BEFORE THE CONTROLLER OF PATENTS - .BEFORE THE CONTROLLER OF PATENTS PATENT OFFICE, MUMBAI, PATENTS

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Transcript of BEFORE THE CONTROLLER OF PATENTS - .BEFORE THE CONTROLLER OF PATENTS PATENT OFFICE, MUMBAI, PATENTS

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    BEFORE THE CONTROLLER OF PATENTS

    PATENT OFFICE, MUMBAI,

    PATENTS ACT 1970

    (SECTION 15)

    In the matter of Patent Act, 1970 and as

    amended Patent (Amendment) Act 2005

    In the mater of Patents Rule, 2003 and as

    amended Patent (Amendment) Rule 2006

    In the matter of Patent Application No.

    1399/MUMNP/2010.

    M/S.Cipla Limited - Applicant

    Hearing Date: 20/02/2016

    Present: - Dr.Indrani Bhattacharya, An authorized Patent Agent.

    ORDER UNDER SECTION. 15

    1. The instant Patent Application bearing No.

    1399/MUMNP/2010 was filed on 30/06/2010, at Patent

    Office, Mumbai, by M/s. CIPLA LIMITED, An Indian

    Company, having its address at 289 Bellasis Road, Mumbai

    Central, Mumbai, Maharashtra, India, filed an application for

    grant of Patent for the titled invention ANTI-RETROVIRAL

    COMBINATION claiming the priority of Indian patent

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    application bearing no.2538/MUM/2007 containing

    following claims,

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    2. The said Patent Application was published under section 11

    (B) on 29/04/2011 in a Patent Office Journal and the Request for

    Examination in Form -18 filed on 22/11/2011, the request no

    assigned as 4197/RQ-MUM/2011.

    3. After filing the Request for Examination the subject Patent

    Application is examined in accordance with the provisions

    of the Patents Act, 1970 (As amended) and under the Patent

    Rules, 2003 ( as amended ) on examination the following

    statement of objections have been generated the first

    examination report was issued to their Authorized Patent

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    Agent D.P.AHUJA & CO., 53, SYED AMIR ALI AVENUE, CALCUTTA 700

    019, WEST BENGAL, INDIA on 27/10/2014, along with an indication

    regarding last date for putting application in order for grant

    and / or reply under section 21(1) of the Patents Act, 1970

    ( as amended) i.e on 27/10/2015

    The Claims 1 to 22 do not constitute an invention u/s

    2(1)(j) of the Patents Act, 1970, as they are not novel

    and do not involve inventive step in view of the prior

    published documents:

    D1: WO 2006/055455; D2: WO2006005720A1; D3:

    SEKAR V J ET AL: "Pharmacokinetic interaction

    between darunavir boosted with ritonavir and

    omeprazole or ranitidine in human

    immunodeficiency virus-negative healthy

    volunteers" ANTIMICROBIAL AGENTS AND

    CHEMOTHERAPY, AMERICAN SOCIETY FOR

    MICROBIOLOGY,-vol. 51, no. 3, 8 January 2007,

    pages 958-961; D4: US 2005/084529; D5: WO

    2006/091529.

    D1 discloses a single solid dosage form comprising

    darunavir (300 - 600mg) (p.5, lin. 11), tipranavir,

    and optionally ritonavir (p.4, lin. 13-15).

    D2 discloses an anti-HIV combination comprising (i)

    tenofovir or its disoproxil fumarate derivative; (ii)

    ritonavir; and (iii) TMC 114 (darunavir), useful for

    the treatment or prevention of HIV infections. It

    further relates to pharmaceutical formulations

    containing such combinations. Each of the

    ingredients of the combination according to the

    invention can be co-formulated in one

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    pharmaceutical form and do not have to be

    administered in a separate pharmaceutical form. The

    daily therapeutic antiretroviral amount of the

    ingredients of the present combination of such co-

    formulated single pharmaceutical form may then be

    given in a single unit dosage form or even in

    multiple unit dosage forms, such as two, three, four,

    five or even more unit dosage forms. Such unit

    dosage forms unit may contain for example about

    300 mg of tenofovir disoproxil fumarate; for

    example 100 to 400 mg, preferably 100 to 200 mg of

    ritonavir; and for example 400 to 1200 mg, of TMC

    114 (See abstract; page 7, lin. 1-10).

    Therefore, claims 1, 8, 10, 12 and 22 are not novel.

    D3 discloses the co-administration of ritonavir and

    darunavir for the treatment of HIV. D3 does not

    disclose a bi-layer tablet or the use of a polymer as

    excipient, but only refers to the combined

    application of the drugs. The problem to be solved

    by the present invention may therefore be regarded

    as providing a pharmaceutical composition which

    contains ritonavir as well as darunavir. The solution

    proposed in the present application cannot be

    considered as involving an inventive stepbecause.

    D4 and D5 already mention that pharmaceutical

    compositions comprising one or more HIV protease

    inhibitor can be prepared in form of bi-layer tablets

    with a polymer as excipient. The tablets can be

    prepared by using, for example melt- extrusion (D4:

    [0073]; D5: p. 11, lin. 26 - p. 12, lin. 7).

    In view of the above disclosures, it would have been

    obvious for the skilled person to combine the

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    teachings of D3 with that of D4 or D5. Therefore,

    the claims 1-22 do not involve inventive step and do

    not constitute an invention u/s 2(1)(j) of the Patents

    Act, 1970.

    2 Claims 10 and 22 are use claims, which are not

    allowable u/s 2 (1) (j) of the Act, as what is claimed

    therein does not constitute an invention as defined

    under said Section of the Act.

    3 Claim 12 are directed to methods of treatments,

    which are statutorily barred from the patentability u/s

    3 (i) of the Act and hence claims 12 is not a

    patentable subject-matter as per the provision of said

    Section of the Act.

    4 Details regarding the search and/or examination

    report including claims of the application allowed, as

    referred to in Rule 12(3) of the Patent Rule, 2003, in

    respect of same or substantially the same invention

    filed in all the major Patent offices along with

    appropriate translation where applicable, should be

    submitted within a period of Six months from the

    date of receipt of this communication as provided

    under section 8(2) of the Indian Patents Act.

    5 Details regarding application for Patents which

    may be filed outside India from time to time for the

    same or substantially the same invention should be

    furnished within Six months from the date of filing

    of the said application under clause(b) of sub

    section(1) of secton 8 and rule 12(1) of Indian Patent

    Act.

    c) You are requested to comply with the objections

    by filing your reply by way of explanation and/or

    amendments within 12 months from the date of issue

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    of FER failing which you application will be treated

    as "Deemed to have been abandoned" under section

    21(1) of the Act. The last Date is 27/10/2015.

    d) You are advised to file your reply at the earliest so

    that the office can further proceed with application

    and complete the process within the prescribed

    period.

    4. An authorized Patent Agent D.P.Ahuja & Co, 53, Syed Amir

    Ali Avenue, Calcutta 700 019, on behalf of the Applicant

    submitted their reply against to the first examination report

    before expiry of the last date i.e. on 27/10/2015,

    The reply to FER submitted reproduced below,

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    5. On receipt of the reply further examination had been carried

    out in accordance with section 13(3), thoroughly and found

    that the reply as submitted could not complied the objection

    raised in First Examination Report, and the Authorized Patent

    Agent on behalf of the Applicant requested for an

    opportunity of hearing being heard the case in case of any

    adverse action Under section 14 of the Act,

    6. Accordingly, a hearing being offered under section 14 of the

    Patents Act, 1970 (as amended) to discuss an outstanding

    objections raised at First Examination Report, having been

    communicated following objections vide this Office letter No.

    1791 Dated 02/02/2016, along with a date and time of

    hearing was scheduled on 19/02/2016 at 12.00 am.

    The submissions in your letter dated 20th Oct 2015 have

    been considered carefully. The requirements of paragraphs 1-

    2 of FER have not been met.

    D6: US 2005/0048112.

    D6 solid pharmaceutical dosage forms comprising

    ritonavir (abstract and paras. [0037], [0084], [0085]) and,

    optionally, further comprises a second species of HIV

    protease inhibitor. D6 identifies 24 species of HIV

    protease inhibitor other than ritonavir, including TMC-114

    (darunavir), (see paras. [0013]-[0036], especially para.

    [0027]). Therefore, D6 provides strong motivation to

    formulate a solid pharmaceutical dosage form that

    comprises both ritonavir and darunavir. D6 additionally

    discloses that the solid pharmaceutical dosage form

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    comprises "at least one pharmaceutically acceptable water-

    soluble polymer" (abstract and para. [0008]).

    D6 thereafter identifies "a copolymer of about 60% by

    weight of the copolymer, N-vinyl pyrrolidone and about

    40% by weight of the copolymer, vinyl acetate" as the

    "particularly preferred polymer" (para. [0065]; see also

    Tables 1 and 2 at paras. [0084]-[0085]).

    D6 additionally discloses that " dosage forms according to

    the invention may be provided as dosage forms consisting

    of several layers, for example l