The nuances of Section 3(d) continue to plague and please litigants, depending on which side of it they end up falling. One issue that regularly pops up is the clash between filing timelines, and clinical trial data necessary to prove ‘enhanced efficacy’, as required to get by the Section 3(d) barrier. Patent applications are often filed as soon as a potential invention is noticed, while clinical trials take years to complete.
Adding to judicial thought on this point, in a recent order in Ischemix Llc vs The Controller Of Patents, the Delhi High Court, noting that written submissions referring to new data are often submitted after final hearings, held that the applicant must clearly place the data to prove enhanced therapeutic efficacy before the Patent Office, prior to the date of the final oral hearing to ensure it is accounted for. Since these matters are technical in nature the court held that the note on enhanced therapeutic efficacy should be handed over and be clearly explained by the Patent Agent to the Examiner during the final hearing. Thereby taking into consideration the human error factor by not holding the examiner responsible for missing out on these crucial details when the same was kept away by the applicant till the 11th hour.
Since the Patent Office had agreed to re-examine the application and hear the applicant again, the court did not go into the merits of the appeal. However, the court did direct (relying on the Astrazeneca v. Intas DB order and the Oyster Point Pharma case) that any benefit of relying on the data filed after the priority date should only be allowed if the same has been made in the complete specification of the invention.
The order thus seeks to put some order in the Indian patent prosecution scene, especially with regard to pharmaceutical products. By reiterating the clinical trial data can be filed after the date of priority, the order tries to strike a balance between the legitimate inability to produce these data at the time of filing the patent application, but restricting such filing before the date of hearing, the court ensures that such data are not filed last minute which would have defeated the purpose of section 3(d) safeguard.
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- Source: https://spicyip.com/2023/11/spicyip-tidbit-dhc-observes-that-evidence-for-enhanced-efficacy-should-be-filed-before-the-final-hearing.html
