| Melanoma (Ex 1) | Pancreatic Cancer (Ex 2) | Gastric Cancer (Ex 3) | Ovarian Cancer (Ex 4) | Glioblastoma (Ex 5) | |
| A/Control | 0.684 | 0.586 | 0.307 | 0.606 | 0.500 |
| B/Control | 0.671 | 0.912 | 0.388 | 1.043 | 0.097 |
| Expected A and B combination/Control | 0.459 | 0.534 | 0.119 | 0.632 | 0.048 |
| Actual A and B combination/Control | 0.320 | 0.215 | 0.097 | 0.164 | 0.041 |
We feel privileged to fetch these brief insights of recently granted patent application 10502/CHENP/2012 as IN317714 on 6th August, 2019. Eisai R&D Management Co. Ltd. had filed PCT/JP2011/064430 claiming priority from two Japanese patent applications viz JP2010-145030 having priority date of June 25th, 2010 (to be considered as it is the earliest priority date) and JP2010-273921 having priority date of December 8th, 2010. Indian Patent application had entered within National Phase on December 17th, 2012. However, its PCT filing date was June 23rd, 2011.
The said patent application primarily claims a therapeutic agent comprising Golvatinib or its acceptable salt and Lenvatinib or its acceptable salt as the main components intended for treating tumour. Further, it has two dependent claims altogether stating that therapeutic agent is administered either as separate administration of main components or as a simultaneous administration of main components in form of a pharmaceutical composition.
As objected in the First Examination Report, the learned Controller aptly pointed out lack of inventive step, non-patentability under section 3(e), lack of unity of invention and lack of clarity/conciseness with respect to all or various claims. Subsequent examination report added objections with respect to non-patentability under section 3(i) and defining scope of claims in context with term “therapeutic agent”. The applicant has skilfully replied to the above raised objections by emphasizing on the synergistic therapeutic effect of the combination of compounds under questioned claim. However, before understanding the final decision and basis of the same, we first need to recollect what synergism is all about:
“When the effect of two drugs given concurrently is additive, this is referred to as summation. However, if the effect of two drugs exceeds the sum of their individual effects, this is referred to as potentiation or synergism. Potentiation requires that the two drugs act at different receptors or effector systems.” (as defined in ‘Introduction to Pharmacology’ by Mannfred A. Hollinger)
Employing this precise concept of synergism, the applicants of the said patent have successfully secured rights of their pharmaceutical combination composition for its anti-tumor activity as under:
These values of relative tumor volume were derived from the data for the last day of each treatment presented as stated in said examples of the patent specification-
“A/Control” = relative tumor volume of Compound A group divided by relative tumor volume of Control group.
In Example 1, 5.92/8.65 = 0.684.
“B/Control” = relative tumor volume of Compound B group divided by relative tumor volume of Control group.
In Example 1,5.80/8.65 = 0.671.
“Expected A and B Combination/Control” = A/Control value multiplied by B/Control value. In Example 1, 0.684 x 0.671 = 0.459.
“Actual A and B Combination/Control” = relative tumor volume of Compound A and B Combination group divided by relative tumor volume of Control group.
In Example 1, 2.77/8.65 = 0.320.
They have summarized pharmacological efficacy obtained on 5 different animal models of human cancer while studying tumor proliferation inhibitory effect in vivo mentioned in the prosecution history and decision led down by the Deputy Controller of Patents and Designs. Keynotes of both were narrowing to the fact that the results drawn from the conducted study demonstrated that the inhibition of tumor growth, resulting from the combination treatment while administering both compounds together, exceeded that which would have been expected from the combination based upon each compound’s individual efficacies. Therefore, no document citation would have possibly led the PHOSITA to predict or arrive at the synergistic therapeutic effects of claimed combination of Golvatinib and Lenvatinib or their pharmaceutically acceptable salts thereof. The above highlighted relative tumor volumes in green are what are achieved surprisingly in contrast with the highlighted results in yellow that were expected to be achieved.
In essence, if you have an invention that can be very well supported and purported with a solid crux, the objections raised under sections 3(e) and 3(i) of the Patents Act, 1970 can be possibly resolved.
We are Excelon IP, a full-service Intellectual Property Solutions provider in Ahmedabad, guiding clients ranging from early-stage start-ups to MNCs across several industries in protecting their intellectual property in India and across the globe. Established with our intellectual capital in the field of IP rights, we are a one-stop escape for all IP related matters.
And you can get a free consultation today, with our expert team of IP attorneys in Ahmedabad. To get your free consultation, click here.