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.
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
The issue of royalty payment has been recently discussed in an article “Public-funded R&D Bill — Creating the ecosystem for innovation” in The Business Line in India by Jyothi Datta. Relevant issue of royalty payment under Bayh Dole type legislation as per the article states:
“The draft Bill seeks to give back to the scientist or inventor, 30 per cent of the revenue from commercialization of his or her research. About 10 per cent is marked to the public-funded institute’s IP Management Cell and the rest of the revenue is ploughed back into the institute. The IPM Cell will help the researcher patent innovative work, besides negotiating with commercial institutions when it is ready to strike.”
Indian Bayh Dole like bill titled “Public Funded R & D Protection of Intellectual Property Bill, 2008” which is before the Indian Parliament provides that inventors receive 30 percent of any royalties stemming from licensing.A similar legislation in South Africa that was recently enacted known as the ‘Intellectual Property Rights from Publicly Financed Research and Development Act’ that intends to enable and encourage recipients of government-funding to protect as Intellectual Property and license the results of their research in order to provide incentives for those recipients to work with industry players to commercialize research. Section 10 of the legislation provides that the creators and the inventors get a portion of the royalty stream generated from the licensing of the invention.
Jyothi Datta points out to the comments by Dr Prabuddha Ganguli, who was on an international expert team to help draft a similar legislation for South Africa:
“Parameters have also been outlined on the royalty that would be paid to the scientist/institute when the patented research gets commercialised, says the Bill’s architect. But IP expert Dr Prabuddha Ganguli, who was recently on an international expert team to help draft a similar legislation for South Africa, is uncomfortable with attempts to outline parameters on issues such as royalty payment. The legislation should be a broad guiding framework and specifics should be left to the rules that are made later taking into account in the changing environment. Though he has not seen the draft of the proposed Indian legislation, he points out that there are several texts and sub-texts to the issue — like whether the research has been fully or partially funded by the government; definition of national interest and if the government exercises its “march-in” rights on a critical product, does it pay for it, and so on.”
WIPO commissioned reports on Tech. Transfer of various Asian Countries in 2003 and they had a set of guidelines for developing models which were divided into 3 levels:
National Policy on Intellectual Property and University-Industry Technology Transfer.
University Policy on Intellectual Property and Technology Transfer.
Institutional Set-up and Practical Aspects for Technology Transfer from Universities to Industry
They include Income distribution (or royalty sharing) as a part of “University Policy on Intellectual Property and Technology Transfer” and not a part of the National Policy/ Law, that is also Dr. Gangully’s view on this issue as was published in an Indian Daily some time back.
In contrast Prof. Karen Hersey in her recent post “Royalty Sharing: A Matter of Law or a Matter of Policy” on the ITTI blog said that “setting a floor of 30% arguably accomplishes two things. first, it sends a message from government to research institutions receiving grants that the efforts of faculty and students who contribute to the process of innovation and commercialization is valued and second, it prevents grant recipients from, quite frankly, playing politics with rewards that their innovators justly earn.”
Although in an article published on SciDev.net, Shamnad Basheer (Ministry of HRD IP Chair Professor at WBNUJS, Kolkata) said that Indian IP Act would ensure that inventors receive at least 30 percent of any royalties stemming from licensing and the same is a laudable aspect of bill unlike the US Bayh-Dole Act, which leaves royalty-sharing policies to the academic institutions. Their remains to be dispute about the fact that having a mandatory provision for royalty sharing might not be the best of ideas and such specifics should be left to the rules that are made later taking into account in the changing environment or to the judgment of the University bodies, looking to their profits and the best way they can incentivize scientists and researchers to maximize the interest of the institutions.
A recent article details Ug99, a stem rust of wheat, one of the most significant threats to global food security at present. Ug99 is a new variety of wheat rust fungus that has potential to spread throughout the major wheat growing regions of the world. Currently it is making its way east from Kenya through Ethiopia and Yemen after damaging crops in Kenya and Ethiopia. Once the fungus attaches to the above-ground wheat plant 50-100% crop loss can occur resulting in a substantial financial hit for farmers as well as decreased global wheat supplies, which in turn leads to increased costs for the consumer. Additionally, famines could occur if supplies are reduced in particular regions such as north Africa, as well as west and central Asia.
First discovered in Uganda in 1999, Ug99 is likely to infect wheat fields to catastrophic proportions, especially in some developing countries where wheat is a staple crop. According to Rick Ward of Cornell University, wheat rust “will translate into widespread food insecurity and civil unrest.” Some fields in east Africa, Kenya particularly, have experienced up to 80% losses.
In a normal setting, scientists’ ability to counter widespread plant diseases including fungi could be achieved by use of pesticides, by traditional plant breeding, and by genetic engineering. Unfortunately, however, Ug99 is highly infectious and thus has the ability to spread quickly through the movement of seeds and by normal weather (primarily wind) and thus remains difficult to contain; the use of fungicides, besides having limited effectiveness, is too expensive for most developing countries; also, traditional breeding takes many years of crossing and selecting; and genetic engineering requires the availability of effective resistance genes and of effective biosafety regulations. But there is hope because plant resistances have been found to be somewhat effective against Ug99 and have already been successfully bred into certain wheat varieties for certain regions. These varieties are currently acceptable to farmers in some regions, but they are not resistant to all rust strains, and some are still susceptible to Ug99 under certain local climatic conditions.
Due to the relatively rapid pace at which the fungus is spreading throughout the world, short-term solutions must be implemented until the time when durable resistance genes can be successfully transferred to wheat and distributed to farmers. Long-term solutions are irrelevant if Ug99 spreads quicker than anticipated, as suggested by Dr. Norman Borlaug of the Borlaug Global Rust Initiative (“BGRI”). Unfortunately, once disease-resistance is bred into modern wheat varieties, it will take years to grow enough seed and subsequently distribute it to farmers in need. And Dr. Borlaug, winner of the Nobel Prize for his wheat breeding work since the late 1940s in Mexico that ultimately led to the Green Revolution, should know. It was Dr. Borlaug who was instrumental in raising alarm some 7-8 years ago, not least of all because his early success in wheat breeding focused on rust resistance. His work and that of many colleagues at CIMMYT and Indian and Pakistani breeders, among others, led to a 50 year period during which stem rust was a minor problem.
There appear to be very few short-term solutions to this problem despite scientists’ confidence that long-term solutions can be had. Whether rust-resistant seeds will arrive soon enough remains but a hope, but given the severity of Ug99 that prospect seems unlikely. In the short term, expensive fungicides are one option for farmers who can afford to purchase them, who are equipped to apply them safely, and who are farming in a relatively well developed area with well trained agricultural extension systems. Many farmers in developing countries, especially in the poorer areas which are on the likely Ug99 path are unlikely to be capable of purchasing and using the fungicides effectively, so funding agencies should consider allocating increased funds for this purpose; concurrently, agricultural chemical companies should consider more targeted tiered pricing of fungicides, thus significantly reducing the cost to lower income countries.
Although fungicides represent a mere temporary solution as part of a more comprehensive approach to a lasting problem, they have potential to increase marketable yields quickly thus increasing farmers’ incomes and keeping food supplies steady. If wheat farmers continue to experience low yields they will be less capable of turning a profit and sustaining their farms into the future thus rendering efforts to engineer rust-resistant seeds an increasingly futile effort if there will be fewer farms left to supply. Farmers experiencing severe crop damage would surely be willing to try fungicides if money were granted for its purchase in developing countries.
If fungicides can be provided to farmers in developing countries some level of education may be necessary. Farmers must be aware of the optimal times to spray upon consideration of the particular variety of wheat they grow. Optimal wheat yields can be achieved by ensuring fungicides are utilized early before Ug99 or other rusts have an opportunity to infiltrate farmers’ fields. Improper application of fungicides in the past has led to yield losses and health risks for farmers, so education is key. This can be accomplished by routine field inspections by qualified individuals and by ensuring farmers’ access to necessary information.
Of course fungicides are merely one component of a short-term solution to threats posed by wheat rust, but if funding agencies realize the seriousness of Ug99 they may be on board with allocating emergency funds for certain regions that have been hit hardest. Currently billions of fungus spores continue to blow east which threatens global food supplies as well as the livelihoods of wheat farmers. Something must be done now to prevent the aforementioned problems until successful Ug99-resistant wheat varieties can be deployed and marketed to farmers throughout the world.
BGRI and its partners are currently attempting to transfer resistance genes from rice to wheat, but this component of the project will take 10 years or more, even if government regulations for the field testing of genetically modified wheat (biosafety regulations) become more science-based and permissible. One presumed reason why the BGRI is not focusing on genetically modified wheat, which could lead to the faster development of Ug99 resistant wheat, is due to the tremendous regulatory roadblocks and resistance to adopt genetically modified crops in general and wheat in particular. Onerous biosafety regulations already increase the development cost of genetically modified crops by millions of dollars and delay the delivery of many crops, including that of Golden Rice by 5 years or more. More efficient, science-based regulations are therefore necessary to combat Ug99 as quickly as possible.
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).
In an effort to protect against artemisnin resistance, global health authorities are trying to assure that it is only administered in combination with other malaria drugs that stay in the bloodstream longer and can take care of any lingering artemisnin resistant parasites. Funding sources for treatment of malaria patients will come from the Thai and Cambodian government as well as the United States. The U.S. will also put aside political considerations and run a malaria monitoring center in Burma. The Bill and Melinda Gates foundation will donate $14 million to the Thai and Cambodian governments to help with the costs of containment including mosquito nets and screening programs.
Col. Alan J. Magill, a researcher at Walter Reed Army Institute of Research in Maryland, believes this is a global emergency and a more aggressive approach is in order. Col. Magill believes that this new resistance should be given the same treatment priority as the SARS outbreak received in 2003. This is a point well taken.
The steps being implemented to contain the disease are commendable but where is the outrage over allowing 2,000 children a day to die of treatable disease? Those equipped to help must do so, and quickly. The CDC reported that 8,098 people were infected by the SARS virus and only 774 actually died. Granted, SARS spread quickly but it spread to countries in North America and Europe - countries that had the resources to funnel into medical experts, research, public health initiatives and treatment. It is doubtful that these resources would have been tapped if SARS could have been quickly contained in an impoverished area of Asia.
The underlying message is that the strength of the effort need only be enough to contain malaria in impoverished countries and ensure that current treatment protocols remain effective in areas with stronger monetary, political and commercial ties to developed nations. Evidence of this can be seen in the combination of treatments recommended by global health officials. Those having the most need for treatment are those that are least likely to be able to afford or have access to one drug let alone a combination. Also, the United States government effort only goes so far as to create a buffer zone of containment in Burma. This is a blatant effort to protect U.S. interests in India and China and offers no practical assistance to malaria sufferers in Cambodia.
There can be little hope that an individual will reach his or her full potential if he or she must battle poverty and disease from the moment of birth. Eradicating malaria from impoverished areas should be the first step in assisting in their development and the goal of creating a truly global community. The Gates Foundation seems to have done its part but the rest of the global community should step forward, even in tough economic times like the present.
Posted by Kyle Jensen on January 4, 2008 at 9:56 pm
As many PIPRA members know, we have a grant from the Sasakawa Peace Foundation (SPF) to teach about IP management in Vietnam. We’re helping public research institutions there learn about patenting, in-licensing, out-licensing, commercialization, and, in general, how to maximize the return on their public research dollars. (Of course, these topics are described in detail in the IP Handbook.)
On November 27th and 28th, PIPRA hosted the first of three annual workshops in Hanoi, Vietnam entitled “Intellectual Property Rights and Commercialization of Research Results of Institutions in the Field of Agriculture and Biotechnology” (a long title, which, we are told sounds better in Vietnamese!). The workshop was co-organized with the National Office of Intellectual Property (NOIP) and the Ministry of Agriculture and Rural Development (MARD).
We happy to say that the workshop was an unqualified success. We had over 80 attendees from more than 21 different institutions and some excellent speakers including Ramon Oliveros, from IRRI; Atty. Antonio Beronio, from PhilRice; Dr. Shashank Mauria, from ICAR; and Dr. Saowaluck Pornkulwat from Monsanto Thailand. In addition, we gave away over 60 electronic copies of the IP Handbook.
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