Madras High Court upholds US company Kibow Biotech’s Indian patent for kidney health supplement Renadyl

The probiotic supplement’s ‘Enteric Dialysis’ technology uses the bowel or colon to assist ailing kidneys in eliminating urea and other toxins

Kibow Biotech Inc, USA was awarded a huge win on its Indian patent by the Madras High Court last week. The Philadelphia-based biotech firm’s Indian patent for Renadyl, its kidney health supplement, was granted in September 2008, but later challenged by La Renon, an Ahmedabad-based company which marketed a similar product. In a well- reasoned decision, India’s specialised intellectual property tribunal, IPAB denied La Renon’s challenge and upheld Kibow’s patent in 2013. La Renon then sought a review of this ruling before the Madras High Court, which effectively agreed with the IPAB and once again upheld Kibow’s patent.

Dr Natarajan Ranganathan, Kibow’s founder and chief architect, hailed the ruling as a huge victory for innovation and the long years of intensive research and development that went into developing Kibow’s unique “Enteric Dialysis” platform technology that forms the basis for Renadyl. This special probiotic dietary supplement uses the bowel and the gut microbiome to assist ailing kidneys in metabolising uremic toxins like urea, creatinine, uric acid and several cardiovascular toxins and thus potentially delay the need for Hemo- Dialysis and Peritoneal Dialysis in many patients.

Renadyl is a product backed by two decades of wide-ranging international research, extensive pharma like validation including three human clinical trials and the endorsement of some of the world’s leading nephrologists for its, safety, efficacy and improving quality of life for many patients,” said Dr Ranganathan, while also pointing to the global health community’s increasing realisation of the vital role the gut microbiome plays in many of our health processes. “Given their easy availability and innocuous nature, the use of well-researched and highly strain-specific probiotics to modulate an unhealthy gut microbiome in CKD patients is a very promising intervention and helps preserve renal function,” he added.

When asked about the exact legal grounds for the patent challenge from La Renon and the argument from Kibow that swung the decision in its favour, Dr Ranganathan told Express Pharma, “La Renon argued that our invention was an “obvious” one and that it merely comprised an admixture of known components. We countered by arguing that Kibow’s patented invention comprises a highly creative combination of a specific strain of the probiotic bacteria Streptococcus thermophilus of the required CFUs to render a stable and sustainable population of the bacteria in the gut and specially selected prebiotics which specifically sustains and stimulate the chosen bacteria. Both the components are contained within a special enteric capsule which delivers the composition at the exact location in the gut where maximum beneficial effect of removal of toxins can occur prior to filtration by the kidney, which proves the synergistic effect of the components. Therefore, the invention is not a mere aggregation of individual components, but a highly creative composition of elements, each of which were chosen because they have a specific effect on each other, and have a specific role to play in the detoxification of uremic/nitrogenous wastes in the gut to augment kidney function prior to filtration by the kidney, and thereby reduce the strain on the kidney.

He further added, “To argue that they are a mere admixture without offering any evidence or scientific proof is to discredit an ingenious invention that has been reviewed rigorously by patent office all around the world and resulting in the grant of a patent in 33 countries. The IPAB agreed with us and upheld our patent. The Madras High court also found that the IPAB decision was the right one and therefore declined to interfere.”

Kibow Biotech Inc has also obtained the same patent (and several more, totaling 35 patents thus far) in Australia, Canada, China, Japan, South Korea, the European Union and USA.

With less than 2000 nephrologists, concentrated largely in urban areas, India’s 1.3 billion population face severe challenges in access to kidney care, especially patients with advanced Chronic Kidney Disease (CKD). Studies show that the prevalence of CKD is 17.2 per cent and the age-adjusted incidence of end-stage kidney disease (ESKD) is 229/million population. As of 2017, over 130,000 patients were receiving dialysis and the number is increasing by about 232 per million populations. RRT (Renal Replacement Therapy) is predominantly driven by private healthcare sector; hence, for a significant number of patients this therapy is unaffordable. Even those who do start RRT, 60 per cent of them have to stop for financial reasons.

Kibow’s Indian partner Centaur Pharmaceuticals also applauded the ruling. The Mumbai-based company Centaur Pharmaceuticals has the exclusive rights for importing, packaging, marketing, distribution and sale of Renadyl throughout India. Centaur Pharmaceuticals are also planning to import the identical specific probiotic strains/ingredients and manufacture the product in their US FDA approved facilities in Pune by the end of this year.