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Posted by virenkonde@gmail.com on December 1, 2009 at 3:58 am
The recent editorial on “Intellectual property and biotechnology innovation: To protect or not protect” by Dr Yali Friedman, Managing Editor of the Journal of Commercial Biotechnology was thought provoking and led to this write-up. The editorial emphasized on the intellectual property protection differences between the developing and developed countries, and their drug manufacturers on the issues of patents, price controls, and research & development investments in the biotechnology sector. The remarks indicate that, the developed countries, being the ‘technology producer’ have favored strong intellectual property protection to motive the innovation and apparently the trade; while the developing countries being the ‘technology consumers’ have exploited the benefits of it at much lower cost by building a weaker intellectual property protection system.
Although it is logical that all countries, whether, developing and developed, should offer the strongest intellectual property protection possible, it is believed that, there are no legal definitions of “developed” and “developing” countries. The WTO members have announced for themselves whether they are “developed” or “developing” countries, with an open option to challenge the decision of a member to make use of provisions available to the developing countries. It was also believed in the agreement that the developed countries need maximalist IP regimes, as they are highly innovative and strong IP regimes provide the requisite incentives in this regard. On the other hand, developing countries require minimalist IP regimes, as they are hardly innovative and are often net importers of technology. These norms have also formed the basis for the 1970’s Indian Patents Act for the ‘developing India’. The amendments to Indian Patent Act in a timely fashion [Indian Patent (Amendment) Acts of 1999, 2002, and 2005] have driven India to ‘innovative (Product Patents) regime’ in its intellectual property policy.
Today, although, India continues to remain a “developing” country; it is also considered a ‘technologically proficient’, and therefore as an innovative developing country. Therefore, in the present times, the older definitions of intellectual property based on the differences between developed versus developing countries can not relate to India. Some developing countries like India are more scientifically advanced than others as a result of decades of investments in education, medical infrastructure, and manufacturing capacity. India hosts more drug manufacturing facilities that have been approved by U.S Food and Drug Administration than any country other than the United States. India’s biotechnology industry is managing to position itself on the strength of contract research, clinical research and contract manufacturing services together with the sales of off-patent biologics in the local as well as lightly regulated markets in the Middle East, Africa and Asia.
Unfortunately, India’s patent regime does not appear to be satisfying to the developed world given that India, though “technologically competent” in certain technology sectors like software and pharmaceuticals have not yet witnessed any significant levels of “innovation” in the biomedical utility sectors like biotechnological products and processes. Recently, the US-based Biotechnology Industry Organization (BIO) criticized India’s patent law and the Office of the US Trade Representatives kept India (and some other countries) on the USTR’s “Priority Watch List” in order to bring India’s patent law more in line with Western IP protections. Clearly, there are some issues and concerns that need clarification and that will be discussed here, such as the patentability criteria under section 3(d), and the provision of compulsory licensing in the Indian Patent Act; the price control and the cost difference of the innovator verses generic biotechnology drugs; the TRIPS mandate on clinical data protection and exclusivity; and also the pre- and post-grant patent opposition provisions used by Indian biogeneric manufacturers.
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.
This year’s World Intellectual Property Day on April 26 focused on promoting green innovation as a key element in meeting the challenges of climate change In his message to mark the day, WIPO Director General Francis Gurry highlighted the contribution that a balanced intellectual property (IP) system can make in enabling the development of technology-based solutions to mitigate the impact of climate change.
The first to convert the discussion to action was the UK Intellectual Property Office when it announced that green inventions will be fast tracked through the patent process.David Lammy, Minister for Intellectual Property, announced the launch an initiative which will enable inventions with an environmental benefit to be given priority within the patent system.
There is speculation that companies in countries like India and China will take the lead in terms of green innovation. As per an Economic Times article a project by the Center for Scientific and Industrial Research (CSIR), an Indian organization, has resulted in a solar powered rickshaw with a top speed of 15 km an hour and a range of 50-70 km. The rickshaw runs on a 36-volt battery that can be replaced at a local solar-power charging station. The vehicle is now being tested in Delhi with the aim of replacing some of the city’s 500 000 rickshaws. If successful, the soleckshaw as it is called, will provide a clean and relatively speedy option for moving around crowded Indian streets.
Another innovation in China produced an inexpensive solar powered car. The car has a sticker price of just over $5000 with a range of up to 150 km. The tiny Chery QQ clone has been fitted with roof mounted solar panels that absorb 95% of the solar energy coming in. Although not luxurious, the vehicle may still be attractive to the rising middle class population in China
The concept behind this speculation is simple – companies in emerging economies innovate in the face of price sensitivity, although their consumers have lower expectations. In the green sector emerging economy players have an additional motivation in the fact that they are often based in countries that are much more polluted than developed nations. There is market demand as well as government impetus to come up with inexpensive ways to clean up the air and water.
The WIPO initiative and a trend following the developments of green inventions being fast tracked through the patent process in the United Kingdom by other nations can kick start a movement where IP will have a definite role to play in mitigate the impact of climate change.
Today, how many people did you see walking down the street that had some sort of body modification, tattoos to be specific? One, two, maybe half a dozen? Tattoos are now a fairly popular form of expression in Western culture. However many of the symbols, as well as processes that are utilized in tattooing come from indigenous cultures where (unlike the west) tattoos are the norm, not the exception.
Tattooing is a process by which pigment is inserted under the skin in order to create a permanent image. Tattooing has only recently gained general acceptance in Western society. Today, tattooing in Western culture is something that is seen as fashionable and can be used to identify oneself with specific subcultures. During the 1990s tattoo artists were looking for new designs and methods of tattooing to explore. Many of them found that the bold lines associated with the tattoos done in the south Pacific added a new unique flavor to their tattoos. From the early 90s to today, tribal tattoo’s popularity has sky-rocketed. Now, almost everyone who goes to get a tattoo, will get a “tribal” design. According to Vanishingtattoo.com’s Tattoo Facts & Statistics page, the keyword most often used when searching for tattoo designs was the word tribal.
So what if Indigenous tattoo designs have become popular with the public? Why should any of this be significant, isn’t it just another form of fashion or personal adornment? The main problem with tribal style tattoos, is that most of them are based off of symbols that have been appropriated from other cultures. These symbols and designs all have culture specific meanings which are lost, simply due to the fact that most of the majority of Western society doesn’t understand the meaning behind many of these symbols.
So the tattoos are taken out of context, surely there is no harm in this? But if we consider the fact that the designs are part of a shared cultural practice and heritage, then these symbols should be under the purview of indigenous knowledge. Though these symbols are used fairly freely in many of the cultures with which they are associated, the cultural concept of things like “public domain” are not universal. Often times before a specific design can be applied a person has to demonstrate that they qualify for this specific tattoo. As I said earlier these symbols sometimes have culture specific meanings, if these tattoos are applied to people who don’t “qualify” for the tattoos then it is often times considered offensive.
The ownership of these symbols is not in question; culturally they are owned by the indigenous people from the country where the design originated. The question is, in today current system of intellectual property, who has control, and can benifit or gain profit from these designs. Since many of these traditional designs are not held under copyright, they are freely used by many people. However if these designs fall under the purview of indigenous knowledge then they should in fact be protected by the United Nations Declaration on the Rights of Indigenous Peoples.
“Indigenous peoples have the right to practice and revitalize their cultural traditions and customs. This includes the right to maintain, protect and develop the past, present and future manifestations of their cultures, such as archaeological and historical sites, artifacts, designs, ceremonies, technologies and visual and performing arts and literature.”
This passage, although not strictly relating to intellectual property, is applicable to the concept. If indigenous people have the right to protect specific designs from their culture, then it follows that they should be able to protect the practice and symbols associated with tattooing. However, it seems highly unlikely that any group of indigenous people would be able to muster the legal force to to stop individuals from tattooing their cultural symbols on their body. For that matter there is no manner of official regulation in the body modification culture whatsoever.
The status of folklore doesn’t appear to be as important as indigenous knowledge relating to the medicinal use of plants. However it is important enough that many governments all over the world have been pushing for legislation that would protect folklore at an international level. In 2000 the WIPO in concert with an intergovernmental committee, have entered into talks to create an international frame-work for the protection of folklore. Many governments have or are moving towards providing for the national protection of folklore, such as the government of Australia
Cultural appropriation has been going on for thousands of years. The free flow and exchange of ideas across cultures is what has helped create the world we live in today. Often times, we see nearby cultures that have similar traditions. In the realm of tattoos, we see this sharing of designs and motifs that occurs among the various Iban people of what was once known as Borneo. These designs were shared even though many of these symbols are associated with specific tribes. With so many years of cultural melding, and exchange, its difficult to say where exactly certain symbols come from. However the world that we live in today, is one of regulations, power and profit. Certain aspects of cultural exchange can be extremely beneficial. However when a profit is being made off a design/idea/process that has been established as belonging to an indigenous population, there needs to be compensation. As of this point there is not system built into the intellectual property framework to deal with the appropriation of cultural designs that is effective. Not even an Access and Benefit Sharing (ABS) regime would even begin to compensate indigenous people. Perhaps if in the future there is a regulatory body for the body modification industry then we may see some changes.
This guest post comes from Professor Marcus Hurn, who is a distinguished Professor at Pierce Law and has taught fifteen different subjects during his teaching tenure. This post on the Taxonomy of Property focuses on classification on Intellectual Property in the Basics of Property. He broadly looks into Property and narrows down to the issues of Intellectual Property and even Trade Secrets.
A Brief Taxonomy of Property
There are four major classes of Property: Land, Goods, Obligations, and Intellectual Property. They differ based on whether they are tangible or not, physically movable or not, universal or not, and exhaustible or not. The traditional classification system has a superstructure, and there are significant sub-categories.
Property is real or personal.
Real property (immovables in civilian parlance) is space defined with reference to the surface of the earth, including the soil and things contained in or affixed to the soil. It is tangible but not movable. It cannot be lost, stolen, or physically destroyed. It has universal scope in the sense that an owner has rights against the whole world. It is exhaustible in the sense that only limited numbers of people can use it at one time. Its boundaries are physically ascertainable. It is ultimately controlled through possession and legal registries.
Personal property (movables in civilian parlance) is tangible or intangible.
Tangible personal property is goods/chattels.
It is literally movable, and can be lost, stolen, or physically destroyed. It has universal scope and is exhaustible. It physically defines its own boundaries. It is ultimately controlled through possession or sometimes legal registries.
Intangible personal property is Obligations or IP.
At common law most intangibles were choses/things/rights in action and not treated as property, merely as rights to legally compel or prevent some action or recover damages. Now nearly all obligations are assignable property in our system. (The major exception is some claims for personal torts.)
Obligations are rights to demand a performance or payment from some definite person or finite group of persons, thus they are not universal. They are not literally movable. All obligations are exhaustible.
Obligations are of two kinds: Wholly Intangible or Chattelized.
Wholly intangible obligations (e.g. contract rights, uncertificated stock, licenses) cannot be lost, stolen, or physically destroyed, are defined by proof of the legal obligation, and are ultimately controlled by notice to or coercion of the obligor (assignment, garnishment).
Chattelized Obligations (e.g. negotiable instruments, bills of lading, certificated investment securities and their modern electronic analogues) can be lost, stolen, or physically destroyed. They are defined by the words of the document/record and the law, and are controlled by transfer of the document by endorsement and delivery or encrypted transfer of the unique record. Loss of the document or record does not necessarily destroy the underlying obligation– if the document can properly be accounted for, the obligation can be enforced.
Intellectual Property
IP, as intangible property, cannot be lost, stolen, or physically destroyed. The “boundaries” are defined by grant or usage and the relevant law. It is ultimately controlled by assignment and, for some types, registries. Uniquely, it is inexhaustible — a potentially infinite number of persons can use it simultaneously or successively. Its oddity comes from combining one characteristic of tangible property– universality– with inexhaustibility.
Hybrids
There are, of course, some boundary problems and hybrids: e.g. fixtures, products of the soil, software embodied in goods. In a sense chattelized documents are hybrids. The paper form supplies the convenience of physical goods, and the electronic form (ignoring the physicality of the server) preserves that convenience (unique record) in intangible form.
Trade secrets are also a hybrid. They grow out of a combination of the law of tangibles (trespass to land, trespass to chattels– the safe, files, or computer) and obligations (confidentiality agreements). Trade secrets look universal, but are essentially finite obligations– anyone breaching the contract/tort security web is a wrongdoer, but one who learns the secret without culpability is not bound to defer to the original owner.
HIV and TB combined are a particularly lethal combination; each speeding the progress of the other. Someone who is HIV-positive and infected with TB bacilli is about 20 more times likely to get sick than someone who is HIV-negative and infected with TB bacilli in countries with a generalized HIV epidemic (compared with a previous estimate of six), and between 26 and 37 times more likely to develop TB in countries where HIV prevalence is lower (compared with a previous estimate of 30). TB is also more difficult to diagnose and treat in people who are HIV-positive. This leads to delays in treatment of TB and an increased risk that it will spread to other people
As indicated by the reported reduction of the global burden of TB in the 2009 WHO Global TB Report, efforts to achieve the decrease in the disease burden goals of 2004 are meeting with some success. However, the 2009 report also states that “the majority of HIV positive TB cases do not know their HIV status; and the majority of HIV positive TB cases that do know their status are not yet accessing ART [Anti-retroviral treatment].” The conclusion of the report recommends implementing the “range of interventions and approaches included in the Stop TB Strategy, with the necessary financial backing.” This recommendation makes little sense for two reasons. First, the Stop TB Strategy is basically the same approach that was recommended in the 2004 report and second, given the global financial crisis, additional funding will be hard to come by.
The public and private sector must act swiftly to stem this tide. The contribution of public–private initiatives to detection and treatment of TB cases is difficult to quantify, but examples such as Pakistan and the Philippines (where public–private partnerships accounted for 19% and 8% of all notifications, respectively) illustrate their potential to contribute to increased case detection. However, further collaboration is needed to attain a more holistic method of addressing the other circumstances surrounding this issue.
Similar to the recommendations made by the WHO TB Initiative in 2005 to address regulatory concerns, emphasis should be placed on cooperation and information sharing between the various service organizations in developed and developing countries. Those people living with HIV/TB and TB should have ready access to education about medical treatment plans and trials, proper nutrition, hygiene and safe sex practices. This can be accomplished in part by decentralizing HIV testing centers which have historically been the warehouses of such knowledge. According to the 2009 report, on average, worldwide, as of 2007 five TB treatment facilities depended on one HIV testing center. Integrating HIV testing centers and TB treatment centers would also encourage TB patients to get tested for HIV because they could avoid any stigmatization attached to going to a facility specifically for that purpose.
A page should also be taken out of Janet Agaya’s playbook at the Kenya Medical Research Institute. Agaya is the study coordinator for a TB prevalence survey to be used in preparation for an expected TB vaccine study to be conducted in one to two years. While there, Agaya is also doing a behavioral study to determine why some people delay seeking treatment for TB and others self-report. This sort of multi-tasking by researchers and clinicians could not only address some of the immediate education needs stated above but could also result in data that could be extrapolated to other countries.
New strategies of global cooperation and information sharing must be created if the goal of eliminating TB worldwide by 2015 is to be reached. Accomplishing this goal must be a priority. Otherwise, the burden of treating those affected by HIV/TB may crush an already faltering health care system.
Almost everyone who is interested in intellectual property rights should have heard by now about the Creative Commons (the entire content of this ipHandbook website is, after all, licensed under CC license 3.0). The Creative Commons is an organization which came into existence in 2001. The non-profit company seeks to help increase the amount of creative or unique works that are available to be used or built upon by the public. In order to do this the company helps clients create unique licenses. The main reason why these licenses are different from standard copyright licenses is that a simple set of standard licenses have been carefully crafted to allow users make their work available to others for non-commercial purposes There are certain rights which are inherent in all of the licenses that the Creative Commons offers, these are called baseline rights. These rights include, but are not limited to, the right of free distribution, display as well as certain other moral rights.
indigenous Recently there has been a movement to aid in the protection of indigenous knowledge (mostly medicinal preparations but also cultural products) using the Creative Commons licensing system. Certain individuals feel that the Creative Commons are an extremely effective method of protecting indigenous knowledge of substances and preparations. Since the free use defined by the Creative Commons is based on the assumption that there will be no commercial use of the copyrighted work, it is assumed that companies or bioprospectors cannot patent preparations specific to indigenous peoples’ knowledge. At the same time, using the Creative Commons licensing system also places the indigenous knowledge into the public domain for everyone to see.
However, I see a few problems with this approach. Copyright protects literary and artistic works. It serves to protect the “expression of THOUGHT” rather than “IDEAS” which can form the basis for patent protection. A scientific paper on the use of a certain plant can lead others to do some research and isolate the gene for the given compound and patent it without infringing any copyright, nor any Creative Commons license for that matter. Activists intend to use the various Creative Commons licenses to protect indigenous people from being exploited but they may in fact be severely harming indigenous peoples’ cultures and societies. After reading the blog by Preston Henderson, I now realize that there are many more factors at play in the arena of indigenous peoples and intellectual property.
The first thing Henderson’s blog drew to my attention was that we, as a society in the West, have a radically different way of looking at how knowledge passes through society. Henderson talks about how most Western experts feel that knowledge eventually becomes public domain over time. That is, that the knowledge is open and free to be used by all members of society. For example, in America (as well as most of the world) the term for a utility patent is 20 years. This means that 20 years after the filing date, the patent no longer prohibits others from using the invention For copyright, the typical term is 70 years from the date of creation or 50 years from the death of the author, whichever is longer. However many cultures do not have the same concept of ownership that Westerners do. Indigenous knowledge is often not owned, but it is something that is sacred and to be protected by the people. For example, Shamans in many cultures seek knowledge from various spiritual sources, gaining “information” about helpful plants or admixtures, and they become the custodians of this knowledge. When activists or other well meaning individuals put this information out into the world under a creative commons license, they are opening that knowledge up to people all over the world. As a consequence, those people who once held this knowledge are now no longer the guardians or custodians of it.
In my opinion, what comes closest to offering reliable, and arguably culturally contextual protection of indigenous knowledge, is silence. This would be the equivalent of a trade secret in the established intellectual property system. Whereas a trade secret is like a sound-proof room keeping the information enclosed and confidential, the Creative Common’s licenses are like a bullhorn announcing the information to the world.
The one problem that I have with activists who are seeking to protect indigenous knowledge through the current intellectual property system is that many seem to over-simplify the situation. They see the issue as one central problem that needs to be solved, and that failure to resolve the problem is keeping indigenous people from being taken advantage of. The activists see only the big biotech companies and scientist bioprospecting in the rain forest as their adversaries. Rather, they should verify their own understanding of the complex value-systems. What really must occur is communication between activists or government officials to protect indigenous knowledge and the indigenous people themselves. The current system of intellectual property must be carefully explained so that indigenous people can make the choice for themselves about what to do with their knowledge. Since indigenous knowledge can be disseminated over a large culturally varied area, any effective system to protect indigenous knowledge may well be beyond the reach of our times.
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.
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