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    POST GRANT PATENT OPPOSITION IN INDIA

    Post Grant opposition (Section 25(2) and rules 55 – 62)

    How to file post grant patent opposition in India?

    At any time after the grant of patent but before the expiry of a period of one year from the date of publication of grant of patent, any “person interested” may give notice of opposition to the Controller. If the patentee desires to contest the opposition, he shall leave a reply statement (at the appropriate office) fully setting out the grounds upon which the opposition is contested and evidence (if any) in support of his case.

    The opponent may leave at an appropriate office his evidence strictly confined to the patentee’s reply.

    The Controller constitutes an Opposition Board and the Board conducts the examination of the patent and submits their recommendation to the Controller. The Controller then fixes a date of hearing and notifies both the parties. After hearing the parties and upon consideration of the recommendations submitted by the Opposition Board, the Controller decides upon the opposition and notifies his decision to the parties giving reasons thereof.

    Case Laws:

    1. Sugen v/s Cipla
    ORDER No.107/2013
    Date of decision: May 14, 2013
    Applicants- Sugen Inc and Pharmacia & UpjohnCompany LLC
    Respondents- Cipla Ltd. and Controller General of Patents, Design, Trademark


    Sugen was granted a patent (IN 209251) on August 23, 2007 titled “PYRROLE SUBSTITUTED 2- INDOLINONE PROTEIN KINASE INHIBITORS” covering the drug Sunitinib effective against diseases caused by abnormal protein kinase activity. The post grant opposition was filed by Cipla on August 29, 2008 on the following grounds:

    (a) publicly used in India before priority date of claim (Sec 25 (2) (d))

    (b) obviousness and lack of inventive step (Sec 25(2) (e))

    (c) not an invention within the meaning of the Act (Sec 25(2)(f))

    (d) failure to disclose information as required u/s 8 of the Act (Sec 25(2)(h))

    In the written statement under Sec 25 (2), Cipla mentioned that the opposition must be allowed under Sec 25 (2)(e) in view of the following documents:

    a) D1 US 5886020 published on March 23, 1999;

    b) D2 WO/98/50356 published on November 12, 1998; and

    c) D3 WO/99/61422 published on December 2, 1999.

    Cipla filed the evidence under Rule 59 and petitions under Rules 137 & 138 of the Patent Rules. The Opposition Board was constituted and after examination gave its recommendations against the grant of patent. After hearing both the parties, the Controller revoked the patent on September 24, 2012.
    Thereafter, Sugen requested for a copy of the recommendations made by the Opposition Board under RTI, 2005, which was denied by the Patent Office. Sugen challenged the Controller’s decision of revocation on non-furnishing of the Board’s report. The matter finally went to the Supreme Court and it was held that the non-furnishing of the Board’s report resulted in violation of principles of natural justice and the revocation was set aside. The Controller was directed to dispose of the matter afresh. When the matter came back to the Controller the Appellant attacked the revocation order on merits, for not sending affidavit to the Opposition Board, that the reply evidence filed by the respondent was time barred, that Exhibits D1, D2 & D3 should not have admitted since Section 25 (2)(b) was not taken as a ground.

    According to Sugen, the opposition was not maintainable on four grounds. Firstly the ground under Sect.25 (2)(b) was not taken. This ground was conspicuous by its absence and hence the decision of the Controller on the basis of prior publication was not sustainable. The Patent Act requires that the opposition will be entertained only on the grounds mentioned and no other grounds. If Section 25(2)(b) was not put to the Opposition Board, then the Board would have no occasion to deal with it. Next the Appellant was aggrieved by the reception of the reply evidence under Rule 59. According to the Appellant Rule 137 cannot be invoked when 138 (2) is clear.

    Following this, Sugen filed writ petition in the Delhi High Court claiming that Cipla should be prohibited to launch its generic drug in the market. Sugen took the matter to the Hon’ble High Court, Single Bench and the Division Bench. From there the appeals proceeded to the Supreme Court which opined that the recommendations of the Opposition Board should be provided to Sugen. The Supreme Court, then, sent it back to the Patent Office for re-hearing. The Controller again revoked the patent. Sugen filed a Writ Petition to High Court who directed it to IPAB. The Hon’ble IPAB sent the matter back to the Patent Office stating that a new Opposition Board is to be formed and new Controller will conduct the hearing. The verdict of the Controller is awaited.

    The Controller’s decision can be found on the below link: Post Grant final decision.pdf

    The IPAB’s order can be found on the below link: IPAB'S Order.pdf

    2. Roche v/s Cipla
    Date of decision: April 30, 2010
    Patentee- M/s F. Hoffman-La Roche AG
    Opponents- Ranbaxy, Cipla, Bakul Pharma, Matrix Labs Ltd., Delhi Network of Positive People, Indian Networking for People living with HIV/AIDS & The Tamil Nadu,


    Roche was granted patent (207232) titled “2- (2-AMINO-1,6-DIHYDRO-6-OXO-PURIN-9-YL)METHOXY-1,3-PROPANEDIOL DERIVATIVE’ on July 27, 1995 covering L- Valinate Ester of Gancyclovir and all acceptable salts in oral form with increased bioavailability. Post-grant opposition as per Section 25(2) of the Indian Patents Act, 1970 was filed by the following Opponents:

    The grounds of opposition were:

    Novelty and inventive step
    Prior art cited by the Opponents:

    US 5043339 (US‘339), EP 0375329 (EP’ 329), US’ 032, US’ 924

    (i) Acyclovir and Gancyclvovir are similar in structure and function targeting similar diseases (anti-viral). It is known that acyclovir is poorly absorbed and large doses are required to increase its bioavailability. If Acyclovir is converted in an ester form, its bioavailability is increased when administered orally. EP’329 mentions several amino acids which can be used to result in the L-valinate ester of Acyclovir called Valacyclovir. Adding Hydrochloride to acyclovir yields L-valinate ester of Acyclovir called Valacyclvoir (sold as Valtrex, an anti Herpes drug by GSK).

    (ii) L-Valinate ester of Gancyclvovir in the intra-venous form is already in the market against anti-viral diseases (mainly HIV infections).

    (iii) In order to increase the bioavailability a person skilled in the art would have been motivated to come up with an oral form of the compound by following the step of esterization of Gancyclvovir resulting in the L-valinate ester of Gancyclovir (namely Valgancyclovir) and later, a combination with hydrochloric acid to result in Valgancyclovir Hydrochloride (sold as Valcyte by Roche).

    Not an invention

    The patent was held to fall under Section 3(d) of the Patent Act, 1970 as it failed to prove increased efficacy. The controller was of the opinion that increased bioavailability means more drug is available to the cells, it does not guarantee the drug has more therapeutic efficacy. Therefore, efficacy and bioavailability are two different concepts and are independent of each other. In view of the above explanations, the Indian Patent Office held against Roche and challenged the validity of the patent.

    The Controller’s decision can be found on the below link: Controllers' decision.pdf

    For more information on Post Grant Patent Opposition in India please write to us at: admin@maxipconsult.com.
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