- Whether the Controller erred in rejecting the patent application in regards to a formulation under section 3(j), section 3(e) and lack of inventive step under section 15 of The patents Act, 1970
Short description of Patent: The invention relates to the topical formulation of the compounds obtained from the plant ‘Comfrey’ i.e., comfrey or comfrey-derived compound such as allantoin, and tannic acid, and may optionally comprise a penetration enhancer (to promote absorption of drug through the skin) which is used for prophylactic management and / or treatment of arthritis
- The National phase application 904/KOLNP/2009 was filed on 21st May 2005. The FER of the said application raised objections of disunity of invention and non-patentability of the present invention under Section 3(c), Section 3(e), Section 3(i) and Section 3(j).
- Subsequently, the first hearing notice was issued on 15/09/2015 and pursuant to an adjournment request by the appellant, a second hearing notice was issued on 30/09/2015 and the hearing was held on 12/10/2015.
- The controller against the hearing notice dated 30/09/2015 refused the patent application under section 3(j), section 2(1)(ja) and section 3(e), leaving other objection of hearing notice unaddressed under section 15 of the Patents Act. This appeal is against the said order.
SUBMISSION BY APPELLANTS
- According to the appellants, the invention is related to a topical formulation of the compounds obtained from the plant ‘Comfrey’ i.e., comfrey or comfrey-derived compounds such as allantoin, and tannic acid. Thus, it cannot be objected under section 3(j) as the formulation is utilizing extracts from plants in a specific concentration and not itself the plant or part thereof.
- The Respondent erred in refusing the application under section 3(e). It was submitted that the synergistic effect on an improvement in joint stiffness in patients is evident from the specification.
- According to the appellant, none of the cited prior art, either individually or in any combination, even remotely suggest, teach or disclose the invention claimed in the present invention. It was also submitted that the respondents had merely mosaiced citations from different jurisdictions / corresponding applications and cited them in the present application.
SUBMISSION BY RESPONDENTS
- According to the respondents the instant invention is a formulation that includes the compounds as extracted from comfrey root extract, comfrey leaf extract or a combination which is a mere admixture resulting in an aggregation or duplication of known properties of prior art compounds having known components and known uses lacking synergism objected under section 3(j), section 3(e) and section 2(1)(ja) respectively.
- The invention lacks inventive steps with regard to prior art disclose the use of a cream comprising comfrey root extract (Kytta) for the treatment of arthritis.
- The court opined that invention is related to ‘topical formulation’ prepared of a combination of (i) comfrey and (ii) tannic acid in a particular proportion rather than claiming plants and animals in whole or any part thereof nor relating to seeds, varieties and species and essentially biological processes for production or propagation of plants and animals. Thus, this would not attract section 3(j) of the Patents Act, 1970.
- According to the court, objection of section 3(e) is overcome by the synergistic effect of the invention on joint stiffness indicated by greater reduction in the WOMAC index of the compounds respectively.
- The court clarified that the grant of patent in some other jurisdiction has no binding effect on the Indian Patent Office; but if the novelty and /or inventive step is questioned on the same prior arts, then it amounts to injustice and is against the principles of equity and fair play. Further the court accepted the submission of appellant with regards to inventive step and held that the respondents submission with respect to inventive step and section 2(1) (ja) does not sustain.
- The court waived off all the other unaddressed issues by the respondent.
Therefore, impugned order is set aside and the court directed to amend few claims
Copy of judgement
IPAB order No: OA/16/2016/PT/KOL
Citation 2021 SCC OnLine IPAB 99