SpicyIP:Going Green



Quite clearly the hue of the season, much Green was seen in the otherwise gray horizon of the last year-the green bill may have withered, but in sharp contrast green medicine, green gold green fuel, green food was quite the buzz and trendsetter of times to come.

I quite perceive this as going back to basics, a bid to derive strength from within and around; to wade through what was a challenging year in more ways than one, to rely on traditional ways of living and being. …’from the tech back to the tree’ if I may say so!

India has been rated as one of the most resilient of economies drawing from its innate strengths and resources amidst this all. One has also seen the country building on its green strengths, more particularly in its TK /TM drive.

The National Knowledge Commission unveiled its ambitious agenda towards fostering the indigenous med industry, policy debates/ legislations and sui generis TK legislations feature in mainstream debates, and infrastructure building initiatives is at an all time high.

Interesting business trends signal the emergence of sunrise industries that seek to capitalize on green India’s’ reserves of ethno botanicals.

The Pharma Industry is waking up to the huge potential of the natural drugs that is considered to be the next gen pharma minefield. Both natural block buster essential drugs and the neutraceutical drug segment look to be promising revenue grosser for the country

The global nutraceuticals market, comprising two principal segments — dietary supplements and functional foods — is poised to grow at a compounded annual growth rate (CAGR) of 6.1 per cent during 2000-2010. Sales of nutraceuticals are projected to reach $187.4 billion by 2010 against an estimated $155.9 billion in 2007.

Natural drugs, especially of plant origin, are expected to play a major role in the healthcare program in the 21st century

“The revival of interest in plant-based drugs and other herbal products is mainly because of the widespread belief that ‘green medicine’ is healthier than the synthetic products,” said veteran scientist P Pushpangadan in a paper titled ‘Health Food and Neutraceutical – Traditional Wisdom’.

The preference for green food and medicine has resulted in the rapid growth of plant-based drugs, pharmaceuticals, nutraceuticals, functional foods and even cosmaceuticals

A few months back I was prescribed Ashawagndha supplements by my Ayurvedcic practitioner. Not knowing what it was I set out to do my own little homework. On discovering that Ashwagandha is the innocuous Indian Cherry touted to be the Indian Ginseng and a potent stress buster, I was reveling in the wonders of Indian medicine, when I chanced upon this information that took me by surprise.

The USPTO and the JPO had generously doled out patents for this herb which was so explicitly labeled as the Indian Ginseng. The Company Natreon that held the patent was incidentally having a field day exploiting not only the Ashwagandha but other precious Indian herbs the Amla (Indian Gooseberry)the Shilajit et al.

A press release on the company website states that ‘Natreon’ plans to take the functional extracts to Asia, came across as too much of a paradox. Effectively what this means, is that having learnt of the medicinal properties of these herbs from our indigenous medicinal system that’s about 5000 years old, they plan to resourcefully re-label them as functional foods and resell it in the Asian markets. I am tempted to quip’ that this akin to selling peanuts to the monkey itself’ Is anyone talking of benefit sharing and TK here at all !
Delving deeper, I learnt that a slew of patents for had been granted to a wide variety of Indian botanicals ranging from the Karela, Jamun (for its anti-diabetic properties), ginger, and the bitter gourd as early as 2001.
The Neem, Haldi, Basmati saga pales in comparison. The ravages on the Indian flora apparently were more rampant than what has been perceived.

A lone crusader Vandana Shiva attempted to counter this menace in court then, albeit inconclusively .Merits serious questioning if these PILs’ need to be brought out of the dusty archives of the court houses and taken to the forefront, given the fact that India is keen on promoting its TK image in the international market place.

International Courts too tend to favor the vigilant stakeholder .As Shamnad rightly pointed out in his interview a reactive strategy may just not suffice to nurture or insulate our TK.A pre-emptive strategy seems to be more the need of the hour.

Drawing from an international case study on canalsing TK wealth back to its origins, the Hoodia of South Africa is an illuminating example for our learning.. The Hoodia shrub of South Africa has been traditionally used by the Bushmen of Africa for its hunger reducing properties.

Companies like Unilever and Phytopharm who tried to tap into its health related benefits and commercialize it were negotiated into signing tight benefit sharing agreements India’s’ TKDL has worked to lend credibility to India’s’ TK. Its time next to commence an initiative linked to the TKDL that provides for the creation of a TK fund and a TK watchdog before India’s’ biodiversity, TK wealth / knowledge runs dry and the green turns arid.

10 comments.

  1. AvatarGirish Malhotra

    Dear Ms. Shaukat:

    I would beg to differ with you on Pharmaceuticals going “green”. Based on my experiences in their manufacturing practices, yields of less than 40% are acceptable. At these poor yields, they are still able to make money because their pricing is not on competitive basis but the highest market can bear.

    With such low yields they have to invest heavily to treat their out fall. Pharmaceuticals being toxic [that is how they cure a disease] still have sufficient toxins left in the ecosystem after doing the necessary treatment. The linked article might be of interest.
    http://www.pharmpro.com/ShowPR.aspx?PUBCODE=021&ACCT=0000100&ISSUE=0711&RELTYPE=PR&Cat=0&SubCat=0&ProdCode=0000&PRODLETT=M&SearchText=epcot

    Drugs from Nature is not going “green”. Yes there is significant potential but if one can make their profit margin, investing in better technologies becomes secondary. These are basic economic principles until one is cornered.

    Thanks.

    Reply
  2. AvatarAysha Shaukat

    Mr.Gopakumar Nair writes in :

    Is the Indian Biodiversity Authority doing the right thing by preventing Indians to commercialising in India while anybody anywhere outside India can enjoy unlimited Patent Protection on Indian Herbs ?
    Gopakumar G Nair

    Reply
  3. AvatarAnonymous

    I think this issue is being sensationalised.

    Even if foreign company works and extracts the active parts of Ashwagandha, no body stops others from eating ashwagandha tablets or chyawanprash…

    So, why hullaballoo over patents for actives/ extracts from plants?

    Frequently Anon.

    Reply
  4. AvatarAysha Shaukat

    Hello All,

    Thanks for your comments.
    @Anon Coward

    The key point that I wish to raise here is that the know how for these western neutraceuticals such as Sensoril(Ashwagandha) and the like is derived from the Traditional Indian Medicinal systems. That be, normatively speaking the benefits of such knowledge should either be passed on to the domestic neutraceutical industry and/or the proceeds should accrue to the TK fund. In this case both dont seem to be happening.Had we remained silent on the Basmati or the Neem issue,the economic loss and a far greater heritage loss would have been ours to bear.

    @Mr.Malhotra,

    If one were to examine the drug development patterns from natural patterns, there is enough affirming evidence to suggest that there is resuregent interest in the pharma industry to tap the medicinal potential of plant extracts.

    Notably, I would like to point in the direction of drug discovery and development of natural blockbuster cancer drugs cancer drugs that are being increasingly relied upon as againstthe synthetic cytotoxic agents.Doxorubicin, Paclitaxel, Vinblastince,germcitabine and the like are are all natural cancer therapeutic drugs.

    Further statistics from research on this subject reports that of the 974 small molecule new entities developed over the last 25 years,63%were nature based products.

    R&D expenditure of pharma biggies also signals a marked interest in the area of green pharmaceuticals.

    Given the above, there is much evidence pointing in the direction of the going green trend.

    Thanks

    Aysha

    Reply
  5. AvatarAnonymous

    Dear Aysha,

    a) I am ‘Frequently anon’, not ‘anon coward’. That is another gentleman.
    b) Pray do tell me about the following:
    How is the know how for these western neutraceuticals such as Sensoril(Ashwagandha) and the like is derived from the Traditional Indian Medicinal systems/
    Ashwagandha, for e.g. may have thousands of compounds… if some company isolates the one active compound that causes activity, then its a worthy invention.
    Alternatively, the other invention could [patentable] could be a process to deliver/ isolate particular parts/ extracts from such plants.

    What benefits of knowledge must either be passed on to the domestic neutraceutical industry and/or the proceeds should accrue to the TK fund?
    The Company has put in efforts on R & D and found the one active compound/ process for delivery. It is NOT taking away the right of companies like Sandu/ Zandu/ Himalaya etc to sell thier ayurvedic medicines nor does it stop you and me to make or use chawyanprash.

    In this case both dont seem to be happening. Had we remained silent on the Basmati or the Neem issue, the economic loss and a far greater heritage loss would have been ours to bear.
    Aysha, please don’t talk like a normal news reporter. The claims for neem were never stopping any Indian to practise what Indians had been doing for ages… Similarly, the Basmati patent claims were for modified rice strains. It was not stopping Indians from selling their rice in
    India.

    Aysha, reporters dont [but you and I know that] any patent is a right within that country. Again, any patent does NOT stop people from doing what they where doing before the patent… it does not in that sense ask for a change of lifestyle/ traditional remedies etc.

    Frequently Anon.

    Reply
  6. AvatarAysha Shaukat

    Hi Frequently Anon,

    Apologies for the mix up with your title….Anonymous nevertheless and too many of those floating around:)

    The way I see it , there are two ways to look at the issue you have raised

    As mentioned in my last comment, my concern lies in the fact that the TK of the country is being transported without any benefit being ploughed back to its origins. The medicinal benefits of these herbs is knowledge that is based on our Indigenous medicinal system that predates any other elsewhere. No discounting the fact that it our sages of yore who brought out this knowledge.

    Nonetheless I would agree with you when you say that since herbs like Ashwagandha are already in the public domain, a retrospective regulation or claim might be futile esp since it is not community based knowledge

    However , it appears imperative that we do contemplate upon structuring a TK fund , where the proceeds are applied towards funding TK initiatives in the country.

    Thanks

    Aysha

    Reply
  7. AvatarAnonymous

    Aysha,

    a) I have no problems with a benefit sharing in a special situation like the Kani tribe case;

    b) But I do have a big problem every time some reporter says that neem/ turmeric/ basmati were an attack/ assuage upon India and that we should protect them… ga..ga..

    c) I personally think that the money spent on turmeric invalidation was an exercise in futility… the turmeric patent with its very specific claim would not have stopped any one.. just that our reporters/ ‘leaders’ did not explain it properly to the public.

    d) Again, coming back to your present comment.
    Benefit sharing across the globe has not been a very successful case. Our Arogyapacha/ kani case is not an isolated case.

    Frequently Anon.

    Reply
  8. AvatarAnonymous Coward

    @Frequently Anon.
    I’m afraid I have to disagree with you. I believe that TK _should_ be protected. But it should be protected negatively, not positively. By that I mean that patent law should prevent (and India does prevent) TK from being patented. Thus, while I agree with you that journalistic pieces in the mass media on GI and TK are very much sensationalistic, I disagree with your view that the invalidation is an exercise in futility. I believe that TK should be free for all of humanity, and not just for those in the country where it apparently originates. (I use the word “apparently” because it would be rather arrogant to assume that each instance of TK is unique.) To achieve that, patents should be disallowed on TK-based inventions regardless of the country of patent or the country of TK origination.

    I am a bit sad to say that I just don’t understand the concept of “benefit sharing”. In case of neem, for instance, with whom would the benefits be shared?

    I’ll end with a thought experiment. You say “the turmeric patent with its very specific claim would not have stopped any one”. However, consider the case where casein is added to curcumin and that resultant mixture is used to cure colds. Well, that’s exactly what me mum does when she gives me a mixture of turmeric powder and milk. We both know that over-broad patents are granted by various patent offices (especially the USPTO!) _all_ the bloody time. Heck, _the wheel_ was patented in Australia and (a method of swinging on a swing) was patented in the United States of America. Given such glorious histories, I wouldn’t trust the patent offices with ensuring that patents for TK-based inventions aren’t covertly patents for the TK itself.

    Cheers,
    Anon. Cow.

    Reply
  9. AvatarAnonymous

    Anon. Cow,

    Before we go on to your Hypo, let me repeat.
    a) The Turmeric case had a very narrow claim. Its grant did not stop any one in India or US using turmeric when they got a cut etc.
    b) When a patent that does not stop any one [above] what purpose is solved by spending lacs of $$ on invalidating it?
    c) I do not say that give patents for items based on TK. I am only saying that a company should be given a patent, if it isolates the key compound from 1000s of compounds that a particular herb may have.
    d) Again, I never said that “all” invalidation is an exercise in futility. I said that the turmeric case one, since [reason a] above.
    e) I too am perplexed as to how do we go about sharing benefits for cases such as Neem.. as a matter of fact, I have been debating this concept with Shamnad too.
    f) FINALLY,
    even if the specific claim in your Hypo was granted, tell me — how would it stop your Mom to give you the same drink? The patent would nto stop you in practising the home remedy… hence any money spent on invalidating this claim, which anyways would NOT stop your home use, to me seem futile.
    The only way that this claim would be infringed is if some 1 [not patentee] came and sold a pure mix of the 2 compounds — definitely not your Mom in her kitchen 🙂

    Frequently Anon

    Reply
  10. AvatarAnonymous

    Hi Aysha,

    I appreciate your post and totally agree with you.

    I take immense interest in Ayurveda and admire the most sought out herb ashwagandha.

    While going through the product profile of Sensoril ashwagandha, I found out that the ashwagandha extract is using roots and leaves. Whereas to my knowledge, ayurveda advocates the usage of roots alone for the therapeutic efficacy. Vim, vigor, vitality and strengthening properties of ashwagandha are attributed to their roots alone. Even clinical trials across the world on ashwagandha has proved the efficacy from the roots alone. I think, in order to increase the active constituent (withanolides in this case), products like sensoril are adulterated with leaves.

    I recently came across ashwagandha extract called KSM-66. some Indian based company manufactures this extract and claims it to be world’s best ashwagandha. I was truly impressed with its product profile. Wanted to procure it for my personal use, but guess they dont manufacture the finished capsules of their ashwagandha.

    I also totally agree that few companies from the west are tapping our ancient knowledge and making money our of it, without giving back anything to us.

    Reply

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