Last month, the Delhi High Court in the case of DS Biopharma Limited v. The Controller of Patents and Designs clarified the procedural requirements to be met for the application of Section 3(d) of the Patents Act against pharmaceutical patent applications. Briefly, the case concerned an appeal from DS Biopharma under Section 117A of the Patents Act challenging an order passed by the Assistant Controller of Patents & Designs in relation to a pharmaceutical composition. The Controller had initially raised objections against patent application no.201717040270 titled ‘compositions comprising 15-oxo-epaor15-oxodgla and methods of making and using same’, stating that there was a lack of inventive step as required under Section 2(1)(ja); the composition was hit by Section 3(i); and that there was a lack of clarity and conciseness as required under Section 10(4)(c) and Section 10(5) of the Patents Act in the First Examination Report (FER). Once the appellant had an opportunity to respond to the FER, the renewed objection from the Patent Controller stated that the subject matter of the compositions was not patentable under Section 3(d) of the Patents Act. The hearing notice issued by the Controller for the same had not identified the ‘known substance’ against which the claimed composition was compared to arrive at the conclusion that it did not pass the Section 3(d) threshold. Highlighting this, the applicant had filed an appeal in the Delhi High Court against the rejection stating that they were not given a fair opportunity to rebut the Section 3(d) objections raised by the Controller. The High Court ruled in favor of the applicant stating that they had not received an adequate opportunity to deal with the objection under Section 3(d) as the Controller had merely specified the objection without mentioning the manner in which it applied.
The Order highlights the need for patent controllers to identify the ‘known substance’ when applying Section 3(d). Quite commonly patent controllers simply state that a certain composition is barred from being granted a patent because it is hit by Section 3(d) without backing it with any mention or evidence that identifies how the section applies in those cases. This rather subjective approach has been noted to commonly involve controllers merely stating that because the claimed composition is fairly similar to existing prior art, the improvements are obvious and hence barred by Section 3(d). The application of Section 3(d) to reject patent claims requires a technical examination that compares the existing efficacy of a compound against the efficacy of the claimed compound based on data from clinical trials. The rejections that do not fully capture the essence of this comparison in their orders do not seem to be deliberately analyzed but rather hasty and lacking adequate reasoning, leaving open much room for appeal by patent applicants.
It also becomes evident from the High Court Order that the Patent Controller’s hearing notice regarding the objections raised against the application was not consistent with it being noted by the appellant’s counsel that, “…there is contradiction between the hearing notice which states claim 1,4 and the final impugned order where claims 1,3 are stated to be not meeting the requirement”, which further go on to show the lack of attention to procedural tenets that ensure proper and just hearing of claims. The High Court’s Order also points this out by noting that the Section 3(d) objection raised by the Controller was not adequately captured in the hearing notice. The applicant referred to the Fresenius Kabi Oncology Limited v. Glaxo Group Limited judgment by the IPAB, to highlight the necessity of raising Section 3(d) objections after clearly identifying the ‘known substance’ and mentioning how the new/claimed compound is a ‘new form’ of the same and hence does not meet the efficacy requirement. The High Court Order notes that the burden of identifying the ‘known substance’ cannot fall on the applicant. Finally, it was held by the High Court that in not capturing the details regarding the ‘known substance’ in the hearing notice, the Patent Controller did not provide adequate opportunity for the applicant to address the objection.
Quite appropriately the High Court’s Order reiterates the Patent Controller’s responsibilities while raising Section 3(d) objections against patent claims. Without accurately identifying the previously ‘known substance’ against which the claimed compound is being compared to, applicants are often left to deduce the substance against which efficacy improvements are required to be exhibited. Thus, making for a system in which there remains a high possibility of unnecessary rejections which potentially affects important pharmaceutical innovations, and also a high possibility of over-extending patent protection when patent claims are not adequately examined. This dual disadvantage can appropriately be addressed when patent controllers clearly state their objection claims while applying Section 3(d) by identifying the ‘known substance’ and by capturing how a claimed substance compares against the same.
(A following post will cover another side of this issue, wherein a judgment from the Delhi High Court has rebuked a patentee for causing unwarranted delays in the application process.)