An appeal against the order dated 29^th December 2021 passed by the Assistant Controller of Patents and Designs, refusing the application for grant of patent application No. 201817040811 for an invention title “Composition for use in the Prophylaxis of Allergic Disease” has been allowed by the Delhi High Court and the patent office has been directed to grant a Patent.

The patent application is directed towards a composition which is a mixture comprising DGLA and certain omega-3 polyunsaturated fatty acids. The complete specification states that these omega-3 polyunsaturated fatty acids, which are to be used in combination with DGLA in the composition, could be either DHA (Docosahexaenoic acid) or EPA (Eicosapentaenoic acid) or even a combination of DHA and EPA. It has also been specified that the concentration of DGLA will be more than the concentration of DHA, EPA or the mixture of DHA and EPA.

The Court noted that the appellant has provided in the specification that the administration of this composition yields the technical advancement/effect of reduction of allergies in the offspring of a mammalian subject.

Before the rejection of the Controller in the impugned order and the reasons of the Delhi High Court allowing the appeal are discussed, it is important to see the claims of the application that were pending before the hearing, and the revisions that were made by the Appellant pursuant to the hearing, based on which the refusal order was issued.

The pending Claim 1 at the time of hearing was as follows:

“1. A composition comprising DGLA for use in the prophylaxis of allergic disease in an offspring of a mammalian subject, comprising administration of the composition to said subject pre-pregnancy and/or during pregnancy and/or during lactation and preferably wherein said composition is a composition enriched in DGLA wherein said composition also contains an omega-3 polyunsaturated fatty acid, selected from the group consisting of DHA and EPA or a combination of DHA and EPA, wherein said DGLA is comprised in said composition in a concentration of at least 3wt% relative to the total fatty acid content of the composition and more preferably in a concentration of at least 5wt%, at least 10wt%, at least 20wt%, at least 30wt%, at least 35wt%, or at least 40wt% relative to the total fatty acid content of the composition; and wherein the concentration of DGLA is greater than the concentration of DHA or EPA.”

23. After hearing, the Claim was amended to read as follows:

“1. A composition comprising DGLA wherein the composition is enriched in DGLA and contains an omega-3 polyunsaturated fatty acid, selected from the group consisting of DHA and EPA or a combination of DHA and EPA, wherein said DGLA is comprised in said composition in a concentration of at least 35wt%, relative to the total fatty acid content of the composition; and wherein the concentration of DHA is 20 to 26wt% and concentration of EPA is 7wt%.”

The impugned order passed by the Patent Office held that:

(i) Claims of the patent application of the appellant defined a method for treatment of human body and were therefore, not patentable as the scope of the Claims fell under Section 3(i) of the Act.

(ii) The amended Claims filed by the appellant were not permissible in terms of Section 59 of the Act, as the amended Claims sought to confer greater scope of protection, in comparison to the originally filed Claims, which Section 59 of the Act prohibits.

(iii) The data given by the appellant for the claimed composition was not demonstrating stabilized synergism and the appellant failed to provide data comparing individual effects of each drugs/active ingredients with combination of them so as to prove synergy.

Therefore, as per the impugned order, the patent application did not meet the requirements of Section 2(1)(ja) and Section 3(e) of the Act.

As far as the rejection of non-patentability under Section 3(i) is concerned, the Court held that the subject claims are directed towards a composition, comprising DGLA, EPA and DHA. The said composition has been developed for the purpose of using the same in prophylactic treatment of allergic diseases. The court also noted that the appellant has also claimed that the said composition is useful in preventing or reducing the risk of development of allergies.

The court held that claims prior to hearing, and those filed after the hearing, both, were in respect of a composition comprising DGLA and not towards a process of prophylactic treatment. The court clarified that the expression composition comprising DGLA directed towards treatment was used only for defining the composition and not directed towards a method of treatment.  The Court therefore held that the composition claims do not fall under Section 3(i).

As far as the second rejection on amendment is concerned, the Counsel representing the controller of patents  argued that while amending the Claims, the original scope of the claims stood expanded and the protection claimed was enhanced, as instead of being a purpose-related claim (as it was in prior to the hearing), it became a general claim over the composition pursuant to the hearing. Based on this, and on a query raised by the Delhi High Court regarding the claims the appellant wished to pursue, the Appellant proposed claims of the kind that existed prior to the hearing.

Counsel for the respondent submitted that it was not permissible for the appellant to resort to the previously filed Claims at this stage. The Delhi High Court however disagreed and allowed the amendment. The court held that:-

• Amendment can be filed at any stage, even at appeal stage;
• Only requirement under the Act is that the amendment has to fulfil the requirements under Section 59 of the Act;
• the consideration that has to be kept in mind is that the amended Claims should not be inconsistent with the earlier claims in the original specification;

The court noted that the appellant is resorting back to the previously filed Claim, and held that the same is fully covered under Section 59 of the Act.

For Section 3(e), the Court held that the perusal of the material on record shows that the appellant has provided extensive experimental data in the specification supported by examples as well as drawings showing synergistic effect of the claimed composition when compared to the individual components.

The Court also considered that the invention claimed is inventive as: –

• the prior arts cited are having priority dates in the year 1995 whereas the present patent application has a priority date of 1^st June, 2016.
• the prior arts cited are more than 20 years older than the subject Patent Application.
• when the cited prior arts are considerably old, it is a clear indicator of non-obviousness.
• the prior arts cited by the Indian Patent Office are the same as that were cited by the European Patent Office (EPO) when the corresponding European (EU) patent application was being prosecuted.
• Grant in other jurisdictions is also persuasive and in support of the grant of the Indian Patent Application, especially when the same prior art has been cited.

The Court therefore directed the patent office to grant the application.