Guest Post – TKDL: A success- Really?


Mahima Rathi, who has recently guest blogged for us, over here, has sent us this very interesting case study regarding the use of the Traditional Knowledge Digital Library (TKDL) before the European Patent Office.

TKDL: A success – Really?
by,
Mahima Rathi
Much has been said about the success of TKDL in preventing cases of misappropriation of Traditional Knowledge related to Genetic Resources (TKGRs). In fact, the TKDL website refers to several cases of withdrawals, amendments and rejection of patent applications which involve such kind of subject matter. (See here
It is not denied that TKDL has actually prevented misappropriation of TKGRs in various cases but the fact remains that the number of such success stories is very less. If we put the success stories (as mentioned on the TKDL website) to scrutiny, we’ll find that most of the applications mentioned therein are cases of deemed withdrawals and they always have the option of being re-examined after the payment of certain amount of fee. CSIR takes pride in indicating cases of deemed withdrawals but fails to follow up the position afterwards to ensure that the withdrawal is actual withdrawal and not a case where re-examination occurs and ultimately results in patent grant. 
There is only one case (EP1520585) where CSIR acknowledged the grant of patent in spite of having sent the third party observations. There are two such cases (EP2112929 and EP1849473) but their status has not been clarified by CSIR. (I’m not sure if it is out of ignorance or otherwise) 
Hereunder is an evaluation of the first case which yields surprising arguments and shocking conclusions in relation to acceptance of TKDL as prior art. Few things which have to be kept in mind before reading further are: 
1. Since TKDL authorities have themselves mentioned this case, they ought to be well aware of the arguments made therein for non acceptance of TKDL citations. 
2. The TKDL Authorities have mentioned that the reason for grant of the patent in the given case was that the claim was made for Pistacia terebinthus while the TKDL evidences related to Pistacia vera.( And on further reading you’ll see that this is not the case) 
Invention: Cancer Treatment Using Natural Plant Products or Essential Oils or Components from some Pistacia Species (EP1520585) 
Independent Claims: 
1. Use of an essential oil obtained from a plant of Pistacia genus selected from Pistacia vera and Pistacia integerrima for manufacturing a medicarment for treating or preventing cancer in a mammal, including a human by administration of an effective amount. 
2. The use of (-)-bornyl acetate for manufacturing medicarment for treating or preventing cancer selected from the group consisting of colon adenocarcinoma and ovary adenocarcinoma. 
The Prior art in the present case (submitted in the form of TKDL citations) belongs to the Unani System of Indian Medicine. Following is a comparison of the invention and the prior art.
CONTENTS

Prior Art

Invention

          1. Lead Oxide

        2. Pistacia vera( Pistacio Nut, Turpentine trees’ pistacia nut)

          3.Bixa Orellana

          4. Indian frankinscence

          5. Bixa Orellana

          6. Indian frankincence

          7. Dorema ammoniacum

          8. Bees Wax

          9. Olive Oil

1.      Aerial parts of the plant and store @ -21 degrees celcius (leaves, flowers, fruits, branches, galls , nuts)- In minced form

2.      Ethylic Ester

3.      Anhydrous Sodium Sulphate

PROCEDURE

Oil heated- wax/fat is dissolved, thoroughly mixed

Fine powder of the drug is then added stirred well and allowed to cool till it turns into a semi solid mass i.e. marham

Material is minced -exposed to hydro distillation – then condensed

Distillate mixed with ethylic ester

Organic phase is treated with sodium sulphate, filtered, evaporated.

( The use of these processes facilitates the extraction of the actual oil containing the active ingredient)

When asked by the EPO to take position on the Prior art cited by TKDL, the patent applicant presented the following reasoning/defence for not treating TKDL as prior art: 
1. Applicant is using Bornyl Acetate as the chemical for treatment but TKDL nowhere mentions it. 
2. E7 ( English Translation of the Persian Unani Text) -not a translation of original Persian text 
3. Gross mistranslation of words (in the TKDL) 
4. English disclosure is not a part of prior art- only found in TKDL- not available to public or the applicant before filing of the application. 
5. E7 being an extract from the book I’laaj – al – Amraaz( 18th century AD) by Mohd.Shareef Khan, Edn 1921, Afzal – al – Matabe, Barqi Press Delhi which is the only original and only public source – the applicant wasn’t able to find such publication despite two worldwide inter library search and investigation on other public libraries. Barqi press was not dedicated to medicine and was probably dedicated to lithography. Hence the applicant couldn’t work with the original text. 
Now, in case of such a blatant refusal and after having known that such arguments have been made, CSIR merely stated that the grant of patent was made because there was a difference in the Genetic Resource claimed and cited!!! I am not sure if it is intentional, but the statement made by the authorities is in fact misleading and the reason for grant of patent is not what has been indicated by CSIR. In spite of calling itself the sole custodian of TKDL, CSIR did not make even a single attempt to clarify its stand. 
The fact that the database is not accessible by public is creating problems and it is evident from the arguments above. After all, the accessibility to prior art is one of the basic concepts of patent law and compliance with the same should be ensured. Such a refusal to admit TKDL as prior art highlights the need to allow public access to the database and gives more reasons for CSIR to do so. 
It was shocking to see the argument that the book (which was admitted as the only original and public source) was not traceable. The fact that a scanned copy of the same is available indicates the very existence of the book. However, in order to clarify and settle the doubts, I enquired the availability of the book in the library of Rajasthan Unani Medical College and Hospital, Jaipur and was in fact present!! (So, the point of non availability could have been easily rebutted) 
At first, I was unable to accept the contention about TKDL translations being wrong and thought that even if a translational error exists, an error in mentioning the genetic resource is not expected as the very purpose of the library is to protect the same. 
I had said in an earlier post that obvious conclusions are forbidden in this story. Contrary to my expectations that there could be an error, when I got the original Persian text translated from Professors at the Rajasthan Unani Medical College and Hospital, Jaipur, they said that the Unani medicine employed the nut of a plant grown along with pistachio nut and not pistachio nut itself. They added that the exact plant could not be verified as the formula is very old. I wonder how CSIR got this particular formulation verified when the practitioners themselves are unable to trace it. Now, this is just one case. There might be others too. I could not have produced better evidence to show that what appears is not always true. TKDL had been created with a view to prevent misappropriation and if it is failing in doing so (and the above example shows how miserably it is failing) the whole purpose of creating the database gets frustrated.
Prashant Reddy

Prashant Reddy

T. Prashant Reddy graduated from the National Law School of India University, Bangalore, with a B.A.LLB (Hons.) degree in 2008. He later graduated with a LLM degree (Law, Science & Technology) from the Stanford Law School in 2013. Prashant has worked with law firms in Delhi and in academia in India and Singapore. He is also co-author of the book Create, Copy, Disrupt: India's Intellectual Property Dilemmas (OUP).

6 comments.

  1. AvatarAnonymous

    Dear Mahima,
    Prashant did claim in one of his earlier blog that you have done so much research on TKDL that you can write a book, my impression is that you have not understood the even ABC of TKDL concepts and have even not read the TKDL website carefully before attempting your current blog.You have mentioned that most of the cases are deemed withdrawal and TKDL has failed to fallow up. You are wrong on both the account. At EPO there are total of 59 withdrawal cases are posted on TKDL website out of that 38 have been closed with no possibility of reopening this information is posted in last column which either you did not care to read or did not understood . 18 cases are under modified claim category with no possibility of change Similarly at Canada 14 cases which have become dead are reported with no possibility of reopening At USPTO cases reported are under modified claim category or claim rejected category. Therefore attempt to mislead in open domain information does not work. Yes deemed withdrawal is not closure and can be taken up again as has happened in case of EP1520585 where EPO set aside their intention to grant based on TKDL submission, subsequently it granted the patent when applicant was able to prove the novelty in accordance with the examination procedure at EPO and TKDL has posted all the factual information and have not tried to mislead. Incidently out of about 100 plus cases of withdrawal/cancellation/closure I could see only one such case. Now lets come to concepts, it is a fact CSIR/India fought and won turmeric and Neem cases after 4/10 years of expensive and legally complex battle. Since it was fought after the grant of patent. CSIR/India was able to by establish the prior art from Ayurveda/Unani/Siddha at huge legal and other costs running in to crores of Rupees. Whereas TKDL attempts to establish prior art before the grant of patent and decision on novelty is taken by examiner so there is no question of fallow up like turmeric and Neem in TKDL approach since it means time period of 4-10 years and huge cost, If in last 2 years TKDL has given outcome in 100 plus cases I as Indian feel proud since other countries are still fallowing the hugely expansive and time consuming route of opposition after the grant which India was also forced to fallow when TKDL did not exist

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  2. AvatarAnonymous

    Incidently we should not undermine the modification of claims as in Basmati patent at USPTO India after a prolong legal battle after the grant of patent could get few claims cancelled and/or modified patent did not get invalidated. However this till date is protecting the interest of Basmati exporters from India and Pakistan

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  3. AvatarPrashant Reddy

    Hi Anon,

    Pending Mahima’s reply, I would like to clarify that CSIR had no role in the neem dispute. It was initiated by a European organization.

    Interestingly CSIR itself has tried to patent a neem-related invention before the EPO and it was a European party which managed to successfully oppose the CSIR patent.

    Also the Basmati patent was challenged by APEDA not CSIR. This leaves only the turmeric patent, which I agree was succesfully challenged by CSIR.

    Prashant

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  4. AvatarMahima

    Hi Anon
    Firstly, thanks for the statistics. If you would have read my post carefully, I’d acknowledged the existence of few success stories in the beginning of my post.

    My intention was to point towards a more important issue which is the error in indicating the genetic resource itself. If you wish to read more on the problems being caused by TKDL translations you can refer to this report http://www.holmepatent.dk/fundanemt/files/WIPR_NovDec_2010.pdf which comes from a European patent attorney. That’ll help in understanding that the case is mention is just one of many.

    With respect to the statistics you mentioned- they might be success stories. But after having come across such an error in indicating the genetic resource, I must say that I’m seriously doubtful about the validity of those other submissions made in other cases which would have created those success stories mentioned on the TKDL Website.

    Also, CSIR officials had indicated that about 2000 applications relating to Indian Medicinal Systems were being ‘granted’ annually ( See http://www.wipo.int/export/sites/www/meetings/en/2011/wipo_tkdl_del_11/pdf/tkdl_gupta.pdf) Now, since you have already mentioned the details stats above, we can easily judge the success rate. Out of about 5000 applications (going by 2000 per annum) in 2.5 years, only a handful of cases have been identified.

    You made a point about CSIR putting up all the factual information and not misleading. If it was so, how come it failed to mention that its own database was being denied as prior art? When you say that the applicant successfully established the criteria of novelty, you overlooked that it was actually established by denying acceptance of the database as prior art and the arguments made to strengthen this point were actually easily rebuttable.

    You mentioned about the huge investment made in fighting the neem case. I don’t think TKDL has come for a cheap cost either. Just for the year 2012, the sanction is 2 CRORES!! You can imagine the average cost since 1999.

    Moreover, I feel that the need for creation of the database could have been easily fulfilled if those books which have been scanned and digitized would have been translated in one language ( english for that matter) and kept as a set of those 150 books in the libraries. I think that would have been easy to access and easy to understand.

    I’d be glad if an explanation to errors in indicating the genetic resource and the need for such a huge investment (when a cheaper and easier option was available) could be justified and then I’ll also have another reason be a proud Indian.

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  5. AvatarAnonymous

    For Basmati I mentioned India and APEDA is a GOI organisation and in case of Neem Dr. Shiva was closely associated As usual you read what you wish to read. Also for Mahima, TKDL did present prior art as available in Unani to EPO and examiner did act afterward in the perception of examiner applicant was able to establish the novelty and that is the objective of TKDL that it will attempt to establish the prior art of Ayurveda, Unani and Siddha before the grant, relevance of the prior art is to be agreed by the examiner under whose jurisprudence it lies.TKDL has not attempt to mislead by giving wrong information and/or impression, whereas you and Prashant seems to be attempting the same at least in the blog relating to the access of TKDL to IPO though have failed to achieve your objectives in my view I agree it is impossible to argue with you and Prashant since in your earlier blog after posting TKDL Agreement of July 2009 between CSIR and Indian Patent Office (IPO) and collecting RTI data that IPO was contributor and partner in creation of TKDL you continued to argue that examiners are not trained in TKDL usage, quite funny, a fourth year student can access TKDL (being easy and friendly) and claim to have become the expert capable of writing a book on TKDL and examiners of IPO who partnered in creation of TKDL do not know how to use it.I can only wish both of you great success in your future blogs and career

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  6. AvatarMahima

    Hi Anon ( @10:45 am)

    1. Your wishes: Thanks. Both of us are destined to do well in everything we attempt to do.

    2. Neem Patent: It’s a story prior to the existence of TKDL. So, not of much relevance to the present discussions.

    3. My Case study and acceptance of prior art: You have still not understood my concern. When I have proved that the translation of the genetic resource itself was wrong- what rebuttals do you have in relation to that? The question of grant or non grant is immaterial unless you come up with an answer to this. The problem is that there is error in the very thing the database intends to protect.

    4. Our attempts to mislead: Your observation is not well founded. When I said that CSIR is misleading, I proved my evidence and each of my statements is backed by evidence. You have failed to appreciate the difference in the reason mentioned on the website and the reason in the documents. The one on web is strikingly different from the actual reason!!

    5. CSIR-IPO link: To provide something on paper and to implement are two different things. If you disagree with us, kindly circulate a questionnaire among the patent examiners to judge their knowledge about the USAGE of the database and you will know the actual position for yourself. Also, if the patent office itself tells me that it is using the representative database and does not have access to the original one; I refuse to believe anyone else on this point. If you can procure your set of evidence, please share.

    6. Claim to be an expert: It was just a kind gesture on Prashant’s part to have written that. Please help him in solving this mystery and I’m sure he’ll appreciate you as well.

    7. IPO was a partner in creating TKDL: Please know that CSIR does not acknowledge the involvement of IPO in creation of the database. When I asked them about the creators and specially third parties- they stated that the parties involved are CSIR and AYUSH ONLY. (Another ambiguity) and please know that the draft agreements discussed in 2005 contained the name of CGPDTM as one of the creators and suddenly the actual agreement misses its name. Reasoning to the same extent is missing in the documents relating to vetting. (provide an answer if you can.)

    I’ve backed each of my statement with strong evidence. If you could do the same while posting a comment next time, we can evaluate both sets.

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