CAN A CAREFULLY OPTIMISED COMBINATION OF KNOWN HERBALINGREDIENTS QUALIFY FOR PATENT PROTECTION?

In a recently issued order, the Indian patent office refused patent application no.

202541106546 under section 15 of the Patents Act, 1970. The Controller refused the

application as the specification failed to enable the claimed invention and the applicant did

not demonstrate a synergistic effect supported by adequate experimental evidence.

Background of the Invention

The applicant claimed a herbal shampoo comprising Sapindus mukorossi extract, fermented

rice water, Phyllanthus emblica extract, aloe vera gel, Azadirachta indica extract, Ocimum

sanctum extract, Zingiber officinale extract, xanthan gum, clove oil, and fennel oil of specific

quantitative ranges, and asserted that the formulation had desirable physiochemical

characteristics including pH between 6.5 and 6.7, viscosity between 1.10 and 1.40 cP, and a

foaming index of about 500.

Following the publication of the application, a First Examination Report was issued, which

raised objections under Section 10(4), 2(1)(ja), and 3(e) of the Patents Act, 1970. The

applicant responded to the First Examination Report. A Hearing Notice was then issued. The

applicant attended the hearing and filed amended claims, written submissions, an affidavit

and experimental data. However, the Controller held that the objections remained unresolved

and refused the application.

Client Arguments and Controller Analysis

Sufficiency of Disclosure – Section 10(4)

Section 10(4) of Indian Patents Act, 1970 states that every complete patent specification is to

fully and particularly describe the invention, disclose the best method known to the applicant,

and end with clear claims defining the scope of the invention. The Controller observed that,

although the current specification disclosed the concentration ranges for all the claimed

ingredients, it lacked detailed working examples, experimental protocols, comparative

studies, testing methods, and technical data.

The applicant filed an affidavit containing a composition optimisation study. However, the

Controller noted that the study varied only 2 the Sapindus mukorossi extract and fermented

rice water and omitted the remaining eight ingredients claimed in claim 1. Consequently, the

reported results could not be correlated with the claimed invention due to which the

Controller decided that the specification along with affidavit failed to provide the disclosure

as required under Section 10(4).

The Controller’s decision was based on the Calcutta High Court’s decision in Fraunhofer-

Gesellschaft vs Controller General of Patents, Designs and Trade Marks, where the court

emphasised that an enabling disclosure is required in exchange for exclusive monopoly

granted by a patent.

Inventive Step under Section 2(1)(ja)

Next, the Controller examined whether the claimed formulation involved an inventive step

and used the five-step approach to assess the same. The closest prior art was found to be an

earlier Indian Patent application describing a sulphate-free herbal shampoo containing

fermented rice water, Sapindus mukorossi, Phyllanthus emblica, Azadirachta indica, Ocimum

sanctum, natural thickeners, essential oils, and other herbal ingredients for cleansing,

conditioning, and scalp nourishment. Another published literature related to fermented rice

water shampoo and polyherbal shampoo formulation was also relevant.

While comparing the claimed invention with the cited prior art, the Controller found out that

all ingredients along with their functions were already disclosed. The only distinguishing

features were the concentration ranges and physiochemical parameters like pH, viscosity and

foaming index. Hence, a person skilled in the art, faced with the problem of providing an

optimised herbal shampoo possessing desirable physiochemical characteristics, would have

routinely arrived at the same, by combining the teachings of the cited prior art, without undue

Experimentation.

The applicant depended on experimental data to show the technical advancement. However,

the Controller found that only 2 ingredients were investigated, the applicant did not compare

the claimed formulation with the closest prior art, and optimisation of concentrations

constituted routine formulation work. Therefore, the Controller concluded that the claimed

invention was a routine optimisation and lacked an inventive step.

Mere Admixture under Section 3(e)

According to Section 3(e) of the Indian Patents Act, 1970, a substance obtained by a mere

admixture resulting only in the aggregation of the properties of the components thereof or a

process for producing such substance is not considered an invention and cannot be patented.

For formulation-based inventions, applicants must prove that the interaction between

ingredients produces a synergistic effect rather than an additive effect.

The Controller observed that every ingredient performed only its well-established known

function. As a result, the invention was held to represent only as an aggregation of known

properties and fell within the purview of section 3(e).

Key Takeaways for Inventors

Inventors must establish synergy through appropriately designed comparative studies and

provide necessary experimental data.

How we can Help?

We at Quadriga work closely with our clients to evaluate prior art, prepare clear

specifications, and ensure that technical disclosures are backed with supporting data that are

aligned with the legal requirements of the Indian Patents Act, 1970.