Does a change in the molecular formula, viscosity or Phosphorous/nitrogen ratio satisfy the
test of novelty u/s 3(d)?

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The Hon’ble Court of Madras on 20.12.2024 in Italfarmaco SPA Vs The Deputy Controller of Patents & Designs [(T) CMA (PT) No.45 of 2023] had given insights for judgment for novelty criteria with regards to section 3(d) of the Patents Act 1970.

In order for Section 3(d) to have application the first two conditions i.e (i) the compound has to be a known substance; and (ii) the compound has to be for a new form of that substance have to be satisfied. The testing of a product for therapeutic efficacy is only after these two conditions are found applicable.

The Applicant Italfarmaco SPA has contested that the Controller has failed to appreciate the differences between the different types of casein and the meaning of the phrase “casein of suitable purity for a pharmaceutical process” reported in the prior art document (D1). Further, the prior art documents in which the purity parameters of casein for human use are defined had also not been appreciated. At last, the Controller fails to appreciate that instead of the specific parameters of casein such as P/N ratio, the Controller ought to have determined the advantageous results of the invention.

The Controller has observed that the invention relates to an iron (III) caseinsuccinylate characterized by a content of iron comprised between 4.5% and 7% by weight and by solubility in water greater than about 92% having P/N ratio greater than 5%. Further, it also relates to the method of preparing iron (III) caseinsuccinylate. On the contrary, the prior arts uses commercial casein and it is pretty clear that if the starting material is of good quality then the product shall also be in a good quality. Hence, it is obvious for a person skilled in the art to replace the commercial grade casein with the purified casein.

In particular, D1 had already disclosed “casein of suitable purity” which is enough for a person skilled in the art to prepare the iron succinylated casein with different range of qualities as starting material. Further, examples of the claimed invention also fall within the disclosures of D1, D2, D3 and D5. Hence, it is obvious to the person skilled in the art to replace the commercial grade casein with that of the purified casein as starting material.

Therefore, the Controller had came to the conclusion that reactants casein, succinic anhydride and iron chloride are same and the product iron succinilated casein is a known product, which does not involve any inventive step of the Appellant, and thus, the patent application has to be refused under Section 3(d) of the Act when compared with the examples of D1, D2, D3 and D5 with that of claimed invention.

VERDICT

The enhancement of efficacy is an essential condition to overcome the objection u/s 3(d). Moreover, the invention also needs to be totally new. If there is only a change in the molecular formula of the substance used in the drug, then the invention is not patentable, because, it is not new and novel. The product in question needs to be undoubtedly new. Merely to change the molecular formula does not satisfy the test of novelty and hence, such inventions cannot be patented.

The Hon’ble court has observed that the Controller had provided justifiable reasons in the impugned order to refuse the grant of the Patent Application and there is no contra evidence procured by the Appellant to dispute the same, and the Controller’s order has been upheld.