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    PRE GRANT PATENT OPPOSITION IN INDIA

    Pre Grant Opposition (Section 25(1) and Rule 55 of the Patents Act, 1970)

    How to file a pre grant patent opposition in India?

    Where an application for a patent has been published but a patent has not been granted, any person may, in writing, represent, by way of opposition to the Controller against the grant of patent.

    The patent applicant may contest the opposition. The Controller considers the statement and evidence submitted by the patent applicant and thereafter decides whether to grant the patent as such or refuse to grant a patent or require amendment to the complete specification to his satisfaction.

    Case Laws:

    1. Novartis case v. Cancer Patients Aid Association & ANR.
    CIVIL APPEAL Nos. 2706-2716 of 2013 with CIVIL APPEAL No. 2728 of 2013 and CIVIL APPEAL Nos. 2717-2727 of 2013
    APPELLANT- Novartis
    RESPONDENTS- Cancer Patients Aid Association & ANR.


    In 1993 Novartis filed a patent application for a free base called “Imatinib”. It was then further researched upon and improved to obtain a beta crystalline version of one of the salts of Imatinib (Imatinib mesylate) which was found to be effective for the treatment of chronic myeloid leukemia (CML). The corresponding drug was sold by the name Gleevec.

    In technical terms this substance is a particular polymorphic form of the methane sulfonic acid addition salt of imatinib mesylate. Novartis had been granted 35 patents covering this salt in various countries. At that time due to unavailability of product patents, Novartis filed a mailbox application on July 17, 1998 covering the ‘beta crystalline form of imatinib mesylate ’ and was able to obtain exclusive marketing rights (EMR) for a period of five years. The granting of EMR was a TRIPS obligation for countries like India, which did not grant patents for pharmaceutical products before 2005 (subject to a number of conditions).

    In 2005, Indian Patents Act, 1970 was amended and Indian Patent Office began examining pharmaceutical product patent applications. EMRs would either be replaced by patents (if granted) or canceled (if patents were rejected). This mailbox application was then opened and examined pursuant to the amendments to the Indian Patents Act. The application was immediately objected by many generic drug manufacturing companies and Cancer Patients Aid Association in the Chennai patent office on several grounds such as:

    • lack of novelty;

    • the claimed salt did not have any added “efficacy” under Section 3(d);

    • obviousness; and

    • wrongful priority

    In January 2006, the Assistant Controller of Patents rejected the patent application on the grounds of section 3(d) i.e. the application claimed 'only a new form of a known substance’. On 17 May 2006 Novartis challenged the Controller’s order and provisions of the Indian Patent Law by filing two writ petitions in the Madras High Court seeking a reversal of the Assistant Controller’s order and challenging the constitutionality of section 3(d). Novartis in its petition claimed that section 3(d) is not in compliance with the TRIPS Agreement and hence should be declared unconstitutional. The High Court transferred the first petition to the Intellectual Property Appellate Board (IPAB).

    The Madras High Court dismissed both the Writ Petitions and held that Section 3(d) aims to prevent ever greening of patents and to provide easy access for Indian citizens to life saving drugs. Novartis did not challenge the order of the Madras High Court. In the appeals, the IPAB reversed the Patent Controller’s order and held that the claimed invention was novel and inventive. However, it agreed with the Patent Controller that it was hit by Section 3(d) and rejected the patent application as Novartis did not provide data to show that the beta-crystalline form of imatinib mesylate exhibited significantly enhanced therapeutic efficacy over imatinib mesylate, the known substance.

    It was against this order that Novartis filed the Special Leave Petition in the Supreme Court. It was submitted by the Union of India that “in pharmacology, efficacy is distinct from affinity, potency and bioavailability.” Bioavailability is a pharmacokinetic property and is used to indicate the fraction extent to which a dose of drug reaches its site of action or a biological fluid from which the drug has access to its site of action.” A demonstration of increase in bioavailability is not a demonstration of enhanced efficacy. On 01 April 2013, Supreme Court rejected Novartis’s appeal by stating that Gleevec fails in both the tests of invention and patentability as provided under clauses (j), (ja) of section 2(1) and section 3(d) respectively of Indian Patents Act.

    The Supreme Court’s order can be found on the below link: Supreme Courts' order

    2. Novartis v. Cipla
    Date of decision: June 17, 2011
    Applicant- Novartis AG
    Opponent- Cipla Ltd.


    On April 11, 2005 Novartis AG filed a patent application (593/CHENP/2005) for their invention titled “Dispersible tablets comprising Deferacirox”. Cipla (referred to as the ‘Opponent’ herein) filed a pre-grant opposition against Novartis application as per Section 25(1) of the Act, the same being allowed by the Assistant Controller of Patents. Novartis filed a reply statement with evidence. The arguments made during the hearing are summarized as below:

    Novelty (Section 25(1) (b))
    Prior art cited by the Opponent:

    • WO/1997/49395 (WO’395)- disclosing deferacirox in free acid form, pharmaceutically acceptable salt, crystalline form and all conventional pharmaceutical dosage forms including dispersible tablet along with list of suitable excipients and carriers. Applicant’s argument: WO’395 taught the preparation of several forms (sugar-coated, shard gelatin) and oral suspension powders but it failed to disclose the preparation of dispersible tablets containing deferacirox. The Assistant Controller decided in favor of the applicant and held that “All the components of the present invention were not specifically disclosed in the prior art documents. Therefore the claimed invention was novel over the cited prior art.”

    Inventive step (Section 25(1) (b))
    Prior art cited by the Opponent:

    • US5698221 (US’221) - disclosed a dispersible tablet comprising compounds useful for the treatment of Alzheimer’s disorders.

    • US/2002/0061333 (US’333) - disclosed a dispersible macrolide compound with a specific concentration of the active pharmaceutical ingredient (API) and excipients. The Opponent argued that by combining US’221, US’333 and WO’395, it would have been obvious for a person skilled in the art to combine the specific range of excipients as disclosed in US’221, US’333 and replacing the API with deferacirox as mentioned in WO’395 to arrive at the patent under consideration which claims a dispersible tablet which disperses within 2 to 5 minutes.

    The Controller held that the drug dosage used in the patent application fell within the range of the cited prior art and hence adjusting the dose range does not amount to technological advancement. It was further held that the Applicant had failed to disclose:

    (1) the API and all excipients specifically with proportion in any composition or new drug delivery system for a known drug.

    (2) support pertaining to unforeseen effect of the composition or new drug delivery system for the known drug with the closest prior art shall be provided in the specification. In view of aforesaid, claims 1, 2, 13 and their dependent claims were held as not involving an inventive step and hence opposition was allowed under section 25(1)(e) of the Act.

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

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