The opportunity to amend the claims to meet the requirements of the Patents Act, as raised by the Controller, gives the applicant a fair chance to counter the refusal of their patent application. The Controller is duty-bound to review the amendments made by the applicant during the prosecution of the application and reconsider the changed position before any adverse decision is taken to refuse the application.
In President And Fellows Of Harvard College vs Controller General of Patents Designs and Trademarks [March 28, 2026], in the case under appeal, the Delhi High Court found that the Impugned Order of the Controller was based on findings arrived at while considering the original claims only, even when the Controller had mentioned that the amended claims were placed on record through the post-hearing written submissions as an “Alternative set of Claims”. This clearly indicates that the amended claims were not considered while passing the Impugned Order. The Court held that the failure to consider the amended claims was a glaring error and accordingly set aside the impugned order of the Controller. In support, the Court cited the ruling of the High Court in Jitendra Kohli vs The Controller of Patents, wherein the Court held that:
“8. The Court has perused the entire order, which clearly shows ……….. The amended claims have not been taken into consideration by the Assistant Controller at the time of deciding the fate of the Appellant’s application. This is clearly a glaring error.
10. Under these circumstances, the impugned order is set aside. The matter shall be reconsidered by the office of Controller General of Patents, Designs, & Trademarks (CGPDTM) afresh. A fresh order shall be passed after duly considering the amended claims on all counts, including novelty, inventive step, and patentability.”
Agreeing with the appellant that the Controller failed to consider the amended claims submitted during post-hearing proceedings, the Court observed that these amendments may have shifted the focus from composition claims to specific claims for non-native pancreatic ß cells, which should have been considered by the Controller.
Factual Matrix
The Controller of Patents and Designs refused Patent Application No. 201617000758 titled “SC-ß Cells and Compositions and Methods for Generating the Same”, filed by Harvard on January 8, 2016, for being non-patentable under Sections 3(j) and 3(e) of the Patents Act, 1970. Additionally, the Controller stated that the claims fell under Sections 10(4) and 10(5), being unsupported by a sufficient description. The appellant claimed that their invention relates to SC-β cells, which are engineered pancreatic beta cells designed to produce insulin. The appellant filed a national phase application for this invention based on the application filed under the Patent Cooperation Treaty. On January 8, 2016, the Appellant filed Form No. 13 for amendments to the claims, as the PCT Application had 1 claim, whereas the Subject Application had 29 claims. On June 1, 2017, the Appellant filed a request for examination and voluntarily amended the claims.
Appellant’s Case
The appellant contended that the SC-β cells claimed by them are distinct from native biological entities due to stable gene expression patterns (INS, PDX1, NKX6-1, and ZNT8) and consistent mono-hormonal features. Therefore, they cannot be termed naturally occurring biological entities under Section 3(j). The appellant submitted that, by carrying out the voluntary amendments, the originally filed composition claims underwent a transition from composition claims to β-cell claims. The appellant submitted that they now claimed a non-native pancreatic β cell instead of the composition as set out in the originally filed claims. The appellant further submitted that amended claims were also filed along with the post-hearing Written Submissions, clearly indicating this change.
Respondent’s Reply
The respondent Controller maintained that the claimed invention relates to a composition of naturally occurring biological entities and hence is not patentable under Section 3(j), and that composition claims containing them among other ingredients are not patentable under Section 3(e) without showing a synergistic effect. The respondent Controller also contended that the claims fell short of the requirement of sufficient disclosure under Sections 10(4) and 10(5), and that they were not supported by sufficient description.
Analysis and Findings of the Court
On perusal of the impugned order, the Court found that the findings of the Controller in the impugned order, as regards the objections under Sections 3(j) and 3(e) of the Act, were based on the original claims. According to the Court, the Controller concluded that the Complete Specification neither disclosed a composition per se nor disclosed all the components, their amounts, or synergy data. The Court found that the amended claims were not composition claims, as evident from the comparison of original Claim No. 1 with the amended claims, wherein the applicant claimed a non-native pancreatic β cell instead of the composition claimed in the original claims. According to the Court, such amended claims should have been considered before passing any adverse order.
Decision of the Court
The Court allowed the appeal and set aside the order, directing the Controller to reconsider the Subject Application in view of the amended claims submitted along with the post-hearing Written Submissions. The Controller shall pass a detailed order on the Subject Application after considering the amended claims. The Court clarified that the merits of the case had not been considered, and the Subject Application shall be decided in accordance with the law without being influenced by any observations made in the judgment. The Court held that:
“Consequently, amended claims that significantly alter the original claims, transitioning from a composition to a non-native pancreatic β cell, must be duly considered by the learned Controller independently, without being influenced by prior conclusions regarding the original claims in the Impugned Order.”
Conclusion
The Controller should consider all amendments proposed by the applicant before pronouncing an order refusing a patent. Ignoring the proposed amendments will be seen by the Court as a glaring error, in view of the earlier ruling in the Jitendra Kohli case. Orders refusing patents by the Patent Office are liable to be set aside by the Court, as happened in the present case. This is particularly so when the amendments clearly indicate changes in the character of the claims from a composition to a non-native pancreatic β cell. This case also highlights how the original claims may be amended to meet objections raised under Sections 3(j) and 3(e). Quashing of Patent Office refusal orders by the appellate courts is becoming nearly routine, as 9 out of 10 cases are remanded back for reconsideration, where the Court finds glaring errors such as violation of principles of natural justice, failure to follow judicial precedents such as the Hoffman Test, or non-consideration of amendments, among other pertinent reasons for sending the matter back for reconsideration.