As we celebrate the efficacy of section 3(d) and our stringent patent opposition mechanism that inter alia, led to the invalidation of a key patent underlying Tamiflu, the Chinese have taken an alternative route, albeit a healthier one. Don’t get me wrong; the term “healthy” does not reflect a comparative value judgment of any sort..it simply highlights the fact that, as with most things allopathic, Tamiflu comes with its fair share of side effects.“Jin Hua Qing Gan Fang, a Chinese herbal remedy, is found effective in A/H1N1 swine flu patients, according to a leading Chinese daily.
Jin Hua Qing Gan Fang, also called “Jin Hua” is being hailed as the world’s first traditional Chinese medicine to treat the A/H1N1 swine flu by the Chinese news papers.
Clinical studies spanning seven months have come out with adequate scientific evidence that the Chinese herbal remedy Jin Hua Qing Gan Fangan can shorten patients’ fever period and improve their respiratory systems, reports said quoting medical experts from China.
Jin Hua Qing Gan Fangan has no adverse side-effects.
Above all, Jin Hua Qing Gan Fangan is also very cheap. The medication cost only about a quarter of the cost of Tamiflu – the widely used anti-flu drug of Swiss drugmaker Roche Holding recommended by the World Health Organization (WHO) for the treatment of the A/H1N1 swine flu.
The municipal government in Beijing has gathered the most outstanding medical experts in the Chinese capital to develop the new medication, stated Zhao Jing, director of the Beijing Municipal Administration of Traditional Chinese Medicine, which had earmarked 10 million yuan (1.47 million U.S. dollars) for the project.
More than 120 medical specialists, led by academicians Wang Yongyan and Li Lianda from the Chinese Academy of Engineering, had participated in the research over the past seven months.”
India and TK Incentives?
All this leads one to wonder: has India been successful at leveraging its traditional medicinal wisdom in a manner similar to the Chinese? Some reports claim the efficacy of an ancient Indian medicinal plant, the “Tulsi” in taking on the flu. But have any of our local herbal companies tried “innovating” from traditional Tulsi leaves to reach an optimal cure–in much the same way that the Chinese did. Have they, at the very least, conducted some trials to establish the efficacy of Tulsi in this regard?
One may remember the controversial Satwant Committee (data exclusivity) report, a controversy enlivened more recently by the commissioning of a WHO/government of India sponsored report on this theme. Perhaps the one proposal (by the Satwant Committee) that met with the least resistance was to have a fixed exclusivity period for protecting data generated from clinical trials involving traditional medicines. AYUSH, the governmental department responsible for traditional medicines, was firmly behind this proposal–the idea being that such exclusivity might incentivise herbal players to do more testing on traditional medication and make it more palatable for Western export markets. Perhaps its time to revisit this proposal again.
Unfortunately, as we’ve often lamented in the past, the key obstacle to having any sort of healthy discussion on innovation policy in India is that we’ve framed our entire debate around pharmaceutical patents, an area characterised more by shrill emotions than cold logic. If we have to move forward, it is imperative that we delink our innovation policy debates from pharmaceuticals and adopt a more sector based approach.
Our patent regime (section 3(p) of the Indian patents Act) currently prevents the patenting of any invention based on traditional knowledge. The critical question is: how much work does one need to do on traditional knowledge before it becomes patentable? Much like section 3(d), would we peg the standards high?
These and other issues need careful deliberation and it is critical that we align our incentive structures in an optimal manner to achieve what I’d earlier called the “Neem Revolution”. We cannot afford to remain content with a “defensive” approach, where we block patents that free ride on our ancient wisdom. Rather we have to pro-actively leverage our traditional knowledge to bring in more wealth for the nation and health for the world. The TKDL initiative is a pioneering one, that many other countries appear to be copying. However, it needs to move beyond its “defensive” confines and find ways to actively leverage the wealth of wisdom trapped inside.
But before I sign off, I want to pick your brains on an issue that continues to puzzle me:
Does India’s excessive focus on generics come at the cost of it’s progress on traditional medicine? Or are the two mutually exclusive? Most of us are well aware that, notwithstanding the intense hostility between innovators and generics, “price controls” are one area where both these waring factions come together… both oppose it vehemently! Are “traditional medicines” the other area that provokes sentiments sharp enough to bring these two strange bedfellows together?
Kudos to the Chinese. They are taking full advantage of the IPR system.
Indians have documented their TK and gave it to the foreigners (I refer to the TKDL saga). Funny enough …. Traditional Knowledge Digital Library (TKDL) is yet to shared with Indian Patent Office and Indian Research Organisations.
Now let the foreigners do research on it, and prove how innovations could be made on TK and how to patent the inventions. The hues and cries of Indians will follow.
In fact Section 3(d) do not prevent any inventions based on TK being patented. But of course you need to prove the Novelty and Inventive step.
It is high time that we started innovating on TK. Else, wait until the foreigners teach Indians.
Section 3(p)of Indian Patent Act prevents patenting of traditional knowledge ‘per se’ or mere aggregation of TK components (If there are no synergistic effects)
Why can’t inventions based on TK be patented if they are novel and inventive ? Research on TK should encouraged.
There are Indian patents also on TK-based inventions. Let me post below a news item from THE HINDU (Business news) titled “Arjuna Natural Extracts gets Indian patent for Biocurcumax”
Patent awarded for reconstituted product of curcumin
KOCHI: The Controller of Patents in India has granted a patent to the Aluva-based Arjuna Natural Extracts Ltd. for its speciality product Biocurcumax.
The patent has been awarded for a reconstituted product of curcumin, an active constituent of turmeric and essential oil of turmeric in a specific proportion, said a communication from the company.
Biocurcumax has enhanced bioavailability and better absorption of curcumin into blood besides longer retention time compared to normal curcumin powder.
Curcumin has proved to be beneficial in the treatment of cancer and Alzheimer’s disease. The product of the invention is currently exported to the United States (U.S.) and Japan, said the company communiqué.
Curcumin isolated from turmeric is rapidly metabolised in the body and the body does not retain clinically significant concentrations.
As a result, its health benefits were largely unrealised, according to earlier observation made by researchers.
A team of researchers, led by Benny Antony, technical director, Arjuna Natural Extracts, found a solution to the problem after three years of study.
Biocurcumax has shown 700 per cent more activity in human clinical trials, helping reduction in dosage required for clinical benefits.
The company is awaiting the U.S. patent.
Dear Sir
I agree with the idea that innovations using traditional knowledge must be patentable. Unfortunately the whole area of traditional knowledge seems to have been taken over by people with a viewpoint that traditional knowledge does not have any scope of growth.
In India, all traditional knowledge has historically been researched and innovated upon. Even our ancient texts like the Patanjali Yoga Sutras etc. exhort the practitioners of these sciences to constantly innovate and research upon the knowledge of the previous Masters.
That is why we find so much variety in Yoga techniques, and traditional herbal medicines. An informal patent system has always existed wherein the followers of a particular method of meditation or method of treatment are only allowed to teach that technique or perform that particular method of treatment to the exclusion of others. Nobody else will teach or perform that method to you if he/she is not authorised to teach-that is a code of honour between the various schools and traditions of Yoga and Ayurveda/Siddha, whether old or relatively contemporary. For example, Kriya Yoga as taught by Paramhansa Yogananda or his other brother monks is taught only by people belonging to their tradition and not anybody else while the various schools and clinics of Ayurveda in Kerala follow their own mixture of oils etc. for their massages and cleansing processes.
If anybody wants to go for a patent of these improvements made by him/her in those fields, they should be allowed subject to rigorous specialized checks. Maybe we will need specialized examiners for this as well as the testimonies and opinions of established practitioners in these fields.We would also need an exhaustive TK database in these traditional sciences for this purpose.
To effectively harness our vast and rich traditional knowledge for the economic and equitable development of our society as well as for the preservation and adaptation of our rich cultural heritage we need a two pronged approach of conservation and innovation in traditional knowledge. Conservation can be effectively achieved by the mapping, registration, marketing and enforcement of Geographical Indications and innovation by permitting those desirous of patenting innovations over traditional knowledge to do so.
Regards
Achintya Nath Sexena
LLB-2
RGSOIPL
IIT-Kharagpur
Dear Sir
I agree with the idea that innovations using traditional knowledge must be patentable. Unfortunately the whole area of traditional knowledge seems to have been taken over by people with a viewpoint that traditional knowledge does not have any scope of growth.
In India, all traditional knowledge has historically been researched and innovated upon. Even our ancient texts like the Patanjali Yoga Sutras etc. exhort the practitioners of these sciences to constantly innovate and research upon the knowledge of the previous Masters.
That is why we find so much variety in Yoga techniques, and traditional herbal medicines. An informal patent system has always existed wherein the followers of a particular method of meditation or method of treatment are only allowed to teach that technique or perform that particular method of treatment to the exclusion of others. Nobody else will teach or perform that method to you if he/she is not authorised to teach-that is a code of honour between the various schools and traditions of Yoga and Ayurveda/Siddha, whether old or relatively contemporary. For example, Kriya Yoga as taught by Paramhansa Yogananda or his other brother monks is taught only by people belonging to their tradition and not anybody else while the various schools and clinics of Ayurveda in Kerala follow their own mixture of oils etc. for their massages and cleansing processes.
If anybody wants to go for a patent of these improvements made by him/her in those fields, they should be allowed subject to rigorous specialized checks. Maybe we will need specialized examiners for this as well as the testimonies and opinions of established practitioners in these fields.We would also need an exhaustive TK database in these traditional sciences for this purpose.
To effectively harness our vast and rich traditional knowledge for the economic and equitable development of our society as well as for the preservation and adaptation of our rich cultural heritage we need a two pronged approach of conservation and innovation in traditional knowledge. Conservation can be effectively achieved by the mapping, registration, marketing and enforcement of Geographical Indications and innovation by permitting those desirous of patenting innovations over traditional knowledge to do so.
Regards
Achintya Nath Sexena
LLB-2
RGSOIPL
IIT-Kharagpur
Dear Praveen and Achintya,
Thanks very much for your comments. You’re absolutely right–the challenge is to adequately balance “conservation” imperatives with the need to innovate.
I’ve just edited the post to add a paragraph on the TKDL. However, I plan to tackle TKDL more fully in a future post.
The below mentioned link and the information as given provided on it suggests that INDIA also INVENTS the TRADITIONAL WAY..
http://india.bigpatents.org/apps/4MSNwxsV
HERBAL TREATMENT FOR CANCER
1103/DEL/2007 A (1103/DEL/2007)
Filed on 2007-05-22
Publication date 2008-12-19
This invention relates to medicinal preparation which comprises a mixture of herbs viz. Cressa cretica, Tridax procumhens, Euphorbia microphylla and other optional herbs. This herbal formulation has been found to be effective for the treatment of cancer, thus providing an effective alternative/supplement to the conventional treatments of surgery, chemotherapy and/or radiotherapy.
Applicant
MR. VISHNU KUMAR SHARMA
S/O. SHRI RAM SAHAY SHARMA VILLAGE & POST : NANGLA LOTWADA DIRSTRICT-DAUSA RAJASTHAN INDIA Rajasthan India
Inventor
MR. VISHNU KUMAR SHARMA
We have to learn from failures. Though India demonstrated the first ever “Benefit Sharing arrangement” in the world, we could not fully capitalise on this (JEEVANI).
TBGRI had applied for a process patent for Jeevani in India. I called for the file when I was working in Chennai patent office to affirm whether the patent was in force.
The observation was shocking. Though the patent application was “in order” for grant, patent was not sealed pending the remittance of mandatory renewal fee. This lethargy has resulted in TBGRI losing the Intellectual Property Rights in JEEVANI.
Jeevani is still available in the market. Many companies are profiting from its sale. But there is no revenue in sight for TBGRI (or kanis) as the patent is not in force.