The Delhi High Court once again emphasized that inventive step assessment of an invention must be conducted by applying a recognized assessment test thereto with sufficient scientific reasoning. The Hon’ble Justice has overturned the Controller’s decision for resorting to a scattered patentability analysis backed by insufficient reasoning, without following a proper methodology.
In its order dated 20 September 2024, the Hon’ble Delhi High Court set aside the decision of the Controller, and thereby remanding the application to the Controller for re-examination by applying a recognised inventive step assessment test with sufficient scientific reasoning.
BRIEF FACTS OF THE CASE
BIOTYX MEDICAL (SHENZHEN) CO. LTD sought a patent for an absorbable iron-based alloy implanted medical device. The invention 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 zinc-containing protector can delay the corrosion of the iron- based alloy substrate during the early stage of implantation, such that the iron-based alloy substrate essentially avoids corrosion during the early stage of implantation and the clinical mechanical property requirements for the device in the early stage of implantation can be satisfied.
The application was filed as a national phase entry of PCT application on 3rd August 2018 with a priority date of 8th January 2016. The subject application has been refused by the Assistant Controller of Patents and Designs under Section 15 of the Patent Act, 1970 by the order dated 10th July 2020, after a hearing, both on novelty and inventive step.
Allowing the appeal, the Hon’ble Justice Saurabh Banerjee has held that the Controller has erred in adjudicating the patentability assessment of the invention.
The following are the basis of his decision:
ANALYSIS OF NOVELTY
The Controller alleged that Claims 1 to 13 of the invention have been anticipated by D1, cited by the examiner, and the invention therefore lacks novelty under Section 2(1)(j) for prior claiming under Section 13(1)(b) of the Act.
Paragraph 5.4 of the Order elucidates that,
“To determine the issue of novelty and to check whether the claims of the subject application has been claimed in any claim of D1, the inevitable step is to first and foremost claim comparison of the prior art document D1 with the subject application…”
A thorough analysis of the Claims of the prior art document D1 with that of the subject application to find whether both claims overlap and result in prior claiming reveals that the prior art claims focus on alkaline protectors (Zinc Oxide/ Zinc Hydroxide), while the subject application claims a zinc-containing protector (Zinc and/or a Zinc alloy, or a mixture of Zinc and/ or the Zinc alloy). 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.
The Hon’ble Court has firmly pointed out that the impugned order has failed to explicate how or why zinc/ zinc alloy protective layer of the present invention is equivalent (physically and functionally) to Zinc Hydroxide or Zinc Oxide.
“…. 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.”
ASSESSMENT OF INVENTIVE STEP:
Conforming to the five-step test promulgated by the Hon’ble Division Bench of the Delhi High Court in Hoffmann-La Roche Ltd. & Anr. v. Cipla Ltd. 2015, the Hon’ble Court has observed whether the Controller has sufficiently and correctly adhered to the test.
The five-step test, which has also been reiterated in the Manual of Patent Office Practice and Procedure, 2019, is a laid down methodology for assessing the inventive step of an invention, and licitly followed by various Courts, across India. The steps comprises: 1.identifying a person skilled in the art (PSITA); 2. determining the inventive concept embodied in the patent; 3. attributing to a skilled but unimaginative person what was common general knowledge in the art at the priority date; 4. identifying the differences between the prior art and the alleged invention; 5. assessing whether these differences constituted steps that would have been obvious to the skilled person while avoiding a hindsight approach.
The Court has observed that, the controller in the impugned order assumed that the Zinc substitution is predictable, albeit without probing further as to whether there could be a non-obvious technical advantage in the specific configuration as given in the subject application. Taking the same into consideration, the controller has examined the inventive step in the subject application without referring to the five-step test.
INSUFFICIENT SCIENTIFIC REASONING:
The Court also pointed out that the (impugned) order of the Controller must be a scientifically reasoned order. If not, it will be in violation of Manohar v. State of Maharashtra & Ors. 9 [AIR 2013 SC 681]. In the said order, upon reiterating the settled position of law qua the relevance for principle of natural justice, it was held that application of mind and recording of reasoned decision are the basic elements of natural justice.
Thus, the Court held that the impugned order required to be more evaluative and reasoned while analyzing the patentability.
It is noteworthy that in the recent past, many appeals from the patent refusals have been reversed by Courts based on lack of reasoning, non consideration of submission or invalid determination. The Indian Patent Office is already into streamlining the examination procedure to make it aligned with established Jurisprudence and patent provisions.
The decision once more underscored the very necessity of a scientifically reasoned order – particularly in the case of patentability analysis.
CONCLUSION:
The judgment reinforces the necessity for the Patent Officers to conduct meticulous analysis of prior arts and inventive step involved in an invention. This practice would not only protect the interest of the applicant, but also foster a competitive environment amongst the investors, and enable an overall technological growth. The ruling also has a far-fetched implication for the medical device sector in India, which is vastly evolving with the healthcare industry. The investors will be encouraged to invest more in such research and development, knowing that the innovations would be protected under the Law.
Author:
Dipanjana Chakraborty – Patent Attorney
