Biotyx Medical Shenzhen Co. Ltd. v. Assistant Controller of Patents and Designs

High Court of Delhi at New Delhi | Decided: 19 May 2026 C.A.(COMM.IPD-PAT) No. 47 of 2024 Bench: Hon’ble Ms. Justice Jyoti Singh

Background

Biotyx Medical Shenzhen Co., Ltd., the appellant, is a Chinese company providing minimally invasive medical devices for cardiovascular diseases and disorders. The appellant filed Indian Patent Application No. 201917030431 on 27 July 2019 in respect of an invention titled “ABSORBABLE STENT,” claiming a priority date of 31 December 2016. The application was published on 25 October 2019. A Request for Examination was filed on 27 July 2019. The First Examination Report was issued on 18 March 2021 raising objections of lack of novelty and inventive step. The appellant filed a reply to the FER on 7 September 2021. A hearing notice was issued on 5 January 2024. The hearing was held on 6 February 2024 and post-hearing written submissions were filed on 20 February 2024. By the impugned order dated 4 April 2024, the Assistant Controller of Patents and Designs refused the application under Section 15 of the Patents Act, 1970 for lack of inventive step under Section 2(1)(ja) in light of prior arts D1 (US 9427344 B2) and D2 (US 2015/265438 A1).

The invention relates to an absorbable stent for cardiovascular applications. The technical problem addressed by the invention is the need to balance two competing performance requirements in absorbable stents shorter corrosion and absorption cycle on the one hand and adequate radial supporting strength to meet clinical requirements during the early stages of implantation on the other. A shorter corrosion cycle, desirable for patient safety, is typically achieved by reducing matrix volume per unit vascular area, but this reduction tends to lower radial supporting strength. Conversely, a stent with higher radial strength tends to have a longer corrosion and absorption cycle. The claimed invention addresses this tension by identifying a specific relationship between two design parameters matrix volume per unit vascular area in the range of 4 to 40 micrometres and section length of each supporting strut in the range of 0.4 to 9 millimetres such that a desirable balance between corrosion cycle and mechanical strength is achieved. The absorbable matrix of the stent comprises a plurality of wave-shaped rings arrayed axially, connected by connection units, with each wave-shaped ring comprising circumferentially arrayed waves each having a peak, a valley and a supporting strut connecting the peak with the valley. Two adjacent wave-shaped rings and the connection units form a closed side branch unit. The matrix material is selected from magnesium-based alloy, iron-based alloy and zinc-based alloy.

To overcome objections in the FER relating to novelty and lack of inventive step, the appellant introduced a limitation in the characterising portion of the claim reciting the section length of the supporting strut in the range of 0.4 to 9 millimetres.

Prior art D1 disclosed a tube or cylindrical shaped bioabsorbable stent made of polymer, with low immunogenicity, manufactured from a crystallized polymer blend. Prior art D2 disclosed a frustum-shaped stent device made from a polymer comprising a network of rings interconnected by links, wherein a ring is formed by struts connected at crowns to form a zig-zag or undulating pattern about a bore axis and wherein a link connects a ring to an adjacent ring at either a Y crown or a W crown. D2 also disclosed in paragraph 0204, as a generic disclosure, that medical devices may include bio-erodible metals or metal alloys including magnesium, iron and zinc alloys, but the independent claim 1 of D2 was limited to polymer material for the scaffold.

The Controller’s impugned order held that D2 had a similar scaffold structure to the claimed invention and that D1 taught a tubular or cylindrical biodegradable vascular stent. The Controller concluded there was sufficient motivation for a person skilled in the art to combine the teachings of D1 and D2 to arrive at the claimed invention and that the matrix volume per unit vascular area and strut lengths were general principles of vascular stent design well known in the art. The Controller further reasoned that if D2’s frustum-shaped stent were cylindrical in shape, its properties would be the same as the proposed device of the claimed invention.

The appellant challenged the impugned order on multiple grounds, contending that it failed to consider three essential elements the invention disclosed in the prior arts, the invention disclosed in the application under consideration and the manner in which the subject invention would be obvious to a person skilled in the art as required by the three-step framework established in Agriboard International LLC v. Deputy Controller of Patents and Designs. The appellant submitted that D1 did not teach any relationship between matrix volume per unit vascular area and section length of supporting struts; that the Controller had replicated the appellant’s submissions on D1 from the post-hearing written submissions but had completely failed to deal with them in the reasons for decision; that the Controller’s finding regarding D2 being the closest prior art was misconceived since D2 disclosed a polymer-based frustum-shaped stent materially different from the claimed metal-based cylindrical stent; and that the Controller’s reasoning that a cylindrical version of D2’s frustum stent would necessarily have the same properties as the claimed invention was based on impermissible hindsight and was wholly hypothetical.

Issues for Determination

1. Whether the impugned order was a reasoned and speaking order in compliance with the principles of natural justice and the three-element framework mandated by the court in Agriboard International LLC v. Deputy Controller of Patents and Designs for the rejection of a patent application on the ground of lack of inventive step under Section 2(1)(ja) of the Patents Act, 1970.
2. Whether the Controller erred in finding that the claimed invention lacked inventive step in view of the combined teachings of prior arts D1 and D2 specifically whether the Controller failed to consider the appellant’s submissions on D1 in the reasons for decision, whether the Controller’s treatment of D2 as the closest prior art without adequately addressing the material differences between the scaffold materials and structural properties was sustainable and whether the Controller’s conclusion that a cylindrical version of D2 would have the same properties as the claimed invention constituted impermissible hindsight reasoning.
3. Whether the matter deserved to be remanded to the Controller for fresh and complete examination in light of the identified errors.

Key Holdings of the Court

• First, the Court held that the impugned order was not a reasoned and speaking order in compliance with the mandatory three-element framework for rejecting patent applications on the ground of lack of inventive step. Following Agriboard International LLC v. Deputy Controller of Patents and Designs, the Court reiterated that when rejecting an invention for lack of inventive step, the Controller is required to consider and analyse three elements the invention disclosed in the prior art, the invention disclosed in the application under consideration and the manner in which the subject invention would be obvious to a person skilled in the art. The Court found that this exercise had been undertaken more in violation of law than in compliance.
• Second, the Court identified a glaring error and violation of principles of natural justice in the impugned order’s treatment of prior art D1. While the appellant had made detailed submissions in its post-hearing written submissions explaining why D1 did not provide any teaching or motivation to arrive at the claimed invention specifically that the objective of D1 was to provide a lockable and expandable bioabsorbable scaffold having low immunogenicity from a crystallised polymer blend and that D1 contained no teaching of any relationship between matrix volume per unit vascular area and section length of supporting struts the impugned order noted these submissions but completely failed to deal with them in the reasons for decision. The Court found that D1, which formed a large part of the impugned order, did not even figure in the reasoning part.
• Third, the Court held that the Controller’s treatment of D2 as the closest prior art without adequately addressing the material differences between the scaffold of D2 and the claimed invention was erroneous. The independent claim 1 of D2 was limited to a polymer material for the scaffold. The appellant had contended that the Controller had based its finding on paragraph 0204 of D2 which was a mere generic disclosure of bio-erodible metals and that a wholesome reading of D2 established that the polymer material was the essential and preferred material, such that a person skilled in the art reading D2 without knowledge of the claimed invention would find no reason to depart from polymer material. The Court found that this point had not been dealt with in the impugned order and that if it had been considered, it would have had a material bearing on the final decision.
• Fourth, the Court held that the Controller’s conclusion that if D2 disclosed a cylindrical shape instead of a frustum shape, its properties would be the same as the proposed device of the claimed invention, was wholly hypothetical, misconceived and constituted impermissible hindsight reasoning. The approach was completely hypothetical since there was no reasoning provided to arrive at this presumptive conclusion. The Controller had relied on information revealed by the present invention to hypothesise about what D2 would have disclosed if it were structured differently. An order cannot be based on hypothesis. The hindsight approach adopted was impermissible in law.
• Fifth, the Court held that the correct and settled principles for determining inventive step as articulated in Agriboard, Avery Dennison Corporation v. Controller of Patents and Designs, Gogoro Inc. v. Controller of Patents and Designs and the approaches drawn from Windsurfing International Inc. v. Tabur Marine Ltd., Pozzoli Spa v. BDMO SA, the Division Bench of this Court in F. Hoffmann-La Roche Ltd. v. Cipla Ltd. and the UK Supreme Court in Actavis v. ICOS had not been followed by the Respondent. The Court specifically noted the principle that while mosaicking of prior arts is allowed, when refusing a patent on the ground of obviousness, the common thread linking the prior art to the claimed invention must be traced and identified. The order must specifically disclose the portions of each prior art which, when mosaicked together, would teach, suggest or motivate a person skilled in the art to take the disclosures to the claimed invention.
• Sixth, the Court quashed and set aside the impugned order dated 4 April 2024 and remanded the matter to the Respondent for considering Indian Patent Application No. 201917030431 afresh in respect of the objection of lack of inventive step. The Respondent was directed to grant an opportunity of hearing to the appellant and to take into consideration the detailed response to FER and written submissions. The decision was directed to be taken within an outer limit of four months from the date of the order. The Court expressly stated that it had not expressed any opinion on the merits of the case. The appeal was disposed of in these terms.

Statutory Provisions Involved

Section 2(1)(ja) of the Patents Act, 1970 defines inventive step as a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art. The Court applied this provision in examining whether the Controller had correctly assessed the inventive step of the claimed invention. The Court held that to refuse an application under this provision, the Controller is required to analyse what is the existing knowledge and how the person skilled in the art would move from the existing knowledge to the subject invention. Without such analysis, the rejection would be contrary to the provision itself.

Section 15 of the Patents Act, 1970 empowers the Controller to refuse an application for grant of a patent if, after hearing the applicant, the Controller is satisfied that the application does not comply with the requirements of the Act. The Controller had invoked this provision in the impugned order. The Court found that the exercise of this power was not in compliance with the principles of natural justice and the statutory standard for assessing inventive step under Section 2(1)(ja).

Section 117A of the Patents Act, 1970 confers a statutory right of appeal to the High Court against an order of the Controller under Section 15. This provision was the jurisdictional basis of the present appeal.

Reasoning of the Court

The Court’s reasoning proceeded by first identifying the controlling legal standard and then methodically applying it to reveal the specific failures in the impugned order.

On the controlling legal standard, the Court relied on the three-element framework established in Agriboard International LLC v. Deputy Controller of Patents and Designs requiring the Controller to consider and analyse the invention in the prior art, the invention in the application and the manner in which the subject invention would be obvious to a person skilled in the art. The Court also drew on the comprehensive articulation of inventive step principles in Avery Dennison Corporation v. Controller of Patents and Designs, which surveyed multiple approaches including the obvious-to-try approach, the problem-solution approach, the could-would approach, the Teaching Suggestion Motivation test and the four-step Windsurfing test as refined in Pozzoli and subsequently in Actavis. The consistent principle emerging from all these authorities is that obviousness must be assessed from the standpoint of a person skilled in the art without using hindsight knowledge of the claimed invention and that when combining prior art documents, the party claiming obviousness must demonstrate not merely that the prior art exists but how the person of ordinary skill in the art would have been led to combine the relevant components.

Applying this standard, the Court identified three distinct and serious failures in the impugned order. The first was the complete absence of the D1 analysis from the reasons for decision. The appellant had made specific and substantial submissions in its post-hearing written submissions explaining why D1 provided no teaching or motivation toward the claimed invention. These submissions were noted in the impugned order but then entirely disregarded in the reasoning section. This constituted a glaring error and a violation of the principle of audi alteram partem as articulated by the Supreme Court in Assistant Commissioner v. Shukla and Brothers and Manohar v. State of Maharashtra, which require application of mind and recording of reasoned decisions.

The second failure was the treatment of D2 as the closest prior art without adequately addressing the fundamental material difference that D2 was directed to a polymer-based scaffold while the claimed invention used metal-based alloys. The Controller had relied on paragraph 0204 of D2, a generic disclosure, to overcome this difference. The Court found this inadequate because the independent claim 1 of D2 was expressly limited to polymer material for the scaffold, clearly indicating where the invention in D2 lay and a person skilled in the art reading D2 without hindsight knowledge of the claimed invention would find no reason to depart from polymer material and select the teaching of a generic paragraph over the clear focus of the independent claim.

The third and most fundamental failure was the Controller’s hypothetical reasoning that if D2 disclosed a cylindrical shape instead of a frustum shape, its properties would be the same as the claimed invention. The Court characterised this as impermissible hindsight, reasoning constructed by working backwards from knowledge of the claimed invention to find a path through the prior art that leads to it. Such reasoning, the Court held, is expressly prohibited by every established test for inventive step it uses the claimed invention as a guide through the maze of prior art references rather than requiring a person skilled in the art to arrive at the invention independently without that guide.

Doctrinal Significance

The Biotyx Medical judgment, while a remand order expressing no opinion on the merits, makes an important contribution to the body of Delhi High Court decisions on the procedural and substantive standards governing the Controller’s rejection of patent applications for lack of inventive step.

Its primary contribution is the continued reinforcement and application of the three-element Agriboard framework requiring the Controller to analyse the prior art, the subject application and the manner of obviousness to a person skilled in the art as a mandatory and non-negotiable requirement of any reasoned rejection under Section 2(1)(ja). By identifying in specific and granular terms the three ways in which the present impugned order failed to comply with this framework, the Court has provided concrete guidance to Controllers and patent examiners on the minimum analytical content that a legally sustainable rejection must contain.

The judgment also consolidates and applies the anti-hindsight principle in the specific context of mosaicking prior art documents in the field of medical devices and interventional technology. The Court’s finding that the Controller’s hypothesis about what D2 would have disclosed if it were shaped differently constitutes impermissible hindsight reasoning gives a clear practical illustration of the boundary between permissible combination of prior art and impermissible hindsight reconstruction. An order that conjectures what prior art would have disclosed had it been structured differently rather than working from what the prior art actually disclosed falls on the wrong side of this boundary.

The judgment further reinforces the principle that when a party makes substantial written submissions in response to a hearing notice and these submissions are noted in the impugned order, the failure to address them in the reasons for decision constitutes a violation of the principles of natural justice, specifically the audi alteram partem principle as requiring not merely an opportunity to be heard but genuine application of mind to the submissions made. This is a practically important statement for patent applicants who invest significant resources in post-hearing written submissions and are entitled to have those submissions genuinely considered rather than merely recorded.

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