The Delhi High Court delivered its judgement in the case of Biotyx Medical (Shenzhen) Co. Ltd. vs The Assistant Controller of Patents[C.A.(COMM.IPD-PAT) 403/2022, 2024:DHC:7217, judgement dated September 20, 2024], setting aside the order passed by the Controller in patent application number 201817029244, entitled “Absorbable Iron-Based Alloy Implantable Medical Device”. The impugned order held the claimed invention non-patentable under Sections 2(1)(j), 2(1)(ja), and 13(1)(b) of the Patents Act, 1970.

Biotyx’s application disclosed an absorbable iron-based alloy implantable medical device including¾an iron-based alloy substrate, a degradable polymer coating, and a zinc-containing protector¾on the surface of the Iron-based alloy substrate. The purpose of the zinc-containing protector was asserted to delay the corrosion of the iron-based alloy substrate during the early stage of implantation. The zinc-containing protector was described to be selected from Zinc and/or a Zinc alloy, or a mixture of Zinc and/or a zinc alloy and a degradable binder.

The impugned order had cited prior art document D1 (IN 201817020284) for refusing the subject application for lack of novelty by prior claiming under Sections 2(1)(j) and 13(1)(b) of the Patents Act. The Court undertook a detailed analysis of the claims in document D1 and the claims of the subject application and determined that the claims of the subject application did not overlap with the prior art claims as the focus of document D1 was on alkaline protectors (specifically zinc oxide and zinc hydroxide), while the claims of the subject application required a zinc-containing protector (Zinc and/or a Zinc alloy, or a mixture of Zinc and/or the Zinc alloy). Therefore, based on finding that the type of protector recited in the claims of document D1 and the subject application was different, the Court held that the subject application did not fall under the purview of Sections 13(1)(b) and 2(1)(j).

With regards to the objection of lack of inventive step, the Controller had relied on the combined teaching of documents D2-D5. Biotyx contested the relevance of these documents, arguing that the Controller failed to provide a reasoned explanation as to how the claimed invention was obvious to a person skilled in the art (PSITA). The Court found that the Controller had failed to apply the five-step test for assessing obviousness and inventive step laid down by the Delhi High Court’s Division Bench in Hoffmann-La Roche Ltd. & Anr. vs Cipla Ltd. [2015:DHC:9674-DB]. The Court noted that the Controller failed to:

• Identify a PSITA relevant to the subject invention.
• Attribute to a skilled but unimaginative person the common general knowledge that existed in the field at the time of priority: The Controller’s analysis was held to lack a detailed prior art search concerning elemental zinc and its alloys. Notably, the Controller had referenced documents D2-D5 to determine that the use of zinc ions to inhibit iron corrosion was part of the common general knowledge. This conclusion was reached despite the Appellant’s extensive arguments that zinc ions function differently in elemental zinc and zinc alloys while showing anti-corrosion properties compared to zinc oxide.
• Assess whether the claimed invention would have been obvious to a PSITA while avoiding a hindsight approach: The impugned order was held to lack a detailed technical evaluation of whether a specific configuration of elemental zinc-based protective layer as opposed to zinc oxide in a polymer matrix in prior art documents would lead to an unexpected result. Put differently, the Controller simply assumed that the zinc substitution was predictable without further examining as to whether there could be a non-obvious technical advantage in the specific configuration as claimed in the subject application.  

The Court also observed that the impugned order violated the principles of natural justice as it did not provide sufficient scientific reasoning or clarity regarding the inventive step of the claimed invention.

In view of the foregoing, the Court set aside the impugned order and remanded the matter to the Patent Office for reconsideration.

The Delhi High Court delivered its judgement in the case of Biotyx Medical (Shenzhen) Co. Ltd. vs The Assistant Controller of Patents[C.A.(COMM.IPD-PAT) 403/2022, 2024:DHC:7217, judgement dated September 20, 2024], setting aside the order passed by the Controller in patent application number 201817029244, entitled “Absorbable Iron-Based Alloy Implantable Medical Device”. The impugned order held the claimed invention non-patentable under Sections 2(1)(j), 2(1)(ja), and 13(1)(b) of the Patents Act, 1970.

Biotyx’s application disclosed an absorbable iron-based alloy implantable medical device including¾an iron-based alloy substrate, a degradable polymer coating, and a zinc-containing protector¾on the surface of the Iron-based alloy substrate. The purpose of the zinc-containing protector was asserted to delay the corrosion of the iron-based alloy substrate during the early stage of implantation. The zinc-containing protector was described to be selected from Zinc and/or a Zinc alloy, or a mixture of Zinc and/or a zinc alloy and a degradable binder.

The impugned order had cited prior art document D1 (IN 201817020284) for refusing the subject application for lack of novelty by prior claiming under Sections 2(1)(j) and 13(1)(b) of the Patents Act. The Court undertook a detailed analysis of the claims in document D1 and the claims of the subject application and determined that the claims of the subject application did not overlap with the prior art claims as the focus of document D1 was on alkaline protectors (specifically zinc oxide and zinc hydroxide), while the claims of the subject application required a zinc-containing protector (Zinc and/or a Zinc alloy, or a mixture of Zinc and/or the Zinc alloy). Therefore, based on finding that the type of protector recited in the claims of document D1 and the subject application was different, the Court held that the subject application did not fall under the purview of Sections 13(1)(b) and 2(1)(j).

With regards to the objection of lack of inventive step, the Controller had relied on the combined teaching of documents D2-D5. Biotyx contested the relevance of these documents, arguing that the Controller failed to provide a reasoned explanation as to how the claimed invention was obvious to a person skilled in the art (PSITA). The Court found that the Controller had failed to apply the five-step test for assessing obviousness and inventive step laid down by the Delhi High Court’s Division Bench in Hoffmann-La Roche Ltd. & Anr. vs Cipla Ltd. [2015:DHC:9674-DB]. The Court noted that the Controller failed to:

• Identify a PSITA relevant to the subject invention.
• Attribute to a skilled but unimaginative person the common general knowledge that existed in the field at the time of priority: The Controller’s analysis was held to lack a detailed prior art search concerning elemental zinc and its alloys. Notably, the Controller had referenced documents D2-D5 to determine that the use of zinc ions to inhibit iron corrosion was part of the common general knowledge. This conclusion was reached despite the Appellant’s extensive arguments that zinc ions function differently in elemental zinc and zinc alloys while showing anti-corrosion properties compared to zinc oxide.
• Assess whether the claimed invention would have been obvious to a PSITA while avoiding a hindsight approach: The impugned order was held to lack a detailed technical evaluation of whether a specific configuration of elemental zinc-based protective layer as opposed to zinc oxide in a polymer matrix in prior art documents would lead to an unexpected result. Put differently, the Controller simply assumed that the zinc substitution was predictable without further examining as to whether there could be a non-obvious technical advantage in the specific configuration as claimed in the subject application.  

The Court also observed that the impugned order violated the principles of natural justice as it did not provide sufficient scientific reasoning or clarity regarding the inventive step of the claimed invention.

In view of the foregoing, the Court set aside the impugned order and remanded the matter to the Patent Office for reconsideration.