India's claims to Traditional Knowledge washed up and spat out

This Kat posted last week on the topic of Traditional Knowledge, raising concerns at proposals to give Traditional Knowledge special sui generis protection.  One of his worries, elaborated in a comment on the blogpost, and in earlier posts (here and here), is that many cited examples of alleged expropriation of Traditional Knowledge simply do not stand up to scrutiny.  Another example has recently arisen, raising allegations of misuse of Traditional Knowledge from India relating to various herbs.  The IPKat was therefore delighted to receive this Guest Post on this latest development from esteemed former Kat David Pearce, writing under his famous feline nom de guerre Tufty the Cat.  Over to Tufty:
I wrote a guest post on Spicy IP a while ago about a claim by the Traditional Knowledge Digital Library (TKDL) to have successfully foiled an attempt by Nestec S.A. to get a European patent for an age-old Indian remedy. After analysing the case in question, I found that this claim turned out to be untrue. After also taking a look at a few more of the cases where the TKDL had been cited in third party observations at the EPO, it appeared to me that its use in preventing patents being acquired for traditional knowledge was greatly over-stated and it was nowhere near as relevant as the people who run it claim it to be.

I therefore greeted the recent announcement from the Indian Government (as reported here, here, here and here, among other places) to have "foiled an attempt by consumer goods giant Colgate-Palmolive to patent a mouthwash formula containing herb extract by citing ancient texts that show it was traditionally used in ancient medicinal practices" with a certain degree of scepticism. Although neither the press release nor any of the subsequent press coverage mentioned the patent applications in question, after a bit of digging I found two that seemed to fit the bill: European applications 08835291.9 and 13189942.9 (the latter being a divisional of 10787235.0). The second of these is mentioned in the "TKDL Major Milestones" list here under its publication number EP2689806.

The first application, titled "Compositions for oral applications containing botanical extracts", initially claimed a mouthwash with at least two botanical ingredients derived from one or more plants selected from a list. The initial claim was very broad. 
Unsurprisingly, the international examiner found some relevant prior art, finding the claims to lack either novelty or inventive step. The applicant then narrowed the claims down to a composition including an active ingredient derived from five (or possibly six) plants. The EPO examiner, however, was not convinced and objected that the claims were still too broad and unclear. The applicant then narrowed the claims further, and specified percentage ranges of extracts from each of six plants in an amended claim 1. 
Following this, the CSIR stepped in with some third party observations in April 2011, claiming that there were several references in the TKDL where three of the plants mentioned had been used for treatment of oral ailments. After forwarding these to the applicant, a few months later the EPO examiner issued a further examination report citing a document mentioned in the application itself, and objecting that the new claims lacked novelty. The applicant filed yet further amendments, narrowing the claims again, but the examiner objected that these lacked an inventive step over the applicant's own cited document. The applicant then changed tack, and amended the claims in an entirely different way, claiming a composition from one of the original dependent claims. The examiner, apparently a bit miffed by this point, was still having none of it and objected that these too lacked an inventive step, pointing out that 
"an inventive step cannot automatically be acknowledged for every novel combination under original claim 1; that would, for instance, enable unacceptable possibilities of speculative draftings at filing date, followed by much later selections" (annex to the communication dated 15 June 2012). 
Examination then continued back and forth until in March this year the examiner issued a communication following a telephone conversation, indicating that the claims still lacked novelty. The applicant failed to respond to the deadline set by the communication, and a notice of loss of rights issued on 12 June 2015. The applicant currently has until 24 August to respond to this, so the application is not quite dead yet, but it does look like the applicant will struggle to get anything allowed. The important point to make, however, is that the TKDL references have played absolutely no part in getting to the current state. The main references have instead been those cited in the application itself, together with a further one cited by the examiner. Any claim that the TKDL has played any part in foiling an attempt to get a European patent in this case is therefore quite clearly false.

The parent of the second application, titled "Oral compositions containing extracts of myristica fragrans and related methods", initially also claimed a mouthwash with a broad scope, in this case specifying a combination of extracts including one from Myristica fragrans (nutmeg). The international examiner, after some amendments had been filed to include another natural extract from a long list of options, objected that the invention was either not novel or not inventive over various cited documents. Following further amendments filed on European regional phase entry, third party observations were filed by CSIR, claiming that there were several references in the TKDL where Myristica fragrans, among others, had been used for oral ailments. After duly forwarding the observations to the applicant, the examiner issued an examination report, objecting that the invention was still not inventive over the documents already cited. No mention was made of the TKDL citations. Following another round of examination, a summons to oral proceedings was issued, with the inventive step objections still raised. and the application was refused at a hearing held on 26 November 2013. The decision made no mention of the TKDL references.

The divisional, 13189942.9, which was filed shortly before the hearing was held on the parent, claimed the original composition from the parent application, which the examiner unsurprisingly objected to.  CSIR then file observations again in May 2014, following which the applicant filed amended claims in response to the search opinion. The examiner then issued an examination report, objecting that the claims were in the form that resulted in refusal of the parent application, and were not allowable for the same reasons as set out in the refusal. The applicant failed to respond in due time, with the result that the application was deemed withdrawn. The application is now officially dead.

Assuming the applications are indeed the ones in question, it appears to me that the recent claim by the Indian Government is not just a bit exaggerated, but completely false. Not only have TKDL references not been instrumental in these cases in preventing Colgate-Palmolive from patenting a mouthwash based on ancient medicinal practice, but they have been shown to be not relevant at all. This is even more striking than in the other applications I looked at previously, where TKDL references were at least mentioned by the EPO examiner, along with other more relevant references. I still wonder then whether there have been any cases at the EPO where the TKDL has been a key factor in preventing something from being patented. I have yet to see one, but I would be happy to be proven wrong.
India's claims to Traditional Knowledge washed up and spat out India's claims to Traditional Knowledge washed up and spat out Reviewed by Darren Smyth on Tuesday, July 21, 2015 Rating: 5

19 comments:

  1. I wonder how many of the references offered across the whole range of technical fields in an observation have actually had an influence on a European case. If I were an examiner, I would feel more proud if I had found a devastating reference myself, rather than have to rely on an outsider. Perhaps the observation just puts a subtle pressure on the examiner, thereby creating a more thorough examination, which is for the public good. Whether they can afford to is another matter.

    There is no simple way of finding out the actual relevance of observations, and thank you Darren, for having spent the couple of hours studying the files and reporting in these specific cases!

    George Brock-Nannestad

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  2. Dear George

    Thank you for your comment. I must point out that it was Tufty the Cat and not me that did the work and wrote the post. For which again my thanks.

    Darren

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  3. ah, unsalaried help!

    George

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  4. From personal experience, I know that third party observations can be quite powerful at the EPO. If a new relevant citation is presented, this can change the course of examination. In the cases discussed here, however, this did not happen. I see no sign that the course of examination was altered at all. I think it is patronising to suggest that the examiner might feel some kind of subtle pressure from the observations. The observations in these cases were simply nowhere near as relevant as the citations the examiner had already found, and were therefore rightly ignored.

    As a general comment, having reviewed quite a few cases where the TKDL has been used in observations, I think the TKDL is pretty useless as a source of prior art. If the Indian government want to continue funding it, that's their business. I doubt though whether it will ever be actually useful as a way of preventing anything being patented in Europe, as the content is simply too vague and general to be relevant to any but the most hopelessly broad applications, which would always be knocked down by a European examiner anyway.

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  5. Internal studies at the EPO showed that a high proportion of third party observations that were reasoned had a material effect on scope, either resulting in significant limitation or refusal/withdrawal. That is one of the reasons that they have been encouraged by the EPO, and why examiners now have to indicate whether the 3PO has been taken into account. While opposition rates have been static or falling for some time, rates of 3POs have been rising strongly.

    However, a significant number of 3POs are just irrelevant, being less on point than art already on the file.

    So the moral of the story is, that if some applicants are Cowboys, the Indians might not be able to stop them but the Sheriff (examiner) can.

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  6. Can I draw everybody's attention to the AIPPI work on TK and specifically the UK contribution (specially the contribution of Sophie Holcombe)? Make your own mind up but do see the work we have done on it; it is on the AIPPI website somewhere. We found the whole thing to be far more interesting and complicated than we first thought.

    Ashley

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  7. A link would be helpful. The AIPPI website looks useless to me and Google searches throw up all sorts of pointless meeting minutes. I'm sure TK is very interesting and complicated, but the point I am making in this post is that the TKDL is very poor as a source of prior art.

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  8. Tufty, you want some links. Here are a few.

    https://www.aippi.org/?sel=publications&sub=onlinePub&cf=questionaires

    https://www.aippi.org/download/commitees/166/QS16601_summary_report_questionnaire.pdf

    https://www.aippi.org/download/commitees/166/QS166united_kingdom.pdf

    They don't seem to undermine your point though.

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  9. Dear Tufty the Cat

    Here is the link.

    https://www.aippi.org/?sel=questions&sub=listingcommittees&viewQ=232#232

    Check Q232.

    I mentioned AIPPI's work on TK as it has within the corpus of work which was done on the question an interested countries survey. One of the difficulties which many countries identified was access to TK and identifying it. That might go to the prior art question.

    I cannot think of a soubriquet Tufty so I'll sign off as plain Ashley, though my older daughter might pop the word "weird" in somewhere.

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  10. Dear Tufty

    I was not trying to "undermine" your point, I was contributing to the question. I thought that your point was a good one.

    Ashley

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  11. Thanks for the links. I agree with the UK response, in that the key point is a definition of what TK is and that this should be a matter for national law because a harmonised definition would be extremely vague and incredibly broad. I think a similar point has already been made by Darren.

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  12. I found one! It looks like EP application 05852369.7 has been amended as a direct result of TKDL documents being cited as third party observations. Something about anti-ageing properties of a plant extract. Applicant is Avon Products, Inc.

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  13. There was one largely commented case about extracts of neem tree, and I could find that it was EP0436257. The patent has been revoked in opposition proceedings for lack of inventive step based on a prior art document, although I am not sure if it originated from the TKDL.

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  14. The opposition on EP0436257 resulted in decision T 416/01. The cited art was not from the TKDL, but was a book on plant pathology and some affidavits. The issue of traditional knowledge was briefly mentioned though.

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  15. https://register.epo.org/application?number=EP13189942&lng=en&tab=doclist

    If you see the EPO communication dated 6th October 2014, it clearly specifies the 3rd party observations (TKDL) and mentions that they are very relevant and that each document cited therein anticipates the claimed invention. There is no rebuttal to this in the File wrapper and the file has been closed on June 22, 2015. As per this post, the Examiner made no mention or reliance on TKDL citations. Am i missing something here?

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  16. No, I don't think you're missing something. It looks like I unfortunately missed that last paragraph, and the divisional application is actually one where the TKDL references were stated as being relevant. It looks like it would certainly have been refused anyway, but I admit that the third party references could have been used to at least limit the claims if the examiner had concentrated on them.

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  17. Okay thanks. May be then you can amend the concluding lines of your post which state that the CSIR claim is completely false.

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  18. Maybe I should say it's only partly false instead. I would be happy for the last paragraph to be amended to:

    Assuming the applications are indeed the ones in question, it appears to me that the recent claim by the Indian Government is at best a bit exaggerated. The latest examination report on the divisional application (13189942.9) stated that the subject matter was not considered allowable for the reasons as set out in the refusal on the parent application, which made no mention of the TKDL references, instead relying on a single published US patent application. A final paragraph in the report on the divisional indicated that the third party observations were considered relevant, but went into no detail except to refer to the observations themselves (this is the point I missed first time round). I would therefore say that in this case the TKDL references have not been instrumental in preventing Colgate-Palmolive from patenting a mouthwash based on ancient medicinal practice, in the parent case were not relevant at all and in neither case were the references necessary to justify refusing the application. This seems to be fairly usual practice for the TKDL, where plenty of exaggerated and downright false claims have been made about its relevance and usefulness as prior art. I expand a bit more on these claims in a further post here, where I show that some of them are possibly true, but most are just false.

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  19. Without having read all of the file, the examiner's comments appear to be less precise and more likely to be have been used to cover backs than Tufty may have been forced to concede. The docs are described as 'relevant' and only appearing to be novelty destroying. No direct analysis is given other than to refer to the third party letter. My take is that the application is to be refused but, in case the given argument with D1 is refuted, the examiner is making clear that the applicant should explain why the TKDL references are not problematic. Failure to write something of this ilk tends to get a response dealing only with D1, whereafter the examiner has to analyse all of the TDKL. For the examiner, it is more efficient to pass this on to the applicant given that he expects to be able to refuse based on D1 - why waste time with the TDKL, but cover any possible later steps. I would do this so that the applicant is not misled into thinking there is only one issue while not wasting time on unnecessary issues (you can only kill an application once).

    An examiner

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