Kibow has sought marketing approval for Renadyl, a biological supplement that helps kidney patients sustain themselves without dialysis, and has already set up a local entity
Mumbai: Kibow Biotech Inc., which fought off a patent challenge in India last week, is planning to enter the nation’s fast-growing dietary supplement market with Renadyl, a biological supplement that helps kidney patients sustain themselves without dialysis.
The US biotech firm has sought a marketing approval for the product in India and has already set up a local entity in India, said an executive from Kibow Biotech. India’s patent tribunal ruled in favour of the US company, reinstating the validity of its Renadyl product patent. The tribunal said the innovation is novel and deserves the exclusivity rights, but it turned down the process patent as the method of composition is obvious and lacks inventiveness.
Kibow, a biotech start-up founded by Indian-American scientist Natarajan Ranganathan, was granted two patents in India for its pioneering technology in 2009. While the first patent covered the innovative technology and the product—a composition of microorganisms that metabolize nitrogenous waste that has diffused from the bloodstream into the bowel therefore effectively maintaining a healthy kidney function, the other was for the process that it used for mixing the microorganisms to make the formulation. But, these Indian patents faced a revocation petition filed by Ahmedabad-based La Renon Healthcare Pvt. Ltd at the Intellectual Property Appellate Board (IPAB) earlier this year.
“In India, we have made the needed application formalities as a food supplement (probiotic) with the Food Safety and Standards Authority of India and waiting for their approval for import of our dietary supplement product into India for marketing, distribution and sale," said Ranganathan, senior vice-president of research and development at Kibow Biotech.
Probiotics are microorganisms that have claimed health benefits when consumed. India is emerging as a major probiotic market with an annual growth rate of 22.6%. The country’s probiotic market is dominated by companies such as Amul, Mother Dairy, Yakult Danone and Nestlé. The Indian probiotic market is expected to reach $8 million by 2015, according to the estimates of Probiotic Association of India.
La Renon has been selling a similar product under the brand name Cudo for sometime in the domestic market. Although Kibow sued La Renon for patent infringement in the Madras high court earlier, the case was dismissed by the court saying the US company did not have a local presence and thereby doesn’t come under its jurisdiction.
“We will now rectify the infringement petition on the back of the IPAB ruling that established the product patent in India," said Essense Obhan, Kibow’s lawyer in India.
“The striking down of our process patent by India’s IPAB has no impact on us," Ranganathan said. “However, since the product patent has been upheld, no one can copy or replicate or make the product for legal marketing or sale our product in India."
Renadyl is currently sold in the US and Canada.
“The potential of our product in India is extremely large and appealing since one of two diabetic patients eventually end up with kidney health problems," said Ranganathan.
Also, with this product, we want to make kidney healthcare accessible not only in developed countries, but make it very affordable in poor and developing countries around the globe, he added.
While Renadyl is sold at a price of ₹ 5,000 for a bottle of 40 capsules online, La Renon’s Cudo is priced at ₹ 4,500 for 30 capsules, a month’s dosage.
La Renon may challenge the IPAB ruling.
“Although our product doesn’t infringe Kibow’s product patent, we will certainly appeal against the IPAB ruling as the patent was granted wrongly," said Pankaj Singh, LaRenon’s spokesman on Friday.
“The landmark decision by India’s patent tribunal to uphold Kibow Biotech’s key product patent is a major victory for a small biotech company based in the US. It not only establishes the patent validity, but also demonstrates India’s strong judiciary system and its commitment to respect true invention," says Shamnad Basheer, a patent law expert and a professor of intellectual property law at the National University of Juridical Sciences, Kolkata.
While the IPAB has invalidated the weaker process patent, it upheld the product patent. When compared to a process patent, a product patent is infinitely more valuable as it permits the patentee to prevent third parties such as La Renon from making a copy of the product, irrespective of the process that they use to arrive at the product, said Basheer.
Kibow's patents covering the product and process on the probiotic dietary food supplement has already been granted in Australia, Canada, China, Japan, Korea and the US, and is pending in the European Union.
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