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Nuances in Patent Claim Scope

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    Vikram Pratap Singh [email protected]

    Copyright 2012, Intellecture 1

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    Introduction to claims

    Patent claim types

    Claim construction and application

    Scope of protection

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    Part of patentspecification

    Heart and soul of aninvention

    Defines the metes andbounds of an invention

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    The central claiming system claims identify the "centre" of the patented invention Protection on the basis of the inventors contribution

    The peripheral claiming system claims identify the exact periphery, or boundary of the

    conferred protection Protection on what is claimed Allows for easy infringement analysis

    Purely central or peripheral claiming system doesnot exist.

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    Preamble

    Transition phrase

    Body

    A gel composition fortreatment of pain

    comprising; 2-10

    percent by weightBenzocaine and atleast

    one of propylene glycol

    and glycerine as a co-solvent.

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    Preamble A gel composition for treatment of pain

    Transition Phrase comprising

    Body 2-10 percent by weight Benzocaine and at

    least one of propylene glycol and glycerine as a co-

    solvent.

    Claim elements

    2-10 percent by weight Benzocaine

    Propylene glycol or Glycerine

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    Introduces the invention It sets out the basic class of the invention

    Remove ambiguity as far as possible Example

    1. apparatus for shaking articles to dislodge impuritiescomprising...

    2. apparatus for shaking articles to dislodge impurities,the apparatus comprising...

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    Connects the preamble to the body

    Defines how to interpret the elements

    Two types of transitional phrases Open ended

    Comprising Closed ended Consisting of

    Consisting essentially of

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    It recites the elements that define theinvention

    Describes how these elements structurally,physically or functionally co-operate witheach other to make the invention or how theelements should be interconnected

    All the unnecessary elements should beremoved which will limit the claim

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    Independent Stand on their own

    E.g. - A gel composition for treatmentof pain comprising

    Dependant Depend on another claim

    The gel as claimed in claim 1, wherein....

    Advantage Clarifies the independent claim

    language claim differentiation

    Stand after a possible invalidity of thebase claim

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    Product claim New chemical entity

    Claimed generally by structure or name

    A compound of general formula X

    Considered superior claim type

    Process (method) claim Steps performed

    If no order expressed, no order is claimed

    Avoid numbering or using terms suggesting specific order,unless important

    E.g. Claim 1 - A process for treating the surface of apolyethylene article to increase its receptivity to a printing ink,which comprises

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    Markush claim Eugene Markush the first inventor to use it successfully in a US

    Patent application.

    An alternative to writing or in claims selected from the

    group consisting of A, B, and C. define alternative chemical ingredients - have a common

    property useful in the combination claimed

    E.g. Claim 1 - A process for treating the surface of a

    polyethylene article to increase its receptivity to a printing ink,which comprises:

    exposing the surface of the article to a saturated solution ofsodium dichromate in an acid selected from the groupconsisting of concentrated sulfuric, nitric and phosphoricacids.

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    Product by process claim product cannot be described in any other manner

    than by the process by which it was made

    Product to be novel and non-obvious Disadvantageous in comparison to product claims

    Infringement product and process;

    Invalidate - product

    "Product obtained by the process of claim X,"

    E.g. 8. A polyethylene article having a surfacetreated in accordance with the process of claim 5.

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    Omnibus claim Involves giving a reference to the description or the

    drawings without stating explicitly any technical

    features "An x as shown in Figure y Not allowed in US Not allowable, unless absolutely necessary (Europe)

    No legal basis - desirable to avoid (India)

    E.g. An apparatus substantially as herein abovedescribed in the specification with reference to theaccompanying drawings

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    Swiss type claim

    cover the subsequent medical use of a known

    substance or composition "Use of substance X in the manufacture of a

    medicament for the treatment of condition Y

    EPO Swiss type claim format no longer

    acceptable

    "A product X for the treatment of disease Y"

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    Intrinsic factors

    Specification

    Prosecution history

    Extrinsic factors

    Dictionary Encyclopaedia

    Expert testimony

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    Why claimconstruction?

    "The court must properlyinterpret the claims, because an

    improper claim construction maydistort the infringementandvalidity analyses."

    -Amazon.com v.BarnesandNoble.com (Fed. Cir.2001)

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    A gel composition for

    treatment of pain comprising;

    2-10 % by weight Benzocainein atleast in part as the free

    base; and

    atleast one of propylene

    glycol and glycerine as a

    solvent.

    Infringing?

    A gel for treating

    neuropathies causing pain at

    a site by inducing analgesia.The gel is administered

    intradermally. The gel has 10

    % by weight of Benzocaine

    and glycerine as solvent.

    PATENT PRODUCT

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    Claim Construction

    Comparison

    Claim by claim -

    element by element

    X

    A

    B

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    A gel composition for

    treatment of pain comprising;

    2-10 % by weightBenzocaine in atleast in part

    as the free base; and

    atleast one of propylene

    glycol and glycerine as a

    solvent.

    Infringing?

    A gel for treating

    neuropathies causing pain at

    a site by inducing analgesia.

    The gel is administered

    intradermally.

    The gel has 10 % by weightof Benzocaine and glycerine

    as solvent.

    PATENT PRODUCT

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    PATENT

    What I claim is a gel

    composition for treatmentof pain comprising;

    2-10 % by weightBenzocaine in atleast in

    part as the free base; and

    propyl paraben.

    PRODUCT

    A gel for treatingneuropathies causing painat a site by inducinganalgesia.

    The gel is administeredintradermally.

    The gel has 10% by weightof Benzocaine and methylparaben.

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    In substance equivalent if the infringing goods are made with the same

    objectin view which is obtained by the patentedproduct, then a minor variation does not meanthat there is no infringement. A person is guilty

    of infringement if he makes what is in substancethe equivalentof the patented article- RajPrakash Vs. Mangat Ram (1977)

    Function / Way / Result Test The doctrine of equivalents is founded on the

    theory that, if two devices do the same work insubstantially the same way and accomplishsubstantially the same result, they are thesame, even though they differ in name, form orshape.- Graver Tank & Mfg. Co. V. Linde Air

    Products Co.

    1 literal scope boundary

    2 range of equivalent

    3 accused product

    1

    2

    3

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    The differences between theaccused product or processand the claimed invention

    must be "insubstantial."

    The range of equivalentsgranted under the doctrine

    cannot extend so far as toensnare that which waspublicly done before the"prior art.

    1 literal scope boundary

    2 range of equivalent

    3 prior art

    1

    2

    3

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    The patentee cannotrecapture subjectmatter relinquished

    during the applicationprocess (under thedoctrine ofprosecution historyestoppel).

    PHE bars applicationof DOE

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    Facts a filtering process for the purification of a dye solution Amendment by patentee (pH 6-9)

    Alleged infringing process (pH 5) Infringement under Doctrine of equivalents ?

    Amendment during prosecution: purpose not related to patentability demonstrated court

    decides based on purpose Patent holder unable to establish purpose estoppel

    applies

    Hilton Davis v. Warner Jenkinson case

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    Process of treating dry fruits Elements

    Sulphuric Acid - Washing Soda Bleaching powder (3%) Bleaching powder (4.5%)

    Acetic acid - muriatic acid

    Sulphur dioxide fumes under pressure - Sulphurdioxide fumes without pressure

    Lallubhai v. Chimanlal case

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    Patent heating the resulting batter-coated dough to a

    temperature in the range of about 400 F to 850

    F. Product

    Dough is heated at a temperature at 400 F.

    Infringement?

    Case - Chef America V. Lamb Weston

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    Claim 1. A hydrosolwhich comprises solid

    particles of a

    cyclosporin and astabilizer which

    maintains the size

    distribution of saidparticles

    Cyclosporin not verysoluble in water,

    difficult to administer

    Cyclosporin

    formulation as a

    hydrosol

    Hydrosol in injectable

    form

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    Product is in the form of a capsule that containscyclosporin dissolved in a small amount ofethanol instead of water.

    Hydrosol formation, when ingested

    Infringing?

    Novartis Pharmaceuticals Corp. v. Eon Labs Mfg. 363 F.3d 1306 (Fed.Cir., 2004)

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    Broad definition

    a dispersion of solid particles in aqueous colloidal

    solution formed in the patients stomach

    Limited definition

    medicinal preparation formed outside the body.

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    Formulation containing moxifloxacinand sodium chloride

    1. Aqueous formulation, comprisingmoxifloxacin hydrochloride andsodium chloride.

    8. A method of treating or preventinga disease comprising administering toa host in need thereof an effectiveamount of an aqueous solution ...

    9. Acombination preparationcomprising an aqueous solution ofmoxifloxacin hydrochloride and anaqueous solution comprising sodiumchloride...

    US 1, 8 and 9

    Europe and India 1 and 9

    Patents referred: EP1206281

    US6548079

    IN214011

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    Aripiprazole complex formulation and method

    1. An inclusion complex of aripiprazole in asubstituted beta- cyclodextrin.

    4. A pharmaceutical formulation comprisingaripiprazole and a substituted (3-cyclodextrin.

    22. A method for administering injectablearipiprazole to a patient in need oftreatment

    24. A method of treating schizophrenia,which comprises administering [US] 22. Use of the formulation as defined in Claim 5 for

    the manufacture of a medicament for treatingschizophrenia (Europe)

    US 1, 4, 22 and 24

    Europe 1, 4, 24 (corresponding

    claims swiss type seeclaim 22 in EP patent)

    India 4 (including limitations)

    Patents referred: EP1542668

    US7115587

    IN244698

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    Think from the worst possible scenario ofinfringement

    The infringer should have a great difficulty indesigning around the claims.

    Clearly define claim terms in the specification.

    Be cautious when responding to Examination reports

    Include claim types based on the countries of interest

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