Kerala Ayurveda Wins Rare US Patent For Herbal Formulation Uniquely Processed In Ancient Indian Tradition

Kerala Ayurveda Limited (KAL), one of the oldest full-spectrum ayurveda companies in India as well as the world, with a continuous 80-year tradition, has won its first patent from the United States (US) Patent Office.

It received the patent for a herbal composition that addresses disorders related to a metabolic syndrome.

The announcement was made last month on the sidelines of the Ninth World Ayurveda Congress in Goa.

US patents are difficult to obtain since proving novelty and efficacy with already-known herbal ingredients is a major challenge. KAL was able to accomplish this through its proprietary processing method, which has also been granted a patent.

Despite the fact that it is a herbal formulation, the product has undergone rigorous pre-clinical and clinical trials, as well as pharmaceutical procedures such as double-blind placebo-controlled trials*, to establish its efficacy and safety.

Like most of the company's products launched in the US, the formulation also met the ‘California Prop 65’ standard, deemed to be among the most stringent in the world for drugs, and even exceeding some standards set by the US Food and Drug Administration.

From Ancient Wisdom To Modern Practice

Among a small minority of practitioners of the traditional and pristine form of ayurvedic medicine of the Kerala school, KAL has made a successful transition to the ranks of modern pharmaceutical and wellness companies, with a strong presence in markets like the US and the European Union.

The company runs Kerala Ayurveda Academy in Milpitas — in the heart of the US Silicon Valley in California — the largest vocational ayurvedic institute in the US. It has a network of 3,000-plus professionals of ayurveda and a slate of 200 products specially made for the American market.

The Academy recently opened a branch in Norway, after KAL launched its business there last year.

Manages Metabolic Disorders

The patent (No 11,491,202) was awarded last month to nine researchers of KAL, based in Kerala, Bengaluru, and the US. It states that it "generally relates to an herbal composition effective in management of disorders related to metabolic syndrome…. The invention further relates to the use of the herbal composition in preparation of food supplements, pharmaceuticals and nutraceuticals for the management of disorders related to metabolic syndrome."

The patent specifies: "The herbal composition comprises of herbs selected from Curcuma longa, Emblica officinalis, Vernonia anthelmintica, Tinospora cordifolia, Trigonella foenum-graecum, Ixora coccinea and Syzygium cumini."

These are better known in India as (respectively): Haridra, Amalaki, Aranyajeeraka, Guduchi, Methi, Paranthi, and Jamun.

Pharmacist and senior scientist Jayashree Madhavan, one of the co-inventors credited in the patent, explains that as in all new formulations launched by KAL, the basic studies are made by ayurvedic vaidyans and Sanskrit scholars based in Kerala who consult ancient root texts of ayurveda like Ashtanga Hrudayam and Sahasrayogam.

Once they have brainstormed to decide on a new formula, KAL’s R&D (research and development) laboratory takes over and applies intense and pharmaceutical rigour to realise the product in a manner that meets  stringent national and international production standards, before releasing samples for clinical trials.

"Our main goal with this latest invention was to establish safety, purity, and efficacy, as well as providing a standardised process for such herbal compositions, resulting in batch-to-batch consistency."

More In The Pipeline

Products based on the newly patented formulation — which could include capsules, tablets, granules, or liquids — should be in the Indian and international markets in three to six months, Vangal added.

He revealed that the companies have another six to seven formulations under development for patenting in a 10-product series codenamed K-10. These would address complaints like obesity, arthritis, gout, irritable bowel syndrome, and osteoporosis.

Ayurveda Acharya Vaidyan Kollasseril Govindan Kunju Panicker, a doyen in the field of ayurveda, founded Kerala Ayurveda in 1945 at Aluva near Kochi. His son Dr K Anil Kumar continues in the family tradition and today serves as the executive director of KAL.

The company still houses its main plant and herbal garden nearby at Athani, just off the Kochi International Airport.

Kerala Ayurveda’s sharp transition into a technologically and digitally driven international enterprise, while still firmly rooted in ancient ayurvedic traditions, is generally acknowledged to have happened after 2005.

That's when the company became part of the Katra Group, co-founded by IIT Madras and London Business School alumnus Ramesh Vangal in 2001.

*In such trials, some participants get the treatment, others get a harmless placebo, which is an inactive substance like sugar or starch. No one — not even the research team — knows who gets the treatment and who receives the placebo. Since participants, family members, and staff all are “blind” to the treatment while the study is underway, the study is called a “double-blind, placebo-controlled” clinical trial.