This case concerns the rejection of Indian Patent Application No. 201817029244 by the Assistant Controller of Patents and Designs. Filed by Biotyx Medical (Shenzhen) Co. Ltd, the application pertains to an "Absorbable Iron-Based Alloy Implantable Medical Device." The rejection was on grounds of lack of novelty and inventive step under Sections 2(1)(j), 13(1)(b), and 2(1)(ja) of the Patents Act, 1970. The Delhi High Court, presided over by Hon’ble Mr. Justice Saurabh Banerjee, was tasked with evaluating the legality of the decision.

Background:
The patent application was a national phase entry of a PCT application filed on August 3, 2018, claiming priority from January 8, 2016. The invention related to a medical device designed to inhibit corrosion during the early stages of implantation using a zinc-containing protector. The application was rejected on July 10, 2020, by the Assistant Controller, citing lack of novelty and inventive step. This appeal challenges the validity of that decision.

Facts of the Subject Matter Patent:

• The invention proposed an absorbable iron-based alloy implantable medical device comprising:
• Iron-Based Alloy Substrate: Provides structural support during implantation.
• Degradable Polymer Coating: Allows gradual degradation of the device.
• Zinc-Containing Protector: A layer comprising zinc or a zinc alloy, intended to delay the onset of corrosion during implantation.
• The innovation claimed that this specific configuration ensured the mechanical stability of the device in its early stages, which was critical for medical applications.

Issues Raised Regarding Inventive Step:

• Whether the invention lacked novelty under Sections 2(1)(j) and 13(1)(b)?
• Whether the invention involved an inventive step under Section 2(1)(ja)?
• Whether the Assistant Controller failed to apply a proper analytical framework to assess inventive step?

Judgments Referred and Their Context:

• Biswanath Prasad Radhey Shyam v. Hindustan Metal Industries Ltd. (1979) 2 SCC 511: Defined the test for inventive step as requiring technical advancement or economic significance that is not obvious to a person skilled in the art (PSITA).
• Hoffmann-La Roche Ltd. & Anr. v. Cipla Ltd. 2015 DHC: Established a five-step test to evaluate inventive step.
• Manohar v. State of Maharashtra AIR 2013 SC 681: Emphasized the need for reasoned decision-making to satisfy the principles of natural justice.
• Sankalp Rehabilitation Trust v. Hoffman La Roche (OA/8/2009/PT/CH, 2012): Discussed the role of common general knowledge in determining inventive step.

Provisions of Law Discussed:

• Section 2(1)(j): Defines an invention as a new product or process involving an inventive step and capable of industrial application.
• Section 2(1)(ja): Elaborates on inventive step, requiring technical advancement or economic significance.
• Section 13(1)(b): Mandates examiners to ensure that the claimed invention is not anticipated in prior art.

Judge’s Discussion on Inventive Step:

• The court identified deficiencies in the Assistant Controller’s reasoning and applied the five-step test outlined in Hoffmann-La Roche Ltd. to assess inventive step:
• Identify PSITA: The court noted that the Assistant Controller failed to clearly define the PSITA for this field.
• Determine the Inventive Concept: The key inventive concept was the use of zinc-based protection to delay corrosion.
• Assess Common General Knowledge: Prior arts D2-D5 disclosed the use of zinc oxide for corrosion inhibition but did not cover the specific use of zinc or zinc alloy in direct contact with the iron-based substrate.
• Evaluate Differences from Prior Art: The court highlighted the technical distinction between zinc-based protection in the invention and zinc oxide coatings in prior art.
• Assess Obviousness: The court found no evidence that the invention was obvious to a PSITA, as prior art did not suggest using zinc or zinc alloys in this specific manner.

Deficiencies in Rejection Order:

• The rejection order lacked sufficient technical reasoning.
• The Assistant Controller relied on hindsight reasoning without a structured inventive step analysis.
• Procedural lapses, such as inadequate consideration of submissions, violated natural justice principles.

Decision:

• The Delhi High Court set aside the rejection order and remanded the application to the Assistant Controller for reconsideration with the following directions:
• Re-evaluate the inventive step using recognized tests.
• Issue a reasoned decision addressing all aspects of novelty and inventive step.
• Conclude the proceedings within four months of granting a hearing.

Concluding Note:
This case highlights the importance of adherence to structured analytical frameworks in patent rejection cases. It underscores the judiciary's role in ensuring accountability and procedural fairness in administrative decisions. The judgment reinforces the need for reasoned and scientifically grounded decisions to foster innovation and protect intellectual property rights.

Case Title: Biotyx Medical (Shenzhen) Co. Ltd vs. The Assistant Controller of Patents and Designs
Date of Order: September 20, 2024
Case No.: C.A. (COMM.IPD-PAT) 403/2022
Neutral Citation: 2024:DHC:
Court: High Court of Delhi
Judge: Hon’ble Mr. Justice Saurabh Banerjee

Disclaimer:
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Written By: Advocate Ajay Amitabh Suman, IP Adjutor - Patent and Trademark Attorney
Email: [email protected], Ph no: 9990389539