Willowood Chemicals Private Limited’s (hereinafter “the Patentee”) patent was revoked by the Controller of Patents (hereinafter “Controller”) due to post-grant opposition as the Controller held that the Patentee had failed to display any technical advancement and synergism between the components of the claimed composition across the breath of the claims.
The Patentee had filed an application (No. 3591/DEL/2014) titled “A Novel Synergistic Seed Treatment Composition” in 2014, and was granted patent on May 09, 2019, with patent no. 312514. The granted claims[1] were directed to a synergistic seed treatment composition, comprising a chloronicotinyl insecticide compound (Neonicotinoids), selected from the group consisting acetamiprid, clothianidin, dinoteforan, imidacloprid, nitenpyram, nithiazine, thiaclopridand thiamethoxam; fungicidal actives consisting carboxin, thiram, and excipients wherein the chloronicotinyl insecticide compound and fungicidal actives are in a ratio of 1:2 to 1:5.
Thereafter, the Haryana Pesticide Manufactures Association (hereinafter “Opponent”) filed a post-grant opposition on the grounds of lack of novelty (Section 25(2)(b)); lack of inventive step (Section 25(2)(e)); invention being not patentable under Section 3(e) (Section 25(2)(f)). The Opponent cited nine prior arts to elaborate on the objection related to lack of inventive step.
During the hearing, the Opponent withdrew its anticipation/ lack of novelty objection, which was raised in view of cited prior arts D1-D2, and was thus not contested.
As far as obviousness/ lack of inventive step is concerned, the Opponent submitted that granted claims 1 of the impugned patent were not inventive, as various cited documents, such as D1, D3, D5, D6, and D8 provided sufficient teachings and suggestions to a person skilled in the art of formulating compositions comprising provided insecticides. It was further submitted that it was obvious for any person skilled in the art to modify the amount of imidacloprid, carboxin and thiram, as disclosed in cited art, to arrive at the opposed patent without any significant technical advancement.
The Opponent also objected to the composition being a patentable invention under the Act, as claimed in the impugned patent, as it attracted the provisions of Section 3(e) of the Act and was a mere admixture of known substances. It was also submitted that the data relied upon by the Patentee showed that the impact of the claimed composition varied. In some instances, it exhibited a mere increase when compared to other combinations, while in other cases, it surprisingly decreased. Moreover, it was also perplexing for the experts in the field, as they were uncertain about whether to opt for the Carboxin+Thiram+Imidacloprid combination or simply Carboxin+Thiram (which also produced similar results).
Further, the data was considered inadequate to support the breath of claims, all compositions/ combinations covered in all ratios for all conditions.
The Patentee disagreed and submitted that the composition of the claimed patent showed synergistic effect with low active ingredients to provide effective seed germination, control of seed decay and seedling infection, and better yield with no phytotoxicity. The Patentee further submitted that the composition of the subject patent in the claimed ratio was more efficacious and thus synergistic than the individual components and indicated an unexpected effect associated with the composition and that none of the prior arts cited by the opponent suggested combining imidacloprid with carboxin and thiram in the claimed ratio of 1:2 to 1:5 of the present invention.
After going through the patent and cited art, the controller agreed with the recommendation of the opposition board and the arguments of the opponent that claimed that 1-6 lacked inventive step and therefore the ground raised u/s 25(2)(e) by the opponent was found valid.
The claimed composition was also considered a mere admixture of known actives, i.e., imidacloprid, carboxin, thiram and excipients. Also, the Controller noted that the Patentee failed to show any technical advancement or synergism in the claimed composition. The Controller pointed out various limitations and shortcomings in the data provided by the Patentee. The key ones being:-
- The treatment T7 (composition of the patent no. 312514) provided almost similar germination of seeds percentage, as compared to the treatment T2 to T6 (compositions provided in prior art), resulting in almost same effective control of fungal diseases;
- The data provided in the form of affidavit by Dr. Nath was for a specific ratio, crop and disease, but the subject matter of the claims did not reflect any specific disease or crop, hence the data was not significant for the whole breadth of the claimed subject matter;
- There was no clarity and inconsistency regarding the form in which the formulation was prepared, which at places was water dispersible powder for slurry seed treatment, and in others, was wettable powder;
- The results indicated that the impact of the claimed composition on inoculated seeds was not notably different from the impact on healthy clean seeds treated with the same claimed composition, particularly in germination, seed decay and seedling infection;
- The data showed more than expected value for T7 for flag smut/ loose smut control, but the data was for a specific ratio, used to treat a specific disease (flat/ loose smut) in a particular crop (wheat). It cannot be presumed that such activity will be shown for different diseases among different variety of crops for all covered ratios;
- T1 to T5 treatment groups demonstrated a similar percentage of germination rate, lower aphid population and plant damage when compared to T7 treatment.
The Controller observed that the impugned patent was nothing but a mere admixture of already known actives and several conventional excipients, for which the Patentee failed to show any synergistic effect. The Controller, therefore, concluded that the Opponent had successfully proved the grounds of opposition under Section 25(2)(e), i.e., lack of inventiveness; and under Section 25 (2)(f), i.e., non patentable subject matter under Section 3(e). Thus, Patent no. 312514 was revoked.
[1] 1. A synergistic seed treatment composition comprising: a chloronicotinyl insecticide compound (Neonicotinoids) selected from the group consisting of acetamiprid, clothianidin, dinoteforan, imidacloprid, nitenpyram, nithiazine, thiaclopridand thiamethoxam; fungicidal actives consisting of carboxin; thiram; and excipients wherein the chloronicotinyl insecticide compound and fungicidal actives are in a ratio in the range of 1:2 to 1:5.
2. The composition as claimed in claim 1, wherein the composition comprised: (a) imidacloprid; (b) carboxin; (c) thiram and excipients.
3. The composition as claimed in claim 1, wherein the preferred ratio of chloronicotinyl insecticide compound to fungicide actives is 1:2.5.
4. The composition as claimed in claims 1 and 3 wherein the ratio of carboxin and thiram is 1: 1.
5. The composition as claimed in claim 1, wherein excipients are agrochemically acceptable wetting agent, dispersing agent, binding agent, thixotropic agent, warning colour, defoaming agent, and carrier.
6. The composition as claimed in claim 1 can be formulated as dust, powder, granules, encapsulated granules, water dispersible powder for slurry seed treatment, water soluble tablets, wettable powder and water dispersible granules
