2008 CSUCI BIOL503 Intellectual Property Class 2 part 4c: Nonobviousness(49 slides)

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    2008 CSUCI BIOL503 Intellectual Property Class 2 part 4c: Nonobviousness(49 slides) - Presentation Transcript

    1. Intellectual Property II: Nonobviousness CSUCI2008 BIOL503 K. Pessin Biotechnology Law and Regulation
    2. Intellectual Property II: Patents, Non-Obviousness
      • Law and policy
      • Current Issues
      • Special Issues re: Biotechnology
      • Examples
      Hot Potato
    3. Intellectual Property II
    4. Intellectual Property II: Patents, Non-Obviousness
      • 35 U.S.C. 103 Conditions for patentability; non-obvious subject matter.
        • A patent may not be obtained . . . if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
    5. Intellectual Property II: Patents, Non-Obviousness, Policy
      • Competition + Innovation vs. Paralysis
        • Grant patents only to things which are truly inventive
        • “ Patent-free” zone around public domain encourages inventiveness
        • “ Pioneering patents” (outmoded)
          • Increasing novelty, increasing value of patent
        • “ Me too” patents – narrowly construe, lower value
    6. Intellectual Property II: Patents, Non-Obviousness
      • Invention: Method of making doorknobs made of clay or porcelain.
      • Prior art: Exact same method used to make knobs of wood and metal.
      • Court: Obvious
      • Hotchkiss v. Greenwood , 52 U.S. (11 How.) 248 (1851).
      Prior art: Same method for making, but wood or metal knobs. Claimed invention: method for making porcelain or clay doorknobs
    7. Intellectual Property II: Patents, Non-Obviousness
      • “ [U]nless more ingenuity and skill in applying the old method of fastening the shank and the knob were required in the application of it to the clay or porcelain knob than were possessed by an ordinary mechanic acquainted with the business, there was an absence of that degree of skill and ingenuity which constitute essential elements of every invention. In other words, the improvement is the work of the skilful mechanic, not that of the inventor.” Hotchkiss v. Greenwood , 52 U.S. (11 How.) 248 (1851).
      Hotchkiss v. Greenwood, 52 U.S. (11 How.) 248 (1851).
    8. Intellectual Property II: Patents, Non-Obviousness
      • What is the obviousness test?
      • The scope and content of the prior art
      • The differences between the prior art and the claimed invention.
      • The level of ordinary skill in the pertinent art
      • Secondary considerations such as commercial success and long-felt need in the art.
      • Graham v. John Deere & Co. (Supreme Court 1966)
    9. Intellectual Property II: Patents, Non-Obviousness
        • What prior art: Same as available for novelty
        • Analogous and Non Analogous Art:
          • Field in which patentee was working
          • “ Reasonably pertinent” to problem
          • Art in “Background” section of patent
      Garage sale Unrestricted university lab Trade show Car pool
    10. Intellectual Property II: Patents, Non-Obviousness
      • Avoid “hindsight bias”
        • “ Obvious to try” not proper standard
      • A juror’s knowledge of the invention makes the juror much more likely to believe that the invention would have been obvious.
    11. Intellectual Property II: Patents, Non-Obviousness http://papers.ssrn.com/sol3/papers.cfm?abstract_id=928662
    12. Intellectual Property II: Patents, Non-Obviousness http://www.patentlyo.com/patent/2006/11/hindsight_bias.html Test given by author of “Patently-O” blog
    13. Intellectual Property II: Patents, Non-Obviousness
      • Major issue: How is obviousness determined from combining prior art?
      • “ Teaching-suggestion-motivation” test
        • Must be some motivation, suggestion, or teaching to combine the prior art.
      • “ Function-shift” test
        • “ a combination which only unites old elements with no change in their respective functions” is obvious
        • “ Business-method” patents: all aspects perform respective functions, and no “function shift”
    14. Intellectual Property II: Patents, Non-Obviousness
      • KSR v. Teleflex (Supreme Court, argued 2006, decision likely 2007)
      • Claimed invention: Gas pedal with electronic sensor control
        • Prior art: adjustable pedal
        • Prior art: electronic sensor control
      Off the shelf brake components combined
    15. Intellectual Property II: Patents, Non-Obviousness Justice Scalia to patent bar: “It’s Gobbledygook!” http://www.unfg.org/ gobbledygook generator
    16. Intellectual Property II: Patents, Non-Obviousness Chief Justice Roberts to Patent Bar: “Your experts are paid shills!”
    17. Intellectual Property II: Patents, Non-Obviousness Justice Breyer to Patent Bar: “If that’s inventive, then so is keeping the raccoons away!”
    18. Intellectual Property II: Patents, Non-Obviousness
      • IN GENERAL post-KSR for biopharma:
        • IN GENERAL – Show an unexpected result from combining art references
        • KSR International Co. v. Teleflex Inc. , 127 S. Ct. 1727 (2007)
          • No application of “teaching, suggestion, or motivation” (“TSM”) test as a “rigid and mandatory formula”
          • “‘ some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness,’” but such reasoning “need not seek out precise teachings directed to the specific subject matter of the challenged claim.”
      • Examples:
        • “ Unexpected result” – known protein + known excipient
        • “ Structural obviousness” – chemical cases
    19. Intellectual Property II: Patents, Non-Obviousness
    20. Intellectual Property II: Patents, Non-Obviousness
    21. Intellectual Property II: Patents, Non-Obviousness
    22. Intellectual Property II: Patents, Non-Obviousness prima facie = on first appearance arguendo = for the sake of argument
    23. Intellectual Property II: Patents, Non-Obviousness
    24. Intellectual Property II: Patents, Non-Obviousness
    25. Intellectual Property II: Patents, Non-Obviousness
    26. Intellectual Property II: Patents, Non-Obviousness
      • “ Structural similarity” chemical cases
        • In re Dillon (CAFC 1990): Structural similarity between claimed and prior art subject matter, proved by combining references or otherwise, where the prior art gives reason or motivation to make the claimed compositions, creates a prima facie case of obviousness . . .”
        • Example: Lilly v. Zenith (CAFC 2006), change from halide to hydrogen not obvious
    27. Intellectual Property II: Patents, Non-Obviousness
      • Lilly v. three generic manufacturers
      • Zyprexa®, antipsychotic for treating schizophrenia
      • Prior art: Use a halide (fluoride or chloride) for the antipsychotic effects
      • Patent: hydrogen used, not halide
      • Holding: Not obvious to use hydrogen where prior art expressly “taught away” from using anything but a halide
      http://www.fedcir.gov/opinions/05-1396.pdf
    28. Intellectual Property II: Patents, Non-Obviousness http://www.fedcir.gov/opinions/05-1396.pdf
    29. Intellectual Property II: Patents, Non-Obviousness
      • Aventis v. King (CAFC 2007)
      • Rampiril (ACE inhibitor)
      • Held: Purified form obvious over prior art mixture
      http://www.cafc.uscourts.gov/opinions/06-1530.pdf
    30. Intellectual Property II: Patents, Non-Obviousness Europe: Problem-solution approach Claim: Use of known HSV mutant to treat brain tumors
    31. Intellectual Property II: Patents, Non-Obviousness Claim: Use of known HSV mutant to treat brain tumors
    32. Intellectual Property II: Patents, Non-Obviousness Problem-solution
    33. Intellectual Property II: Patents, Non-Obviousness Discovery: Virus shuts off tumor protein production
    34. Intellectual Property II: Patents, Non-Obviousness Solution doesn't add that much to the art, but that's ok because the claim is narrow.
    35. Intellectual Property II: Patents, Non-Obviousness
      • Person having ordinary skill in the art
        • Not the inventor skill level (inventor may be an expert, not ordinary)
        • “PHOSITA”
        • Ordinary skilled artisan
        • One of ordinary skill in the art
      • What is the “art”?
      • Team of people?
    36. Intellectual Property II: Patents, Non-Obviousness, level of skill in the art
      • The level of education and experience of persons actively working in the field at the time of the invention;
      • The types of problems encountered in the art at the time of the invention;
      • The prior art patents and publications;
      • The activities of others;
      • Prior art solutions to the problems; and
      • The sophistication of the technology.
    37. Intellectual Property II: Patents, Non-Obviousness, level of skill in the art
      • Daiichi Sankyo v. Apotex ( Fed. Cir. 2007 ).
        • Invention: Ear medication
        • Lower court: inventor was a pediatrician, so ordinary skilled person was a pediatrician
        • Federal Circuit: an otologist who is engaged in developing pharmaceutical formulations
        • Ruling: Invention obvious because otologist would have found formulation obvious
    38. Intellectual Property II: Patents, Non-Obviousness, level of skill in the art http://legal.european-patent-office.org/dg3/pdf/t930412eu1.pdf "One skilled in the art" = team
    39. Intellectual Property II: Patents, Non-Obviousness, level of skill in the art Claim: Proton beam patient facility (to treat cancer patients, for example) Prior art: Neutron beam patient facility Optivus and Loma Linda v. Ion Beam Apps . (Fed. Cir. 2006) http://www.fedcir.gov/opinions/05-1518.pdf Patentee: Our proton beam is not obvious -- one skilled in the art could not have modified the prior neutron beam without making a death ray!
    40. Intellectual Property II: Patents, Non-Obviousness, level of skill in the art “ Heh heh some death ray… More like a mild heat rash ray, I’d say…” Court: One of ordinary skill in the art at the time the invention was made would have avoided a death ray by turning down the proton intensity so it wouldn’t kill the patient. Optivus and Loma Linda v. Ion Beam Apps . (Fed. Cir. 2006) http://www.fedcir.gov/opinions/05-1518.pdf
    41. Intellectual Property II: Patents, Non-Obviousness, objective indicia
      • Commercial success
      • Long felt need
      • Unsuccessful attempts by others
      • Copying
      • Unexpected superior results
      • Industry acceptance
      • Prior art “teaches away”
      • Others in the field don’t believe results
    42. Intellectual Property II: Patents, Non-Obviousness, objective indicia
      • Hybritech v. Monoclonal Antibodies (CAFC 1985)
      • Monoclonal Antibodies’ argument: “Hey! Hybritech’s monoclonal sandwich assay would have been obvious in view of the prior art polyclonal sandwich assays!”
      Y e Y Immobilized monoclonal antibody Antigen Labelled Monoclonal antibody x
    43. Intellectual Property II: Patents, Non-Obviousness, objective indicia
    44. Intellectual Property II: Patents, Non-Obviousness, objective indicia Objective indecia of non-obviousness: Commercial success of the invention -- and not due to advertising hyperbole.
    45. Intellectual Property II: Patents, Non-Obviousness, objective indicia http://www.fedcir.gov/opinions/05-1396.pdf Long-felt need for Zyprexa
    46. Quiz
      • People have a protein which causes them to stop growing muscle tissue. There are many antagonists in the state of the art – such as antibodies which block the function of the protein. These seem to work too well, however, and animals and humans are musclebound.
      • You find an antagonist which doesn’t work as well.
      • Obvious?
    47. Intellectual Property II: Patents, Non-Obviousness
      • Summary
        • “Obviousness” : lack of novelty viewing a combination of prior art references
        • No-bright line standard
        • Analysis involves looking at technical references as well as looking at circumstances relevant to the art at the date of invention
    48. Intellectual Property II: Patents, Non-Obviousness
      • References and links:
        • 35 USC 103 (via Cornell Law Library/Legal Information Institute
        • Manual of Patent examining procedure, 35 USC 103 conditions for patentability; non-obvious subject matter
        • KSR v. Teleflex (US Supreme Court 2006) (via SCOTUS web site)
        • Legal commentator, “Patently-O” on obviousness cases
    49. Intellectual Property II: Nonobviousness CSUCI2007 BIOL503 END Next: Inventorship

    + Karol PessinKarol Pessin, 2 years ago

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    BIOL 503 Spring 2008
    Nonobviousness
    Policy and re more

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