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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 of patents 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.