On inventive step and evolving judicial interpretation standards in India.
Dr. Deepti Malhotra
Advocate | IP Attorney (LL.M.) | Registered Patent Agent | WIPO IP Expert, DL-Tutor & Mentor | Technology expert/Patent Engineer | TIFAC Fellow | Marie Curie/ERS Fellow | NIH Fellow | NIEHS Fellow
In India, for the grant of a Patent, an invention (Section 2(1)(j) of the Patents Act, 1970 (as amended, referred to as ‘the Act’ hereinafter) has to cross the thresholds of various patentability requirements, the most complex technically being the inventive step (Section 2(1)(ja) of the Act). Section 2(1)(ja) of the Act states: “inventive step" means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art”. The Act however does not provide any discernible explanation or definition for the afore-highlighted terms used in the definition leading to a lot of confusion and arbitrariness in the interpretation of this mandatory threshold requirement by the Indian Patent Office (IPO). One may prima facie understand inventive step requirement as one requiring the novel “features” to not be trifling, rather they should add non-obvious technical advancement over and above what would be known to a fictitious person of skill in the art. Consequently, the test of inventive step is subjective unlike the test of novelty, which is objective in nature involving looking at the novelty of technical “features” as compared with the closest prior art, and requiring all said novel features to be disclosed in a single prior art (1). Hence, inventors, Patent Attorneys, Lawyers, examiners, and Controllers of the IPO look to the Courts of Law to provide judicial guidelines on the interpretation of the same and set some standards to bring uniformity and clarity to this complex techno-legal issue. Similar issues have been raised and addressed across jurisdictions especially looking at the same/similar inventions, and the Courts in India take note of those developments on evolving interpretations of inventive steps noting equivalent underlying principles despite different tests being applied there. One thing is clear the assessment of the inventive step presents a mixed question of fact (technical) and law (legal), and hence, variation on a case-to-case basis is expected when designing any standard. Additionally, the nature of Patent rights being a negative, monopoly right demands that the Government implying the IPO must be cautious in awarding such rights to only creditable inventions.?
??????????? The Novartis case (2) represents a turning point in the judicial evaluation of patent eligibility and not so much patentability criteria of an invention in India and it primarily relates to derivative or secondary chemical or pharmaceutical inventions. Interestingly, unlike the ruling by the IPO that rejected the application for Patent on lack of novelty as one of the shortcomings, the Supreme Court in India (“SC” hereinafter) found that the beta-crystalline form of Imatinib Mesylate was not inherently disclosed in the earlier Zimmerman Patent (3) and held the same to be novel. Even so, the SC overlooked the next patentability criteria of the inventive step and rather went into voluminous discussion on patent eligibility in view of Section 3(d) (“3(d)” hereinafter) of the Indian Patent Act, 1970 (as amended) (“Act” hereinafter) (4). The SC in fact mentioned that “Whether or not it involves an ‘inventive step’ is another matter, and there is no need to go into that aspect of the matter now” (2) and skipped from patentability requirements of whether the disclosure qualified as an “invention” to patent eligibility criteria for “inventions that are not patentable”. Even when judging with reference 3(d), where the Court should have looked at the patent eligibility from the perspective of the person skilled in the art of “efficacy”, SC chose not to do so, which would have benefitted from a clearer discussion and interpretation on inventive step and instead went on a policy-based exclusion criterion. However, this decision highlighted the need to promulgate and develop indigenized standards, tests, and principles that relate to the domestic patent legislation and highlights the need for legal pluralism different from the one of the West.?
??????????? In a recent judgment, Avery Dennison Corporation Vs Controller of Patents And Designs (5), the Delhi High Court (“DHC” hereinafter) adjudged an impugned order of the IPO on the refusal to grant a Patent to an invention titled “Notched Fastener”, particularly with regard to the question of lack of inventive step under Section 2(1)(ja) of the Act. The DHC went through the evolution of approaches and tests from various jurisdictions to address the issue of inventive steps in view of prior arts and technical advancement on the priority date of the instant application. The Court looked into the IPO’s argument that the subject application did not involve an inventive step based on the argument that “mere change in shape or position of the notch in the subject patent would be obvious to a person skilled in the art…would merely constitute a workshop improvement for a person skilled in the art.”. To substantiate the same, they relied on the decision in Bristol-Myers Squibb Holdings Ireland Unlimited Company v. BDR Pharmaceuticals International Pvt. Ltd. (6).
The DHC further looked into various tests of inventive step and lack of obviousness including (a) “Obvious to try approach” – based on the examination guidelines of the USPTO for 35 U.S. Code § 103 defined as “choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success” and the Supreme Court of USA (“SCU” hereinafter) has held in their decision in KSR International Co. v. Teleflex Inc. (7) that “obvious to try” is a valid test of obviousness. (b) “Problem/solution approach” – based on the EPO examination guideline’s three-stage test: “(i) determining the “closest prior art”, (ii) establishing the "objective technical problem" to be solved, and (iii) considering whether or not the claimed invention, starting from the closest prior art and the objective technical problem, would have been obvious to a person skilled in the art.” The Division Bench of the DHC already discussed this test in its decision in F. Hoffmann-La Roche Ltd. and Ors. v. Cipla Ltd. (8). (c) “Could-Would approach” – also based in the EPO examination guidelines with regard to the third stage of the aforesaid problem/solution approach, this explores the question, whether there is any teaching in the prior art as a whole that would and not simply could have prompted a skilled person, with the knowledge of the objective technical problem, to either modify or adapt the closest prior art to arrive at the subject matter of the claims. (d) “Teaching Suggestion Motivation (TSM) test” – based on the case law, Graham v. John Deere Co. (9) in the USA, where an invention may be considered obvious if based on the TSM, a person of ordinary skill in the art can modify the prior art reference or combine prior arts to arrive at the claimed invention and it involves the steps of determining the scope and content of the prior art(s); ascertaining the differences between the claimed invention and the prior art(s); and resolving the level of ordinary skill in the pertinent art. The aforementioned KSR case law (7) provided that the TSM test must not be applied is a narrow manner.
The DHC further discussed the chronology of the various approaches and the need for case-to-case variation in the applicability of said approaches and further discussed the seminal test laid down by the House of Lords in the UK in Windsurfing International Inc. v. Tabur Marine Ltd. (10) case law. The aforesaid Windsurfing (10) case laid down a four-step test to determine inventive step and lack of obviousness as follows: “1. Identifying the inventive concept embodied in the patent; 2. Imputing to a normally skilled but unimaginative addressee what was common general knowledge in the art at the priority date; 3. Identifying the differences if any between the matter cited and the alleged invention; and 4. Deciding whether those differences, viewed without any knowledge of the alleged invention, constituted steps that would have been obvious to the skilled man or whether they required any degree of invention.” The aforesaid tests were further analyzed in the England and Wales Court of Appeals in the case law, Pozzoli Spa v. BDMO SA (11), and modified to “1. (a) Identify the notional “person skilled in the art”, (b) Identify the relevant common general knowledge of that person; 2. Identify the inventive concept of the claim in question or if that cannot be readily done, construe it; 3. Identify what, if any, differences exist between the matter cited as forming part of the “state of the art” and the inventive concept of the claim or the claim as construed; 4. Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention?” Importantly, the abovementioned F. Hoffmann-La Roche Ltd. (8) case law added a further step and clarity to the above test: “1. To identify an ordinary person skilled in the art, 2. To identify the inventive concept embodied in the patent, 3. To impute to a normal skilled but unimaginative ordinary person skilled in the art what was common general knowledge in the art at the priority date. 4. To identify the differences, if any, between the matter cited and the alleged invention and ascertain whether the differences are ordinary applications of law or involve various different steps requiring multiple, theoretical and practical applications, 5. To decide whether those differences, viewed in the knowledge of the alleged invention, constituted steps which would have been obvious to the ordinary person skilled in the art and rule out a hindside approach.” The DHC again referred to the Bristol-Myers (6) case law to clarify the idea of hindside as “(i) A hindsight reconstruction by using the patent in question as a guide through the maze of prior art references in the right way so as to achieve the result of the claim in the suit, is required to be avoided…(vii) Though it would be tempting to put together a combination of prior arts this requires a significant degree of hindsight, both in the selection of relevant disclosures from these documents and also in disregarding the irrelevant or unhelpful teachings in them,” i.e., how the person of skill in the art would have combined the relevant components of the prior art without any prior knowledge of the instant invention. Additionally, the DHC emphasized approaching each invention and patent application for evaluation of inventive step in a proper manner even involving a combination of the aforementioned approaches and not in a straightjacket approach by referring to a non-exhaustive list of 10 relevant considerations as laid down by the UK Supreme Court in Actavis v. ICOS (12). The DHC further cautioned the IPO against merely arriving at a bare conclusion that the subject invention lacks inventive step contrary to Section 2(1)(ja) of the Act as insufficient by referring to Agriboard International LLC. (13) case law.
Based on the above citations and in consideration of the instant invention in the Avery (5) case law, the DHC held that (a) “simplicity in the invention cannot be a deterrent to patent grant” taking support from the Vickers v. Siddell (14) case law that observed “If the apparatus be valuable by reason of its simplicity, there is a danger of being misled by that very simplicity into the belief that no invention was needed to produce it”; and also laid down that (b) “time gap between prior arts and the invention being examined should also be accounted for while analyzing obviousness,” wherein if a long time has passed since the publication of the prior art documents and a simple change, which no one had thought of, it contributes to a significant technical advancement and deserves to be recognized as non-obvious by referring to the UK Patents Court in Brugger v. Medic-Aid Ltd. (15) case law, which observed “The fact that a piece of prior art has been available for a long time may indicate, contrary to first impressions, that it was not obvious to make the patented development from it… In other words, the age of prior art may be an indication that a development from it is not obvious”. The DHC further considered the approach where the grant of Patents in various jurisdictions including the USA, Japan, South Korea, and China, also establishes the inventive merit of the instant Application and hence, must be given due regard.
The DHC in Biomoneta Research Pvt. Ltd. (16) case law has assessed the question of whether the invention claimed in ‘Air Decontamination Assembly’ [Application No. 201741016833] is no more than a workshop improvement/mere application of an old contrivance? The DHC held that the subject invention here was not a mere addition to a well-known combination and rather it was an improvement on the method that resulted in greater efficiency. The DHC relying on the EPO examination guidelines observed that “if the claims consist of a combination of features, then it is incorrect to argue that separate features taken by themselves are obvious and that therefore the whole subject matter claimed is obvious.” Accordingly, the DHC held that “if the interactions of the individual features i.e., the combination as a whole produced a synergistic effect, then the subject matter is patentable.”
Thus, the Courts in India are rightfully looking at the need of the inventors, Patent practitioners, and the IPO alike to provide better guidelines and tests for assessing the most crucial aspect of an invention, i.e., the inventive step to be granted a patent assessed as a mixed question of fact and law, and it is a welcome change requiring proper implementation by the IPO.
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REFERENCES
1.????? 3M Innovative Properties Company & Anr. v. M/S Venus Safety & Health Pvt. Ltd. & Anr. on 30 May 2014 https://indiankanoon.org/doc/23379929/ accessed 01 October 2023.
2.????? Novartis v Union of India on 1 April 2013 www.indiankanoon.org/doc/165776436/ accessed 01 October 2023.
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3.????? US patent number 5,521,184.
4.????? The Patents Act, 1970 https://ipindia.gov.in/writereaddata/Portal/ev/sections-index.html accessed 01 October 2023.
5.????? Avery Dennison Corporation Vs Controller of Patents And Designs on 25 July 2022 https://indiankanoon.org/doc/169801355/ accessed 01 October 2023.
6.????? Bristol-Myers Squibb Holdings Ireland Unlimited Company v. BDR Pharmaceuticals International Pvt. Ltd. on 30 January 2020 https://indiankanoon.org/doc/176152364/ accessed 01 October 2023.
7.????? KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
8.????? F. Hoffmann-La Roche Ltd. and Ors. v. Cipla Ltd., 2016(65) PTC 1 (Del).
9.????? Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966); https://supreme.justia.com/cases/federal/us/383/1/ accessed 01 October 2023.
10.?? Windsurfing International Inc. v. Tabur Marine Ltd., [1985] RPC 59.
11.?? Pozzoli Spa v BDMO SA, [2006] EWHC 1398 (Ch).
12.?? Actavis v. ICOS, [2019] UKSC15.
13.?? Agriboard International LLC. v. Deputy Controller of Patents& Designs on 31 March 2022 https://indiankanoon.org/doc/126889519/ accessed 01 October 2023.
14.?? Vickers v. Siddell (1890) 7 R.P.C. 292; https://academic.oup.com/rpc/article/7/33/292/1596735 accessed 01 October 2023.
15.?? Brugger v. Medic-Aid Ltd, [1996] R.P.C. 635; https://academic.oup.com/rpc/article-abstract/113/19/635/1610508 accessed 01 October 2023.
16.?? Biomoneta Research Pvt. Ltd. & Anr. vs Controller General Of Patents, Design, Trademark and Geographical Indication & Anr. [CA(COMM.IPD-PAT) 297/2022].