- The data for overcoming section 3(d) to show therapeutic efficacy should be submitted before the date of final oral hearing.
2. “Whenever any patent Applicant wishes to place on record and demonstrate therapeutic efficacy, the same has to be done precisely. The Applicant must ensure that comparative tables, and a clear explanation as to the manner in which the new form of the known substance has significant enhancement in therapeutic efficacy is placed before the Patent Office during prosecution of the application. The same could be in the form of comparative tables, in-vitro and in-vivo data as also clinical trial data.”
The issue came in the context of a Patent application no. ‘9739/DELNP/2011’, filed by Ischemix LLC for the application titled ‘Compositions and Methods for Treating Ischemia and Ischemia-Reperfusion Injury’. The application was refused by the Indian Patent Office under Section 3(d) of the Act. The applicant Ischemix LLC filed an appeal before Delhi High Court under Section 117A of the Patents Act, challenging the Order of the controller refusing the Patent application.
The applicant in its Appeal to the High Court against the refusal Order argued that the data on therapeutic efficacy, of the claimed compound, that was submitted has not been referred and that there is no discussion in respect of the same in the impugned order. The therapeutic efficacy of the claimed isomer was demonstrated by:
- submitting data relating to in-vitro, in-vivo studies, and clinical trials; and
- the reports of two experts to support the plea for enhanced therapeutic efficacy was also filed.
The Counsel on behalf of the Indian Patent Office submitted.
- “the Appellant may have given some data in support of the claim for enhanced efficacy, but failed to show how the same constituted therapeutic efficacy.”
- In an email note recently filed by the Appellant, a clear and definitive explanation has been given on how the Appellant wishes to substantiate its claim of enhanced therapeutic efficacy. The same was not presented during patent prosecution. Thus, the Patent Office is willing to reconsider and re-examine the subject patent application”.
The court, after hearing both the parties, observed that that the settled position with Supreme Court Ruling in Novartis AG, on section 3(d) is that whenever any patent Applicant wishes to place on record and demonstrate therapeutic efficacy, the same must be done precisely. The Applicant must ensure that comparative tables, and a clear explanation as to the way the new form of the known substance has significant enhancement in therapeutic efficacy is placed before the Patent Office during prosecution of the application. The same could be in the form of comparative tables, in-vitro and in-vivo data as also clinical trial data.
The court also discussed the relevant extract from DS Biopharma Limited v. The Controller of Patents and Designs and Anr. for directions to be followed by patent applicants while attempting to overcome the objections under Section 3(d) of the Act:
- The Appellant shall file its response on the basis of the identified known substances and the extracts of the impugned order as set out above. In response, the Appellant may also produce efficacy data and support its submissions as to how Section 3(d)is not applicable.
- The said response shall be filed by the Appellant within a period of 8 weeks – upon which, a fresh hearing shall be granted on the issue of whether the claims 1-4 are liable to be granted or not in view of the objections under Section 3(d)of the Act.
The court thus issued following practice directions:
- A patent application relating to the derivative compounds, the patent specification, itself, ought to contain some data and results of lab experiments which demonstrate enhancement of efficacy of the subject invention for which patent is sought.
- If additional data becomes available, the said data ought to be submitted by the patent Applicant and placed before the Patent Office prior to the date of final oral hearing.
Finally, the court noted that often the patent applicants file experimental data at the stage of final written submissions. At this stage the oral hearings before the Patent Office are concluded and the said data may not be referred during oral hearings. This may potentially lead to a situation, as in the present case, where the Patent Office is likely to have overlooked the data and failed to consider the same. There is also the possibility of the data not being completely understandable, in mere written submissions without oral explanation. Therefore, the experimental data for the therapeutic efficacy of a derivative compound should be submitted before the hearing, for the consideration of the controller, in the form of comparative tables, in-vitro , in-vivo data or the clinical trial data, with a clear explanation as to the how the new form of the known substance has significant enhancement in therapeutic efficacy.
Author: Ranjan Narula and Suvarna Pandey