The recent ruling of the Delhi High Court on Biotyx Medical (Shenzhen) Co. Ltd. dated September 20, 2024, concerning patent application no. 201817029244, offers an insightful example of the challenges in assessing novelty and inventive steps.
In patent law, determining the three test criteria for patentability is indispensable for the future success of any invention. While assessing the patentability of medical devices in India, the following key criteria must be evaluated, as outlined in the manual of patent office practice and procedure:
- Under Section 2(1)(j), the invention must be novel, meaning it has not been previously disclosed or used anywhere in the world, necessitating a thorough patent search.
- Under Section 2(1)(ja), the invention includes an inventive step, indicating it should not be obvious to a person skilled in the art at the time of filing, thereby demonstrating a significant improvement over existing technologies.
- Under Section 2(1)(ac), the invention must have industrial applicability, meaning it should be capable of being made or used in some industry, demonstrating practical utility.
- Under Section 10(4), the patent application must provide sufficient disclosure, adequately describing the invention’s technical aspects and functionalities to enable reproduction by someone skilled in the field.
- The invention must not fall under exclusions from patentability, with regard to Section 3(b) and Section 3(f) specifically.
THE CONFLICT AND THE VERDICT:
Biotyx Medical filed an Indian Patent application no. 201817029244 filed on August 3, 2018for an implantable medical device made of an absorbable iron-based alloy. The mechanical integrity of the device is provided by the iron-based alloy substrate, biodegradable polymer coating, and zinc-containing protection, that worked together to prevent corrosion during the initial phases of implantation.
The primary aim of the invention was to enhance the corrosion resistance of iron-based alloys and thus, improving the mechanical properties of the device during early implantation. However, on July 10, 2020, the Assistant Controller of Patents rejected the application under Section 15 of the Patent Act, 1970. According to the rejection, the claimed invention has already been shown in previous art, citing a lack of novelty under Section 2(1)(j) and Section 13(1)(b) as well as a lack of inventive step under Section 2(1)(ja).
Biotyx Medical’s Arguments: Biotyx Medical’s central argument was that their invention was highlighting the use of a zinc-containing protector in their medical device.. that played a critical role in delaying corrosion during early implantation that is not discloses in the cited prior art documents. They contended that prior art describes different types of protectors, such as alkaline substances like zinc hydroxide or zinc oxide, which are not equivalent to the zinc or zinc alloy layer in their invention.
Biotyx Medical further argued that the rejection overlooked the functional and material distinctions between their zinc-based protector and the alkaline protectors. They emphasized that their invention provided superior mechanical integrity during the initial stages of implantation, which was a unique feature.
Biotyx Medical asserted that the prior art, whether considered individually or collectively, lacked the necessary teachings to suggest the use of a zinc-based protector in an iron-based implantable device, as claimed in the patent.
Controller of Patents’ Arguments: The Assistant Controller of Patents maintained that the subject matter of Biotyx’s claims had already been disclosed in prior art that describes a similar iron-based implantable device with protective layers. The Controller mentioned that the differences between Biotyx’s zinc-containing protector and the alkaline protectors were not substantial enough to establish novelty. The Controller further contended that the use of zinc ions to inhibit corrosion was well-known, citing prior art documents that disclosed the use of various coatings and protectors for corrosion resistance, so application is obvious.
The High Court, after reviewing the arguments, held that the Assistant Controller had erred in rejecting the application on the grounds of novelty and inventive steps. The Court noted that the key difference between the invention and the prior art was the use of a zinc-containing protector, which was not disclosed in the prior art. Therefore, the claims of the subject application could not be considered as anticipated by cited references.
Justice Saurabh Banerjee of the Delhi High Court overturned the decision on September 20, 2024, and gave the order for a reassessment of the application. The Court ruled that the previous evaluation did not adequately consider the differences between Biotyx Medical’s claims and the cited prior art, particularly regarding the zinc-based protective layer. As a result, the case was remanded for a fresh review, with instructions to reassess the inventive step using a recognized test and provide sufficient intellect and logical reasoning.
Regarding the inventive step, the Court pointed out that the Assistant Controller had not applied the proper methodology to assess the inventive step, particularly the five-step test formulated by the Delhi High Court in Hoffmann-La Roche Ltd. v. Cipla Ltd. (2015).
In order to determine the patentability of a subject invention after the novelty test is clear, the inventive step criteria must be assessed in an appropriate manner. The five-step test for determining inventive step must be followed that includes:
- The first step involves identifying the level of expertise of a person skilled in the relevant technical field.
- The second step requires determining the Inventive Concept embodied in the patent.
- The third step involves assessing what was commonly known in the relevant technical field at the time the invention was made.
- The fourth step involves determining the differences between the invention and the prior art, analyzing whether these differences are significant or merely obvious.
- The fifth step includes to assess whether these differences, viewed in the context of the known invention constituted steps that would have been obvious to the skilled person while avoiding a hindsight approach.
SOME GRANTED CASES OF MEDICAL DEVICE IN INDIAN JURISDICTION
- IN489910
Title- Biodegradable jacket for medical implants
Applicant- Meril Life Sciences Pvt. Ltd.
The patent discloses a biodegradable jacket that consists of two layers made of biodegradable polymers.
The patent was granted because after examination and a hearing, the objections raised under Sections 2(1)(j), 3(f), and 3(d) were addressed, clarifying that the invention was novel and non-obvious in view of prior art references.
2. IN526375
Title- Catheter System
Applicant- Northward Ventures, LLC
The patent discloses a catheter system for accessing a patient’s anatomy, incorporating a syringe with two parallel chambers, an access needle, a pliable catheter, and a guidewire.
The patent application was granted after amendments to claims 1-12 addressed clarity and conciseness under Section 10(5) of the Patents Act, 1970. Independent claim 1 was revised to highlight novel and inventive steps, and multiple dependencies in dependent claims were removed.
3. IN523130
Title- Implant Device
Applicant- Biotyx Medical (Shenzhen) Co., Ltd
The patent discloses a metal material for use in implantable devices.
The Patent focuses on a metal substrate for implantable devices, specifically addressing the optimization of the relationship between wall thickness, particle size, and particle content to improve the substrate’s plastic deformation capacity.
OPINION:
The Delhi High Court’s decision in favor of Biotyx Medical highlights the crucial role of the inventive step in patent law, emphasizing the need for thorough scientific reasoning and methodical evaluation in patent assessments. The court emphasized the significance of separating significant discoveries from obvious applications of prior knowledge by mandating a reevaluation utilizing accepted inventive step requirements. The decision has significant implications for the medical device sector, encouraging further research and development by ensuring stronger protection for genuine innovations. However, it also draws attention to ongoing challenges in the patent system specifically to life sciences, such as the subjective nature of evaluating inventive steps and the need for patent standards to keep pace with technological advancements. Understanding the key benchmarked concept that what invention is bringing out technically over the related prior arts would amount in the proceeding of the subject application in a worthy direction.
At Aumirah, we possess in-depth expertise in patent law, particularly in the field of medical devices and life sciences. We guide clients through the complexities of patentability, focusing on key criteria such as novelty and inventive steps. Our insights enable firms to resolve patent assessments and gain strong protection for their innovations, particularly with regard to recent court opinions.
