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Delhi High Court Sets Aside Patent Refusal for Absorbable Stent: Detailed Analysis of Biotyx Medical Shenzhen Co. Ltd. v. Assistant Controller of Patents
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Biotyx Medical Shenzhen Co., Ltd. v. Assistant Controller of Patents and Design: Delhi High Court Reaffirms Proper Assessment of Inventive Step and Prior Art Analysis in Patent Examination
Introduction
The decision of the Delhi High Court in Biotyx Medical Shenzhen Co., Ltd. v. Assistant Controller of Patents and Design is an important judgment concerning the examination of patent applications on the ground of lack of inventive step under Section 2(1)(ja) of the Patents Act, 1970. The case arose from the rejection of a patent application relating to an absorbable cardiovascular stent by the Patent Office. The Court examined whether the Assistant Controller had correctly applied the legal principles governing inventive step, obviousness, prior art analysis and the requirement of passing a reasoned order.
The judgment is significant because it reiterates that a patent application cannot be rejected merely by stating that the invention is obvious in view of prior art documents. The Patent Office must explain how a person skilled in the art would actually move from the prior art to the claimed invention. The Court emphasized that patent examination must be based on a proper legal analysis and not on assumptions, hindsight reasoning or hypothetical conclusions.
Factual and Procedural Background
The appellant, Biotyx Medical Shenzhen Co., Ltd., is a Chinese company engaged in developing minimally invasive medical devices for treatment of cardiovascular diseases. The company filed Indian National Phase Patent Application No. 201917030431 titled “Absorbable Stent” on 27 July 2019. The claimed priority date was 31 December 2016. A request for examination was filed on the same date and the application was published on 25 October 2019. The First Examination Report (FER) was issued on 18 March 2021, to which a response was filed on 7 September 2021. A hearing notice was subsequently issued on 5 January 2024, hearing took place on 6 February 2024 and post-hearing submissions were filed on 20 February 2024. Thereafter, the Assistant Controller refused the application on 4 April 2024 under Section 15 of the Patents Act, 1970.
The invention related to an absorbable vascular stent used in treatment of cardiovascular diseases. According to the applicant, the invention sought to solve a long-standing technical problem in the field of absorbable stents. Existing absorbable stents often faced a trade-off between a shorter corrosion and absorption cycle and sufficient mechanical strength. If the stent degraded quickly, its supporting strength reduced. Conversely, if greater strength was provided, degradation became slower. The invention claimed to achieve a balance between these competing requirements through a specific structural arrangement involving wave-shaped rings, supporting struts and matrix volume per unit vascular area.
The Patent Office refused the application by holding that the claimed invention lacked inventive step in light of two prior art references, namely D1 (US Patent No. 9,427,344 B2) and D2 (US Patent Application Publication No. 2015/0265438 A1). According to the Controller, a skilled person could combine the teachings of these documents and arrive at the claimed invention without exercising inventive ingenuity.
Aggrieved by the refusal, the applicant filed an appeal before the Delhi High Court under Section 117A of the Patents Act, 1970.
The Dispute Before the Court
The primary dispute before the Court was whether the Assistant Controller had correctly concluded that the claimed absorbable stent lacked inventive step under Section 2(1)(ja) of the Patents Act.
The appellant argued that neither D1 nor D2 disclosed the inventive concept underlying the claimed invention. It was submitted that D1 related to polymer-based absorbable stents designed primarily to address immunogenicity and flexibility concerns, whereas the present invention involved metal-based absorbable stents that achieved a specific balance between corrosion cycle and mechanical strength. Similarly, D2 disclosed a frustum-shaped scaffold having varying mechanical properties over its length, whereas the present invention related to a cylindrical stent having different structural characteristics. The appellant contended that the Controller had failed to identify any teaching, suggestion or motivation in the prior art that would lead a skilled person to arrive at the claimed invention.
The Patent Office defended the refusal order by arguing that D1 and D2 disclosed substantially similar absorbable stent structures. According to the Controller, matrix volume per unit vascular area and strut length were well-known design parameters in vascular stent technology and the claimed invention merely represented an obvious optimization of known features. It was further argued that a skilled person would naturally combine the teachings of D1 and D2 to arrive at the claimed invention.
Thus, the core issue was whether the Controller had properly applied the law relating to inventive step and obviousness.
Reasoning and Analysis of the Judge
Justice Jyoti Singh carefully examined both the impugned order and the submissions made by the parties. The Court found serious deficiencies in the reasoning adopted by the Patent Office.
The Court first noted that the invention sought to achieve a balance between two conflicting objectives: reducing the corrosion and absorption cycle of the stent while simultaneously maintaining adequate mechanical strength and radial support. The Court observed that the appellant had specifically argued that the inventive concept lay in the relationship between matrix volume per unit vascular area and the section length of supporting struts, which together achieved the desired balance.
The Court observed that although the Controller had recorded the appellant’s submissions regarding D1, those submissions were never actually analysed in the reasoning section of the order. Justice Singh described this omission as a glaring error and a violation of principles of natural justice because the Patent Office had effectively ignored crucial arguments advanced by the applicant.
The Court further found that the Controller had not adequately addressed the appellant’s argument that D2 disclosed a polymer-based scaffold whereas the claimed invention involved a metal-based absorbable matrix. The Patent Office had relied upon a general disclosure in paragraph 204 of D2 mentioning bio-erodible metals. However, the Court noted that the appellant had specifically argued that the essential claim of D2 was directed towards polymer-based scaffolds. This important distinction had not been properly considered by the Controller.
A major criticism made by the Court concerned the Controller’s conclusion that if the frustum-shaped scaffold disclosed in D2 were converted into a cylindrical scaffold, its properties would become similar to those of the claimed invention. Justice Singh held that this conclusion was entirely hypothetical and unsupported by any reasoning. Patent refusals cannot be based upon assumptions or speculative reasoning. More importantly, the Court found that this approach amounted to hindsight analysis, which is impermissible in patent law.
The Court observed that the Patent Office had failed to demonstrate why a skilled person would be motivated to modify D2 in the manner suggested. Mere structural similarities between prior art documents and the claimed invention are not sufficient. What is required is a clear explanation of how the prior art teaches, suggests or motivates the claimed advancement.
Discussion of Earlier Judgments and Legal Principles Relied Upon
Justice Jyoti Singh relied heavily upon earlier decisions of the Delhi High Court concerning inventive step and patent examination.
The Court referred to Agriboard International LLC v. Deputy Controller of Patents and Designs. In that case, the Court had held that while rejecting a patent application for lack of inventive step, the Controller must analyse three elements: the invention disclosed in the prior art, the invention disclosed in the application under consideration, and the manner in which the claimed invention would be obvious to a person skilled in the art. Without such analysis, rejection would be contrary to Section 2(1)(ja) itself.
The Court also relied upon the Supreme Court decision in Assistant Commissioner, Commercial Tax Department v. Shukla & Brothers, where it was held that passing a reasoned and speaking order is an essential aspect of the doctrine of audi alteram partem and natural justice. The Court emphasized that application of mind and recording reasons are indispensable components of fair decision-making.
Reference was also made to Manohar v. State of Maharashtra, where the Supreme Court reiterated that application of mind and recording reasons are fundamental requirements of natural justice.
The Court further discussed the detailed principles laid down in Avery Dennison Corporation v. Controller of Patents and Designs. That judgment reviewed international and Indian tests relating to inventive step, including the Obvious-to-Try Test, Problem-Solution Approach, Could-Would Approach, Teaching-Suggestion-Motivation (TSM) Test, the Windsurfing Test and the Pozzoli Test. The judgment also emphasized that hindsight reconstruction of an invention through selective reading of prior art must be avoided.
The Court additionally referred to the Division Bench decision in F. Hoffmann-La Roche Ltd. v. Cipla Ltd., which elaborated the structured approach for assessing inventive step and obviousness.
Reliance was also placed on Gogoro Inc. v. Controller of Patents and Designs, where a patent refusal was set aside because the Controller had failed to explain why the invention was obvious in light of prior art references.
After considering these authorities, Justice Singh concluded that the Controller had not followed the established principles governing inventive step analysis.
Final Decision of the Court
The Delhi High Court held that the refusal order dated 4 April 2024 could not be sustained. The Court found that the Patent Office had failed to properly analyse the appellant’s submissions, had relied upon hindsight reasoning, had adopted hypothetical assumptions and had not undertaken the legally required examination of inventive step.
Consequently, the Court quashed and set aside the impugned order and remanded the matter back to the Patent Office for fresh consideration of the patent application. The Court directed that a fresh hearing be granted to the applicant and that the detailed response to the FER and written submissions be properly considered. The Patent Office was directed to take a fresh decision within four months. The Court expressly clarified that it had not expressed any opinion on the merits of patentability itself.
Point of Law Settled
The judgment reinforces that while examining inventive step under Section 2(1)(ja) of the Patents Act, the Controller must identify the prior art, identify the invention claimed in the application and explain how a person skilled in the art would move from the prior art to the claimed invention. Mere assertions that the invention is obvious are insufficient.
The decision further establishes that patent refusals must be supported by detailed reasoning and cannot be based upon hindsight analysis, assumptions or hypothetical modifications of prior art references. Structural similarity alone does not establish obviousness. The Patent Office must identify a clear teaching, suggestion or motivation that would lead a skilled person to arrive at the claimed invention.
The judgment also reiterates that reasoned orders and application of mind are essential requirements of natural justice in patent examination proceedings.
Case Details
Title: Biotyx Medical Shenzhen Co., Ltd. Vs. Assistant Controller of Patents and Design
Date of Order: 19 May 2026
Case Number: C.A.(COMM.IPD-PAT) 47/2024
Neutral Citation: 2026:DHC:____ (Neutral citation not available in the uploaded copy)
Court: High Court of Delhi
Hon'ble Judge: Justice Jyoti Singh
Headnote
The Delhi High Court set aside the refusal of a patent application relating to an absorbable stent and remanded the matter for fresh consideration. The Court held that while rejecting a patent application for lack of inventive step under Section 2(1)(ja) of the Patents Act, the Patent Office must undertake a detailed analysis of the prior art, the claimed invention and the manner in which a person skilled in the art would arrive at the invention. The Court emphasized that patent refusals cannot be based on hindsight reasoning, hypothetical assumptions or unexplained combinations of prior art documents. A reasoned and speaking order is an essential requirement of natural justice.
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Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi
Disclaimer: Readers are advised not to treat this as substitute for legal advise as it may contain errors in perception, interpretation, and presentation.
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