lecture-2/ presentation on biotechnology and ip

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    Biotechnology and IP

    ByKalyan C KankanalaChief Knowledge OfficerBrain League IP [email protected]

    Copyright, Brain League IP Services, Non-commercial use is permitted

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    US Patent Law andBiotechnology

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    Overview

    Article 1 Section 1 Clause 8 Quid Pro Quo Incentives Title 35

    www.uspto.gov www.fedcir.gov

    http://www.uspto.gov/http://www.uspto.gov/
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    Patentability requirements

    Patentable subject matter Utility Novelty

    Nonobviousness Specification

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    INVENTIONS

    Subject Matter

    Usefulness

    Novelty

    Non-obviousness

    Specification

    PATENTS

    Kalyans PatentFilter Model

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    How to frame an issue?

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    Example

    Example: A stabs B with a long knife after beingprovoked byB's statemements about his wife.

    Issue Whether A's act of stabing B with a long knife

    with the intention of killing him amounts tomurder under section 300 of IPC?

    Wheter A's act of stabing B after beingprovoked by B's humiliating statementsamounts to murder under section 300 of IPC?

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    Patentable Subject Matter

    Section 101 - Process, machine, manufacture,composition of matter and Improvements

    Funk Bros. v. Kalo Diamond v. Chakrabarty

    Pioneer Hibebred v. J.E.M.Arguments and Issues

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    Funk Bros

    Rhizobium bacteria Innoculum of mutually inhibiting

    bacteria Is it a product of nature?

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    Chakrabarty's case

    Psuedomonas bacteria Four different plasmids inserted. Is it a product of Nature?

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    Utility

    Current Substantial Credible

    Brenner v. Manson Gene/protein sequences

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    Novelty

    Section 102 Know of used Patented or published Public use or On sale

    Abandoned Foreign Priority Patented in another country

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    Novelty

    Derived Suppressed or Concealed Diligence Single prior art reference

    Isolated or purified- activity

    Hybritech v. Monoclonal

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    Nonobviousness

    Scope of prior art Differeneces- invention and prior art Level of oridnary skill Secondary Indiicia

    At the time of conception Obvious to try

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    Hybritech v. Monoclonal

    immunometric assays using monoclonalantibodies

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    Prior Art a. Kohler and Milstein's Nobel Prize-Winning Work for

    Producing Monoclonal antibodies in vitro; b. The Work of Drs. Oi and Herzenberg, in which they used

    monoclonal antibodies to "map" epitopes or determine thenumber and location of different antibody binding sites on aknown quantity of IgE antigen by attaching to it an antibodybound to a carrier and exposing that antigen to othermonoclonal antibodies;

    c. The Frankel Article that disclosed Monoclonal AntibodiesHaving Affinities of 109 liters/mole; and

    d. Articles "Predicting" Widespread Use of Monoclonalantibodies. [Id.]

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    In re Deuel:

    Isolated and purified DNA and cDNAmolecules encoding heparin-binding

    growth factors ("HBGFs")

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    Prior Art

    Bohlen's patent application disclosed a groupof protein growth factors designated asheparin-binding brain mitogens ("HBBMs")useful in treating burns and promoting theformation, maintenance, and repair of tissue,particularly neural tissue. Bohlen determinedthe first 19 amino acids of the proteins' N-terminal sequences, which were found to beidentical for human and bovine HBBMs. Heprovided no teachings concerning DNA orcDNA coding for HBBMs in his application.

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    Prior Art

    Maniatis described a method of isolatingDNAs or cDNAs by screening a DNA or

    cDNA library with a gene probe. Thereference outlined a general techniquefor cloning a gene but did not describe

    how to isolate a particular DNA or cDNAmolecule.

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    Recent Developments

    KSR Vs. Teleflex In re Kubin

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    Specification

    Written Description Enablement Best Mode Claims

    Object: Notice and Dissemination

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    Example

    A stent coated with taxol for "treating orpreventing recurrent stenosis.

    Prior ArtStents Existing Taxol known for Tumor treatment by

    angiogenesis Article - Re-stenosis dangers and need

    for a treatment - suggests various options

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    Thank you

    Kalyan C. Kankanala

    Chief Knowledge Officer,

    Brain League IP Services

    Email: [email protected]

    Ph: 91-80-41489502/4

    URL: www.brainleague.com Blog: http://indianipinfo.blogspot.com/

    Copyright, Brain League IP Services,

    mailto:[email protected]:[email protected]://www.brainleague.com/http://indianipinfo.blogspot.com/http://indianipinfo.blogspot.com/http://www.brainleague.com/mailto:[email protected]:[email protected]