The recent ruling by the Delhi High Court regarding Biotyx Medical (Shenzhen) Co. Ltd.’s patent application has significant implications for the patent landscape in India, particularly within the medical device sector.

The case revolves around an application for an “absorbable iron-based alloy implantable medical device,” which was initially rejected by the Assistant Controller of Patents and Designs. This decision was based on claims of lack of novelty and inventive step under the Indian Patents Act 1970.

However, the High Court’s subsequent judgment highlights the need for a comprehensive analysis of inventive steps and the importance of scientific reasoning in patent evaluations. This article will explore the judgment's implications, the nuances of patent law as it applies to medical devices, and the broader context of innovation in healthcare technology.

Biotyx Medical sought a patent for a medical device that includes an iron-based alloy substrate, a degradable polymer coating, and a zinc-containing protector arranged on the surface of the Iron-based alloy substrate. The patent application was filed as a national phase entry of PCT application on August 3, 2018 with a priority date of January 8, 2016 having the Application No. 201817029244 titled “ABSORBABLE IRON-BASED ALLOY IMPLANTABLE MEDICAL DEVICE."

The invention was aimed to improve the corrosion resistance of iron-based alloys during the early stages of implantation, thereby enhancing the device's mechanical properties. However, the Patent Controller rejected the patent application under Section 15 of the Patent Act, 1970 on July 10, 2020, after a hearing, citing that subject matter has been allegedly demonstrated a prior art D1 and thus lacked novelty and inventive step under Section 2 (1)(j) along with Section 13(1)(b) of the Act.

The High Court's ruling, delivered Justice Saurabh Banerjee, overturned this decision, ordering a reassessment of the application. The judgment emphasized that the previous evaluation did not sufficiently account for the differences between Biotyx’s claims and the cited prior art, particularly regarding the type of protective layer employed.

After a thorough analysis of the claims of the prior art document D1 with that of the subject application, the Court ruled that,

“The prior art claims focus on alkaline protectors, while the subject application claims a zinc-containing protector. With this difference in the type of protector (Zinc vs Alkaline) and the additional configurations or features introduced in the claims of the subject application, it appears that the subject application does not overlap with the prior art claims.”

Further, the Court ruled that since the prior art would not fall under the purview of Section 13(1)(b) of the Act, the controller has erred in recognising the differences between the claims of the prior art document D1 and the claims of the subject application, which resulted in the wrong conclusion.

The Court also ruled that,

“The impugned order has failed to provide reason or rationale as to how the teachings of the cited prior art documents D2 to D5 can be combined to provide a clearly identifiable and actionable roadmap to motivate a PSITA to reliably arrive at the present invention."

Regarding the inventive step, the court examined that whether the controller has followed the five-step test as promulgated by the Hon’ble Division Bench of the Delhi High Court in the case of Hoffmann-La Roche Ltd. & Anr. (supra) 2022/DHC/004697.

The Court observed that the controller in the impugned order has assumed that the Zinc substitution is predictable without examining as to whether there could be a non-obvious technical advantage in the specific configuration. By taking the same into consideration, the Court has said that the controller has not referred the five-step test promulgated in Hoffmann-La Roche Ltd. & Anr. (supra).

In view of the findings, the Court ruled that the impugned order actually lacks a proper methodology and insufficient scientific reasoning as it gives a scattered analysis.

The Court observed that the order of the Controller has to be clearly a scientifically reasoned order. If it is not so, such order will be in violation of the ruling in Manohar v. State of Maharashtra & Ors [AIR 2013 SC 681], and would affect the principle of natural justice. In the Manohar ruling, the Court held that application of mind and recording of reasoned decision are the basic elements of natural justice.

Consequently, the Court set aside the Controller's order and ruled that,

“The impugned order delivered by the Controller lacks sufficient scientific reasoning and clarity regarding the inventive step of the invention under Section 2(1)(ja) of the Act as also since the Controller has erred in adjudicating the novelty of the invention under Sections 2(1)(j) and 13(1)(b) of the Act, the impugned order cannot sustain in the eyes of law and is liable to be set aside.”

The Court ordered Controller to reconsider the application with proper scientific reasoning.

In patent law, the concept of inventive step is crucial. It refers to a feature of an invention that involves a technical advance compared to existing knowledge and is not obvious to a person skilled in the art.

The Court's analysis underscored the need for a detailed examination of the inventive step in light of the prior art cited by the Assistant Controller.

The ruling pointed out that the differences between Biotyx’s claims and the prior art were not adequately recognized, leading to an erroneous conclusion about the novelty of the invention.

The judgment also stressed the importance of scientific reasoning in patent evaluations. For an invention to be patentable, it must not only be novel but also demonstrate an inventive step that is not immediately obvious to those with relevant expertise. The Court directed the Controller to utilize recognized inventive step assessment tests to ensure a thorough evaluation, thus reinforcing the need for a methodical approach to patent assessments.

The decision has far-reaching implications for the medical device sector in India. As the healthcare industry continues to evolve, the demand for innovative solutions such as biocompatible materials and advanced medical devices is increasing. The Delhi High Court’s ruling could set a precedent that encourages companies to invest more in research and development, knowing that their innovations are more likely to be recognized and protected under patent law.

Moreover, the ruling reinforces the necessity for patent examiners to conduct meticulous analyses of prior art and the inventive steps involved in new applications. This emphasis on rigorous evaluation not only protects the interests of inventors but also serves to foster a competitive environment that encourages technological advancement.

Despite the positive implications of the ruling, challenges remain within the patent system. The criteria for patentability can sometimes be subjective, leading to inconsistencies in how applications are evaluated. For instance, the interpretation of what constitutes a non-obvious inventive step can vary, leading to different outcomes for similar inventions. Additionally, the volume of patent applications can overwhelm patent offices, resulting in rushed evaluations that may overlook critical aspects of an invention.

The ongoing evolution of technology, particularly in fields like biotechnology and nanotechnology, further complicates the patent landscape. As new materials and methods emerge, the standards for what constitutes novelty and inventive steps must adapt accordingly. This dynamic environment necessitates ongoing dialogue among legal experts, scientists, and industry stakeholders to ensure that patent law keeps pace with innovation.

The Delhi High Court’s judgment in favor of Biotyx Medical represents a significant moment in the realm of patent law, particularly for the medical device sector.

By emphasizing the importance of thorough scientific reasoning and a clear understanding of inventive steps, the ruling not only protects the rights of inventors but also encourages continued innovation in healthcare technology.

As the industry progresses, it is essential to address the challenges within the patent system to ensure that it remains a robust framework for fostering creativity and technological advancements. The implications of this case extend beyond Biotyx Medical; it serves as a reminder of the critical balance between protecting intellectual property and promoting innovation. By refining the standards for patentability and fostering an environment conducive to research and development, the legal framework can play a pivotal role in shaping the future of medical technology.

About the authors: Mahua Roy Chowdhury is the Managing Partner of Royzz & Co. Muthu Pandi is a Partner at the Firm.