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BIO Magazine - Patens of Life (Bio Patents) Δεκέμβριος 2015
Δεκέμβριος 2015 No38

BIO Patent

Patens of Life (Bio Patents)
Patens of Life (Bio Patents)

What is patent of life?

Patents of living organisms, that can include plant and animal species, and related biological and biotechnology-enabled inventions, are classified as patents on life forms, or bio-patents. Originally, the system of granting patents started off with machines and instruments and such gadgets and ideas that were the brainchild of great minds and may be seen as a reward for superior intellect, so long as they met the criteria of being non-obvious, novel and usable. In the Unites States, the patent law considers "isolated and purified" compounds as patentable subject matter; e.g. patent no 141072 granted to Louis Pasteur in 1873 for a type of yeast that was free from disease. Later US courts upheld patents on biological substances like adrenaline, chemicals, basic elements, and similar biological inventions. When biotechnology and its immense potential became obvious, companies earnestly resorted to protecting biotechnological IP, which included not merely substances and processes, but also new discoveries of old knowledge, and results of uncertain, debatable and questionable scientific experiments. The court increasingly played a big role in settling cases of infringement and gradually permitted patents on life forms to creep in by the back door – you could claim legal protection to own plants, animals and human genes.

 

Example

Leaves and twigs of the Neem tree and manufactured Neem products have been used for centuries in India and other South Asian countries, for their excellent medicinal, anti-fungal, and pest repellent properties. The Neem tree is called ‘the free tree’ in one of the South Asian languages. As part of nature’s bounty, it was acknowledged as such and accorded a rightful place in local tradition and culture.

WR Grace Corporation and the US Department of Agriculture obtained a patent on (a fungicidal product obtained from) the ‘free’ Neem tree, with an eye on capitalizing on and monopolizing the obviously vast and potent usefulness. This meant that local users, who for generations together had been using the Neem unrestrictedly when needed, could no longer use it without being ‘guilty’ of ‘infringing’ patent rights. Thus arose an absurd situation where an upstart company made a mockery of traditions and indigenous knowledge. To traditional users, such acts understandably constitute (avoidable) plagiarism, and are seen as both unethical (placing material gains above social responsibilities) and immoral (stealing / copying / plagiarizing what belonged to someone else) on the part of unthinking companies and countries. The idea of privatizing natural resources continues to be unacceptable to indigenous communities. Challenged in 1995 by India, the patent was ultimately revoked in 2005 in Europe.

 

Origin of bio patents

The patenting of the Neem tree is just one of the many instances where patents have been granted on life forms despite them not meeting the essential conditions of non-obviousness and novelty. The law of patents was extended to living organisms in the year 1980 with a US court ruling on microorganisms that “a live human-made microorganism is patentable matter”. Ever since, biotechnology firms have sprung up to make genetically engineered substances for a variety of uses. Ever since commercial considerations came to be uppermost in companies’ schema of things, there have been direct, indirect and downright devious means of cornering undeserved glory.

There has been a phenomenal number of patent applications for this kind of patent, each nearly always accompanied by not only questions regarding ethical and moral issues, but also doubts over the essential nature of such patent-grants. All IP protection activities related to agriculture, and living forms is fraught with these controversies. One of the biotechnological ‘intellectual property’ processes is that of cloning a particular organism. Here’s a possible scenario with respect to this ‘advancement’ that serves to illustrate two different but relevant issues – one of ownership and another of novelty (originality). These have been pointed out by India in the stand the country has taken vis-à-vis patents on life forms.

Suppose I was to be cloned, who owns my clone? The (clone) Maker or I? When I patent a gadget I own it, does that mean that I own a life if I were able to clone it? Can I not go a step further and start the barbaric practice of slavery all over again?

The idea of cloning is not new. Stories of a demon named ‘Blood Seed’ are well known in ageless Indian mythology. Positive elements fighting the demon had to ensure that no drop of its blood fell to the ground; each drop could give rise to thousands of the demon’s clones.

 

Instances and Issues

Biotechnology companies work hard and long, researching and experimenting, to find products that will alleviate human suffering and improve quality of life on several different facets such as medical and pharmaceutical, agricultural and ecological. While such intentions and efforts warrant complete public support, the industry itself needs to keep its social responsibilities foremost in all its efforts, instead of letting greed overtake ethics. There are ever so many instances that turned out to be court cases; all of them avoidable had not commercial benefits overtaken social interests in the business models of biotechnology companies. Some famous ones are listed here.

  1. US patent number 5663484 on Basmati rice, granted to RiceTec Inc in 1997. This patent meant that the company could claim monopoly on not only the famous aromatic rice variety, but also the name Basmati that had thus far been unique to the Indian sub-continent. India and Pakistan are fighting together against the USPTO to have this patent revoked.
  2. U.S. patent on turmeric granted to the University of Mississippi Medical Center in 1995 for the use of turmeric in healing bruises. Who would have thought that brat companies would be allowed to claim age-old knowledge of curative properties of natural resources like turmeric (and Neem) as inventions and discoveries? This patent was successfully contested by India’s Council of Scientific and Industrial Research CSIR, and the patent got revoked in 1997.
  3. US patent granted to Loren Miller on a variety of Ayahuasca or Yage (Banisteriopsis caapi), a plant of hallucinogenic properties held sacred by some 400 indigenous groups in nine countries of South America. This patent was revoked in November 1999.
  4. Lucrative patent grants on life-saving drugs like Cipro (that counters Anthrax) granted to the multinational Bayer AG. Many such drugs can be made available in abundance by cheaper means.
  5. The notorious case of Monsanto Company trying to claim a patent on Chinese Soya just because it discovered that substance’s gene sequence.
  6. US Department of Agriculture attempted to patent Thailand’s Jasmine rice violating a trust agreement on donated seed samples. It’s like taking someone’s recipe for cake, subsequently, make, eat and sell the cake, and thereafter tell the original owner to buy back the recipe.

Several relevant issues have come to the forefront on the subject of patents on life forms. All these issues have national and international significance, since they pertain to several ‘facts’ or ‘truths’ hitherto accepted as such and considered unquestionable:

  • The World’s regions have local richness of species, some very plentiful in variety, others showing hardly any diversity of flora and fauna.
  • Regions possess traditional knowledge of the properties and uses of local plant varieties.
  • Natural heritage belongs to no one yet belongs to all.
  • Regions have their own religious / non-religious faith in Nature’s bounty.

 

Specific Issues

The issues that arose and shook the very foundation of the above acknowledged beliefs have had to be defined in World forums, and are described in brief here. Each issue plays its part in helping to understand the pros and cons of granting patents on life forms.

Biodiversity: Each region of the Earth is endowed with numerous flora and fauna. The quantum of their variety and the numbers of different plant and animal species constitutes the biodiversity of a given environment. This term can also mean habitat diversity or genetic diversity. The tropical regions are rich in biodiversity; the Polar Regions are not. A treaty for preservation of biodiversity was adopted in the Earth Summit of 1992.

Indigenous knowledge: Natives of countries with histories that date well back to pre common-era days have a treasure of wealth in the form of use of native plants and native techniques that are region-specific and came into use through intuition, chance or gradual practice.

Biodiplomacy: It is acknowledged that biotechnology initiatives have both beneficial and negative potential. An indistinctly fragile line that can become totally obscure separates the two sides. With the recognition that the value of biodiversity is non-renewable has arisen the need for national and international regulations, laws and policies that both promote innovation, as well as respect the “environment and existing biological, genetic, and cultural integrity. Negotiators must confront not only technical and economic concerns, but also sensitive ethical, social, and cultural issues. Biodiplomacy encompasses a complex set of negotiation processes that seek to regulate scientific innovation, biotechnology, and trade in natural products, while also recognizing the non-commercial values of biodiversity and the potential for innovative responses to global food and health needs based on traditional knowledge systems”. (Biodiplomacy – bringing life to international negotiations)

Biopiracy: All countries possess traditional knowledge that passes from one generation to the next through informal means, and that was never disputed, only banked and built on for future or for public good. But with the kind of fame, glory and financial power that patents offer, this realm of homely wisdom has been invaded and usurped by certain institutions. Biopiracy refers to the practice by which unscrupulous, mostly greedy external organizations like corporates, laboratories, institutes and governments exercise muscle to illegally use and exploit knowledge of biological resources of a country that originally possessed that knowledge. The term encompasses such activities as: monopolistic commercial rights on life forms (plants, animals, organs, microorganisms, genes), commercialization of traditional knowledge and patenting of biological resources. Biopiracy is the ‘unapproved and uncompensated use of genetic resources and traditional knowledge’

Biosafety: There are always risks in the usage of newly produced biotechnology products, however thorough and intense the basic research and experimentation work. The efforts taken to reduce or eliminate such risks are generally termed biosafety and obviously, these can never be complete, or enough. The Biosafety Protocol recommends a ‘precautionary approach, whereby the lack of full scientific certainty should not be used as an excuse to postpone action when there is a threat of serious or irreversible damage’. Such necessary biosafety systems are well defined in advanced countries that dominate the biotechnology industry; the countries of the South are just waking up to this requirement.

Plant breeder’s rights: The Intellectual Property rights in respect of plant varieties dates much earlier than the 1970-born question of life patents. There are a lot of lessons to be learnt from plant variety protection that will help in getting a better perspective on the subject of IP and life forms. Traditionally, plant variety management never came under the preview of IP rights. Seed saving and exchange were rational practices among agriculturists who placed the fulfillment of food needs well above profit-making intentions. In the US and Europe early last century, private investment in agriculture increased when government involvement reduced, and that was how the IP protection concept entered the seed industry. Plant breeder’s rights were likened to conventional patent rights; and received official international recognition in 1961 at Paris (International Convention for the Protection of New Varieties of Plants, called UPOV-1961). There have been several revisions, notably in 1978 and 1991. (From ‘Intellectual Property Protection and Sustainable Development’, published by LexisNexis Butterworths, © Philippe Cullet, 2005).

Farmer’s rights: In 1983, an International Undertaking passed at a FAO (Food and Agricultural Organization) conference affirmed “plant genetic resources are a heritage of humankind which should be made available without restriction to anyone”. This was meant to include not only traditional cultivars and wild species, but also laboratory-produced varieties. While this noble concept received due respect, some nations claimed sovereign right over their plant genetic resources. At the 1989 session of FAO, the role of farming communities in “maintaining sustainable agricultural practices, conserving plant genetic resources and enhancing agro-biodiversity though their innovation” was recognized as Farmer’s rights, similar to the already extant plant breeder’s rights. (From ‘Intellectual Property Protection and Sustainable Development’, published by LexisNexis Butterworths, © Philippe Cullet, 2005).

Bioprospecting: Biotechnologists looking for ever-newer resources for their research, explore the biodiversity of the remotest locations of the globe, searching for ‘extremophiles’. Such biological prospecting has enormous implications in achieving medical / agricultural / ecological advancements from harnessing organisms of the plant or animal world that have evolved to survive the most extreme climatic conditions and environs. One of the latest such activities has been the search for Antarctica’s indigenous life forms. While the advancements may mean new frontiers in agricultural produce or in the cure of diseases, over-adventuring and / or environmental misadventures by irresponsible prospectors are not impossibilities. Thankfully there is awareness about such possibilities of destructive exploitation. (Report: Accelerate Global Agreement to Oversee Exploitation of South Pole “Extremophiles”)

Benefit Sharing: Conflicts have arisen when biotechnology companies of the North monopolise the use, through patent grants, of traditionally accepted indigenous resources of the South. In their view, patents are the only means to recover and safeguard huge capital investments. This conflict has brought about the concept of Benefit Sharing - a biodiplomacy effort that awards contracts between source countries and bioprospectors, with the intention that royalties are shared between the two amicably.

 

International Treaties

With such major issues cropping up, each requiring bilateral or multilateral give-and-take, consideration, cooperation, implementation, and mutual or overall acceptability, it become obvious that no country could operate or be left in isolation. For example, much of the Third World depends on advancements in the First World for their health needs, whereas the (industries in) First World not only source their various raw materials from countries of the Third World, but also have them as the major markets for their products. What resulted was the need to draft workable international agreements that found acceptance and compliance by all players. Some of the more important treaties and agreements, (each with its own degree of bias or leanings toward vested interests, but agreements nevertheless), that have attempted to address these issues are described here.

 

CBD

In 1994, an agreement that granted sovereign rights to countries over their indigenous biological resources come into force - the CBD (Convention on Biological Diversity). This treaty was expected to provide ‘southern’ countries to reap some measure of benefit from international use of their indigenous knowledge. Firms could bioprospect only with consent, and both the firm and the species-rich country would need to share any and all benefits. A decade later, it’s obvious that biopiracy continues despite CBD.

 

Bio-patents under TRIPs, GATT

General Agreement on Tariffs and Trade (GATT), a treaty aimed at freeing international trade and reducing tariffs, feeds the interests of huge companies while giving short shrift to the welfare of nations and their economic and social interests. In the mandate to ensure the 20-year patent life, including patents on life forms like seeds, patent holders can demand royalties on their inventions. Unfortunately, in opposition to normal rules of justice, the (unfairly) accused have to prove their innocence, which itself is a very costly process for small farmers dependent on seeds for their produce. In the case of patented seeds, companies prefer to market these rather than established varieties, so peasant farmers suffer economically. GATT also requires that all member countries grant protection to patents owned by other nationals. Patents on life were globalized at the Uruguay Round of GATT where intellectual property rights were included in trade treaties (Trade Related Intellectual Property Rights – TRIPs). Life forms thus entered IPR regimes, and subsequently gave rise to ‘biocolonialism’. (North-South Conflicts in Intellectual Property Rights)

TRIPs covers areas from pharmaceuticals to information technology, business practices to human gene sequences, and has brought out vary sharp differences between the so-called First and Third Worlds. Not only does the ‘agreement’ deny the Third World from making and importing cheaper variants of patented drugs for epidemics and debilitating diseases like AIDs. It also makes it mandatory for member countries to recognize a variety of bio-patents that include genes, cell lines, organisms and living processes that change “life into commodities”. With the phenomenal advancement of the US in this field, this means that many countries have agreed to terms and conditions that they have not fully grasped. (Why Biotech Patents Are Patently Absurd - Scientific Briefing on TRIPs and Related Issues)

Article 27.3(b) of TRIPs pertains to the patenting of life forms and living processes. There are several questions that can easily be answered with reason and logic; these are the grounds on which patents of life can and should be expeditiously terminated:

Since the scientist does not control the entire process involved in the bio-patent research or product, and are thus ‘expropriations from life’, are they inventions?

The scientific experiments are trial and error methodologies; and harm health and biodiversity; are they inventions?

Scientific basis is totally absent in the patenting of genes, genomes, cells and micro organisms; at best are they not discoveries?

Since bio-patents devastate common man’s living, oppose basic human rights, create avoidable suffering in animals “or are otherwise contrary to public order and morality”, aren’t most bio-patents unethical?

Since many patents involve direct or indirect use of traditional knowledge of indigenous species that has been used as needed but never exploited by local communities for millennia, don’t they constitute acts of plagiarism and biopiracy?

“When TRIPs was forced on countries during the Uruguay Round, many issues of public concern were bypassed and the full ethical, ecological and economic implications of patenting life were not discussed. Third World countries were coerced into accepting the Western style IPR system. Anything short of stopping biopiracy through reforming TRIPs is participation in a crime against nature and the poor”. (North-South Conflicts in Intellectual Property Rights). This is the most straightforward statement on the subject of patents on life in its present form in TRIPs.

 

International Seed Treaty (PGRFA)

One of the best examples of responsible international governance is the PGRFA, which ensures that genetic resources are maintained in the public domain and there is sufficient safeguard against future adversity. With the extensive revision of the International Undertaking of 1983, the International Treaty on Plant Genetic Resources for Food and Agriculture (PGRFA), well known as the International Seed Treaty got ratified in June 2004, despite heavyweights US and Japan not signing on the dotted line. The treaty complements and supplements the provisions in CBD, and the two aim at ensuring food security for all through the preserving, conserving, exchanging and prudently using the world's plant genetic resources for food and agriculture, as well as unbiased benefit sharing. Its other noble intentions include recognition of Farmers’ Rights to have free access to genetic resources without IP regime restrictions and also to participate in policy discussions, and decision making while continuing to use / save / sell / exchange seeds conforming to applicable law.

To realize these intentions, the Treaty incorporates a Multilateral System (MLS) to enable access to and share benefits accruing from 64 important food and forage crops that are needed to ensure food security through interdependence for all the signatories. Since it includes compulsory benefit sharing, one of its funding mechanisms is in place. The Commission on Genetic Resources for Food and Agriculture (CGRFA), acting under UN’s Food and Agriculture Organization is currently administering the Treaty till a dedicated governing body is formed.

 

Country specific rules

Each country has its national economic, social, environmental, demographic and other priorities. These priorities define and guide its approach to any and all international transactions, and it remains the perceived duty of each nation to safeguard and positively effect its interests. Countries where the industry has invested enormous amounts of capital see developments in life forms as IP-worthy. Countries whose biodiversity, indigenous / traditional knowledge and peoples’ rights are under threat would like to see complete elimination of the concept of life forms being patentable.

For example, the procedure by which patents are granted in the US are quite different from the method followed in India. In India, the patent office examines the application, then widely publishes it for third parties to challenge, and subsequently grants the patent depending on the merit of the case. In the US, the PTO keeps the patent application under wraps and grants it without allowing other parties to challenge it. Only after grant of patent can third parties appeal against the patent as India and Pakistan are now doing in the Basmati case. While all nations can agree on the necessity to protect IP, the individual country’s means to this end clearly consists of shortfalls, pitfalls and doubtful standards. The more universal the acceptable terms, the better to prevent future cases like this from occurring.

 

Patents of life forms – USA

With an already strong patent regime in place both within the US and internationally, it was not long before patenting of life forms came to be legally permissible in that country. The US Supreme Court interpreted life as "manufacture or composition of matter" when granting the first patent on life in 1980. The floodgates opened to permit patenting of seeds, cows, sheep, human cells and microorganisms. To critics, it appears as though the US is happy with setting in motion a mean practice based on defective scientific assumptions “that ignore the self-organizing, dynamic, interactive nature of life forms”, treating them as just "composition of matter". They also feel that the US insists on patents on life for the purpose of supporting its biotechnology industry. The US patent office has been granting patents not just to genetically modified organisms (GMOs), but also to processes and products derived from indigenous knowledge of biological resources. (That was how turmeric, neem and basmati have become patentable in the US). In contrast, most Third World countries want TRIPs changed to exclude patents on life, as well as other forms of biopiracy. To Third World countries, patenting of traditional knowledge handed down to each generation through the millennia is unacceptable, sometimes even unholy.

 

Patents of life forms – Europe

The European Commission’s directive 98/44/EC on the legal protection of biotechnological inventions contains not only several essential definitions, but also rules on their interpretation and scope of allowable and applicable IP protection. It spells out what can or cannot be patented; it specifies ways to solve glitches that occur in the patenting of plant varieties. The directive also lists provisions that aim at synchronizing and harmonizing the process of patent grants by offices in member countries, so that uniform legislation is practiced. The directive also attempts to adapt and align the rules of the law ofpatents to the field of biotechnology so that biotechnological inventions have comparable levels of protection. Though the directive came into effect from July 1998, nine member states - Germany, Austria, Belgium, France, Italy, Luxembourg, the Netherlands, Portugal and Sweden had not formulated national law as of late 2002, for reasons of protests against patents on life forms. Several scientific institutions and NGO’s have demanded that the directive be suspended on the grounds that “living things are not inventions and therefore cannot be patented”. (“Patenting Life”)

 

Patents of life forms – India

(from Patents on life forms should be re-examined, says India) India has taken a very sane and bold stand on the whole controversial issue. In a discussion paper on the TRIPs agreement in its present form, India has articulated several relevant issues that probably find echoes all over the Third World.

Developing and ‘under-developed’ countries will need more time to “acquire experience on the level of protection necessary and desirable as well as the exceptions and balances necessary for ethical, social and economic needs of their peoples”, says India in the discussion paper. Stressing on the time factor, India suggests that rather than debating the issue of patent protection to biological inventions, “it may be ideal to exclude patent protection for life forms from all national laws till such time”. India has highlighted three issues:

How, if at all, should exclusion from patentability apply to plants and animals per se (patenting of life forms)?

What has been the effect of protection granted to microorganisms and non-biological and microbiological processes (scope and definition of micro-organisms)?

How, if at all, can protection of plant varieties through sui generis systems be an effective form of protection (effectiveness of plant variety protection)?

India addresses two ethical questions that are obvious to thinkers of the subject.

The extent of private ownership that can be applied to life forms

The concept of IP, seen by the First World and IP’s position amidst the larger issues of ownership, use, exchange and dissemination of knowledge.

IPR regimes in the world permit only formal systems of knowledge. India has glorious, strong and worthy informal systems, ‘revelations’ (shrutis) and ‘canon’ or ‘rules’ (smritis) which cannot be ignored, and have to be included in existing and new IP systems. Going further, India suggests that till such time as acceptably fair systems are formulated, patents on life forms should be comprehensively excluded, or at least those based on indigenous knowledge, and any and all such applications should reveal the original source-country, obtain its consent and ensure fair sharing of benefits.

 

The debate continues

The debate started with microorganisms. Several unclear areas still to be resolved in deciding the scope of patentable microorganisms and non-biological and microbiological processes. WTO has to address the issues explicitly, listen to and assuage indignant nations and not let multinational conglomerates do all the talking. Going back to the original intention for which patents were allowed, the international community has to clarify the basic questions on discovery and invention, and ensure complete conformation in letter and spirit to the criteria of patentable inventions being novel, non-obvious and useful.

“The US states that requiring patent applicants to identify the source of genetic materials or traditional knowledge used in developing their claim "would be impractical." Forcing all countries to change their patent laws in spite of protests is considered practical. Changing the world's cultures and enforcing property rights on seed is considered practical. Collecting royalties from the poor in the Third World for resources and knowledge that came from them in the first place is considered practical. But taking the simple step to change one clause in one law in the US and one clause in TRIPs is considered impractical. This suggests that the US is committed to promoting biopiracy.” (North-South Conflicts in Intellectual Property Rights).

Third world countries have enough to contend with in these days of skewed globalization - poverty and hunger, ill-health and epidemics, education and infrastructure, and they can very well do without imposed legal hassles that are sprung as nasty surprises on them as a result of the IPR regime. Why should they spend precious resources in fighting for what was theirs in the first place? Such below the belt hits by developed nations reek of unashamed greed for commercial benefits and misplaced, even ruthless hankering after vainglory. The NGO Greenpeace terms it “INDUSTRY GREED OVERRIDES MORAL AND ETHICAL CONCERNS”.

There are so many issues that confront international lawmakers, and the earlier they address them, the better for all humankind.

What could be other possible tangible rewards for the ‘inventors’?

How can ethical and moral values, principles and ideals be sacrosanct?

Aren’t we all actually stealing from Nature?

How else can meaningful and purpose-filled research progress? Does the concept of progress itself require redefinition?

Archaeological sites and finds are worthy of protection as world heritage; surely nature’s bounties endowed on earth’s regions warrant only protection and sustainable use, never mindless exploitation?

It’s time the debate on IP rights as applied to biological forms is intensified to reach an ultimate solution that does not conflict with peoples’ interests. The IPR regime impacts society, environment and human rights concepts and development in national and international legal frameworks.

http://www.tutorial-reports.com/innovation/patent/whatispatentlife.php

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