IPAB’s order granting a patent to University of Miami may refine the perplexed examination process

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BACKGROUND OF THE CASE:

An Indian national phase application, titled “Topical Co-enzyme Q10 (CoQ 10) Formulations and Methods of use” (application number – 2090/KOLNP/2006) having a set of 1 -37 claims was filed on July 25, 2006. An examination report was issued on May 05, 2010 by the Controller of Patents (herein Respondent in this case).The major objection raised in the first examination report (FER) were as follows:

a) Claims lack novelty and inventive step in view of the cited prior art references; and

b) Claim 8 -32 falls within the purview of non – patentable subject matter under sec (3) (i).

The appellant filed a response to the first examination report with amended or revised set of claims on May 02, 2011, three days prior to the deadline (May 05, 2010) for filing the response. The Respondent, on 11 July, 2012, issued a hearing notice appointing a hearing to be held on 22 August, 2012. Major objections raised in the hearing notice were as follows:

  • Title of the application was not precise.
  • Amended claims lack novelty and inventive step in view of the prior references cited in the FER.
  • Amended claims were not allowable under sec 3 (d) and 3 (e).
  • Claims 47 to 49 not supported by the specification.

Moving on, the hearing to be held on 22 August, 2012 was adjourned and a later date i.e. 02 August, 2013, was fixed for the hearing. A further discussion was also scheduled on 07, Feb 2014, by the Respondent. Data in the form of affidavits in support of the patent application was also filed along with the written submission. After a hearing held again on 27 February, 2014, the Respondent passed an order on 27 February, 2015 rejecting the grant of the appellant’s patent application.

 Grounds for rejection from the order is produced below:

1) Use of liposome as carrier of active drug molecules is already known in the art. The proposed revision of claim, combining the carrier liposome with active drug molecule, Coenzyme Q 10 and evidence for enhancement of activity (as proposed by further documents) are beyond the scope of ‘invention’ as described in the complete specification as on record.

ii) Post filing data or technical results cannot be included in the descriptive part of the complete specification as it is not allowable as per section 59 of the ‘Act.

iii) Applicant did not incorporate the further experimental results in the specification by way of amendment within stipulated time period. At this stage, inclusion of major technical data and change of direction of the invention is not acceptable and merit of the invention has to be decided based on the disclosure as on record.

iv) As per present disclosure, specification lacks in technical data for enhancement of efficacy or synergism. Therefore, the ‘invention’ cannot be acknowledged to involve inventive step [as per section 2(1)(j)] and also not patentable under section 3(d) of the ’Act.

v) The revised claim as drafted fall u/s 3(i) [method of treatment] of the ‘Act and thus, not allowable.

The Appellant filed an appeal to the IPAB against the order dated 27 February, 2015 passed by the Respondent rejecting the grant of the Appellant’s Indian patent application numbered 2090/KOLNP/2006.

IPAB DECISION:

IPAB set aside the decision of the Controller and granted a patent in favour of the appellant. The judgement was passed considering the arguments provided by the appellant as there were no representative on behalf of the Respondent. Grounds considered to grant the patent application are as follows:

  • Incorrect rejection under sec 3 (i)

IPAB stated that the Respondent had incorrectly rejected the patent application under section 3 (i), as such objection was not even raised in the hearing notice. Rejection based on the ground, which was even not communicated to the appellant is against the principal of natural justice. The order passed violates section 14 of the patent law, which mandates the Controller to give an opportunity to be heard before any decision is made against the appellant.

  • Non speaking order – Grounds for rejection not clear

In the refusal order, the Respondent had vaguely mentioned that the patent application lacks inventive step, non- patentable under section 3 (d) & 3 (i) and claims not supported by the specification. Grounds for rejection were not elaborated, which is again violation of the principles of natural justice and also the principle of law established in the country. Relying on a legal principle under patent law and also held by IPAB in the decisions like ORDER No.08/2014, IPAB states that the refusal order has to be a speaking order and the details regarding the grounds for refusal, and how those grounds are established on the subject matter claimed has to be elaborated.

  • Composition claims do not fall under sec 3 (d)

    • The Respondent had wrongly objected that the claims of the patent application fall under the purview of sec 3 (d), as the revised claims of the patent application relates to composition. IPAB relies on the previous IPAB order no. 173 of 2013 and specifically referring to paragraph 84 of the above mentioned IPAB order, it concluded that composition claim do not fall under section 3 (d). Further, the board also stated that refusal order fails to disclose the known substance for which the efficacy data has to be shown and how section 3 (d) is applicable for the patent application at issue.
    • The Respondent was wrong in rejecting the application as the same is a breakthrough invention for treatment of cancer, an embodiment of which is being studied at the clinical stage for treatment of cancer.
    • The claims are novel and also inventive in view of the cited documents and completely supported by the specification as originally filed.
  • Additional documents:

Affidavits from experts providing data supporting the invention were also submitted along with the post hearing written submission. The Respondent erred in disallowing said post filing data submitted by the appellant in support of the patentability of the claimed invention.

The IPAB implemented “Principle of natural justice” and set aside the order of the Respondent. Based on the present order, the Respondent has to abide by the principles of natural justice, while examining any patent application and also should rightly exercise his discretion power vested under section 15 of the Patent Act. The Respondent cannot reject the grant of a patent application by providing vague reasons and not providing details as how the cited references are applicable to the patent application. In other words, the order passed by the Respondent should be a speaking order, not a nonspeaking order. Any additional documents such as clinical trial data or any experimental data submitted to support the patentability of the invention has to be considered by the Respondent, on passing an order that may be against the right of the appellant.

In practice, the FER issued by the Indian patent office hardly provides detail as how the cited references are applicable to the patent application. In such scenarios, it may be difficult for the applicant to understand the underlying reasons for which the prior is cited and how the cited references are comparable to the patent application being examined. Therefore, the arguments and amendments provided by the applicant in the response filed for the FER issued may not be convincing to the Controller and lengthen the patent prosecution process. The present order binds the Controller to provide reasons as how the cited references are applicable to the patent application being examined. This makes an ease for the applicant to understand how the cited references are compared to the patent application and prepare arguments and amendments accordingly that may be convincing to the Controller and shorten the prosecution process.

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