19 judgments of the Delhi High Court, the Madras High Court and 1 other court applying Patents Act s.3(d), from 2023–2026, each with a headnote by BRB Legal.
Refusal of a polymorph application set aside and remanded, with a clear finding on section 3(d). The monohydrate crystalline polymorph keeps the fungicide Benzovindiflupyr stable between 50 and 60 degrees Celsius so that it does not crystallise into lumps that clog spraying machinery, making it usable in regions where temperatures exceed 40 degrees. The Court held that this is a reasonable enhancement of efficacy satisfying section 3(d), and that the absence of enhanced therapeutic efficacy is not a bar where the product is not a medicine. The order was separately vitiated by the Patent Office omitting the data the applicant had submitted without sufficient reasoning, and relying on existing knowledge without citing any source.
Two appeals dismissed on section 3(i). The Court held that the fact a method is performed in vitro does not by itself make it patentable so long as the purpose of the process is to diagnose a medical condition: here the method of methylation of samples drawn from a pregnant woman produced a result sufficient to eliminate her from further testing, which brought it within the exclusion. Grants of the same invention in foreign jurisdictions could not displace the statutory prohibition in India. As the second application differed from the first only in the polynucleotide sequences, the analysis in the first bound the appellants in both.
Letters Patent Appeal allowed in part in a pre-grant opposition over a process for recovering potassium sulphate from distillery spent wash. The Division Bench rejected the opponent's objection that the process was unpatentable under section 3(d), and remanded only the objection under section 25(1)(e) read with section 2(1)(ja), confined to the prior art the opponent had already cited.
Appeal dismissed and refusal of a divisional application for an intermediate compound upheld. The Court held it obvious for a person skilled in the art to replace ethoxy with methoxy to provide alternative intermediates useful in synthesising aminothiazole derivatives, both being lower alkyl, and noted that the prior art documents and the subject application lay in the same field and shared a common inventor, which it treated as of much relevance. On the law, it held that an inventive step under section 2(1)(ja) must be more than a variety or an add-on variation and must lie beyond what is known to a person in the relevant field, so a trivial run-of-the-mill improvement or modification reflecting no creativity is not an inventive step.
Refusal under sections 2(1)(ja) and 3(d) quashed as a non-speaking order. The Controller ignored the gap between the amended claims and the prior art, never considered the written submissions, the responses to the objections or the amended claims, and gave no reason for concluding that the core structure of the claimed compound was the same as that of the cited document, which on a prima facie view disclosed a different core. On Novartis, the test of efficacy for a medicine claiming to cure a disease can only be therapeutic efficacy, but the order said nothing about why the claimed invention failed that test. Following Avery Dennison, a significant technical advancement suffices to satisfy inventive step, and following BlackBerry, a Controller cannot refuse by merely reproducing the objections raised in the First Examination Report.
Refusal of a hemisulphate salt claim under section 3(d) set aside and the application remanded. The Court held that Novartis left the door open for incremental inventions based on enhanced bioavailability, the Supreme Court having noticed but not decided the contention that therapeutic efficacy can be established only on pharmacodynamic properties. Enhanced therapeutic efficacy founded on bioavailability must therefore be tested on its own criteria and not on enhanced intrinsic pharmacological activity per unit of active ingredient, which is the test the Controller had applied. The specification disclosed bioavailability of 34.73% for the salt against 4.54% for the base compound in dogs, together with recitals on therapeutic benefit, and those aspects had never been considered.
Refusal under section 3(d) set aside. The Controller had reasoned that once a device for a repair is made, the method of repairing with it is simply part of the manual of operation, so the method claim was the mere use of a known device. The Court held that section 3(d) contains four distinct categories, and that although the Controller placed the claim in the fourth, the mere use of a known process, machine or apparatus, the order nowhere identified what that known machine or apparatus was, nor cited any prior art from which the device implementing the method was known. No objection to novelty had been taken against the device claim in the same application, so the Controller had in effect acknowledged novelty and inventive step; a device claimed in the same application cannot be presumed known, and in any event what is relied on must be known before the priority date. Following D.S. Biopharma, a section 3(d) objection raised without identifying the known substance and without a proper opportunity to answer cannot sustain a refusal, and on Manohar and Agriboard the Patent Office must issue a speaking order reflecting application of mind.
Refusal of a biomass hydrolysis process set aside outright. Going through each cited document, the Court found that none taught the key feature, that the hydrolysed species of the feedstock itself acts as the solvent for fresh feedstock, and that one taught away from it. On sufficiency it held, following FDC v. Sanjeev Khandelwal, that section 10(4) requires the specification to describe the invention fully and particularly and to disclose the best method, but does not require the claims to be representative of the best method; following Tata Global Beverages, that examples need not be given across the entire range claimed; and following Farbwerke Hoechst, that processes forming part of common general knowledge need not be described, the specification being addressed to those with a high degree of knowledge in the field. Disclosure of at least one way of working the invention suffices. On section 10(5) it is enough that the claims are fairly, not exactly, based on the description. On section 3(d), following Natco Pharma, where the solution itself was not known before the invention it cannot be the mere use of a known process; the could-would approach asks not whether the skilled person could have carried out the invention but whether he would have done so expecting to solve the problem or gain an advantage; and on Gandhimathi Appliances a combination of known integers showing a new use is patentable where the claimant was first to visualise it. The same prior art had been cited and overcome in the European application, and the invention stood granted in 23 jurisdictions.
A section 3(d) refusal of a crystal form of a prodrug was set aside. The Controller treated lanosterol as the known substance without explaining how he had got there, when the claims were to a crystal form of the lanosterol prodrug; and he dismissed the specification's data as going only to stability, permeability and bioavailability without appreciating that the experimental examples relied on were pharmacodynamic studies, which go to the effect of the drug on the body rather than the effect of the body on the drug.
Appeal dismissed, but on only two of the three grounds of refusal. The rejection under section 3(a) as frivolous was held untenable, that ground having been raised for the first time in the impugned order and in neither the First Examination Report nor the hearing notice. The rejection on industrial applicability was also untenable: the filter requires only that the claimed invention be capable of being put to practical use, not that it be cheaper than the prior art, so the objection that replacing the filtration material is expensive went to economic significance rather than industrial applicability. On inventive step the refusal was sustained. Section 2(1)(ja) requires both a technical advance over existing knowledge or economic significance, and non-obviousness to the person skilled in the art. Applying the Windsurfing and Pozzoli steps, with the caveat from Rhodia that the skilled person is of above average skill and normal imagination but lacks ingenuity, the Court identified a chemical engineer working in composite solid propellants, and held that selecting among known filtering materials was obvious from the prior art and common general knowledge, while limiting exposure time to reach the ideal doping percentage was routine experimentation. Without comparative cost data, economic significance was not established either.
Refusal set aside and the application for a method of detecting inclusions in diamonds directed to proceed to grant, subject to amendment of claim 1 and deletion of claim 4. On obviousness, the Controller had reasoned with hindsight: there was no discernible link between the two groups of prior art, the document relied on as a bridge taught away, and the notional team would not have combined them. On section 3(d), the second limb excludes claims to a new use of a known substance, and a method claim that immerses a diamond in molten selenium is not a monopoly claim over selenium, so the exclusion did not apply. A request to narrow substantially comprising selenium to consisting of selenium could not be refused for delay once inventive step was established. Claim 4 was rejected as insufficiently enabled.
Refusal set aside and the application for enzyme granules for animal feed directed to proceed to grant. On obviousness, the prior art disclosed a granule whose core might comprise either an organic or an inorganic salt among many combinations, but the order contained no discussion of why a person skilled in the art would select a zinc salt of an organic acid to solve the problem of enzyme stabilisation, and the Controller had been conscious that the prior art did not exemplify that effect yet concluded it would be obvious anyway. On section 3(d) the Court made a short point of construction: the same order had acknowledged novelty because the granule was not disclosed in the cited prior art, and if the granule is novel it cannot be a known substance, so section 3(d) has no application to it.
The Controller shifted the goalpost three times within one section. The First Examination Report objected on the first limb of section 3(d); the hearing notice gave up that limb and all five cited documents, moved to the third limb and cited two fresh documents; and the order then reverted to the first limb, which the applicant had had no occasion to meet because the hearing notice had abandoned it. An applicant is required to answer only the objection actually raised.
Appeal partly allowed. On obviousness the Court held that the order gave no reason why a person skilled in the art would pick one compound out of more than a hundred in the cited prior art and add a methyl substituent to arrive at the claimed compound, particularly when several other compounds in that document had lower IC50 values, and that without hindsight it did not appear possible. The order had also brushed aside the other claimed technical advancements without reasons. On section 3(d) the Court held that since the parent compound was not a known substance, its polymorphic forms could not be treated as obvious and section 3(d) did not apply, so enhanced efficacy need not be shown; the x-ray diffraction pattern identifies a polymorph rather than being a technical advancement. The composition claim failed section 3(e) because no synergy between the ingredients had been asserted or demonstrated.
Refusal set aside and the application for a method of producing a polyvinyl alcohol film for plant cultivation directed to proceed to grant on amended claims. The Controller had concluded that the claims failed to identify the critical steps contributing to the technical effect, that the steps were known in the general state of the art, and that optimisation of workable ranges lies within the skill of the person skilled in the art, but gave no source or basis for the conclusions resting on the general state of the art. The non-disclosure finding was untenable against the complete specification, which set out the mode of carrying out the invention, the methods of measuring birefringence, swelling degree and penetration resistance, and a table of evaluation results. The cited prior art taught away, proposing a laminate for its purpose.
A refusal under section 3(d) recorded that there was an absence of experimental data when the complete specification set out the studies carried out, including the enhanced effect relied on, and the conclusion on obviousness never engaged the detailed differentiation of each cited document in the written submissions. Comparative extracts showed the order was for the most part a reproduction of the First Examination Report and the hearing notice.
Refusal of an antiviral compound application set aside and the matter remanded. The order had rested on a selective reading of the specification and failed to deal with comparative tables showing that compounds with cyclic substitutions were active against three viral antigens where acyclic substitutions were not. On section 3(d) the Court held that the order did not identify the known substance, its known efficacy, or the new form said to be derived from it, and noted that the provision speaks of a known compound in the singular. It also recorded that section 3(d) does not bar patent protection for all incremental inventions, as Novartis itself makes clear. On section 8, the appellant having furnished details of foreign prosecution, those materials ought to have been considered though not binding.
Allowed in part. The refusal was set aside as regards claims 1 to 7, which were directed to proceed to grant, while the rejection of composition claims 8 to 11 was upheld. On section 3(e) the court held that the provision, unlike sections 3(d), 3(f) and 3(p), does not contain the word "known", and declined to read that adjective into it, departing from the IPAB's view in Stempeutics Research. The consequence is that where an ingredient independently satisfies the requirements of an invention, a patent may be granted for it notwithstanding section 3(e). A composition claim remains excluded where the substance merely exhibits the aggregate properties of its constituents, and the court held that section 3(e) is not confined to independent claims.
Refusal of a patent for a fungicidal treatment for black sigatoka was set aside and the application remanded. The finding that the invention lacked inventive step was unreasoned: the Controller compared prior art D1 to D7 without appreciating what they taught, left the applicant's written submissions unanswered, and did not apply the inventive step tests set out in Avery Dennison. The court restated that a specification is construed by reading the description of the invention before the claims, following Bishwanath Prasad Radhey Shyam.
