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The Controller General of Patents has issued guidelines for processing of patent applications relating to Traditional Knowledge (TK) and biological materials on November 08, 2012 which can be accessed here.
The guidelines have been issued in lieu of the fact that a number of the Indian Patent Applications relating to herbal (plant) compositions/extracts/alkaloids (and other biological resources from India) are being granted in India even though their corresponding Foreign applications in the jurisdictions (US/EP/JPO etc.) where the TKDL access have been provided are being rejected. Due to lack of any standard procedures, different Examiners/Controllers have been analysing the inventions from the patentability criteria differently.
Among the various points discussed in the guidelines, the assessment of novelty and inventive step are the most useful ones especially the inventive step determination, which even though the patent agents/attorneys know well sometimes that the composition is obvious, the Applicants still want to go ahead in filing. Thus these guidelines would provide great clarity not only to the Examiners/Controllers but also to inventors/Applicants.
The novelty determination for example is straight. The claims on extracts/alkaloids/”isolation of active ingredients” will not be considered novel for a treatment of a disease when such extracts/alkaloids are already known in the art to be used in the treatment of said disease. There are some examples cited in the guidelines throwing clarity which can be read from there.
The inventive step determination is also described therein with various examples. One clear principle described is that a herbal composition comprising more than one plant parts/extracts with known-therapeutic effect for the treatment of disease wherein all these plants are known for treating the same disease would be considered obvious, even though such combinations of medicinal plants would be more effective than each of the medicinal plants when applied separately (additive effect).
Another principle described is that when a plant ingredient/extract/alkaloid is already known for the treatment of a disease, then it creates a presumption of obviousness that a combination product comprising this known active ingredient (with other plant extracts) would be effective for the treatment of same disease.
Another important guiding principle is on the claimed concentration ranges of the ingredients of the composition. The guidelines make this clear that discovering the optimum or workable ranges of plant ingredients by routine experimentation is not inventive. It is emphasised that although cited art may not specifically teach the claimed percentage ranges, however the amount of specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Therefore all the claims claiming,
“A pharmaceutical formulation comprising an extract of Pongamia pinnata in the range of 2 to 20%, an extract of Lawsonia alba in the range of 5 to 15%, an extract of Dhatura alba in the range of 2 to 20% and an extract of Cocos nucifera in the range of 20 to 60% for the treatment of chronic ulcer, diabetes ulcer and wounds” would be obvious if the plant parts are known in the art for treating the same diseases.
The guidelines however do not discuss certain other scenarios, such as, what if different plant part of the same plant is used in a composition as opposed to the plant part known in the prior art. For example, let’s say the claim is follows:
“A pharmaceutical formulation comprising an extract of root of X; an extract of leaf of Y, and an extract of stem of Z for treating a disease A”. Suppose it has been discussed in the literature that the different plant parts of same plant, say X, has different biological activities (due to different biological components). In that case is it obvious if the Applicant claims a composition comprising an extract of a different part of the plant from the plant part as disclosed in the prior art?
Another scenario not clarified in the guidelines is on the obviousness criterion of claiming a composition with different species of same genus. For example, a genus Phyllanthus has many species including P. acidus, P, emblica, P. Niruri and so on. Will it be obvious for a skilled person to arrive at a composition comprising one species of the same genus plant wherein the prior art discloses a different species of the same genus plant for the same disease further when the scientific literature proves that different species have different biological activities. There had been a prosecution case with us for example wherein we got a couple of scientific literature articles. Amongst them, some proved different biological activities of different plant parts of the same plant X and some others proved different biological activities of different species of the same genus plant Y. We argued in one of the office actions that since different plant part of X is used in the prior art and different species of Y is used in the prior art for treating the same disease, it would not be obvious to use different plant part and species and yet achieve better efficacy as the skilled person would not to motivated to use such different plant part and species. The patent was granted, of course, in addition of the number of other technical arguments including unexpected results and so on. Well, that’s a different story to tell.
Coming back to the guidelines, the same also discuss the formalities requirements in filing Form 1. The permission of National Biodiversity Authority (NBS) would be sought in a form of declaration in paragraph 9 (in) in the form of “the invention as disclosed in the specification uses the biological material from India and the necessary permission from the competent authority shall be submitted by me/us before the grant of patent to me/us”.
In the concluding statement, I believe that these guidelines will indeed be proven a useful means for the Examiners/Controllers and the Applicants alike for clarifying the obviousness criterion which at the moment is not being met properly at the Indian Patent Office due to lack of uniformity in examiners/controllers decisions as is evident from certain Indian granted patents. Protecting our therapeutic biological resources from monopolistic rights is indeed a duty of each and every one of us and we should contribute in any way we can, whether we are examiners, inventors or agents.
About the Author: Meenakshi Khurana, Patent Attorney, available at firstname.lastname@example.org