The Stockholm Network is delighted to announce a new policy briefing note, which explores the debate around standards, competition and innovation. As well as providing background on the relationship between intellectual property rights and open standards, the Polybrief also explores the debate between open and proprietary-based standards, as well as identifying and outlining new governmental approaches to standards.
Stockholm Network Polybriefs provide concise summaries of pressing issues and policy debate throughout Europe.
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Posted by sfarrell on November 19, 2009 at 8:00 am
The blog that I wrote last week was about India’s government taking steps to ensure the protection of indigenous knowledge. This week I would like to examine how geographic indicators could be used in order to aid in the protection of indigenous knowledge systems and indigenous products. Everyone who is involved in intellectual property and patent law knows what a geographic indicator is, but for clarity’s sake I will review the concept.
A geographic indicator (herein referred to as GI), is a form of protection, which utilizes the name of a region or area where the product originates. This label helps to ensure the consumer that the product is of a certain quality, and has a reputation associated with it. In many countries the law restricts the use of GI, allowing the term to only be used if the product is created from or is a substances that comes from a specific associated area. GI is like a trademark in that it has many of the same functions. Although the two forms of protections are similar it is prohibited to register a trademark which constitutes a GI (Indication).
For example the country of France has a monopoly on the production of the wine named Champagne. Any wine that is produced outside of the Champagne region of France cannot legally be called Champagne. Although this is only the case in countries that acknowledge GI as a legitimate form of protection. In the United States there is a provision in the law that allows for the use of the name Champagne by long time producers of the sparkling wine. The same is true for Jasmine rice (Thailand), and Roquefort (France).
In 1999 the government of India passed the Geographical Indications of Goods (Registration and Protection) Act. The act has been in effect for six years, since 2003 (Geographical). The infrastructure and laws are in place for the government of India to take advantage of GI as a protective measure for the products of their traditional knowledge system. The reason why I personally feel that the use of GI to aid in the protection of indigenous knowledge and traditional medicine is that the system of GI seems to be better established than the Convention on Biodiversity. With in the TRIPS agreement there are already two well defined provisions which must be upheld by WTO member countries.
Article 22 of the TRIPS Agreement says that all governments must provide legal opportunities in their own laws for the owner of a GI registered in that country to prevent the use of marks that mislead the public as to the geographical origin of the good. This includes prevention of use of a geographical name which although literally true “falsely represents” that the product comes from somewhere else.
Article 23 of the TRIPS Agreement says that all governments must provide the owners of GI the right, under their laws, to prevent the use of a geographical indication identifying wines not originating in the place indicated by the geographical indication. This applies even where the public is not being misled, where there is no unfair competition and where the true origin of the good is indicated or the geographical indication is accompanied by expressions such as “kind”, “type”, “style”, “imitation” or the like. Similar protection must be given to geographical indications identifying spirits (Agreement).
By registering traditional remedies, and ayuverdic preparations as the GI property of the country of India, the country would gain much economically. Individuals outside of the country could still produce their own mixtures and remedies of a similar design, but the products produced in India by Indian businesses would be given an added assurances of quality and reputation simply due to their registration as GI.
However this is not, and should not be considered a cure-all to the problem of Indigenous property rights. If anything this is only a temporary band-aid to discourage what the Indian government sees as theft of common knowledge. There could be multiple problems with this approach as well. Many of the preparations in Ayuverdic medicine are used in India as well as surrounding countries. This means that these othe countries may try to lay claim to the GI of these remidies. Other countries in the area surrounding India have recently been putting thier own GI laws in place. Pakistan passed their own Geographical Indications of Goods (Registration and Protection) Act in 2000, and claim that India has wrongfully registered a product that originates from Pakistan as a GI belonging to thier country (Pakistan).
I feel that Geographic Indicators are something that really needs to be explored by developing nations, both as a means of protecting thier indigenous knowledge, but also in order to help them create new buisness opportunities. Entire industries could be developed around the preparation of a specific line of natural supplements, handicrafts or other goods which have been made for hundreds if not thousands of years.
Sources Cited
Agreement on Trade-Related Aspects of Intellectual Property Right (Agreement)
Geographical Indications of Goods (Registration & Protection) Act, 1999 (Geographical)
“Geographical Indication.” Wikipedia. 2009. Wikimedia. 29 Mar 2009 <http://en.wikipedia.org/wiki/Geographical_Indication>. (Indication)
“Pakistan expresses urgency to go the GI way.” Institute of International Trade 26 March 2009 29 Mar 2009 <http://iitrade.ac.in/news-archive.asp?news=377>. (Pakistan)
At its essence, the triple helix model is a partnership between the industrial, academia and governmental groups which recognizes the differing goals and stakeholder communities of these three groups but emphasizes on the common interest of those groups in order to provide value to the societies in which they reside. It is often operationalized as cosponsored programs. These programs support both small and large firms to transfer technologies from government and academic research laboratories and have enabled societies to more greatly benefit from the technological research that those same societies fund.
The landmark attempt towards the triple helix model was made by the U.S. when it enacted the Bayh-Dole legislation in 1980. This legislation granted permission for federally funded researchers to file for patents, and to issue licenses for these patents to other parties, thereby increasing participating of U.S. universities in national patenting. Conversely, in Eastern Europe, during the transition from socialism, some reformers were trying to remove government from a role in science and technology policy. Innovation systems were largely coming to a halt. Even though foreign direct investment was encouraged, it seldom involved utilizing local R&D resources. More recently, political leaders are moving away from that rigid position and bringing government back into the picture to take advantage of the R&D resources left behind from the previous era.
In the U.S., government-industry relations assumed increased significance in the 1990s even as university-industry bonds came to the forefront of attention in the 1980s. In much of the European Community these two sets of bilateral relations developed in reverse sequence with academic-industry connections following upon the development of government-industry relations. Academic-industry-government relations in the U.S. are taking on the cast that government-industry labor relations have long had in Europe. In the EU, EU sponsored activities, other efforts by European governments, NEXUS, IVAM are all examples of Government, Academia and Industry working together in order to maximize the commercial potential of macro and nano technologies in Europe.
This post in Part I on the larger area I intend to cover on the triple helix model for Technology Transfer on this blog.
Richard Barras, ‘Interactive Innovation in Financial and Business Services: The vanguard of the Service Revolution,” Research Policy, 19 (1990) 215- 37.
As the World Health Organization has raised its pandemic alert for swine flu to “phase 5” the second highest level, meaning that it believes a global outbreak of the disease is imminent, the relationship between patent rights and access to essential medicines has elicited again. As per WHO the phase 5 alert means there is sustained human to human spread in at least two countries. It also signals that efforts to produce a vaccine will be ramped up.
As it turns out that there is no vaccine available as yet and Tamiflu (Oseltamivir), a drug patented by Gilead and exclusively licensed to Roche is considered as one of the best drugs available today to cater to this kind of flu. Even at the time of the bird flu, it was known that Tamiflu was not the optimal drug to cater to such viruses– but only that of all the possible alternatives, it was the best.
In India, Deputy Controller of Patents, in a decision on the 23rd of March 2009, struck down Gilead’s patent application covering Oseltamavir compositions on the grounds of lack of inventive step, failure to comply with section 3(d) and failure to sufficiently disclose the invention claimed.
Since Gilead hasn’t patented this drug in all countries and has recently lost the Indian patent battle over “Tamiflu” just about a month back, these governments may turn to generic manufacturers for a cheaper priced alternative. And even if a patent exists , if Roche can’t meet the demands in terms of quantity and price some of these governments may decide to override the patent and grant compulsory licenses (treating it a case of national emergency) to enable cheaper alternatives.
It is interesting to note that the US does not have any compulsory licensing clauses within its patent regime that can be invoked. But there is a possible alternative that the situations can be worked into the ‘takings clause’ in 28 USC §1498 and perhaps the fifth amendment to the US constitution that contains ‘eminent domain’ principle. Under these principles, the government could use the patent without the permission of the patentee, subject only to payment of some reasonable compensation. The US had threatened to do something similar with Bayer’s patent during the Anthrax crisis.
But the bigger issue that was pointed out by Dr. Anatole Krattiger in a recent discussion with me is that “Back then, with Bayer’s Cipro, the US back-peddaled quickly so as not to undermine private patent rights. And now, most Western governments have stockpiled Tamiflu. But who will supply Tamiflu now to the low-income countries that have not had the currency reserves to stockpile Tamiflu?”
Further Reading:
Shamnad Basheer and Tahir Amin,Taming of the Flu: Working through the Tamiflu Patents in India , Journal of Intellectual Property Rights, Vol. 2, p. 113, March 2006
Whenever the term bioprospecting is mentioned, the country of Brazil is often cited. This is because the laws and regulations which have been created by Brazil are seen as extremely strict. In fact many people feel that instead of protecting the country against biopiracy, as Brazil undoubtedly seeks to, they are in fact reducing biodiversity research and slowing scientific advancement. The main reasons that the laws regarding biopiracy/bioprospecting were put into place is that the Brazilian government wanted to protect its indigenous people as well as its own financial interests in terms of seeing a product from its genetic and natural resources. The real questions are these: Is the level of restriction these laws impose justified in order to protect the indigenous peoples of Brazil? Or is the highly restrictive process put into place because the government is afraid of foregoing income?
At first, access to genetic resources and traditional knowledge was covered by the Provisional Measure 2.186-16 which was codified into law in 2001. These laws where fairly restrictive as far as the authorization for access to biodiversity was concerned, with all forms of access and research requiring the approval of the Brazilian government. However, that original provisional measure was also less restrictive in certain ways. For example it didn’t provide for by-products of genetic resources, and only covered pure genetic information.
Just last year Brazil passed a new bill which changed the way in which they approach the issue of bioprospecting/biopiracy. Unfortunately, I couldn’t examine the new bill myself because I couldn’t find a version of it that wasn’t in Portuguese, but I did find this article which had a good summary of the differences between Provisional Measure 2.186-16 and the new bill. The main differences between the two documents appears to be that the newer bill requires a much clearer paper trail to keep track of the use of genetic resources. For example patent applications now must have a corresponding “access license” for any genetic resource or by-product of genetic resources obtained in Brazil. Whereas before, even non-profit or humanitarian research efforts using the genetic resources of Brazil had to be sanctioned by the government, the new bill does not require Government approval for access and research that is designated as non-profit. I speculate that even though it appears that Brazil wants to tighten their law regarding who benefits from the use of its genetic resources, they seem to be moving towards allowing easier access for non-profit research. I think this because with easier access to resources for research dedicated to non-profit research, the greater the opportunity for scientific advancement. It appears that the Brazil thinks along the same lines.
Brazil has a large native population whose indigenous knowledge and resources the government is trying to protect. And rightly so. There is an incredible amount of attention focused on Brazil and the rain forests in our modern era. Celebrities are trying to save it as it may hold the next cure for cancer or even HIV/AIDS. Is this the reason that so many people are focused on protecting the peoples and rainforest? Why isn’t there a huge emphasis on indigenous knowledge and biodiversity protection in New Zealand or the Samoan Islands? Is Brazil constantly in the news because of the biodiversity-rich rain forest or is it because the indigenous peoples are really making themselves heard?
I feel that the issue of bioprospecting is something that we are going to be dealing with for at least as long as there are unexplored areas of the earth, while there is still flora and fauna that have yet to be discovered. The most important thing that we have to keep in mind though is that the modern patent system, which is part of a greater system of intellectual property, is based upon the protection of “new” inventions, or processes, as opposed to protecting knowledge which is communally held or has been in existence for some time. Many Tribes of the Brazilian rainforest have expressed anger at the bioprospectors who use their help and knowledge of the forest to find plants useful for research. Then often times the bioprospector turns a profit from their ventures, and give nothing back to the tribes, although increasingly various companies (such as Diversa) as well as academic groups (such as the International Cooperative Biodiversity Groups ) are working to changing this. The system of intellectual property was not made with the protection of indigenous knowledge in mind, since native peoples at that time were only a dream in the minds of novelists and scientific speculator.
Trying to create a system by which indigenous knowledge and resources can be protected is a challenge within the current patent system. Strategies such as the use of Access and Benefit Sharing programs are on the right track to creating a system by which indigenous knowledge and resources can be protected, yet accessed and used, but there is still a long way to go. Countries like Brazil may seem overzealous in some of their rules and regulations, but these laws are only being passed in order to protect their interests and the interest of their people. However these provisions cannot be made at the expense of the furtherance of science, which, in turn, can benefit the very people who shared their knowledge and resources at the first place.
2010 will be an important year for industry and developing countries that hope to promote the commercialization of genetic resources (GR) and traditional knowledge (TK).Next year, the Convention on Biological Diversity (CBD) plans to conclude negotiations to develop an international regime on access and benefit-sharing (ABS) of biological resources.Bio-diversity rich developing countries with relatively little research and development expertise and funding resources have a particular interest in these negotiations to promote international collaborations.The ongoing negotiations cover many topics such as compensation for resource providers, prior informed consent of knowledge holders, the logistics of providing access to the GR, and how benefits resulting from the collaborations will be shared.One important topic of ongoing discussion is whether the CBD should create international standards to implement ABS or allow contracts to be negotiated on a case by case basis pursuant to a set of underlying standards and principles.(See Source 1).
Material Transfer Agreements (MTA) are one type of agreement that can be tailored to benefit both developing countries and industry collaborators alike.MTA’s are agreements governed by contract law that generally define the provider and recipient of materials, the identity of the materials, what the recipient can do with them, and the obligations of each party.MTA’s can also protect the GR or TK of a discrete local community as a trade secret, assuming the knowledge is not widely known.MTA’s involve legal concepts from contract law, intellectual property law, technology transfer, antitrust law, and sometimes may include biodiversity and biosafety issues.MTA’s have the additional advantage of being accepted and even endorsed for the purpose of developing GR and TK by industry, such as the American BioIndustry Alliance (ABIA).
The use of MTA’s has been proposed for the protection of biological resources such as plants, seeds, genes, and chemical compounds around the world. (See Source 2).The MTA provides the ownership rights necessary for the developing countries to protect their GR and TK in the course of bioprospecting and to combat biopiracy.Bioprospecting involves analyzing biological materials for active components that may have commercial value.However, biopiracy occurs when the country harboring the material, sometimes knowing of its medicinal qualities for thousands of years, is denied revenue or royalties from industries that have successfully commercialized the material.
The countries that are the most vulnerable to loosing commercial opportunities relating to their biological resources are those countries with legal and regulatory systems which cannot effectively monitor bioprospecting.Further, the misappropriation of a country’s biological resources may or may not actually be illegal in that country, depending on the whether laws regarding biopiracy have been instituted.The MTA may be a particularly useful tool in such a system to document the ownership of these resources.Countries often require a permit to remove indigenous plants at a minimum, but may be lacking in defining and documenting the ownership and purpose of the removal or, more importantly, may not have sufficient capacity to negotiate mutually beneficial terms.
The MTA has been proposed to be used to transfer indigenous biological resources in conjunction with Prior Informed Consent (PIC) from the local community in which the biological resource originated.PIC is required under Article 15 of the United Nations Convention on Biological Diversity, which reaffirms that “states have sovereign rights over their own biological resources.” Obtaining PIC necessarily requires the bioprospector to seek the approval and recognize the rights of the local community in which they are harvesting their research materials.To properly manage the use of a MTA and PIC, a government must develop MTA’s that properly address the ownership rights desired, that maintain the confidentiality necessary to preserve the patentability of the biological resource, and a mechanism to verify the truthfulness and accuracy of the informed consent.This may still be a daunting prospect for some governments, so the use of a private institution to manage the MTA and PIC agreements may be desirable.For example, Costa Rica chose to employ the National Institute of Biodiversity (INBio), a private research and biodiversity management center in Costa Rica that tracks that country’s biological resources and encourages their sustainable use.
The CBD should consider the MTA as part of an integrated solution to implementing ABS standards.MTA’s are a flexible legal tool that can conform to protect the interests of a variety of parties and meet the specific contract terms that must be tailored to the circumstances of each GR and TK.
Vanessa Lancaster
Additional Sources
1. Sikina Jinnah and Stefan Jungcurt, Could Access Requirements Stifle Your Research? 323 Science 464 (2009).
2. Daniel M. Putterman, Model Material Transfer Agreements for Equitable Biodiversity Prospecting, 7 Colo. J. Int’l Envtl. L. & Pol’y 149 (1995).
Today there is great interest in natural remedies, and panaceas from other cultures. Many supermarkets that cater to the organic crowd are stocking homeopathic medicines as well as remedies either based off of traditional treatments. In recent years pharmaceutical and nutraceutical companies have looked to Asia and South America in search of new treatments and compounds which can be patented and brought to the western consumer for a profit. Most of the time traditional medicinal systems as well as cultural practices are examined to see if there are any plants or compounds which might be useful as medical treatments in the west.
Recently however the Indian government, among others, has begun asking governments to revoke patents on traditional preparations and medicines that were “discovered” by various individuals and or companies. Their reasoning behind this is that these preparations have been known and used publicly in many parts of the Indian subcontinent for hundreds if not thousands of years.
The traditional medical systems of India and other parts of Asia include Auyverda, Unani, and Siddha. Each of these systems has thousands of preparations utilizing local flora and fauna to treat various ailments; ailments which are also supposedly treated by the preparations which have been patented by pharmaceutical and nutraceutical companies. For example an extract/preparation of the Himalayan plant Phyllanthus amarus has been recently patented as a treatment for HIV, while in traditional medical texts the plant is cited as being used to treat immuno-suppressive emaciating diseases. Almost the same exact use. However the patent could still be considered valid because it is not clear whether or not the extract preparation process is novel (see US Patent Application No 10/398,379). However the novelty of extraction extraction processes utilizing alcohol, water or hexane is in question That being said, too often the patenting process is not fair to everyone who has a stake in the legitimacy or illegitimacy of these patents. In all of this the Indian government is still trying to say that these preparations are not novel and should not be considered as legitimate patents by various countries in which they are registered as such.
In order to combat what they see as the usurpation of indigenous knowledge, the Indian government is creating an indigenous knowledge database, which will now be used by the European patent office to check against new claims to determine whether or not they are novel and therefore legitimate. This would help keep in check so called bio-pirates and the practice of bio-piracy. The government of India has spent over 5 million dollars in the last ten years trying to lift the patents on several traditional remedies in many countries. In addition to this the government of India is pushing the WTO to include a provision within the TRIPS agreement relating to the protection of indigenous rights and biodiversity. There are more than one hundred countries in the WTO that are supporting this initiative, however several big players including the US, Japan, and Canada, feel that more evidence and investigation is necessary before proceeding with this addition to the TRIPS agreement (see the article by Ramesh).
The original process and rules associated with patenting were never meant to take indigenous knowledge into account. With out provisions to provide for undisclosed communal knowledge events like this will continue to occur. However that is not to say that we should rush to make amendments to the TRIPS agreement, or immediately provide provisions and protection for such knowledge. Until countries can create infrastructure for the storage and cataloging of indigenous knowledge (like what the government of India is doing), it will be difficult to provide protection, and show that the claims of indigenous people are legitimate. A solution which could be immediately implemented is the creation of an Access and Benefit Sharing system. Individuals seeking to utilize genetic/biological resources that originate from a specific country would have to inform the country of their intent. In turn the countries would try and find ways in which to make their resources more accesable to the international community (see ABS Factsheet).
Posted by Anatole Krattiger on March 24, 2009 at 8:44 pm
We all have friends or colleagues who appear to inhabit a “parallel universe,” false, divorced from reality, leading to disastrous personal and business decisions. All the more serious is it when an entire organization, in this case the World Trade Organization (WTO), attempts to base negotiations on such “parallel” realities, as it has with the CDB/TRIPS issue.
CBD/TRIPS refers to the relationship between the Convention on Biological Diversity and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Throughout the 1990s, development “experts” asserted that WTO/TRIPS obligations conflicted with the CBD, the latter seeking to amend TRIPS patent obligations for genetic resources (GR) and related traditional knowledge (TK). In the current Doha round of trade negotiations, this belief has fueled demands to make disclosure of course and origin of GR (and possibly of TK) a requirement for patent applications and a new trigger for possible patent revocation. It is further being stated that this would be in the interest of developing countries.
Interestingly, thinking has advanced among CBD negotiators who have focused increasingly on how developing countries can create enabling environments to promote sustainable utilization of GR- and TK-related assets for the creation of meaningful benefits. (They realized that benefits can only be shared once benefits are created). Major developing countries recognize their responsibility for—and opportunities in—implementing regimes that facilitate access and promote the sharing of benefits from sustainable commercialization of natural products. At the most recent CBD ministerial meeting, for example, India’s minister for environment and forestry identified a lack of meaningful domestic implementation of CBD disciplines as the single most important barrier to benefit sharing.
Indeed, small- and medium-size enterprises (SMEs) in developing countries share key qualities with large companies, including multinationals: they are risk takers, they are entrepreneurs, they are innovators, and they need reasonable intellectual property protection for their inventions to bring products to market that serve society. They are the new “bio-preneurs.” Particularly in the area of natural products, SME entrepreneurs in developing countries already work much harder than their U.S. or European counterparts in their efforts to protect patents needed to bring their innovative ideas to the market. Their results are impressive in more than one aspect. The progress is undoubtedly best epitomized by the large delegations of Brazil, India, Malaysia, and Thailand, among many other countries, that visit the annual meetings of the Biotechnology Industry Organization (BIO) where they network, meet collaborators and investors and all over the world.
Similarly, at the most recent CBD general meeting, negotiators agreed on a comprehensive road map for work over the next two years to elaborate and negotiate key measures to help states gain meaningful benefits from the sustainable development of biodiversity resources. Appropriately, amending patent regimes were not considered during these discussions.
Surprizingly, none of these positive developments under CDB percolated into the “Geneva environment”, where WTO negotiators are working overtime to dilute and weaken the very patents needed by developing country scientists and bio-preneurs. At latest report, more than 80 WTO members supported amending TRIPS to require new, mandatory disclosure obligations that would reduce the certain title to patents—the same title needed by bio-preneurs all over the world to raise capital and to survive the famous “valley of death” that leads to the demise of most start-up companies.
Any amendment to TRIPS would require changing patent law in most countries, weakening the protections needed by life-sciences companies, large or small, anywhere in the world. Additional disclosure obligations also would further increase costs as well as the risks of “gaming” the patent system, whereby unscrupulous competitors may initiate spurious litigation on the basis of incentives relating to disclosure of source/origin of genetic resources.
Creation of additional, new hurdles to biotechnology patents would increase uncertainty, would discourage commercial activities related to genetic resources, and would not expand or redistribute benefits. New mandatory patent disclosure obligations also adds additional responsibilities to overburdened patent offices that already face increasing backlogs to their effective operations, including those offices in most developing countries and even the U.S. and European offices. Although patent regime reform is urgently needed, any changes will take up to a decade to negotiate and another decade to implement.
At the time of this writing, there seems to be a near consensus that renegotiating TRIPS and weakening the patent regimes is the cost that may lead to a successful conclusion to the Doha round. TRIPS is by no means perfect but the decade since its implementation has shown that developing countries in particular can gain much when they develop national laws, build transparent court systems, and strengthen enabling environments for bio-preneurs. And much more can be done in these areas.
Would it not be cynical to weaken life-science patents at a time when innovative and forward-looking enterprises in developing countries are taking off, in part thanks to the (imperfect though workable) patent regime? This is not to excuse any inappropriate access to germplasm (the so-called biopiracy) or unduly issued patents. It is simply a pragmatic idea. And it echoes the recent Commentary on www.Forbes.com by Susan Finston.
The pause in negotiations may be an ideal opportunity for Geneva negotiators to escape their seemingly parallel universe and pay the real world a visit. WTO negotiators, for example, could travel to Thailand’s BIOTec or Malaysia’s Sarawak Biodiversity Center or Brazil’s Sao Paulo area or Costa Rica’s INBio, to name but a few, and see how their own scientists and SMEs rely on appropriate patent protection for biodiversity resources. And, without wanting to ask too much, they could even bring WTO talks into conformity with those of the CBD—the international organization responsible for the development of international rules for access and benefit sharing (ABS).
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