Another pharmaceutical patent refusal came under the judicial scanner in the Calcutta High Court. This time, a patent application filed by Oramed Ltd. for a novel oral insulin composition aimed at eliminating the need for daily insulin injections was refused by the Deputy Controller for lack of inventive step and composition falling under Section 3(e) of the Patents Act. Aggrieved by this refusal, the applicant filed an appeal before the Calcutta High Court [IPDPTA/8/2022] (OA/14/2020/PT/KOL).
In Oramed Ltd. vs the Controller General of Patents, the Calcutta High Court set aside the decision vide order dated July 4, 2025, and remanded the case for a fresh hearing before a different Controller. This case was remanded earlier by the Calcutta High Court vide its order dated June 19, 2019, passed in the Writ Petition No. WP (9575) of 2019. Significantly, in that order, this Court had directed the respondent to consider all materials made available and filed by the appellant in deciding the application, which was ignored in passing the impugned order.
Admitted Infirmities in the Order
It is interesting to note that when the appellant raised certain infirmities in the impugned order, the respondent fairly admitted that:
"that the impugned order does not deal with the expert evidence or the scientific technical materials which had been furnished by the appellant. In particular, the expert evidence of Miriam Kidron has been ignored in the impugned order. "
Even in respect of the mismatch of the referred to prior arts, i.e. D1 to D4, in the hearing notice, the respondent admitted that:
"the Hearing Notice referred to prior arts i.e. D1 to D4. However, the impugned order concludes that the invention lacked inventive steps only on the basis of the prior arts D1 and D4 and ignores D2 and D3. Any such change ought to have been made known to the appellant and an opportunity ought to have been provided to the appellant to contest the new combination of documents D1 and D4 alone."
Erroneous Interpretation of D4
The Court observed that the inventive step determination by the Deputy Controller was based on the erroneous interpretation of D4. The Court held that:
"On the aspect of inventive step, as well as section 3(e),the Deputy Controller has regarded pharmaceutically acceptable pH lowering agent or protease inhibitor to be present in a manner as if these in combination amount to two protease inhibitors. On that basis, the Deputy Controller held that D4 teaches the use of two protease inhibitors. The above premise is based on an erroneous interpretation of D4. D4 does not mention the presence of double or multiple protease inhibitors. Thus, the Deputy Controller erred in its finding that D4 teaches two protease inhibitors. In view of the above, the conclusion of obviousness cannot be supported."
Misapplication of Criteria of Therapeutic Efficacy under Section 3(e)
Another serious flaw in the impugned order, according to the Court, was
"14. The finding of the Deputy Controller that bioavailability alone does not establish synergism and requires therapeutic efficacy for the purpose of section 3(e) is incorrect and is based on a misconception of the provisions. While the latter is a criteria for adjudication under section 3(d) of the Act, it is wholly irrelevant for the purposes of interpreting section 3(e) of the Act. The impugned order proceeds on the basis of section 3(d) of the Act while considering the application for grant of patent. On the contrary, the hearing notice was under section 3(e) read with section 2(1)(ja) of the Act. This is a serious flaw in the impugned order inasmuch as it brings elements of section 3(d) inter-alia enhancement of therapeutic efficacy as well as bioavailability which are wholly irrelevant and immaterial insofar as section 3(e) of the Act is concerned."
Order Passed Ignoring the Patent Office Manual
Acknowledging the sufficiency of guidance to be found in the Patent Office Manual with regard to the scope and applicability of Sections 3(d) and 3(e) of the Act (Clauses 09.03.05.04 and 09.03.05.05 of the Patent Manual of Version 3.0 dated November 26, 2019), the Court found that 'which has been disregarded in passing the impugned order." by the Deputy Controller in this case.
Takeaways
Sufficient guidance can be found in the Patent Office Manual with regard to the scope and applicability of Sections 3(d) and 3(e), and ignoring the guidelines is not a best practice. It incorporates the elements of Section 3(d) inter alia enhancement of therapeutic efficacy as well as bioavailability, which are wholly irrelevant and immaterial insofar as Section 3(e) of the Act, as a conflated intermixing of two distinct provisions. Erroneously conflating the legal parameter under Sections 3(e) and 3(d) of the Patents Act, 1970 is not justified. The Controller must judicially consider all the submitted material and expert evidence to determine the inventive step. This decision serves as a forerunner for expecting reasoned orders from the patent office in the future. The impugned orders with similar serious flaws may not stand the close scrutiny of the appeal court.
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