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?
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)
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.
1. Lead Oxide
2. Pistacia vera( Pistacio Nut, Turpentine trees’ pistacia nut)
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
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.