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Sunday, 15 December 2013

Readers' comments on the Nagoya Protocol

This moggy posted last week about the Nagoya Protocol and the current status of the implementation of it in the EU.  He was blogging from scratch about something that has not been written about as much as is deserved, and he left out a very major factoid - the United States of America is about the only major country that is not a signatory to the Convention on Biological Diversity (the only other listed non-signatories are the Holy See, South Sudan and Andorra), and the USA likewise has not signed the Nagoya Protocol (nor has any plans to do so, apparently).  This has major consequences.

The IPKat will adopt the Socratic method of exposition.  He received the following email from Correspondent A:

As I understand it, the US has not signed the CBD.

If that is correct, does it have the consequences:

1.       That the US can go bioprospecting/ biopirating to its heart’s content and provided it gets the material into the US it is home free; and

2.       A drug developed in the US as a result of such bioprospecting/ biopirating could be freely sold in the US, but would infringe the CBD and the EU regulations in Europe, whether or not those regulations are limited to future work or past and future work?

 If that is correct it must be a wonderful inducement to do pharma and other research using bio materials in the US rather than the EU.

If this is wrong, apologies, but please let me know why!

And then the following response from Correspondent B:

I think that's broadly right.  The 'country of origin' (if it can identify itself as such) may have rights against the US company for breach of its local law, which perhaps it can enforce in its local courts,  but it will have problems in asserting such rights in USA.  But the US firm may not be able to export to Europe (or other Nagoya signatories).  How all this will fit in with normal WTO rules on international trade is obscure.

But if useful drugs are developed by this route, the rest of the world is going to want access to them (as they do with HIV drugs, for example).  So no doubt some sort of fudge will be cooked up.

This Kat has two further observations.  Even if a company never engages in any "bioprospecting", there is likely to be a bureaucratic burden on demonstrating Nagoya-compliance. So simply the EU ratifying the protocol and the USA not will put European businesses at a disadvantage.  Secondly, in response to the situation outlined by Correspondent A, it may well be that a product that is indirectly developed using biopirated resources in the USA will nevertheless not be illegal in Nagoya compliant countries.  It depends on exactly how the Protocol is implemented, and, in the narrower implementation favoured by the European Commission, this Kat does not see that the downstream products of biopiracy, no longer containing genetic material, would be outlawed in Europe.  So in the scenario hypothesized the drug itself might will be marketable worldwide (except perhaps in the country where the biopiracy occurred, so that an illegal act took place), resulting in the envisaged advantage to the US company.

This may seem speculative, but that seems inevitable in the case of the creation of an entirely new sui generis quasi property right in genetic material as such.

The post itself attracted some very high quality comments, even if the number was not large.  This Kat is very grateful to Norman for posting this link to submissions by the Intellectual Property Institute of Canada (the Canadian IP practitioners’ professional association)  regarding Canada’s possible signature of the Nagoya Protocol.  They are well worth a read and contain some very thoughtful objections to the Nagoya Protocol scheme.

This Kat's final comment, arising from reading the comments of Graham Dutfield, is that it seems that the "Benefit" of the Access/Benefit Sharing arrangements is supposed to go to the Party, ie the signatory state from which the genetic resource is extracted.   He does not read the Nagoya Protocol as requiring that it goes to indigenous peoples.  So there may be no benefit to indigenous peoples at all from all of this.

1 comment:

Norman said...

“Even if a company never engages in any ‘bioprospecting’, there is likely to be a bureaucratic burden on demonstrating Nagoya-compliance.” This is correct. One proposed enforcement mechanism for Nagoya, that has been extensively discussed at WIPO and elsewhere, is to require all applications for inventions based on a genetic resource to disclose the source of that resource. The idea is that this will allow detection of cases in which benefit sharing will be triggered under Nagoya, but the disclosure requirement would apply to any invention based on genetic resources, regardless of the source (since of course the source is not known before it is disclosed). Switerland and, as I understand it, Norway, have already implemented such a disclosure requirement. The exact scope of the disclosure requirement depends on how it is implemented. The Swiss provision, Art. 49a PatG, requires disclosure of the source when the invention is “directly based on” a “genetic resource.” The Swiss Patent Office FAQs on Biodiversity indicate that this means a claim to any material “containing functional units of heredity.” This would seem to encompass claims to DNA as such, but also to eg bacteria. However, para 27 of WIPO document PCT/R/WG/6/11, interpreting a proposal by Switzerland which exactly mirrors the wording of the Swiss provision, states that “for example, the source of a plant would have to be declared in the patent application if the respective invention relates to a chemical compound which the inventor extracted from this plant.” That is, the geographic origin of the physical material which was the ultimate origin of the claimed compound would have to be tracked and disclosed for all compounds which have a biological origin. Again, this is regardless of whether benefit sharing would be required under Nagoya. This is a much broader view than the Swiss have taken of this provision.

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