Intellectual Property II: Nonobviousness CSUCI2008 BIOL503 K. Pessin Biotechnology Law and Regulation

Intellectual Property II: Patents, Non-Obviousness Law and policy Current Issues Special Issues re: Biotechnology Examples Hot Potato

Law and policy

Current Issues

Special Issues re: Biotechnology

Examples

Intellectual Property II

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.

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.

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

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

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

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).

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).

“ [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).

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)

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)

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

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

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.

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.

Intellectual Property II: Patents, Non-Obviousness http://papers.ssrn.com/sol3/papers.cfm?abstract_id=928662

Intellectual Property II: Patents, Non-Obviousness http://www.patentlyo.com/patent/2006/11/hindsight_bias.html Test given by author of “Patently-O” blog

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”

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”

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

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

Intellectual Property II: Patents, Non-Obviousness Justice Scalia to patent bar: “It’s Gobbledygook!” http://www.unfg.org/ gobbledygook generator

Intellectual Property II: Patents, Non-Obviousness Chief Justice Roberts to Patent Bar: “Your experts are paid shills!”

Intellectual Property II: Patents, Non-Obviousness Justice Breyer to Patent Bar: “If that’s inventive, then so is keeping the raccoons away!”

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

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

Intellectual Property II: Patents, Non-Obviousness

Intellectual Property II: Patents, Non-Obviousness

Intellectual Property II: Patents, Non-Obviousness

Intellectual Property II: Patents, Non-Obviousness prima facie = on first appearance arguendo = for the sake of argument

Intellectual Property II: Patents, Non-Obviousness

Intellectual Property II: Patents, Non-Obviousness

Intellectual Property II: Patents, Non-Obviousness

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

“ 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

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

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

Intellectual Property II: Patents, Non-Obviousness http://www.fedcir.gov/opinions/05-1396.pdf

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

Aventis v. King (CAFC 2007)

Rampiril (ACE inhibitor)

Held: Purified form obvious over prior art mixture

Intellectual Property II: Patents, Non-Obviousness Europe: Problem-solution approach Claim: Use of known HSV mutant to treat brain tumors

Intellectual Property II: Patents, Non-Obviousness Claim: Use of known HSV mutant to treat brain tumors

Intellectual Property II: Patents, Non-Obviousness Problem-solution

Intellectual Property II: Patents, Non-Obviousness Discovery: Virus shuts off tumor protein production

Intellectual Property II: Patents, Non-Obviousness Solution doesn't add that much to the art, but that's ok because the claim is narrow.

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?

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?

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.

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.

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

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

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

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!

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

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

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

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

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!”

Intellectual Property II: Patents, Non-Obviousness, objective indicia

Intellectual Property II: Patents, Non-Obviousness, objective indicia Objective indecia of non-obviousness: Commercial success of the invention -- and not due to advertising hyperbole.

Intellectual Property II: Patents, Non-Obviousness, objective indicia http://www.fedcir.gov/opinions/05-1396.pdf Long-felt need for Zyprexa

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?

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?

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

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

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

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

Intellectual Property II: Nonobviousness CSUCI2007 BIOL503 END Next: Inventorship