An appeal filed on behalf of the Appellant – DS Biopharma Limited, under Section 117A of the Patents Act, 1970, challenging the order dated 13th January, 2021 passed by the ld. Assistant Controller of Patents has been allowed. The claims refused by the Controller were as follows:-

“1. A composition comprising 0.1g to 4g of (5Z,8Z,11Z,13E,17Z)-15-oxoicosa-5,8,11,13,17-
pentaenoic acid (“15-oxo-EPA”).

2. A pharmaceutical composition comprising (5Z,8Z,11Z,13E,17Z)-15-oxoicosa-5,8,11,13,17-
pentaenoic acid (“15-oxo-EPA”) and one or more of antioxidants, surfactants, preservatives, flavoring agents, co-solvents, viscosity aids, suspension aids, and lipophilic phases.

3. A composition comprising 0.1g to 4g of (8Z,11Z,13E)-15-oxoicosa-8,11,13-trienoic acid (“15-
oxo-DGLA”).

4. A pharmaceutical composition comprising (8Z,11Z,13E)-15-oxoicosa-8,11,13-trienoic acid (“15- oxo-DGLA”) and one or more of antioxidants, surfactants, preservatives, flavoring agents, cosolvents, viscosity aids, suspension aids, and lipophilic phases.”

Appellant submitted that the only objection which was raised in the hearing notice was in respect of Section 3(d) of the Act. Despite this being the position, in the impugned order, the grounds of lack of inventive step under section 2(1)(ja) in addition to Section 3(d) and lack of clarity under Section 10(4)(c) of the Act have also been used as grounds to reject the patent application.

The appellant also submitted that there is no clarity as to whether claims 1, 4 have been rejected or claims 1-4 have been rejected. In fact, there is contradiction between the hearing notice which states claim 1,4 and the final impugned order where claims 1, 3 are stated to be not meeting the requirement. This is violation of principles of natural Justice.

The Court noted that the legal position in respect of an objection under Section 3(d) was considered by the IPAB in ORA/22/2011/PT/KOL titled Fresenius Kabi Oncology Limited v. Glaxo Group Limited & Anr.

The relevant portion of the order is as follows:

“56. It is true that it is the patentee who must prove the enhanced therapeutic efficacy of his invention. But in a revocation the applicant must plead and prove that it is hit by S.3(d) and that it has the same therapeutic efficacy as the known substance. Then the respondent will counter it either by proving that it is not a derivative of a known substance or by proving that though it is only a new form of a known substance he has shown that it has enhanced therapeutic efficacy. In the present case, there are no such pleadings. It is not enough to plead that because Ex1 and 2 are admitted prior arts, this is only a new form of those compounds. That is vague. It is
only when the pleadings show how the invention is one kind of a derivative of known substance the patentee will have to explain how the grant of patent is justified because of the enhancement of therapeutic efficacy. In this case the pleadings are not adequate. We hold that the S.3(d) ground has not been proved.”

Though not in the context of a patent office objection, the observations would be relevant to examine as to how the objection under Section 3(d) is to be raised.

The Court held that Section 3(d) bars patentability of a new form’ of a known substance’, without establishing enhanced therapeutic efficacy. For the said objection to be raised, the basic pre-condition would be the identification of the a known substance’. The said known substance’ could be one substance or a compound/s derived from a Markush formula. However, it has to be identified. It cannot be left to the Applicant to deduce as to what is the known substance and thereafter give efficacy data qua that known substance, based on the said deduction. It is only new forms of substances which are derived from the same known substance that would attract the rigors of Section 3(d).

In the present case, the finding of the Controller was as under:
“The claimed compounds differ from the compounds of the prior art only on the account of minor modifications, namely the presence of an oxo group at position 15 of the carboxylic acid chain instead of a OH group of H atom with respect to the compounds of D1 and D4 respectively, and the presence of a double bound between C17-C18 of the carboxylic acid chain instead of a single bond with respect to the compound of D6.”

Thus, as per the Court, the Controller clearly holds in the impugned order that the identified compounds are in D1 and D4 in which at position 15, a substitution has been made by the Appellant. The identified known substances are also in D6 where the presence of double bond between C17 and C18 of the carboxylic acid chain, instead of the single bond in the claim of the Appellant. However, the Court noted that these facts could have been contained in the hearing notice, upon which, the Appellant could have responded as to how the objection under Section 3(d) was not attracted or the Appellant could have also established that the subject compounds had enhanced therapeutic efficacy to satisfy the pre-conditions under Section 3(d).

Therefore, holistically read, the Court held that the Appellant has not had adequate opportunity to deal with the objection under Section 3(d) in as much as apart from merely specifying the said objection for the first time in the hearing notice, the manner in which the said objection was attracted was completely absent.

In order to afford the Appellant a fair opportunity to deal with the objection, the Court set aside the impugned order and gave the following directions:

i) The Appellant to file its response on the basis of the identified known substances and the extracts of the impugned order as set out above and in the response, the Appellant may also produce efficacy data and support its submissions as to how Section 3(d) is not applicable.

ii) The said response to be filed by the Appellant within a period of 8 weeks – upon which, a fresh hearing shall be granted on the issue of whether the claims 1-4 are liable to be granted or not.

iii) The Controller is also permitted to consider along with the objection of Section 3(d) the objection relating to lack of inventive step, if any.