TWN Info Service on Biodiversity and Traditional Knowledge (Feb13/01)
Dear friends and colleagues,
The role of patents and other intellectual property (IP) claims in the biopiracy of genetic resources and associated traditional has been raised by developing countries in several international fora, including the WTO TRIPS Council, the negotiations of the Nagoya Protocol on Access and Benefit Sharing as well as the World Intellectual Property Organization (WIPO).
On 4-8 February, the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) met at the WIPO headquarters in Geneva, for its first negotiation session on the "Consolidated Document relating to Intellectual Property and Genetic Resources" (WIPO/GRTKF/IC/23/4). The meeting focussed on an obligation to disclose the origin of genetic resources and associated traditional knowledge when they are the subject of IP claims.
Below is a report by Edward Hammond who attended the IGC meeting, which clearly shows the sharp divergence between developing and developed countries on this issue.
WIPO PATENT DISCLOSURE NEGOTIATIONS STAY ON TRACK BUT CONSENSUS WILL PROVE DIFFICULT
Austin, 26 February (Edward Hammond) – A World Intellectual Property Organization (WIPO) committee has stalled efforts by the United States, Japan, South Korea, and Canada to sidetrack negotiations focused on creating an obligation to disclose the origin of genetic resources and associated traditional knowledge when they are the subject of intellectual property (IP) claims.
The WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC), which met from 4-8 February at the WIPO headquarters in Geneva, will submit its consolidated negotiating text to the next WIPO General Assembly. The four dissenting countries sought to also transmit less ambitious alternative texts that they drafted. The consolidated text, which is intended to result in an “international legal instrument”, reflects submissions from all regions made during previous meetings of the committee. It was tabled and first negotiated last week.
Although the four countries’ move to circumvent the consolidated text did not succeed, the diverging positions held by WIPO members on the subject of disclosure of origin of genetic resources in intellectual property claims suggest that it will be difficult to achieve a consensus.
Positions on Disclosure of Origin of Genetic Resources and Traditional Knowledge
Developing countries, led by Brazil, Nigeria, Peru, India, China, and South Africa, favor an agreement obligating WIPO members to create a strong disclosure requirement in national intellectual property laws, so as to identify and stop misappropriation of genetic resources (in other words, biopiracy).
A number of these countries, including China, Brazil, India, and Peru, have already enacted domestic disclosure rules. They would like to see an obligation for all WIPO members to adopt equivalent provisions in their laws, particularly in the North, where patent offices have allowed claims on biopirated genetic resources and knowledge.
Many developing countries see the establishment of an international disclosure requirement as supporting the Convention on Biological Diversity, with 193 Parties, and its Nagoya Protocol concluded in October 2010, the international instrument to regulate access and benefit sharing (ABS) for genetic resources, whose entry into force is pending ratifications. Some industrialized countries, mainly Europe, may be willing to accept some such linkages, albeit with hesitancy.
The United States, Japan, and South Korea, however, are entirely opposed to a mandatory disclosure requirement. They argue that disclosure of origin of genetic resources in patent applications is not relevant, per se, to legal criteria for patentability (novelty, utility, and inventive step). They thus claim that disclosure is an unnecessary complication for the patent system, would create “legal uncertainty” about ownership of patents, and say it would be burdensome to administer.
(The latter assertion is disputed by countries that already have disclosure systems, including China, which processes more patent applications than any other country.)
Canada’s positions are very close to those of the US, Japan, and South Korea. While in principle offering slightly more flexibility than the others, in practice Canada often played the role of a heckler, repeatedly intervening in working sessions to ask numerous questions whose effect was to obfuscate rather than create clarity and advance the negotiation. On the sidelines and in plenary interventions, several delegations noted this phenomenon.
The four dissenting countries say that biopiracy (“erroneous patents” is their favored term) can be avoided through creation of voluntary guidelines for patent examiners and by building databases to store and search indigenous knowledge. They say biopiracy, which is termed “misappropriation” in the text by developing countries, should be addressed by civil lawsuits and not be a subject of consideration by the patent system.
Russia, while speaking little, concurs with these four countries’ view in its major aspects, although it repeatedly stopped short of fully endorsing them.
Europe generally occupies a middle ground, accepting the need for a disclosure requirement but seeking it in a less robust form than developing countries. Important aspects of the European Union’s position, however, were not closely tested by the negotiating session, which was more occupied by debates such as whether or not to have a disclosure provision, rather than methodical discussion of the precise content of disclosure and circumstances in which it would be required.
While the EU says it will accept a disclosure provision in principle, it is clear that the EU would be satisfied with disclosure of a considerably more limited applicability than the South wants, as well as much milder sanctions for failure to disclose. For instance, the EU favors fines, and opposes revocation of patents, when disclosure requirements are not followed. It also takes a more hesitant position than developing countries with respect to linkages between the WIPO negotiation and the Nagoya Protocol.
Switzerland and Norway, like some developing countries, have disclosure requirements in their national legislation, and expressed views largely similar to the EU. Switzerland set itself apart, however, by making a number of practical proposals for how a disclosure requirement would work in international law, including amendments to the Patent Cooperation Treaty and Patent Law Treaty. Like the EU, however, the level of disclosure and severity of sanctions that Switzerland favors fall short of what is sought by developing countries.
Australia is also in the middle. It expresses doubts about mandatory disclosure but shows a considerably greater willingness than Canada, the US, Japan, and South Korea to work within the consolidated text, although the ideas it offers are frequently at odds with the proposals of developing countries.
On the issues of creating a mandatory disclosure requirement and mutual support for the Convention on Biological Diversity and Nagoya Protocol, no major disagreements between South countries were apparent.
Organization of the Meeting
The WIPO IGC met in its 23rd Session from 4-8 February. Ambassador Wayne McCook of Jamaica chaired, and was assisted by facilitators from Australia, India, and South Africa, whose role was to follow discussions and edit and draft text in accordance with the views expressed.
The meeting was organized in plenary and expert group sessions, which were not held concurrently. Representation in the expert group was on a regional basis, and included a small number of representatives of indigenous people. The expert group proceedings were simultaneously transmitted to the plenary room, enabling other delegates to follow the discussions.
The negotiating text, consolidated by the Chair from previous IGC submissions from countries in all regions, was first reviewed in plenary, then sent to the expert group, returned to the plenary, and then back to the expert group a second time. A final consolidated text (Rev. 2) was returned to the plenary on the final day (8 February), when countries could make observations (including placing brackets and smaller text amendments), but where no further negotiation took place.
In practice, because the expert group was unable to go through the entire text in detail twice, some portions received relatively little consideration, particularly later articles. The meeting was largely dedicated to basic provisions such as terms, objective, and disclosure requirement. Some of the later articles, such as language on indigenous knowledge databases, are also considered implementation-related issues (rather than core business) by many countries, who say they would be best considered at a later stage.
Thus, the text that will be reported to the WIPO General Assembly contains some elements that have had deeper consideration than others. By consensus the entire text is deemed a work in progress without prejudice to any country’s final position.
After the formalities of an opening plenary, the meeting suspended for an indigenous peoples-sponsored panel including comments from James Anaya, the UN Special Rapporteur on the rights of indigenous peoples. Anaya noted that indigenous peoples’ right to prior informed consent in access to their genetic resources and traditional knowledge flows from existing rights under customary and international law, and need not be independently elaborated by the IGC.
Anaya noted that there is no inherent conflict between state sovereignty to genetic resources and the rights of indigenous people, but that in creating national access and benefit sharing (ABS) rules that governments needed to respect indigenous peoples rights in a manner consistent with international human rights standards. He projected modest expectations for the IGC, saying that he “hold[s] out hope of success”.
First Plenary Discussion
As the IGC got down to work on the afternoon of Monday the 4th, many introductory interventions were submitted in writing to the chair. Of those taking the floor for brief statements, BRAZIL emphasized the need to establish a mandatory disclosure requirement and for consistency with the Nagoya Protocol. BOLIVIA reiterated its opposition to patenting of life forms and signaled its willingness to work with other countries to have this reflected in the text. BELGIUM, speaking for WIPO’s “Group B” of industrialized countries, noted unresolved conflicts in the text and emphasized listening to business interests. NIGERIA said the time to finalize negotiations on disclosure had arrived. RUSSIA said it appreciated genetic resource and traditional knowledge issues, but that it was too early to know the legal character of a final instrument.
The Chair began plenary discussion of the draft text, and invited interventions on the policy objectives portion.
The UNITED STATES took the floor with lengthy comments, the thrust of which was that it rejects a mandatory disclosure requirement in patent applications as “extraneous information”, because it believes that prior informed consent (PIC) and mutually agreed terms (MAT) for ABS are a matter of contract law. The US said it opposed “illegitimate” use of genetic resources (GR) but that the patent system has no place in resolving biopiracy disputes. The US maintains that disclosure of origin has no relevance per se to the criteria for patentability and, therefore, doesn’t belong in a patent application. The US also said it wondered if published (i.e. “public domain”) traditional knowledge could be claimed by anyone, that it did not understand what is meant by the term “derivative” (with respect to genetic resources), and that it could not accept references to the Convention on Biological Diversity (CBD) or the Nagoya Protocol. (The US has not ratified the CBD.)
NIGERIA replied by suggesting that the US is overreacting because what it favored was perfectly compatible with existing international patent law, and that concerns or misunderstandings about the potential administrative procedures to implement disclosure need not get in the way of setting an international norm. With respect to the US concern about references to the CBD, NIGERIA said that there were standing principles for how to reconcile these issues in new international legal instruments.
CHINA said it saw a mandatory disclosure requirement as an enhancement to intellectual property law to bring it in line with the CBD.
PERU said it had experienced a number of problematic patents granted on its GR in foreign jurisdictions, often because foreign patent offices didn’t have relevant information on hand. PERU said disclosure was a key step to resolving this problem.
The Chair steered discussion into Article 1 of the text, concerning the objective or, in an alternate title, “subject matter of protection”. Here countries generally agreed that “protection” was an inappropriate term, sometimes for different reasons. BRAZIL, NAMIBIA, NIGERIA, and others believe that “protections” for GR are established in the CBD and implemented via national law for that treaty and its protocols. The US and CANADA also didn’t like “protections”, noting that they suggested the creation of a new right. The two countries were also uncomfortable with use of terms from the Nagoya Protocol.
IRAN, PERU, NIGERIA, and NAMIBIA preferred that the objectives refer to all intellectual property rather than just patents, noting the genetic resources and associated traditional knowledge may be subject to other kinds of IP claims. Others wanted to refer to patents only. From this discussion and similar ones later, “intellectual property” and “patent” and similar references (such as “intellectual property offices” or “patent offices”), became bracketed as options throughout the text. An open issue is if and how any agreement would relate (or not) to the UPOV regime of plant breeders rights.
[The International Union for the Protection of New Varieties of Plants (UPOV) is an intergovernmental organization with headquarters in Geneva. It was established by the 1961 International Convention for the Protection of New Varieties of Plants, with revisions made to the Convention on in 1972, 1978 and 1991. Its current form is criticized for shifting the balance away from small farmers in favor of formal plant breeders.]
After a short discussion of Article 2 (beneficiaries or objectives), members had an initial exchange on Article 3, the principal article on mandatory disclosure and which in draft form included a short text to create a national obligation to create law to protect traditional knowledge.
JAPAN said that access and benefit sharing is an issue for the Nagoya Protocol, not WIPO, and that a mandatory disclosure requirement would have “a chilling effect on industry patent applications” and would harm industry’s motivation to innovate. It suggested that rather than a disclosure requirement, databases of traditional knowledge should be developed for use by patent examiners in prior art searches.
NAMIBIA noted, in response to JAPAN, that during the negotiation of the Nagoya Protocol some countries said that the WIPO IGC was the forum in which to discuss a disclosure requirement, but that some of those same countries were now saying they would not discuss it at WIPO IGC.
The US offered its standard objections to disclosure (see above), tailored to the specific text proposals (which it, of course, opposed), and agreed with Japan that the best approach was improving patent office’s access to traditional knowledge, which would, the US says, prevent erroneous patents on grounds of lack of novelty.
SOUTH KOREA said that its internal patent office studies revealed many patents in which the origin of genetic resources was unclear. This work “required extensive resources,” including looking at patents “one by one”. Although patent offices already should look carefully at patent applications one by one, in the context of a mandatory disclosure requirement, South Korea reasoned that this was an argument against disclosure.
BOLIVIA, with support from VENEZUELA, reiterated its opposition to anything in the text that would encourage or require patenting of life forms.
BRAZIL, NIGERIA, PERU, and IRAN expressed their support for mandatory disclosure.
Plenary review of further articles fell into the same predictable pattern, with the US and JAPAN seeking to eliminate any legally binding language and draft articles predicated on a mandatory disclosure requirement. Developing countries, on the latter items including CHINA and SOUTH AFRICA, did the opposite. SWITZERLAND aimed for a weaker yet mandatory disclosure rule, while the EUROPEAN UNION remained silent, having submitted a statement in writing.
First Expert Group Meeting
At the first expert group meeting, the Chair invited members to express their thoughts about the consolidated text and posed questions. A sometimes meandering discussion ensued. On how to best protect traditional knowledge as prior art, the Chair asked, was it either a database or disclosure, or was a mixed approach possible?
The US replied that a mixed approach was possible, but mixed only in the sense that origin of genetic resources might sometimes be material to the substantive criteria for patentablility. In such situations, the US said, origin could be disclosed (but not via a new requirement).
The Chair then moved the Expert Group ahead to try to refine a disclosure requirement, as there was no in principle objection from member states to disclosure of origin, although in at least the US case there is a major proviso that such disclosure be “material to patentability.”
While this understanding enabled further discussion, it papered over a large rift between countries, as the US would not consider disclosure to be of relevance to patentability in a majority of circumstances under which developing countries would deem it to be appropriate and required.
This understanding, made at the outset of the Expert Group, would haunt JAPAN near the end of the meeting when, in explaining its support for a WIPO study on the costs of disclosure requirements, JAPAN initially seemed to double back, stating that it could not support negotiation on mandatory disclosure. (This is discussed in detail below.)
Further discussions centered on “erroneous patents,” which the UNITED STATES and JAPAN said can be addressed by databases. AUSTRALIA supported this notion, wondering if all countries had access to the latest and largest technical databases. Most other countries, including BRAZIL, PERU, CHILE, said they could discuss “erroneous patents” (in this exchange, at least, considered closely with databases) but that it “isn’t the most important point” (BRAZIL).
PERU explained linkages between disclosure and preventing erroneous patents, saying that disclosure facilitates identifying pertinent patent applications in other jurisdictions, which enables Peruvian institutions to present information to foreign patent offices on origin of genetic resources and traditional knowledge that, Peru considered, reveals the foreign patent applications to be misappropriation. Peru observed, however, that its success in pursing this approach is thus far mixed. On databases, Peru noted that “out of sight, out of mind” was a problem, and that “If it’s not in your database, you don’t think it exists”. Peru therefore saw shortcomings to reliance on databases.
CANADA could not accept mandatory disclosure as an objective of the agreement “because it would connect a nascent disclosure system with an evolving ABS regime”. “We can’t talk about disclosure as an objective,” Canada said, “because its not one.” The UNITED STATES and AUSTRALIA backed CANADA’s generalized support for “access and benefit sharing” as a detached principle without articulation with the intellectual property system (i.e. addressing ABS issues purely as matters of contract law). Thus simultaneous to accepting ABS, they asserted that the patent system “is not the right system to fit” ABS concerns.
Language about indigenous peoples rights was decided to belong (with other items) in a preamble, as it was widely considered that the purpose of the legal instrument, while including recognition of indigenous peoples’ and local community rights, was not about creation of new rights.
A related but difficult issue, however (unresolved at the end of the meeting), was how indigenous peoples’ rights related to the interconnectedness of genetic resources and associated traditional knowledge. Countries including NIGERIA and IRAN could not wholly separate many genetic resources from traditional knowledge, as they viewed those genetic resources as having emerged through inputs from indigenous peoples, whose knowledge they reflect and incorporate. Other countries were more willing to understand genetic resources as being tangible objects that are more readily separable from traditional knowledge about them.
BOLIVIA, BRAZIL, INDIA, IRAN, and others reiterated that prevention of misappropriation (biopiracy) needed to be an objective, and that this concept was not wholly captured by the idea of preventing erroneous patents.
The EUROPEAN UNION replied that it understood misappropriation to mean “not in accordance with the requirements of the ABS regime”, thereby suggesting that if ABS were an objective of the agreement that misappropriation need not be separately included. This position was an ambiguous one, however, because the discussion on ABS as a objective of the agreement was very vague, with some members, such the UNITED STATES, embracing concepts of ABS that many members would not consider compliant with the CBD and Nagoya Protocol.
To wit, the UNITED STATES said that it defined misappropriation as “violation of a national access regime”, with no reference to the CBD, and that “We don’t see a link between misappropriation and patent system.”
On objectives, it was provisionally concluded by the facilitators, for the purpose of drafting, that there was “no objection” to disclosure or to ABS “in principle”, although it was apparent stark differences existed in practicality. Differences were also noted in links to the Nagoya Protocol. There was agreement to continue discussions on databases, but disagreement as to their role and importance.
The discussion then shifted to terms, including “genetic resources” and “derivatives”, and whether to include them in the text (especially “derivatives”) and, if so, whether or not to use definitions from the CBD and Nagoya Protocol.
AUSTRALIA pounced on the derivatives issue, raising questions about the meaning of the term, but made technical mistakes (or perhaps was insufficiently specific) in its observations, for instance, equating “genetic resources” with DNA, and muddling distinctions between derivatives as they appear in intellectual property claims versus derivatives when they appear as products, saying that snake venom is a product, not a derivative.
[In fact, it is both. Snake venom can be a product (commodity) when it is collected and sold for research purposes or the production of antivenin. It can also be a derivative in the sense of the Nagoya Protocol when an intellectual property application is filed on its constituent compounds – or uses of the venom as a whole.]
BRAZIL pleaded, “let’s not reopen this,” and urged use of CBD and Nagoya Protocol definitions
NAMIBIA corrected Australia’s statement that “functional units of heredity” amount to DNA, noting genetic resources can include RNA and other molecules. (This is an important clarification considering that the genes of many pathogens, including influenza virus, are composed of RNA, not DNA.)
On “genetic resources” it was decided to use the CBD text.
On derivatives, the UNITED STATES and EUROPEAN UNION wanted the word deleted from the text. AUSTRALIA, on the other hand, preferred “dealing with the devil I know” to one it didn’t, and would assent to using Nagoya Protocol definitions, as urged by NAMIBIA and others. TRINIDAD, BRAZIL, and CHILE agreed with Namibia. The US and the EU agreed to move forward after placing the term in brackets.
An inconclusive discussion took place on the term “traditional knowledge”, which is not defined in the Nagoya Protocol. Serious discussion was postponed until the next session of the IGC, when a definition will be considered in the context not only of genetic resources but traditional cultural expressions and other aspects of traditional knowledge. (These two topics are subject matter of separate negotiations in the WIPO IGC.)
Discussion of Article 3 began not with disclosure but with the component of the draft article to create a requirement, under national law, for WIPO members to enact protections for traditional knowledge. The EUROPEAN UNION and UNITED STATES sought to delete the entire provision. IRAN suggested dividing it out and into a separate article. PERU, SOUTH AFRICA, IRAN, NIGERIA expressed support for the principle of a “positive protection” for traditional knowledge, but not for the specifics contained in the draft text. NIGERIA summed up the mood among supporters by saying it should be “lean and mean” (i.e. a requirement but without detail). AUSTRALIA also supported a “focused” positive protection. BRAZIL observed that for it, the big issue is about misappropriation, but allowed that other measures might be included.
On the major aspect of Article 3, the disclosure requirement, the Expert Group exchange was largely predictable. BRAZIL, NIGERIA, INDIA, NAMIBIA, and PERU weighed in on its importance, with BRAZIL and INDIA making particular reference to the role of the patent office as a checkpoint under the Nagoya Protocol. NIGERIA and NAMIBIA emphasized dissemination of disclosures of origin, to enable genetic resource providing countries to search for disclosures relevant to them.
The UNITED STATES was opposed to the requirement, saying it is burdensome on patent applicants and even alleging that a requirement might contribute to natural product chemistry “dying off”. It further said that patent examiners were not positioned to verify disclosure information. CANADA piled on, emphasizing a potential burden on patent offices.
The EUROPEAN UNION stated that it could accept disclosure as a formal requirement for purposes of transparency, however, “unknown source” should be an option and it wanted no retroactive applicability of any requirement.
SOUTH AFRICA said it did not see any agreement as applying retroactively.
PERU said that while other countries kept claiming that disclosure would be burdensome to patent offices, that it did not believe this was the case. (And Peru has practical experience, as its patent law includes a disclosure requirement.)
NAMIBIA agreed and noted that it mainly wanted disclosure, not verification of disclosed information by foreign patent offices, which it would not trust.
SWITZERLAND emphasized that disclosure should be only for cases where genetic resources are “directly” the subject of intellectual property claims, and suggested that the fears of opponents could be allayed by the agreement defining maximum sanctions for failure to disclose. It saw a disclosure requirement as a part of due diligence in implementing the Nagoya Protocol, and wanted to amend the (WIPO) Patent Cooperation Treaty such that disclosure could be accomplished at the international patent publication level, thereby making life easier for businesses.
BOLIVIA introduced text clarifying that genetic resources as found in nature should not be patented, language which the UNITED STATES opposed.
JAPAN then said, without detailed explanation, that even if a patent application obtains PIC and MAT (mutually agreed terms), that a disclosure requirement generates risk, and discourages innovation.
The CHAIR encouraged JAPAN to stop seeing issues as “so black and white”.
SOUTH KOREA said that, “patent offices can’t judge if disclosure is correct and truthfully reported.” AUSTRALIA said it had trouble with patent offices verifying disclosure information too.
BRAZIL agreed that patent examiners may not always be the ones doing the verifying. (BRAZIL, like INDIA, refers disclosure information in patent applications to national biodiversity authorities for consideration.)
NORWAY said it supports a disclosure requirement and hadn’t found it to be a burden in its law. To allay concerns of disclosure opponents, it also said that if an applicant obtained a genetic resource from a genebank that it could indicate as much in its law.
(There is a problem with Norway’s position. Many genebanks maintain secrecy about their accessions, especially in the context of intellectual property applications. They also may not maintain clear records. Thus, disclosure of the name of a genebank as the origin, even if including an accession number, may not make any usable information about origin available, even if the genebank possesses it.)
NIGERIA responded to JAPAN and others saying that it was tiring of them always talking about industry as “innovators”, when we know that indigenous people and local communities are important innovators whose interests are present as well. It chided claims that disclosure would create uncertainty about patents. The delegate noted, “I’m a litigator. We sue people all the time. Claims of infringement occur. The notion that patents must be bulletproof just isn’t real.”
This concluded the Expert Group’s time for a first consideration of the text. Later articles, including sanctions, were not discussed in this session.
Second plenary discussion of the negotiating text
A second plenary discussion of the text, presented as a facilitator’s Rev.1 document, began on Wednesday (6 February). The text was much shorter, with many proposals from the first version placed in an annex. A number of items termed “aspirational” were moved to a preamble, a new component of the text. The preamble was bracketed and while a number of opinions were offered about its content, and sub-brackets placed within, its text was not given specific consideration in this plenary or any subsequent meeting of the session.
On the new terms in the text, CANADA opposed the term “associated traditional knowledge”, while FRANCE wanted modifications to language about indigenous peoples, saying its constitution recognized no collective rights based on ethnicity. VENEZUELA thought FRANCE could be more flexible given past agreements, and FRANCE conceded that CBD language might work.
BRAZIL bracketed some divergences from CBD definitions in the new draft, while the EUROPEAN UNION bracketed “biotechnology” and references to a certificate of origin (a reference to the Nagoya Protocol). The EU also wanted to remove reference to PIC and MAT.
The INTERNATIONAL CHAMBER OF COMMERCE questioned the utility of the concept of “country of origin” and claimed that the issue of ex-situ collections may preclude any action on disclosure.
PERU asked that the phrase “and their derivatives” be added following all references to genetic resources.
Opening a discussion on the new draft policy objectives, JAPAN said that the patent system can only prevent grant of erroneous patents, and that “Misappropriation has nothing to do with it.” A discussion ensued, with participants taking their customary positions, on how to include (or not) misappropriation in the instrument objectives.
On scope, the EUROPEAN UNION echoed the Swiss position that disclosure should only apply to patent applications that are “directly based” on genetic resources.
On beneficiaries of the agreement, CAMEROON, JAMAICA, BOLIVIA, and others observed that the Rev. 1 drafted seem to make practically everyone a beneficiary and that the text should be more focused on providers and indigenous peoples and local communities. GRULAC (Group of Latin American and Caribbean countries) worked to harmonize use of the terms “use” and “utilization” between the Rev. 1 text and the Nagoya Protocol.
CANADA said everything related to the CBD should be bracketed.
Moving to Article 3, the text contained two options: mandatory disclosure or not.
INDIGENOUS CAUCUS expressed unease with the way the text was treating traditional knowledge considered by some to be “public domain”, and said that they expected PIC and MAT for such knowledge when used in intellectual property claims.
NAMIBIA thought that a yes/no decision on disclosure was the right issue for a diplomatic conference to consider.
NIGERIA again supported disclosure, and continued working to introduce the concept of “freeriding” on provider’s resources and traditional knowledge, a term it thought might be more comfortable for the North than “misappropriation” (which itself is a euphemism for biopiracy).
IFPMA (International Federation of Pharmaceutical Manufacturers and Associations) and BIO (Biotechnology Industry Organization) agreed that disclosure creates uncertainty and supported the no disclosure option. The Intellectual Property Owners Association (IPO) said it supports transparency to a competent national authority (apparently using the term as in the CBD) but not to the patent office.
Other members, North and South, adopted their normal positions on disclosure and sought text amendments in accordance with them.
The EUROPEAN UNION, whose position is less detailed than many others, said that it could accept the option for mandatory disclosure but had issues to raise with the text that it would bring up in due course.
The Rev. 1 text contained a section on exclusions to a disclosure requirement, for example human and pathogen genetic resources, that had been carried forward from the original consolidated text but which was not discussed by the Expert Group. Some of these exclusions are large. BRAZIL, BOLIVIA, PERU, and others had it bracketed.
The plenary discussion led to some of the first comments being made on sanctions – the measures to be taken for failure to comply with disclose requirements. CHINA noted that its law did not allow a patent to be granted on a genetic resource or traditional knowledge if it was being used illegally, yet the draft did not seem to allow for this possibility. CHINA asked if it was proper to allow a patent at all on an illegal use of genetic resources.
Brief discussion took place of later articles (after sanctions), mostly opposed by the UNITED STATES as they presume a disclosure requirement, bracketed by dubious North countries, and mostly considered premature for detailed discussion by disclosure proponents.
Second Expert Group consideration of the text
Late on Wednesday afternoon (6 February), the Expert Group resumed meeting to consider the Rev. 1 document on which members had just commented in plenary. The meeting came to take the form more of discussion than text negotiation, as it was decided to postpone discussion of sanctions until Thursday morning.
The Chair moved to open the discussion on triggers for disclosure (part of Article 3), and the facilitator explained that there were two options: the first, narrower option representing an approximation of the views of Europe (including Switzerland and Norway), and the other from Africa and others.
NIGERIA immediately sought clarification on how triggers would be discussed given that a few countries opposed a disclosure requirement to begin with. As if to confirm Nigeria’s fears, the UNITED STATES said triggers were inextricably linked to disclosure, and that it saw nothing in either option that it wanted.
BRAZIL said that requiring provision of the provider country, PIC, and MAT to the patent office was the important part.
CANADA at this point began to ramp up an obfuscating approach to the discussions, saying that it saw a “continuum of problems” related to triggers. It tossed out numerous questions, many based on unlikely hypotheses, and requests for information that seemed to a reflect desire to bring the discussion to a confused halt rather than create clarity.
The Chair chided Canada and asked it to propose more precise language if it found areas of the text too vague or hard to understand.
NIGERIA forcefully replied to CANADA saying that disclosure did not burden the patent system but prevented freeriding. NIGERIA said disclosure is the quid pro quo for the patent right, and that when aspects of disclosure are suppressed by failure to cite prior art or misappropriation, then as a matter of law and equity it should be addressed. NIGERIA said that the standards of patentability don’t deal with the misappropriation problem and that “unless a country claims that misappropriation doesn’t exist, then it is disingenuous to say it can be addressed without disclosure.” Opposing a patent or mentioning prior art after grant doesn’t really benefit anybody or appropriately recognize what’s been taken, NIGERIA stated, questioning CANADA.
A discussion of the burden posed by disclosure on patent offices ensued. SWITZERLAND said its system was not a problem, as a number of other countries with disclosure earlier stated. CANADA was still unsatisfied, saying that freeriding was an ABS, not a patent, issue and that insufficient experience with disclosure requirements has been garnered to merit making them an international obligation.
The UNITED STATES weighed in supporting CANADA, and said that on freeriding, almost all inventions are based on something else, and that’s the process of innovation. “We shouldn’t frown on it,” the US said, because “the progress of humanity is based on the work of others.” The INDIGENOUS CAUCUS did not appear to be pleased with this perspective.
PERU reiterated its experience that disclosure requirements had not been burdensome, saying, “we’ve had no difficulty.”
NAMIBIA noted that disclosure in patent applications was not the whole ABS system. A disclosure requirement was rather a small part of the ABS system, which exists separately from the patent system. The question, NAMIBIA said, is if the IP system can help meet the objectives of a vast majority of countries, who are CBD members. “If it keeps going down this road,” NAMIBIA said, “the US runs the risk of creating conflict between the two.”
CHINA concurred that the discussion was about creating balance in the system, to stop cases of genetic resources being illegally acquired and prevent illegally acquired resources from being granted exclusive rights. CHINA said its national law does this for genetic resources and it was working to also include traditional knowledge. It said no invalidation of a patent has yet taken place for failure to disclose, but if there is illegal use, it should be punished. This is not a burden.
AUSTRALIA asked, on triggers, what would be the subject of disclosure? It supports ABS regimes, so AUSTRALIA thought that maybe a trigger could be if the genetic resources in question are the subject of ABS requirements under national law. “Patent offices can’t be sole policeman of the world’s environment,” AUSTRALIA said, despite the intervention of NAMIBIA and others.
NAMIBIA noted that on the question of “samples that have been sitting around for 30 years” that “few serious researchers work in such a haphazard manner.” But if that was the case, NAMBIA said, it’s not a problem. The applicant could disclose the situation, and it would then be up to the possible country of origin to investigate. This, NAMIBIA said, indicates the illogic of allowing exclusions to disclosure. If an applicant believed a genetic resource was not subject to ABS, then it is in the applicant’s interest to disclose. Honest mistakes won’t compromise things.
NIGERIA said that some governments were seeking MOUs with CHINA’s patent office, and seeking to create reciprocal exchange of disclosure data. Concerns about burden on examiners are national issues, NIGERIA said, and not really an obstacle.
On CANADA’s and the UNITED STATES’ demand for more national experience and examples of disclosure-related litigation before considering mandatory disclosure, NIGERIA said that a utility requirement for patents has existed since the 15th Century yet there was not a litigated case in the US until the 1960s. The gap between establishment of norms and litigation can be long, and lack of data doesn’t lead to the conclusion that there is lack of need for a standard.
JAPAN replied that legal uncertainty is a business risk. If a patent applicant doesn’t know the origin, or even if it discloses faithfully, what if there is refusal? With so little experience in national systems, there are limited “exemplified practices”. JAPAN wants evidence based on examination experience that bona fide applicants won’t suffer.
CANADA lengthily reiterated its view that more data on disclosure requirements is needed but then also said that if a patent applicant stole a genetic resource that it wouldn’t disclose anyway. In other words, it said that even if the data is strong, in CANADA’s view, disclosure requirements would be futile. Instead of disclosure, CANADA said, it has offered a “solution,” and that is to stop granting patents in error.
COLOMBIA noted that it has a system of disclosure like PERU’s and did not have problems with it.
The UNITED STATES returned to the question of ex situ collections, saying that NIGERIA begged the question of companies with pre-CBD ex-situ collections. It would take years to track the origin of these collections down. Would they be liable for not having information?
CHILE concluded the discussion by recalling that disclosure requirements are not only useful domestically, but that with their implementation in other countries, providers may be able to detect misappropriation. CHILE also said that patent applications already are complex and involve a high level of detail. As to adding a disclosure requirement, CHILE said patent applications are so complex anyway, disclosure of origin doesn’t give rise to big new difficulty or fear.
Sanctions for non-compliance?
On Thursday morning (7 February), the Expert Group reconvened to discuss the draft articles on databases and on sanctions for non-compliance with disclosure requirements. On databases the main question was whether they constituted a protection against misappropriation, or a way to possibly support implementation of a disclosure requirement. On sanctions, members needed to sort out a general approach – would it be short and left up to members? Would there be minimum sanctions? Or both minimum and maximums described in the text?
NIGERIA, with support from BRAZIL, said the instrument should describe a range of sanctions, including a minimum, and that different members would take different approaches. BRAZIL said its sanctions were administrative and criminal, and both inside and outside the intellectual property system. Both countries favored “effective, persuasive, proportional measures”.
BOLIVIA noted that an international obligation for sanctions was needed because its experience with biopiracy was that it isn’t a domestic problem but rather one of claims on its genetic resources in other places.
AUSTRALIA wanted minimum and maximum sanctions, to create “happy house for everybody, including users [of genetic resources].”
SWITZERLAND said that the goal of sanctions isn’t punishment or enriching the state, it’s to make users comply. Revocation of a granted patent would destroy the basis of benefit sharing, so SWITZERLAND did not support it. It asked proponents of disclosure, “Can we exclude revocation [of granted patents] as a price for you to pay in return for a disclosure requirement?”
The Chair thought that might be a question for the end-stage of negotiation.
CANADA resumed its stance of having inexhaustible information needs. We want to hear about various existing disclosure regime. We want examples of national sanctions being applied. Maybe ABS and disclosure sanctions can’t be wholly separated at the conceptual level.
CHILE said that any sanction needs to be consistent with character of the disclosure requirement. CHILE sees disclosure as an administrative aspect, not a new patentability requirement. So failure to comply should give rise to an equivalent administrative sanction. Arbitration is also a possibility. (It was unclear from CHILE’s statement whether or not it also favors additional sanctions as part of the ABS regime.)
NIGERIA said there was a special need to share information to identify repeat offenders. As far as the sanctions it favored, possibilities include co-ownership of a patent by the group from which it was taken, an auction of the patent, or its assignment to new owners.
The EUROPEAN UNION was not in favor of revoking patents as a consequence of failure to accurately disclose the origin of genetic resources. It said that an objective is to facilitate a link between the ABS and patent systems and that sanctions shouldn’t threaten either system. The EU opined that sanctions that result in revocation would limit benefit sharing and thereby hurt the ABS system. (The logic of the latter assertion, which SWITZERLAND also made, is questionable, as it presumes that patent income is actually shared.)
BRAZIL said its legislation provides for possibility of revocation, but that sanction hasn’t been applied. Sanctions are dissuasive, because applicants want to comply. BRAZIL also needs to know what’s happening in other countries. How can we know what kind of appropriation is happening in other countries when they aren’t tracking what is going on? “We have the sense that it’s bad, but we don’t know,” said BRAZIL.
SOUTH AFRICA was happy that the EU had “finally made a statement” about its preferences, and noted that remedies like dispute resolution could be included.
NORWAY opposed revocation as a sanction. It noted that if you know the material is acquired without PIC or MAT, then ABS system sanctions can be enforced. NORWAY said its national sanctions are only if wrongful information is provided deliberately. For that there is a fine and imprisonment. This has not been applied.
BRAZIL asked to submit, in writing, a proposal for minimum standards and it was agreed that the facilitators would attempt to make sense of the discussion.
The EUROPEAN UNION then asked for a discussion of Article 3 (disclosure) “in general”.
The US, CANADA, JAPAN, and SOUTH KOREA all expressed their support for no disclosure requirement.
The Chair then asked for comments on Article 4, relationships with other agreements.
BRAZIL said it was concerned about language on a “coherent system” and was looking instead for “mutually supportive”. By mutually supportive BRAZIL meant supporting ABS but not revising what the CBD does, “to do what is WIPO’s part and not intrude on others’ work.”
CHILE said the outcome should be flexible enough to deal with differences in ratifications.
The UNITED STATES said that Articles 4, 5, 6, and 7 all support disclosure, and since it did not, the US would not go into the language of these (bracketed) paragraphs.
On these articles there was inconclusive discussion, with most considering discussion in detail to be premature. Written submissions were invited on discussed paragraphs for inclusion in the facilitator’s text, later tabled as Rev. 2.
FINAL PLENARY: CONTROVERSIAL “PARALLEL” PROPOSAL TABLED
The final plenary session, which began on Thursday afternoon (7 February), started late due to brewing controversy surrounding proposals from the UNITED STATES, JAPAN, CANADA, and SOUTH KOREA to commission a WIPO study on disclosure as well as to re-introduce a “joint declaration” emphasizing databases and guidelines for patent examiners as the appropriate response to biopiracy.
The UNITED STATES, JAPAN, CANADA, and SOUTH KOREA first tabled a draft “joint recommendation” on genetic resources and traditional knowledge that it said would serve as a “confidence building measure” that, the UNITED STATES claimed, reflected the views of all regions.
Other delegations viewed the proposal as being an attempt to create a parallel process to the negotiation of the consolidated text. ALGERIA, on behalf of the AFRICAN GROUP, said the proposal prejudged the IGC’s work on the consolidated text and that, in any event, the joint declaration did not reflect the views of Africa.
SOUTH AFRICA said that the declaration’s content “doesn’t meet our minimum requirements ... nothing of our demands is met by this document ... this is a diversion.”
The EUROPEAN UNION said that it thought that the joint recommendation “is relevant and on the table” and nothing more.
RUSSIA considered it to be a very useful document with useful elements for patent offices.
NIGERIA said there may be value in a joint recommendation after completing the international legal instrument. But that the proposal, at this juncture, might terminate the important process of the negotiating text.
BRAZIL supported the Africa Group position, “The declaration would prejudge the result of our process”.
CANADA said preemption wasn’t its intent and, despite the interventions from Africa, still claimed that, “our proposal reflects common ground.”
EGYPT supported the Africa Group, as did INDIA.
SOUTH KOREA said that its patent office needs information and the best way is through contracts and databases of traditional knowledge. It co-sponsored the proposal.
PERU said the pick and choose approach of the document is disturbing, and that developing countries were not asked how to incorporate disclosure into the document. PERU said it could deal with the concepts of the draft declaration inside the negotiating text, but not in parallel.
CHILE said the declaration does not reflect a common understanding of these issues.
JAPAN claimed a parallel discussion of the declaration would support a text-based negotiation. The UNITED STATES said a declaration is an international legal instrument, so it fit the mandate of the WIPO General Assembly.
The Chair then said that the plenary took note of the proposal and asked the UNITED STATES to introduce its text for the next agenda item, terms of reference (TORs) for a study on disclosure.
The UNITED STATES tabled the lengthy proposal, which was focused on costs of disclosure, and said that in addition to JAPAN, CANADA, and SOUTH KOREA, that RUSSIA might join as a sponsor
RUSSIA said it was interested in “conducting a study on non-grant of erroneous patents,” but stopped short of co-sponsorship.
In a fateful turn at the microphone, JAPAN said that a disclosure requirement is new, and that there is little experience and no fact-based evidence on it working in practice. JAPAN said that evidence has always been gathered to support new norms and there was no supporting evidence here. JAPAN said there was a need to listen to business, for quantitative analysis, and that voluntary disclosure is better.
On the latter point, the Chair asked JAPAN if it meant that it cannot negotiate on mandatory disclosure.
JAPAN replied, “Yes, you are correct,” prompting audible reactions across the room. The Chair then suspended the discussion on the TORs agenda item and invited Japan to consult with its co-sponsors, as JAPAN seemed to be taking a stand to stop work on the negotiating text.
At the invitation of the Chair, JAPAN then introduced a third agenda item, a joint recommendation on databases.
SOUTH KOREA expressed its support.
ALGERIA, for the AFRICAN GROUP, said the substance of databases was already being discussed in the consolidated text.
The EUROPEAN UNION said that the proposal was “of interest” and that it needed time to consider.
The UNITED STATES supported Japan.
PERU, EGYPT, CHILE, INDIA, SOUTH AFRICA, and BOLIVIA all agreed with the AFRICAN GROUP.
JAPAN then noted that its position on the TORs proposal was not intended to stop text-based negotiations.
The Chair adjourned discussion until Friday morning (8 February), when a new consolidated text (Rev. 2, dated 7 February 2013, 19:30), drafted by the facilitators, was tabled. Members were invited to offer general opinions, technical revisions, and allowed to place brackets, but the text was not negotiated.
The Chair began the plenary on Friday by requesting the UNITED STATES to clarify the status of its TORs proposal, whose intent was made unclear by JAPAN. The US replied that it wished to consult on the idea and would return to the topic at the next IGC meeting.
Moving to the Rev. 2 text, DOMINICAN REPUBLIC, for GRULAC, clarified that it considers the entire preamble to be in brackets.
The EUROPEAN UNION agreed, placing additional items in brackets as per previous interventions, including the terms “derivatives”, “utilization”, and “misappropriation”. The EU also wanted a note attached to the text characterizing it as a work in progress, without prejudice to positions and outcome.
The definition for misappropriation was a new (and previously not discussed) item in Rev. 2.
INDIA made similar smaller revisions to language in accordance with previously stated ideas.
ALGERIA, on behalf of the AFRICAN GROUP, noted that the definition of “associated traditional knowledge” should include reference to genetic resources, and that the two definitions could be combined (as in “genetic resources and associated traditional knowledge”).
SWITZERLAND (as with the EU) did not like deletion of detailed options for triggers for disclosure and said it would return to the topic, including older text. It also thought that the patent office should set a time limit in which any disclosure deficiency should be remedied.
The HOLY SEE regretted that language prohibiting patenting of life forms had weakened during the course of the week.
CHINA said there were many differences in Rev. 2 from the previous document, and that with limited manpower in hand, it could only make preliminary comments. It said sovereign rights and PIC seem to be missing in places. On sanctions, CHINA wanted invalidation of patents added as a possibility.
BRAZIL said more time was needed for a number of items, and more precision on the relationship between genetic resources and traditional knowledge. It noted the new definition for misappropriation and said it needed to consult with capital to react. It sought to clean up (or bracket) use of terms to clarify and strengthen support for the Nagoya Protocol. BRAZIL also said it had many concerns about databases and would offer further comment on them at the next meeting.
SRI LANKA, speaking for the ASIA GROUP, said that more time was needed before detailed comments.
COLOMBIA echoed CHINA’s preference for making invalidation of patents an option.
CANADA said the negotiating text was a work in progress and insisted that other options were possible. It did not like the term “associated traditional knowledge” (preferring “traditional knowledge associated with genetic resources”), and bracketed a reference to the UN Declaration on the Rights of Indigenous People, as well as all references to the CBD, Nagoya Protocol, and access and benefit sharing.
The UNITED STATES supported the EU’s request that the Chairman’s note from document WIPO/GRTKF/IC/23/4 be retained in the reporting of the text from the meeting and imposed brackets in line with its previous interventions.
PERU emphasized the need for consistency in use of terms and noted this was not presently the case with “derivatives”. It supported COLOMBIA on the option of revoking patents.
The Chair then noted that South Africa’s Ambassador had joined the meeting and called on SOUTH AFRICA.
SOUTH AFRICA took the floor to address a procedural issue related to the mandate of the IGC. It said that comments have been made that there could be other, parallel texts (referring to Japan and the US). SOUTH AFRICA said the IGC mandate clearly says which text we are to negotiate. SOUTH AFRICA considered that the documents submitted by the US, JAPAN, CANADA, and SOUTH KOREA were for “noting”, and those documents are not linked to the text-based negotiation.
JAPAN then took the floor and said it shared CANADA’s dislike of the term “associated traditional knowledge”. It placed further brackets in line with its position that no disclosure requirement be adopted.
Like the EU and SWITZERLAND, AUSTRALIA also sought to recover some language from the previous draft on triggers.
BOLIVIA sought to protect the language it proposed on prohibiting patents on genetic resources as found in nature and, building on the AFRICAN GROUP and BRAZIL, further amended the definition of misappropriation to use language more closely in line with the Nagoya Protocol. It shared BRAZIL and others’ concern about databases, saying that they might encourage rather than stop biopiracy, and agreed with other countries on the possibility for revocation of patents that fail to properly disclose origins.
SOUTH KOREA insisted there be no references to the Nagoya Protocol in the text.
The Chair then abruptly suspended the meeting well before lunch, as it was clear that the dispute over the status of the text introductions by the UNITED STATES and allies (referred to by SOUTH AFRICA and others) required informal consultations.
The plenary reconvened for a final session in the afternoon, with the only remaining substantive issue a resolution of the status of the US, CANADA, JAPAN, and SOUTH KOREA parallel texts. The decision transmitted the Rev. 2 negotiating text to the WIPO General Assembly, and merely “took note” of the four countries’ other texts.
While the decision text indicates that SOUTH AFRICA, reflecting the view of developing countries, prevailed, CANADA nevertheless said that it understood the mandate of the next IGC to include a “stock taking element,” and suggested that the proposals might be revived there.
The Chair allowed that the agenda of the next meeting permitted discussion but no new negotiation would take place on genetic resources.
In concluding remarks, NIGERIA thanked “delegations that speak their position forthrightly, deliberately and not deliberately” (i.e. Japan, Canada). The UNITED STATES had the final word and, like CANADA, suggested it would come back with its parallel proposals again. The US said that it was “Willing to engage moving forward,” and that “Our proposals reflect our commitment. We want to engage and work on all documents tabled.”
With that, the meeting was adjourned and the Rev. 2 text, characterized as a work in progress, will be transmitted to the WIPO General Assembly.