Patent office refuses review petition of Sun Pharma for its anti-dengue botanical drug

New Delhi, March 10, 2023 :

The Indian Patent Office has upheld its earlier decision refusing patent rights to Sun Pharmaceuticals for its botanical drug to treat dengue following a review petition, as the company representatives neither attended nor filed submissions against the hearing notice issued by the authority.

The patent application, initially filed by Ranbaxy Laboratories and took over by its acquirer Sun Pharmaceutical, was to seek exclusive rights for its invention related to anti-dengue activity of Cissampelos pereira extracts, which is also known as Velvet Leaf and Patha in Hindi, and an ayurvedic medicinal plant used traditionally for the treatment of irregular heartbeat, acute diarrhoea, cancer and irritable bowel syndrome among others.

The patent office in November, 2019, issued an order refusing the patent application, observing that the company has not mentioned whether the approval from National Biodiversity Authority (NBA) has been taken or awaiting approval and concluding that the company has not applied for NBA approval. However, it said that the first seven claims by the company are novel and innovative over the prior art, considering that one of the prior documents disclose the claimed process for preparation of an extract of Cissampelos pareira for treating dengue virus infection.

The company submitted a review petition in January, 2020. However, when the hearing of the review petition was fixed in two days in February, 2023, the company or its authorised agent neither attended the hearing nor filed any submissions related to this, said an order issued on March 6, 2023.

“In view of the above, the ‘review petition’ is refused and the earlier decision of the Controller stands,” said the latest order by the Deputy Controller of Patents and Designs, Patent Office, Delhi.

In May, 2016, the company has said that it has signed an agreement with International Centre for Genetic Engineering and Biotechnology (ICGEB) to develop a novel botanical drug Cissampelos pareira (Cipa), for treatment of dengue.

Through the agreement Sun Pharma announced to follow up on earlier pre-clinical collaboration between ICGEB and erstwhile Ranbaxy Laboratories Ltd to develop Cipa by following a drug registration process similar to a new chemical entity, consisting of all required in-vitro, in-vivo, pre-clinical and clinical studies meeting all regulatory standards of India and other regulatory agencies worldwide.

The company, during the time, said that considering the significance of the public health risk dengue raises in the country, a drug for the disease is an unmet need and using the traditional knowledge of Indian medicine, it is exploring the indigenous herbal bio-resource to identify plants with pan dengue virus inhibitory activity, following which it has identified Cipa as a safe, affordable and effective solution. The terms of the agreement permits Sun Pharma access to all intellectual properties of the drug across 17 countries, it said during the time.

A botanical drug is a plant-derived medicinal product that is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans. These medicines are based on complex botanical compounds and can offer multiple agent solutions, selectively and differentially affecting various target tissues. These characteristics make botanical drugs safe and effective.

ICGEB has said earlier that it has identified Cipa to be highly potent against all four dengue virus stereotypes. Pharmabiz