice between </li></ul><ul><ul><li>Dealing with the hurt feelings of non-inventors, or </li></ul></ul><ul><ul><li>An invalid patent (and the lost income from that patent) </li></ul></ul>
  36. 36. IP created during research <ul><li>Am I ready disclose my IP? </li></ul><ul><li>Who are the inventors? </li></ul><ul><li>Will a patent application be filed on my IP? </li></ul>
  37. 37. Will a patent application be filed? <ul><li>An application will not be filed if the invention does not meets the criteria for patentability. </li></ul><ul><li>Three criteria for a patentable invention </li></ul><ul><ul><li>Useful </li></ul></ul><ul><ul><li>Novel (New) </li></ul></ul><ul><ul><li>Non-obvious </li></ul></ul>
  38. 38. Meaning of Novelty <ul><li>United States </li></ul><ul><ul><li>No person invented before you, and </li></ul></ul><ul><ul><li>Publication/Sale </li></ul></ul><ul><ul><ul><li>Either you have not published or offered to sell the invention before filing a patent application OR </li></ul></ul></ul><ul><ul><ul><li>Your invention </li></ul></ul></ul><ul><ul><ul><ul><li>was in public use, or </li></ul></ul></ul></ul><ul><ul><ul><ul><li>appeared in a “printed publication” or </li></ul></ul></ul></ul><ul><ul><ul><ul><li>was offered for sale, </li></ul></ul></ul></ul><ul><ul><ul><ul><li>one year has not elapsed </li></ul></ul></ul></ul>
  39. 39. Meaning of Novelty <ul><li>Rest of the World </li></ul><ul><ul><li>“ Absolute novelty” </li></ul></ul><ul><ul><li>Prior to filing a patent application, the invention did not appear in a printed publication or in public use </li></ul></ul><ul><ul><li>You are the first to file a patent application claiming the invention </li></ul></ul><ul><ul><ul><li>Initial filing can be in the US </li></ul></ul></ul>
  40. 40. Novelty: Meaning and Relevance of Public Use <ul><li>Using the completed invention in the presence of people who have no confidential relationship with the inventor </li></ul><ul><li>If there is public use of the invention, please disclose your invention to us before one year has passed. </li></ul><ul><li>If disclosed later, your invention cannot be patented (will not be novel) </li></ul>
  41. 41. Novelty: Meaning and Relevance of P rinted Publication <ul><li>Must be </li></ul><ul><ul><li>be in a fixed form (not an oral presentation) </li></ul></ul><ul><ul><li>disclosed to those not in a confidential relationship </li></ul></ul><ul><ul><li>have sufficient detail about the invention to enable the invention to be practiced. </li></ul></ul><ul><li>Can be a poster presentation! </li></ul><ul><li>Starts the one-year novelty clock! </li></ul>
  42. 42. Preserving Novelty <ul><li>Worldwide </li></ul><ul><ul><li>Maintain confidentiality until you file a patent application </li></ul></ul><ul><li>Only in the United States </li></ul><ul><ul><li>File a patent application </li></ul></ul><ul><ul><li>Before one year has passed </li></ul></ul><ul><ul><li>After publication or offer for sale </li></ul></ul>
  43. 43. Preserving Novelty <ul><li>Procedure for impending publication </li></ul><ul><ul><li>File a detailed disclosure with us </li></ul></ul><ul><ul><ul><li>Including a statement of usefulness </li></ul></ul></ul><ul><ul><ul><li>Reveals everything needed to make and/or use your invention </li></ul></ul></ul><ul><ul><li>Notify us that publication is imminent </li></ul></ul><ul><ul><li>We can file a “cover sheet” provisional patent application </li></ul></ul><ul><ul><li>Deemed filed the day we place it in the mail </li></ul></ul>
  44. 44. Will a patent application be filed? <ul><li>An application will not be filed if the invention does not meets the criteria for patentability. </li></ul><ul><li>Three criteria for a patentable invention </li></ul><ul><ul><li>Useful </li></ul></ul><ul><ul><li>Novel (New) </li></ul></ul><ul><ul><li>Non-obvious </li></ul></ul>
  45. 45. Obviousness <ul><li>When we tell inventors that their invention is not novel, </li></ul><ul><ul><li>they take it pretty well </li></ul></ul><ul><ul><li>they understand that their invention may have appeared in some obscure journal </li></ul></ul><ul><li>When we tell inventors that their invention is obvious </li></ul><ul><ul><li>they take offense </li></ul></ul><ul><ul><li>“ Your baby is ugly” </li></ul></ul>
  46. 46. Meaning of Obviousness <ul><li>Not an insult </li></ul><ul><li>Legal term </li></ul><ul><li>All of the pieces of your invention are in the public domain </li></ul><ul><li>Someone (in an obscure journal) has suggested putting the pieces together to make your invention </li></ul><ul><li>No remedy (but you can attack the elements) </li></ul>
  47. 47. When will IP become an issue? <ul><li>Terms of agreements that precede clinical research </li></ul><ul><li>IP created by you during research </li></ul><ul><li>IP (owned by others) that you use during research </li></ul>
  48. 48. IP owned by others <ul><li>Patent infringement </li></ul><ul><li>Unauthorized </li></ul><ul><ul><li>Making </li></ul></ul><ul><ul><li>Using </li></ul></ul><ul><ul><li>Selling </li></ul></ul><ul><ul><li>Importing </li></ul></ul><ul><li>The patented invention of another </li></ul>
  49. 49. Remedies for Infringement <ul><li>Injunction, stopping you from practicing the technology </li></ul><ul><li>Money damages </li></ul><ul><ul><li>Willful Infringement </li></ul></ul><ul><ul><ul><li>You know you are infringing </li></ul></ul></ul><ul><ul><ul><li>Treble damages </li></ul></ul></ul>
  50. 50. Avoiding Infringement <ul><li>Buy the technology you need for your research from an authorized dealer, or </li></ul><ul><li>Enter into a license agreement with the inventor </li></ul>
  51. 51. Avoiding Infringement <ul><li>“ Physicians’ Immunity” Statute </li></ul><ul><li>Activities in preparation of an NDA </li></ul>
  52. 52. Physicians’ Immunity (Good) <ul><li>A patent on a medical procedure cannot be enforced against a medical practitioner using that medical procedure on a body. </li></ul><ul><ul><li>“ Body” includes a human body, organ or cadaver, or a nonhuman animal used in medical research or instruction directly relating to the treatment of humans. </li></ul></ul><ul><ul><li>Provides immunity to those working at the direction of the practitioner </li></ul></ul><ul><li>Provides immunity to the institution affiliated with the practitioner </li></ul>
  53. 53. Physicians’ Immunity (Bad) <ul><li>Does not apply </li></ul><ul><ul><li>When the procedure involves the use of a patented medical device. </li></ul></ul><ul><ul><li>The provision of pharmacy or clinical laboratory services, unless provided in a physicians office. </li></ul></ul><ul><ul><li>To patents applied for before September 30, 1996 </li></ul></ul>
  54. 54. Preparation of an NDA <ul><li>it is not &quot;an act of [patent] infringement to … use … or import into the United States a patented invention … solely for uses reasonable related to the development and submission of information under a Federal law which regulates the … use … of drugs.” </li></ul><ul><li>Interpreted very broadly </li></ul>
  55. 55. Preparation of an NDA <ul><li>To be entitled to this defense you must: </li></ul><ul><ul><li>have a reasonable basis for believing that a patented compound may work, </li></ul></ul><ul><ul><li>through a particular biological process, </li></ul></ul><ul><ul><li>to produce a particular physiological effect, </li></ul></ul><ul><ul><li>use the compound in research that would be appropriate to include in a submission to the FDA. </li></ul></ul>
  56. 56. Preparation of an NDA <ul><li>You are entitled to this defense even though: </li></ul><ul><ul><li>the drug is not yet the subject of an FDA submission or </li></ul></ul><ul><ul><li>a patented compound is used in experiments that are not ultimately submitted to the FDA </li></ul></ul>
  57. 57. Summary <ul><li>There are legal constraints preventing UK from transferring IP to a sponsor </li></ul><ul><li>File your disclosures with us when you have data </li></ul><ul><li>Be ruthless in naming the correct inventors </li></ul><ul><li>Keep in mind that some technology you use may be patented </li></ul>
  58. 58. Where to Get More Information <ul><li>Our web site: http://www.rgs.uky.edu/IP </li></ul><ul><li>Patent office web site: http://www.uspto.gov </li></ul>

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