Summary
he Madras High Court has set aside the Assistant Controller of Patents’ decision rejecting Shaperon Inc’s patent application for compositions to treat allergic skin disorders. The Court found that the Controller had failed to properly consider Shaperon’s arguments, supporting data, and the existence of foreign patents for the same invention. Shaperon argued that its invention, involving GPCR19 agonists for topical use, showed unexpected therapeutic results and had already received patents in the U.S., Europe, and Japan. The Court also criticized the Controller’s omission of an affidavit demonstrating enhanced efficacy through transdermal administration. As a result, the case has been remanded to a different officer for re-evaluation and a fresh, reasoned order within four months.
The Madras High Court upheld an appeal filed by Shaperon Inc, challenging the rejection of its patent application for compositions aimed at the prevention or treatment of allergic skin disorders by the Assistant Controller of Patents. The Court found that the rejection order lacked proper consideration of Shaperon’s key arguments, supporting evidence, and foreign patent grants.
Background
Shaperon had filed a patent application in March 2014 titled “Compositions for preventing or treating allergic skin disorders, containing GPCR19 agents as active ingredients.” A First Examination Report (FER) was issued on 25th May 2018, raising objections on the grounds of lack of novelty and inventive step based on four prior art references, as well as non-patentability under Section 3(e) of the Patents Act. Following a hearing notice issued on 6th February 2020, Shaperon submitted written submissions along with amended claims. However, the application was rejected by the impugned order dated 22nd April 2020.
Shaperon contended that prior art documents D1 and D3 relate to the use of GPCR19 agonists for the treatment of sepsis, whereas the claimed invention is specifically limited to and directed towards infectious skin disorders. Prior art D2 disclosed a different compound, namely a GPBAR1 agonist, intended for the treatment of inflammatory conditions, while D4 failed to disclose the claimed active ingredient, sodium taurodeoxycholate. They further argued that the Controller had failed to consider the inventor’s affidavit, which stated that oral administration of GPCR19 agonist in the form of an injection resulted in a very short half-life, whereas topical administration led to an enhanced therapeutic effect. Further, Shaperon highlighted that the claimed invention had been granted patents in jurisdictions including the United States of America, Japan and Europe, despite similar prior art references being cited.
In response to Shaperon’s arguments, the Controller’s counsel contended that the claimed invention lacked inventive step in view of prior arts D1, D2, and D3, which disclosed the use of GPCR19 agonists, such as sodium taurodeoxycholate, for the treatment of inflammatory conditions, including atopic dermatitis, through topical administration.
Court’s analysis
The Court noted that the Controller had found claim 1 to be similar to what was disclosed in D1. However, the Controller did not consider Shaperon’s arguments that D1 primarily focused on sepsis, lacked data on the efficacy of the method for treating atopic dermatitis, and that D4 disclosed different compounds. It also observed that similar objections raised in relation to D3 were not addressed by the Controller.
The Court further noted that the Controller had rejected the claimed invention as obvious over D1 to D4, stating that there were no demonstrated unexpected or surprising effects arising from the claimed external preparation over the known formulations/preparations.
Furthermore, the Court observed that the Controller had failed to consider the affidavit by Dr. Seong Seung-Yong, which highlighted the unexpected therapeutic effect of HY2191 when administered transdermally for the treatment of atopic dermatitis, as compared to oral or injectable routes.
The Court also noted that the submission made by the Controller’s counsel, referring to paragraph [0038] of D1 which mentioned the transdermal administration of the GPCR19 agonist, would require reconsideration upon remand, particularly in light of Shaperon’s argument that D1 focused on the treatment of sepsis and not atopic dermatitis.
Additionally, the Court observed that the claimed invention had been granted patents in multiple jurisdictions, including the United States of America, Japan and Europe. It also noted that the European Patent Office had considered the same prior art references as cited by the Controller. In view of the above, the Court held that these foreign grants should have been taken into consideration as one of the factors in the decision-making process.
Conclusion
In conclusion, the Court set aside the impugned order dated 22.04.2020 and remanded the matter for fresh consideration by a different officer to avoid any pre-determination. The Court also directed that a reasoned order be passed within four months, after giving the appellant a reasonable opportunity of being heard.
Citation: Shaperon Inc vs Assistant Controller Of Patents (OA/27/2020/PT/CHN) (H.C. Madras March 6, 2025). Available at: https://indiankanoon.org/doc/12969129/
Authored by Dr. Vasundhara Paliwal, Patents Team, BananaIP Counsels.
Article review by Neetha Mohan
Accessibility review by Gaurav Mishra