Cosmetic compositions and methods, like any other invention, are expected to meet the three-step requirement of patentability in India before obtaining legal protection, i.e. the invention must meet the criteria of “Novelty”, “Inventive step” and ” Industrial Application. ”The invention should also not fall under the list of exceptions contained in Section 3 of the Patents Act, 1970 (” the Act “), and its related provisions.
For the patentability of cosmetic compositions, in addition to being new and inventive, typically, the composition must also avoid the exceptions contained in Sections 3 (d), 3 (e) and 3 (p) of the Act.
I. Section 3 (d)
Section 3 (d) bars from patentability the mere discovery of a new form of a known substance which does not lead to the enhancement of the known efficacy of that substance or the mere discovery of a new property or use for a known substance.
In IN742 / KOLNP / 2012, the application regarding vanillin derivatives for use in cosmetic compositions was challenged under this provision. The applicant was able to address the objections by demonstrating that the claimed compound has better retention and efficacy properties than the prior known vanillin.
ii. Section 3 (e)
Section 3 (e) bars from patentability a mere mixture that results only in the aggregation of the properties of the components. In other words, Section 3 (e) requires that in a composition, the components must result in a synergistic effect.
According to paragraph 10.16 of the “Guidelines for the examination of patent applications in the pharmaceutical sector”, in a composition if the functional interaction between the characteristics achieves a combined technical effect greater than the sum of the technical effects of the individual characteristics, it indicates that this composition is more than a mere aggregation of the characteristics.
In Indian Patent Application (IPA) 201827046903 for a cosmetic method and composition for improved transdermal administration of alkyl substituted resorcinol, the Indian Patent Office (“IPO”) objected to patentability under Section 3 (e). The IPO accepted the applicant’s arguments that a pyridine compound of formula I or formula II aids in the transdermal administration of an alkyl-substituted resorcinol when present together in a cosmetic composition. Furthermore, the data presented showed that a combination of 4-hexyl resorcinol and picolinamide in a certain amount provides 13% inhibition in melanin synthesis compared to the respective controls which showed 3% inhibition and inhibition of melanin. ‘1%.
iii. Section 3 (p)
Section 3 (p) excludes from patentability traditional knowledge or an invention that is an aggregation or duplication of known properties of traditionally known components.
Patent application IN728 / MUM / 2015 relating to an ester of nicotinic acid or its derivatives, coming from a vegetable oil, was rejected pursuant to Section 3 (p). The IPO found that the effect of the claimed invention is due to coconut oil, traditionally known for treating the skin. The IPO relied on the experimental data presented with the application to arrive at this conclusion. The data experiment involved the application of ethyl nicotinate on the one hand and the ethyl nicotinate coconut ester of the claimed invention on the other. The hand on which ethyl nicotinate was applied became red in color, while the other hand did not show this red color, thus confirming the non-irritating property of the coconut ester of ethyl nicotinate.
IN161 / KOL / 2011 relating to a skin care composition comprising methanol extract from aerial parts of Hairy Tephrosia as an active ingredient, it was also rejected under Section 3 (p), based on usage Tephrosia hairy for skin care is well known and traditionally obvious.
Patent applications for cosmetic treatments tend to face objections under Section 3 (i) of the law.
I. Section 3 (i)
Section 3 (i) bars from patentability any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of humans or any process for similar treatment of animals to render them disease-free or to increase their economic value or that of their product.
The Patent Office Manual of Practice and Procedure, Version 3.0, paragraph 09.03.05.08 and the “Guidelines for examining patent applications for biotechnology”, paragraph 15 (i), clarify that cosmetic treatments are excluded from Section 3 (i) and “the application of substances to the body for purely cosmetic purposes is not therapy” and are therefore excluded from the scope of Section 3 (i).
To understand the scope of “purely cosmetic” purposes, IN 201917045923 is an illustrative patent application, which relates to the computer-assisted colorimetric make-up method for camouflaging skin color deviations. The application was challenged under Section 3 (i), as the camouflage of a tonal imperfection falls within the scope of Section 3 (i). The IPO accepted the applicant’s arguments that the invention concerned a method of accurately selecting and depositing a pigmented cosmetic composition comprising matting particles on human skin to camouflage tonal imperfections and that the term “tonal imperfection” does not refer to any disease. Consequently, the deposition of the pigmented cosmetic composition of the invention is purely cosmetic and does not cure any disease in any way.
On the other hand, IN1376 / DELNP / 2007 relating to a method of changing eye color was rejected by the IPO, which concluded that the claimed method of changing eye color involves the formation of an annular canal in the eye. human using surgical blade or laser technique and cutting the cornea of the eye is a surgical method as it requires significant physical intervention by a highly trained person. The IPO also took into consideration the applicant’s arguments that the claimed invention is not provided to treat humans to make them disease free, but is only a cosmetic method of coloring the eye in such a way that people with insufficient pigment in the iris are not prone to eye-related diseases; and that the method is merely a preventive method of shielding the eye from harmful radiation at a later stage. However, the IPO noted that even with this argument, the claims would appeal to section 3 (i) as the method falls under the prophylactic method, which is a course of action used to prevent disease.
Therefore, for a cosmetic treatment to be patentable, it must be demonstrated that the treatment does not in any way involve the cure or prevention of any disease or condition.
In IN4605 / DELNP / 2012 relating to anchors and systems and methods of using the hair implant, while claims relating to the hair implant device were allowed, claims relating to the hair implantation method were not permitted. The IPO was of the view that these claims indirectly referred to methods of treating the human or animal body by surgery or therapy.
Similarly, in IN1357 / CHE / 2009 relating to the method and apparatus for stimulating a hair cell by means of an acoustic signal, the IPO allowed for statements regarding the apparatus to stimulate a hair cell by acoustic stimulation, but not the statements relating to a method to stimulate a hair cell.
IN8930 / DELNP / 2008 relating to a cleaning method of an oral surface, was rejected by the IPO, as relating to a curative and prophylactic process of oral cavity treatment and therefore falls under Section 3 (i).
In some cases relating to cosmetic treatments, applicants attempted to address objections under Section 3 (i) by introducing the limitation of the “non-therapeutic” method in the preamble of the claims. However, it was noted that such limitations may not be able to address the Section 3 (i) objection. For example, in IN2562 / MUMNP / 2015, the applicant had changed the previous objected treatment method by adding the phrase “non-therapeutic method”. However, the Holder maintained the objection, as “Article 3 (i) is not limited to the only therapeutic or surgical method, etc. while other treatments of human beings or to increase their economic value or that of their products are also under section 3 (i) as a whole which also includes any process for medicinal, surgical, curative, prophylactic, diagnostic, therapeutic purposes and the declared object is dermatological or cosmetic, which is applied to human skin.
In addition to the requirements of the Patent Act, an invention relating to cosmetic compositions or methods may be required to comply with the Biological Diversity Act, 2002 (“the BD Act”).
Under the BD Act, any person / entity filing a patent application anywhere in the world for any invention based on a biological resource obtained from India must obtain the appropriate approvals. Approval must be obtained from the National Biodiversity Authority (“NBA”) and can be applied for and obtained after filing a patent, but it must be previous one to the granting of a patent. The term “biological resources” means plants, animals and microorganisms or parts thereof, their genetic material and by-products (excluding value-added products) with actual or potential use or value. The definition does not include human genetic material.
Therefore, cosmetic compositions involving herbs and plant extracts would require NBA approval.
In IN728 / MUM / 2015 (supra), the IPO required the applicant to obtain approval under the BD Act, as the invention used aerial parts extracts of Tephrosia hairy. In response, the applicant argued that the material is value added material and therefore the BD law was not applicable. The IPO rejected this argument and found the material to be within the scope of biological resources under the BD Act.
The patentability of cosmetic compositions and treatments in India implies compliance with the requirements not only under the Patents Act, 1970, but also under the Biodiversity Act, 2002. Depending on the nature of the invention, it is likely that different types of objections to pursue a patent application. Careful drafting and vindication can help prevent objections under the Patents Act, while the use of herbs and plant material in such inventions would require additional administrative approvals from the Indian government. It is important to note that these approvals are required for all inventions using biological resources from India, regardless of where in the world the application is filed.